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 @ 9:06 PM
Ignite Modification Date:
2025-12-25 @ 6:57 PM
NCT ID:
NCT03475004
Group ID:
EG000
Title:
Safety run-in
Description:
Ten patients will be accrued to stage 1 and treated with standard doses of pembrolizumab, binimetinib and bevacizumab. If the standard doses are not tolerable and 2 or more patients experience a DLT, then patients would be enrolled in dose level -1 which would comprise of standard doses of pembrolizumab and bevacizumab but binimetinib would be at a dose lower of 30 mg PO BID. If 2 or more patients experience a DLT at dose level-1, then patients will be enrolled in dose level -2 which will comprise of standard doses of pembrolizumab and bevacizumab but a lower dose of binimetinib at 15 mg BID. Upon determination of the safety and tolerability of the treatment regimen, the study will proceed to stage 2.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
3
Serious Number At Risk:
11
Other Number Affected:
11
Other Number At Risk:
11
Study:
NCT03475004
Results Section:
NCT03475004
Adverse Events Module:
NCT03475004