Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2025-12-29 @ 4:56 AM
Study NCT ID:
NCT00585195
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2007-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D017728', 'term': 'Lymphoma, Large-Cell, Anaplastic'}], 'ancestors': [{'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077547', 'term': 'Crizotinib'}, {'id': 'D012293', 'term': 'Rifampin'}, {'id': 'D017964', 'term': 'Itraconazole'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000631', 'term': 'Aminopyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D010879', 'term': 'Piperazines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to maximum of 189 months', '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': [{'id': 'EG000', 'title': 'Low Dose Escalation Cohort: Crizotinib 50 mg QD', 'description': 'Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Low Dose Escalation Cohort: Crizotinib 100 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.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', '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 QD for up to 34 cycles (each cycle 28 days).', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Low Dose Escalation Cohort: Crizotinib 200 mg BID', '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).', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Low Dose Escalation Cohort: Crizotinib 250 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).', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG005', 'title': 'Low Dose Escalation Cohort: Crizotinib 300 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.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'High Dose Escalation Cohort: Crizotinib 300 mg QD', '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).', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG007', 'title': 'High Dose Escalation Cohort: Crizotinib 400 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).', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 4, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG008', 'title': 'High Dose Escalation Cohort: Crizotinib 500 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).', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG009', 'title': 'High Dose Escalation Cohort: Crizotinib 650 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).', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG010', 'title': 'High Dose Escalation Cohort: Crizotinib 800 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).', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 1, 'seriousNumAffected': 4}, {'id': 'EG011', '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 105 cycles (each cycle 28 days).', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 53, 'seriousNumAtRisk': 53, 'deathsNumAffected': 10, 'seriousNumAffected': 24}, {'id': 'EG012', '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 55 cycles (each cycle 28 days).', 'otherNumAtRisk': 85, 'deathsNumAtRisk': 85, 'otherNumAffected': 85, 'seriousNumAtRisk': 85, 'deathsNumAffected': 15, 'seriousNumAffected': 54}, {'id': 'EG013', '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 orally twice daily (BID) with or without food for up to 101 cycles (each cycle 28 days).', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 41, 'seriousNumAtRisk': 41, 'deathsNumAffected': 8, 'seriousNumAffected': 25}, {'id': 'EG014', '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 twice daily (BID) with or without food for up to 70 cycles (each cycle 21 days).', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 46, 'seriousNumAtRisk': 48, 'deathsNumAffected': 13, 'seriousNumAffected': 22}, {'id': 'EG015', '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 orally BID with or without food for up to 70 cycles (each cycle 21 days).', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 18, 'seriousNumAtRisk': 18, 'deathsNumAffected': 9, 'seriousNumAffected': 9}, {'id': 'EG016', '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 twice daily (BID) with or without food for up to 133 cycles (each cycle 28 days).', 'otherNumAtRisk': 154, 'deathsNumAtRisk': 154, 'otherNumAffected': 154, 'seriousNumAtRisk': 154, 'deathsNumAffected': 25, 'seriousNumAffected': 75}, {'id': 'EG017', 'title': 'RP2D Cohort: Enriched Other: 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).', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 66, 'seriousNumAtRisk': 66, 'deathsNumAffected': 15, 'seriousNumAffected': 29}, {'id': 'EG018', 'title': 'Itraconazole Interaction Sub-study: Crizotinib 250 mg', '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.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 18, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG019', 'title': 'RP2D Cohort: Rifampin Interaction: Crizotinib 250 mg +Rifampin', '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.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 18, 'seriousNumAtRisk': 18, 'deathsNumAffected': 1, 'seriousNumAffected': 6}, {'id': 'EG020', 'title': 'Midazolam Interaction Cohort: Crizotinib 250', '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.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 4, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 53, 'numAffected': 8}, {'groupId': 'EG012', 'numAtRisk': 85, 'numAffected': 14}, {'groupId': 'EG013', 'numAtRisk': 41, 'numAffected': 8}, {'groupId': 'EG014', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG016', 'numAtRisk': 154, 'numAffected': 17}, {'groupId': 'EG017', 'numAtRisk': 66, 'numAffected': 15}, {'groupId': 'EG018', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG019', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG020', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG015', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 154, 'numAffected': 14}, {'groupId': 'EG017', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 53, 'numAffected': 9}, {'groupId': 'EG012', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG014', 'numAtRisk': 48, 'numAffected': 5}, {'groupId': 'EG015', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG016', 'numAtRisk': 154, 'numAffected': 26}, {'groupId': 'EG017', 'numAtRisk': 66, 'numAffected': 5}, {'groupId': 'EG018', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG019', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG012', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 154, 'numAffected': 6}, {'groupId': 'EG017', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG018', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG019', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 53, 'numAffected': 7}, {'groupId': 'EG012', 'numAtRisk': 85, 'numAffected': 13}, {'groupId': 'EG013', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG014', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 154, 'numAffected': 13}, {'groupId': 'EG017', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG018', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG019', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 53, 'numAffected': 5}, {'groupId': 'EG012', 'numAtRisk': 85, 'numAffected': 11}, {'groupId': 'EG013', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG014', 'numAtRisk': 48, 'numAffected': 5}, {'groupId': 'EG015', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 154, 'numAffected': 9}, {'groupId': 'EG017', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG018', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG013', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 154, 'numAffected': 9}, {'groupId': 'EG017', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG018', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 53, 'numAffected': 5}, {'groupId': 'EG012', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 154, 'numAffected': 3}, {'groupId': 'EG017', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG019', 'numAtRisk': 18, 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0}, {'groupId': 'EG012', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Dose-Escalation Cohort: Maximum Tolerated Dose (MTD) of Crizotinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Escalation Cohort: Crizotinib 50 mg QD', 'description': 'Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).'}, {'id': 'OG001', 'title': 'Low Dose Escalation Cohort: Crizotinib 100 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': '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 QD for up to 34 cycles (each cycle 28 days).'}, {'id': 'OG003', 'title': 'Low Dose Escalation Cohort: Crizotinib 200 mg BID', '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': 'OG004', 'title': 'Low Dose Escalation Cohort: Crizotinib 250 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': '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 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': 'OG006', 'title': 'High Dose Escalation Cohort: Crizotinib 300 mg QD', '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': 'OG007', 'title': 'High Dose Escalation Cohort: Crizotinib 400 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': 'OG008', 'title': 'High Dose Escalation Cohort: Crizotinib 500 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': 'OG009', 'title': 'High Dose Escalation Cohort: Crizotinib 650 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': 'OG010', 'title': 'High Dose Escalation Cohort: Crizotinib 800 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).'}], 'classes': [{'categories': [{'measurements': [{'value': '250', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}, {'value': '250', 'groupId': 'OG002'}, {'value': '250', 'groupId': 'OG003'}, {'value': '250', 'groupId': 'OG004'}, {'value': '250', 'groupId': 'OG005'}, {'value': '250', 'groupId': 'OG006'}, {'value': '250', 'groupId': 'OG007'}, {'value': '250', 'groupId': 'OG008'}, {'value': '250', 'groupId': 'OG009'}, {'value': '250', 'groupId': 'OG010'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 1 (28 days)', 'description': 'MTD: Dose level at which at most 1 of 6 participants experienced DLT within and including 28 days of treatment (during Cycle 1 \\[1 cycle=28 days\\]) with next higher dose having at least 2/3 or 2/6 participants experiencing a DLT. DLT was defined as any of following: Hematologic toxicities- 1) prolonged grade 4 neutropenia for \\>7 days. 2) Febrile neutropenia: grade 4 neutropenia with fever greater than (\\>) 38.5 degree Celsius, both sustained over a 24 hour period (3) neutropenic infection: greater than or equal to (\\>=) Grade 3 neutropenia with Grade \\>=3 infection. (4) Grade \\>=3 thrombocytopenia with bleeding/grade 4 lasting \\>=7 days. Other non-hematologic toxicity included: Grade 3/4 toxicities (except for alopecia, Grade 3/4 hypophosphatemia, grade 3 hypertension with controlled blood pressure \\[less than (\\<) 140/90 millimeter of mercury, and Grade 3/4 hyperuricemia without signs and symptoms of gout). Nausea, vomiting/diarrhea must persist at grade 3/4 despite maximal medical therapy.', 'unitOfMeasure': 'milligram', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis (SA) set included all enrolled participants who received at least one dose of Crizotinib on Cycle 1 Day 1.'}, {'type': 'PRIMARY', 'title': 'Dose-Escalation Cohort: Recommended Phase 2 Dose (RP2D) of Crizotinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Escalation Cohort: Crizotinib 50 mg QD', 'description': 'Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).'}, {'id': 'OG001', 'title': 'Low Dose Escalation Cohort: Crizotinib 100 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': '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 QD for up to 34 cycles (each cycle 28 days).'}, {'id': 'OG003', 'title': 'Low Dose Escalation Cohort: Crizotinib 200 mg BID', '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': 'OG004', 'title': 'Low Dose Escalation Cohort: Crizotinib 250 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': '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 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': 'OG006', 'title': 'High Dose Escalation Cohort: Crizotinib 300 mg QD', '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': 'OG007', 'title': 'High Dose Escalation Cohort: Crizotinib 400 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': 'OG008', 'title': 'High Dose Escalation Cohort: Crizotinib 500 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': 'OG009', 'title': 'High Dose Escalation Cohort: Crizotinib 650 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': 'OG010', 'title': 'High Dose Escalation Cohort: Crizotinib 800 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).'}], 'classes': [{'categories': [{'measurements': [{'value': '250', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}, {'value': '250', 'groupId': 'OG002'}, {'value': '250', 'groupId': 'OG003'}, {'value': '250', 'groupId': 'OG004'}, {'value': '250', 'groupId': 'OG005'}, {'value': '250', 'groupId': 'OG006'}, {'value': '250', 'groupId': 'OG007'}, {'value': '250', 'groupId': 'OG008'}, {'value': '250', 'groupId': 'OG009'}, {'value': '250', 'groupId': 'OG010'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 1 (28 days)', 'description': 'RP2D was defined as a dose below or equal to MTD, at which crizotinib was unlikely to cause a significant inhibition of CYP3A4 activity.', 'unitOfMeasure': 'milligram', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis (SA) set included all enrolled participants who received at least one dose of Crizotinib on Cycle 1 Day 1.'}, {'type': 'PRIMARY', 'title': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Crizotinib on Day -7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '29', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Escalation Cohort: Crizotinib 50 mg QD', 'description': 'Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (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 QD for up to 34 cycles (each cycle 28 days).'}, {'id': 'OG002', 'title': 'Low Dose Escalation Cohort: Crizotinib 200 mg BID', '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 250 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 300 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': 'High Dose Escalation Cohort: Crizotinib 300 mg QD', '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 400 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 500 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 650 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 800 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': 'RP2D Cohort: Crizotinib 250 mg', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '274.43', 'spread': '22', 'groupId': 'OG000'}, {'value': '1378.05', 'spread': '144', 'groupId': 'OG001'}, {'value': '946.93', 'spread': '38', 'groupId': 'OG002'}, {'value': '1817.35', 'spread': '34', 'groupId': 'OG003'}, {'value': '2320.00', 'groupId': 'OG004'}, {'value': '3457', 'spread': '42', 'groupId': 'OG005'}, {'value': '3078', 'spread': '119', 'groupId': 'OG006'}, {'value': '2107', 'spread': '53', 'groupId': 'OG007'}, {'value': '3979', 'spread': '39', 'groupId': 'OG008'}, {'value': '7547', 'spread': '76', 'groupId': 'OG009'}, {'value': '2489.39', 'spread': '53', 'groupId': 'OG010'}]}]}], 'paramType': 'GEOMETRIC_MEAN', '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', 'description': 'AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) extrapolated to infinite time (0-inf).', 'unitOfMeasure': 'nanogram*hour per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (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. "Overall number of participants analyzed (N)" signifies participants evaluable for this outcome measure (OM). Data for this OM was planned to be collected for individual arms of low and high dose escalation and combined RP2D Cohort excluding "Low Dose Escalation Cohort: Crizotinib 100 mg QD" arm.'}, {'type': 'PRIMARY', 'title': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib on Day -7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '46', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Escalation Cohort: Crizotinib 50 mg QD', 'description': 'Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (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 QD for up to 34 cycles (each cycle 28 days).'