Comparison · NCT03582475-sae
Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer vs Cohort 2: Small Cell or Neuroendocrine Prostate Cancer: 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 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer vs Cohort 2: Small Cell or Neuroendocrine Prostate Cancer: serious adverse events. Trial comparisons, record NCT03582475-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03582475-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 | 1 | 0.646 | 1 | wilson | |
| Risk in group 2 | 0.875 | 0.529 | 0.978 | wilson | |
| Risk difference, group 1 minus group 2 | 0.125 | -0.244 | 0.471 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.14 | 0.88 | 1.49 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
Number needed to harm, for one more participant with a serious adverse event on Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer than on Cohort 2: Small Cell or Neuroendocrine Prostate Cancer | 8 | 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 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer | Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1 (Cohort 1). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Cisplatin: Given IV~Docetaxel: Given IV~Etoposide: Given IV~Pembrolizumab: Given IV | 7 | 7 | EG000 |
| Group 2 | Cohort 2: Small Cell or Neuroendocrine Prostate Cancer | Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3, carboplatin IV on day 1, and docetaxel IV on day 1 (Cohort 2). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. | 7 | 8 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events are collected form consent to 90 days post treatment with a median follow up of 34 months.
Source ClinicalTrials.gov
Trial
- Title
- Pembrolizumab With Combination Chemotherapy in Treating Participants With Locally Advanced or Metastatic Small Cell/Neuroendocrine Cancers of Urothelium or Prostate
- NCT number
- NCT03582475
- Phases
- PHASE1
- Conditions
Bladder Small Cell Neuroendocrine Carcinoma, Castration-Resistant Prostate Carcinoma, Metastatic Bladder Urothelial Carcinoma, Metastatic Urethral Urothelial Carcinoma, Prostate Carcinoma Metastatic in the Bone, Prostate Neuroendocrine Neoplasm, Prostate Small Cell Carcinoma, Stage III Bladder Cancer American Joint Committee on Cancer ( AJCC) v8, Stage III Prostate Cancer AJCC v8, Stage III Urethral Cancer AJCC v8, Stage IV Bladder Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8, Stage IV Urethral Cancer AJCC v8, Stage IVA Bladder Cancer AJCC v8, Stage IVB Bladder Cancer AJCC v8, Ureter Small Cell Carcinoma, Urothelial Carcinoma
- Interventions
- Carboplatin, Cisplatin, Docetaxel, Etoposide, Pembrolizumab
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Results first posted
- 2025-06-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03582475?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/NCT03582475-sae