Comparison · NCT02704403-sae
120 mg Elafibranor vs Placebo: 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. 120 mg Elafibranor vs Placebo: serious adverse events. Trial comparisons, record NCT02704403-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02704403-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 | 0.133 | 0.116 | 0.151 | wilson | |
| Risk in group 2 | 0.132 | 0.11 | 0.159 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0000925 | -0.0314 | 0.0295 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.796 | 1.26 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.768 | 1.3 | log | |
| Number needed to harm, for one more participant with a serious adverse event on 120 mg Elafibranor than on Placebo | 10,800 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 120 mg Elafibranor | Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water | 190 | 1,433 | EG000 |
| Group 2 | Placebo | Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water | 95 | 717 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days.
Source ClinicalTrials.gov
Trial
- Title
- Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
- NCT number
- NCT02704403
- Phases
- PHASE3
- Conditions
- Nonalcoholic Steatohepatitis (NASH) With Fibrosis
- Interventions
- Elafibranor, Placebo
- Lead sponsor
- Genfit
- Results first posted
- 2022-03-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02704403?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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