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:
EG000
Title:
Phase 1b Cohort I: Cisplatin Eligible - Pembrolizumab 200 mg
Description:
Cisplatin-eligible subjects were received pembrolizumab at starting dose of 200mg (dose level 0) in combination with gemcitabine and cisplatin. Once the MTD is established, this portion of the study will close and the phase II will open to cohorts I and II at the recommended phase II dose (RP2D).
Pembrolizumab: In this dose-finding cohort, pembrolizumab (MK-3475) were administered (cisplatin-eligible patients only) at starting dose 200mg IV every 21 days for 4 cycles to determine RP2D. Once MTD is established in phase Ib, pembrolizumab will be administered on phase II cohorts I and II at RP2D every 21 days for 5 cycles.
Gemcitabine: For cisplatin-eligible patients on phase Ib, gemcitabine 1000mg/m2 IV, D1 and D8 every 21 days for 4 cycles.
Cisplatin: For cisplatin-eligible patients, cisplatin 70mg/m2 IV will be administered D1 every 21 days for 4 cycles.
Deaths Number Affected:
1
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
6
Other Number Affected:
6
Other Number At Risk:
6
Study:
NCT02365766
Results Section:
NCT02365766
Adverse Events Module:
NCT02365766