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:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2025-12-25 @ 1:16 PM
NCT ID:
NCT03128359
Group ID:
EG000
Title:
Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis)
Description:
Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -3 and melphalan hydrochloride IV over 20 minutes on day -2.
Patients undergo PBSC HCT on day 0.
Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity.
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Hematopoietic Cell Transplantation: Undergo PBSC HCT
Laboratory Biomarker Analysis: Correlative studies
Melphalan Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV or PO
Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT
Quality-of-Life Assessment: Ancillary studies
Tacrolimus: Given IV
Deaths Number Affected:
9
Deaths Number At Risk:
None
Serious Number Affected:
12
Serious Number At Risk:
19
Other Number Affected:
19
Other Number At Risk:
19
Study:
NCT03128359
Results Section:
NCT03128359
Adverse Events Module:
NCT03128359