Comparison · NCT04871529-sae
Gemcitabine + Carboplatin + Avelumab + Surgery vs Surgery Only: 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. Gemcitabine + Carboplatin + Avelumab + Surgery vs Surgery Only: serious adverse events. Trial comparisons, record NCT04871529-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04871529-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 | 0 | 0.658 | wilson | |
| Risk in group 2 | 0 | 0 | 0.793 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.793 | 0.658 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
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 | Gemcitabine + Carboplatin + Avelumab + Surgery | Participants receive gemcitabine and carboplatin every 3 weeks for up to 4 cycles and avelumab every 2 weeks for up to 6 cycles, followed by radical cystectomy, nephroureterectomy, or ureterectomy.~Of the 3 participants assigned to this arm, 2 were eligible and included in the at-risk for all cause mortality population. The two participants who receive treatment are included in the at risk for adverse events population. | 0 | 2 | EG000 |
| Group 2 | Surgery Only | Participants receive radical cystectomy, nephroureterectomy, or ureterectomy.~Of the 3 participants assigned to this arm, all were eligible and included in the at-risk for all cause mortality population. 1 participant on this arm receive protocol treatment and is included in the at risk for adverse events population. | 0 | 1 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Treatment start to 90 days post surgery
Source ClinicalTrials.gov
Trial
- Title
Testing the Addition of an Anti-Cancer Immunotherapy Drug, Avelumab, to Gemcitabine and Carboplatin Chemotherapy Prior to Surgery in Muscle Invasive Urinary Tract Cancer vs. Surgery Alone in Patients Who Are Not Able to Receive Cisplatin Therapy (SWOG GAP TRIAL)
- NCT number
- NCT04871529
- Phases
- PHASE2
- Conditions
- Bladder Carcinoma Infiltrating the Muscle of the Bladder Wall, Infiltrating Renal Pelvis and Ureter Urothelial Carcinoma, Stage II Bladder Cancer AJCC v8
- Interventions
- Therapeutic Conventional Surgery, Avelumab, Gemcitabine Hydrochloride, Carboplatin
- Lead sponsor
- SWOG Cancer Research Network
- Results first posted
- 2024-12-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04871529?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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