Comparison · NCT01339910-sae
Myeloablative Conditioning Regimen (MAC) vs Reduced Intensity Conditioning (RIC): 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. Myeloablative Conditioning Regimen (MAC) vs Reduced Intensity Conditioning (RIC): serious adverse events. Trial comparisons, record NCT01339910-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01339910-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 | 0.159 | 0.106 | 0.231 | wilson | |
| Risk in group 2 | 0.12 | 0.0754 | 0.186 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0388 | -0.0458 | 0.124 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.32 | 0.723 | 2.42 | log | |
| Odds ratio, group 1 over group 2 | 1.38 | 0.687 | 2.79 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Myeloablative Conditioning Regimen (MAC) than on Reduced Intensity Conditioning (RIC) | 25.8 | 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 | Myeloablative Conditioning Regimen (MAC) | One of three different regimens in MAC will be administered; busulfan and fludarabine, busulfan and cyclophosphamide, or cyclophosphamide and total body irradiation.~Busulfan and Fludarabine: (Bu/Flu)~* Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or mg/m\^2/day with Bu Css 900±100 ng/mL (total dose of 16 mg/kg, 12.8 mg/kg or 520 mg/m\^2, respectively) on Days -5 to -2~* Fludarabine: 30 mg/m\^2/day on Days -5 to -2: Flu (total dose of 120 mg/m\^2)~Busulfan and Cyclophosphamide: (Bu/Cy)~* Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or 130 mg/m\^2/day with Bu Css 900 ± 100 ng/mL (total dose of 16 mg/kg or 12.8 mg/kg or 520 mg/m\^2, respectively) on Days -7 to -4~* Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)~Cyclophosphamide and Total Body Irradiation: (Cy/TBI)~* TBI: 1200-1420 cGy on Days -7 to -4~* Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg) | 21 | 132 | EG000 |
| Group 2 | Reduced Intensity Conditioning (RIC) | One of two different regimens in RIC will be administered; fludarabine and busulfan, or fludarabine and melphalan.~Fludarabine and Busulfan: (Flu/Bu)~* Fludarabine: 30 mg/m\^2/day on Days -6 to -2 (total dose of 150 mg/m\^2)~* Busulfan: 4 mg/kg/day PO or 3.2 mg/kg/day (total dose of 8 mg/kg or 6.4 mg/kg, respectively) on Days -5 to -4~Fludarabine and Melphalan: (Flu/Mel)~* Fludarabine: 30 mg/m\^2/day on Days -5 to -2 (total dose of 120 mg/m\^2)~* Melphalan: 140 mg/m\^2 on Day -2 | 16 | 133 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 18 months post-randomization
Source ClinicalTrials.gov
Trial
- Title
- Reduced Intensity Regimen vs Myeloablative Regimen for Myeloid Leukemia or Myelodysplastic Syndrome (BMT CTN 0901)
- NCT number
- NCT01339910
- Phases
- PHASE3
- Conditions
- Leukemia, Myelocytic, Acute
- Interventions
- Fludarabine and Busulfan, Fludarabine and Melphalan, Busulfan and Fludarabine, Busulfan and Cyclophosphamide, Cyclophosphamide and Total Body Irradiation
- Lead sponsor
- Medical College of Wisconsin
- Results first posted
- 2018-05-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01339910?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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