{"denoms":[{"counts":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"7"},{"groupId":"BG004","value":"8"},{"groupId":"BG005","value":"6"},{"groupId":"BG006","value":"6"},{"groupId":"BG007","value":"5"},{"groupId":"BG008","value":"3"},{"groupId":"BG009","value":"6"},{"groupId":"BG010","value":"9"},{"groupId":"BG011","value":"53"},{"groupId":"BG012","value":"85"},{"groupId":"BG013","value":"41"},{"groupId":"BG014","value":"48"},{"groupId":"BG015","value":"18"},{"groupId":"BG016","value":"154"},{"groupId":"BG017","value":"66"},{"groupId":"BG018","value":"18"},{"groupId":"BG019","value":"18"},{"groupId":"BG020","value":"12"},{"groupId":"BG021","value":"578"}],"units":"Participants"}],"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":"BG000","title":"Low Dose Escalation Cohort: Crizotinib 50 mg QD"},{"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":"BG001","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 QD for up to 34 cycles (each cycle 28 days).","id":"BG002","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":"BG003","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":"BG004","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":"BG005","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":"BG006","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":"BG007","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":"BG008","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":"BG009","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":"BG010","title":"High Dose Escalation Cohort: Crizotinib 800 mg QD"},{"description":"Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 105 cycles (each cycle 28 days).","id":"BG011","title":"RP2D Cohort: ROS1-Positive NSCLC: Crizotinib 250 mg"},{"description":"Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 55 cycles (each cycle 28 days).","id":"BG012","title":"RP2D Cohort: MET Exon 14 Alterations NSCLC: Crizotinib 250 mg"},{"description":"Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 101 cycles (each cycle 28 days).","id":"BG013","title":"RP2D Cohort: MET Amplification NSCLC: Crizotinib 250 mg"},{"description":"Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) with or without food for up to 70 cycles (each cycle 21 days).","id":"BG014","title":"RP2D Cohort: ALK-Negative Cohort 1, NSCLC: Crizotinib 250 mg"},{"description":"Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally BID with or without food for up to 70 cycles (each cycle 21 days).","id":"BG015","title":"RP2D Cohort: ALK-Negative Cohort 2, NSCLC: Crizotinib 250 mg"},{"description":"Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) with or without food for up to 133 cycles (each cycle 28 days).","id":"BG016","title":"RP2D Cohort: ALK-Positive Cohort, NSCLC: Crizotinib 250 mg"},{"description":"Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 54 cycles (each cycle 28 days).","id":"BG017","title":"RP2D Cohort: Enriched Other: Crizotinib 250 mg"},{"description":"Participants received with or without food Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet QD from Cycle 1Day1 to Cycle 2 Day1 thereafter 250 mg BID from Cycle 2 Day 2 up to 58 cycles (each cycle 28 days). Participants also received Itraconazole 200 mg QD from Cycle 1 Day 1 to Cycle 1 Day 16.","id":"BG018","title":"RP2D Cohort: Itraconazole Interaction: Crizotinib 250 mg +Itraconazole"},{"description":"Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) with or without food from Cycle 1 Day 1 up to 13 cycles (each cycle 28 days). Participants also received commercially available Rifampin 650 mg QD from Cycle 1 Day 16 to Cycle 2 Day 1 (14 days) either one hour before or 2 hours after food.","id":"BG019","title":"RP2D Cohort: Rifampin Interaction: Crizotinib 250 mg +Rifampin"},{"description":"Participants received Crizotinib 250 mg tablet/capsule (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) orally BID with or without food from Day 1 Cycle 1 up to 133 cycles (each cycle 28 days). Participants also received single 2 mg oral dose of Midazolam on Day -7 and another single 2-mg oral dose of Midazolam concurrently with Crizotinib on Cycle 2 Day 1","id":"BG020","title":"RP2D Cohort: Midazolam Interaction: Crizotinib 250 mg +Midazolam"},{"description":"Total of all reporting