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 @ 9:29 PM
Ignite Modification Date:
2025-12-25 @ 7:14 PM
NCT ID:
NCT01350232
Group ID:
EG000
Title:
HSCT
Description:
Subjects receive the preparative regimen in 2 steps. The "first step" will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the "first step" of the transplant graft - the donor lymphocytes. The "second step" of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the "second step" of the transplant graft - the stem cells.
Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.
Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen
Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine
Cellular Infusions: Subjects will receive the cellular
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
2
Other Number Affected:
2
Other Number At Risk:
2
Study:
NCT01350232
Results Section:
NCT01350232
Adverse Events Module:
NCT01350232