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 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 12:23 AM
NCT ID:
NCT03165994
Group ID:
EG000
Title:
Sotigalimab With SOC ChemoRT
Description:
Participants received SOC chemoRT, consisting of:
* External beam radiation in daily fractions (28 fractions) from Weeks 1-6, administered once per day up to 5 days/week.
* Carboplatin (AUC = 2) and paclitaxel (50 mg/m\^2) chemotherapy IV over 1 hour, once weekly, from Weeks 1-5.
The participants also received concurrent 0.3 mg/kg sotigalimab IV over 1 hour, once weekly, on Weeks 1, 2, 4, and 6 (2-3 days after chemoRT).
Surgical resection of the tumor was planned to be performed from Week 10 up to approximately Week 17, as indicated in the protocol amendment under which each participant was enrolled.
Deaths Number Affected:
7
Deaths Number At Risk:
None
Serious Number Affected:
16
Serious Number At Risk:
33
Other Number Affected:
33
Other Number At Risk:
33
Study:
NCT03165994
Results Section:
NCT03165994
Adverse Events Module:
NCT03165994