{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Any Grade 1"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Any Grade 2"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Any Grade 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Any Grade 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Any Grade 5"}],"denoms":[{"counts":[{"groupId":"OG000","value":"22"}],"units":"Participants"}],"description":"Phase II: Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. 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. 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. All participants who receive any investigational treatment will be evaluable for safety and toxicity evaluations.","groups":[{"description":"Phase II in newly diagnosed, untreated, locoregional p16-positove oropharyngeal cancer (OPC) (cohort 2) and in newly diagnosed. Arm 2A: HPV vaccine at recommended phase 2 dose (RP2D) as determined at completion of Arm 1A. HPV vaccine at 5x10\\^11 Viral Particles (VP).","id":"OG000","title":"Phase II Cohort 2, Arm 2A, Dose Level 2"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"Date treatment consent signed up to 28 days after last treatment","title":"Phase II: Safety - Number of Treatment-related Serious Adverse Events (AE) of Grades 1, 2, 3, 4 and/or 5 Along With the AE Term","type":"SECONDARY","unitOfMeasure":"Adverse events"}