Comparison · NCT01349101-sae
Myeloablative HSCT vs Reduced Intensity HSCT: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Download JSON
Cite this record
ConductScience Library. Myeloablative HSCT vs Reduced Intensity HSCT: serious adverse events. Trial comparisons, record NCT01349101-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01349101-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 | 0.152 | 0.0665 | 0.309 | wilson | |
| Risk in group 2 | 0.111 | 0.0484 | 0.235 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0404 | -0.11 | 0.21 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.36 | 0.429 | 4.33 | log | |
| Odds ratio, group 1 over group 2 | 1.43 | 0.378 | 5.4 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Myeloablative HSCT than on Reduced Intensity HSCT | 24.7 | 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 | Myeloablative HSCT | Myeloablative Hematopoietic Stem Cell Transplantation (HSCT): Patients will receive myeloablative transplants or nonmyeloablative transplants depending on their disease type.~Total Body Irradiation: Myeloablative HSCT Arm: Total body irradiation (TBI) is given in 8 fractions over 4 days (total dose of 12 Gy)~Cyclophosphamide: Cyclophosphamide is administered on the third day after the hematopoietic stem cell transplantation (HSCT) to help reduce graft-versus-host disease (GVHD). It is given at a dose of 60 mg/kg/d for 2 days on days +3 and +4.~Tacrolimus: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).~Mycophenolate mofetil: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).~Hematopoietic stem cell transplantation: Allogeneic marrow transplantation given after the last dose of total body irradiation (TBI) | 5 | 33 | EG000 |
| Group 2 | Reduced Intensity HSCT | Reduced Intensity Hematopoietic Stem Cell Transplantation (HSCT): Patients who have received a previous transplant, patients who have received dose limiting radiation, and patients with a DLCO \<45% will receive the reduced intensity conditioning regimen.~Total Body Irradiation: Reduced Intensity HSCT Arm: TBI is given in one fraction (total dose of 2 Gy)~Cyclophosphamide: Cyclophosphamide is administered on the third day after the hematopoietic stem cell transplantation (HSCT) to help reduce graft-versus-host disease (GVHD). It is given at a dose of 60 mg/kg/d for 2 days on days +3 and +4.~Tacrolimus: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).~Mycophenolate mofetil: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).~Fludarabine: Started the fifth day before the transplant. Given for four days at 30 mg/m2/d.~Busulfan: Started the fourth day before the transplant. Given for two days at 3.2 mg/kg.~Hematopoietic stem cell transplantation: Allogeneic marrow transplantation given after the last dose of total body irradiation (TBI) | 5 | 45 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were recorded for 100 days following transplant.
Source ClinicalTrials.gov
Trial
- Title
- A Research Study of Bone Marrow Transplantation From Unrelated or Partially Matched Related Donors
- NCT number
- NCT01349101
- Phases
- PHASE2
- Conditions
- Hematological Malignancies
- Interventions
- Total Body Irradiation, Cyclophosphamide, Tacrolimus, Mycophenolate mofetil, Fludarabine, Busulfan, Hematopoietic stem cell transplantation
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Results first posted
- 2025-12-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01349101?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/NCT01349101-sae