{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.00","upperLimit":"4.02","value":"2.52"},{"groupId":"OG001","lowerLimit":"4.00","upperLimit":"4.00","value":"4.00"},{"groupId":"OG002","lowerLimit":"2.05","upperLimit":"8.02","value":"4.00"},{"groupId":"OG003","lowerLimit":"1.00","upperLimit":"9.08","value":"4.05"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"98"}],"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 100 mg capsule or tablet orally QD for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 100 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":"OG000","title":"Low Dose Escalation Cohort: Crizotinib 100 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":"OG001","title":"Low Dose Escalation Cohort: Crizotinib 200 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":"OG002","title":"Low Dose Escalation Cohort: Crizotinib 300 mg BID"},{"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":"OG003","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 low dose escalation cohorts (excluding Crizotinib 50 mg QD, Crizotinib 200 mg QD and Crizotinib 250 mg BID arms) and combined RP2D cohort and was not planned to be collected for high dose escalation cohort.","reportingStatus":"POSTED","timeFrame":"Pre-dose, 2, 4 and 6 hours post dose on Cycle 1 Day 1","title":"Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Crizotinib on Cycle 1 Day 1","type":"PRIMARY","unitOfMeasure":"hour"}