Comparison · NCT02854631-sae
Selonsertib + Prednisolone vs Placebo + Prednisolone: 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. Selonsertib + Prednisolone vs Placebo + Prednisolone: serious adverse events. Trial comparisons, record NCT02854631-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02854631-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 | 0.5 | 0.366 | 0.634 | wilson | |
| Risk in group 2 | 0.404 | 0.282 | 0.539 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0962 | -0.0941 | 0.277 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.24 | 0.804 | 1.91 | log | |
| Odds ratio, group 1 over group 2 | 1.48 | 0.674 | 3.23 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Selonsertib + Prednisolone than on Placebo + Prednisolone | 10.4 | 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 | Selonsertib + Prednisolone | Participants received selonsertib (GS-4997) 18 mg tablet orally once daily + prednisolone 40 mg (4 x 10 mg tablets) orally once daily for 28 days. | 25 | 50 | EG000 |
| Group 2 | Placebo + Prednisolone | Participants received placebo-to-match selonsertib 18 mg tablet orally once daily + prednisolone 40 mg (4 x 10 mg tablets) orally once daily for 28 days. | 21 | 52 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse Events: Up to Day 28 plus 30 days; All-Cause Mortality: Up to 24 weeks
Source ClinicalTrials.gov
Trial
- Title
- Selonsertib in Combination With Prednisolone Versus Prednisolone Alone in Participants With Severe Alcoholic Hepatitis (AH)
- NCT number
- NCT02854631
- Phases
- PHASE2
- Conditions
- Alcoholic Hepatitis (AH)
- Interventions
- Selonsertib, Prednisolone, Placebo
- Lead sponsor
- Gilead Sciences
- Results first posted
- 2019-02-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02854631?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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