Comparison · NCT01674140-sae
Everolimus vs 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. Everolimus vs Placebo: serious adverse events. Trial comparisons, record NCT01674140-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01674140-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 | 0.206 | 0.18 | 0.234 | wilson | |
| Risk in group 2 | 0.0874 | 0.0705 | 0.108 | wilson | |
| Risk difference, group 1 minus group 2 | 0.119 | 0.0858 | 0.151 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.36 | 1.84 | 3.03 | log | |
| Odds ratio, group 1 over group 2 | 2.71 | 2.04 | 3.6 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Everolimus than on Placebo | 8.44 | 6.61 | 11.6 | 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 | Everolimus | Patients receive an approved endocrine therapy regimen as in arm I. Patients also receive everolimus PO daily for 1 year in the absence of disease progression or unacceptable toxicity. | 180 | 874 | EG001 |
| Group 2 | Placebo | Patients receive an approved endocrine therapy comprising tamoxifen citrate\*, goserelin acetate\*\* or leuprolide acetate\*\*, or aromatase inhibitor (anastrozole, letrozole, or exemestane) for 2-5 years. Patients also receive a placebo orally (PO) daily for 1 year in the absence of disease progression or unacceptable toxicity.~NOTE: \*Men receive tamoxifen citrate PO for 5 years. NOTE: \*\*Goserelin acetate or leuprolide acetate is given if patient is or becomes postmenopausal. | 77 | 881 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
Source ClinicalTrials.gov
Trial
- Title
- S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer
- NCT number
- NCT01674140
- Phases
- PHASE3
- Conditions
- Breast Cancer
- Interventions
- anastrozole, everolimus, exemestane, goserelin acetate, letrozole, leuprolide acetate, tamoxifen citrate, placebo
- Lead sponsor
- SWOG Cancer Research Network
- Results first posted
- 2023-12-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01674140?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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