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 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
NCT ID:
NCT01702558
Group ID:
EG003
Title:
Phase 2 (mBC): T-DM1 + Cape
Description:
In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle along with capecitabine at a dose level of 700 mg/m\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.
Deaths Number Affected:
18
Deaths Number At Risk:
None
Serious Number Affected:
11
Serious Number At Risk:
82
Other Number Affected:
75
Other Number At Risk:
82
Study:
NCT01702558
Results Section:
NCT01702558
Adverse Events Module:
NCT01702558