}, {'id': 'OG002', 'title': 'Low Dose Escalation Cohort: Crizotinib 200 mg BID', '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 250 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 300 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': 'High Dose Escalation Cohort: Crizotinib 300 mg QD', '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 400 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 500 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 650 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 800 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': 'RP2D Cohort: Crizotinib 250 mg', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '137.40', 'spread': '8', 'groupId': 'OG000'}, {'value': '658.64', 'spread': '136', 'groupId': 'OG001'}, {'value': '338.39', 'spread': '50', 'groupId': 'OG002'}, {'value': '558.01', 'spread': '33', 'groupId': 'OG003'}, {'value': '863.00', 'groupId': 'OG004'}, {'value': '1731', 'spread': '51', 'groupId': 'OG005'}, {'value': '1377', 'spread': '114', 'groupId': 'OG006'}, {'value': '1300', 'spread': '61', 'groupId': 'OG007'}, {'value': '1906', 'spread': '39', 'groupId': 'OG008'}, {'value': '3423', 'spread': '57', 'groupId': 'OG009'}, {'value': '741.50', 'spread': '45', 'groupId': 'OG010'}]}]}], 'paramType': 'GEOMETRIC_MEAN', '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', 'description': 'Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau), where dosing interval is 12 hours for BID dose and 24 hours for QD dose.', 'unitOfMeasure': 'nanogram*hour per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', '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 reported for individual arms of low and high dose escalation and combined RP2D Cohort excluding "Low Dose Escalation Cohort: Crizotinib 100 mg QD" arm.'}, {'type': 'PRIMARY', 'title': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib on Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '88', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Escalation Cohort: Crizotinib 100 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 200 mg BID', '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 300 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': 'OG003', 'title': 'RP2D Cohort: Crizotinib 250 mg', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '457.55', 'spread': '32', 'groupId': 'OG000'}, {'value': '383.98', 'spread': '10', 'groupId': 'OG001'}, {'value': '763.71', 'spread': '57', 'groupId': 'OG002'}, {'value': '663.39', 'spread': '56', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 2, 4 and 6 hours post dose on Cycle 1 Day 1', 'description': 'Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau), where dosing interval is 12 hours for BID dose and 24 hours for QD dose.', 'unitOfMeasure': 'nanogram*hour per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', '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 cohort (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.'}, {'type': 'PRIMARY', 'title': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib on Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '19', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Escalation Cohort: Crizotinib 50 mg QD', 'description': 'Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).'}, {'id': 'OG001', 'title': 'Low Dose Escalation Cohort: Crizotinib 100 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': '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 QD for up to 34 cycles (each cycle 28 days).'}, {'id': 'OG003', 'title': 'Low Dose Escalation Cohort: Crizotinib 200 mg BID', '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': 'OG004', 'title': 'Low Dose Escalation Cohort: Crizotinib 250 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': '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 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': 'OG006', 'title': 'High Dose Escalation Cohort: Crizotinib 300 mg QD', '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': 'OG007', 'title': 'High Dose Escalation Cohort: Crizotinib 400 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': 'OG008', 'title': 'High Dose Escalation Cohort: Crizotinib 500 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': 'OG009', 'title': 'High Dose Escalation Cohort: Crizotinib 650 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': 'OG010', 'title': 'High Dose Escalation Cohort: Crizotinib 800 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': 'OG011', 'title': 'RP2D Cohort: Crizotinib 250 mg', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '206.13', 'spread': '76', 'groupId': 'OG000'}, {'value': '1086.99', 'spread': '34', 'groupId': 'OG001'}, {'value': '2047.13', 'spread': '45', 'groupId': 'OG002'}, {'value': '1780.21', 'spread': '69', 'groupId': 'OG003'}, {'value': '3083.93', 'spread': '31', 'groupId': 'OG004'}, {'value': '4066.67', 'spread': '53', 'groupId': 'OG005'}, {'value': '4375', 'spread': '34', 'groupId': 'OG006'}, {'value': '3385', 'spread': '24', 'groupId': 'OG007'}, {'value': '6655', 'spread': '4', 'groupId': 'OG008'}, {'value': '6362', 'spread': '37', 'groupId': 'OG009'}, {'value': '10480', 'spread': '76', 'groupId': 'OG010'}, {'value': '3879.56', 'spread': '45', 'groupId': 'OG011'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 1, 2, 4, 6, 8, 9 and 24 hours post dose on Cycle 1 Day 15', 'description': 'Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau), where dosing interval is 12 hours for BID dose and 24 hours for QD dose.', 'unitOfMeasure': 'nanogram*hour per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population included all participants treated (including Day -7 dose) who have at least 1 of the PK parameters of interest for Crizotinib. Here, "Overall number of participants analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measures was planned to be collected for individual arms of dose escalation cohorts and combined RP2D Cohort.'}, {'type': 'PRIMARY', 'title': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib on Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '16', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Escalation Cohort: Crizotinib 50 mg QD', 'description': 'Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).'}, {'id': 'OG001', 'title': 'Low Dose Escalation Cohort: Crizotinib 100 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': '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 QD for up to 34 cycles (each cycle 28 days).'}, {'id': 'OG003', 'title': 'Low Dose Escalation Cohort: Crizotinib 200 mg BID', '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': 'OG004', 'title': 'Low Dose Escalation Cohort: Crizotinib 250 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': '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 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': 'OG006', 'title': 'High Dose Escalation Cohort: Crizotinib 300 mg QD', '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': 'OG007', 'title': 'High Dose Escalation Cohort: Crizotinib 400 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': 'OG008', 'title': 'High Dose Escalation Cohort: Crizotinib 500 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': 'OG009', 'title': 'High Dose Escalation Cohort: Crizotinib 650 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': 'OG010', 'title': 'High Dose Escalation Cohort: Crizotinib 800 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': 'OG011', 'title': 'RP2D Cohort: Crizotinib 250 mg', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '425.90', 'spread': '49', 'groupId': 'OG000'}, {'value': '1595.58', 'spread': '30', 'groupId': 'OG001'}, {'value': '1719.30', 'spread': '68', 'groupId': 'OG002'}, {'value': '2255.70', 'spread': '14', 'groupId': 'OG003'}, {'value': '3054.45', 'spread': '29', 'groupId': 'OG004'}, {'value': '3644.72', 'spread': '17', 'groupId': 'OG005'}, {'value': '4815', 'spread': '23', 'groupId': 'OG006'}, {'value': '3839', 'spread': '65', 'groupId': 'OG007'}, {'value': '6330', 'spread': '64', 'groupId': 'OG008'}, {'value': '7273', 'spread': '48', 'groupId': 'OG009'}, {'value': '8733', 'spread': '63', 'groupId': 'OG010'}, {'value': '4163.77', 'spread': '40', 'groupId': 'OG011'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 1, 2, 4, 6, 8, 9 and 24 hours post dose on Cycle 2 Day 1', 'description': 'Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau), where dosing interval is 12 hours for BID dose and 24 hours for QD dose.', 'unitOfMeasure': 'nanogram*hour per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population included all participants treated (including Day -7 dose) who have at least 1 of the PK parameters of interest for Crizotinib. Here, "Overall number of participants analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measures was planned to be collected for individual arms of dose escalation cohorts and combined RP2D Cohort.'}, {'type': 'PRIMARY', 'title': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Trough Concentration (Ctrough) of Crizotinib Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Escalation Cohort: Crizotinib 50 mg QD', 'description': 'Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).'}, {'id': 'OG001', 'title': 'Low Dose Escalation Cohort: Crizotinib 100 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': '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 QD for up to 34 cycles (each cycle 28 days).'}, {'id': 'OG003', 'title': 'Low Dose Escalation Cohort: Crizotinib 200 mg BID', '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': 'OG004', 'title': 'Low Dose Escalation Cohort: Crizotinib 250 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': '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 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': 'OG006', 'title': 'RP2D Cohort: Crizotinib 250 mg', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.29', 'spread': '42', 'groupId': 'OG000'}, {'value': '32.61', 'spread': '36', 'groupId': 'OG001'}, {'value': '48.18', 'spread': '58', 'groupId': 'OG002'}, {'value': '126.76', 'spread': '97', 'groupId': 'OG003'}, {'value': '232.59', 'spread': '33', 'groupId': 'OG004'}, {'value': '307.83', 'spread': '59', 'groupId': 'OG005'}, {'value': '280.43', 'spread': '75', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose on Cycle 1 Day 15', 'description': 'Ctrough refers to plasma concentration of Crizotinib observed just before treatment administration.', 'unitOfMeasure': 'nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', '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 dose escalation and combined RP2D Cohort and not planned to be collected for high dose escalation cohort".'}, {'type': 'PRIMARY', 'title': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Trough Concentration (Ctrough) of Crizotinib on Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Escalation Cohort: Crizotinib 50 mg QD', 'description': 'Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).'}, {'id': 'OG001', 'title': 'Low Dose Escalation Cohort: Crizotinib 100 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': '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 QD for up to 34 cycles (each cycle 28 days).'}, {'id': 'OG003', 'title': 'Low Dose Escalation Cohort: Crizotinib 200 mg BID', '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': 'OG004', 'title': 'Low Dose Escalation Cohort: Crizotinib 250 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': '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 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': 'OG006', 'title': 'RP2D Cohort: Crizotinib 250 mg', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.68', 'spread': '94', 'groupId': 'OG000'}, {'value': '31.91', 'spread': '34', 'groupId': 'OG001'}, {'value': '54.04', 'spread': '85', 'groupId': 'OG002'}, {'value': '157.24', 'spread': '17', 'groupId': 'OG003'}, {'value': '232.45', 'spread': '32', 'groupId': 'OG004'}, {'value': '329.50', 'spread': '40', 'groupId': 'OG005'}, {'value': '312.99', 'spread': '55', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose on Cycle 2 Day 1', 'description': 'Ctrough refers to plasma concentration of Crizotinib observed just before treatment administration.', 'unitOfMeasure': 'nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', '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 dose escalation and combined RP2D Cohort and not planned to be collected for high dose escalation cohort".'}, {'type': 'PRIMARY', 'title': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Maximum Observed Plasma Concentration (Cmax) of Crizotinib on Day -7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '46', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Escalation Cohort: Crizotinib 50 mg QD', 'description': 'Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (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 QD for up to 34 cycles (each cycle 28 days).'}, {'id': 'OG002', 'title': 'Low Dose Escalation Cohort: Crizotinib 200 mg BID', '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 250 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 300 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': 'High Dose Escalation Cohort: Crizotinib 300 mg QD', '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 400 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 500 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 650 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 800 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': 'RP2D Cohort: Crizotinib 250 mg', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.19', 'spread': '36', 'groupId': 'OG000'}, {'value': '67.64', 'spread': '106', 'groupId': 'OG001'}, {'value': '55.73', 'spread': '45', 'groupId': 'OG002'}, {'value': '87.02', 'spread': '34', 'groupId': 'OG003'}, {'value': '130.00', 'groupId': 'OG004'}, {'value': '184.7', 'spread': '65', 'groupId': 'OG005'}, {'value': '115.9', 'spread': '85', 'groupId': 'OG006'}, {'value': '146.6', 'spread': '31', 'groupId': 'OG007'}, {'value': '154.3', 'spread': '30', 'groupId': 'OG008'}, {'value': '270.9', 'spread': '47', 'groupId': 'OG009'}, {'value': '108.40', 'spread': '42', 'groupId': 'OG010'}]}]}], 'paramType': 'GEOMETRIC_MEAN', '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', 'description': 'Cmax is defined as the observed maximum plasma concentration post drug administration.', 'unitOfMeasure': 'nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population set. "N"=participants evaluable for this outcome measure. Data for this OM was planned to be collected for dose escalation cohorts (both low and high) and combined RP2D Cohort excluding "Low Dose Escalation Cohort: Crizotinib 100 mg QD" cohort arms.'}, {'type': 'PRIMARY', 'title': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Maximum Observed Plasma Concentration (Cmax) of Crizotinib on Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Escalation Cohort: Crizotinib 100 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 200 mg BID', '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 300 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': 'OG003', 'title': 'RP2D Cohort: Crizotinib 250 mg', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.89', 'spread': '53', 'groupId': 'OG000'}, {'value': '64.14', 'spread': '2', 'groupId': 'OG001'}, {'value': '114.09', 'spread': '48', 'groupId': 'OG002'}, {'value': '98.86', 'spread': '55', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 2, 4 and 6 hours post dose on Cycle 1 Day 1', 'description': 'Cmax is defined as the observed maximum plasma concentration post drug administration.', 'unitOfMeasure': 'nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', '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 cohort (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.'}, {'type': 'PRIMARY', 'title': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Maximum Observed Plasma Concentration (Cmax) of Crizotinib on Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '24', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Escalation Cohort: Crizotinib 50 mg QD', 'description': 'Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).'}, {'id': 'OG001', 'title': 'Low Dose Escalation Cohort: Crizotinib 100 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': '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 QD for up to 34 cycles (each cycle 28 days).'}, {'id': 'OG003', 'title': 'Low Dose Escalation Cohort: Crizotinib 200 mg BID', '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': 'OG004', 'title': 'Low Dose Escalation Cohort: Crizotinib 250 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': '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 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': 'OG006', 'title': 'High Dose Escalation Cohort: Crizotinib 300 mg QD', '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': 'OG007', 'title': 'High Dose Escalation Cohort: Crizotinib 400 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': 'OG008', 'title': 'High Dose Escalation Cohort: Crizotinib 500 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': 'OG009', 'title': 'High Dose Escalation Cohort: Crizotinib 650 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': 'OG010', 'title': 'High Dose Escalation Cohort: Crizotinib 800 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': 'OG011', 'title': 'RP2D Cohort: Crizotinib 250 mg', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.44', 'spread': '68', 'groupId': 'OG000'}, {'value': '85.66', 'spread': '66', 'groupId': 'OG001'}, {'value': '149.06', 'spread': '29', 'groupId': 'OG002'}, {'value': '188.84', 'spread': '56', 'groupId': 'OG003'}, {'value': '326.51', 'spread': '24', 'groupId': 'OG004'}, {'value': '420.15', 'spread': '46', 'groupId': 'OG005'}, {'value': '315.2', 'spread': '50', 'groupId': 'OG006'}, {'value': '215.5', 'spread': '26', 'groupId': 'OG007'}, {'value': '395.3', 'spread': '16', 'groupId': 'OG008'}, {'value': '379.2', 'spread': '28', 'groupId': 'OG009'}, {'value': '671.3', 'spread': '76', 'groupId': 'OG010'}, {'value': '411.11', 'spread': '51', 'groupId': 'OG011'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 1, 2, 4, 6, 8, 9 and 24 hours post dose on Cycle 1 Day 15', 'description': 'Cmax is defined as the observed maximum plasma concentration post drug administration.', 'unitOfMeasure': 'nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population included all participants treated (including Day -7 dose) who have at least 1 of the PK parameters of interest for Crizotinib. Here, "Overall number of participants analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measures was planned to be collected for individual arms of dose escalation cohorts (both low and high) and combined RP2D Cohort.'