Comparison · NCT03136055-sae
Part A: Pembrolizumab Only vs Part B: Pembrolizumab + Chemotherapy: 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. Part A: Pembrolizumab Only vs Part B: Pembrolizumab + Chemotherapy: serious adverse events. Trial comparisons, record NCT03136055-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03136055-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 | 0.0714 | 0.0127 | 0.315 | wilson | |
| Risk in group 2 | 0.273 | 0.132 | 0.482 | wilson | |
| Risk difference, group 1 minus group 2 | -0.201 | -0.418 | 0.08 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.262 | 0.0352 | 1.95 | log | |
| Odds ratio, group 1 over group 2 | 0.205 | 0.0218 | 1.93 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Part A: Pembrolizumab Only than on Part B: Pembrolizumab + Chemotherapy | 4.97 | 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 | Part A: Pembrolizumab Only | Participants will receive 200 mg of pembrolizumab via IV over 30 minutes every 3 weeks for 24 months or 35 administrations (whichever comes first). | 1 | 14 | EG000 |
| Group 2 | Part B: Pembrolizumab + Chemotherapy | Participants will receive 200 mg of pembrolizumab via IV over 30 minutes every 3 weeks for 24 months or 35 administrations (whichever comes first) and chemotherapy treatment of 125 mg/m\^2 of irinotecan via IV on days 1 and 8 of each 21-day cycle or paclitaxel via IV on days 1, 8, and 15 of each 21-day cycle per physician discretion. | 6 | 22 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 32 months
Source ClinicalTrials.gov
Trial
- Title
- Pembrolizumab-based Therapy in Previously Treated High Grade Neuroendocrine Carcinomas
- NCT number
- NCT03136055
- Phases
- PHASE2
- Conditions
- High Grade Malignant Neuroendocrine Carcinoma (Diagnosis)
- Interventions
- Pembrolizumab, Irinotecan, Paclitaxel
- Lead sponsor
- University of California, San Francisco
- Results first posted
- 2022-12-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03136055?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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