Comparison · NCT00067002-sae
Un-Manipulated CB Arm vs Expanded CB Arm: 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. Un-Manipulated CB Arm vs Expanded CB Arm: serious adverse events. Trial comparisons, record NCT00067002-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00067002-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 | 0.173 | 0.0938 | 0.297 | wilson | |
| Risk in group 2 | 0.0755 | 0.0297 | 0.179 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0976 | -0.0324 | 0.23 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.29 | 0.753 | 6.99 | log | |
| Odds ratio, group 1 over group 2 | 2.56 | 0.737 | 8.92 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Un-Manipulated CB Arm than on Expanded CB Arm | 10.2 | 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 | Un-Manipulated CB Arm | Transplantation of Two Unmanipulated CB units. Rituxan 375 mg/m2 IV Day -9 for participants with CD20 + malignancies. Melphalan 140 mg/m2 IV on Day -8. Thiotepa 5 mg/Kg IV on Day -7. Fludarabine 40 mg/m2 IV on Days -6 to -3. | 9 | 52 | EG000 |
| Group 2 | Expanded CB Arm | Transplantation One Unmanipulated and One Expanded CB Unit. Rituxan: 375 mg/m2 IV on Day - 9 for CD20 + malignancies. Fludarabine 40 mg/m2 IV on Days -6 to -3. Cyclophosphamide 50 mg/kg IV on Day -6. Mesna 10 mg/kg IV before the 1st dose of Cyclophosphamide, then 10 mg/kg every 4 hours for four more doses (total of 50 mg/Kg). TBI Day -1 at 2 Gy. | 4 | 53 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse event collection through first 100 days following transplant.
Source ClinicalTrials.gov
Trial
- Title
- Randomized Double Cord Blood Transplant Study
- NCT number
- NCT00067002
- Phases
- PHASE2
- Conditions
- Leukemia, Lymphocytic, Acute, Leukemia, Myelocytic, Acute, Leukemia, Myeloid, Chronic, Lymphoma, Non-Hodgkin
- Interventions
- Expanded allogeneic cord blood (CB), One Unmanipulated and One Expanded Cord Blood Unit, Rituxan, Melphalan, Thiotepa, Fludarabine, Cyclophosphamide, Mesna, Total body irradiation (TBI)
- Lead sponsor
- M.D. Anderson Cancer Center
- Results first posted
- 2019-05-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00067002?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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