Comparison · NCT00796068-sae
Arm I (Low Risk for Graft Failure) vs Arm II (High Risk for Graft Failure): serious adverse events
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 I (Low Risk for Graft Failure) vs Arm II (High Risk for Graft Failure): serious adverse events. Trial comparisons, record NCT00796068-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00796068-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 | 0.409 | 0.299 | 0.53 | wilson | |
| Risk in group 2 | 0.359 | 0.253 | 0.482 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0497 | -0.115 | 0.21 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.14 | 0.735 | 1.76 | log | |
| Odds ratio, group 1 over group 2 | 1.23 | 0.608 | 2.51 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm I (Low Risk for Graft Failure) than on Arm II (High Risk for Graft Failure) | 20.1 | 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 I (Low Risk for Graft Failure) | Patients receive a conditioning regimen comprising fludarabine phosphate IV over 1 hour every day (QD) on days -6 to -2 and treosulfan IV over 120 minutes on days - 6 to -4. Patients undergo (total body irradiation (TBI) on day -1. Patients then undergo donor cord blood transplantation (CBT) on day 0.~Patients receive graft-versus-host disease (GVHD) prophylaxis comprising cyclosporine IV over 1 hour or by mouth (PO) 2-3 times daily on days -3 to 100, followed by a taper in the absence of GVHD. Patients also receive mycophenolate mofetil IV 3 times daily on days 0 to 40, followed by a taper in the absence of GVHD.~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given IV~Total-Body Irradiation: TBI administered day -1: 200 centigray (cGy) (or escalated to 300 cGy, 400 cGy, or 450 cGy per protocol statistical section)~Treosulfan: Given IV~Umbilical Cord Blood Transplantation (UCBT): Undergo single or double unit UCBT | 27 | 66 | EG000 |
| Group 2 | Arm II (High Risk for Graft Failure) | Patients receive a conditioning regimen, TBI, donor UCBT, GVHD prophylaxis, and mycophenolate mofetil as in Arm I.~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given IV~Total-Body Irradiation: TBI administered day -1: 200 cGy (or escalated to 300 cGy, 400 cGy, or 450 cGy per protocol statistical section)~Treosulfan: Given IV~Umbilical Cord Blood Transplantation: Undergo single or double unit UCBT | 23 | 64 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events (AE) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational product in this study through day +100 post-transplant. The start of the adverse event reporting for a study subject will coincide with signing of the informed consent. All-cause mortality data was censored at two-year follow-up.
Source ClinicalTrials.gov
Trial
- Title
- Treosulfan, Fludarabine Phosphate, and Total-Body Irradiation in Treating Patients With Hematological Cancer Who Are Undergoing Umbilical Cord Blood Transplant
- NCT number
- NCT00796068
- Phases
- PHASE2
- Conditions
Acute Biphenotypic Leukemia, Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia in Remission, Blasts Under 5 Percent of Bone Marrow Nucleated Cells, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Myelodysplastic Syndrome (MDS)
- Interventions
- Cyclosporine, Fludarabine Phosphate, Laboratory Biomarker Analysis, Mycophenolate Mofetil, Total-Body Irradiation, Treosulfan, Umbilical Cord Blood Transplantation
- Lead sponsor
- Fred Hutchinson Cancer Center
- Results first posted
- 2023-02-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00796068?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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