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 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
NCT ID:
NCT01690520
Group ID:
EG000
Title:
Arm I (Standard of Care)
Description:
CONDITIONING REGIMEN: One of two possible conditioning regimens is chosen by the attending physician: Patients receive fludarabine phosphate IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 to -6., and undergo high dose TBI BID on days -4 to -1 OR Patients receive fludarabine phosphate IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 4 hours on days -5 to -4, and undergo middle intensity TBI QD on days -2 to -1.
TRANSPLANT: Patients undergo single-unit or double-unit unmanipulated UCB transplant on day 0.
GVHD PROPHYLAXIS: Patients receive cyclosporine IV over 1 hour BID (adults) or TID (children) or PO on days -3 to 100 with taper beginning on day 101. Patients also receive MMF IV TID a day on days 0-7 then may receive MMF PO TID. Patients remain on MMF TID for a minimum of 30 days, and then may begin a taper if there is no evidence of GVHD and are well-engrafted from one donor unit.
Cyclophosphamide: Given IV
Cyclosporine: Given IV or PO
Fludarabine Phosphate: Given IV
Mycophenolate Mofetil: Given IV or PO
Thiotepa: Given IV
Total-Body Irradiation: Undergo high dose or middle intensity TBI
Umbilical Cord Blood Transplantation: Undergo single-unit or double-unit unmanipulated umbilical cord blood transplant
Deaths Number Affected:
25
Deaths Number At Risk:
None
Serious Number Affected:
48
Serious Number At Risk:
78
Other Number Affected:
71
Other Number At Risk:
78
Study:
NCT01690520
Results Section:
NCT01690520
Adverse Events Module:
NCT01690520