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 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 12:34 AM
NCT ID:
NCT00201760
Group ID:
EG000
Title:
Arm 1 Gemcitabine/Cisplatin/Trastuzumab
Description:
Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Cisplatin 30 mg/m2 iv over 90 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only).
Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8.
Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly.
Cisplatin: 30 mg/m2 IV on Day 1 and Day 8.
Deaths Number Affected:
1
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
5
Other Number Affected:
5
Other Number At Risk:
5
Study:
NCT00201760
Results Section:
NCT00201760
Adverse Events Module:
NCT00201760