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 @ 7:00 PM
Ignite Modification Date:
2025-12-25 @ 4:33 PM
NCT ID:
NCT01740557
Group ID:
EG000
Title:
Treatment (Genetically Modified T-cells, High-dose Aldesleukin
Description:
Participants receive cyclophosphamide IV over 2 hours on days -7 and -6, fludarabine phosphate IV daily over 15-30 minutes on days -5 to -1, and CXCR2-transduced autologous TIL and NGFR-transduced autologous TIL IV over up to 4 hours on day 0. Participants then receive high-dose aldesleukin IV over 15 minutes every 8-16 hours on days 1-5 (up to 15 doses) and 22-26 (up to 15 doses).
Aldesleukin: Given IV
CXCR2-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
NGFR-transduced Autologous T Lymphocytes: Given IV
Quality-of-Life Assessment: Ancillary studies
Deaths Number Affected:
1
Deaths Number At Risk:
None
Serious Number Affected:
8
Serious Number At Risk:
8
Other Number Affected:
8
Other Number At Risk:
8
Study:
NCT01740557
Results Section:
NCT01740557
Adverse Events Module:
NCT01740557