{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"25.1","upperLimit":"80.8","value":"53.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"13"}],"units":"Participants"}],"description":"Complete response (CR) rate, defined as the percentage who achieved CR+ CR(clinical) with minimal residual skin abnormality (CRc) after treatment with Tagraxofusp.\n\nCR criteria according to Cheson BD et al, The International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol 2007;25:579-586:\n\nMarrow: normalization of blast percentage (≤5%).\n\nPeripheral blood: normalization of neutrophil count (≥ 1,000/µL) and platelet count (≥ 100,000/µL) - absence of leukemic blasts\n\nSkin: 100% clearance of all skin lesions from baseline; no new lesions in patients without lesions at baseline\n\nNodal masses: regression to normal size on CT\n\nSpleen, liver: not palpable, nodules disappeared\n\nCRc criteria: all the above except for skin: marked clearance of all skin lesions from baseline; residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed)","dispersionType":"95% Confidence Interval","groups":[{"description":"First-line blastic plasmacytoid dendritic cell neoplasm (BPDCN) patients enrolled in stage 3","id":"OG000","title":"First-line BPDCN"}],"paramType":"NUMBER","populationDescription":"Pre-defined efficacy primary end point assessed in Stage 3, standalone, pivotal efficacy cohort of only patients with first-line BPDCN exposed to 12 μg/kg/day were enrolled.","reportingStatus":"POSTED","timeFrame":"at pre-defined treatment cycle intervals from randomization up to disease progression, up to 3.5 years","title":"CR Rate in First-line BPDCN (Stage 3, Pivotal Cohort)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}