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 @ 4:47 PM
Ignite Modification Date:
2025-12-25 @ 2:33 PM
NCT ID:
NCT01105650
Group ID:
EG002
Title:
Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2
Description:
Fludarabine: Administered intravenously, 25 mg/m\^2, days -6 through -2 (5 days).
Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.
Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14
Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10\^7 cells/kg will be given.
Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m\^2 3 times per week for 6 doses).
Methylprednisolone: Administered intravenously, 1 mg/kg Days -2 to +9
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
5
Serious Number At Risk:
7
Other Number Affected:
7
Other Number At Risk:
7
Study:
NCT01105650
Results Section:
NCT01105650
Adverse Events Module:
NCT01105650