Comparison · NCT01572662-sae
Arm 1: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 16,000 Umol/l vs Arm 2: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 20,000umol/l.: 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 1: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 16,000 Umol/l vs Arm 2: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 20,000umol/l.: serious adverse events. Trial comparisons, record NCT01572662-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01572662-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 | 0.122 | 0.0573 | 0.242 | wilson | |
| Risk in group 2 | 0.0533 | 0.0273 | 0.102 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0691 | -0.012 | 0.192 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.3 | 0.838 | 6.29 | log | |
| Odds ratio, group 1 over group 2 | 2.48 | 0.815 | 7.53 | log | |
Number needed to harm, for one more participant with a serious adverse event on Arm 1: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 16,000 Umol/l than on Arm 2: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 20,000umol/l. | 14.5 | 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 | Arm 1: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 16,000 Umol/l | Allogeneic stem cell transplant for patients with hematologic malignancies: The randomization was stratified equally for the first 100 patients at study entry and conditioned regimen with Fludarabine/Timed sequential Busulfan AUC 16,000umol/l vs. Fludarabine/Timed Sequential (TS) Busulfan AUC 20,000umol/l. | 6 | 49 | EG000 |
| Group 2 | Arm 2: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 20,000umol/l. | Allogeneic stem cell transplant for patients with hematologic malignancies: The randomization was stratified equally for the first 100 patients at study entry and conditioned regimen with Fludarabine/Timed sequential Busulfan AUC 16,000umol/l vs. Fludarabine/Timed Sequential (TS) Busulfan AUC 20,000umol/l. | 8 | 150 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were collected up to 3 years post transplant.
Source ClinicalTrials.gov
Trial
- Title
- Allogeneic Transplantation Using Timed Sequential Busulfan and Fludarabine Conditioning
- NCT number
- NCT01572662
- Phases
- PHASE2
- Conditions
Leukemia, Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia, Myeloproliferative Diseases, Non-Hodgkins Lymphoma, Hodgkins Lymphoma, Multiple Myeloma, Myelodysplastic Syndrome
- Interventions
- Fludarabine monophosphate, Busulfan, Stem Cell Infusion, Tacrolimus, Methotrexate, G-CSF
- Lead sponsor
- M.D. Anderson Cancer Center
- Results first posted
- 2023-06-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01572662?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/NCT01572662-sae