{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"4"}]}],"title":"Any TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"}]}],"title":"Grade 3 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Grade 4 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"Grade 5 TEAE (Death)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"3"}]}],"title":"Treatment-related TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"title":"SAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"TEAE leading to withdrawal"}],"denoms":[{"counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"4"}],"units":"Participants"}],"description":"Analysis of treatment-emergent adverse events (TEAEs) reported from clinical laboratory tests, physical examinations, and vital signs from pre-treatment through 4 weeks after the last dose of study treatment.","groups":[{"description":"Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.","id":"OG000","title":"Cohort 1 (Safety Analysis Set)"},{"description":"Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU \\[dose level 6\\]) that was determined to be the pyrogenic dose level in Cohort 1.","id":"OG001","title":"Cohort 2 (Safety Analysis Set)"}],"paramType":"NUMBER","populationDescription":"The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.","reportingStatus":"POSTED","timeFrame":"Up to 3 months","title":"Number of Participants With Treatment-emergent Adverse Events (TEAEs)","type":"PRIMARY","unitOfMeasure":"participants"}