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 @ 1:09 AM
Ignite Modification Date:
2025-12-25 @ 11:20 PM
NCT ID:
NCT03448393
Group ID:
EG000
Title:
GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%)
Description:
Lymphodepleting chemotherapy regimen with Fludarabine and Cyclophosphamide.
Fludarabine: Fludarabine is administered as an intravenous (IV) infusion in an appropriate solution over 30 minutes. The dose will be based on body surface area (BSA) at 25 mg/m\^2/dose on Day -4, -3, -2.
Cyclophosphamide: Cyclophosphamide will be diluted in an appropriate solution and infused over one hour. The dose will be based on the body surface area (BSA) at 900 mg/m\^2/dose after fludarabine infusion on Day -2.
Cluster of differentiation 19 (CD19)/cluster of differentiation 22 (CD22)-chimeric antigen receptor (CAR)-transduced T cells Dose Level 1, 3 x10\^5 transduced T cells/kg (+or-20%) infused on Day 0 after lymphodepleting chemotherapy regimen.
Deaths Number Affected:
4
Deaths Number At Risk:
None
Serious Number Affected:
2
Serious Number At Risk:
4
Other Number Affected:
4
Other Number At Risk:
4
Study:
NCT03448393
Results Section:
NCT03448393
Adverse Events Module:
NCT03448393