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 @ 4:18 PM
Ignite Modification Date:
2025-12-25 @ 2:15 PM
NCT ID:
NCT03487666
Group ID:
EG002
Title:
Arm C Nivolumab + Capecitabine
Description:
Nivolumab 360mg iv q3weeks + Capecitabine 1250mg/m2 bid D1-D14 q3 weeks x 6 cycles
Nivolumab: Nivolumab is a human programmed death receptor-1 (PD-1) antibody currently approved in different diseases.
Capecitabine: Capecitabine was selected for Arm B given the recent results from CREATE-X trial and the increasing use by the community (feasibility). Importantly, available data from other scenarios indicates that capecitabine does not have immunosuppressive effects
Deaths Number Affected:
2
Deaths Number At Risk:
None
Serious Number Affected:
3
Serious Number At Risk:
15
Other Number Affected:
15
Other Number At Risk:
15
Study:
NCT03487666
Results Section:
NCT03487666
Adverse Events Module:
NCT03487666