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 @ 4:26 PM
Ignite Modification Date:
2025-12-25 @ 2:19 PM
NCT ID:
NCT02365766
Group ID:
EG002
Title:
Phase II Cohort II: Cisplatin Ineligible -Pembrolizumab 200 mg
Description:
Cisplatin ineligible (receive treatment in Phase II only): Cisplatin ineligible subjects receive gemcitabine every week (weekly) for three consecutive weeks, repeated every 28 days for 3 cycles. Pembrolizumab is given every 3 weeks for 5 doses starting with Cycle 1 Day 8 (C1D8). NOTE: due to the timing of gemcitabine cycles every 4 weeks, and every three week dosing of pembrolizumab, there are two doses of pembrolizumab given during cycle 2: days 1 and 22. Additionally, the last dose of pembrolizumab falls on what would be day 8 of a 4th 'chemo' cycle; however gemcitabine is NOT GIVEN.
Deaths Number Affected:
16
Deaths Number At Risk:
None
Serious Number Affected:
17
Serious Number At Risk:
38
Other Number Affected:
38
Other Number At Risk:
38
Study:
NCT02365766
Results Section:
NCT02365766
Adverse Events Module:
NCT02365766