{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.95","upperLimit":"5.95","value":"5.95"},{"groupId":"OG001","lowerLimit":"6.00","upperLimit":"24.0","value":"15.0"},{"groupId":"OG002","lowerLimit":"4.17","upperLimit":"6.00","value":"5.08"},{"groupId":"OG003","lowerLimit":"4.00","upperLimit":"5.95","value":"4.00"},{"groupId":"OG004","lowerLimit":"2.97","upperLimit":"6.73","value":"4.99"},{"groupId":"OG005","lowerLimit":"3.00","upperLimit":"23.5","value":"3.98"},{"groupId":"OG006","lowerLimit":"3.00","upperLimit":"24.1","value":"6.00"},{"groupId":"OG007","lowerLimit":"4.00","upperLimit":"25.0","value":"6.00"},{"groupId":"OG008","lowerLimit":"3.95","upperLimit":"23.8","value":"6.02"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"12"},{"groupId":"OG005","value":"8"},{"groupId":"OG006","value":"9"},{"groupId":"OG007","value":"4"},{"groupId":"OG008","value":"10"}],"units":"Participants"}],"title":"PK run-in dose escalation phase"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.00","upperLimit":"2.92","value":"2.46"},{"groupId":"OG001","lowerLimit":"3.00","upperLimit":"3.98","value":"3.49"},{"groupId":"OG002","lowerLimit":"2.98","upperLimit":"7.95","value":"3.00"},{"groupId":"OG003","lowerLimit":"3.00","upperLimit":"7.18","value":"4.00"},{"groupId":"OG004","lowerLimit":"2.98","upperLimit":"24.0","value":"6.08"},{"groupId":"OG005","lowerLimit":"1.93","upperLimit":"6.00","value":"3.95"},{"groupId":"OG006","lowerLimit":"0.00","upperLimit":"23.6","value":"4.00"},{"groupId":"OG007","lowerLimit":"2.00","upperLimit":"24.0","value":"5.97"},{"groupId":"OG008","lowerLimit":"3.00","upperLimit":"7.95","value":"5.03"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"13"},{"groupId":"OG005","value":"9"},{"groupId":"OG006","value":"9"},{"groupId":"OG007","value":"5"},{"groupId":"OG008","value":"8"}],"units":"Participants"}],"title":"C1D8 dose escalation phase"},{"categories":[{"measurements":[{"groupId":"OG008","lowerLimit":"1.13","upperLimit":"24.0","value":"6.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"208"}],"units":"Participants"}],"title":"C1D1 dose escalation phase for 750mg"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.00","upperLimit":"6.00","value":"5.00"},{"groupId":"OG001","lowerLimit":"2.08","upperLimit":"2.08","value":"2.08"},{"groupId":"OG002","lowerLimit":"4.00","upperLimit":"23.9","value":"8.00"},{"groupId":"OG008","lowerLimit":"0.00","upperLimit":"22.6","value":"6.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"133"}],"units":"Participants"}],"title":"C2D1 dose escalation & dose expansion phases"}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"14"},{"groupId":"OG005","value":"10"},{"groupId":"OG006","value":"10"},{"groupId":"OG007","value":"5"},{"groupId":"OG008","value":"252"}],"units":"Participants"}],"description":"Tmax is the time to reach Cmax. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. Cycle 1 Day 1 = C1D1; Cycle 1 Day 8 = C1D8; Cycle 2 Day 1 = C2D1. However, there was no PK sampling during C1D1 and C2D1 except for 750 mg dose to compute PK parameter Tmax.","dispersionType":"Full Range","groups":[{"description":"Participants receiving 50 mg of LDK378","id":"OG000","title":"LDK378 50 mg"},{"description":"Participants receiving 100 mg of LDK378","id":"OG001","title":"LDK378 100 mg"},{"description":"Participants receiving 200 mg of LDK378","id":"OG002","title":"LDK378 200 mg"},{"description":"Participants receiving 300 mg of LDK378","id":"OG003","title":"LDK378 300 mg"},{"description":"Participants receiving 400 mg of LDK378","id":"OG004","title":"LDK378 400 mg"},{"description":"Participants receiving 500 mg of LDK378","id":"OG005","title":"LDK378 500 mg"},{"description":"Participants receiving 600 mg of LDK378","id":"OG006","title":"LDK378 600 mg"},{"description":"Participants receiving 700 mg of LDK378","id":"OG007","title":"LDK378 700 mg"},{"description":"Participants receiving 750 mg of LDK378.","id":"OG008","title":"LDK378 750 mg"}],"paramType":"MEDIAN","populationDescription":"Pharmacokinetic Analysis Set (PAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least 1 dose of LDK378 \\& had at least 1 evaluable PK sample","reportingStatus":"POSTED","timeFrame":"PK run-in of dose escalation phase, Cycle 1 Day 8 of dose escalation phase, Cycle 1, Day 1 of dose escalation phase, Cycle 2 Day 1 of dose escalation & dose expansion phases","title":"Primary Pharmacokinetics (PK) Parameter: Tmax","type":"SECONDARY","unitOfMeasure":"hour"}