Comparison · NCT04674761-sae
Odevixibat (A4250) 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. Odevixibat (A4250) vs Placebo: serious adverse events. Trial comparisons, record NCT04674761-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04674761-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 | 0.143 | 0.0626 | 0.294 | wilson | |
| Risk in group 2 | 0.118 | 0.0329 | 0.343 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0252 | -0.214 | 0.198 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.21 | 0.262 | 5.63 | log | |
| Odds ratio, group 1 over group 2 | 1.25 | 0.217 | 7.22 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Odevixibat (A4250) than on Placebo | 39.7 | 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 | Odevixibat (A4250) | Capsules for oral administration once daily for 24 weeks.~Odevixibat: Odevixibat is a small molecule and selective inhibitor of IBAT. | 5 | 35 | EG000 |
| Group 2 | Placebo | Capsules for oral administration (to match active) once daily for 24 weeks.~Placebo: Placebo identical in appearance to experimental drug (odevixibat). | 2 | 17 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
The safety reporting period for adverse events is from the first dose of study drug through the last planned study visit or 28 calendar days after the last dose of the study drug, whichever occurs later, up to 203 days.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome
- NCT number
- NCT04674761
- Phases
- PHASE3
- Conditions
- Alagille Syndrome
- Interventions
- Odevixibat, Placebo
- Lead sponsor
- Albireo
- Results first posted
- 2023-11-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04674761?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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