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 @ 7:19 PM
Ignite Modification Date:
2025-12-25 @ 4:58 PM
NCT ID:
NCT00460603
Group ID:
EG000
Title:
Phase 1: Axitinib + FOLFOX + Bevacizumab (Cohort 1)
Description:
Bevacizumab 1 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
3
Serious Number At Risk:
6
Other Number Affected:
6
Other Number At Risk:
6
Study:
NCT00460603
Results Section:
NCT00460603
Adverse Events Module:
NCT00460603