Comparison · NCT04677504-sae
Arm B: Atezo+PBO+CisGem (Cycle*1-8), Followed by Atezo+PBO (Cycle*9 and Beyond) vs Arm A: Atezo+Bev+CisGem (Cycle*1-8), Followed by Atezo+Bev (Cycle*9 and Beyond): 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. Arm B: Atezo+PBO+CisGem (Cycle*1-8), Followed by Atezo+PBO (Cycle*9 and Beyond) vs Arm A: Atezo+Bev+CisGem (Cycle*1-8), Followed by Atezo+Bev (Cycle*9 and Beyond): serious adverse events. Trial comparisons, record NCT04677504-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04677504-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 | 0.531 | 0.423 | 0.636 | wilson | |
| Risk in group 2 | 0.462 | 0.355 | 0.571 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0693 | -0.0844 | 0.219 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.15 | 0.839 | 1.58 | log | |
| Odds ratio, group 1 over group 2 | 1.32 | 0.708 | 2.46 | log | |
Number needed to harm, for one more participant with a serious adverse event on Arm B: Atezo+PBO+CisGem (Cycle*1-8), Followed by Atezo+PBO (Cycle*9 and Beyond) than on Arm A: Atezo+Bev+CisGem (Cycle*1-8), Followed by Atezo+Bev (Cycle*9 and Beyond) | 14.4 | 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 | Arm B: Atezo+PBO+CisGem (Cycle*1-8), Followed by Atezo+PBO (Cycle*9 and Beyond) | \*Cycle is 21 days. Cisplatin is administered on Days 1 and 8 of each 21 day cycle for cycles 1-8. | 43 | 81 | EG000 |
| Group 2 | Arm A: Atezo+Bev+CisGem (Cycle*1-8), Followed by Atezo+Bev (Cycle*9 and Beyond) | \*Cycle is 21 days. Cisplatin is administered on Days 1 and 8 of each 21 day cycle for cycles 1-8. | 36 | 78 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the first study drug until the data cut-off on 25 August 2023 (up to approximately 30 months)
Source ClinicalTrials.gov
Trial
- Title
- A Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer
- NCT number
- NCT04677504
- Phases
- PHASE2
- Conditions
- Biliary Tract Cancer
- Interventions
- Atezolizumab, Bevacizumab, Placebo, Cisplatin, Gemcitabine
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2023-06-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04677504?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.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT04677504-sae