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Comparison · NCT01471444-57243f90

Arm A (Flu+Bu) vs Arm B (Flu+Clo+Bu): Number of Participants With Non Relapse Mortality at 100 Day Post Transplant

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Arm A (Flu+Bu) vs Arm B (Flu+Clo+Bu): Number of Participants With Non Relapse Mortality at 100 Day Post Transplant. Trial comparisons, record NCT01471444-57243f90. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01471444-57243f90

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.02310.007880.0657wilson
Risk in group 20.050.02310.105wilson
Risk difference, group 1 minus group 2-0.0269-0.08380.0234newcombe hybrid score
Risk ratio, group 1 over group 20.4620.1181.8log
Odds ratio, group 1 over group 20.4490.111.84log
Number needed to treat, for one fewer participant with the outcome on Arm A (Flu+Bu) than on Arm B (Flu+Clo+Bu)37.1from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Arm 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.
3130OG000
Group 2Arm 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.
6120OG001

Outcome

Type
SECONDARY
Title
Number of Participants With Non Relapse Mortality at 100 Day Post Transplant
Description
Number of participants expired from complications other than relapsed disease at 100 day Post Transplant.
Time frame
100 day Post Transplant
Population

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

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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