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 @ 3:09 AM
Ignite Modification Date:
2025-12-26 @ 1:48 AM
NCT ID:
NCT00717405
Group ID:
EG000
Title:
Bevacizumab + Trastuzumab
Description:
Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m\^2 IV 5-fluorouracil, 100 mg/m\^2 IV epirubicin, and 500 mg/m\^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m\^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative \[neoadjuvant + adjuvant\] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
20
Serious Number At Risk:
52
Other Number Affected:
52
Other Number At Risk:
52
Study:
NCT00717405
Results Section:
NCT00717405
Adverse Events Module:
NCT00717405