{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"105","spread":"93401","upperLimit":"118","value":"376577"},{"groupId":"OG001","spread":"91349","value":"341183"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"24"}],"units":"Participants"}],"description":"AUC (0-t) was one of the pharmacokinetic endpoints to confirm pharmacokinetic similarity between Melphalan HCl for Injection (Propylene Glycol-Free) and Alkeran for Injection in patients with multiple myeloma. Pharmacokinetic similarity was defined as a difference of 20% or less in the 90% confidence intervals (CIs) for the ratios of the pharmacokinetic parameters (calculated using log-transformed data) for the two formulations.\n\nThe AUC results provided is the summary of Melphalan PK following Melphalan-Alkeran injection in Sequence 1 and Alkeran-melphalan injection in Sequence 2.","dispersionType":"Standard Deviation","groups":[{"description":"Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Melphalan dose administration regardless of cross over sequence","id":"OG000","title":"Melphalan"},{"description":"Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Alkeran dose administration regardless of cross over sequence","id":"OG001","title":"Alkeran"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"The pharmacokinetic-evaluable population was defined as all patients who completed dosing and adequate pharmacokinetic blood draws for the calculation of AUC and Cmax for both Melphalan HCl for Injection and Alkeran for Injection.\n\nThe results are presented by each drug group that combines data from both sequence.","reportingStatus":"POSTED","timeFrame":"Day -3 and Day -2","title":"Area Under the Curve (0-t)","type":"PRIMARY","unitOfMeasure":"min*ng/mL"}