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 @ 4:36 PM
Ignite Modification Date:
2025-12-25 @ 2:27 PM
NCT ID:
NCT01332266
Group ID:
EG003
Title:
Phase 2: Arm 1: Golvatinib 400 mg + Cetuximab 400 mg/m^2
Description:
Participants with platinum-resistant SCCHN received golvatinib 400 mg (RP2D) tablets, orally, once daily and cetuximab 400 mg/m\^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m\^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After 6 cycles, at the discretion of the investigator, participants who experienced clinical benefit could continue for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
Deaths Number Affected:
33
Deaths Number At Risk:
None
Serious Number Affected:
15
Serious Number At Risk:
42
Other Number Affected:
42
Other Number At Risk:
42
Study:
NCT01332266
Results Section:
NCT01332266
Adverse Events Module:
NCT01332266