Comparison · NCT03071406-sae
Arm A: Nivolumab + Ipilimumab vs Arm B: Nivolumab + Ipilimumab + SBRT: 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. Arm A: Nivolumab + Ipilimumab vs Arm B: Nivolumab + Ipilimumab + SBRT: serious adverse events. Trial comparisons, record NCT03071406-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03071406-sae
On this page
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 | 0.52 | 0.335 | 0.7 | wilson | |
| Risk in group 2 | 0.52 | 0.335 | 0.7 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.258 | 0.258 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.587 | 1.7 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.33 | 3.03 | log | |
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
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 | Arm A: Nivolumab + Ipilimumab | Nivolumab every 2 weeks and Ipilimumab every 6 weeks until progression or unacceptable toxicity.~Nivolumab: Nivolumab 240 mg/dose intravenously (IV) every 2 (q2) weeks.~Ipilimumab: Ipilimumab 1 mg/kg/dose IV q6 weeks. | 13 | 25 | EG000 |
| Group 2 | Arm B: Nivolumab + Ipilimumab + SBRT | Nivolumab every 2 weeks and Ipilimumab every 6 weeks until progression or unacceptable toxicity. Stereotactic Body Radiation Therapy (SBRT) to be given at the start of week 2.~Nivolumab: Nivolumab 240 mg/dose intravenously (IV) every 2 (q2) weeks.~Ipilimumab: Ipilimumab 1 mg/kg/dose IV q6 weeks.~Stereotactic Body Radiation Therapy (SBRT): Stereotactic Body Radiation Therapy 24Gy in 3 fractions. | 13 | 25 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
Source ClinicalTrials.gov
Trial
- Title
- Randomized Study of Nivolumab+Ipilimumab+/- SBRT for Metastatic Merkel Cell Carcinoma
- NCT number
- NCT03071406
- Phases
- PHASE2
- Conditions
- Merkel Cell Carcinoma, Skin Cancer
- Interventions
- Nivolumab, Ipilimumab, Stereotactic Body Radiation Therapy (SBRT)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Results first posted
- 2023-05-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03071406?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
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT03071406-sae