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 @ 4:25 PM
Ignite Modification Date:
2025-12-25 @ 2:19 PM
NCT ID:
NCT04109066
Group ID:
EG003
Title:
Arm B: Nivo Placebo + Chemo (PTX QW + AC Q2W) / ET
Description:
Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:
Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW
Followed by:
Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W):
Nivolumab Placebo Q2W + AC Q2W
Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:
Adjuvant Cycles 1-7 (1 cycle = Q4W):
Endocrine Therapy (ET)
Deaths Number Affected:
4
Deaths Number At Risk:
None
Serious Number Affected:
26
Serious Number At Risk:
132
Other Number Affected:
130
Other Number At Risk:
132
Study:
NCT04109066
Results Section:
NCT04109066
Adverse Events Module:
NCT04109066