Comparison · NCT02308111-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 NCT02308111-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02308111-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 | 0.315 | 0.25 | 0.389 | wilson | |
| Risk in group 2 | 0.319 | 0.253 | 0.394 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0038 | -0.103 | 0.0952 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.988 | 0.721 | 1.35 | log | |
| Odds ratio, group 1 over group 2 | 0.983 | 0.62 | 1.56 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Obeticholic Acid than on Placebo | 263 | 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 | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score).~Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants).~Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. | 53 | 168 | EG000 |
| Group 2 | Placebo | Participants received one tablet daily (or a lower frequency depending on CP score) for the remainder of the study. | 53 | 166 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline up to the last IP dose plus 30 days and prior to commercial OCA initiation date, approximately 7 years
Source ClinicalTrials.gov
Trial
- Title
- Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis
- NCT number
- NCT02308111
- Phases
- PHASE4
- Conditions
- Liver Cirrhosis, Biliary
- Interventions
- Obeticholic Acid (OCA), Placebo
- Lead sponsor
- Intercept Pharmaceuticals
- Results first posted
- 2023-03-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02308111?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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