{"classes":[{"categories":[{"measurements":[{"comment":"Standard deviation is not calculable because only one participant had an estimable AUC value in this Arm/Group.","groupId":"OG000","spread":"NA","value":"5540"},{"groupId":"OG001","spread":"755","value":"2180"},{"groupId":"OG002","spread":"963","value":"5430"},{"groupId":"OG003","spread":"4480","value":"13000"},{"groupId":"OG004","spread":"8360","value":"23900"},{"groupId":"OG005","spread":"19600","value":"33700"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"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 area under the serum concentration versus time curve (AUC) of NC525","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 includes participants who received NC525 and had sufficient concentration-time data to estimate AUC using noncompartmental analysis for Cycle 1 Day 1. Participants without adequate quantifiable PK samples were excluded for this parameter. Descriptive statistics were calculated when multiple participants had estimable AUC values. When only one participant had an estimable value, the mean is reported and the standard deviation is not calculable.","reportingStatus":"POSTED","timeFrame":"During Cycles 1, 2, 3, 5, 7, and 11 (each cycle is 28 days), Cycle 1 reported","title":"Area Under the Serum Concentration Versus Time Curve (AUC) of NC525","type":"SECONDARY","unitOfMeasure":"h*μg/mL"}