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Comparison · NCT02684253-sae

Nivolumab 3mg/kg IV Every 2 Weeks vs Stereotactic Body Radiotherapy & Nivolumab: 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 3mg/kg IV Every 2 Weeks vs Stereotactic Body Radiotherapy & Nivolumab: serious adverse events. Trial comparisons, record NCT02684253-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02684253-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 10.1250.04970.281wilson
Risk in group 20.09090.03140.236wilson
Risk difference, group 1 minus group 20.0341-0.1290.201newcombe hybrid score
Risk ratio, group 1 over group 21.380.3345.66log
Odds ratio, group 1 over group 21.430.2936.96log
Number needed to harm, for one more participant with a serious adverse event on Nivolumab 3mg/kg IV Every 2 Weeks than on Stereotactic Body Radiotherapy & Nivolumab29.3from 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 1Nivolumab 3mg/kg IV Every 2 WeeksNivolumab 3mg/kg IV every 2 weeks~Nivolumab432EG000
Group 2Stereotactic Body Radiotherapy & Nivolumab
Image Guided, Stereotactic Body Radiotherapy (27 Gy over 3 fractions given every other day) to a single lesion to start by study day 14 (study day 1 is day of first dose of Nivolumab).~Nivolumab 3mg/kg IV starting day 1 and then every 2 weeks thereafter. Treatment with Nivolumab will continue until progression or unacceptable toxicity.~Nivolumab~Stereotactic Body Radiation Therapy (SBRT)
333EG001

Harm

What it counts
Total, serious adverse events
Time frame
Up tp 30 months

Source ClinicalTrials.gov

Trial

Title
Screening Trial of Nivolumab With Image Guided, Stereotactic Body Radiotherapy (SBRT) Versus Nivolumab Alone in Patients With Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
NCT number
NCT02684253
Phases
PHASE2
Conditions
Head and Neck Squamous Cell Carcinoma (HNSCC)
Interventions
Nivolumab, Stereotactic Body Radiation Therapy (SBRT)
Lead sponsor
Memorial Sloan Kettering Cancer Center
Results first posted
2022-03-10

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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