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 @ 5:58 PM
Ignite Modification Date:
2025-12-25 @ 3:21 PM
NCT ID:
NCT04287868
Group ID:
EG000
Title:
Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies
Description:
Cohort 1, Arm 1, Treatment Assignment Code (TAC) 1: Participants with HPV associated malignancies will receive human papillomavirus (HPV) vaccine every (q) 4 weeks x6, then q3 months (MO) x2 + NHS-IL12 q 4 weeks (wks) + M7824 q 2 wks.
PDS0101 will be administered on Day (D)1, D15, D29 followed by booster vaccines every 4 weeks for up to a year. Subcutaneous 1.0mL (2.4mg of total peptide and 3 mg of R-DOTAP (Versamune) injection).
M7824 will be administered at a flat dose of 1,200 mg intravenous (IV) (over 1 hour) once every 2 weeks.
NHS-IL12 will be administered by subcutaneous (SC) injection every 4 weeks.
Deaths Number Affected:
28
Deaths Number At Risk:
None
Serious Number Affected:
18
Serious Number At Risk:
47
Other Number Affected:
47
Other Number At Risk:
47
Study:
NCT04287868
Results Section:
NCT04287868
Adverse Events Module:
NCT04287868