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:
EG001
Title:
Arm II (Experimental)
Description:
CONDITIONING REGIMEN: Patients receive the conditioning regimen chosen by the attending physician as in Standard of Care Arm.
TRANSPLANT: Patients undergo single-unit or double-unit unmanipulated UCB transplant on day 0. Patients also undergo infusion of ex vivo-expanded cord blood progenitor cell infusion at least 4 hours after completion of UCB transplant.
GVHD PROPHYLAXIS: Patients receive cyclosporine IV or PO and mycophenolate mofetil IV or PO as in Standard of Care Arm.
Cyclophosphamide: Given IV
Cyclosporine: Given IV or PO
Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion: Given IV
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:
21
Deaths Number At Risk:
None
Serious Number Affected:
55
Serious Number At Risk:
82
Other Number Affected:
73
Other Number At Risk:
82
Study:
NCT01690520
Results Section:
NCT01690520
Adverse Events Module:
NCT01690520