Comparison · NCT02115282-sae
Arm A (Exemestance, Entinostat) vs Arm A (Exemestance, Placebo): 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 (Exemestance, Entinostat) vs Arm A (Exemestance, Placebo): serious adverse events. Trial comparisons, record NCT02115282-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02115282-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 | 0.51 | 0.453 | 0.567 | wilson | |
| Risk in group 2 | 0.16 | 0.123 | 0.207 | wilson | |
| Risk difference, group 1 minus group 2 | 0.35 | 0.276 | 0.418 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.18 | 2.39 | 4.23 | log | |
| Odds ratio, group 1 over group 2 | 5.45 | 3.7 | 8.02 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm A (Exemestance, Entinostat) than on Arm A (Exemestance, Placebo) | 2.86 | 2.39 | 3.62 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Arm A (Exemestance, Entinostat) | Patients receive exemestane PO QD on days 1-28 and entinostat PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Pre/perimenopausal female patients and all male patients also receive goserelin acetate SC on day 1.~Entinostat: Given PO~Exemestane: Given PO~Goserelin Acetate: Given SC | 151 | 296 | EG000 |
| Group 2 | Arm A (Exemestance, Placebo) | Patients receive exemestane as in Arm A and placebo PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Pre/perimenopausal female patients and all male patients also receive goserelin acetate SC on day 1.~Exemestane: Given PO~Goserelin Acetate: Given SC~Placebo Administration: Given PO | 47 | 293 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Assessed every cycle (1 cycle=28 days) while on treatment and for 30 days after the end of treatment, up to 10 years from study entry
Source ClinicalTrials.gov
Trial
- Title
- Exemestane With or Without Entinostat in Treating Patients With Recurrent Hormone Receptor-Positive Breast Cancer That is Locally Advanced or Metastatic
- NCT number
- NCT02115282
- Phases
- PHASE3
- Conditions
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Breast Adenocarcinoma, HER2/Neu Negative, Locally Advanced Breast Carcinoma, Metastatic Breast Carcinoma, Recurrent Breast Carcinoma
- Interventions
- Biospecimen Collection, Computed Tomography, Entinostat, Exemestane, Goserelin, Goserelin Acetate, Magnetic Resonance Imaging, Placebo Administration, Quality-of-Life Assessment
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2021-11-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02115282?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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