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Comparison · NCT02756572-sae

Post-Chemotherapy vs Post-Transplant: 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. Post-Chemotherapy vs Post-Transplant: serious adverse events. Trial comparisons, record NCT02756572-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02756572-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 110.8861wilson
Risk in group 210.7011wilson
Risk difference, group 1 minus group 20-0.1140.299newcombe hybrid score
Risk ratio, group 1 over group 2111log
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harmfrom the risk difference intervalthe two groups' risks are equal

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Post-Chemotherapy
All patients enrolled received bridge chemotherapy prior to anticipated allogeneic hematopoietic cell transplantation (HCT). Patients received G-CLAM chemotherapy (consisting of G-CSF, mitoxantrone, cladribine, and cytarabine).
3030EG000
Group 2Post-Transplant
Allogeneic peripheral blood stem cell transplant with reduced-intensity conditioning regimen consisted of fludarabine and melphalan, with total body irradiation for subjects over age 55. Prophylaxis for acute graft-vs-host-disease was mycophenylate mofetil (MMF), cyclosporine, and sirolimus.
99EG001

Harm

What it counts
Total, serious adverse events
Time frame
Serious adverse events monitoring started Day 1 of G-CLAM therapy or the date of consent, whichever date came first, until: • Up to day 100 after transplant, for subjects who are successes • The date the subject is off-study, for subjects who are failures and did not receive transplant within 60 days All-cause mortality monitoring started on Day 1 of G-CLAM therapy or the date of consent, whichever date came first, to 6-months post transplant.

Source ClinicalTrials.gov

Trial

Title
Early Allogeneic Hematopoietic Cell Transplantation in Treating Patients With Relapsed or Refractory High-Grade Myeloid Neoplasms
NCT number
NCT02756572
Phases
PHASE2
Conditions
Blasts 10 Percent or More of Bone Marrow Nucleated Cells, Chronic Myelomonocytic Leukemia-2, High Grade Malignant Neoplasm, Myelodysplastic Syndrome, Myelodysplastic Syndrome With Excess Blasts-2, Myeloid Neoplasm, Previously Treated Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Interventions
Cladribine, Cyclosporine, Cytarabine, Filgrastim, Fludarabine Phosphate, Allogeneic Hematopoietic Stem Cell Transplantation, Laboratory Biomarker Analysis, Melphalan, Mitoxantrone Hydrochloride, Mycophenolate Mofetil, Questionnaire Administration, Sirolimus, Total-Body Irradiation, Melphalan Hydrochloride
Lead sponsor
University of Washington
Results first posted
2021-03-22

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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