Trial Outcomes & Findings for Ledipasvir/Sofosbuvir in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Are on Dialysis for End Stage Renal Disease (NCT NCT03036839)
NCT ID: NCT03036839
Last Updated: 2020-03-02
Results Overview
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. The exact 95% confidence interval (CI) for the percentage within treatment group was based on the Clopper-Pearson method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
95 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2020-03-02
Participant Flow
Participants were enrolled at study sites in Taiwan, Italy, Germany, the United States, and Belgium. The first participant was screened on 27 June 2017. The last study visit occurred on 14 February 2019.
124 participants were screened.
Participant milestones
| Measure |
LDV/SOF for 8 Weeks
Treatment-naive genotype 1 participants without cirrhosis received ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily orally with or without food for 8 weeks.
|
LDV/SOF for 12 Weeks
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
|
LDV/SOF for 24 Weeks
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
45
|
31
|
19
|
|
Overall Study
COMPLETED
|
42
|
31
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
5
|
Reasons for withdrawal
| Measure |
LDV/SOF for 8 Weeks
Treatment-naive genotype 1 participants without cirrhosis received ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily orally with or without food for 8 weeks.
|
LDV/SOF for 12 Weeks
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
|
LDV/SOF for 24 Weeks
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
|
Overall Study
Death
|
3
|
0
|
3
|
|
Overall Study
Withdrew Consent
|
0
|
0
|
1
|
Baseline Characteristics
Ledipasvir/Sofosbuvir in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Are on Dialysis for End Stage Renal Disease
Baseline characteristics by cohort
| Measure |
LDV/SOF for 8 Weeks
n=45 Participants
Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
|
LDV/SOF for 12 Weeks
n=31 Participants
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
|
LDV/SOF for 24 Weeks
n=19 Participants
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
59 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
65 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
61 years
STANDARD_DEVIATION 10.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
21 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Belgium
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Region of Enrollment
Taiwan
|
21 participants
n=5 Participants
|
29 participants
n=7 Participants
|
10 participants
n=5 Participants
|
60 participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
9 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
16 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
8 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
IL28b Status
CC
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
IL28b Status
CT
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
IL28b Status
TT
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
HCV RNA
|
5.8 log10 IU/mL
STANDARD_DEVIATION 0.80 • n=5 Participants
|
5.9 log10 IU/mL
STANDARD_DEVIATION 0.95 • n=7 Participants
|
5.9 log10 IU/mL
STANDARD_DEVIATION 0.63 • n=5 Participants
|
5.8 log10 IU/mL
STANDARD_DEVIATION 0.82 • n=4 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
24 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
21 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Cirrhosis Status
Yes
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Cirrhosis Status
No
|
45 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
HCV Genotype
Genotype 1
|
45 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
HCV Genotype
Genotype 2
|
0 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
HCV Genotype
Genotype 4
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
HCV Genotype
Genotype 5
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
HCV Genotype
Genotype 6
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
HCV Genotype
Indeterminate
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: The Full Analysis Set (FAS) included participants who were enrolled into the study and received at least 1 dose of study drug. Participants were grouped within the Full Analysis Set by genotype and treatment group to which they were enrolled.
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. The exact 95% confidence interval (CI) for the percentage within treatment group was based on the Clopper-Pearson method.
Outcome measures
| Measure |
LDV/SOF for 8 Weeks
n=45 Participants
Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
|
LDV/SOF for 12 Weeks
n=31 Participants
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
|
LDV/SOF for 24 Weeks
n=19 Participants
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
|
93.3 percentage of participants
Interval 81.7 to 98.6
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
84.2 percentage of participants
Interval 60.4 to 96.6
|
PRIMARY outcome
Timeframe: First dose date up to Week 24Population: The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
Outcome measures
| Measure |
LDV/SOF for 8 Weeks
n=45 Participants
Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
|
LDV/SOF for 12 Weeks
n=31 Participants
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
|
LDV/SOF for 24 Weeks
n=19 Participants
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event
|
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 (ie, 15 IU/mL) at 4 weeks after stopping study treatment. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method.
Outcome measures
| Measure |
LDV/SOF for 8 Weeks
n=45 Participants
Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
|
LDV/SOF for 12 Weeks
n=31 Participants
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
|
LDV/SOF for 24 Weeks
n=19 Participants
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
|
97.8 percentage of participants
Interval 88.2 to 99.9
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
84.2 percentage of participants
Interval 60.4 to 96.6
|
SECONDARY outcome
Timeframe: Posttreatment Week 24Population: Participants in the Full Analysis Set were analyzed.
