{"classes":[{"categories":[{"measurements":[{"comment":"N/A = Week1 pre-dose concentrations were below limit of quantitation","groupId":"OG000","spread":"NA","value":"NA"},{"comment":"N/A = Week1 pre-dose concentrations were below limit of quantitation","groupId":"OG001","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"139"}],"units":"Participants"}],"title":"Week 1 (0 h (pre-dose))"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"78.29","value":"207.76"},{"groupId":"OG001","spread":"97.13","value":"586.76"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"128"}],"units":"Participants"}],"title":"Week 3 (0 h (pre-dose))"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"68.89","value":"372.26"},{"groupId":"OG001","spread":"70.42","value":"1012.63"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"70"},{"groupId":"OG001","value":"120"}],"units":"Participants"}],"title":"Week 5 (0 h (pre-dose))"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"67.30","value":"559.29"},{"groupId":"OG001","spread":"63.43","value":"1353.06"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"101"}],"units":"Participants"}],"title":"Week 9 (0 h (pre-dose))"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"60.79","value":"714.01"},{"groupId":"OG001","spread":"61.57","value":"1443.84"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"85"}],"units":"Participants"}],"title":"Week 13 (0 h (pre-dose))"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"64.43","value":"688.93"},{"groupId":"OG001","spread":"59.88","value":"1574.21"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"81"}],"units":"Participants"}],"title":"Week 17 (0 h (pre-dose))"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"52.57","value":"841.78"},{"groupId":"OG001","spread":"39.47","value":"1803.74"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"35"}],"units":"Participants"}],"title":"Week 17 (1 h (post-dose))"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"50.79","value":"939.56"},{"groupId":"OG001","spread":"34.90","value":"1922.38"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"32"}],"units":"Participants"}],"title":"Week 17 (2 h (post-dose))"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"62.22","value":"842.31"},{"groupId":"OG001","spread":"53.32","value":"1750.70"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"33"}],"units":"Participants"}],"title":"Week 17 (4 h (post-dose))"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"63.43","value":"759.88"},{"groupId":"OG001","spread":"41.53","value":"1673.95"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"32"}],"units":"Participants"}],"title":"Week 17 (6 h (post-dose))"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"63.58","value":"707.49"},{"groupId":"OG001","spread":"63.92","value":"1547.41"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"67"}],"units":"Participants"}],"title":"Week 21 (0 h (pre-dose))"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"93.11","value":"702.67"},{"groupId":"OG001","spread":"74.80","value":"1477.60"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"49"}],"units":"Participants"}],"title":"Week 33 (0 h (pre-dose))"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"76.02","value":"697.92"},{"groupId":"OG001","spread":"79.60","value":"1368.87"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"35"}],"units":"Participants"}],"title":"Week 45 (0 h (pre-dose))"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"117.27","value":"559.17"},{"groupId":"OG001","spread":"78.96","value":"1257.42"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"26"}],"units":"Participants"}],"title":"Week 57 (0 h (pre-dose))"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"154.33","value":"530.91"},{"groupId":"OG001","spread":"89.03","value":"1355.91"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"23"}],"units":"Participants"}],"title":"Wek 69 (0 h (pre-dose))"}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"139"}],"units":"Participants"}],"description":"Blood PK samples were collected either by direct venipuncture or an indwelling cannula inserted in a forearm vein for the determination of trough (Cmin) plasma concentrations of sonidegib and its main circulating metabolite, LGE899, from all patients who enrolled in the study. Blood was collected in Weeks 1, 3, 5, 9 (pre-dose), and subsequently pre-dose every 4 weeks up to Week 21, and every 12 weeks thereafter up to week 69.","dispersionType":"Geometric Coefficient of Variation","groups":[{"description":"Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.","id":"OG000","title":"LDE225 200 mg qd"},{"description":"Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.","id":"OG001","title":"LDE225 800 mg qd"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"The PK analysis set (PAS) consisted of all patients with at least one evaluable plasma concentration.","reportingStatus":"POSTED","timeFrame":"Weeks 1, 3, 5, 9, 13, 17, 21, 33, 45, 57, 69","title":"Plasma Concentration of Sonidegib (LDE225)","type":"SECONDARY","unitOfMeasure":"ng/mL"}