Comparison · NCT04223856-sae
Enfortumab Vedotin + Pembrolizumab vs Standard of Care: 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. Enfortumab Vedotin + Pembrolizumab vs Standard of Care: serious adverse events. Trial comparisons, record NCT04223856-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04223856-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 | 0.5 | 0.453 | 0.547 | wilson | |
| Risk in group 2 | 0.39 | 0.346 | 0.437 | wilson | |
| Risk difference, group 1 minus group 2 | 0.11 | 0.0438 | 0.174 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.28 | 1.1 | 1.49 | log | |
| Odds ratio, group 1 over group 2 | 1.56 | 1.19 | 2.04 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Enfortumab Vedotin + Pembrolizumab than on Standard of Care | 9.12 | 5.74 | 22.8 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: standard of care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Enfortumab Vedotin + Pembrolizumab | Participants received enfortumab vedotin at 1.25 mg/kg as an IV infusion over approximately 30 minutes on Days 1 and 8 of each cycle, and pembrolizumab 200 mg as an IV infusion over approximately 30 minutes on Day 1 of each cycle, after completion of the enfortumab vedotin infusion. 1 cycle = 3 weeks. | 220 | 440 | EG000 |
| Group 2 | Standard of Care | Participants received gemcitabine at 1000 mg/m\^2 as an IV infusion on Days 1 and 8 of each cycle, and either cisplatin (70 mg/m\^2) or carboplatin (AUC 4.5, or AUC 5 according to local guidelines) on Day 1 of each cycle, with adequate pre- and post-hydration, by IV infusion per institutional standards. 1 cycle = 3 weeks. | 169 | 433 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Source ClinicalTrials.gov
Trial
- Title
- Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer
- NCT number
- NCT04223856
- Phases
- PHASE3
- Conditions
- Urothelial Cancer
- Interventions
- Enfortumab vedotin, Pembrolizumab, Cisplatin, Carboplatin, Gemcitabine
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Results first posted
- 2024-09-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04223856?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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