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 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
NCT ID:
NCT02046733
Group ID:
EG001
Title:
Nivolumab + Ipilimumab
Description:
* Induction phase to start within 6-8 weeks (42-56 days) after the start of chemotherapy cycle 4, and not more than 2 weeks (14 days) after the date of randomisation): Nivolumab at a dose of 1 mg/kg i.v. over a period of 30 minutes followed (on the same day) by Ipilimumab at a dose of 3 mg/kg i.v. over a period of 90 minutes once every 3 weeks (+/- 3 days, without dosing delay), for 4 cycles.
* Maintenance phase (to start 3 weeks (21 days) after the last IMP dose of induction phase): Nivolumab 240 mg i.v. over a period of 30 minutes, once every 2 weeks (+/- 2 days, without dosing delay), for a maximum of 12 months from the start of maintenance phase.
Deaths Number Affected:
34
Deaths Number At Risk:
None
Serious Number Affected:
48
Serious Number At Risk:
78
Other Number Affected:
72
Other Number At Risk:
78
Study:
NCT02046733
Results Section:
NCT02046733
Adverse Events Module:
NCT02046733