Comparison · NCT00378534-sae
T Cell Depletion Transplant Participants vs Stem Cell Donors: 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. T Cell Depletion Transplant Participants vs Stem Cell Donors: serious adverse events. Trial comparisons, record NCT00378534-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00378534-sae
On this page
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 | 0.241 | 0.15 | 0.365 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0621 | wilson | |
| Risk difference, group 1 minus group 2 | 0.241 | 0.131 | 0.365 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm, for one more participant with a serious adverse event on T Cell Depletion Transplant Participants than on Stem Cell Donors | 4.14 | 2.74 | 7.66 | from the risk difference interval |
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 | T Cell Depletion Transplant Participants | Participants with hematological malignancies received a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation followed by an infusion of stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a delayed T cell depletion add back as donor lymphocyte infusion at day 90. | 14 | 58 | EG000 |
| Group 2 | Stem Cell Donors | An HLA 6/6 identical family member will be co-enrolled into this study as a stem cell donor. The stem cell collection aspect of this protocol is not investigational. | 0 | 58 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 36 months
Source ClinicalTrials.gov
Trial
- Title
- Methods to Enhance the Safety and Effectiveness of Stem Cell Transplants
- NCT number
- NCT00378534
- Phases
- PHASE2
- Conditions
- Chronic Myelogenous Leukemia, Acute Myelogenous Leukemia, Chronic Lymphocytic Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome
- Interventions
- Miltenyi reagent system, Fludarabine, Cyclosporine, Cyclophosphamide, FILGRASTIM (G-CSF)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Results first posted
- 2015-01-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00378534?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
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT00378534-sae