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 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 10:00 PM
NCT ID:
NCT01012258
Group ID:
EG001
Title:
Cetuximab: Late Phase
Description:
Participants received cetuximab 400 milligram/square meter (mg/m\^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m\^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy: 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially, once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses were separated by at least a 6-hour interval. Late phase, i.e. adverse events which occur or worsen more than 60 days after the last trial treatment administration (cetuximab or radiotherapy), and before end of trial.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
14
Serious Number At Risk:
62
Other Number Affected:
20
Other Number At Risk:
62
Study:
NCT01012258
Results Section:
NCT01012258
Adverse Events Module:
NCT01012258