Comparison · NCT03633227-sae
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. Obeticholic Acid (OCA) vs Placebo: serious adverse events. Trial comparisons, record NCT03633227-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03633227-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 | 0.7 | 0.397 | 0.892 | wilson | |
| Risk in group 2 | 0.75 | 0.468 | 0.911 | wilson | |
| Risk difference, group 1 minus group 2 | -0.05 | -0.393 | 0.292 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.933 | 0.554 | 1.57 | log | |
| Odds ratio, group 1 over group 2 | 0.778 | 0.119 | 5.1 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Obeticholic Acid (OCA) than on Placebo | 20 | 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 (OCA) | Participants initiated treatment with OCA 5 mg tablets orally once weekly. At Week 12, if there were no safety concerns, the dose was up-titrated to OCA 5 mg twice weekly. Every 6 weeks thereafter, based on tolerability assessments, further up-titration of dose was considered. At each titration visit, the participants started the higher dose regimen no earlier than 2 days after the prior dose. The maximum dose titration was OCA 10 mg twice weekly at least 3 days apart. The minimum treatment duration was 48-weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years). | 7 | 10 | EG001 |
| Group 2 | Placebo | Participants received OCA matching placebo tablets orally once weekly or twice weekly for the duration of at least 48-weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years). | 9 | 12 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline up to approximately 3 years
Source ClinicalTrials.gov
Trial
- Title
- Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment
- NCT number
- NCT03633227
- Phases
- PHASE4
- Conditions
- Liver Cirrhosis, Biliary
- Interventions
- Obeticholic Acid (OCA), Placebo
- Lead sponsor
- Intercept Pharmaceuticals
- Results first posted
- 2022-09-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03633227?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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