Comparison · NCT02743494-sae
Nivolumab 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. Nivolumab vs Placebo: serious adverse events. Trial comparisons, record NCT02743494-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02743494-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 | 0.368 | 0.329 | 0.41 | wilson | |
| Risk in group 2 | 0.381 | 0.324 | 0.441 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0123 | -0.0847 | 0.0582 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.968 | 0.799 | 1.17 | log | |
| Odds ratio, group 1 over group 2 | 0.949 | 0.699 | 1.29 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Nivolumab than on Placebo | 81 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Nivolumab | Nivolumab 240 mg Q2W for 8 cycles (16 weeks) followed by Nivolumab 480 mg Q4W for 9 cycles. | 196 | 532 | EG000 |
| Group 2 | Placebo | Placebo IV Q2W for 8 cycles (16 weeks) followed by Placebo IV Q4W for 9 cycles | 99 | 260 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months).
Source ClinicalTrials.gov
Trial
- Title
- An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer
- NCT number
- NCT02743494
- Phases
- PHASE3
- Conditions
- Advanced Cancer
- Interventions
- Nivolumab, Placebo
- Lead sponsor
- Bristol-Myers Squibb
- Results first posted
- 2021-06-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02743494?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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