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 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
NCT ID:
NCT01517802
Group ID:
EG000
Title:
Abiraterone Acetate + Prednisone/Prednisolone
Description:
Participants who received at least 3 months of abiraterone acetate treatment in previously completed abiraterone acetate studies (COU-AA-001 \[NCT00473512\], COU-AA-002 \[NCT00473746\], COU-AA-006 \[NCT00910754\], COU-AA-206 \[NCT01400555\], COU-AA-301 \[NCT00638690\], COU-AA-302 \[NCT00887198\], COU-AA-BMA \[NCT00544440\]) continued to receive abiraterone acetate 1000 milligrams (mg) (four 250 mg tablets) along with low dose corticosteroid (prednisone/prednisolone) 5 mg tablet orally twice daily starting Day 1 Cycle 1 (each cycle was of 28 days) according to dosing regimen established in the previously completed study until the investigator determined that the participant no longer received benefit or the sponsor terminated the study or the participant had continued the treatment in this study and were followed-up for safety for up to 9 years.
Deaths Number Affected:
1
Deaths Number At Risk:
None
Serious Number Affected:
16
Serious Number At Risk:
31
Other Number Affected:
0
Other Number At Risk:
31
Study:
NCT01517802
Results Section:
NCT01517802
Adverse Events Module:
NCT01517802