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 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
NCT ID:
NCT00542451
Group ID:
EG000
Title:
Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer
Description:
80 mg of paclitaxel per square meter of body-surface area weekly for 12 weeks and a loading dose of 4 mg of intravenous trastuzumab per kilogram of body weight on day 1, followed by 2 mg per kilogram weekly, for a total of 12 doses. After the completion of 12 weeks of treatment with Trastuzumab, the dosing of Trastuzumab could be continued on a weekly basis, or the regimen could be changed to 6 mg per kilogram every 3 weeks for 40 weeks to complete a full year of intravenous treatment with trastuzumab.
Deaths Number Affected:
2
Deaths Number At Risk:
None
Serious Number Affected:
60
Serious Number At Risk:
406
Other Number Affected:
406
Other Number At Risk:
406
Study:
NCT00542451
Results Section:
NCT00542451
Adverse Events Module:
NCT00542451