{"description":"Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).","id":"EG000","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":0,"seriousNumAtRisk":3,"title":"Low Dose Escalation Cohort: Crizotinib 50 mg QD"},{"deathsNumAffected":0,"deathsNumAtRisk":4,"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":"EG001","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":0,"seriousNumAtRisk":4,"title":"Low Dose Escalation Cohort: Crizotinib 100 mg QD"},{"deathsNumAffected":0,"deathsNumAtRisk":8,"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":"EG002","otherNumAffected":8,"otherNumAtRisk":8,"seriousNumAffected":1,"seriousNumAtRisk":8,"title":"Low Dose Escalation Cohort: Crizotinib 200 mg QD"},{"deathsNumAffected":0,"deathsNumAtRisk":7,"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":"EG003","otherNumAffected":7,"otherNumAtRisk":7,"seriousNumAffected":2,"seriousNumAtRisk":7,"title":"Low Dose Escalation Cohort: Crizotinib 200 mg BID"},{"deathsNumAffected":0,"deathsNumAtRisk":8,"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":"EG004","otherNumAffected":8,"otherNumAtRisk":8,"seriousNumAffected":4,"seriousNumAtRisk":8,"title":"Low Dose Escalation Cohort: Crizotinib 250 mg BID"},{"deathsNumAffected":0,"deathsNumAtRisk":6,"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":"EG005","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":2,"seriousNumAtRisk":6,"title":"Low Dose Escalation Cohort: Crizotinib 300 mg BID"},{"deathsNumAffected":1,"deathsNumAtRisk":6,"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":"EG006","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":2,"seriousNumAtRisk":6,"title":"High Dose Escalation Cohort: Crizotinib 300 mg QD"},{"deathsNumAffected":0,"deathsNumAtRisk":5,"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":"EG007","otherNumAffected":4,"otherNumAtRisk":5,"seriousNumAffected":2,"seriousNumAtRisk":5,"title":"High Dose Escalation Cohort: Crizotinib 400 mg QD"},{"deathsNumAffected":1,"deathsNumAtRisk":3,"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":"EG008","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":1,"seriousNumAtRisk":3,"title":"High Dose Escalation Cohort: Crizotinib 500 mg QD"},{"deathsNumAffected":1,"deathsNumAtRisk":6,"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":"EG009","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":2,"seriousNumAtRisk":6,"title":"High Dose Escalation Cohort: Crizotinib 650 mg QD"},{"deathsNumAffected":1,"deathsNumAtRisk":9,"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":"EG010","otherNumAffected":9,"otherNumAtRisk":9,"seriousNumAffected":4,"seriousNumAtRisk":9,"title":"High Dose Escalation Cohort: Crizotinib 800 mg QD"},{"deathsNumAffected":10,"deathsNumAtRisk":53,"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":"EG011","otherNumAffected":53,"otherNumAtRisk":53,"seriousNumAffected":24,"seriousNumAtRisk":53,"title":"RP2D Cohort: ROS1-Positive NSCLC: Crizotinib 250 mg"},{"deathsNumAffected":15,"deathsNumAtRisk":85,"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":"EG012","otherNumAffected":85,"otherNumAtRisk":85,"seriousNumAffected":54,"seriousNumAtRisk":85,"title":"RP2D Cohort: MET Exon 14 Alterations NSCLC: Crizotinib 250 mg"},{"deathsNumAffected":8,"deathsNumAtRisk":41,"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":"EG013","otherNumAffected":41,"otherNumAtRisk":41,"seriousNumAffected":25,"seriousNumAtRisk":41,"title":"RP2D Cohort: MET Amplification NSCLC: Crizotinib 250 mg"},{"deathsNumAffected":13,"deathsNumAtRisk":48,"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":"EG014","otherNumAffected":46,"otherNumAtRisk":48,"seriousNumAffected":22,"seriousNumAtRisk":48,"title":"RP2D Cohort: ALK-Negative Cohort 1, NSCLC: Crizotinib 250 mg"},{"deathsNumAffected":9,"deathsNumAtRisk":18,"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":"EG015","otherNumAffected":18,"otherNumAtRisk":18,"seriousNumAffected":9,"seriousNumAtRisk":18,"title":"RP2D Cohort: ALK-Negative Cohort 2, NSCLC: Crizotinib 250 mg"},{"deathsNumAffected":25,"deathsNumAtRisk":154,"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":"EG016","otherNumAffected":154,"otherNumAtRisk":154,"seriousNumAffected":75,"seriousNumAtRisk":154,"title":"RP2D Cohort: ALK-Positive Cohort, NSCLC: Crizotinib 250 mg"},{"deathsNumAffected":15,"deathsNumAtRisk":66,"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":"EG017","otherNumAffected":66,"otherNumAtRisk":66,"seriousNumAffected":29,"seriousNumAtRisk":66,"title":"RP2D Cohort: Enriched Other: Crizotinib 250 mg"},{"deathsNumAffected":0,"deathsNumAtRisk":18,"description":"Participants received 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":"EG018","otherNumAffected":18,"otherNumAtRisk":18,"seriousNumAffected":7,"seriousNumAtRisk":18,"title":"Itraconazole Interaction Sub-study: Crizotinib 250 mg"},{"deathsNumAffected":1,"deathsNumAtRisk":18,"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":"EG019","otherNumAffected":18,"otherNumAtRisk":18,"seriousNumAffected":6,"seriousNumAtRisk":18,"title":"RP2D Cohort: Rifampin Interaction: Crizotinib 250 mg +Rifampin"},{"deathsNumAffected":4,"deathsNumAtRisk":12,"description":"Participants received Crizotinib 250 mg tablet/capsule (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) orally BID from Day 1Cycle 1 up to p 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":"EG020","otherNumAffected":12,"otherNumAtRisk":12,"seriousNumAffected":6,"seriousNumAtRisk":12,"title":"Midazolam Interaction Cohort: Crizotinib 250"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 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and lymphatic system disorders","sourceVocabulary":"MedDRA 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and lymphatic system disorders","sourceVocabulary":"MedDRA 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and lymphatic system disorders","sourceVocabulary":"MedDRA 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