{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.66"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"11"}],"units":"Participants"}],"description":"Phase I: proportion of participants that are hospitalized because of adverse events attributed to disease progression. Adverse events were 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. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors(RECIST) and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progression.","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"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"Date treatment consent signed to date of progression, an average of 6 months","title":"Phase I: Proportion of Participants That Are Hospitalized Because of Adverse Events Attributed to Disease Progression","type":"SECONDARY","unitOfMeasure":"proportion of participants"}