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 @ 5:37 PM
Ignite Modification Date:
2025-12-25 @ 3:08 PM
NCT ID:
NCT03003468
Group ID:
EG001
Title:
Imprime PGG 4 mg/kg
Description:
Phase Ib (Imprime PGG 4 mg/kg):
Participants will receive pembrolizumab 200mg IV on Day 1 of each 21 day cycle. Imprime PGG will be administered at 4 mg/kg on Day 1,8, and 15. On Day 1 of each cycle, the Imprime PGG intravenous infusion is given first followed 15-30 minutes later by the pembrolizumab.
Phase II (Imprime PGG 4 mg/kg):
Imprime PGG will be dosed at the dose established as the MTD in Phase Ib (4mg/kg) on Day 1, 8, and 15 for Cycles 1-4, and on Day 1 only for Cycles 5-16 of the 21 day cycle. Pembrolizumab will be infused at 200 mg on Day 1 of the 21 day cycle. On day 1 of each cycle, the Imprime PGG intravenous infusion is given first followed 15-30 minutes later by the pembrolizumab infusion.
Deaths Number Affected:
21
Deaths Number At Risk:
None
Serious Number Affected:
9
Serious Number At Risk:
30
Other Number Affected:
29
Other Number At Risk:
30
Study:
NCT03003468
Results Section:
NCT03003468
Adverse Events Module:
NCT03003468