{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"10.6","value":"26.1"},{"groupId":"OG001","spread":"36.5","value":"58.8"},{"groupId":"OG002","spread":"16.3","value":"106"},{"groupId":"OG003","spread":"107","value":"268"},{"groupId":"OG004","spread":"178","value":"445"},{"groupId":"OG005","spread":"176","value":"585"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"9"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"3"}],"units":"Participants"}],"description":"To evaluate the maximum observed serum concentration (Cmax) of NC525. The values reported are Cmax at Cycle 2 Day 1.","dispersionType":"Standard Deviation","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":"MEAN","populationDescription":"The PK analysis set (PAS) will include all the subjects whose blood samples are collected for PK analysis.","reportingStatus":"POSTED","timeFrame":"During Cycles 1, 2, 3, 5, 7, and 11 (each cycle is 28 days)","title":"Maximum Observed Serum Concentration (Cmax) of NC525","type":"SECONDARY","unitOfMeasure":"μg/mL"}