{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.75","upperLimit":"4.08","value":"2.00"},{"groupId":"OG001","lowerLimit":"1.08","upperLimit":"6.00","value":"4.09"},{"groupId":"OG002","lowerLimit":"4.00","upperLimit":"4.08","value":"4.00"},{"groupId":"OG003","lowerLimit":"1.00","upperLimit":"8.95","value":"4.00"},{"groupId":"OG004","lowerLimit":"2.02","upperLimit":"2.02","value":"2.02"},{"groupId":"OG005","lowerLimit":"2.00","upperLimit":"6.00","value":"4.00"},{"groupId":"OG006","lowerLimit":"1.00","upperLimit":"6.00","value":"2.15"},{"groupId":"OG007","lowerLimit":"2.00","upperLimit":"8.00","value":"4.00"},{"groupId":"OG008","lowerLimit":"1.98","upperLimit":"6.00","value":"4.00"},{"groupId":"OG009","lowerLimit":"2.15","upperLimit":"6.13","value":"4.99"},{"groupId":"OG010","lowerLimit":"2.00","upperLimit":"9.33","value":"4.00"}]}]}],"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":"Tmax was defined as the time to reach the observed maximum plasma concentration (Cmax).","dispersionType":"Full Range","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":"MEDIAN","populationDescription":"PK parameter analysis population included all participants treated (including Day -7 dose) who had at least 1 of the PK parameters of interest for Crizotinib. Here, \"N\" signifies participants evaluable for this OM. Data for this OM was planned to be collected for individual arms of low and high dose escalation cohorts (excluding 'Low Dose Escalation Cohort: Crizotinib 100 mg QD' arm) and combined RP2D.","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: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Crizotinib on Day -7","type":"PRIMARY","unitOfMeasure":"hour"}