{"classes":[{"categories":[{"measurements":[{"comment":"The upper bound of the 95% confidence interval for the median overall survival could not be estimated due to the very small sample size and limited number of participants in this cohort. Although all participants experienced the event, the Kaplan-Meier variance estimate was insufficient to calculate an upper confidence limit.","groupId":"OG000","lowerLimit":"3.6","upperLimit":"NA","value":"3.8"},{"comment":"The upper bound of the 95% confidence interval for the median overall survival could not be estimated due to the very small sample size and limited number of participants in this cohort. Although all participants experienced the event, the Kaplan-Meier variance estimate was insufficient to calculate an upper confidence limit.","groupId":"OG001","lowerLimit":"3.1","upperLimit":"NA","value":"6"},{"comment":"The upper bound of the 95% confidence interval for the median overall survival could not be estimated due to the very small sample size and limited number of participants in this cohort. Although all participants experienced the event, the Kaplan-Meier variance estimate was insufficient to calculate an upper confidence limit.","groupId":"OG002","lowerLimit":"2.5","upperLimit":"NA","value":"6.5"},{"groupId":"OG003","lowerLimit":"1.1","upperLimit":"7.7","value":"4.1"},{"comment":"The median overall survival and corresponding upper confidence interval could not be estimated due to the very small sample size and insufficient information to support Kaplan-Meier estimation.","groupId":"OG004","lowerLimit":"1.5","upperLimit":"NA","value":"NA"},{"comment":"The upper bound of the 95% confidence interval for the median overall survival could not be estimated due to the very small sample size and limited number of participants in this cohort. Although all participants experienced the event, the Kaplan-Meier variance estimate was insufficient to calculate an upper confidence limit.","groupId":"OG005","lowerLimit":"2.6","upperLimit":"NA","value":"3.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"9"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"2"}],"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. The analysis population includes all participants who received at least one dose of NC525 in each dose cohort. All participants were included in the analysis regardless of whether they experienced the event (death). Overall survival was analyzed using the Kaplan-Meier method.","reportingStatus":"POSTED","timeFrame":"Time until death, up to 23 months","title":"To Evaluate the Clinical Benefit of NC525 by Assessing Overall Survival (OS).","type":"SECONDARY","unitOfMeasure":"months"}