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 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
NCT ID:
NCT03300505
Group ID:
EG001
Title:
Level 2
Description:
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV) Enzalutamide: Given by mouth (PO) Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
Deaths Number Affected:
1
Deaths Number At Risk:
None
Serious Number Affected:
2
Serious Number At Risk:
5
Other Number Affected:
5
Other Number At Risk:
5
Study:
NCT03300505
Results Section:
NCT03300505
Adverse Events Module:
NCT03300505