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 @ 11:48 PM
Ignite Modification Date:
2025-12-25 @ 9:42 PM
NCT ID:
NCT04129151
Group ID:
EG000
Title:
PALBOCICLIB and GANITUMAB
Description:
Participants receive up to 12 cycles of therapy (cycle duration=28 days).
Palbociclib: Oral, 100mg, daily on days 1-21 Ganitumab: Intravenous, 18mg/kg, days 1, 15
Per protocol, participants were monitored for dose-limiting toxicity over cycle one according to an interim safety analysis. The safety monitoring rule was triggered after 3 patients had enrolled, prompting an amendment according to Contingency Plan A which was a reduction of the palbociclib dose from 125mg (days 1-21).
Deaths Number Affected:
6
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
10
Other Number Affected:
10
Other Number At Risk:
10
Study:
NCT04129151
Results Section:
NCT04129151
Adverse Events Module:
NCT04129151