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 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
NCT ID:
NCT01749293
Group ID:
EG000
Title:
Haploidentical Transplant
Description:
All subjects will be dosed with pre-transplant Fludarabine (180mg/m2)and Busulfan total AUC 2400 μmol\*min/L or 6.4mg/kg. Subjects will then undergo total body irradiation 2Gy. Subjects will undergo haploidentical allogeneic bone marrow transplant, followed by Cyclophosphamide, Tacrolimus and MMF based GVHD prophylaxis.
Fludarabine: Subjects in this trial will receive Fludarabine 30 mg/m2 IV QD, adjusted for CrCl from Days -8 through -3.
Busulfan: Subjects in this trial will receive Busulfan total AUC 2400 μmol\*min/L or 6.4mg/kg in 4 doses with seizure prophylaxis from Days -6 through -3.
Total Body Irradiation: Subjects in this trial will receive total body irradiation (2Gy fractionated) from Day -2 or -1.
Cyclophosphamide: Subjects in this trial will receive Cyclophosphamide 50 mg/kg IV QD on Days 3 and 4 post-transplant.
Deaths Number Affected:
2
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
3
Other Number Affected:
0
Other Number At Risk:
3
Study:
NCT01749293
Results Section:
NCT01749293
Adverse Events Module:
NCT01749293