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 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
NCT ID:
NCT03007732
Group ID:
EG001
Title:
Cohort 1: Prostate Only Sites (ADT, SBRT, Pembrolizumab, SD-101)
Description:
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days. TLR9 agonist SD-101 will be injected into the dominant prostatic tumor lesion at time of fiducial marker placement (1-5weeks prior to Cycle 1 Day 1) and 1-3 weeks after Cycle 1 Day 1.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
5
Other Number Affected:
5
Other Number At Risk:
5
Study:
NCT03007732
Results Section:
NCT03007732
Adverse Events Module:
NCT03007732