SVR24 was defined as HCV RNA \< LLOQ (ie, 15 IU/mL) at 24 weeks after stopping study treatment. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method.
Outcome measures
| Measure |
LDV/SOF for 8 Weeks
n=45 Participants
Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
|
LDV/SOF for 12 Weeks
n=31 Participants
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
|
LDV/SOF for 24 Weeks
n=19 Participants
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
|
93.3 percentage of participants
Interval 81.7 to 98.6
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
84.2 percentage of participants
Interval 60.4 to 96.6
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 6, 8, 12, 16, 20, 24Population: Participants in the Full Analysis Set with available data were analyzed.
The total number of participants with HCV RNA \< LLOQ was the sum of the number of participants with HCV RNA "\< LLOQ detected" plus the number of participants with HCV RNA "\< LLOQ target not detected (TND)". LLOQ was 15 IU/mL. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method.
Outcome measures
| Measure |
LDV/SOF for 8 Weeks
n=45 Participants
Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
|
LDV/SOF for 12 Weeks
n=31 Participants
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
|
LDV/SOF for 24 Weeks
n=19 Participants
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 2
|
84.4 percentage of participants
Interval 70.5 to 93.5
|
90.3 percentage of participants
Interval 74.2 to 98.0
|
84.2 percentage of participants
Interval 60.4 to 96.6
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 4
|
100.0 percentage of participants
Interval 92.0 to 100.0
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
100.0 percentage of participants
Interval 82.4 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 6
|
100.0 percentage of participants
Interval 92.0 to 100.0
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
94.7 percentage of participants
Interval 74.0 to 99.9
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 8
|
100.0 percentage of participants
Interval 92.0 to 100.0
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
100.0 percentage of participants
Interval 81.5 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 12
|
—
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 16
|
—
|
—
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 20
|
—
|
—
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 24
|
—
|
—
|
100.0 percentage of participants
Interval 79.4 to 100.0
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 6, 8, 12, 16, 20, 24Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
LDV/SOF for 8 Weeks
n=44 Participants
Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
|
LDV/SOF for 12 Weeks
n=31 Participants
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
|
LDV/SOF for 24 Weeks
n=19 Participants
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
|
|---|---|---|---|
|
HCV RNA
Week 2
|
1.17 log10 IU/mL
Standard Deviation 0.107
|
1.22 log10 IU/mL
Standard Deviation 0.261
|
1.18 log10 IU/mL
Standard Deviation 0.098
|
|
HCV RNA
Week 4
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
|
HCV RNA
Week 6
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
|
HCV RNA
Week 8
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
|
HCV RNA
Week 12
|
—
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
|
HCV RNA
Week 16
|
—
|
—
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
|
HCV RNA
Week 20
|
—
|
—
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
|
HCV RNA
Week 24
|
—
|
—
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 6, 8, 12, 16, 20, 24Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
LDV/SOF for 8 Weeks
n=44 Participants
Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
|
LDV/SOF for 12 Weeks
n=31 Participants
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
|
LDV/SOF for 24 Weeks
n=19 Participants
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in HCV RNA
Change at Week 2
|
-4.63 log10 IU/mL
Standard Deviation 0.799
|
-4.71 log10 IU/mL
Standard Deviation 0.894
|
-4.67 log10 IU/mL
Standard Deviation 0.631
|
|
Change From Baseline in HCV RNA
Change at Week 4
|
-4.61 log10 IU/mL
Standard Deviation 0.805
|
-4.79 log10 IU/mL
Standard Deviation 0.950
|
-4.71 log10 IU/mL
Standard Deviation 0.631
|
|
Change From Baseline in HCV RNA
Change at Week 6
|
-4.61 log10 IU/mL
Standard Deviation 0.805
|
-4.79 log10 IU/mL
Standard Deviation 0.950
|
-4.81 log10 IU/mL
Standard Deviation 0.474
|
|
Change From Baseline in HCV RNA
Change at Week 8
|
-4.61 log10 IU/mL
Standard Deviation 0.805
|
-4.79 log10 IU/mL
Standard Deviation 0.950
|
-4.81 log10 IU/mL
Standard Deviation 0.474
|
|
Change From Baseline in HCV RNA
Change at Week 12
|
—
|
-4.79 log10 IU/mL
Standard Deviation 0.950
|
-4.79 log10 IU/mL
Standard Deviation 0.480
|
|
Change From Baseline in HCV RNA
Change at Week 16
|
—
|
—
|
-4.79 log10 IU/mL
Standard Deviation 0.480
|
|
Change From Baseline in HCV RNA
Change at Week 20
|
—
|
—
|
-4.79 log10 IU/mL
Standard Deviation 0.480
|
|
Change From Baseline in HCV RNA
Change at Week 24
|
—
|
—
|
-4.75 log10 IU/mL
Standard Deviation 0.466
|
SECONDARY outcome
Timeframe: Baseline up to Posttreatment Week 24Population: Participants in the Full Analysis Set were analyzed.
