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 @ 3:57 PM
Ignite Modification Date:
2025-12-25 @ 2:00 PM
NCT ID:
NCT00578292
Group ID:
EG000
Title:
Bone Marrow or Stem Cell Infusion
Description:
Mesna, Cyclophosphamide, Busulfan, Fludarabine, Campath 1H
Bone Marrow or Stem Cell infusion with pre-meds to take place on Day 0.
Bone marrow dose/stem cell dose: To ensure the probability for bone marrow engraftment, 4 x 10e8 nucleated cells/kg patient weight or 5 x 10e6/kg of CD34+ cells/kg patient weight if the product is mobilized peripheral blood, will be the target to be obtained from the unrelated donor.
Busulfan: 4.0 mg/kg/day divided into four doses daily for four days; total dose = 16 mg/kg
Days -9 through -6
Fludarabine: 30mg/m2 Day -5 through Day -2
Campath 1H: Per institutional guidelines Days -5 through -2
Cyclophosphamide: 50 mg/kg Days -5 through -2
MESNA: 10 mg/kg x 5 Days -5 through -2
Deaths Number Affected:
1
Deaths Number At Risk:
None
Serious Number Affected:
4
Serious Number At Risk:
10
Other Number Affected:
9
Other Number At Risk:
10
Study:
NCT00578292
Results Section:
NCT00578292
Adverse Events Module:
NCT00578292