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 @ 1:40 PM
Ignite Modification Date:
2025-12-25 @ 12:36 PM
NCT ID:
NCT02379195
Group ID:
EG000
Title:
Arm A: TIL + IFNalpha
Description:
The patients are admitted to hospital day -8 and receive lymphodepleting chemotherapy with cyclophosphamide 60 mg/kg on day -7 and -6 and fludarabine 25 mg/m2 on day -5 to day -1.
TIL infusion: The maximum number of expanded TILs are infused over 30-45 min on day 0
Interleukin-2: Interleukin-2 are administered as a continuous i.v. infusion in a decrescendo regimen (18 MIU/m2 IL-2 over 6 hours, 18 MIU/m2 IL-2 over 12 hours, 18 MIU IL-2 over 24 hours followed by 4.5 MIU/m2 IL-2 over another 24 hours for three days)
Peginterferon alfa-2b: Peginterferon alpha-2b, 3 microgram/kg are administered as subcutaneous injection on day -2, day 7 and day 14.
Deaths Number Affected:
8
Deaths Number At Risk:
None
Serious Number Affected:
4
Serious Number At Risk:
12
Other Number Affected:
12
Other Number At Risk:
12
Study:
NCT02379195
Results Section:
NCT02379195
Adverse Events Module:
NCT02379195