{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Pyrogenic Dose: 250 EU"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Pyrogenic Dose: 750 EU"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Pyrogenic Dose: 2250 EU"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Pyrogenic Dose: 20,300 EU"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Pyrogenic Dose: 60,800 EU"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Pyrogenic Dose: 182,000 EU"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"Pyrogenic Dose: 547,000 EU"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Desired Pyrogenic Effect Not Observed"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Discontinued Before Pyrogenic Effect Observed"}],"denoms":[{"counts":[{"groupId":"OG000","value":"13"}],"units":"Participants"}],"description":"Intrasubject dose escalation performed over a dose range of 250 to 547,000 EU until achievement of the desired pyrogenic effects (i.e., body temperature increase to 38°C to 39.5°C). Of note, the median pyrogenic dose was 60,800 EU.","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)"}],"paramType":"NUMBER","populationDescription":"The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.","reportingStatus":"POSTED","timeFrame":"Weeks 1 through 6","title":"Number of Participants With Pyrogenicity at Each Dose Level Tested in the Intrasubject Dose Escalation Performed Over a Dose Range of 250 to 547,000 EU","type":"PRIMARY","unitOfMeasure":"participants"}