Trial Outcomes & Findings for Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic HCV Infection (NCT NCT02201940)
NCT ID: NCT02201940
Last Updated: 2018-11-15
Results Overview
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
741 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2018-11-15
Participant Flow
Participants were enrolled at study sites in the United States, Canada, Europe, and Asia. The first participant was screened on 18 July 2014. The last study visit occurred on 23 September 2015.
847 participants were screened.
Participant milestones
| Measure |
SOF/VEL
Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered orally once daily for 12 weeks
|
Placebo
SOF/VEL placebo tablet administered orally once daily for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
625
|
116
|
|
Overall Study
COMPLETED
|
613
|
0
|
|
Overall Study
NOT COMPLETED
|
12
|
116
|
Reasons for withdrawal
| Measure |
SOF/VEL
Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered orally once daily for 12 weeks
|
Placebo
SOF/VEL placebo tablet administered orally once daily for 12 weeks
|
|---|---|---|
|
Overall Study
Randomized/Enrolled but Never Treated
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
2
|
113
|
|
Overall Study
Lost to Follow-up
|
5
|
0
|
|
Overall Study
Withdrew Consent
|
2
|
1
|
|
Overall Study
Investigator's Discretion
|
1
|
1
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic HCV Infection
Baseline characteristics by cohort
| Measure |
SOF/VEL
n=624 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
|
Placebo
n=116 Participants
SOF/VEL placebo tablet administered orally once daily for 12 weeks
|
Total
n=740 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 10.9 • n=93 Participants
|
53 years
STANDARD_DEVIATION 10.4 • n=4 Participants
|
54 years
STANDARD_DEVIATION 10.8 • n=27 Participants
|
|
Sex: Female, Male
Female
|
250 Participants
n=93 Participants
|
48 Participants
n=4 Participants
|
298 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
374 Participants
n=93 Participants
|
68 Participants
n=4 Participants
|
442 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
589 Participants
n=93 Participants
|
111 Participants
n=4 Participants
|
700 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
52 participants
n=93 Participants
|
12 participants
n=4 Participants
|
64 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
493 participants
n=93 Participants
|
89 participants
n=4 Participants
|
582 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
62 participants
n=93 Participants
|
11 participants
n=4 Participants
|
73 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian/ Alaska Native
|
7 participants
n=93 Participants
|
0 participants
n=4 Participants
|
7 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hawaiian or Pacific Islander
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 participants
n=93 Participants
|
3 participants
n=4 Participants
|
9 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Not Disclosed
|
3 participants
n=93 Participants
|
0 participants
n=4 Participants
|
3 participants
n=27 Participants
|
|
Region of Enrollment
Canada
|
55 participants
n=93 Participants
|
7 participants
n=4 Participants
|
62 participants
n=27 Participants
|
|
Region of Enrollment
Belgium
|
40 participants
n=93 Participants
|
5 participants
n=4 Participants
|
45 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
234 participants
n=93 Participants
|
45 participants
n=4 Participants
|
279 participants
n=27 Participants
|
|
Region of Enrollment
China
|
19 participants
n=93 Participants
|
4 participants
n=4 Participants
|
23 participants
n=27 Participants
|
|
Region of Enrollment
Italy
|
16 participants
n=93 Participants
|
2 participants
n=4 Participants
|
18 participants
n=27 Participants
|
|
Region of Enrollment
United Kingdom
|
91 participants
n=93 Participants
|
13 participants
n=4 Participants
|
104 participants
n=27 Participants
|
|
Region of Enrollment
France
|
126 participants
n=93 Participants
|
32 participants
n=4 Participants
|
158 participants
n=27 Participants
|
|
Region of Enrollment
Germany
|
44 participants
n=93 Participants
|
8 participants
n=4 Participants
|
52 participants
n=27 Participants
|
|
Cirrhosis Status
Present
|
121 participants
n=93 Participants
|
21 participants
n=4 Participants
|
142 participants
n=27 Participants
|
|
Cirrhosis Status
Absent
|
501 participants
n=93 Participants
|
95 participants
n=4 Participants
|
596 participants
n=27 Participants
|
|
Cirrhosis Status
Missing
|
2 participants
n=93 Participants
|
0 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
HCV Genotype
Genotype 1
|
328 participants
n=93 Participants
|
65 participants
n=4 Participants
|
393 participants
n=27 Participants
|
|
HCV Genotype
Genotype 2
|
104 participants
n=93 Participants
|
21 participants
n=4 Participants
|
125 participants
n=27 Participants
|
|
HCV Genotype
Genotype 4
|
116 participants
n=93 Participants
|
22 participants
n=4 Participants
|
138 participants
n=27 Participants
|
|
HCV Genotype
Genotype 5
|
35 participants
n=93 Participants
|
0 participants
n=4 Participants
|
35 participants
n=27 Participants
|
|
HCV Genotype
Genotype 6
|
41 participants
n=93 Participants
|
8 participants
n=4 Participants
|
49 participants
n=27 Participants
|
|
IL28b Status
CC
|
186 participants
n=93 Participants
|
36 participants
n=4 Participants
|
222 participants
n=27 Participants
|
|
IL28b Status
CT
|
339 participants
n=93 Participants
|
53 participants
