Comparison · NCT03250273-sae
Arm A - Cholangiocarcinoma vs ARM B - Pancreatic 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. Arm A - Cholangiocarcinoma vs ARM B - Pancreatic Cancer: serious adverse events. Trial comparisons, record NCT03250273-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03250273-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 | 0.308 | 0.127 | 0.576 | wilson | |
| Risk in group 2 | 0.1 | 0.0346 | 0.256 | wilson | |
| Risk difference, group 1 minus group 2 | 0.208 | -0.0313 | 0.484 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.08 | 0.799 | 11.8 | log | |
| Odds ratio, group 1 over group 2 | 4 | 0.748 | 21.4 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm A - Cholangiocarcinoma than on ARM B - Pancreatic Cancer | 4.81 | 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 | Arm A - Cholangiocarcinoma | Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle).~Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle). | 4 | 13 | EG000 |
| Group 2 | ARM B - Pancreatic Cancer | Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle).~Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle). | 3 | 30 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 29 months
Source ClinicalTrials.gov
Trial
- Title
- A Clinical Trial of Entinostat in Combination With Nivolumab for Patients With Previously Treated Unresectable or Metastatic Cholangiocarcinoma and Pancreatic Adenocarcinoma
- NCT number
- NCT03250273
- Phases
- PHASE2
- Conditions
- Metastatic Cholangiocarcinoma, Cholangiocarcinoma, Pancreatic Cancer, Metastatic Pancreatic Cancer, Unresectable Pancreatic Cancer, Unresectable Cholangiocarcinoma
- Interventions
- Entinostat, Nivolumab, Entinostat, Nivolumab
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Results first posted
- 2021-12-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03250273?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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