{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"22"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"22"}],"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":"Phase I, Dose Level 1 in recurrent/metastatic (R/M) Human Papillomavirus Vaccine (HPV) associated cancers (cohort 1). Arm 1A: Monotherapy HPV vaccine, Dose escalation. HPV vaccine at 1x10\\^11 Viral Particles (VP).","id":"OG000","title":"Phase I Cohort 1, Arm 1A, Dose Level 1"},{"description":"Phase I, Dose Level 2 in recurrent/metastatic (R/M) Human Papillomavirus Vaccine (HPV) associated cancers (cohort 1). Arm 1A: Monotherapy HPV vaccine, Dose escalation. HPV vaccine at 5x10\\^11 Viral Particles (VP).","id":"OG001","title":"Phase I Cohort 1A, Arm 1A, Dose Level 2"},{"description":"Phase I in recurrent/metastatic (R/M) Human Papillomavirus Vaccine (HPV) associated cancers (cohort 1). Arm 1B: Combination: HPV vaccine at recommended phase 2 dose (RP2D) as determined at completion of Arm 1A plus bintrafusp alfa 1200 mg. HPV vaccine at 5x10\\^11 Viral Particles (VP).","id":"OG002","title":"Phase I Cohort 1, Arm 1B, Dose Level 2"},{"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":"OG003","title":"Phase II Cohort 2, Arm 2A, Dose Level 2"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"Date treatment consent signed to date off study, approximately 27 months and 1 day, 9 months and 9 days, 30 months and 11 days, and 9 days for each group respectively.","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"}