{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"63.1","upperLimit":"85.2","value":"75.4"},{"groupId":"OG001","lowerLimit":"33.5","upperLimit":"79.7","value":"57.9"},{"groupId":"OG002","lowerLimit":"0.1","upperLimit":"14.2","value":"3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"19"},{"groupId":"OG002","value":"36"}],"units":"Participants"}],"description":"Objective response rate (ORR) defines as the percentage of patients who achieved CR (CR+CRc), CR with incomplete blood count recovery (CRi), or partial response (PR) after treatment with Tagraxofusp according to the previously reported definitions of CR, CRc and the following one of CRi and PR:\n\nCRi: CR with incomplete of neutrophil and/or platelet count and absence of leukemic blast in the peripheral blood\n\nMarrow: PR defined as decrease by ≥50% in blast percentage to 5-25%\n\nPeripheral blood: PR defined as normalization of neutrophil count (≥ 1,000/µL) and platelet count (≥ 100,000/µL)\n\nSkin: 50%-\\<100% clearance of all skis lesions from baseline; no new lesions in patients without lesions at baseline\n\nNodal masses: ≥50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes\n\nSpleen, liver: ≥50% in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen","dispersionType":"95% Confidence Interval","groups":[{"description":"First-line BPDCN patients enrolled across stages","id":"OG000","title":"First-line BPDCN"},{"description":"R/R BPDCN patients enrolled across stages","id":"OG001","title":"R/R BPDCN"},{"description":"AML patients enrolled in stages 1 and 2","id":"OG002","title":"Acute Myeloid Leukemia"}],"paramType":"NUMBER","populationDescription":"Efficacy population including evaluable patients treated at 12 μg/kg/day in the first-line BPDCN, R/R BPDCN and AML","reportingStatus":"POSTED","timeFrame":"at pre-defined treatment cycle intervals from randomization up to disease progression, up to 5 years","title":"ORR in First-line BPDCN, R/R BPDCN and AML","type":"SECONDARY","unitOfMeasure":"percentage of evaluable patients"}