{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"7"},{"groupId":"OG004","value":"8"},{"groupId":"OG005","value":"6"},{"groupId":"OG006","value":"6"},{"groupId":"OG007","value":"4"},{"groupId":"OG008","value":"3"},{"groupId":"OG009","value":"6"},{"groupId":"OG010","value":"9"},{"groupId":"OG011","value":"53"},{"groupId":"OG012","value":"85"},{"groupId":"OG013","value":"41"},{"groupId":"OG014","value":"47"},{"groupId":"OG015","value":"18"},{"groupId":"OG016","value":"154"},{"groupId":"OG017","value":"66"},{"groupId":"OG018","value":"18"},{"groupId":"OG019","value":"18"},{"groupId":"OG020","value":"12"}]}],"title":"AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"2"},{"groupId":"OG007","value":"2"},{"groupId":"OG008","value":"1"},{"groupId":"OG009","value":"2"},{"groupId":"OG010","value":"4"},{"groupId":"OG011","value":"24"},{"groupId":"OG012","value":"54"},{"groupId":"OG013","value":"25"},{"groupId":"OG014","value":"22"},{"groupId":"OG015","value":"9"},{"groupId":"OG016","value":"75"},{"groupId":"OG017","value":"29"},{"groupId":"OG018","value":"7"},{"groupId":"OG019","value":"6"},{"groupId":"OG020","value":"6"}]}],"title":"SAEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"7"},{"groupId":"OG004","value":"8"},{"groupId":"OG005","value":"6"},{"groupId":"OG006","value":"6"},{"groupId":"OG007","value":"5"},{"groupId":"OG008","value":"3"},{"groupId":"OG009","value":"6"},{"groupId":"OG010","value":"9"},{"groupId":"OG011","value":"53"},{"groupId":"OG012","value":"85"},{"groupId":"OG013","value":"41"},{"groupId":"OG014","value":"48"},{"groupId":"OG015","value":"18"},{"groupId":"OG016","value":"154"},{"groupId":"OG017","value":"66"},{"groupId":"OG018","value":"18"},{"groupId":"OG019","value":"18"},{"groupId":"OG020","value":"12"}],"units":"Participants"}],"description":"An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. AEs included both serious and all non-serious adverse events. TEAEs were those with initial onset or increasing in severity on or after the first dose of investigational product administration.","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 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":"OG001","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":"OG002","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":"OG003","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":"OG004","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":"OG005","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":"OG006","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":"OG007","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":"OG008","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":"OG009","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":"OG010","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":"OG011","title":"RP2D Cohort: ROS1-Positive NSCLC: Crizotinib 250"},{"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":"OG012","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":"OG013","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":"OG014","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":"OG015","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":"OG016","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":"OG017","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":"OG018","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":"OG019","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":"OG020","title":"RP2D Cohort: Midazolam Interaction: Crizotinib 250 mg +Midazolam"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"SA set included all enrolled participants who received at least one dose of Crizotinib on Cycle 1 Day 1.","reportingStatus":"POSTED","timeFrame":"up to 189 Months","title":"Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Number of Participants With Treatment Emergent Adverse Events (TEAES) and Serious Adverse Events (SAEs)","type":"PRIMARY","unitOfMeasure":"Participants"}