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:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-26 @ 10:59 AM
NCT ID:
NCT01998906
Group ID:
EG000
Title:
HER2+ TC
Description:
Participants with HER2+ breast cancer received treatment as follows:
Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off.
Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off.
Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, (collectively CMF) on Day 1, followed by 2 weeks off.
Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Days 1 and 8, followed by 1 week off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
18
Serious Number At Risk:
115
Other Number Affected:
113
Other Number At Risk:
115
Study:
NCT01998906
Results Section:
NCT01998906
Adverse Events Module:
NCT01998906