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 @ 9:49 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
NCT ID:
NCT00971932
Group ID:
EG000
Title:
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)
Description:
Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m\^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m\^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m\^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m\^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 \[AUC5\]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
12
Serious Number At Risk:
33
Other Number Affected:
33
Other Number At Risk:
33
Study:
NCT00971932
Results Section:
NCT00971932
Adverse Events Module:
NCT00971932