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 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
NCT ID:
NCT01797120
Group ID:
EG000
Title:
Fulvestrant & Everolimus
Description:
Fulvestrant Day 1 \& 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus everolimus daily x 12 cycles.
Fulvestrant: Fulvestrant 500 mg Day 1 \& 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).
If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.
Everolimus: Everolimus 10 mg (2 tablets) daily x 12 cycles.
If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.
Deaths Number Affected:
30
Deaths Number At Risk:
None
Serious Number Affected:
31
Serious Number At Risk:
64
Other Number Affected:
59
Other Number At Risk:
64
Study:
NCT01797120
Results Section:
NCT01797120
Adverse Events Module:
NCT01797120