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 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
NCT ID:
NCT03556358
Group ID:
EG000
Title:
TX05 (Trastuzumab)
Description:
• Intravenous (IV) epirubicin, 75 mg/m\^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles
Followed by:
• IV TX05 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles
TX05 (trastuzumab): 8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)
Paclitaxel: 175 mg/m\^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)
Epirubicin: 75 mg/m\^2, IV bolus infusion, every 3 weeks (Cycles 1-4)
Cyclophosphamide: 600 mg/m\^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
11
Serious Number At Risk:
394
Other Number Affected:
246
Other Number At Risk:
394
Study:
NCT03556358
Results Section:
NCT03556358
Adverse Events Module:
NCT03556358