{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"36","value":"24.19"},{"groupId":"OG001","spread":"106","value":"67.64"},{"groupId":"OG002","spread":"45","value":"55.73"},{"groupId":"OG003","spread":"34","value":"87.02"},{"groupId":"OG004","value":"130.00"},{"groupId":"OG005","spread":"65","value":"184.7"},{"groupId":"OG006","spread":"85","value":"115.9"},{"groupId":"OG007","spread":"31","value":"146.6"},{"groupId":"OG008","spread":"30","value":"154.3"},{"groupId":"OG009","spread":"47","value":"270.9"},{"groupId":"OG010","spread":"42","value":"108.40"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"9"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"6"},{"groupId":"OG006","value":"5"},{"groupId":"OG007","value":"3"},{"groupId":"OG008","value":"6"},{"groupId":"OG009","value":"8"},{"groupId":"OG010","value":"46"}],"units":"Participants"}],"description":"Cmax is defined as the observed maximum plasma concentration post drug administration.","dispersionType":"Geometric Coefficient of Variation","groups":[{"description":"Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).","id":"OG000","title":"Low Dose Escalation Cohort: Crizotinib 50 mg QD"},{"description":"Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally QD for up to 34 cycles (each cycle 28 days).","id":"OG001","title":"Low Dose Escalation Cohort: Crizotinib 200 mg QD"},{"description":"Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally twice daily (BID) for up to 34 cycles (each cycle 28 days).","id":"OG002","title":"Low Dose Escalation Cohort: Crizotinib 200 mg BID"},{"description":"Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet BID for up to 34 cycles (each cycle 28 days).","id":"OG003","title":"Low Dose Escalation Cohort: Crizotinib 250 mg BID"},{"description":"Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet orally BID for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 300 mg on Cycle 2 Day 1 only. Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.","id":"OG004","title":"Low Dose Escalation Cohort: Crizotinib 300 mg BID"},{"description":"Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).","id":"OG005","title":"High Dose Escalation Cohort: Crizotinib 300 mg QD"},{"description":"Participants received Crizotinib 400 mg (4 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).","id":"OG006","title":"High Dose Escalation Cohort: Crizotinib 400 mg QD"},{"description":"Participants received Crizotinib 500 mg (5 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).","id":"OG007","title":"High Dose Escalation Cohort: Crizotinib 500 mg QD"},{"description":"Participants received Crizotinib 650 mg (6 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) for up to 7 cycles (each cycle 28 days).","id":"OG008","title":"High Dose Escalation Cohort: Crizotinib 650 mg QD"},{"description":"Participants received Crizotinib 800 mg (8 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).","id":"OG009","title":"High Dose Escalation Cohort: Crizotinib 800 mg QD"},{"description":"Participants received Crizotinib 250 mg tablet/capsule (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) orally BID up to 124 months.","id":"OG010","title":"RP2D Cohort: Crizotinib 250 mg"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"PK parameter analysis population set. \"N\"=participants evaluable for this outcome measure. Data for this OM was planned to be collected for dose escalation cohorts (both low and high) and combined RP2D Cohort excluding \"Low Dose Escalation Cohort: Crizotinib 100 mg QD\" cohort arms.","reportingStatus":"POSTED","timeFrame":"Pre-dose, 1, 2, 4, 6, 8, 9, 24, 48 and any two time points (72, 96, 120 and 144 hours) post-dose on Day -7","title":"Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Maximum Observed Plasma Concentration (Cmax) of Crizotinib on Day -7","type":"PRIMARY","unitOfMeasure":"nanogram per milliliter"}