{"classes":[{"categories":[{"measurements":[{"comment":"Insufficient number of participants with events.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Insufficient number of participants with events.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Insufficient number of participants with events.","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Insufficient number of participants with events.","groupId":"OG003","lowerLimit":"1.8","upperLimit":"NA","value":"NA"},{"comment":"Insufficient number of participants with events.","groupId":"OG004","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Insufficient number of participants with events.","groupId":"OG005","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}]}],"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":"Disease Assessments will be performed using the European Leukemia Net (ELN) Guidelines for the ELN Outcome Measures.","dispersionType":"95% Confidence Interval","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":"MEDIAN","populationDescription":"Full Analysis Set (FAS): The FAS includes all subjects enrolled in the study who received at least one full dose of NC525. The FAS will be used for summaries and analyses of all data that are not safety or PK","reportingStatus":"POSTED","timeFrame":"Cycle 1 Day 1 to day remission is achieved, up to 23 months (each cycle is 28 days)","title":"Assessment of Time to Achieve Response, Defined as CR, CRi, or CRh","type":"SECONDARY","unitOfMeasure":"months"}