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:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:22 AM
NCT ID:
NCT03835533
Group ID:
EG001
Title:
Cohort B: SBRT + CDX-301 + Poly-ICLC + Nivolumab
Description:
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
Stereotactic body radiation therapy (SBRT) (Cohort B): Radiation therapy will be administered at 30 - 50 Gy in 1 - 5 doses, starting on Day 1 or 2 of Cycle 1
CDX-301 (Cohort B and C): CDX-301 will be subcutaneously once a day for 5 days for cohort B. CDX-301 will be subcutaneously once a day for 10 days of immune-priming lead-in for cohort C.
Poly-ICLC (Cohort B): Poly-ICLC will be administered intramuscularly twice weekly for 3 weeks starting on Day 1 of Cycle 1
Deaths Number Affected:
10
Deaths Number At Risk:
None
Serious Number Affected:
4
Serious Number At Risk:
15
Other Number Affected:
15
Other Number At Risk:
15
Study:
NCT03835533
Results Section:
NCT03835533
Adverse Events Module:
NCT03835533