Comparison · NCT03912818-sae
Cohort I (Durvalumab, DD MVAC) vs Cohort III (Durvalumab, Carbo-gem): 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. Cohort I (Durvalumab, DD MVAC) vs Cohort III (Durvalumab, Carbo-gem): serious adverse events. Trial comparisons, record NCT03912818-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03912818-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 | 0.667 | 0.208 | 0.939 | wilson | |
| Risk in group 2 | 1 | 0.439 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | -0.333 | -0.792 | 0.291 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.667 | 0.3 | 1.48 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with a serious adverse event on Cohort I (Durvalumab, DD MVAC) than on Cohort III (Durvalumab, Carbo-gem) | 3 | 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 | Cohort I (Durvalumab, DD MVAC) | Durvalumab (MEDI4736), at1500 mg fixed dose, administered intravenously (IV) over 60 minutes. Standard chemotherapy will be administered as an IV infusion during each of the 4 cycles. Dose Dense Methotrexate, Vinblastine, Doxorubicin, Cisplatin (DD MVAC), in 14 day cycles (2 weeks), Methotrexate 30 mg/m2 on Cycle Day 1, Vinblastine 3 mg/m2 on Cycle Day 2, Doxorubicin 30 mg/m2 on Cycle Day 2 and Cisplatin 70 mg/m2 on Cycle Day 2. Patients undergo cystectomy within 6 weeks. | 2 | 3 | EG000 |
| Group 2 | Cohort III (Durvalumab, Carbo-gem) | Durvalumab (MEDI4736), at 1500 mg fixed dose, administered intravenously (IV) over 60 minutes. Standard chemotherapy will be administered as an IV infusion during each of the 4 cycles. Carboplatin: AUC 5 on Cycle Day 1 and gemcitabine 1,000 mg/m2 on Cycle Day 1 and Day 8 in 21 day cycles (3 weeks). Patients undergo cystectomy within 6 weeks. | 3 | 3 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Time of Consent to end of study treatment plus 90 days (average approximately 20 weeks)
Source ClinicalTrials.gov
Trial
- Title
- Durvalumab and Standard Chemotherapy Before Surgery in Treating Patients With Variant Histology Bladder Cancer
- NCT number
- NCT03912818
- Phases
- PHASE2
- Conditions
Bladder Adenocarcinoma, Bladder Mixed Adenocarcinoma, Bladder Squamous Cell Carcinoma, Bladder Urothelial Carcinoma, Infiltrating Bladder Urothelial Carcinoma Sarcomatoid Variant, Infiltrating Bladder Urothelial Carcinoma With Giant Cells, Infiltrating Bladder Urothelial Carcinoma With Glandular Differentiation, Infiltrating Bladder Urothelial Carcinoma With Trophoblastic Differentiation, Infiltrating Bladder Urothelial Carcinoma, Clear Cell Variant, Infiltrating Bladder Urothelial Carcinoma, Micropapillary Variant, Infiltrating Bladder Urothelial Carcinoma, Nested Variant, Infiltrating Bladder Urothelial Carcinoma, Plasmacytoid Variant
- Interventions
- Carboplatin, Cisplatin, Cystectomy, Doxorubicin, Durvalumab, Gemcitabine, Methotrexate, Vinblastine
- Lead sponsor
- Stanford University
- Results first posted
- 2023-09-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03912818?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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