Comparison · NCT01471444-sae
Arm A (Flu+Bu) vs Arm B (Flu+Clo+Bu): 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 (Flu+Bu) vs Arm B (Flu+Clo+Bu): serious adverse events. Trial comparisons, record NCT01471444-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01471444-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 | 0.192 | 0.134 | 0.268 | wilson | |
| Risk in group 2 | 0.325 | 0.248 | 0.413 | wilson | |
| Risk difference, group 1 minus group 2 | -0.133 | -0.238 | -0.0242 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.592 | 0.382 | 0.916 | log | |
| Odds ratio, group 1 over group 2 | 0.495 | 0.277 | 0.883 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm A (Flu+Bu) than on Arm B (Flu+Clo+Bu) | 7.54 | 4.19 | 41.3 | 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 | Arm A (Flu+Bu) | Fludarabine 40 mg/m2 intravenous (IV) over 1 hour. Busulfan dose calculated to achieve a systemic exposure dose of 6000 µMol-min IV for 60 years and younger or 4000 uMol-min IV for 61 years and older over 3 hours every 24 hours. Both delivered for 4 consecutive days (days -6 to -3). Stem cell transplant Day 0. | 25 | 130 | EG000 |
| Group 2 | Arm B (Flu+Clo+Bu) | Fludarabine 10 mg/m2 over 1 hour. Clofarabine 40 mg/m2 diluted in normal saline to produce a final concentration of 0.4 mg/mL, infused over 1 hour. Busulfan dose calculated to achieve a systemic exposure dose of 6000 µMol-min IV for 60 years and younger or 4000 uMol-min IV for 61 years and older over 3 hours every 24 hours, immediately after Clofarabine. All delivered on 4 consecutive days (days -6 through -3). Stem cell transplant Day 0. | 39 | 120 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Through study completion, an average of 5 years.
Source ClinicalTrials.gov
Trial
- Title
- Fludarabine-IV Busulfan ± Clofarabine and Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
- NCT number
- NCT01471444
- Phases
- PHASE3
- Conditions
- Disorder Related to Bone Marrow Transplantation, Leukemia, Transplantation Infection
- Interventions
- Fludarabine, Clofarabine, Busulfan, Thymoglobulin, Stem Cell Infusion, Tacrolimus, Methotrexate
- Lead sponsor
- M.D. Anderson Cancer Center
- Results first posted
- 2021-12-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01471444?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/NCT01471444-sae