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 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
NCT ID:
NCT01468818
Group ID:
EG000
Title:
Immunotherapy for Metastatic Melanoma
Description:
Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
18
Other Number Affected:
18
Other Number At Risk:
18
Study:
NCT01468818
Results Section:
NCT01468818
Adverse Events Module:
NCT01468818