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 @ 2:34 PM
Ignite Modification Date:
2025-12-25 @ 1:06 PM
NCT ID:
NCT02551159
Group ID:
EG002
Title:
Standard of Care (SOC)
Description:
either cisplatin (at a dose of 100 mg/m2 of body surface area as an IV infusion) or carboplatin (at an area under the concentration curve of 5 mg/mL/min as an IV infusion) on Day 1 of up to six 3-week cycles, and an infusion of 5-fluorouracil (5FU) (at a dose of 1000 mg/m2/day on Days 1 through 4) every 3 weeks, along with 400 mg/m2 of cetuximab on Cycle 1 Day 1 and 250 mg/m2 weekly for up to 6 cycles and maintenance cetuximab at 250 mg/m2 administered via IV infusion weekly thereafter in patients who achieved stable disease (SD) or better upon completion of chemotherapy until disease progression, toxicity, or withdrawal of consent
Deaths Number Affected:
171
Deaths Number At Risk:
None
Serious Number Affected:
94
Serious Number At Risk:
196
Other Number Affected:
182
Other Number At Risk:
196
Study:
NCT02551159
Results Section:
NCT02551159
Adverse Events Module:
NCT02551159