Comparison · NCT02915523-f1b0b609
Phase 1B: Avelumab + Entinostat (3 mg) vs Phase 1B: Avelumab + Entinostat (5 mg): Phase 1b: Number of Participants With at Least One Dose Limiting Toxicity (DLT) Adverse Event (AE)
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 1B: Avelumab + Entinostat (3 mg) vs Phase 1B: Avelumab + Entinostat (5 mg): Phase 1b: Number of Participants With at Least One Dose Limiting Toxicity (DLT) Adverse Event (AE). Trial comparisons, record NCT02915523-f1b0b609. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02915523-f1b0b609
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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 | 0.0000000000000000278 | 0.39 | wilson | |
| Risk in group 2 | 0.125 | 0.0224 | 0.471 | wilson | |
| Risk difference, group 1 minus group 2 | -0.125 | -0.471 | 0.279 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with the outcome on Phase 1B: Avelumab + Entinostat (3 mg) than on Phase 1B: Avelumab + Entinostat (5 mg) | 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 | Phase 1B: Avelumab + Entinostat (3 mg) | Participants received entinostat 3 mg administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle). | 0 | 6 | OG000 |
| Group 2 | Phase 1B: Avelumab + Entinostat (5 mg) | Participants received entinostat 5 mg administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle). | 1 | 8 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Phase 1b: Number of Participants With at Least One Dose Limiting Toxicity (DLT) Adverse Event (AE)
- Description
A DLT was defined as the occurrence of any protocol-specified event within the first 2 cycles of treatment (from Cycle 1 Day 1 through the end of Cycle 2) of entinostat in combination with avelumab that were considered by the investigator to be at least possibly related to study drug.
- Time frame
- Day 1 through Day 28 (Cycles 1 and 2)
- Population
- Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
Source ClinicalTrials.gov
Trial
- Title
- Study of Avelumab With or Without Entinostat in Participants With Advanced Epithelial Ovarian Cancer
- NCT number
- NCT02915523
- Phases
- PHASE1, PHASE2
- Conditions
- Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- Interventions
- entinostat, avelumab, Placebo
- Lead sponsor
- Syndax Pharmaceuticals
- Results first posted
- 2024-01-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02915523?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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