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 @ 3:23 PM
Ignite Modification Date:
2025-12-25 @ 1:41 PM
NCT ID:
NCT04738292
Group ID:
EG000
Title:
Onapristone In Combination With Fulvestrant
Description:
All participants will receive onapristone 50 mg p.o. BID (twice) daily and fulvestrant (500 mg) intramuscular injection on days 1, 15 (cycle 1), then two weeks later (cycle 2, day1), then once every 28 days thereafter. A cycle is defined as 28 days.
There will be no breaks between dosing cycles.
Onapristone: Onapristone is a type I antiprogestin which prevents the PgR from dimerizing and blocks ligand induced protein kinase-mediated phosphorylation of the PgR.
Fulvestrant: Fulvestrant binds, blocks and degrades the ER, completely inhibiting ER signaling.
Deaths Number Affected:
1
Deaths Number At Risk:
None
Serious Number Affected:
3
Serious Number At Risk:
11
Other Number Affected:
11
Other Number At Risk:
11
Study:
NCT04738292
Results Section:
NCT04738292
Adverse Events Module:
NCT04738292