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Comparison · NCT01668784-sae

NIVOLUMAB vs EVEROLIMUS: serious adverse events

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. NIVOLUMAB vs EVEROLIMUS: serious adverse events. Trial comparisons, record NCT01668784-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01668784-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.6110.5630.657wilson
Risk in group 20.6120.5630.659wilson
Risk difference, group 1 minus group 2-0.00125-0.06840.0659newcombe hybrid score
Risk ratio, group 1 over group 20.9980.8941.11log
Odds ratio, group 1 over group 20.9950.7491.32log
Number needed to treat, for one fewer participant with a serious adverse event on NIVOLUMAB than on EVEROLIMUS798from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1NIVOLUMABNivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.248406EG000
Group 2EVEROLIMUSEverolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.243397EG001

Harm

What it counts
Total, serious adverse events
Time frame
All-cause mortality was assessed from first dose to study completion (up to 105 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (approximately up to 107 months)

Source ClinicalTrials.gov

Trial

Title
Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025)
NCT number
NCT01668784
Phases
PHASE3
Conditions
Advanced or Metastatic (Medically or Surgically Unresectable) Clear-cell Renal Cell Carcinoma
Interventions
Nivolumab, Everolimus
Lead sponsor
Bristol-Myers Squibb
Results first posted
2016-04-29

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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