Comparison · NCT02039219-sae
10 mg Obeticholic Acid (OCA) 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. 10 mg Obeticholic Acid (OCA) vs Placebo: serious adverse events. Trial comparisons, record NCT02039219-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02039219-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 | 0.75 | 0.409 | 0.929 | wilson | |
| Risk in group 2 | 0.455 | 0.213 | 0.72 | wilson | |
| Risk difference, group 1 minus group 2 | 0.295 | -0.136 | 0.596 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.65 | 0.771 | 3.53 | log | |
| Odds ratio, group 1 over group 2 | 3.6 | 0.491 | 26.4 | log | |
| Number needed to harm, for one more participant with a serious adverse event on 10 mg Obeticholic Acid (OCA) than on Placebo | 3.38 | 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 | 10 mg Obeticholic Acid (OCA) | 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 6 weeks.~10 mg Obeticholic Acid (OCA): 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 6 weeks. | 6 | 8 | EG001 |
| Group 2 | Placebo | Placebo~Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 6 weeks. | 5 | 11 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 6 months
Source ClinicalTrials.gov
Trial
- Title
- Trial of Obeticholic Acid in Patients With Moderately Severe Alcoholic Hepatitis (AH)
- NCT number
- NCT02039219
- Phases
- PHASE2
- Conditions
- Alcoholic Hepatitis
- Interventions
- Placebo, 10 mg Obeticholic Acid (OCA)
- Lead sponsor
- Naga P. Chalasani
- Results first posted
- 2020-01-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02039219?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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