}, {'type': 'PRIMARY', 'title': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Maximum Observed Plasma Concentration (Cmax) of Crizotinib on Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '18', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Escalation Cohort: Crizotinib 50 mg QD', 'description': 'Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).'}, {'id': 'OG001', 'title': 'Low Dose Escalation Cohort: Crizotinib 100 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': '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 QD for up to 34 cycles (each cycle 28 days).'}, {'id': 'OG003', 'title': 'Low Dose Escalation Cohort: Crizotinib 200 mg BID', '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': 'OG004', 'title': 'Low Dose Escalation Cohort: Crizotinib 250 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': '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 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': 'OG006', 'title': 'High Dose Escalation Cohort: Crizotinib 300 mg QD', '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': 'OG007', 'title': 'High Dose Escalation Cohort: Crizotinib 400 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': 'OG008', 'title': 'High Dose Escalation Cohort: Crizotinib 500 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': 'OG009', 'title': 'High Dose Escalation Cohort: Crizotinib 650 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': 'OG010', 'title': 'High Dose Escalation Cohort: Crizotinib 800 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': 'OG011', 'title': 'RP2D Cohort: Crizotinib 250 mg', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.99', 'spread': '23', 'groupId': 'OG000'}, {'value': '133.69', 'spread': '48', 'groupId': 'OG001'}, {'value': '146.26', 'spread': '38', 'groupId': 'OG002'}, {'value': '238.84', 'spread': '12', 'groupId': 'OG003'}, {'value': '327.94', 'spread': '25', 'groupId': 'OG004'}, {'value': '474.68', 'spread': '43', 'groupId': 'OG005'}, {'value': '275.0', 'spread': '28', 'groupId': 'OG006'}, {'value': '248.2', 'spread': '60', 'groupId': 'OG007'}, {'value': '327.9', 'spread': '47', 'groupId': 'OG008'}, {'value': '419.8', 'spread': '36', 'groupId': 'OG009'}, {'value': '700.0', 'spread': '37', 'groupId': 'OG010'}, {'value': '477.85', 'spread': '44', 'groupId': 'OG011'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 1, 2, 4, 6, 8, 9 and 24 hours post dose on Cycle 2 Day 1', 'description': 'Cmax is defined as the observed maximum plasma concentration post drug administration.', 'unitOfMeasure': 'nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population included all participants treated (including Day -7 dose) who have at least 1 of the PK parameters of interest for Crizotinib. Here, "Overall number of participants analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measures was planned to be collected for individual arms of dose escalation cohorts (both low and high) and combined RP2D Cohort.'}, {'type': 'PRIMARY', 'title': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Crizotinib on Day -7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '46', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Escalation Cohort: Crizotinib 50 mg QD', 'description': 'Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (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 QD for up to 34 cycles (each cycle 28 days).'}, {'id': 'OG002', 'title': 'Low Dose Escalation Cohort: Crizotinib 200 mg BID', '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 250 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 300 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': 'High Dose Escalation Cohort: Crizotinib 300 mg QD', '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 400 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 500 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 650 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 800 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': 'RP2D Cohort: Crizotinib 250 mg', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.75', 'upperLimit': '4.08'}, {'value': '4.09', 'groupId': 'OG001', 'lowerLimit': '1.08', 'upperLimit': '6.00'}, {'value': '4.00', 'groupId': 'OG002', 'lowerLimit': '4.00', 'upperLimit': '4.08'}, {'value': '4.00', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '8.95'}, {'value': '2.02', 'groupId': 'OG004', 'lowerLimit': '2.02', 'upperLimit': '2.02'}, {'value': '4.00', 'groupId': 'OG005', 'lowerLimit': '2.00', 'upperLimit': '6.00'}, {'value': '2.15', 'groupId': 'OG006', 'lowerLimit': '1.00', 'upperLimit': '6.00'}, {'value': '4.00', 'groupId': 'OG007', 'lowerLimit': '2.00', 'upperLimit': '8.00'}, {'value': '4.00', 'groupId': 'OG008', 'lowerLimit': '1.98', 'upperLimit': '6.00'}, {'value': '4.99', 'groupId': 'OG009', 'lowerLimit': '2.15', 'upperLimit': '6.13'}, {'value': '4.00', 'groupId': 'OG010', 'lowerLimit': '2.00', 'upperLimit': '9.33'}]}]}], 'paramType': 'MEDIAN', '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', 'description': 'Tmax was defined as the time to reach the observed maximum plasma concentration (Cmax).', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', '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.'}, {'type': 'PRIMARY', '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Escalation Cohort: Crizotinib 100 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 200 mg BID', '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 300 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': 'OG003', 'title': 'RP2D Cohort: Crizotinib 250 mg', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.52', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '4.02'}, {'value': '4.00', 'groupId': 'OG001', 'lowerLimit': '4.00', 'upperLimit': '4.00'}, {'value': '4.00', 'groupId': 'OG002', 'lowerLimit': '2.05', 'upperLimit': '8.02'}, {'value': '4.05', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '9.08'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 2, 4 and 6 hours post dose on Cycle 1 Day 1', 'description': 'Tmax was defined as the time to reach the observed maximum plasma concentration (Cmax).', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', '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.'}, {'type': 'PRIMARY', 'title': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Crizotinib on Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '24', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Escalation Cohort: Crizotinib 50 mg QD', 'description': 'Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).'}, {'id': 'OG001', 'title': 'Low Dose Escalation Cohort: Crizotinib 100 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': '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 QD for up to 34 cycles (each cycle 28 days).'}, {'id': 'OG003', 'title': 'Low Dose Escalation Cohort: Crizotinib 200 mg BID', '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': 'OG004', 'title': 'Low Dose Escalation Cohort: Crizotinib 250 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': '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 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': 'OG006', 'title': 'High Dose Escalation Cohort: Crizotinib 300 mg QD', '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': 'OG007', 'title': 'High Dose Escalation Cohort: Crizotinib 400 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': 'OG008', 'title': 'High Dose Escalation Cohort: Crizotinib 500 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': 'OG009', 'title': 'High Dose Escalation Cohort: Crizotinib 650 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': 'OG010', 'title': 'High Dose Escalation Cohort: Crizotinib 800 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': 'OG011', 'title': 'RP2D Cohort: Crizotinib 250 mg', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '2.51', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '6.08'}, {'value': '4.07', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '6.00'}, {'value': '5.01', 'groupId': 'OG003', 'lowerLimit': '2.08', 'upperLimit': '8.03'}, {'value': '4.00', 'groupId': 'OG004', 'lowerLimit': '0.97', 'upperLimit': '6.07'}, {'value': '4.99', 'groupId': 'OG005', 'lowerLimit': '3.98', 'upperLimit': '6.22'}, {'value': '5.13', 'groupId': 'OG006', 'lowerLimit': '1.93', 'upperLimit': '7.88'}, {'value': '5.17', 'groupId': 'OG007', 'lowerLimit': '0.933', 'upperLimit': '6.00'}, {'value': '4.00', 'groupId': 'OG008', 'lowerLimit': '4.00', 'upperLimit': '9.00'}, {'value': '5.98', 'groupId': 'OG009', 'lowerLimit': '4.00', 'upperLimit': '6.00'}, {'value': '5.03', 'groupId': 'OG010', 'lowerLimit': '4.00', 'upperLimit': '6.03'}, {'value': '4.00', 'groupId': 'OG011', 'lowerLimit': '0.00', 'upperLimit': '9.03'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 1, 2, 4, 6, 8, 9 and 24 hours post dose on Cycle 1 Day 15', 'description': 'Tmax was defined as the time to reach the observed maximum plasma concentration (Cmax).', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population included all participants treated (including Day -7 dose) who have at least 1 of the PK parameters of interest for Crizotinib. Here, "Overall number of participants analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measures was planned to be collected for individual arms of dose escalation cohorts (both low and high) and combined RP2D Cohort.'}, {'type': 'PRIMARY', 'title': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Crizotinib Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '18', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Escalation Cohort: Crizotinib 50 mg QD', 'description': 'Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).'}, {'id': 'OG001', 'title': 'Low Dose Escalation Cohort: Crizotinib 100 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': '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 QD for up to 34 cycles (each cycle 28 days).'}, {'id': 'OG003', 'title': 'Low Dose Escalation Cohort: Crizotinib 200 mg BID', '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': 'OG004', 'title': 'Low Dose Escalation Cohort: Crizotinib 250 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': '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 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': 'OG006', 'title': 'High Dose Escalation Cohort: Crizotinib 300 mg QD', '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': 'OG007', 'title': 'High Dose Escalation Cohort: Crizotinib 400 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': 'OG008', 'title': 'High Dose Escalation Cohort: Crizotinib 500 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': 'OG009', 'title': 'High Dose Escalation Cohort: Crizotinib 650 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': 'OG010', 'title': 'High Dose Escalation Cohort: Crizotinib 800 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': 'OG011', 'title': 'RP2D Cohort: Crizotinib 250 mg', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.02', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '3.98', 'groupId': 'OG001', 'lowerLimit': '2.00', 'upperLimit': '4.02'}, {'value': '4.00', 'groupId': 'OG002', 'lowerLimit': '2.00', 'upperLimit': '4.17'}, {'value': '4.00', 'groupId': 'OG003', 'lowerLimit': '3.95', 'upperLimit': '4.00'}, {'value': '4.00', 'groupId': 'OG004', 'lowerLimit': '4.00', 'upperLimit': '6.00'}, {'value': '4.05', 'groupId': 'OG005', 'lowerLimit': '3.98', 'upperLimit': '9.00'}, {'value': '3.00', 'groupId': 'OG006', 'lowerLimit': '1.00', 'upperLimit': '5.95'}, {'value': '4.00', 'groupId': 'OG007', 'lowerLimit': '2.08', 'upperLimit': '6.00'}, {'value': '7.59', 'groupId': 'OG008', 'lowerLimit': '6.18', 'upperLimit': '9.00'}, {'value': '4.30', 'groupId': 'OG009', 'lowerLimit': '4.00', 'upperLimit': '9.00'}, {'value': '5.00', 'groupId': 'OG010', 'lowerLimit': '4.00', 'upperLimit': '6.00'}, {'value': '4.00', 'groupId': 'OG011', 'lowerLimit': '0.00', 'upperLimit': '9.02'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 1, 2, 4, 6, 8, 9 and 24 hours post dose on Cycle 2 Day 1', 'description': 'Tmax was defined as the time to reach the observed maximum plasma concentration (Cmax).', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population included all participants treated (including Day -7 dose) who have at least 1 of the PK parameters of interest for Crizotinib. Here, "Overall number of participants analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measures was planned to be collected for individual arms of dose escalation cohorts (both low and high) and combined RP2D Cohort.'}, {'type': 'PRIMARY', 'title': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Plasma Decay Half-Life (t1/2) of Crizotinib on Day -7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '31', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Escalation Cohort: Crizotinib 50 mg QD', 'description': 'Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (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 QD for up to 34 cycles (each cycle 28 days).'}, {'id': 'OG002', 'title': 'Low Dose Escalation Cohort: Crizotinib 200 mg BID', '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 250 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 300 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': 'High Dose Escalation Cohort: Crizotinib 300 mg QD', '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 400 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 500 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 650 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 800 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': 'RP2D Cohort: Crizotinib 250 mg', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.20', 'groupId': 'OG000', 'lowerLimit': '45.50', 'upperLimit': '56.80'}, {'value': '46.70', 'groupId': 'OG001', 'lowerLimit': '30.40', 'upperLimit': '67.20'}, {'value': '52.60', 'groupId': 'OG002', 'lowerLimit': '51.70', 'upperLimit': '53.50'}, {'value': '47.35', 'groupId': 'OG003', 'lowerLimit': '36.80', 'upperLimit': '57.70'}, {'value': '45.70', 'groupId': 'OG004', 'lowerLimit': '45.70', 'upperLimit': '45.70'}, {'value': '43.33', 'groupId': 'OG005', 'lowerLimit': '35.4', 'upperLimit': '52.3'}, {'value': '49.06', 'groupId': 'OG006', 'lowerLimit': '33.2', 'upperLimit': '79.3'}, {'value': '46.36', 'groupId': 'OG007', 'lowerLimit': '43.0', 'upperLimit': '49.8'}, {'value': '42.17', 'groupId': 'OG008', 'lowerLimit': '28.3', 'upperLimit': '53.8'}, {'value': '38.78', 'groupId': 'OG009', 'lowerLimit': '30.9', 'upperLimit': '55.3'}, {'value': '43.20', 'groupId': 'OG010', 'lowerLimit': '27.10', 'upperLimit': '63.40'}]}]}], 'paramType': 'MEDIAN', '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', 'description': 'Plasma decay half-life is the time measured for the plasma concentration of Crizotinib to decrease by one half.', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', '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 cohort and combined RP2D cohort excluding "Low Dose Escalation Cohort: Crizotinib 100 mg QD" arm.'}, {'type': 'PRIMARY', 'title': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Number of Participants With Treatment Emergent Adverse Events (TEAES) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}, {'value': '53', 'groupId': 'OG011'}, {'value': '85', 'groupId': 'OG012'}, {'value': '41', 'groupId': 'OG013'}, {'value': '48', 'groupId': 'OG014'}, {'value': '18', 'groupId': 'OG015'}, {'value': '154', 'groupId': 'OG016'}, {'value': '66', 'groupId': 'OG017'}, {'value': '18', 'groupId': 'OG018'}, {'value': '18', 'groupId': 'OG019'}, {'value': '12', 'groupId': 'OG020'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Escalation Cohort: Crizotinib 50 mg QD', 'description': 'Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).'}, {'id': 'OG001', 'title': 'Low Dose Escalation Cohort: Crizotinib 100 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': '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 QD for up to 34 cycles (each cycle 28 days).'