Comparison · NCT03459846-sae
Durva + Olaparib vs Durva + 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. Durva + Olaparib vs Durva + Placebo: serious adverse events. Trial comparisons, record NCT03459846-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03459846-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 | 0.487 | 0.378 | 0.597 | wilson | |
| Risk in group 2 | 0.342 | 0.245 | 0.454 | wilson | |
| Risk difference, group 1 minus group 2 | 0.145 | -0.0115 | 0.291 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.42 | 0.966 | 2.1 | log | |
| Odds ratio, group 1 over group 2 | 1.82 | 0.949 | 3.51 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Durva + Olaparib than on Durva + Placebo | 6.91 | 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 | Durva + Olaparib | Patients received a combination of durvalumab 1500mg intravenous (IV) every 4 weeks (q4w) with olaparib 300mg orally (PO) twice daily (BID) adjusted based on patient's creatinine clearance | 37 | 76 | EG000 |
| Group 2 | Durva + Placebo | Patients received durvalumab 1500mg IV q4w and placebo PO BID | 26 | 76 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months
Source ClinicalTrials.gov
Trial
- Title
- A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU)
- NCT number
- NCT03459846
- Phases
- PHASE2
- Conditions
- Urinary Bladder Neoplasms
- Interventions
- Durvalumab, Olaparib, Placebo
- Lead sponsor
- AstraZeneca
- Results first posted
- 2022-10-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03459846?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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