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 @ 7:49 PM
Ignite Modification Date:
2025-12-25 @ 5:25 PM
NCT ID:
NCT00524303
Group ID:
EG001
Title:
Lapatinib
Description:
Participants received lapatinib alone (1250 mg orally \[PO\] once daily \[QD\]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m\^2, epirubicin 75 mg/m\^2, cyclophosphamide 500 mg/m\^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
7
Serious Number At Risk:
34
Other Number Affected:
34
Other Number At Risk:
34
Study:
NCT00524303
Results Section:
NCT00524303
Adverse Events Module:
NCT00524303