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 @ 5:23 PM
Ignite Modification Date:
2025-12-25 @ 2:58 PM
NCT ID:
NCT01779050
Group ID:
EG001
Title:
Arm II (Definitive Therapy, Trastuzumab)
Description:
Patients receive definitive surgery and best practice standard chemotherapy according to NCCN guidelines. The 5 chemo backbone options are:
* doxorubicin or epirubicin plus cyclophosphamide followed by paclitaxel or docetaxel
* docetaxel plus cyclophosphamide
* single-agent paclitaxel
* docetaxel plus carboplatin
* fluorouracil plus epirubicin plus cyclophosphamide followed by paclitaxel or docetaxel
Patients will also receive trastuzumab IV over 30-90 minutes for 52 weeks starting such that there is a minimum of 8 weeks of overlap with the standard of care chemotherapy. Trastuzumab may be given weekly, every 2 weeks, or every 3 weeks while overlapping with standard of care chemotherapy. Trastuzumab will be given every 3 weeks after all standard of care chemotherapy has concluded. Treatment continues in the absence of disease progression or unacceptable toxicity.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
3
Other Number Affected:
3
Other Number At Risk:
3
Study:
NCT01779050
Results Section:
NCT01779050
Adverse Events Module:
NCT01779050