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 @ 9:32 PM
Ignite Modification Date:
2025-12-25 @ 7:16 PM
NCT ID:
NCT04938232
Group ID:
EG000
Title:
Disease Progression After Previous Therapy
Description:
Participants will receive Ipilimumab alone and depending on response will receive either a maintenance course of Ipilimumab or a course of Nivolumab and Ipilimumab in combination followed by a maintenance course of Ipilimumab. Patients who have progressive disease after fewer than 4 cycles of ipilimumab are also eligible to proceed to combination therapy with nivolumab and ipilimumab, if they are clinically stable.
* Ipilimumab Monotherapy: Every 3 weeks for 4 study cycles
* Complete Response/Partial Response: Maintenance Ipilimumab every 12 weeks for 8 cycles
* Stable or Progressive Disease Response: Nivolumab and Ipilimumab every 3 weeks for 4 study cycles, followed by Maintenance Ipilimumab every 12 weeks for 7 cycles
Nivolumab: Intravenous infusion
Ipilimumab: Intravenous infusion
Deaths Number Affected:
1
Deaths Number At Risk:
None
Serious Number Affected:
6
Serious Number At Risk:
13
Other Number Affected:
13
Other Number At Risk:
13
Study:
NCT04938232
Results Section:
NCT04938232
Adverse Events Module:
NCT04938232