Comparison · NCT01222715-sae
Regimen A vs Regimen 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
Cite this record
ConductScience Library. Regimen A vs Regimen B: serious adverse events. Trial comparisons, record NCT01222715-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01222715-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 | 0.795 | 0.655 | 0.888 | wilson | |
| Risk in group 2 | 0.762 | 0.615 | 0.865 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0335 | -0.141 | 0.208 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.04 | 0.833 | 1.31 | log | |
| Odds ratio, group 1 over group 2 | 1.22 | 0.438 | 3.37 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Regimen A than on Regimen B | 29.8 | 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 | Regimen A | Vinorelbine/cyclophosphamide (VC) + bevacizumab | 35 | 44 | EG000 |
| Group 2 | Regimen B | Vinorelbine/cyclophosphamide (VC) + temsirolimus | 32 | 42 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Vinorelbine Tartrate and Cyclophosphamide in Combination With Bevacizumab or Temsirolimus in Treating Patients With Recurrent or Refractory Rhabdomyosarcoma
- NCT number
- NCT01222715
- Phases
- PHASE2
- Conditions
Adult Rhabdomyosarcoma, Childhood Alveolar Rhabdomyosarcoma, Childhood Pleomorphic Rhabdomyosarcoma, Childhood Rhabdomyosarcoma With Mixed Embryonal and Alveolar Features, Previously Treated Childhood Rhabdomyosarcoma, Recurrent Adult Soft Tissue Sarcoma, Recurrent Childhood Rhabdomyosarcoma
- Interventions
- Bevacizumab, Cyclophosphamide, Laboratory Biomarker Analysis, Temsirolimus, Vinorelbine Tartrate
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2017-05-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01222715?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.
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GET https://conductscience.org/api/comparisons/v1/NCT01222715-sae