{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"}],"units":"Participants"}],"description":"2-year progression-free survival (PFS2). Evidence of local recurrence, distant metastasis, or death from any cause within 2 years counted as events in the time-to-event Kaplan-Meier analysis of progression-free survival. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions","groups":[{"description":"Patients receive 650 mg Acetaminophen and 50 mg Benadryl orally 30 minutes prior to MV-NIS then receive MV-NIS IV over 1 hour on day 1.","id":"OG000","title":"Phase II (Acetaminophen + Benadryl + MV-NIS)"}],"paramType":"NUMBER","populationDescription":"Phase II specified secondary endpoint will only include Phase II patients. Phase II Cohort A and Phase II Cohort B were combined for this analysis due to accrual terminating early in Cohort B.","reportingStatus":"POSTED","timeFrame":"At 2 years","title":"Progression-free Survival (Phase II)","type":"SECONDARY","unitOfMeasure":"percentage of patients"}