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 @ 10:54 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
NCT ID:
NCT00439569
Group ID:
EG000
Title:
Cohorts 1 & 2 (500 mg/kg/Day)
Description:
Cohort 1 was assigned a dosage of 500 mg/kg/day. One subject was replaced due to an allergic reaction and four subjects due to less than 80 percent study drug compliance. Due to these replacements, more than 3 subjects were enrolled in the first cohort. Cohort 2 was assigned a dosage of 500 mg/kg/day by the MCRM and approved by the SMC due to dose-limiting toxicities experienced in Cohort 1. For the purpose of reporting adverse events, these two cohorts were combined for a total of 9 enrolled subjects.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
9
Other Number Affected:
9
Other Number At Risk:
9
Study:
NCT00439569
Results Section:
NCT00439569
Adverse Events Module:
NCT00439569