Comparison · NCT02607800-sae
SOF/VEL/VOX 8 Weeks vs SOF/VEL 12 Weeks: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. SOF/VEL/VOX 8 Weeks vs SOF/VEL 12 Weeks: serious adverse events. Trial comparisons, record NCT02607800-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02607800-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0299 | 0.0182 | 0.0488 | wilson | |
| Risk in group 2 | 0.0159 | 0.00773 | 0.0325 | wilson | |
| Risk difference, group 1 minus group 2 | 0.014 | -0.00625 | 0.0346 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.88 | 0.774 | 4.57 | log | |
| Odds ratio, group 1 over group 2 | 1.91 | 0.771 | 4.73 | log | |
| Number needed to harm, for one more participant with a serious adverse event on SOF/VEL/VOX 8 Weeks than on SOF/VEL 12 Weeks | 71.3 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | SOF/VEL/VOX 8 Weeks | SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks | 15 | 501 | EG000 |
| Group 2 | SOF/VEL 12 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily with or without food for 12 weeks | 7 | 440 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 12 weeks plus 30 days
Source ClinicalTrials.gov
Trial
- Title
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir and Sofosbuvir/Velpatasvir in Adults With Chronic HCV Infection Who Have Not Previously Received Treatment With Direct-Acting Antiviral Therapy
- NCT number
- NCT02607800
- Phases
- PHASE3
- Conditions
- Hepatitis C
- Interventions
- SOF/VEL/VOX, SOF/VEL
- Lead sponsor
- Gilead Sciences
- Results first posted
- 2017-11-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02607800?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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