{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"3"}],"units":"Participants"}],"description":"Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.","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"},{"description":"Cohort 2, Arm 2, Treatment Assignment Code (TAC) 1: Participants with cervical cancer with prior pelvic radiation and boost brachytherapy will receive human papillomavirus (HPV) vaccine + NHS-IL12 + M7824 (MSB0011359C) at reduced doses.\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":"OG001","title":"Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"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 Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)","type":"OTHER_PRE_SPECIFIED","unitOfMeasure":"Participants"}