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:
EG000
Title:
Phase 1b: Cohort 1: Golvatinib 200 mg + Cetuximab 400 mg/m^2
Description:
Participants with platinum-resistant SCCHN received golvatinib 200 mg tablets, orally, once daily (run-in period) 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 for determining MTD or RP2D, 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:
3
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
4
Other Number Affected:
4
Other Number At Risk:
4
Study:
NCT01332266
Results Section:
NCT01332266
Adverse Events Module:
NCT01332266