Trial Outcomes & Findings for A Registry for Participants With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection (NCT NCT02292706)
NCT ID: NCT02292706
Last Updated: 2023-10-04
Results Overview
SVR at Week 240 was defined as HCV RNA\< lower limit of quantification (LLOQ i.e., 15 or 25 international units per milliliter \[IU/mL\]) or last available HCV RNA\< LLOQ with no subsequent follow-up values at Week 240 after enrollment in this registry study. Percentage of participants who maintained SVR status by Week 240 was estimated using a Kaplan-Meier model.
Recruitment status
TERMINATED
Target enrollment
1609 participants
Primary outcome timeframe
Week 240
Results posted on
2023-10-04
Participant Flow
Participants were enrolled at study sites in Australia, Canada, France, Germany, Italy, New Zealand, Spain, the United Kingdom, and the United States.
1609 participants were enrolled in the registry. 36 participants who were enrolled but did not meet the eligibility criteria (including 19 participants in the 'Enrolled from Ineligible Parent Treatment Group') were not included in the Full Analysis Set and Safety Analysis Set, and thus, are not included in the Baseline Characteristics, Outcome Measures and Serious and Other Adverse Event modules.
Participant milestones
| Measure |
SOF+RBV
Participants who were previously treated with sofosbuvir (SOF) along with ribavirin (RBV) were followed up to 5 years.
|
LDV/SOF
Participants who were previously treated with ledipasvir (LDV)/SOF were followed up to 5 years.
|
LDV/SOF+RBV
Participants who were previously treated with LDV/SOF along with RBV were followed up to 5 years.
|
SOF/VEL
Participants who were previously treated with SOF/velpatasvir (VEL) were followed up to 5 years.
|
SOF/VEL+RBV
Participants who were previously treated with SOF/VEL along with RBV were followed up to 5 years.
|
SOF/VEL/VOX
Participants who were previously treated with SOF/VEL/voxilaprevir (VOX) with or without RBV were followed up to 5 years.
|
Other SOF-Based
Participants who previously received other SOF based regimen were followed up to 5 years.
|
Enrolled From Ineligible Parent Treatment Group
Participants were enrolled from ineligible parent treatment group.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
95
|
277
|
265
|
374
|
100
|
338
|
141
|
19
|
|
Overall Study
COMPLETED
|
49
|
145
|
157
|
201
|
35
|
181
|
82
|
0
|
|
Overall Study
NOT COMPLETED
|
46
|
132
|
108
|
173
|
65
|
157
|
59
|
19
|
Reasons for withdrawal
| Measure |
SOF+RBV
Participants who were previously treated with sofosbuvir (SOF) along with ribavirin (RBV) were followed up to 5 years.
|
LDV/SOF
Participants who were previously treated with ledipasvir (LDV)/SOF were followed up to 5 years.
|
LDV/SOF+RBV
Participants who were previously treated with LDV/SOF along with RBV were followed up to 5 years.
|
SOF/VEL
Participants who were previously treated with SOF/velpatasvir (VEL) were followed up to 5 years.
|
SOF/VEL+RBV
Participants who were previously treated with SOF/VEL along with RBV were followed up to 5 years.
|
SOF/VEL/VOX
Participants who were previously treated with SOF/VEL/voxilaprevir (VOX) with or without RBV were followed up to 5 years.
|
Other SOF-Based
Participants who previously received other SOF based regimen were followed up to 5 years.
|
Enrolled From Ineligible Parent Treatment Group
Participants were enrolled from ineligible parent treatment group.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
20
|
44
|
24
|
61
|
21
|
52
|
25
|
0
|
|
Overall Study
Withdrew consent
|
15
|
56
|
43
|
36
|
13
|
51
|
20
|
0
|
|
Overall Study
Death
|
3
|
11
|
16
|
22
|
8
|
17
|
3
|
0
|
|
Overall Study
Study terminated by sponsor
|
0
|
9
|
4
|
21
|
11
|
13
|
3
|
0
|
|
Overall Study
Investigator's discretion
|
4
|
9
|
7
|
11
|
4
|
10
|
1
|
0
|
|
Overall Study
Liver transplant
|
1
|
1
|
11
|
16
|
5
|
6
|
5
|
0
|
|
Overall Study
Enrolled but not met eligibility criteria
|
1
|
2
|
2
|
2
|
2
|
6
|
2
|
19
|
|
Overall Study
Subject terminated by sponsor
|
1
|
0
|
0
|
2
|
1
|
0
|
0
|
0
|
|
Overall Study
Missing
|
0
|
0
|
1
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
Virologic relapse or reinfection
|
1
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Registry for Participants With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection
Baseline characteristics by cohort
| Measure |
SOF+RBV
n=94 Participants
Participants who were previously treated with SOF along with RBV were followed up to 5 years.
