Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
NCT ID:
NCT01252667
Group ID:
EG005
Title:
Part 2 - Dose 3 (50 mg/m^2 Clofarabine)
Description:
CONDITIONING REGIMEN: Patients receive 50 mg/m\^2 clofarabine IV over 2 hours on days -6 to -2. Patients also undergo TBI on day 0.
IMMUNOSUPPRESSION: Patients with related donors receive cyclosporine PO every 12 hours on days -3 to 56 with taper to day 180 and mycophenolate mofetil PO every 12 hours on days 0 to 28. Patients with unrelated donors receive cyclosporine PO every 12 hours on days -3 to 100 with taper to day 180 and mycophenolate mofetil PO every 8 hours on days 0 to 40 with taper to day 96.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Clofarabine: Given IV
Cyclosporine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic hematopoietic PBSCT
Pharmacological Study: Optional correlative studies
Total-Body Irradiation: Undergo TBI
Deaths Number Affected:
13
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
35
Other Number Affected:
18
Other Number At Risk:
35
Study:
NCT01252667
Results Section:
NCT01252667
Adverse Events Module:
NCT01252667