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 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:26 AM
NCT ID:
NCT01998633
Group ID:
EG000
Title:
Hematopoietic Stem Cell Transplant
Description:
Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
Hematopoietic Stem Cell Transplant: NOTE: The - sign is the number of days before the transplant and the + sign is the number of days after the transplant.
* Alemtuzumab 0.2mg/kg Day-14,-13,-12,-11,-10
* Fludarabine 30 mg/m2 on Day -8,-7,-6,-5,-4
* Melphalan 140mg/m2 on Day -3
The GVHD prophylaxis will consist of the following:
* Cyclosporine on Day -3 to Day +100, maintaining a level of 250-500 ng/mL, then taper to Day +180.
* Methylprednisolone 2 mg/kg/day on Day -2 and -1, 1 mg/kg/day on Day 0 to Day +28, then taper over 1 month. Oral prednisone may be substituted starting on Day 0 (1.2 mg/kg/day)
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
14
Serious Number At Risk:
46
Other Number Affected:
0
Other Number At Risk:
46
Study:
NCT01998633
Results Section:
NCT01998633
Adverse Events Module:
NCT01998633