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 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
NCT ID:
NCT01824693
Group ID:
EG001
Title:
Arm II (Busulfan, Fludarabine Phosphate)
Description:
CONDITIONING REGIMEN: Patients receive busulfan as in Arm I and fludarabine phosphate IV over 1 hour on days -5 to -2.
TRANSPLANT: Patients undergo allogeneic HCT as in Arm I.
Patients receive tacrolimus IV or PO on days -1 to 98 (related donor) or 180 (unrelated donor) and mycophenolate mofetil IV over 2 hours or PO every 8 hours on days 1-30 (related donor) or 45 (unrelated donor).
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic HCT
Busulfan: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given IV or PO
Pharmacological Study: Correlative studies
Tacrolimus: Given IV or PO
Deaths Number Affected:
5
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
9
Other Number Affected:
7
Other Number At Risk:
9
Study:
NCT01824693
Results Section:
NCT01824693
Adverse Events Module:
NCT01824693