|
LDV/SOF
n=275 Participants
Participants who were previously treated with SOF/LDV were followed up to 5 years.
|
LDV/SOF+RBV
n=263 Participants
Participants who were previously treated with SOF/LDV along with RBV were followed up to 5 years.
|
SOF/VEL
n=372 Participants
Participants who were previously treated with SOF/VEL were followed up to 5 years.
|
SOF/VEL+RBV
n=98 Participants
Participants who were previously treated with SOF/VEL along with RBV were followed up to 5 years.
|
SOF/VEL/VOX
n=332 Participants
Participants who were previously treated with SOF/VEL/VOX with or without RBV were followed up to 5 years.
|
Other SOF-Based
n=139 Participants
Participants who previously received other SOF based regimen were followed up to 5 years.
|
Total
n=1573 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
60 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
60 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
58 years
STANDARD_DEVIATION 7.3 • n=4 Participants
|
58 years
STANDARD_DEVIATION 6.9 • n=21 Participants
|
59 years
STANDARD_DEVIATION 7.6 • n=8 Participants
|
59 years
STANDARD_DEVIATION 8.1 • n=8 Participants
|
59 years
STANDARD_DEVIATION 7.6 • n=24 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
87 Participants
n=8 Participants
|
55 Participants
n=8 Participants
|
497 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
181 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
257 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
245 Participants
n=8 Participants
|
84 Participants
n=8 Participants
|
1076 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
87 Participants
n=5 Participants
|
239 Participants
n=7 Participants
|
219 Participants
n=5 Participants
|
331 Participants
n=4 Participants
|
90 Participants
n=21 Participants
|
281 Participants
n=8 Participants
|
117 Participants
n=8 Participants
|
1364 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
49 Participants
n=8 Participants
|
22 Participants
n=8 Participants
|
196 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
13 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
82 Participants
n=5 Participants
|
230 Participants
n=7 Participants
|
234 Participants
n=5 Participants
|
324 Participants
n=4 Participants
|
86 Participants
n=21 Participants
|
292 Participants
n=8 Participants
|
117 Participants
n=8 Participants
|
1365 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
3 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
138 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
44 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
|
Region of Enrollment
New Zealand
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
66 Participants
n=24 Participants
|
|
Region of Enrollment
Canada
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
50 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
50 Participants
n=5 Participants
|
221 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
241 Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
228 Participants
n=8 Participants
|
136 Participants
n=8 Participants
|
1118 Participants
n=24 Participants
|
|
Region of Enrollment
Italy
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
26 Participants
n=24 Participants
|
|
Region of Enrollment
United Kingdom
|
14 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
49 Participants
n=24 Participants
|
|
Region of Enrollment
Australia
|
14 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
65 Participants
n=24 Participants
|
|
Region of Enrollment
France
|
0 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
122 Participants
n=24 Participants
|
|
Region of Enrollment
Germany
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
26 Participants
n=24 Participants
|
|
Region of Enrollment
Spain
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
51 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Week 240Population: Full Analysis Set included all participants who met all inclusion criteria and did not meet any of the exclusion criteria, and with at least one post-enrollment visit measurement available.
SVR at Week 240 was defined as HCV RNA\< lower limit of quantification (LLOQ i.e., 15 or 25 international units per milliliter \[IU/mL\]) or last available HCV RNA\< LLOQ with no subsequent follow-up values at Week 240 after enrollment in this registry study. Percentage of participants who maintained SVR status by Week 240 was estimated using a Kaplan-Meier model.
Outcome measures
| Measure |
SOF+RBV
n=94 Participants
Participants who were previously treated with SOF along with RBV were followed up to 5 years.
|
LDV/SOF
n=275 Participants
Participants who were previously treated with LDV/SOF were followed up to 5 years.
|
LDV/SOF+RBV
n=263 Participants
Participants who were previously treated with LDV/SOF along with RBV were followed up to 5 years.
|
SOF/VEL
n=372 Participants
Participants who were previously treated with SOF/VEL were followed up to 5 years.
|
SOF/VEL+RBV
n=98 Participants
Participants who were previously treated with SOF/VEL along with RBV were followed up to 5 years.
|
SOF/VEL/VOX
n=332 Participants
Participants who were previously treated with SOF/VEL/VOX with or without RBV were followed up to 5 years.
|
Other SOF-Based
n=139 Participants
Participants who previously received other SOF based regimen were followed up to 5 years.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Maintaining Sustained Virologic Response (SVR) at Week 240
|
98.9 percentage of participants
|
100 percentage of participants
|
99.6 percentage of participants
|
99.7 percentage of participants
|
100 percentage of participants
|
99.6 percentage of participants
|
100 percentage of participants
|
PRIMARY outcome
Timeframe: Enrollment up to 240 weeksPopulation: Participants in Full Analysis Set who did not develop liver-associated event prior to entering the registry were analyzed.
