{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2165.0","upperLimit":"6596.0","value":"3827.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"}],"units":"Participants"}],"description":"Geometric mean liposome-encapsulated daunorubicin volume of distribution following IV infusion will be determined for patients in the dose-finding phase.","dispersionType":"Full Range","groups":[{"description":"COURSE 1: Patients receive cytarabine IT on day 0 and at day 28-30 or up to 7 days prior to day 1 of course 2, and liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5. Patients with CNS1 receive no further CNS-directed therapy in course 1. Patients with CNS2 disease may receive additional 4-6 doses of cytarabine IT twice weekly starting 48 hours after the third dose of liposome-encapsulated daunorubicin-cytarabine until CNS is clear at the discretion of the investigator. Patients meeting criteria for CR, CRp, and CRi may proceed to course 2.\n\nCOURSE 2: Patients receive filgrastim on days 1-5 and then on day 15 until blood count recovery, and fludarabine phosphate IV over 30 minutes and high-dose cytarabine IV over 1-3 hours QD on days 1-5.","id":"OG000","title":"Treatment (CPX-351 and FLAG)"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"Patients in the efficacy phase excluded (n=32). 1 dose finding patient excluded because dose record was not consistent with treatment plan.","reportingStatus":"POSTED","timeFrame":"Prior to infusion on day 5 and, 45 and 90 minutes post day 5 infusion of cycle 1","title":"Liposome-encapsulated Daunorubicin Volume of Distribution","type":"SECONDARY","unitOfMeasure":"MILLILITER"}