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 @ 1:35 PM
Ignite Modification Date:
2025-12-25 @ 12:35 PM
NCT ID:
NCT01210495
Group ID:
EG003
Title:
Placebo
Description:
Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration (up to a maximum of 55 cycles). The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
16
Serious Number At Risk:
68
Other Number Affected:
55
Other Number At Risk:
68
Study:
NCT01210495
Results Section:
NCT01210495
Adverse Events Module:
NCT01210495