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 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 11:09 PM
NCT ID:
NCT03769467
Group ID:
EG002
Title:
Cohort 2: Checkpoint Inhibitor Naïve
Description:
Checkpoint inhibitor naive subjects during the treatment phase received IV infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to \< 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10\^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84- day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
0
Other Number Affected:
0
Other Number At Risk:
0
Study:
NCT03769467
Results Section:
NCT03769467
Adverse Events Module:
NCT03769467