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 @ 3:54 PM
Ignite Modification Date:
2025-12-25 @ 1:59 PM
NCT ID:
NCT01869192
Group ID:
EG000
Title:
Arm A
Description:
Arm A: Epirubicin 90 mg/m2 day 1 IV and Cyclophosphamide 600 mg/m2 day 1 IV q 3 weeks for 4 cycles, then surgery, then Docetaxel 75 mg/m2 IV day 1 plus Capecitabine 1000 mg/m2/dose po bid x 14 days q 3 weeks for 4 cycles, then radiation therapy as indicated. Post surgical chemotherapy must be initiated within 35 days after completion of definitive surgical treatment
Epirubicin: Epirubicin 90 mg/m2 d1 q3w
Cyclophosphamide: Cyclophosphamide 600 mg/m2 d1 q3w
Radiation Therapy: Standard dosing, fields depending on clinical findings
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
37
Other Number Affected:
0
Other Number At Risk:
37
Study:
NCT01869192
Results Section:
NCT01869192
Adverse Events Module:
NCT01869192