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 @ 1:37 PM
Ignite Modification Date:
2025-12-25 @ 12:36 PM
NCT ID:
NCT01773395
Group ID:
EG000
Title:
GVAX
Description:
GVAX vaccine
Participants in the GVAX vaccine arm will undergo a conditioning regimen with busulfan and fludarabine prior to allogeneic hematopoietic stem cell transplant. Immediately after allogeneic hematopoietic stem cell transplant participants will start tacrolimus and methotrexate to prevent GVHD.
Conditioning regimen: In this study the condition regimen will include 2 chemotherapy drugs: busulfan (twice a day or four times a day for 4 days) and fludarabine (once daily for 4 days). Depending on participant's age, and other clinical factors, the transplant doctor will decide whether the participant will receive a higher or lower dose of busulfan.
Allogeneic Hematopoietic Stem Cell Transplant: Between 1-2 days after participant finishes the chemotherapy, the participant will receive the blood stem cell or marrow from their donor.
GVHD Prevention:
* Tacrolimus- This will be taken orally twice daily start 3 days before the transplant, and will continue for about 6-9 months.
* Methotrexate- This will be given a short intravenous infusion on days 1, 3, 6, and 11 after the transplant.
GVAX: GVAX vaccination will begin between 30 to 45 days following participant's transplant, provided participant meets vaccination initiation criteria.
Deaths Number Affected:
14
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
30
Other Number Affected:
10
Other Number At Risk:
30
Study:
NCT01773395
Results Section:
NCT01773395
Adverse Events Module:
NCT01773395