{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"28.22","value":"2350.7402"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"}],"units":"Participants"}],"title":"Pralatrexate-R in Cycle 1 week 6（20mg/m2）"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"152.16","value":"3979.1069"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"}],"units":"Participants"}],"title":"Pralatrexate-R in Cycle 1 week 6（30mg/m2）"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"43.70","value":"3586.2925"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"14"}],"units":"Participants"}],"title":"Pralatrexate-R in Cycle 1 day 1（30mg/m2）"}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"}],"units":"Participants"}],"description":"The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of \\>5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.","dispersionType":"Geometric Coefficient of Variation","groups":[{"description":"Vitamin B12 and folic acid will be taken concurrently with pralatrexate\n\npralatrexate: Pralatrexate will be administered at a dose of 30 mg/m2/week for 6 weeks followed by 1 week of rest in a 7-week cycle. Pralatrexate administration occurs once a week during week 1 through week 6 of each cycle.\n\nVitamin B12 and folic acid: The eligible subjects will receive vitamin supplementation at screening phase, at least 10 days prior to pralatrexate administration on cycle 1, dose 1. Vitamin supplementation will consist of vitamin B12 1 mg intramuscular (IM) q 8-10 weeks and folic acid 1.2mg by mouth (PO) once a day (QD). Once pralatrexate is permanently discontinued, vitamin supplementation should continue at least 1 month after the last pralatrexate dose, or longer at the discretion of the investigator.","id":"OG000","title":"Pralatrexate"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"Based on PK population","reportingStatus":"POSTED","timeFrame":"Cycle 1 day1，Cycle 1 week 6(Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection)","title":"Area Under the Curve [AUC] for R-pralatrexate","type":"SECONDARY","unitOfMeasure":"h*ng/ml"}