n=4 Participants
|
392 participants
n=27 Participants
|
|
IL28b Status
TT
|
94 participants
n=93 Participants
|
26 participants
n=4 Participants
|
120 participants
n=27 Participants
|
|
IL28b Status
Missing
|
5 participants
n=93 Participants
|
1 participants
n=4 Participants
|
6 participants
n=27 Participants
|
|
HCV RNA
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.66 • n=93 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.58 • n=4 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.65 • n=27 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
163 participants
n=93 Participants
|
29 participants
n=4 Participants
|
192 participants
n=27 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
461 participants
n=93 Participants
|
87 participants
n=4 Participants
|
548 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: participants randomized or enrolled into the study and received at least 1 dose of study drug.
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Outcome measures
| Measure |
SOF/VEL
n=624 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
|
Placebo
n=116 Participants
SOF/VEL placebo tablet administered orally once daily for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
|
99.0 percentage of participants
Interval 97.9 to 99.6
|
0 percentage of participants
Interval 0.0 to 3.1
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Safety Analysis Set
Outcome measures
| Measure |
SOF/VEL
n=624 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
|
Placebo
n=116 Participants
SOF/VEL placebo tablet administered orally once daily for 12 weeks
|
|---|---|---|
|
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
|
0.2 percentage of participants
|
1.7 percentage of participants
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 4 and 24Population: Full Analysis Set
SVR4 and SVR 24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Outcome measures
| Measure |
SOF/VEL
n=624 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
|
Placebo
n=116 Participants
SOF/VEL placebo tablet administered orally once daily for 12 weeks
|
|---|---|---|
|
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4
|
99.2 percentage of participants
Interval 98.1 to 99.7
|
0 percentage of participants
Interval 0.0 to 3.1
|
|
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR24
|
99.0 percentage of participants
Interval 97.9 to 99.6
|
0 percentage of participants
Interval 0.0 to 3.1
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 6, 8, 10, and 12Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL
n=624 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
|
Placebo
n=116 Participants
SOF/VEL placebo tablet administered orally once daily for 12 weeks
|
|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
Week 6 (SOF/VEL: N = 623; Placebo: N = 115)
|
98.9 percentage of participants
Interval 97.7 to 99.5
|
0 percentage of participants
Interval 0.0 to 3.2
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
Week 8 (SOF/VEL: N = 622; Placebo: N = 114)
|
99.7 percentage of participants
Interval 98.8 to 100.0
|
0 percentage of participants
Interval 0.0 to 3.2
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
Week 10 (SOF/VEL: N = 622; Placebo: N = 114)
|
100.0 percentage of participants
Interval 99.4 to 100.0
|
0 percentage of participants
Interval 0.0 to 3.2
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
Week 12 (SOF/VEL: N = 622; Placebo: N = 113)
|
100.0 percentage of participants
Interval 99.4 to 100.0
|
0 percentage of participants
Interval 0.0 to 3.2
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
Week 1 (SOF/VEL: N = 624; Placebo: N = 116)
|
18.8 percentage of participants
Interval 15.8 to 22.0
|
0 percentage of participants
Interval 0.0 to 3.1
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
Week 2 (SOF/VEL: N = 624; Placebo: N = 116)
|
56.9 percentage of participants
Interval 52.9 to 60.8
|
0 percentage of participants
Interval 0.0 to 3.1
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
Week 4 (SOF/VEL: N = 623; Placebo: N = 116)
|
90.5 percentage of participants
Interval 88.0 to 92.7
|
0 percentage of participants
Interval 0.0 to 3.1
|
SECONDARY outcome
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 10, and 12Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL
n=624 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
|
Placebo
n=116 Participants
SOF/VEL placebo tablet administered orally once daily for 12 weeks
|
|---|---|---|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12
Change at Wk 1 (SOF/VEL: N= 617; Placebo: N= 114)
|
-4.29 log10 IU/mL
Standard Deviation 0.647
|
-0.05 log10 IU/mL
Standard Deviation 0.561
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12
Change at Wk 2 (SOF/VEL: N= 622; Placebo: N= 116)
|
-4.82 log10 IU/mL
Standard Deviation 0.685
|
0.01 log10 IU/mL
Standard Deviation 0.280
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12
Change at Wk 4 (SOF/VEL: N= 617; Placebo: N= 114)
|
-5.08 log10 IU/mL
Standard Deviation 0.656
|
-0.01 log10 IU/mL
Standard Deviation 0.297
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12
Change at Wk 6 (SOF/VEL: N= 623; Placebo: N= 115)
|
-5.11 log10 IU/mL
Standard Deviation 0.664
|
0.07 log10 IU/mL
Standard Deviation 0.298
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12
Change at Wk 8 (SOF/VEL: N= 622; Placebo: N= 113)
|
-5.11 log10 IU/mL
Standard Deviation 0.664
|
0.05 log10 IU/mL
Standard Deviation 0.281
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12
