{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"3"}],"units":"Participants"}],"description":"Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities (DLTs) of BION-1301 as a single agent","groups":[{"description":"50 mg BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion.","id":"OG000","title":"BION-1301 50 mg Q2W"},{"description":"150 mg BION-1301 will be administered once every 2 weeks as an IV infusion.","id":"OG001","title":"BION-1301 150 mg Q2W"},{"description":"450 mg BION-1301 will be administered once every 2 weeks as an IV infusion.","id":"OG002","title":"BION-1301 450 mg Q2W"},{"description":"1350 mg BION-1301 will be administered once every 2 weeks as an IV infusion.","id":"OG003","title":"BION-1301 1350 mg Q2W"},{"description":"2700 mg BION-1301 will be administered once every 2 weeks as an IV infusion.","id":"OG004","title":"BION-1301 2700 mg Q2W"},{"description":"1350 mg BION-1301 will be administered as an IV infusion once per week for up to 8 weeks, followed by dosing once every 2 weeks.","id":"OG005","title":"BION-1301 1350 mg QW*8W->Q2W"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety Analysis Set (all participants who received any amount of study drug) in the Phase 1 part of the study.","reportingStatus":"POSTED","timeFrame":"28 days following first administration of BION-1301","title":"Safety (Phase 1)","type":"PRIMARY","unitOfMeasure":"Participants"}