{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.43","upperLimit":"0.57","value":"0.50"},{"groupId":"OG001","lowerLimit":"0.33","upperLimit":"0.44","value":"0.38"},{"groupId":"OG002","lowerLimit":"0.20","upperLimit":"0.30","value":"0.25"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"30"},{"groupId":"OG002","value":"19"}],"units":"Participants"}],"description":"The apparent plasma clearance following oral dosing of eltrombopag (CL/F) was collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. From the final model, a single value of CL/F was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants (par) aged between 12 and 17 years received eltrombopag administered as a tablet for a total of 24 weeks. Par in Part 1 received an Open-Label (OL) treatment (trt) starting at 25 milligrams (mg) once daily (QD) for 24 weeks. Par of East Asian ancestry began at 12.5mg QD. Par randomized to eltrombopag in Part 2 received eltrombopag for 7 weeks starting at 37.5mg QD. All par completing Part 2 received an OL trt of eltrombopag in Part 2/3. Par who received 7 weeks of eltrombopag in Part 2 received an additional 17 weeks of trt to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. Par who received placebo Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 starting at 37.5 mg QD up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.","id":"OG000","title":"Eltrombopag Cohort 1- 12-17 Years"},{"description":"Par aged between 6 and 11 years received eltrombopag administered as a tablet or dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par weighing \\<27 kilograms (kg) started at 12.5mg QD and par weighing \\>=27kg started at 25mg QD. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par weighing \\<27kg started at 25mg QD and par weighing \\>=27kg started at 50mg QD. Par of East Asian ancestry weighing \\<27kg began at 12.5mg QD and those \\>=27kg began at 25mg QD. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.","id":"OG001","title":"Eltrombopag Cohort 2 - 6-11 Years"},{"description":"Par aged between 1 and 5 years received eltrombopag administered as a dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par starting dose was 0.7mg/kg QD, par of East Asian ancestry began at 0.5mg/kg/day. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par starting dose was 1.5mg/kg QD, par of East Asian ancestry weighing began at 0.8 mg/kg/day. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.","id":"OG002","title":"Eltrombopag Cohort 3 - 1-5 Years"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"Pharmacokinetic (PK) population. All subjects who had received at least one dose of the investigational product and provided a PK sample were included in this analysis.","reportingStatus":"POSTED","timeFrame":"From Day 1 of treatment up to Study Week 31","title":"Population Pharmacokinetic (PK) Assessments for Eltrombopag for CL/F During Part 1, 2, and 2/3","type":"SECONDARY","unitOfMeasure":"liter per hour (L/hr)"}