Change at Wk 10 (SOF/VEL: N= 622; Placebo: N= 112)
|
-5.12 log10 IU/mL
Standard Deviation 0.662
|
0.05 log10 IU/mL
Standard Deviation 0.337
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12
Change at Wk 12 (SOF/VEL: N= 622; Placebo: N= 111)
|
-5.12 log10 IU/mL
Standard Deviation 0.662
|
-0.06 log10 IU/mL
Standard Deviation 0.580
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 24Population: Full Analysis Set
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 |
SOF/VEL
n=624 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
|
Placebo
n=116 Participants
SOF/VEL placebo tablet administered orally once daily for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Virologic Failure
|
0.3 percentage of participants
|
100 percentage of participants
|
Adverse Events
SOF/VEL
Serious events: 15 serious events
Other events: 393 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 77 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOF/VEL
n=624 participants at risk
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
|
Placebo
n=116 participants at risk
SOF/VEL placebo tablet administered orally once daily for 12 weeks
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.16%
1/624 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/116 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Cardiac disorders
Palpitations
|
0.16%
1/624 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/116 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.16%
1/624 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/116 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Sudden death
|
0.16%
1/624 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/116 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Abscess limb
|
0.16%
1/624 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/116 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Appendicitis
|
0.16%
1/624 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/116 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Bronchitis
|
0.16%
1/624 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/116 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Cellulitis
|
0.16%
1/624 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/116 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Gastroenteritis
|
0.16%
1/624 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/116 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Influenza
|
0.16%
1/624 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/116 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Vestibular neuronitis
|
0.16%
1/624 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/116 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.16%
1/624 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/116 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.16%
1/624 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/116 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.16%
1/624 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/116 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.16%
1/624 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/116 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Epilepsy
|
0.16%
1/624 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/116 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Mania
|
0.16%
1/624 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/116 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.16%
1/624 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/116 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Vascular disorders
Extremity necrosis
|
0.16%
1/624 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/116 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
Other adverse events
| Measure |
SOF/VEL
n=624 participants at risk
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
|
Placebo
n=116 participants at risk
SOF/VEL placebo tablet administered orally once daily for 12 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
48/624 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.9%
8/116 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
12.0%
75/624 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
11.2%
13/116 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Asthenia
|
6.7%
42/624 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.8%
9/116 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Fatigue
|
20.4%
127/624 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
20.7%
24/116 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Nasopharyngitis
|
12.8%
80/624 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
10.3%
12/116 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.4%
40/624 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.8%
9/116 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.6%
29/624 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
9.5%
11/116 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.0%
25/624 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.2%
6/116 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
29.2%
182/624 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
28.4%
33/116 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Insomnia
|
8.0%
50/624 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
9.5%
11/116 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
39/624 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.4%
4/116 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER