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 @ 5:16 PM
Ignite Modification Date:
2025-12-25 @ 2:53 PM
NCT ID:
NCT04589650
Group ID:
EG006
Title:
Group 2 (6-17 Years) - Placebo Arm
Description:
Group 2: During double-blind randomized study period (from baseline up to Week 16), pediatric participants (6 to 17 years old) will be randomized to receive Placebo (50mg, oral, once daily). After Week 16, participants will be switched to active treatment with alpelisib at the placebo dose level received at the end of the placebo period.
Deaths Number Affected:
1
Deaths Number At Risk:
None
Serious Number Affected:
2
Serious Number At Risk:
28
Other Number Affected:
21
Other Number At Risk:
28
Study:
NCT04589650
Results Section:
NCT04589650
Adverse Events Module:
NCT04589650