Comparison · NCT03219333-sae
Enfortumab Vedotin - Cohort 1 vs Enfortumab Vedotin - Cohort 2: 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 - Cohort 1 vs Enfortumab Vedotin - Cohort 2: serious adverse events. Trial comparisons, record NCT03219333-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03219333-sae
On this page
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 | 0.472 | 0.387 | 0.559 | wilson | |
| Risk in group 2 | 0.393 | 0.298 | 0.497 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0787 | -0.0557 | 0.208 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.2 | 0.873 | 1.65 | log | |
| Odds ratio, group 1 over group 2 | 1.38 | 0.795 | 2.39 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Enfortumab Vedotin - Cohort 1 than on Enfortumab Vedotin - Cohort 2 | 12.7 | 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 | Enfortumab Vedotin - Cohort 1 | Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. | 59 | 125 | EG000 |
| Group 2 | Enfortumab Vedotin - Cohort 2 | Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. | 35 | 89 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Cohort 1: maximum up to 62.36 months of follow-up; Cohort 2: maximum up to 48.95 months of follow-up
Source ClinicalTrials.gov
Trial
- Title
- A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
- NCT number
- NCT03219333
- Phases
- PHASE2
- Conditions
- Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Urologic Neoplasms, Renal Pelvis Neoplasms, Urothelial Cancer, Ureteral Neoplasms, Urethral Neoplasms
- Interventions
- Enfortumab vedotin
- Lead sponsor
- Astellas Pharma Inc
- Results first posted
- 2021-12-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03219333?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
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT03219333-sae