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 @ 7:47 PM
Ignite Modification Date:
2025-12-25 @ 5:24 PM
NCT ID:
NCT01904903
Group ID:
EG000
Title:
HER2 Therapies, Cardiac Medications
Description:
Cardiac intervention - beta-blockers and ACE-inhibitors titrated to the maximum tolerated doses
Oncology intervention - patients will receive one of the three following HER2 targeted therapies at the discretion of the treating oncologist:
* Trastuzumab: loading dose of 8 mg/kg IV, followed by a maintenance dose of 6 mg/kg every 3 weeks, or a loading dose of 4 mg/kg followed by a maintenance dose of 2 mg/kg every week.
* Pertuzumab: loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks, administered concomitantly with trastuzumab.
* Ado trastuzumab emtansine (TDM1): 3.6mg/kg IV every three weeks.
Trastuzumab: HER2 therapy
Pertuzumab: HER2 therapy
Ado Trastuzumab Emtansine: HER2 therapy
Deaths Number Affected:
1
Deaths Number At Risk:
None
Serious Number Affected:
3
Serious Number At Risk:
30
Other Number Affected:
0
Other Number At Risk:
30
Study:
NCT01904903
Results Section:
NCT01904903
Adverse Events Module:
NCT01904903