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 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
NCT ID:
NCT00568633
Group ID:
EG000
Title:
Allo-HSCT + TLI + ATG
Description:
Participants achieving complete remission after consolidation therapy \& who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:
* Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)
* Anti-thymocyte globulin (ATG) Days -11 to -7
* Methylprednisolone Days -11 to -7
* Cyclosporine (CSP) Days -4 to +2
* 5+ of 6 HLA-matched CD34+ cells on Day 0
* Mycophenolate mofetil (MMF), Day 0 to Day +28
Allogeneic HSCT: Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and \< 7 x 10e8 CD3+ cells/kg.
Anti-thymocyte globulin (ATG): 1.5 mg/kg for 5 days by IV
Cyclosporine (CSP): 6.25 mg/kg twice daily oral
Mycophenolate mofetil (MMF): 15 mg/kg twice daily oral
Total lymphoid irradiation (TLI): 80 cGy/fraction radiotherapy in 10 fractions.
Methylprednisolone sodium succinate: 1.0 mg/kg for 5 days by IV
Deaths Number Affected:
16
Deaths Number At Risk:
None
Serious Number Affected:
20
Serious Number At Risk:
25
Other Number Affected:
0
Other Number At Risk:
25
Study:
NCT00568633
Results Section:
NCT00568633
Adverse Events Module:
NCT00568633