{"classes":[{"categories":[{"measurements":[{"comment":"N/A = not estimable","groupId":"OG000","spread":"NA","value":"226"},{"groupId":"OG001","spread":"10.7","value":"467"},{"groupId":"OG002","spread":"55.6","value":"703"},{"groupId":"OG003","spread":"44.7","value":"3440"},{"groupId":"OG004","spread":"78.0","value":"1920"},{"groupId":"OG005","spread":"87.9","value":"2350"},{"groupId":"OG006","spread":"53.4","value":"3590"},{"groupId":"OG007","spread":"137.9","value":"3450"},{"groupId":"OG008","spread":"121.4","value":"3390"}]}],"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","spread":"42.1","value":"435"},{"groupId":"OG001","spread":"41.1","value":"1520"},{"groupId":"OG002","spread":"32.2","value":"4150"},{"groupId":"OG003","spread":"402.8","value":"7660"},{"groupId":"OG004","spread":"77.4","value":"7680"},{"groupId":"OG005","spread":"37.4","value":"12300"},{"groupId":"OG006","spread":"71.7","value":"14700"},{"groupId":"OG007","spread":"0.800","value":"35200"},{"groupId":"OG008","spread":"74.8","value":"13900"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"9"},{"groupId":"OG005","value":"9"},{"groupId":"OG006","value":"7"},{"groupId":"OG007","value":"2"},{"groupId":"OG008","value":"8"}],"units":"Participants"}],"title":"C1D8: dose escalation phase"},{"categories":[{"measurements":[{"groupId":"OG008","spread":"111.9","value":"3340"}]}],"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":"73"}],"units":"Participants"}],"title":"C1D1 dose escalation phase for 750mg"},{"categories":[{"measurements":[{"comment":"N/A = not estimable","groupId":"OG000","spread":"NA","value":"376"},{"comment":"N/A = not estimable","groupId":"OG001","spread":"NA","value":"894"},{"groupId":"OG008","spread":"37.1","value":"22600"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"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":"23"}],"units":"Participants"}],"title":"C2D1 dose escalation & 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":"Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. AUC0 - 24 is the AUC calculated to 24 hour. 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 AUC0-24.","dispersionType":"Geometric Coefficient of Variation","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":"GEOMETRIC_MEAN","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: AUC0-24h","type":"SECONDARY","unitOfMeasure":"ng*h/mL"}