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 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
NCT ID:
NCT03254394
Group ID:
EG000
Title:
Placebo + FOLFOX
Description:
Intravenous infusion of D5W solution over a 130 minute period.
FOLFOX:
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
Placebo: Dextrose 5% in water will be administered as active comparator.
FOLFOX regimen: Each cycle (repeated every 14 days):
Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
12
Other Number Affected:
6
Other Number At Risk:
12
Study:
NCT03254394
Results Section:
NCT03254394
Adverse Events Module:
NCT03254394