Comparison · NCT01265498-sae
Obeticholic Acid 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. Obeticholic Acid vs Placebo: serious adverse events. Trial comparisons, record NCT01265498-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01265498-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 | 0.0922 | 0.0547 | 0.151 | wilson | |
| Risk in group 2 | 0.0704 | 0.0387 | 0.125 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0218 | -0.0443 | 0.0889 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.31 | 0.594 | 2.89 | log | |
| Odds ratio, group 1 over group 2 | 1.34 | 0.568 | 3.17 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Obeticholic Acid than on Placebo | 45.9 | 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 | Obeticholic Acid | obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks | 13 | 141 | EG000 |
| Group 2 | Placebo | Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks | 10 | 142 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- The Farnesoid X Receptor (FXR) Ligand Obeticholic Acid in NASH Treatment Trial(FLINT)
- NCT number
- NCT01265498
- Phases
- PHASE2
- Conditions
- Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH)
- Interventions
- obeticholic acid, placebo
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Results first posted
- 2015-08-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01265498?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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