Virologic failure was defined as: * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) * Virologic relapse: * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.
Outcome measures
| Measure |
LDV/SOF for 8 Weeks
n=45 Participants
Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
|
LDV/SOF for 12 Weeks
n=31 Participants
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
|
LDV/SOF for 24 Weeks
n=19 Participants
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Virologic Failure
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Posttreatment Week 24Population: The Resistance Analysis Population was defined as all participants in the Safety Analysis Set with a virologic outcome and at least 1 gene sequenced. As no participant had a relapse in this study, this outcome could not be analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))Population: The PK Analysis Set included all participants who took at least 1 dose of the study drug and had at least 1 nonmissing postdose concentration value for the corresponding analyte in plasma.
AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.
Outcome measures
| Measure |
LDV/SOF for 8 Weeks
n=44 Participants
Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
|
LDV/SOF for 12 Weeks
n=31 Participants
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
|
LDV/SOF for 24 Weeks
n=19 Participants
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
|
|---|---|---|---|
|
Pharmacokinetics (PK) Parameter: AUCtau of LDV
|
11923.9 h*ng/mL
Standard Deviation 6319.41
|
13632.7 h*ng/mL
Standard Deviation 4648.74
|
13542.5 h*ng/mL
Standard Deviation 6322.88
|
SECONDARY outcome
Timeframe: Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))Population: Participants in the PK Analysis Set with available data were analyzed.
AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.
Outcome measures
| Measure |
LDV/SOF for 8 Weeks
n=24 Participants
Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
|
LDV/SOF for 12 Weeks
n=23 Participants
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
|
LDV/SOF for 24 Weeks
n=12 Participants
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
|
|---|---|---|---|
|
PK Parameter: AUCtau of SOF
|
2435.4 h*ng/mL
Standard Deviation 452.83
|
2296.6 h*ng/mL
Standard Deviation 583.30
|
2838.2 h*ng/mL
Standard Deviation 438.93
|
SECONDARY outcome
Timeframe: Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))Population: Participants in the PK Analysis Set were analyzed.
AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.
Outcome measures
| Measure |
LDV/SOF for 8 Weeks
n=44 Participants
Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
|
LDV/SOF for 12 Weeks
n=31 Participants
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
|
LDV/SOF for 24 Weeks
n=19 Participants
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
|
|---|---|---|---|
|
PK Parameter: AUCtau of GS-331007 (Metabolite of SOF)
|
234980.1 h*ng/mL
Standard Deviation 67648.52
|
269050.3 h*ng/mL
Standard Deviation 93600.65
|
280829.5 h*ng/mL
Standard Deviation 93618.16
|
SECONDARY outcome
Timeframe: Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))Population: Participants in the PK Analysis Set were analyzed.
Cmax is defined as the population PK derived maximum concentration of the drug.
Outcome measures
| Measure |
LDV/SOF for 8 Weeks
n=44 Participants
Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
|
LDV/SOF for 12 Weeks
n=31 Participants
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
|
LDV/SOF for 24 Weeks
n=19 Participants
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
|
|---|---|---|---|
|
PK Parameter: Cmax of LDV
|
544.2 ng/mL
Standard Deviation 271.72
|
618.4 ng/mL
Standard Deviation 204.87
|
607.0 ng/mL
Standard Deviation 267.38
|
SECONDARY outcome
Timeframe: Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))Population: Participants in the PK Analysis Set with available data were analyzed.
Cmax is defined as the population PK derived maximum concentration of the drug.
Outcome measures
| Measure |
LDV/SOF for 8 Weeks
n=24 Participants
Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
|
LDV/SOF for 12 Weeks
n=23 Participants
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
|
LDV/SOF for 24 Weeks
n=12 Participants
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
|
|---|---|---|---|
|
PK Parameter: Cmax of SOF
|
1059.8 ng/mL
Standard Deviation 251.74
|
1005.8 ng/mL
Standard Deviation 204.54
|
1052.5 ng/mL
Standard Deviation 295.06
|
SECONDARY outcome
Timeframe: Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))Population: Participants in the PK Analysis Set were analyzed.
