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 @ 4:56 PM
Ignite Modification Date:
2025-12-25 @ 2:38 PM
NCT ID:
NCT01008150
Group ID:
EG001
Title:
Arm 2: Paclitaxel + Neratinib Then A C
Description:
4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Neratinib 240 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Neratinib
Doxorubicin
Cyclophosphamide
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
7
Serious Number At Risk:
42
Other Number Affected:
42
Other Number At Risk:
42
Study:
NCT01008150
Results Section:
NCT01008150
Adverse Events Module:
NCT01008150