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Comparison · NCT02481830-sae

Group A vs Group B: 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. Group A vs Group B: serious adverse events. Trial comparisons, record NCT02481830-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02481830-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 10.6490.5920.702wilson
Risk in group 20.6450.5860.7wilson
Risk difference, group 1 minus group 20.00365-0.07590.0834newcombe hybrid score
Risk ratio, group 1 over group 21.010.8891.14log
Odds ratio, group 1 over group 21.020.7151.44log
Number needed to harm, for one more participant with a serious adverse event on Group A than on Group B274from 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 1Group ANivolumab 240mg IV on Day 1 of a 14-day cycle183282EG000
Group 2Group BChemotherapy (Topotecan 1.5 mg/m\^2 IV or 2.3 mg/m\^2 oral once daily on Days 1 to 5 of a 21-day cycle / Amrubicin 40 mg/m\^2 IV once daily on Days 1 to 3 of a 21-day cycle)171265EG001

Harm

What it counts
Total, serious adverse events
Time frame
SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to approximately 72 months). Participants were assessed for all-cause mortality from their randomization to study completion (Up to approximately 80 months).

Source ClinicalTrials.gov

Trial

Title
Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer
NCT number
NCT02481830
Phases
PHASE3
Conditions
Lung Cancer
Interventions
Nivolumab, Topotecan, Amrubicin
Lead sponsor
Bristol-Myers Squibb
Results first posted
2020-01-09

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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