}, {'id': 'OG003', 'title': 'Low Dose Escalation Cohort: Crizotinib 200 mg BID', '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': 'OG004', 'title': 'Low Dose Escalation Cohort: Crizotinib 250 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': '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 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': 'OG006', 'title': 'High Dose Escalation Cohort: Crizotinib 300 mg QD', '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': 'OG007', 'title': 'High Dose Escalation Cohort: Crizotinib 400 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': 'OG008', 'title': 'High Dose Escalation Cohort: Crizotinib 500 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': 'OG009', 'title': 'High Dose Escalation Cohort: Crizotinib 650 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': 'OG010', 'title': 'High Dose Escalation Cohort: Crizotinib 800 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': '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 105 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 55 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 orally twice daily (BID) with or without food for up to 101 cycles (each cycle 28 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 twice daily (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 orally BID with or without food for up to 70 cycles (each cycle 21 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 twice daily (BID) with or without food for up to 133 cycles (each cycle 28 days).'}, {'id': 'OG017', 'title': 'RP2D Cohort: Enriched Other: 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': 'OG018', 'title': 'RP2D Cohort: Itraconazole Interaction: Crizotinib 250 mg +Itraconazole', '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': 'OG019', 'title': 'RP2D Cohort: Rifampin Interaction: Crizotinib 250 mg +Rifampin', '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': 'OG020', 'title': 'RP2D Cohort: Midazolam Interaction: Crizotinib 250 mg +Midazolam', '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'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}, {'value': '53', 'groupId': 'OG011'}, {'value': '85', 'groupId': 'OG012'}, {'value': '41', 'groupId': 'OG013'}, {'value': '47', 'groupId': 'OG014'}, {'value': '18', 'groupId': 'OG015'}, {'value': '154', 'groupId': 'OG016'}, {'value': '66', 'groupId': 'OG017'}, {'value': '18', 'groupId': 'OG018'}, {'value': '18', 'groupId': 'OG019'}, {'value': '12', 'groupId': 'OG020'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '24', 'groupId': 'OG011'}, {'value': '54', 'groupId': 'OG012'}, {'value': '25', 'groupId': 'OG013'}, {'value': '22', 'groupId': 'OG014'}, {'value': '9', 'groupId': 'OG015'}, {'value': '75', 'groupId': 'OG016'}, {'value': '29', 'groupId': 'OG017'}, {'value': '7', 'groupId': 'OG018'}, {'value': '6', 'groupId': 'OG019'}, {'value': '6', 'groupId': 'OG020'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 189 Months', '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SA set included all enrolled participants who received at least one dose of Crizotinib on Cycle 1 Day 1.'}, {'type': 'PRIMARY', 'title': 'Dose-Escalation Cohort: Number of Participants With Dose-limiting Toxicities (DLT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Escalation Cohort: Crizotinib 50 mg QD', 'description': 'Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).'}, {'id': 'OG001', 'title': 'Low Dose Escalation Cohort: Crizotinib 100 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': '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 QD for up to 34 cycles (each cycle 28 days).'}, {'id': 'OG003', 'title': 'Low Dose Escalation Cohort: Crizotinib 200 mg BID', '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': 'OG004', 'title': 'Low Dose Escalation Cohort: Crizotinib 250 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': '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 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': 'OG006', 'title': 'High Dose Escalation Cohort: Crizotinib 300 mg QD', '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': 'OG007', 'title': 'High Dose Escalation Cohort: Crizotinib 400 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': 'OG008', 'title': 'High Dose Escalation Cohort: Crizotinib 500 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': 'OG009', 'title': 'High Dose Escalation Cohort: Crizotinib 650 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': 'OG010', 'title': 'High Dose Escalation Cohort: Crizotinib 800 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).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Cycle 1 (28 days)', 'description': 'Dose-limiting toxicity (DLT) was defined as any of the following: Hematologic- prolonged grade 4 neutropenia for \\>7 days. Febrile neutropenia, defined as grade 4 neutropenia with fever greater than (\\>)38.5 degree Celsius, both sustained over a 24 hour period, neutropenic infection: greater than or equal to (\\>=)Grade 3 neutropenia with Grade \\>=3 infection. Grade \\>=3 thrombocytopenia with bleeding or grade 4 lasting \\>=7 days Lymphopenia was not considered a DLT unless accompanied by infection. Other non-hematologic toxicity: Grade 3 or 4 toxicities (except for alopecia, Grade 3/4 hypophosphatemia, grade 3 hypertension with controlled blood pressure \\[less than (\\<) 140/90\\], and Grade 3/4 hyperuricemia without signs and symptoms of gout). Nausea, vomiting or diarrhea must persist at grade 3 or 4 despite maximal medical therapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SA set included all enrolled participants who received at least one dose of Crizotinib on Cycle 1 Day 1.'}, {'type': 'PRIMARY', 'title': 'Midazolam Interaction Cohort: Maximum Observed Plasma Concentration (Cmax) of Midazolam When Taken Alone or Taken With Crizotinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Escalation Cohort: Crizotinib 100 mg QD (Midazolam Alone)', 'description': '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 + Midazolam', 'description': 'Participants received Crizotinib 100 mg capsule or tablet orally QD along with single 2 mg oral dose of Midazolam on Cycle 2 Day 1.'}, {'id': 'OG002', 'title': 'Low Dose Escalation Cohort: Crizotinib 300 mg BID (Midazolam Alone)', 'description': 'Participants who did not receive Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet BID on Day -7, received single 2 mg oral dose of Midazolam on Day -7.'}, {'id': 'OG003', 'title': 'Low Dose Escalation Cohort: Crizotinib 300 mg BID + Midazolam', 'description': 'Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet orally BID along with 2 mg oral dose of Midazolam on Cycle 2 Day 1.'}, {'id': 'OG004', 'title': 'RP2D Cohort: Crizotinib 250 mg (Midazolam Alone)', 'description': 'Participants who did not receive Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet on Day -7, received single 2 mg oral dose of Midazolam on Day -7.'}, {'id': 'OG005', 'title': 'RP2D Cohort: Crizotinib 250 mg + Midazolam', 'description': 'Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) BID along with single 2 mg oral dose of Midazolam on Cycle 2 Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.98', 'spread': '19', 'groupId': 'OG000'}, {'value': '19.26', 'spread': '38', 'groupId': 'OG001'}, {'value': '13.65', 'spread': '10', 'groupId': 'OG002'}, {'value': '32.62', 'spread': '40', 'groupId': 'OG003'}, {'value': '12.78', 'spread': '41', 'groupId': 'OG004'}, {'value': '25.37', 'spread': '67', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of adjusted geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '131.72', 'ciLowerLimit': '96.59', 'ciUpperLimit': '179.63', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of adjusted geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '239.03', 'ciLowerLimit': '172.14', 'ciUpperLimit': '331.93', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Ratio of adjusted geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '201.56', 'ciLowerLimit': '139.33', 'ciUpperLimit': '291.58', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose, 0.5, 1, 2, 4, 6, 8, 9, and 24 hours post dose on Day -7 (midazolam alone arm), pre-dose, 0.5, 1, 2, 4, 6, 8, 9, and 24 hours post dose on Cycle 2 Day 1 (midazolam with crizotinib arm)', 'description': 'Cmax is defined as the observed maximum plasma concentration post drug administration.', 'unitOfMeasure': 'nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK concentration population of midazolam included all participants treated with midazolam (including Day -7 dose) who have at least 1 concentration of midazolam.'}, {'type': 'PRIMARY', 'title': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Midazolam When Taken Alone or Taken With Crizotinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Escalation Cohort: Crizotinib 100 mg QD (Midazolam Alone)', 'description': '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 + Midazolam', 'description': 'Participants received Crizotinib 100 mg capsule or tablet orally QD along with single 2 mg oral dose of Midazolam on Cycle 2 Day 1.'}, {'id': 'OG002', 'title': 'Low Dose Escalation Cohort: Crizotinib 300 mg BID (Midazolam Alone)', 'description': 'Participants who did not receive Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet BID on Day -7, received single 2 mg oral dose of Midazolam on Day -7.'}, {'id': 'OG003', 'title': 'Low Dose Escalation Cohort: Crizotinib 300 mg BID + Midazolam', 'description': 'Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet orally BID along with 2 mg oral dose of Midazolam on Cycle 2 Day 1.'}, {'id': 'OG004', 'title': 'RP2D Cohort: Crizotinib 250 mg (Midazolam Alone)', 'description': 'Participants who did not receive Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet on Day -7, received single 2 mg oral dose of Midazolam on Day -7'}, {'id': 'OG005', 'title': 'RP2D Cohort: Crizotinib 250 mg +Midazolam', 'description': 'Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) BID along with single 2 mg oral dose of Midazolam on Cycle 2 Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.77', 'spread': '27', 'groupId': 'OG000'}, {'value': '90.78', 'spread': '33', 'groupId': 'OG001'}, {'value': '37.71', 'spread': '38', 'groupId': 'OG002'}, {'value': '151.45', 'spread': '31', 'groupId': 'OG003'}, {'value': '32.10', 'spread': '36', 'groupId': 'OG004'}, {'value': '112.78', 'spread': '87', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of adjusted geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '216.19', 'ciLowerLimit': '161.41', 'ciUpperLimit': '289.56', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of adjusted geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '350.00', 'ciLowerLimit': '141.09', 'ciUpperLimit': '868.23', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Ratio of adjusted geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '365.43', 'ciLowerLimit': '263.22', 'ciUpperLimit': '507.31', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose, 0.5, 1, 2, 4, 6, 8, 9, and 24 hours post dose on Day -7 (midazolam alone arm), pre-dose, 0.5, 1, 2, 4, 6, 8, 9, and 24 hours post dose on Cycle 2 Day 1 (midazolam with crizotinib arm)', 'description': 'AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).', 'unitOfMeasure': 'nanogram*hour per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK concentration population of midazolam included all participants treated with midazolam (including Day -7 dose) who have at least 1 concentration of midazolam.'}, {'type': 'PRIMARY', 'title': 'RP2D Cohort: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Crizotinib When Taken With Food', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RP2D Cohort: Crizotinib 250 mg With Food', 'description': 'Participants who were enrolled in enriched RP2D cohort received single dose of Crizotinib 250 mg tablet/capsule (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) orally with food on Day -7.'}], 'classes': [{'categories': [{'measurements': [{'value': '1212.86', 'spread': '46', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose, 1, 2, 4, 6, 8, 9, and 24 hours post-dose on Day -7', 'description': 'AUC0-24 of Crizotinib was defined as the area under the free plasma concentration time curve from time 0 to 24 hours post-dose.', 'unitOfMeasure': 'nanogram*hour per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The food effect analysis set included all participants treated (including Day -7 dose) and in the RP2D cohort who had received a dose of crizotinib under fed conditions and for which at least 1 PK parameter of interest (Cmax or AUC) was available. Here, "Overall number of participants analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'RP2D Cohort: Maximum Observed Plasma Concentration (Cmax) of Crizotinib When Taken With Food', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RP2D Cohort: Crizotinib 250 mg With Food', 'description': 'Participants who were enrolled in enriched RP2D cohort received single dose of Crizotinib 250 mg tablet/capsule (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) orally with food on Day -7.'}], 'classes': [{'categories': [{'measurements': [{'value': '106.24', 'spread': '51', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose, 1, 2, 4, 6, 8, 9, and 24 hours post-dose on Day -7', 'description': 'Cmax is defined as the observed maximum plasma concentration post drug administration.', 'unitOfMeasure': 'nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The food effect analysis set included all participants treated (including Day -7 dose) and in the RP2D cohort who had received a dose of crizotinib under fed conditions and for which at least 1 PK parameter of interest (Cmax or AUC) was available. Here, "Overall number of participants analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib Alone and When Taken With Rifampin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RP2D Cohort: Rifampin Interaction: Crizotinib 250 mg Alone', '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).'}, {'id': 'OG001', 'title': 'RP2D Cohort: Rifampin Interaction: Crizotinib 250 mg With Rifampin', 'description': 'Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) form Cycle 1Day 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 a meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '3110', 'spread': '49', 'groupId': 'OG000'}, {'value': '509.6', 'spread': '35', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of adjusted geometric mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '15.57', 'ciLowerLimit': '10.89', 'ciUpperLimit': '22.26', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose, 2, 4, 6, 8 and 10 hours on Cycle 1 Day 15 (Crizotinib alone arm) and Cycle 2 Day 1 (Crizotinib with Rifampin arm)', 'description': 'Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau).', 'unitOfMeasure': 'nanogram*hour per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter population was defined as all participants in the Rifampin interaction cohort safety population who satisfied following criteria for Cycle 1 Day 15 or Cycle 2 Day 1: a) had at least 1 of the primary PK parameters of Crizotinib (AUCtau and Cmax). b) received adequate dosing prior to PK sampling. Here, "Overall number of participants analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Rifampin Cohort: Maximum Observed Plasma Concentration (Cmax) of Crizotinib Alone and When Taken With Rifampin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RP2D Cohort: Rifampin Interaction: Crizotinib 250 mg Alone', '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).'}, {'id': 'OG001', 'title': 'RP2D Cohort: Rifampin Interaction: Crizotinib 250 mg With Rifampin', 'description': 'Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) form Cycle 1Day 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 a meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '326.4', 'spread': '48', 'groupId': 'OG000'}, {'value': '71.53', 'spread': '49', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of adjusted geometric mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '20.64', 'ciLowerLimit': '14.59', 'ciUpperLimit': '29.18', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose, 2, 4, 6, 8 and 10 hours on Cycle 1 Day 15 (Crizotinib alone) and Cycle 2 Day 1 (Crizotinib with Rifampin)', 'unitOfMeasure': 'nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter population was defined as all participants in the Rifampin interaction cohort safety population who satisfied following criteria for Cycle 1 Day 15 or Cycle 2 Day 1: a) had at least 1 of the primary PK parameters of Crizotinib (AUCtau and Cmax). b) Received adequate dosing prior to PK sampling. Here, "Overall number of participants analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Rifampin Cohort: Ctrough of Crizotinib Alone and When Taken With Rifampin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RP2D Cohort: Rifampin Interaction: Crizotinib 250 mg Alone', '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).'