Comparison · NCT05012098-sae
Cohort 1/Arm 1: Treatment With Bintrafusp Alfa vs Cohort 2/Arm 1: Treatment With Bintrafusp Alfa: 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. Cohort 1/Arm 1: Treatment With Bintrafusp Alfa vs Cohort 2/Arm 1: Treatment With Bintrafusp Alfa: serious adverse events. Trial comparisons, record NCT05012098-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05012098-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 | 0.333 | 0.121 | 0.646 | wilson | |
| Risk in group 2 | 1 | 0.342 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | -0.667 | -0.879 | 0.0614 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.333 | 0.132 | 0.84 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with a serious adverse event on Cohort 1/Arm 1: Treatment With Bintrafusp Alfa than on Cohort 2/Arm 1: Treatment With Bintrafusp Alfa | 1.5 | 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 | Cohort 1/Arm 1: Treatment With Bintrafusp Alfa | Treatment with Bintrafusp alfa~Bintrafusp alfa/M7824: Participants will be treated with bintrafusp alfa 1200 mg intravenous over 60 minutes (+/- 20 minutes) once every 2 weeks for 26 doses. | 3 | 9 | EG000 |
| Group 2 | Cohort 2/Arm 1: Treatment With Bintrafusp Alfa | Treatment with Bintrafusp alfa~Bintrafusp alfa/M7824: Participants will be treated with bintrafusp alfa 1200 mg intravenous over 60 minutes (+/- 20 minutes) once every 2 weeks for 26 doses. | 2 | 2 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All-Cause Mortality was monitored/assessed an average of 6 months. Adverse Events were monitored/assessed from first drug administration through 30 days after the last dose of study drug is administered, an average of 6 months.
Source ClinicalTrials.gov
Trial
- Title
- Phase 2 Study of Bintrafusp Alfa in Recurrent/Metastatic Olfactory Neuroblastoma (BARON).
- NCT number
- NCT05012098
- Phases
- PHASE2
- Conditions
- Olfactory Neuroblastoma, Esthesioneuroblastoma, Neoplasm of the Nasal Cavity
- Interventions
- Bintrafusp alfa/M7824, Ibuprofen, PET scan, CT scan, Tumor tissue biopsy, Brain MRI, Dotate scan, PET FDG scan, Nuclear bone scan, EKG
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2025-08-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05012098?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/NCT05012098-sae