{"classes":[{"categories":[{"measurements":[{"groupId":"OG001","spread":"19.6","value":"49.8"},{"comment":"Standard deviation is not calculable because only one participant had an estimable terminal half-life (t1/2) value in this Arm/Group.","groupId":"OG003","spread":"NA","value":"55.3"},{"comment":"Standard deviation is not calculable because only one participant had an estimable terminal half-life (t1/2) value in this Arm/Group.","groupId":"OG004","spread":"NA","value":"64.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"0"}],"units":"Participants"}],"description":"To evaluate the Terminal Half-life (t1/2) 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 terminal half-life (t1/2) using noncompartmental analysis. Estimation required an identifiable terminal elimination phase with ≥3 quantifiable post-dose samples. Descriptive statistics were calculated when ≥3 participants had an estimable t1/2. When only 1 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":"Terminal Half-life (t1/2) of NC525","type":"SECONDARY","unitOfMeasure":"h"}