Cmax is defined as the population PK derived maximum concentration of the drug.
Outcome measures
| Measure |
LDV/SOF for 8 Weeks
n=44 Participants
Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
|
LDV/SOF for 12 Weeks
n=31 Participants
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
|
LDV/SOF for 24 Weeks
n=19 Participants
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
|
|---|---|---|---|
|
PK Parameter: Cmax of GS-331007 (Metabolite of SOF)
|
9956.3 ng/mL
Standard Deviation 2846.07
|
11392.7 ng/mL
Standard Deviation 3938.33
|
11882.4 ng/mL
Standard Deviation 3951.04
|
Adverse Events
LDV/SOF for 8 Weeks
Serious events: 4 serious events
Other events: 23 other events
Deaths: 3 deaths
LDV/SOF for 12 Weeks
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
LDV/SOF for 24 Weeks
Serious events: 6 serious events
Other events: 15 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
LDV/SOF for 8 Weeks
n=45 participants at risk
Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
|
LDV/SOF for 12 Weeks
n=31 participants at risk
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
|
LDV/SOF for 24 Weeks
n=19 participants at risk
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Cardiac disorders
Cardiac valve disease
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
2.2%
1/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Gastrointestinal disorders
Haemorrhagic erosive gastritis
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
General disorders
Death
|
2.2%
1/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Infections and infestations
Infection
|
2.2%
1/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Infections and infestations
Osteomyelitis
|
2.2%
1/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Infections and infestations
Sepsis
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
2.2%
1/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
3.2%
1/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
3.2%
1/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Overdose
|
2.2%
1/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
3.2%
1/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Psychiatric disorders
Mental status changes
|
2.2%
1/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
Other adverse events
| Measure |
LDV/SOF for 8 Weeks
n=45 participants at risk
Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
|
LDV/SOF for 12 Weeks
n=31 participants at risk
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
|
LDV/SOF for 24 Weeks
n=19 participants at risk
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Cardiac disorders
Cardiac valve disease
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
3.2%
1/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
3.2%
1/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Eye disorders
Cataract
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Eye disorders
Glaucoma
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
6.5%
2/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Gastrointestinal disorders
Constipation
|
2.2%
1/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
12.9%
4/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.4%
2/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
6.5%
2/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Gastrointestinal disorders
Nausea
|
8.9%
4/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
3.2%
1/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Gastrointestinal disorders
Vomiting
|
8.9%
4/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
3.2%
1/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
General disorders
Asthenia
|
2.2%
1/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
21.1%
4/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
General disorders
Chest discomfort
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
3.2%
1/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
General disorders
Chest pain
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
3.2%
1/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
General disorders
Fatigue
|
6.7%
3/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
6.5%
2/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
10.5%
2/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
General disorders
Influenza like illness
|
2.2%
1/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
General disorders
Oedema peripheral
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
3.2%
1/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
General disorders
Pyrexia
|
2.2%
1/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
3.2%
1/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
General disorders
Tenderness
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
6.5%
2/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
3/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
22.6%
7/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Infections and infestations
Shunt infection
|
2.2%
1/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.4%
2/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
9.7%
3/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.2%
1/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
6.5%
2/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
15.8%
3/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
9.7%
3/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
3.2%
1/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
10.5%
2/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
2.2%
1/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
6.7%
3/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Shunt stenosis
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
3.2%
1/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.2%
1/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.4%
2/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
3.2%
1/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
6.5%
2/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.2%
1/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
22.6%
7/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
21.1%
4/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
3.2%
1/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Nervous system disorders
Dizziness
|
4.4%
2/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
12.9%
4/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Nervous system disorders
Headache
|
6.7%
3/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
9.7%
3/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
10.5%
2/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Nervous system disorders
Hypoaesthesia
|
2.2%
1/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Psychiatric disorders
Insomnia
|
2.2%
1/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
12.9%
4/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
3/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
9.7%
3/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.2%
1/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
9.7%
3/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
15.8%
3/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
3.2%
1/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Vascular disorders
Hypertension
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
3.2%
1/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
|
Vascular disorders
Hypotension
|
0.00%
0/45 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
0.00%
0/31 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
5.3%
1/19 • Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
|
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