groups","id":"BG021","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"5"},{"groupId":"BG004","value":"8"},{"groupId":"BG005","value":"6"},{"groupId":"BG006","value":"3"},{"groupId":"BG007","value":"5"},{"groupId":"BG008","value":"3"},{"groupId":"BG009","value":"6"},{"groupId":"BG010","value":"5"},{"groupId":"BG011","value":"23"},{"groupId":"BG012","value":"18"},{"groupId":"BG013","value":"20"},{"groupId":"BG014","value":"30"},{"groupId":"BG015","value":"12"},{"groupId":"BG016","value":"131"},{"groupId":"BG017","value":"51"},{"groupId":"BG018","value":"9"},{"groupId":"BG019","value":"12"},{"groupId":"BG020","value":"9"},{"groupId":"BG021","value":"368"}]}],"title":"less than 65 years"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"3"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"0"},{"groupId":"BG010","value":"4"},{"groupId":"BG011","value":"30"},{"groupId":"BG012","value":"67"},{"groupId":"BG013","value":"21"},{"groupId":"BG014","value":"18"},{"groupId":"BG015","value":"6"},{"groupId":"BG016","value":"23"},{"groupId":"BG017","value":"15"},{"groupId":"BG018","value":"9"},{"groupId":"BG019","value":"6"},{"groupId":"BG020","value":"3"},{"groupId":"BG021","value":"210"}]}],"title":"greater than or equals to 65 years"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Customized","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"4"},{"groupId":"BG005","value":"2"},{"groupId":"BG006","value":"3"},{"groupId":"BG007","value":"5"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"1"},{"groupId":"BG010","value":"3"},{"groupId":"BG011","value":"30"},{"groupId":"BG012","value":"48"},{"groupId":"BG013","value":"19"},{"groupId":"BG014","value":"24"},{"groupId":"BG015","value":"8"},{"groupId":"BG016","value":"80"},{"groupId":"BG017","value":"25"},{"groupId":"BG018","value":"11"},{"groupId":"BG019","value":"9"},{"groupId":"BG020","value":"8"},{"groupId":"BG021","value":"289"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"4"},{"groupId":"BG004","value":"4"},{"groupId":"BG005","value":"4"},{"groupId":"BG006","value":"3"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"3"},{"groupId":"BG009","value":"5"},{"groupId":"BG010","value":"6"},{"groupId":"BG011","value":"23"},{"groupId":"BG012","value":"37"},{"groupId":"BG013","value":"22"},{"groupId":"BG014","value":"24"},{"groupId":"BG015","value":"10"},{"groupId":"BG016","value":"74"},{"groupId":"BG017","value":"41"},{"groupId":"BG018","value":"7"},{"groupId":"BG019","value":"9"},{"groupId":"BG020","value":"4"},{"groupId":"BG021","value":"289"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"7"},{"groupId":"BG003","value":"6"},{"groupId":"BG004","value":"8"},{"groupId":"BG005","value":"6"},{"groupId":"BG006","value":"6"},{"groupId":"BG007","value":"4"},{"groupId":"BG008","value":"2"},{"groupId":"BG009","value":"5"},{"groupId":"BG010","value":"8"},{"groupId":"BG011","value":"30"},{"groupId":"BG012","value":"60"},{"groupId":"BG013","value":"38"},{"groupId":"BG014","value":"35"},{"groupId":"BG015","value":"11"},{"groupId":"BG016","value":"98"},{"groupId":"BG017","value":"49"},{"groupId":"BG018","value":"13"},{"groupId":"BG019","value":"16"},{"groupId":"BG020","value":"11"},{"groupId":"BG021","value":"418"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"1"},{"groupId":"BG008","value":"1"},{"groupId":"BG009","value":"0"},{"groupId":"BG010","value":"0"},{"groupId":"BG011","value":"2"},{"groupId":"BG012","value":"2"},{"groupId":"BG013","value":"2"},{"groupId":"BG014","value":"1"},{"groupId":"BG015","value":"3"},{"groupId":"BG016","value":"5"},{"groupId":"BG017","value":"4"},{"groupId":"BG018","value":"3"},{"groupId":"BG019","value":"2"},{"groupId":"BG020","value":"0"},{"groupId":"BG021","value":"27"}],"title":"Black"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"0"},{"groupId":"BG010","value":"1"},{"groupId":"BG011","value":"21"},{"groupId":"BG012","value":"15"},{"groupId":"BG013","value":"1"},{"groupId":"BG014","value":"9"},{"groupId":"BG015","value":"2"},{"groupId":"BG016","value":"43"},{"groupId":"BG017","value":"9"},{"groupId":"BG018","value":"0"},{"groupId":"BG019","value":"0"},{"groupId":"BG020","value":"0"},{"groupId":"BG021","value":"102"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"1"},{"groupId":"BG010","value":"0"},{"groupId":"BG011","value":"0"},{"groupId":"BG012","value":"8"},{"groupId":"BG013","value":"0"},{"groupId":"BG014","value":"3"},{"groupId":"BG015","value":"2"},{"groupId":"BG016","value":"8"},{"groupId":"BG017","value":"4"},{"groupId":"BG018","value":"2"},{"groupId":"BG019","value":"0"},{"groupId":"BG020","value":"1"},{"groupId":"BG021","value":"31"}],"title":"Other"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race/Ethnicity, Customized","unitOfMeasure":"Participants"}],"populationDescription":"Safety analysis (SA) set included all enrolled participants who received at least one dose of Crizotinib on Cycle 1 Day 1."}