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 @ 4:34 PM
Ignite Modification Date:
2025-12-25 @ 2:25 PM
NCT ID:
NCT00119366
Group ID:
EG003
Title:
Dose Level 9: 26 Gy Iodine-131+ BC8 Monoclonal Antibody
Description:
RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.
CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.
IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.
iodine I 131 monoclonal antibody BC8: Given IV
fludarabine phosphate: Given IV
total-body irradiation: Undergo TBI
allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation
peripheral blood stem cell transplantation: Undergo PBSC transplantation
cyclosporine: Given IV or PO
mycophenolate mofetil: Given PO
laboratory biomarker analysis: Correlative studies
Deaths Number Affected:
2
Deaths Number At Risk:
None
Serious Number Affected:
2
Serious Number At Risk:
2
Other Number Affected:
2
Other Number At Risk:
2
Study:
NCT00119366
Results Section:
NCT00119366
Adverse Events Module:
NCT00119366