}, {'id': 'OG001', 'title': 'RP2D Cohort: Rifampin Interaction: Crizotinib 250 mg With Rifampin', 'description': 'Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) form Cycle 1Day 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 a meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '251.7', 'spread': '46', 'groupId': 'OG000'}, {'value': '26.67', 'spread': '50', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose on Cycle 1 Day 15 (Crizotinib alone arm) and Cycle 2 Day 1 (Crizotinib with Rifampin arm)', 'description': 'Ctrough refers to plasma concentration of Crizotinib observed just before treatment administration.', 'unitOfMeasure': 'nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter population was defined as all participants in the Rifampin interaction cohort safety population who satisfied following criteria for Cycle 1 Day 15 or Cycle 2 Day 1: a) had at least 1 of the primary PK parameters of Crizotinib (AUCtau and Cmax). b) Received adequate dosing prior to PK sampling. Here, "Overall number of participants analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Itraconazole Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib When Taken Alone and When Taken With Itraconazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RP2D Cohort: Itraconazole Interaction: Crizotinib 250 mg Alone', '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).'}, {'id': 'OG001', 'title': 'Itraconazole Interaction Cohort: 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 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. (each cycle 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '4102', 'spread': '31', 'groupId': 'OG000'}, {'value': '6665', 'spread': '16', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of adjusted geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '157.40', 'ciLowerLimit': '136.89', 'ciUpperLimit': '180.97', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose, 1, 2, 4, 6, 8, 9 and 24 hours post dose on Cycle 1 Day 15 (Crizotinib with itraconazole) and Cycle 2 Day 1 (itraconazole alone)', 'description': 'Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau), where dosing interval is 24 hours.', 'unitOfMeasure': 'nanogram*hour per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter evaluable population included participants who had at least 1 of the PK parameters of Crizotinib (AUCtau or Cmax) and had received 10 consecutive doses of both Crizotinib 250 mg QD and itraconazole 200 mg QD immediately prior to end of Crizotinib 250 mg + Itraconazole treatment as well as 10 consecutive doses of Crizotinib 250 mg QD prior to end of Crizotinib 250 mg + Itraconazole treatment. Overall number of participants analyzed =participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Itraconazole Cohort: Maximum Observed Plasma Concentration (Cmax) of Crizotinib When Taken Alone and When Taken With Itraconazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RP2D Cohort: Itraconazole Interaction: Crizotinib 250 mg Alone', '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).'}, {'id': 'OG001', 'title': 'RP2D Cohort: Itraconazole Interaction: Crizotinib 250 mg With Itraconazole', '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. (each cycle 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '259.9', 'spread': '23', 'groupId': 'OG000'}, {'value': '353.2', 'spread': '14', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of adjusted geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '132.81', 'ciLowerLimit': '119.10', 'ciUpperLimit': '148.10', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose, 1, 2, 4, 6, 8, 9 and 24 hours post dose on Cycle 1 Day 15 (Crizotinib with itraconazole) and Cycle 2 Day 1 (itraconazole alone)', 'unitOfMeasure': 'nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter evaluable population included participants who had at least 1 of the PK parameters of Crizotinib (AUCtau or Cmax) and had received 10 consecutive doses of both Crizotinib 250 mg QD and itraconazole 200 mg QD immediately prior to end of Crizotinib 250 mg + Itraconazole treatment as well as 10 consecutive doses of Crizotinib 250 mg QD prior to end of Crizotinib 250 mg + Itraconazole treatment. Overall number of participants analyzed =participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Itraconazole Cohort: Trough Plasma Concentration (Ctrough) of Crizotinib When Taken Alone and When Taken With Itraconazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RP2D Cohort: Itraconazole Interaction: Crizotinib 250 mg Alone', '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).'}, {'id': 'OG001', 'title': 'RP2D Cohort: Itraconazole Interaction: Crizotinib 250 mg With Itraconazole', '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. (each cycle 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '136.0', 'spread': '36', 'groupId': 'OG000'}, {'value': '214.0', 'spread': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose on Cycle 1 Day 15 (crizotinib with itraconazole) and Cycle 2 Day 1 (itraconazole alone)', 'description': 'Ctrough refers to plasma concentration of Crizotinib observed just before treatment administration.', 'unitOfMeasure': 'nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter evaluable population included participants who had at least 1 of the PK parameters of Crizotinib (AUCtau or Cmax) and had received 10 consecutive doses of both Crizotinib 250 mg QD and itraconazole 200 mg QD immediately prior to end of Crizotinib 250 mg + Itraconazole treatment as well as 10 consecutive doses of Crizotinib 250 mg QD prior to end of Crizotinib 250 mg + Itraconazole treatment. Overall number of participants analyzed =participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Recommended Phase 2 Dose (RP2D) Cohort: Percentage of Participants With Objective Response (OR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '116', 'groupId': 'OG004'}, {'value': '66', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', '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 105 cycles (each cycle 28 days).'}, {'id': 'OG001', '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 55 cycles (each cycle 28 days).'}, {'id': 'OG002', '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 orally twice daily (BID) with or without food for up to 101 cycles (each cycle 28 days).'}, {'id': 'OG003', '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 orally BID with or without food for up to 70 cycles (each cycle 21 days).'}, {'id': 'OG004', '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 twice daily (BID) with or without food for up to 133 cycles (each cycle 28 days).'}, {'id': 'OG005', 'title': 'RP2D Cohort: Enriched Other: 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).'}], 'classes': [{'categories': [{'measurements': [{'value': '71.7', 'groupId': 'OG000', 'lowerLimit': '57.7', 'upperLimit': '83.2'}, {'value': '32.3', 'groupId': 'OG001', 'lowerLimit': '21.2', 'upperLimit': '45.1'}, {'value': '31.6', 'groupId': 'OG002', 'lowerLimit': '17.5', 'upperLimit': '48.7'}, {'value': '19.0', 'groupId': 'OG003', 'lowerLimit': '5.4', 'upperLimit': '41.9'}, {'value': '61.2', 'groupId': 'OG004', 'lowerLimit': '51.7', 'upperLimit': '70.1'}, {'value': '8.3', 'groupId': 'OG005', 'lowerLimit': '0.2', 'upperLimit': '38.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 172 months', 'description': 'ORR was defined as participants with a best overall response of complete response (CR) or partial response (PR) divided by the total number of evaluable participants per RECIST version 1.0 (RECIST1.1 for ALK-negative NSCLC cohort 1 and ALK-negative NSCLC cohort 2). CR: Disappearance of all target and non-target lesions, normalization of tumor marker levels, and no appearance of new lesions indicated complete response. PR: At least a 30% decrease in the sum of the longest diameters of target lesions (taking as reference the baseline sum), without progression of non-target lesions and no appearance of new lesions indicated partial response.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Response-evaluable population was defined as all participants in the SA set who had an adequate baseline disease assessment and had met 1 of the following 2 criteria: a) Had at least one post-baseline disease assessment b) withdrew from the trial or experienced progression/death at any time on study. Here, "Overall number of participants Analyzed" signifies number of participants evaluable for this outcome measure. Data was planned to be analyzed for reported arms only.'}, {'type': 'PRIMARY', 'title': 'Recommended Phase 2 Dose (RP2D) Cohort: Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', '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 105 cycles (each cycle 28 days).'}, {'id': 'OG001', '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 55 cycles (each cycle 28 days).'}, {'id': 'OG002', '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 orally twice daily (BID) with or without food for up to 101 cycles (each cycle 28 days).'}, {'id': 'OG003', '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 twice daily (BID) with or without food for up to 133 cycles (each cycle 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '45.4'}, {'value': '6.8', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '13.4'}, {'value': '5.2', 'groupId': 'OG002', 'lowerLimit': '3.8', 'upperLimit': '12.2'}, {'value': '26.2', 'groupId': 'OG003', 'lowerLimit': '8.1', 'upperLimit': '72.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first documentation of response to date of PD or death due to any cause (up to 172 months)', 'description': 'Duration of response (DoR) was the time from first documentation of PR or CR to date of first documentation of progressive disease (PD) or death due to any cause. PR: At least a 30% decrease in the sum of the longest diameters of target lesions (taking as reference the baseline sum), without progression of non-target lesions and no appearance of new lesions indicated partial response. CR: Disappearance of all target and non-target lesions, normalization of tumor marker levels, and no appearance of new lesions indicated complete response. PD: \\>=20% increase in the sum of the longest diameter of target lesions taking as references the smallest sum longest diameter recorded since the treatment started, unequivocal progression of existing non-target lesions, or the appearance of 1 or more new lesions.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Response-evaluable population was defined as all participants in the SA set who had an adequate baseline disease assessment and had met 1 of the following 2 criteria: a) Had at least one post-baseline disease assessment b) withdrew from the trial or experienced progression/death at any time on study. Here, "Overall number of participants analyzed" signifies number of participants who were objective responders. Data was planned to be analyzed for reported arms only.'}, {'type': 'PRIMARY', 'title': 'Recommended Phase 2 Dose (RP2D) Cohort: Time to Response (TTR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', '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 105 cycles (each cycle 28 days).'}, {'id': 'OG001', '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 55 cycles (each cycle 28 days).'}, {'id': 'OG002', '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 orally twice daily (BID) with or without food for up to 101 cycles (each cycle 28 days).'}, {'id': 'OG003', '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 twice daily (BID) with or without food for up to 133 cycles (each cycle 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '103.6'}, {'value': '7.6', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '47.3'}, {'value': '8.0', 'groupId': 'OG002', 'lowerLimit': '7.1', 'upperLimit': '23.6'}, {'value': '7.7', 'groupId': 'OG003', 'lowerLimit': '4.3', 'upperLimit': '39.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose until first documented response of PR or CR (up to 172 months)', 'description': 'TTR: time between first dose until first documented response of PR or CR. PR: At least a 30% decrease in the sum of the longest diameters of target lesions (taking as reference the baseline sum), without progression of non-target lesions and no appearance of new lesions indicated partial response. CR: Disappearance of all target and non-target lesions, normalization of tumor marker levels, and no appearance of new lesions indicated complete response.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Response-evaluable population was defined as all participants in the SA set who had an adequate baseline disease assessment and had met 1 of the following 2 criteria: a) Had at least one post-baseline disease assessment b) withdrew from the trial or experienced progression/death at any time on study. Here, "Overall number of participants analyzed" signifies number of participants who were objective responders. Data was planned to be analyzed for reported arms only.'}, {'type': 'PRIMARY', 'title': 'Recommended Phase 2 Dose (RP2D) Cohort: Percentage of Participants With Disease Control at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', '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 105 cycles (each cycle 28 days).'}, {'id': 'OG001', '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 55 cycles (each cycle 28 days).'}, {'id': 'OG002', '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 twice daily (BID) with or without food for up to 133 cycles (each cycle 28 days).'}, {'id': 'OG003', '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 orally BID with or without food for up to 70 cycles (each cycle 21 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '86.8', 'groupId': 'OG000', 'lowerLimit': '74.7', 'upperLimit': '94.5'}, {'value': '71.8', 'groupId': 'OG001', 'lowerLimit': '61.0', 'upperLimit': '81.0'}, {'value': '79.3', 'groupId': 'OG002', 'lowerLimit': '70.8', 'upperLimit': '86.3'}, {'value': '47.6', 'groupId': 'OG003', 'lowerLimit': '25.7', 'upperLimit': '70.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8', 'description': 'Disease control was defined as the percentage of participants with a confirmed CR, PR, or stable disease (SD) per RECIST version 1.0 (RECIST1.1 for ALK-negative NSCLC cohort 1 and ALK-negative NSCLC cohort 2). PR: At least a 30% decrease in the sum of the longest diameters of target lesions (taking as reference the baseline sum), without progression of non-target lesions and no appearance of new lesions indicated partial response. CR: Disappearance of all target and non-target lesions, normalization of tumor marker levels, and no appearance of new lesions indicated complete response. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Response-evaluable population was defined as all participants in the SA set who had an adequate baseline disease assessment and had met 1 of the following 2 criteria: a) Had at least one post-baseline disease assessment b) withdrew from the trial or experienced progression/death at any time on study. Here, "Overall number of participants analyzed" signifies number of participants evaluable for this outcome measure. Data was planned to be analyzed for reported arms only.'}, {'type': 'PRIMARY', 'title': 'Recommended Phase 2 Dose (RP2D) Cohort: Percentage of Participants With Disease Control at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', '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 105 cycles (each cycle 28 days).'}, {'id': 'OG001', '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 55 cycles (each cycle 28 days).'}, {'id': 'OG002', '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 twice daily (BID) with or without food for up to 133 cycles (each cycle 28 days).'}, {'id': 'OG003', '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 orally BID with or without food for up to 70 cycles (each cycle 21 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '79.2', 'groupId': 'OG000', 'lowerLimit': '65.9', 'upperLimit': '89.2'}, {'value': '51.8', 'groupId': 'OG001', 'lowerLimit': '40.7', 'upperLimit': '62.7'}, {'value': '67.2', 'groupId': 'OG002', 'lowerLimit': '57.9', 'upperLimit': '75.7'}, {'value': '42.9', 'groupId': 'OG003', 'lowerLimit': '21.8', 'upperLimit': '66.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'Disease control was defined as the percentage of participants with a confirmed CR, PR, or stable disease (SD) per RECIST version 1.0 (RECIST1.1 for ALK-negative NSCLC cohort 1 and ALK-negative NSCLC cohort 2). PR: At least a 30% decrease in the sum of the longest diameters of target lesions (taking as reference the baseline sum), without progression of non-target lesions and no appearance of new lesions indicated partial response. CR: Disappearance of all target and non-target lesions, normalization of tumor marker levels, and no appearance of new lesions indicated complete response. