Comparison · NCT01120249-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 NCT01120249-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01120249-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 | 0.208 | 0.18 | 0.239 | wilson | |
| Risk in group 2 | 0.0941 | 0.0749 | 0.118 | wilson | |
| Risk difference, group 1 minus group 2 | 0.114 | 0.0777 | 0.15 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.21 | 1.7 | 2.89 | log | |
| Odds ratio, group 1 over group 2 | 2.53 | 1.86 | 3.44 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Everolimus than on Placebo | 8.77 | 6.65 | 12.9 | 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 oral everolimus once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity. Of the 775 participants assigned to this arm, 755 were eligible for efficacy analysis and included in the at-risk for all cause mortality population. The 740 participants who received everolimus are included in at-risk for adverse event population. | 154 | 740 | EG001 |
| Group 2 | Placebo | Patients receive oral placebo once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity. Of the 770 participants assigned to this arm, 744 were eligible for efficacy analysis and included in the at-risk for all cause mortality population. The 723 participants who received placebo are included in at-risk for adverse event population. | 68 | 723 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Duration of treatment and follow up until death or 10 years post registration
Source ClinicalTrials.gov
Trial
- Title
- S0931, Everolimus in Treating Patients With Kidney Cancer Who Have Undergone Surgery
- NCT number
- NCT01120249
- Phases
- PHASE3
- Conditions
- Kidney Cancer
- Interventions
- everolimus, placebo
- Lead sponsor
- SWOG Cancer Research Network
- Results first posted
- 2024-03-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01120249?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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