Comparison · NCT03875235-sae
Durvalumab + Gemcitabine + Cisplatin vs Placebo + Gemcitabine + Cisplatin: 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. Durvalumab + Gemcitabine + Cisplatin vs Placebo + Gemcitabine + Cisplatin: serious adverse events. Trial comparisons, record NCT03875235-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03875235-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 | 0.497 | 0.444 | 0.55 | wilson | |
| Risk in group 2 | 0.444 | 0.393 | 0.497 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0526 | -0.0223 | 0.127 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.12 | 0.953 | 1.31 | log | |
| Odds ratio, group 1 over group 2 | 1.24 | 0.914 | 1.67 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Durvalumab + Gemcitabine + Cisplatin than on Placebo + Gemcitabine + Cisplatin | 19 | 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 | Durvalumab + Gemcitabine + Cisplatin | Drug: Durvalumab IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria. | 168 | 338 | EG000 |
| Group 2 | Placebo + Gemcitabine + Cisplatin | Drug: Placebo IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria. | 152 | 342 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events: from first dose of study medication up to 90 days after the last dose of study medication or until the initiation of the first subsequent therapy (whichever comes first), up to maximum of approximately 67 months. All-cause mortality (death due to any cause): from randomization up to analysis DCO (28 February 2025). Maximum timeframe of approximately 67 months.
Source ClinicalTrials.gov
Trial
- Title
- Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)
- NCT number
- NCT03875235
- Phases
- PHASE3
- Conditions
- Biliary Tract Neoplasms
- Interventions
- Durvalumab, Placebo
- Lead sponsor
- AstraZeneca
- Results first posted
- 2023-04-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03875235?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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