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 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:26 AM
NCT ID:
NCT02831933
Group ID:
EG000
Title:
Experimental
Description:
ADV/HSV-tk (5 x 1011 viral particles) in a 2-mL total volume will be injected intratumorally on day 0 of the study.
Valacyclovir will be orally administered at a dose of 2 g three times daily for 14 days. Valacyclovir treatment will be administered 24 hours after the gene vector injection from day 1 to day 15 of the study.
SBRT of 30 gray (Gy; 6 Gy X 5 fractions) will be administered over 2 weeks from day 2 to day 16 of the study.
Nivolumab (480 mg) will be administered intravenously over 30 minutes every 4 weeks starting on day 17 of the study and continuing until disease progression, unacceptable toxicity, or up to 12 months in patients without disease progression.
ADV/HSV-tk: Replication-defective recombinant adenovirus vector
Valacyclovir: Prodrug of the antiviral drug acyclovir
SBRT: Low-dose SBRT
nivolumab: Fully human immunoglobulin (Ig) G4 anti-PD-1 monoclonal antibody
Deaths Number Affected:
1
Deaths Number At Risk:
None
Serious Number Affected:
4
Serious Number At Risk:
11
Other Number Affected:
11
Other Number At Risk:
11
Study:
NCT02831933
Results Section:
NCT02831933
Adverse Events Module:
NCT02831933