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Response-evaluable population was defined as all participants in the SA set who had an adequate baseline disease assessment and had met 1 of the following 2 criteria: a) Had at least one post-baseline disease assessment b) withdrew from the trial or experienced progression/death at any time on study. Here, "Overall number of participants analyzed" signifies number of participants evaluable for this outcome measure. Data was planned to be analyzed for reported arms only.'}, {'type': 'PRIMARY', 'title': 'Recommended Phase 2 Dose (RP2D) Cohort: Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '119', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', '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 105 cycles (each cycle 28 days).'}, {'id': 'OG001', '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 55 cycles (each cycle 28 days).'}, {'id': 'OG002', '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 orally twice daily (BID) with or without food for up to 101 cycles (each cycle 28 days).'}, {'id': 'OG003', '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 twice daily (BID) with or without food for up to 133 cycles (each cycle 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '19.3', 'groupId': 'OG000', 'lowerLimit': '15.2', 'upperLimit': '39.1'}, {'value': '7.6', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '9.1'}, {'value': '4.0', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '6.9'}, {'value': '10.0', 'groupId': 'OG003', 'lowerLimit': '8.2', 'upperLimit': '14.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization until PD or death, whichever occurred first (up to 172 months)', 'description': 'Progression free survival (PFS) was the time from randomization date to date of first documentation of PD or death due to any cause RECIST version 1.0 (RECIST1.1 for ALK-negative NSCLC cohort 1 and ALK-negative NSCLC cohort 2). PD: \\>=20% increase in the sum of the longest diameter of target lesions taking as references the smallest sum longest diameter recorded since the treatment started, unequivocal progression of existing non-target lesions, or the appearance of 1 or more new lesions.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'SA set included all enrolled participants who received at least one dose of Crizotinib on Cycle 1 Day 1. Here, "Overall number of participants analyzed" signifies number of participants evaluable for this outcome measure. Data was planned to be analyzed for reported arms only.'}, {'type': 'PRIMARY', 'title': 'Recommended Phase 2 Dose (RP2D) Cohort: Probability of Being Event Free at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '119', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', '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 105 cycles (each cycle 28 days).'}, {'id': 'OG001', '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 55 cycles (each cycle 28 days).'}, {'id': 'OG002', '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 orally twice daily (BID) with or without food for up to 101 cycles (each cycle 28 days).'}, {'id': 'OG003', '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 twice daily (BID) with or without food for up to 133 cycles (each cycle 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '76.9', 'groupId': 'OG000', 'lowerLimit': '62.8', 'upperLimit': '86.1'}, {'value': '57.5', 'groupId': 'OG001', 'lowerLimit': '45.3', 'upperLimit': '68.0'}, {'value': '39.0', 'groupId': 'OG002', 'lowerLimit': '22.8', 'upperLimit': '54.9'}, {'value': '71.9', 'groupId': 'OG003', 'lowerLimit': '61.8', 'upperLimit': '79.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to 6 months', 'description': 'Probability of being event free (event defined as PD or death due to any cause) at 6 months after the first dose of crizotinib was reported. PD: \\>=20% increase in the sum of the longest diameter of target lesions taking as references the smallest sum longest diameter recorded since the treatment started, unequivocal progression of existing non-target lesions, or the appearance of 1 or more new lesions.', 'unitOfMeasure': 'Probability of being event-free', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'SA set included all enrolled participants who received at least one dose of Crizotinib on Cycle 1 Day 1. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Data was planned to be analyzed for reported arms only.'}, {'type': 'PRIMARY', 'title': 'Recommended Phase 2 Dose (RP2D) Cohort: Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '119', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', '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 105 cycles (each cycle 28 days).'}, {'id': 'OG001', '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 55 cycles (each cycle 28 days).'}, {'id': 'OG002', '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 orally twice daily (BID) with or without food for up to 101 cycles (each cycle 28 days).'}, {'id': 'OG003', '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 twice daily (BID) with or without food for up to 133 cycles (each cycle 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '51.4', 'comment': 'Upper limit of 95% CI could not be estimable due to low number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '29.3', 'upperLimit': 'NA'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '13.2', 'upperLimit': '25.7'}, {'value': '10.1', 'groupId': 'OG002', 'lowerLimit': '7.1', 'upperLimit': '12.9'}, {'value': 'NA', 'comment': 'Median and 95% CI could not be estimable due to low number of participants with events.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization date to the date of death (up to 172 Months)', 'description': 'OS was defined as the time from randomization to death due to any cause.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'SA set included all enrolled participants who received at least one dose of Crizotinib on Cycle 1 Day 1. Here, "Overall number of participants analyzed" signifies number of participants evaluable for this outcome measure. Data was planned to be analyzed for reported arms only.'}, {'type': 'PRIMARY', 'title': 'Probability of Participant Survival at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '119', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', '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 105 cycles (each cycle 28 days).'}, {'id': 'OG001', '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 55 cycles (each cycle 28 days).'}, {'id': 'OG002', '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 orally twice daily (BID) with or without food for up to 101 cycles (each cycle 28 days).'}, {'id': 'OG003', '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 twice daily (BID) with or without food for up to 133 cycles (each cycle 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '90.5', 'groupId': 'OG000', 'lowerLimit': '78.7', 'upperLimit': '95.9'}, {'value': '86.7', 'groupId': 'OG001', 'lowerLimit': '77.3', 'upperLimit': '92.4'}, {'value': '67.8', 'groupId': 'OG002', 'lowerLimit': '51.1', 'upperLimit': '79.9'}, {'value': '90.0', 'groupId': 'OG003', 'lowerLimit': '82.7', 'upperLimit': '94.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'description': 'Probability of survival was defined as the probability of being alive at Month 6.', 'unitOfMeasure': 'Probability of participants survival', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'SA set included all enrolled participants who received at least one dose of Crizotinib on Cycle 1 Day 1. Here, "Overall number of participants analyzed" signifies number of participants evaluable for this outcome measure. Data was planned to be analyzed for reported arms only.'}, {'type': 'PRIMARY', 'title': 'Probability of Participant Survival at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '119', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', '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 105 cycles (each cycle 28 days).'}, {'id': 'OG001', '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 55 cycles (each cycle 28 days).'}, {'id': 'OG002', '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 orally twice daily (BID) with or without food for up to 101 cycles (each cycle 28 days).'}, {'id': 'OG003', '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 twice daily (BID) with or without food for up to 133 cycles (each cycle 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '78.8', 'groupId': 'OG000', 'lowerLimit': '65.0', 'upperLimit': '87.7'}, {'value': '66.0', 'groupId': 'OG001', 'lowerLimit': '54.0', 'upperLimit': '75.5'}, {'value': '37.1', 'groupId': 'OG002', 'lowerLimit': '22.4', 'upperLimit': '51.8'}, {'value': '80.5', 'groupId': 'OG003', 'lowerLimit': '70.9', 'upperLimit': '87.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Probability of survival was defined as the probability of being alive at Month 12.', 'unitOfMeasure': 'probability of participants survival', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'SA set included all enrolled participants who received at least one dose of Crizotinib on Cycle 1 Day 1. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Data was planned to be analyzed for reported arms only.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean of Ratio of Total Testosterone, Free Testosterone, Sex Hormone Binding Globulin (SHBG), Luteinizing Hormone, Follicle Stimulating Hormone, Dihydroepiandrosterone Sulfate, Estradiol and Prolactin Levels in Males at Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RP2D Cohort: Crizotinib 250 mg', '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.'}], 'classes': [{'title': 'Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.46', 'groupId': 'OG000', 'lowerLimit': '0.34', 'upperLimit': '0.62'}]}]}, {'title': 'Estradiol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.53', 'groupId': 'OG000', 'lowerLimit': '0.42', 'upperLimit': '0.66'}]}]}, {'title': 'Prolactin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.19', 'groupId': 'OG000', 'lowerLimit': '0.91', 'upperLimit': '1.55'}]}]}, {'title': 'Luteinizing Hormone (LH) Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.58', 'groupId': 'OG000', 'lowerLimit': '0.47', 'upperLimit': '0.73'}]}]}, {'title': 'Follicle Stimulating Hormone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.77', 'groupId': 'OG000', 'lowerLimit': '0.66', 'upperLimit': '0.91'}]}]}, {'title': 'Free Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.96', 'groupId': 'OG000', 'lowerLimit': '0.66', 'upperLimit': '1.40'}]}]}, {'title': 'Sex Hormone Binding Globulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.36', 'groupId': 'OG000', 'lowerLimit': '0.32', 'upperLimit': '0.41'}]}]}, {'title': 'Dihydroepiandrosterone Sulfate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.97', 'groupId': 'OG000', 'lowerLimit': '0.85', 'upperLimit': '1.11'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Cycle 1 Day 15', 'description': 'Geometric mean of ratio (Cycle1Day15/Baseline) of hypogonadism parameters (total testosterone, free testosterone, sex hormone binding globulin, luteinizing hormone, follicle stimulating hormone, dihydroepiandrosterone sulfate, estradiol and prolactin) levels in males was analyzed. Data for this outcome measure was planned to be collected for combined RP2D Cohort only, excluding arms of low and high dose escalation cohorts.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Hypogonadism test evaluable population: Male participants who had completed screening, had received at least 1 dose of crizotinib on Cycle 1 Day 1, had at least 1 post baseline visit data for at least total testosterone, free testosterone, SHBG and included male participants of MET amplification and enriched other Cohort following approval of protocol amendment number 21. "N" =participants evaluable for this OM and \'number analyzed\' =participants with available data for each specified category.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean of Ratio of Total Testosterone, Free Testosterone, Sex Hormone Binding Globulin (SHBG), Luteinizing Hormone, Follicle Stimulating Hormone, Dihydroepiandrosterone Sulfate, Estradiol and Prolactin Levels in Males at Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RP2D Cohort: Crizotinib 250 mg', '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.'}], 'classes': [{'title': 'Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.47', 'groupId': 'OG000', 'lowerLimit': '0.38', 'upperLimit': '0.58'}]}]}, {'title': 'Estradiol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.72', 'groupId': 'OG000', 'lowerLimit': '0.56', 'upperLimit': '0.93'}]}]}, {'title': 'Prolactin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.89', 'groupId': 'OG000', 'lowerLimit': '0.71', 'upperLimit': '1.12'}]}]}, {'title': 'LH Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.42', 'groupId': 'OG000', 'lowerLimit': '0.26', 'upperLimit': '0.70'}]}]}, {'title': 'Follicle Stimulating Hormone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.69', 'groupId': 'OG000', 'lowerLimit': '0.48', 'upperLimit': '1.00'}]}]}, {'title': 'Free Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.31', 'groupId': 'OG000', 'lowerLimit': '0.97', 'upperLimit': '1.77'}]}]}, {'title': 'Sex Hormone Binding Globulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.24', 'groupId': 'OG000', 'lowerLimit': '0.18', 'upperLimit': '0.31'}]}]}, {'title': 'Dihydroepiandrosterone Sulfate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.85', 'groupId': 'OG000', 'lowerLimit': '0.75', 'upperLimit': '0.96'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Cycle 2 Day 1', 'description': 'Geometric mean of ratio (Cycle 2 Day 1/Baseline) of hypogonadism parameters (total testosterone, free testosterone, sex hormone binding globulin, luteinizing hormone, follicle stimulating hormone, dihydroepiandrosterone sulfate, estradiol and prolactin) levels in males was analyzed. Data for this outcome measure was planned to be collected for combined RP2D Cohort only, excluding arms of low and high dose escalation cohorts.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Hypogonadism test evaluable population: Male participants who had completed screening, had received at least 1 dose of crizotinib on Cycle 1 Day 1, had at least 1 post baseline visit data for at least total testosterone, free testosterone, SHBG and included male participants of MET amplification and enriched other Cohort following approval of protocol amendment number 21. "N" =participants evaluable for this OM and \'number analyzed\' =participants with available data for each specified category.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean of Ratio of Total Testosterone, Free Testosterone, Sex Hormone Binding Globulin (SHBG), Luteinizing Hormone, Follicle Stimulating Hormone, Dihydroepiandrosterone Sulfate, Estradiol and Prolactin Levels in Males at Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RP2D Cohort: Crizotinib 250 mg', '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.'}], 'classes': [{'title': 'Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.48', 'groupId': 'OG000', 'lowerLimit': '0.27', 'upperLimit': '0.84'}]}]}, {'title': 'Estradiol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.66', 'groupId': 'OG000', 'lowerLimit': '0.49', 'upperLimit': '0.89'}]}]}, {'title': 'Prolactin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.84', 'groupId': 'OG000', 'lowerLimit': '0.55', 'upperLimit': '1.28'}]}]}, {'title': 'LH Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.75', 'groupId': 'OG000', 'lowerLimit': '0.57', 'upperLimit': '1.00'}]}]}, {'title': 'Follicle Stimulating Hormone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.88', 'groupId': 'OG000', 'lowerLimit': '0.68', 'upperLimit': '1.15'}]}]}, {'title': 'Free Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.63', 'groupId': 'OG000', 'lowerLimit': '0.88', 'upperLimit': '3.01'}]}]}, {'title': 'Sex Hormone Binding Globulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.22', 'groupId': 'OG000', 'lowerLimit': '0.18', 'upperLimit': '0.28'}]}]}, {'title': 'Dihydroepiandrosterone Sulfate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.81', 'groupId': 'OG000', 'lowerLimit': '0.69', 'upperLimit': '0.97'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Cycle 4 Day 1', 'description': 'Geometric mean of ratio (Cycle 4 Day 1/Baseline) of hypogonadism parameters (total testosterone, free testosterone, sex hormone binding globulin, luteinizing hormone, follicle stimulating hormone, dihydroepiandrosterone sulfate, estradiol and prolactin) levels in males was analyzed. Data for this outcome measure was planned to be collected for combined RP2D Cohort only, excluding arms of low and high dose escalation cohorts.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Hypogonadism test evaluable population: Male participants who had completed screening, had received at least 1 dose of crizotinib on Cycle 1 Day 1, had at least 1 post baseline visit data for at least total testosterone, free testosterone, SHBG and included male participants of MET amplification and enriched other Cohort following approval of protocol amendment number 21. "N" =participants evaluable for this OM and \'number analyzed\' =participants with available data for each specified category.