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Comparison · NCT03055013-deaths

Arm A (Nephrectomy + Nivolumab) vs Arm B (Nephrectomy Only): deaths from any cause

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. Arm A (Nephrectomy + Nivolumab) vs Arm B (Nephrectomy Only): deaths from any cause. Trial comparisons, record NCT03055013-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03055013-deaths

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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 10.1190.09080.154wilson
Risk in group 20.09640.07160.129wilson
Risk difference, group 1 minus group 20.0224-0.02030.0655newcombe hybrid score
Risk ratio, group 1 over group 21.230.8291.83log
Odds ratio, group 1 over group 21.260.8111.97log
Number needed to harm, for one more death from any cause on Arm A (Nephrectomy + Nivolumab) than on Arm B (Nephrectomy Only)44.6from 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 1Arm A (Nephrectomy + Nivolumab)
Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 2 cycles. Patients then undergo partial or radical nephrectomy 7-28 days later. Patients then receive nivolumab over 30 IV on day 1. Treatment repeats every 14 days for 6 cycles, and then every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity.~Patients enrolled after Amendment 4 receive nivolumab IV over 30 minutes on day 1. Patients then undergo partial or radical nephrectomy 7-28 days later. Patient then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 4 weeks for up to 9 cycles in the absence of disease progression or unacceptable toxicity.
48404EG000
Group 2Arm B (Nephrectomy Only)Patients undergo partial or radical nephrectomy within 8 weeks after registration followed by observation.40415EG001

Harm

What it counts
Total, all-cause mortality
Time frame
Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 6 years

Source ClinicalTrials.gov

Trial

Title
Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy
NCT number
NCT03055013
Phases
PHASE3
Conditions
Metastatic Renal Cell Carcinoma, Sarcomatoid Renal Cell Carcinoma, Stage II Renal Cell Cancer AJCC v7, Stage III Renal Cell Cancer AJCC v7, Unclassified Renal Cell Carcinoma
Interventions
Nephrectomy, Nivolumab, Patient Observation, Quality-of-Life Assessment, Questionnaire Administration
Lead sponsor
National Cancer Institute (NCI)
Results first posted
2024-04-25

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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