Comparison · NCT02569242-sae
Nivolumab Arm vs Active Comparator Arm （Docetaxel/Paclitaxel）: 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 Arm vs Active Comparator Arm （Docetaxel/Paclitaxel）: serious adverse events. Trial comparisons, record NCT02569242-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02569242-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 | 0.325 | 0.265 | 0.392 | wilson | |
| Risk in group 2 | 0.37 | 0.307 | 0.438 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0448 | -0.135 | 0.0463 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.879 | 0.675 | 1.14 | log | |
| Odds ratio, group 1 over group 2 | 0.82 | 0.548 | 1.23 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Nivolumab Arm than on Active Comparator Arm （Docetaxel/Paclitaxel） | 22.3 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Nivolumab Arm | Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends | 68 | 209 | EG000 |
| Group 2 | Active Comparator Arm （Docetaxel/Paclitaxel） | Docetaxel: Intravenously administered at a dose of 75 mg/m2 every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~OR~Paclitaxel: Intravenously administered at a dose of 100 mg/m2 weekly for 6 weeks followed by 2-week drug holiday until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends | 77 | 208 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Monitoring for any AEs will be continued until 28 days after the end of the treatment phase. In subjects who, at the time of initiation of the follow-up investigation, have any AE for which a causal relationship to the investigational product cannot be ruled out or which led to discontinuation, investigation of the AE will be continued until the event is judged not to require further follow-up. SAEs are to be collected during the treatment period and for 100 days following the last dose.
Source ClinicalTrials.gov
Trial
- Title
- Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer
- NCT number
- NCT02569242
- Phases
- PHASE3
- Conditions
- Esophageal Cancer
- Interventions
- Nivolumab, Docetaxel/Paclitaxel
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Results first posted
- 2022-01-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02569242?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.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT02569242-sae