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 @ 5:23 PM
Ignite Modification Date:
2025-12-25 @ 2:58 PM
NCT ID:
NCT03093350
Group ID:
EG000
Title:
TAA-Specific CTLs
Description:
Patients receiving TAA-specific CTLs as therapy for breast cancer.
TAA-specific CTLs: Each patient will receive 2 injections at a fixed dose, 28 days apart, according to the following dose schedule: The expected volume of infusion will be 1 to 10 cc.
Dose schedule:
Day 0: 2 x 10\^7 cells/m2
Day 28: 2 x 10\^7 cells/m2
If patients have stable disease or a partial response by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria at their 6 week evaluation after the 2nd cell dose, they will be eligible to receive up to 6 additional doses of CTLs, At least one month should have passed before each additional dose.. Each additional infusion will consist of the same cell number or less (if there is not enough product available for the subject's original dose) than their second infusion. Patients will not be able to receive additional doses until the initial safety profile is completed at 6 weeks following the second infusion.
Deaths Number Affected:
5
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
10
Other Number Affected:
7
Other Number At Risk:
10
Study:
NCT03093350
Results Section:
NCT03093350
Adverse Events Module:
NCT03093350