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean of Ratio of Total Testosterone, Free Testosterone, Sex Hormone Binding Globulin (SHBG), Luteinizing Hormone, Follicle Stimulating Hormone, Dihydroepiandrosterone Sulfate, Estradiol and Prolactin Levels in Males at Cycle 6 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RP2D Cohort: Crizotinib 250 mg', '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.'}], 'classes': [{'title': 'Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.49', 'groupId': 'OG000', 'lowerLimit': '0.24', 'upperLimit': '1.01'}]}]}, {'title': 'Estradiol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.75', 'groupId': 'OG000', 'lowerLimit': '0.58', 'upperLimit': '0.97'}]}]}, {'title': 'Prolactin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.69', 'groupId': 'OG000', 'lowerLimit': '0.48', 'upperLimit': '1.00'}]}]}, {'title': 'LH Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.78', 'groupId': 'OG000', 'lowerLimit': '0.60', 'upperLimit': '1.02'}]}]}, {'title': 'Follicle Stimulating Hormone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.07', 'groupId': 'OG000', 'lowerLimit': '0.78', 'upperLimit': '1.46'}]}]}, {'title': 'Free Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.71', 'groupId': 'OG000', 'lowerLimit': '1.01', 'upperLimit': '2.90'}]}]}, {'title': 'Sex Hormone Binding Globulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000', 'lowerLimit': '0.15', 'upperLimit': '0.43'}]}]}, {'title': 'Dihydroepiandrosterone Sulfate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.87', 'groupId': 'OG000', 'lowerLimit': '0.68', 'upperLimit': '1.12'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Cycle 6 Day 1', 'description': 'Geometric mean of ratio (Cycle 6 Day 1/Baseline) of hypogonadism parameters (total testosterone, free testosterone, sex hormone binding globulin, luteinizing hormone, follicle stimulating hormone, dihydroepiandrosterone sulfate, estradiol and prolactin) levels in males was analyzed. Data for this outcome measure was planned to be collected for combined RP2D Cohort only, excluding arms of low and high dose escalation cohorts.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Hypogonadism test evaluable population: Male participants who had completed screening, had received at least 1 dose of crizotinib on Cycle 1 Day 1, had at least 1 post baseline visit data for at least total testosterone, free testosterone, SHBG and included male participants of MET amplification and enriched other Cohort following approval of protocol amendment number 21. "N" =participants evaluable for this OM and \'number analyzed\' =participants with available data for each specified category.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean of Ratio of Total Testosterone, Free Testosterone, Sex Hormone Binding Globulin (SHBG), Luteinizing Hormone, Follicle Stimulating Hormone, Dihydroepiandrosterone Sulfate, Estradiol and Prolactin Levels in Males at Cycle 9 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RP2D Cohort: Crizotinib 250 mg', '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.'}], 'classes': [{'title': 'Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.38', 'groupId': 'OG000', 'lowerLimit': '0.26', 'upperLimit': '0.57'}]}]}, {'title': 'Estradiol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.56', 'groupId': 'OG000', 'lowerLimit': '0.49', 'upperLimit': '0.65'}]}]}, {'title': 'Prolactin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.19', 'groupId': 'OG000', 'lowerLimit': '0.65', 'upperLimit': '2.18'}]}]}, {'title': 'LH Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.72', 'groupId': 'OG000', 'lowerLimit': '0.56', 'upperLimit': '0.93'}]}]}, {'title': 'Follicle Stimulating Hormone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.83', 'groupId': 'OG000', 'lowerLimit': '0.67', 'upperLimit': '1.03'}]}]}, {'title': 'Free Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.23', 'groupId': 'OG000', 'lowerLimit': '1.08', 'upperLimit': '1.40'}]}]}, {'title': 'Sex Hormone Binding Globulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.19', 'groupId': 'OG000', 'lowerLimit': '0.09', 'upperLimit': '0.39'}]}]}, {'title': 'Dihydroepiandrosterone Sulfate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.72', 'groupId': 'OG000', 'lowerLimit': '0.51', 'upperLimit': '1.00'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Cycle 9 Day 1', 'description': 'Geometric mean of ratio (Cycle 9 Day 1/Baseline) of hypogonadism parameters (total testosterone, free testosterone, sex hormone binding globulin, luteinizing hormone, follicle stimulating hormone, dihydroepiandrosterone sulfate, estradiol and prolactin) levels in males was analyzed. Data for this outcome measure was planned to be collected for combined RP2D Cohort only, excluding arms of low and high dose escalation cohorts. 95% CI should be interpreted with cautions due to the limited sample size at this time point.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Hypogonadism test evaluable population: Male participants who had completed screening, had received at least 1 dose of crizotinib on Cycle 1 Day 1, had at least 1 post baseline visit data for at least total testosterone, free testosterone, SHBG and included male participants of MET amplification and enriched other Cohort following approval of protocol amendment number 21. "N" =participants evaluable for this OM and \'number analyzed\' =participants with available data for each specified category.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean of Ratio of Total Testosterone, Free Testosterone, Sex Hormone Binding Globulin (SHBG), Luteinizing Hormone, Follicle Stimulating Hormone, Dihydroepiandrosterone Sulfate, Estradiol and Prolactin Levels in Males at Cycle 12 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RP2D Cohort: Crizotinib 250 mg', '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.'}], 'classes': [{'title': 'Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.38', 'groupId': 'OG000', 'lowerLimit': '0.14', 'upperLimit': '1.04'}]}]}, {'title': 'Estradiol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.66', 'groupId': 'OG000', 'lowerLimit': '0.32', 'upperLimit': '1.37'}]}]}, {'title': 'Prolactin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.06', 'groupId': 'OG000', 'lowerLimit': '0.72', 'upperLimit': '1.57'}]}]}, {'title': 'LH Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.88', 'groupId': 'OG000', 'lowerLimit': '0.59', 'upperLimit': '1.32'}]}]}, {'title': 'Follicle Stimulating Hormone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.02', 'groupId': 'OG000', 'lowerLimit': '0.63', 'upperLimit': '1.65'}]}]}, {'title': 'Free Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.39', 'groupId': 'OG000', 'lowerLimit': '0.68', 'upperLimit': '2.86'}]}]}, {'title': 'Sex Hormone Binding Globulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.23', 'groupId': 'OG000', 'lowerLimit': '0.11', 'upperLimit': '0.46'}]}]}, {'title': 'Dihydroepiandrosterone Sulfate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.75', 'groupId': 'OG000', 'lowerLimit': '0.42', 'upperLimit': '1.34'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Cycle 12 Day 1', 'description': 'Geometric mean of ratio (Cycle 12 Day 1/Baseline) of hypogonadism parameters (total testosterone, free testosterone, sex hormone binding globulin, luteinizing hormone, follicle stimulating hormone, dihydroepiandrosterone sulfate, estradiol and prolactin) levels in males was analyzed. Data for this outcome measure was planned to be collected for combined RP2D Cohort only, excluding arms of low and high dose escalation cohorts. 95% CI should be interpreted with cautions due to the limited sample size at this time point.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Hypogonadism test evaluable population: Male participants who had completed screening, had received at least 1 dose of crizotinib on Cycle 1 Day 1, had at least 1 post baseline visit data for at least total testosterone, free testosterone, SHBG and included male participants of MET amplification and enriched other Cohort following approval of protocol amendment number 21. "N" =participants evaluable for this OM and \'number analyzed\' =participants with available data for each specified category.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean of Ratio of Total Testosterone, Free Testosterone, Sex Hormone Binding Globulin (SHBG), Luteinizing Hormone, Follicle Stimulating Hormone, Dihydroepiandrosterone Sulfate, Estradiol and Prolactin Levels in Males at Cycle 15 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RP2D Cohort: Crizotinib 250 mg', '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.'}], 'classes': [{'title': 'Testosterone', 'categories': [{'measurements': [{'value': '0.49', 'groupId': 'OG000', 'lowerLimit': '0.21', 'upperLimit': '1.14'}]}]}, {'title': 'Estradiol', 'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '0.47', 'upperLimit': '2.25'}]}]}, {'title': 'Prolactin', 'categories': [{'measurements': [{'value': '1.32', 'groupId': 'OG000', 'lowerLimit': '0.86', 'upperLimit': '2.03'}]}]}, {'title': 'LH Serum', 'categories': [{'measurements': [{'value': '0.90', 'groupId': 'OG000', 'lowerLimit': '0.56', 'upperLimit': '1.45'}]}]}, {'title': 'Follicle Stimulating Hormone', 'categories': [{'measurements': [{'value': '0.81', 'groupId': 'OG000', 'lowerLimit': '0.53', 'upperLimit': '1.22'}]}]}, {'title': 'Free Testosterone', 'categories': [{'measurements': [{'value': '1.71', 'groupId': 'OG000', 'lowerLimit': '0.57', 'upperLimit': '5.13'}]}]}, {'title': 'Sex Hormone Binding Globulin', 'categories': [{'measurements': [{'value': '0.24', 'groupId': 'OG000', 'lowerLimit': '0.12', 'upperLimit': '0.49'}]}]}, {'title': 'Dihydroepiandrosterone Sulfate', 'categories': [{'measurements': [{'value': '0.76', 'groupId': 'OG000', 'lowerLimit': '0.57', 'upperLimit': '0.99'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Cycle 15 Day 1', 'description': 'Geometric mean of ratio (Cycle 15 Day 1/Baseline) of hypogonadism parameters (total testosterone, free testosterone, sex hormone binding globulin, luteinizing hormone, follicle stimulating hormone, dihydroepiandrosterone sulfate, estradiol and prolactin) levels in males was analyzed. Data for this outcome measure was planned to be collected for combined RP2D Cohort only, excluding arms of low and high dose escalation cohorts. 95% CI should be interpreted with cautions due to the limited sample size at this time point.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Hypogonadism test evaluable population: Male participants who had completed screening, had received at least 1 dose of crizotinib on Cycle 1 Day 1, had at least 1 post baseline visit data for at least total testosterone, free testosterone, SHBG and included male participants of MET amplification and enriched other Cohort following approval of protocol amendment number 21. "N" =participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean of Ratio of Total Testosterone, Free Testosterone, Sex Hormone Binding Globulin (SHBG), Luteinizing Hormone, Follicle Stimulating Hormone, Dihydroepiandrosterone Sulfate, Estradiol and Prolactin Levels in Males at Cycle 18 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RP2D Cohort: Crizotinib 250 mg', '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.'}], 'classes': [{'title': 'Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.32', 'groupId': 'OG000', 'lowerLimit': '0.22', 'upperLimit': '0.48'}]}]}, {'title': 'Estradiol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.55', 'groupId': 'OG000', 'lowerLimit': '0.03', 'upperLimit': '8.69'}]}]}, {'title': 'Prolactin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.64', 'groupId': 'OG000', 'lowerLimit': '1.12', 'upperLimit': '2.39'}]}]}, {'title': 'LH Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.69', 'groupId': 'OG000', 'lowerLimit': '0.58', 'upperLimit': '0.82'}]}]}, {'title': 'Follicle Stimulating Hormone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.89', 'groupId': 'OG000', 'lowerLimit': '0.53', 'upperLimit': '1.47'}]}]}, {'title': 'Free Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.10', 'groupId': 'OG000', 'lowerLimit': '0.42', 'upperLimit': '2.91'}]}]}, {'title': 'Sex Hormone Binding Globulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.18', 'groupId': 'OG000', 'lowerLimit': '0.07', 'upperLimit': '0.45'}]}]}, {'title': 'Dihydroepiandrosterone Sulfate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.69', 'groupId': 'OG000', 'lowerLimit': '0.20', 'upperLimit': '2.35'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Cycle 18 Day 1', 'description': 'Geometric mean of ratio (Cycle 18 Day 1/Baseline) of hypogonadism parameters (total testosterone, free testosterone, sex hormone binding globulin, luteinizing hormone, follicle stimulating hormone, dihydroepiandrosterone sulfate, estradiol and prolactin) levels in males was analyzed. Data for this outcome measure was planned to be collected for combined RP2D Cohort only, excluding arms of low and high dose escalation cohorts. 95% CI should be interpreted with cautions due to the limited sample size at this time point.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Hypogonadism test evaluable population: Male participants who had completed screening, had received at least 1 dose of crizotinib on Cycle 1 Day 1, had at least 1 post baseline visit data for at least total testosterone, free testosterone, SHBG and included male participants of MET amplification and enriched other Cohort following approval of protocol amendment number 21. "N" =participants evaluable for this OM and \'number analyzed\' =participants with available data for each specified category.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean of Ratio of Total Testosterone, Free Testosterone, Sex Hormone Binding Globulin (SHBG), Luteinizing Hormone, Follicle Stimulating Hormone, Dihydroepiandrosterone Sulfate, Estradiol and Prolactin Levels in Males at Cycle 21 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RP2D Cohort: Crizotinib 250 mg', '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.'}], 'classes': [{'title': 'Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.23', 'groupId': 'OG000', 'lowerLimit': '0.09', 'upperLimit': '0.60'}]}]}, {'title': 'Estradiol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.48', 'groupId': 'OG000'}]}]}, {'title': 'Prolactin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.46', 'groupId': 'OG000', 'lowerLimit': '0.62', 'upperLimit': '3.41'}]}]}, {'title': 'LH Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.53', 'groupId': 'OG000', 'lowerLimit': '0.12', 'upperLimit': '2.42'}]}]}, {'title': 'Follicle Stimulating Hormone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.77', 'groupId': 'OG000', 'lowerLimit': '0.44', 'upperLimit': '1.33'}]}]}, {'title': 'Free Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.23', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '797.68'}]}]}, {'title': 'Sex Hormone Binding Globulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.15', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '20.43'}]}]}, {'title': 'Dihydroepiandrosterone Sulfate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.72', 'groupId': 'OG000', 'lowerLimit': '0.09', 'upperLimit': '5.76'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Cycle 21 Day 1', 'description': 'Geometric mean of ratio (Cycle 21 Day 1/Baseline) of hypogonadism parameters (total testosterone, free testosterone, sex hormone binding globulin, luteinizing hormone, follicle stimulating hormone, dihydroepiandrosterone sulfate, estradiol and prolactin) levels in males was analyzed. Data for this outcome measure was planned to be collected for combined RP2D Cohort only, excluding arms of low and high dose escalation cohorts. 95% CI should be interpreted with cautions due to the limited sample size at this time point.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Hypogonadism test evaluable population: Male participants who had completed screening, had received at least 1 dose of crizotinib on Cycle 1 Day 1, had at least 1 post baseline visit data for at least total testosterone, free testosterone, SHBG and included male participants of MET amplification and enriched other Cohort following approval of protocol amendment number 21. "N" =participants evaluable for this OM and \'number analyzed\' =participants with available data for each specified category.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean of Ratio of Total Testosterone, Free Testosterone, Sex Hormone Binding Globulin (SHBG), Luteinizing Hormone, Follicle Stimulating Hormone, Dihydroepiandrosterone Sulfate, Estradiol and Prolactin Levels in Males at Cycle 24 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RP2D Cohort: Crizotinib 250 mg', '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.'