Comparison · NCT03552380-sae
Phase II, Dose Level 1: Entinostat 5 mg With Nivolumab and Ipilimumab vs Phase II, Dose Level 2: Entinostat 3 mg With Nivolumab and Ipilimumab: 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. Phase II, Dose Level 1: Entinostat 5 mg With Nivolumab and Ipilimumab vs Phase II, Dose Level 2: Entinostat 3 mg With Nivolumab and Ipilimumab: serious adverse events. Trial comparisons, record NCT03552380-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03552380-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 | 0.6 | 0.231 | 0.882 | wilson | |
| Risk in group 2 | 0.429 | 0.158 | 0.75 | wilson | |
| Risk difference, group 1 minus group 2 | 0.171 | -0.318 | 0.562 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.4 | 0.459 | 4.27 | log | |
| Odds ratio, group 1 over group 2 | 2 | 0.194 | 20.6 | log | |
Number needed to harm, for one more participant with a serious adverse event on Phase II, Dose Level 1: Entinostat 5 mg With Nivolumab and Ipilimumab than on Phase II, Dose Level 2: Entinostat 3 mg With Nivolumab and Ipilimumab | 5.83 | 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 | Phase II, Dose Level 1: Entinostat 5 mg With Nivolumab and Ipilimumab | Patients received oral entinostat at a dose of 5 mg every 7 days continuously with nivolumab at a dose of 3 mg/kg mg IV every three weeks in combination with ipilimumab at a dose of 1 mg/kg every 3 weeks X 4 doses. Then, nivolumab 480 mg was continued every 4 weeks. | 3 | 5 | EG000 |
| Group 2 | Phase II, Dose Level 2: Entinostat 3 mg With Nivolumab and Ipilimumab | Patients received oral entinostat at a dose of 3 mg every 7 days continuously with nivolumab at a dose of 3 mg/kg mg IV every three weeks in combination with ipilimumab at a dose of 1 mg/kg every 3 weeks X 4 doses. Then, nivolumab 480 mg was continued every 4 weeks. | 3 | 7 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All-Cause Mortality was monitored up to a maximum of 59 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 31 months.
Source ClinicalTrials.gov
Trial
- Title
- Study of Entinostat With Nivolumab Plus Ipilimumab in Previously Treated Renal Cell Carcinoma
- NCT number
- NCT03552380
- Phases
- PHASE2
- Conditions
- Renal Cell Carcinoma
- Interventions
- Entinostat, Nivolumab, Ipilimumab
- Lead sponsor
- Roberto Pili
- Results first posted
- 2024-09-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03552380?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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