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 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
NCT ID:
NCT02489318
Group ID:
EG000
Title:
Placebo + Androgen Deprivation Therapy (ADT)
Description:
Participants received matching placebo (4 tablets) orally once daily (qd) along with ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. In the event of a positive result at interim or final analysis participants in treatment phase had opportunity to receive Apalutamide +ADT. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
Deaths Number Affected:
35
Deaths Number At Risk:
None
Serious Number Affected:
115
Serious Number At Risk:
527
Other Number Affected:
485
Other Number At Risk:
527
Study:
NCT02489318
Results Section:
NCT02489318
Adverse Events Module:
NCT02489318