{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"45"}]}],"title":"Grade 1"},{"categories":[{"measurements":[{"groupId":"OG000","value":"42"}]}],"title":"Grade 2"},{"categories":[{"measurements":[{"groupId":"OG000","value":"25"}]}],"title":"Grade 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Grade 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Grade 5"}],"denoms":[{"counts":[{"groupId":"OG000","value":"47"}],"units":"Participants"}],"description":"Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.","groups":[{"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.\n\nPDS0101 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).\n\nM7824 will be administered at a flat dose of 1,200 mg intravenous (IV) (over 1 hour) once every 2 weeks.\n\nNHS-IL12 will be administered by subcutaneous (SC) injection every 4 weeks.","id":"OG000","title":"Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Pre-specified in the protocol for cohort 1 only. 1/48 participants in cohort 1 was a screening fail.","reportingStatus":"POSTED","timeFrame":"Date treatment consent signed to date off study, approximately 34 months and 20 days.","title":"Number of Participants With Grades 1, 2, 3, 4 and/or 5 Treatment Related Adverse Events","type":"SECONDARY","unitOfMeasure":"Participants"}