The percentage of participants with any liver-associated events since registry start (enrollment) through Week 240 was estimated using a Kaplan-Meier model.
Outcome measures
| Measure |
SOF+RBV
n=89 Participants
Participants who were previously treated with SOF along with RBV were followed up to 5 years.
|
LDV/SOF
n=259 Participants
Participants who were previously treated with LDV/SOF were followed up to 5 years.
|
LDV/SOF+RBV
n=254 Participants
Participants who were previously treated with LDV/SOF along with RBV were followed up to 5 years.
|
SOF/VEL
n=350 Participants
Participants who were previously treated with SOF/VEL were followed up to 5 years.
|
SOF/VEL+RBV
n=81 Participants
Participants who were previously treated with SOF/VEL along with RBV were followed up to 5 years.
|
SOF/VEL/VOX
n=326 Participants
Participants who were previously treated with SOF/VEL/VOX with or without RBV were followed up to 5 years.
|
Other SOF-Based
n=133 Participants
Participants who previously received other SOF based regimen were followed up to 5 years.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Any Liver-Associated Events
|
18.7 percentage of participants
|
15.0 percentage of participants
|
24.8 percentage of participants
|
18.1 percentage of participants
|
37.6 percentage of participants
|
16.1 percentage of participants
|
18.2 percentage of participants
|
PRIMARY outcome
Timeframe: Enrollment up to 240 weeksPopulation: Participants in the Full Analysis Set with no HCC prior to this registry study were analyzed.
Participants with de novo HCC since registry start were defined as participants who had not been identified with HCC prior to registry start and only had HCC since registry start. The percentage of participants who developed de novo HCC through Week 240 was estimated using a Kaplan-Meier model.
Outcome measures
| Measure |
SOF+RBV
n=92 Participants
Participants who were previously treated with SOF along with RBV were followed up to 5 years.
|
LDV/SOF
n=273 Participants
Participants who were previously treated with LDV/SOF were followed up to 5 years.
|
LDV/SOF+RBV
n=259 Participants
Participants who were previously treated with LDV/SOF along with RBV were followed up to 5 years.
|
SOF/VEL
n=367 Participants
Participants who were previously treated with SOF/VEL were followed up to 5 years.
|
SOF/VEL+RBV
n=98 Participants
Participants who were previously treated with SOF/VEL along with RBV were followed up to 5 years.
|
SOF/VEL/VOX
n=330 Participants
Participants who were previously treated with SOF/VEL/VOX with or without RBV were followed up to 5 years.
|
Other SOF-Based
n=138 Participants
Participants who previously received other SOF based regimen were followed up to 5 years.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Developed Hepatocellular Carcinoma (HCC) Through Week 240
|
11.8 percentage of participants
|
5.01 percentage of participants
|
10.8 percentage of participants
|
10.8 percentage of participants
|
15.3 percentage of participants
|
12.4 percentage of participants
|
11.2 percentage of participants
|
SECONDARY outcome
Timeframe: Enrollment up to 240 weeksPopulation: Participants in Full Analysis Set were analyzed.
Outcome measures
| Measure |
SOF+RBV
n=94 Participants
Participants who were previously treated with SOF along with RBV were followed up to 5 years.
|
LDV/SOF
n=275 Participants
Participants who were previously treated with LDV/SOF were followed up to 5 years.
|
LDV/SOF+RBV
n=263 Participants
Participants who were previously treated with LDV/SOF along with RBV were followed up to 5 years.
|
SOF/VEL
n=372 Participants
Participants who were previously treated with SOF/VEL were followed up to 5 years.
|
SOF/VEL+RBV
n=98 Participants
Participants who were previously treated with SOF/VEL along with RBV were followed up to 5 years.
|
SOF/VEL/VOX
n=332 Participants
Participants who were previously treated with SOF/VEL/VOX with or without RBV were followed up to 5 years.
|
Other SOF-Based
n=139 Participants
Participants who previously received other SOF based regimen were followed up to 5 years.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Detectable HCV RNA Due to Re-emergence of Pre-existing Virus Through Week 240
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Enrollment up to 240 weeksPopulation: Participants in Full Analysis Set were analyzed.
