Comparison · NCT00863655-sae
Everolimus + Exemestane vs Placebo + Exemestane: 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. Everolimus + Exemestane vs Placebo + Exemestane: serious adverse events. Trial comparisons, record NCT00863655-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00863655-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 | 0.328 | 0.287 | 0.371 | wilson | |
| Risk in group 2 | 0.155 | 0.115 | 0.207 | wilson | |
| Risk difference, group 1 minus group 2 | 0.172 | 0.107 | 0.232 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.11 | 1.53 | 2.91 | log | |
| Odds ratio, group 1 over group 2 | 2.65 | 1.78 | 3.95 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Everolimus + Exemestane than on Placebo + Exemestane | 5.8 | 4.32 | 9.35 | from the risk difference interval |
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 | Everolimus + Exemestane | Everolimus 10 mg daily in combination with exemestane 25 mg daily | 158 | 482 | EG000 |
| Group 2 | Placebo + Exemestane | Placebo of everolimus in combination with exemestane 25 mg daily | 37 | 238 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole
- NCT number
- NCT00863655
- Phases
- PHASE3
- Conditions
- Breast Cancer
- Interventions
- Everolimus, Exemestane, Everolimus Placebo
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2012-08-31
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00863655?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.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT00863655-sae