Comparison · NCT00412360-sae
Single UCB Transplant vs Double UCB Transplant: 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. Single UCB Transplant vs Double UCB Transplant: serious adverse events. Trial comparisons, record NCT00412360-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00412360-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 | 0.0446 | 0.0192 | 0.1 | wilson | |
| Risk in group 2 | 0.13 | 0.0788 | 0.206 | wilson | |
| Risk difference, group 1 minus group 2 | -0.085 | -0.165 | -0.00964 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.344 | 0.128 | 0.923 | log | |
| Odds ratio, group 1 over group 2 | 0.314 | 0.109 | 0.904 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Single UCB Transplant than on Double UCB Transplant | 11.8 | 6.05 | 104 | from the risk difference interval |
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 | Single UCB Transplant | Single Umbilical Cord Blood Unit Transplantation | 5 | 112 | EG000 |
| Group 2 | Double UCB Transplant | Double Umbilical Cord Blood Unit Transplantation | 14 | 108 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 2 years post-transplant
Source ClinicalTrials.gov
Trial
- Title
- Single vs Double Umbilical Cord Blood Transplants in Children With High Risk Leukemia and Myelodysplasia (BMT CTN 0501)
- NCT number
- NCT00412360
- Phases
- PHASE3
- Conditions
- Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndrome, Natural Killer Cell Lymphoblastic Leukemia/Lymphoma
- Interventions
- Single Umbilical Cord Blood Unit Transplant, Double Umbilical Cord Blood Unit Transplant, Total Body Irradiation, Cyclophosphamide, Fludarabine, Cyclosporine A, Mycophenolate Mofetil
- Lead sponsor
- Medical College of Wisconsin
- Results first posted
- 2015-12-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00412360?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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