Comparison · NCT00469144-sae
Fixed-Dose Busulfan + Fludarabine vs Adjusted Dose Busulfan + Fludarabine: 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. Fixed-Dose Busulfan + Fludarabine vs Adjusted Dose Busulfan + Fludarabine: serious adverse events. Trial comparisons, record NCT00469144-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00469144-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 | 0.0175 | 0.00482 | 0.0617 | wilson | |
| Risk in group 2 | 0.027 | 0.00923 | 0.0765 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00948 | -0.0605 | 0.0381 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.649 | 0.111 | 3.81 | log | |
| Odds ratio, group 1 over group 2 | 0.643 | 0.105 | 3.92 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Fixed-Dose Busulfan + Fludarabine than on Adjusted Dose Busulfan + Fludarabine | 105 | 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 | Fixed-Dose Busulfan + Fludarabine | Busulfan Fixed Dose = 130 mg/m\^2 intravenous (IV) Daily Over Three Hours x 4 Days. Fludarabine 40 mg/m\^2 IV Daily Over 1 Hour x 4 Days. | 2 | 114 | EG000 |
| Group 2 | Adjusted Dose Busulfan + Fludarabine | Busulfan Adjusted Dose = 32 mg/m\^2 IV Over 2 Hours Test Dose x 1 Day. Fludarabine 40 mg/m\^2 IV Daily Over 1 Hour x 4 Days.~Adjusted Dose = 32 mg/m\^2 IV Over 2 Hours Test Dose x 1 Day; Proceeding dosage level determined by pharmacokinetic studies to achieve a daily area under curve (AUC) of 6,000 microMol-min ± 10%. | 3 | 111 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Source ClinicalTrials.gov
Trial
- Title
- IV Busulfan With Allo-BMT: Study for Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome
- NCT number
- NCT00469144
- Phases
- PHASE3
- Conditions
- Myelodysplastic Syndrome, Leukemia, Acute Myeloid Leukemia
- Interventions
- Busulfan, Fludarabine
- Lead sponsor
- M.D. Anderson Cancer Center
- Results first posted
- 2021-01-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00469144?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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