{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"11"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"11"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"3"}],"units":"Participants"}],"description":"Toxicity grading per NCI CTCAE v5.0.","groups":[{"description":"Subjects received NC525 IV at 2mg/kg bi-weekly (Q2W) for Cycles 1-6, followed by every 4 weeks (Q4W) thereafter.\n\nNC525: Monoclonal antibody specific for LAIR-1","id":"OG000","title":"2mg/kg NC525"},{"description":"Subjects received NC525 IV at 2.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. Subjects in Cohort 2 initially received 3mg/kg weekly but dose was reduced to 2.5mg/kg weekly at FDA request due to change in dosing frequency from Q2W to QW.\n\nNC525: Monoclonal antibody specific for LAIR-1","id":"OG001","title":"2.5mg/kg NC525"},{"description":"Subjects received NC525 IV at 4.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.\n\nNC525: Monoclonal antibody specific for LAIR-1","id":"OG002","title":"4.5mg/kg NC525"},{"description":"Subjects received NC525 IV at 9mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.\n\nNC525: Monoclonal antibody specific for LAIR-1","id":"OG003","title":"9mg/kg NC525"},{"description":"Subjects received NC525 IV at 13.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.\n\nNC525: Monoclonal antibody specific for LAIR-1","id":"OG004","title":"13.5mg/kg NC525"},{"description":"Subjects received NC525 IV at 18mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.\n\nNC525: Monoclonal antibody specific for LAIR-1","id":"OG005","title":"18mg/kg NC525"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety Analysis Set (SAS): The SAS will include all the subjects who receive any amount of NC525 and will be used for summaries and analyses of safety data.","reportingStatus":"POSTED","timeFrame":"Up to 23 months","title":"To Evaluate the Frequency, Duration, and Severity of Treatment-emergent Adverse Events [Safety and Tolerability].","type":"PRIMARY","unitOfMeasure":"Participants"}