Outcome measures
| Measure |
SOF+RBV
n=94 Participants
Participants who were previously treated with SOF along with RBV were followed up to 5 years.
|
LDV/SOF
n=275 Participants
Participants who were previously treated with LDV/SOF were followed up to 5 years.
|
LDV/SOF+RBV
n=263 Participants
Participants who were previously treated with LDV/SOF along with RBV were followed up to 5 years.
|
SOF/VEL
n=372 Participants
Participants who were previously treated with SOF/VEL were followed up to 5 years.
|
SOF/VEL+RBV
n=98 Participants
Participants who were previously treated with SOF/VEL along with RBV were followed up to 5 years.
|
SOF/VEL/VOX
n=332 Participants
Participants who were previously treated with SOF/VEL/VOX with or without RBV were followed up to 5 years.
|
Other SOF-Based
n=139 Participants
Participants who previously received other SOF based regimen were followed up to 5 years.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Detectable HCV Resistance Mutations Through Week 240
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Enrollment up to 240 weeksPopulation: Participants in Full Analysis Set were analyzed.
Reinfection was defined as HCV RNA \> LLOQ on 2 samples collected at least 1 week apart with a different virus than that present prior to treatment baseline in the parent study.
Outcome measures
| Measure |
SOF+RBV
n=94 Participants
Participants who were previously treated with SOF along with RBV were followed up to 5 years.
|
LDV/SOF
n=275 Participants
Participants who were previously treated with LDV/SOF were followed up to 5 years.
|
LDV/SOF+RBV
n=263 Participants
Participants who were previously treated with LDV/SOF along with RBV were followed up to 5 years.
|
SOF/VEL
n=372 Participants
Participants who were previously treated with SOF/VEL were followed up to 5 years.
|
SOF/VEL+RBV
n=98 Participants
Participants who were previously treated with SOF/VEL along with RBV were followed up to 5 years.
|
SOF/VEL/VOX
n=332 Participants
Participants who were previously treated with SOF/VEL/VOX with or without RBV were followed up to 5 years.
|
Other SOF-Based
n=139 Participants
Participants who previously received other SOF based regimen were followed up to 5 years.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Detectable HCV RNA Due to Re-infection Through Week 240
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
SOF+RBV
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
LDV/SOF
Serious events: 0 serious events
Other events: 4 other events
Deaths: 11 deaths
LDV/SOF+RBV
Serious events: 0 serious events
Other events: 1 other events
Deaths: 16 deaths
SOF/VEL
Serious events: 0 serious events
Other events: 1 other events
Deaths: 22 deaths
SOF/VEL+RBV
Serious events: 0 serious events
Other events: 0 other events
Deaths: 8 deaths
SOF/VEL/VOX
Serious events: 0 serious events
Other events: 1 other events
Deaths: 17 deaths
Other SOF-Based
Serious events: 0 serious events
Other events: 1 other events
Deaths: 3 deaths
Enrolled From Ineligible Parent Treatment Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SOF+RBV
n=94 participants at risk
Participants who were previously treated with SOF along with RBV were followed up to 5 years.
|
LDV/SOF
n=275 participants at risk
Participants who were previously treated with LDV/SOF were followed up to 5 years.
|
LDV/SOF+RBV
n=263 participants at risk
Participants who were previously treated with LDV/SOF along with RBV were followed up to 5 years.
|
SOF/VEL
n=372 participants at risk
Participants who were previously treated with SOF/VEL were followed up to 5 years.
|
SOF/VEL+RBV
n=98 participants at risk
Participants who were previously treated with SOF/VEL along with RBV were followed up to 5 years.
|
SOF/VEL/VOX
n=332 participants at risk
Participants who were previously treated with SOF/VEL/VOX with or without RBV were followed up to 5 years.
|
Other SOF-Based
n=139 participants at risk
Participants who previously received other SOF based regimen were followed up to 5 years.
|
Enrolled From Ineligible Parent Treatment Group
Participants were enrolled from ineligible parent treatment group.
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/94 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.73%
2/275 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/263 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/372 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/98 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/332 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.72%
1/139 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
—
0/0 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
|
Injury, poisoning and procedural complications
Incision site rash
|
0.00%
0/94 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/275 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/263 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/372 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/98 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.30%
1/332 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/139 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
—
0/0 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/94 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/275 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.38%
1/263 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/372 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/98 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/332 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/139 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
—
0/0 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/94 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/275 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/263 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.27%
1/372 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/98 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/332 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/139 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
—
0/0 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/94 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.36%
1/275 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/263 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/372 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/98 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/332 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/139 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
—
0/0 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/94 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.36%
1/275 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/263 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/372 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/98 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/332 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/139 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
—
0/0 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/94 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/275 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/263 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/372 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/98 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.30%
1/332 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/139 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
—
0/0 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/94 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/275 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/263 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.27%
1/372 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/98 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/332 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
0.00%
0/139 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
—
0/0 • All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
|
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