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 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
NCT ID:
NCT04688658
Group ID:
EG000
Title:
Duvelisib (15mg) + Nivolumab (240mg)
Description:
Phase 1:
Duvelisib,15mg once a day, 12 hours a part, to determine the recommended dose for the Phase II study when combined with nivolumab.
Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor)
Phase II: The Recommended Phase II dosage of duvelisib administered will not be determined until Phase I is completed.
Nivolumab, 480mg, IV, every 4 weeks, for up to 1 year.
Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer.
Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Deaths Number Affected:
7
Deaths Number At Risk:
None
Serious Number Affected:
6
Serious Number At Risk:
7
Other Number Affected:
7
Other Number At Risk:
7
Study:
NCT04688658
Results Section:
NCT04688658
Adverse Events Module:
NCT04688658