Comparison · NCT01865812-sae
Primary Treatment Phase vs Long-term Safety Extension Phase: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Primary Treatment Phase vs Long-term Safety Extension Phase: serious adverse events. Trial comparisons, record NCT01865812-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01865812-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 | 0.0385 | 0.00682 | 0.189 | wilson | |
| Risk in group 2 | 0.238 | 0.106 | 0.451 | wilson | |
| Risk difference, group 1 minus group 2 | -0.2 | -0.415 | 0.000405 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.162 | 0.0204 | 1.28 | log | |
| Odds ratio, group 1 over group 2 | 0.128 | 0.0137 | 1.2 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Primary Treatment Phase than on Long-term Safety Extension Phase | 5.01 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Primary Treatment Phase | All participants were treated with OCA (oral administration, 10 mg QD) for 8 weeks and continued their prestudy dose of UDCA. After completion of the 8-week PTP of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter the open-label LTSE phase, during which they could receive 10 mg OCA QD for up to 2 years. | 1 | 26 | EG000 |
| Group 2 | Long-term Safety Extension Phase | Participants received OCA 10 mg QD for up to 2 years. | 5 | 21 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse event data were collected from the time of the first dose of investigational product until the participant fully completed participation in the study, up to 2 years.
Source ClinicalTrials.gov
Trial
- Title
- Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis
- NCT number
- NCT01865812
- Phases
- PHASE2
- Conditions
- Primary Biliary Cirrhosis
- Interventions
- Obeticholic Acid
- Lead sponsor
- Intercept Pharmaceuticals
- Results first posted
- 2016-10-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01865812?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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