}], 'classes': [{'title': 'Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.39', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '70772.27'}]}]}, {'title': 'Estradiol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.70', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '11581.59'}]}]}, {'title': 'Prolactin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.13', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '12.55'}]}]}, {'title': 'LH Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.69', 'groupId': 'OG000', 'lowerLimit': '0.09', 'upperLimit': '5.23'}]}]}, {'title': 'Follicle Stimulating Hormone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.53', 'groupId': 'OG000', 'lowerLimit': '0.07', 'upperLimit': '3.81'}]}]}, {'title': 'Free Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.35', 'groupId': 'OG000'}]}]}, {'title': 'Sex Hormone Binding Globulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.20', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '33217.86'}]}]}, {'title': 'Dihydroepiandrosterone Sulfate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.90', 'groupId': 'OG000', 'lowerLimit': '0.48', 'upperLimit': '1.66'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Cycle 24 Day 1', 'description': 'Geometric mean of ratio (Cycle 24 Day 1/Baseline) of hypogonadism parameters (total testosterone, free testosterone, sex hormone binding globulin, luteinizing hormone, follicle stimulating hormone, dihydroepiandrosterone sulfate, estradiol and prolactin) levels in males was analyzed. Data for this outcome measure was planned to be collected for combined RP2D Cohort only, excluding arms of low and high dose escalation cohorts. 95% CI should be interpreted with cautions due to the limited sample size at this time point.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Hypogonadism test evaluable population: Male participants who had completed screening, had received at least 1 dose of crizotinib on Cycle 1 Day 1, had at least 1 post baseline visit data for at least total testosterone, free testosterone, SHBG and included male participants of MET amplification and enriched other Cohort following approval of protocol amendment number 21. "N" =participants evaluable for this OM and \'number analyzed\' =participants with available data for each specified category.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean of Ratio of Total Testosterone, Free Testosterone, Sex Hormone Binding Globulin (SHBG), Luteinizing Hormone, Follicle Stimulating Hormone, Dihydroepiandrosterone Sulfate, Estradiol and Prolactin Levels in Males at Cycle 27 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RP2D Cohort: Crizotinib 250 mg', '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.'}], 'classes': [{'title': 'Testosterone', 'categories': [{'measurements': [{'value': '0.46', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '61000.31'}]}]}, {'title': 'Estradiol', 'categories': [{'measurements': [{'value': '0.97', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '9022.66'}]}]}, {'title': 'Prolactin', 'categories': [{'measurements': [{'value': '1.48', 'groupId': 'OG000', 'lowerLimit': '0.11', 'upperLimit': '20.69'}]}]}, {'title': 'LH Serum', 'categories': [{'measurements': [{'value': '0.70', 'groupId': 'OG000', 'lowerLimit': '0.11', 'upperLimit': '4.50'}]}]}, {'title': 'Follicle Stimulating Hormone', 'categories': [{'measurements': [{'value': '0.66', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '7.53'}]}]}, {'title': 'Free Testosterone', 'categories': [{'measurements': [{'value': '1.86', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '147.95'}]}]}, {'title': 'Sex Hormone Binding Globulin', 'categories': [{'measurements': [{'value': '0.24', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '22059.61'}]}]}, {'title': 'Dihydroepiandrosterone Sulfate', 'categories': [{'measurements': [{'value': '0.95', 'groupId': 'OG000', 'lowerLimit': '0.24', 'upperLimit': '3.78'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Cycle 27 Day 1', 'description': 'Geometric mean of ratio (Cycle 27 Day 1/Baseline) of hypogonadism parameters (total testosterone, free testosterone, sex hormone binding globulin, luteinizing hormone, follicle stimulating hormone, dihydroepiandrosterone sulfate, estradiol and prolactin) levels in males was analyzed. Data for this outcome measure was planned to be collected for combined RP2D Cohort only, excluding arms of low and high dose escalation cohorts. 95% CI should be interpreted with cautions due to the limited sample size at this time point.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Hypogonadism test evaluable population: Male participants who had completed screening, had received at least 1 dose of crizotinib on Cycle 1 Day 1, had at least 1 post baseline visit data for at least total testosterone, free testosterone, SHBG and included male participants of MET amplification and enriched other Cohort following approval of protocol amendment number 21. "N" =participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean of Ratio of Total Testosterone, Free Testosterone, Sex Hormone Binding Globulin (SHBG), Luteinizing Hormone, Follicle Stimulating Hormone, Dihydroepiandrosterone Sulfate, Estradiol and Prolactin Levels in Males at Cycle 30 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RP2D Cohort: Crizotinib 250 mg', '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.'}], 'classes': [{'title': 'Testosterone', 'categories': [{'measurements': [{'value': '0.16', 'groupId': 'OG000'}]}]}, {'title': 'Estradiol', 'categories': [{'measurements': [{'value': '0.38', 'groupId': 'OG000'}]}]}, {'title': 'Prolactin', 'categories': [{'measurements': [{'value': '1.14', 'groupId': 'OG000'}]}]}, {'title': 'LH Serum', 'categories': [{'measurements': [{'value': '0.85', 'groupId': 'OG000'}]}]}, {'title': 'Follicle Stimulating Hormone', 'categories': [{'measurements': [{'value': '0.80', 'groupId': 'OG000'}]}]}, {'title': 'Free Testosterone', 'categories': [{'measurements': [{'value': '1.25', 'groupId': 'OG000'}]}]}, {'title': 'Sex Hormone Binding Globulin', 'categories': [{'measurements': [{'value': '0.09', 'groupId': 'OG000'}]}]}, {'title': 'Dihydroepiandrosterone Sulfate', 'categories': [{'measurements': [{'value': '0.71', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Cycle 30 Day 1', 'description': 'Geometric mean of ratio (Cycle 30 Day 1/Baseline) of hypogonadism parameters (total testosterone, free testosterone, sex hormone binding globulin, luteinizing hormone, follicle stimulating hormone, dihydroepiandrosterone sulfate, estradiol and prolactin) levels in males was analyzed. Data for this outcome measure was planned to be collected for combined RP2D Cohort only, excluding arms of low and high dose escalation cohorts. 95% CI should be interpreted with cautions due to the limited sample size at this time point.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Hypogonadism test evaluable population: Male participants who had completed screening, had received at least 1 dose of crizotinib on Cycle 1 Day 1, had at least 1 post baseline visit data for at least total testosterone, free testosterone, SHBG and included male participants of MET amplification and enriched other Cohort following approval of protocol amendment number 21. "N" =participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean of Ratio of Total Testosterone, Free Testosterone, Sex Hormone Binding Globulin (SHBG), Luteinizing Hormone, Follicle Stimulating Hormone, Dihydroepiandrosterone Sulfate, Estradiol and Prolactin Levels in Males at End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RP2D Cohort: Crizotinib 250 mg', '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.'}], 'classes': [{'title': 'Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.40', 'groupId': 'OG000', 'lowerLimit': '0.08', 'upperLimit': '2.08'}]}]}, {'title': 'Estradiol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.66', 'groupId': 'OG000', 'lowerLimit': '0.39', 'upperLimit': '1.13'}]}]}, {'title': 'Prolactin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.48', 'groupId': 'OG000', 'lowerLimit': '0.49', 'upperLimit': '4.50'}]}]}, {'title': 'LH Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.52', 'groupId': 'OG000', 'lowerLimit': '0.14', 'upperLimit': '1.98'}]}]}, {'title': 'Follicle Stimulating Hormone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.85', 'groupId': 'OG000', 'lowerLimit': '0.26', 'upperLimit': '2.72'}]}]}, {'title': 'Free Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.62', 'groupId': 'OG000', 'lowerLimit': '0.20', 'upperLimit': '1.93'}]}]}, {'title': 'Sex Hormone Binding Globulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.64', 'groupId': 'OG000', 'lowerLimit': '0.24', 'upperLimit': '1.71'}]}]}, {'title': 'Dihydroepiandrosterone Sulfate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.41', 'groupId': 'OG000', 'lowerLimit': '0.21', 'upperLimit': '0.78'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, End of Treatment (28 days post last dose)', 'description': 'Geometric mean of ratio (End of treatment/Baseline) of hypogonadism parameters (total testosterone, free testosterone, sex hormone binding globulin, luteinizing hormone, follicle stimulating hormone, dihydroepiandrosterone sulfate, estradiol and prolactin) levels in males was analyzed. Data for this outcome measure was planned to be collected for combined RP2D Cohort only, excluding arms of low and high dose escalation cohorts. 95% CI should be interpreted with cautions due to the limited sample size at this time point.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Hypogonadism test evaluable population: Male participants who had completed screening, had received at least 1 dose of crizotinib on Cycle 1 Day 1, had at least 1 post baseline visit data for at least total testosterone, free testosterone, SHBG and included male participants of MET amplification and enriched other Cohort following approval of protocol amendment number 21. "N" =participants evaluable for this OM and \'number analyzed\' =participants with available data for each specified category.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low Dose Escalation Cohort: Crizotinib 50 mg QD', 'description': 'Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).'}, {'id': 'FG001', 'title': 'Low Dose Escalation Cohort: Crizotinib 100 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': 'FG002', '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 QD for up to 34 cycles (each cycle 28 days).'}, {'id': 'FG003', 'title': 'Low Dose Escalation Cohort: Crizotinib 200 mg BID', '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': 'FG004', 'title': 'Low Dose Escalation Cohort: Crizotinib 250 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': 'FG005', 'title': 'Low Dose Escalation Cohort: Crizotinib 300 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': 'FG006', 'title': 'High Dose Escalation Cohort: Crizotinib 300 mg QD', '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': 'FG007', 'title': 'High Dose Escalation Cohort: Crizotinib 400 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': 'FG008', 'title': 'High Dose Escalation Cohort: Crizotinib 500 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': 'FG009', 'title': 'High Dose Escalation Cohort: Crizotinib 650 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': 'FG010', 'title': 'High Dose Escalation Cohort: Crizotinib 800 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': 'FG011', '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 105 cycles (each cycle 28 days).'}, {'id': 'FG012', '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 55 cycles (each cycle 28 days).'}, {'id': 'FG013', '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 orally twice daily (BID) with or without food for up to 101 cycles (each cycle 28 days).'}, {'id': 'FG014', '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 twice daily (BID) with or without food for up to 70 cycles (each cycle 21 days).'}, {'id': 'FG015', '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 orally BID with or without food for up to 70 cycles (each cycle 21 days).'}, {'id': 'FG016', '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 twice daily (BID) with or without food for up to 133 cycles (each cycle 28 days).'}, {'id': 'FG017', 'title': 'RP2D Cohort: Enriched Other: 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': 'FG018', 'title': 'RP2D Cohort: Itraconazole Interaction: Crizotinib 250 mg +Itraconazole', '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': 'FG019', 'title': 'RP2D Cohort: Rifampin Interaction: Crizotinib 250 mg +Rifampin', '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': 'FG020', 'title': 'RP2D Cohort: Midazolam Interaction: Crizotinib 250 mg +Midazolam', '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'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '11'}, {'groupId': 'FG011', 'numSubjects': '53'}, {'groupId': 'FG012', 'numSubjects': '85'}, {'groupId': 'FG013', 'numSubjects': '41'}, {'groupId': 'FG014', 'numSubjects': '48'}, {'groupId': 'FG015', 'numSubjects': '19'}, {'groupId': 'FG016', 'numSubjects': '154'}, {'groupId': 'FG017', 'numSubjects': '67'}, {'groupId': 'FG018', 'numSubjects': '21'}, {'groupId': 'FG019', 'numSubjects': '18'}, {'groupId': 'FG020', 'numSubjects': '14'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '9'}, {'groupId': 'FG011', 'numSubjects': '53'}, {'groupId': 'FG012', 'numSubjects': '85'}, {'groupId': 'FG013', 'numSubjects': '41'}, {'groupId': 'FG014', 'numSubjects': '48'}, {'groupId': 'FG015', 'numSubjects': '18'}, {'groupId': 'FG016', 'numSubjects': '154'}, {'groupId': 'FG017', 'numSubjects': '66'}, {'groupId': 'FG018', 'numSubjects': 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Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '8'}, {'groupId': 'FG013', 'numSubjects': '6'}, {'groupId': 'FG014', 'numSubjects': '4'}, {'groupId': 'FG015', 'numSubjects': '1'}, {'groupId': 'FG016', 'numSubjects': '14'}, {'groupId': 'FG017', 'numSubjects': '9'}, {'groupId': 'FG018', 'numSubjects': '2'}, {'groupId': 'FG019', 'numSubjects': '3'}, {'groupId': 'FG020', 'numSubjects': '1'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '5'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '25'}, {'groupId': 'FG012', 'numSubjects': '29'}, {'groupId': 'FG013', 'numSubjects': '26'}, {'groupId': 'FG014', 'numSubjects': '21'}, {'groupId': 'FG015', 'numSubjects': '12'}, {'groupId': 'FG016', 'numSubjects': '94'}, {'groupId': 'FG017', 'numSubjects': '42'}, {'groupId': 'FG018', 'numSubjects': '4'}, {'groupId': 'FG019', 'numSubjects': '9'}, {'groupId': 'FG020', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '8'}, {'groupId': 'FG012', 'numSubjects': '15'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '3'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '7'}, {'groupId': 'FG017', 'numSubjects': '1'}, {'groupId': 'FG018', 'numSubjects': '2'}, {'groupId': 'FG019', 'numSubjects': '2'}, {'groupId': 'FG020', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '19'}, {'groupId': 'FG012', 'numSubjects': '24'}, {'groupId': 'FG013', 'numSubjects': '7'}, {'groupId': 'FG014', 'numSubjects': '11'}, {'groupId': 'FG015', 'numSubjects': '3'}, {'groupId': 'FG016', 'numSubjects': '28'}, {'groupId': 'FG017', 'numSubjects': '12'}, {'groupId': 'FG018', 'numSubjects': '10'}, {'groupId': 'FG019', 'numSubjects': '4'}, {'groupId': 'FG020', 'numSubjects': '2'}]}, {'type': 'Randomized not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '1'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '1'}, {'groupId': 'FG018', 'numSubjects': '3'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '7'}, {'groupId': 'FG013', 'numSubjects': '2'}, {'groupId': 'FG014', 'numSubjects': '8'}, {'groupId': 'FG015', 'numSubjects': '2'}, {'groupId': 'FG016', 'numSubjects': '11'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '2'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}]}, {'type': 'Site Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}]}, {'type': 'Withdrawn Due to Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '1'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'There was a lead-in period of 7 days in which single-dose pharmacokinetics of crizotinib or midazolam was characterized on Day-7, prior to initiation of continuous dosing in the first cycle (each cycle 28 days) of treatment in dose escalation cohorts and recommended phase 2 dose (RP2D) cohorts.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '9', 'groupId': 'BG010'}, {'value': '53', 'groupId': 'BG011'}, {'value': '85', 'groupId': 'BG012'}, {'value': '41', 'groupId': 'BG013'}, {'value': '48', 'groupId': 'BG014'}, {'value': '18', 'groupId': 'BG015'}, {'value': '154', 'groupId': 'BG016'}, {'value': '66', 'groupId': 'BG017'}, {'value': '18', 'groupId': 'BG018'}, {'value': '18', 'groupId': 'BG019'}, {'value': '12', 'groupId': 'BG020'}, {'value': '578', 'groupId': 'BG021'}]}], 'groups': [{'id': 'BG000', 'title': 'Low Dose Escalation Cohort: Crizotinib 50 mg QD', 'description': 'Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).'}, {'id': 'BG001', 'title': 'Low Dose Escalation Cohort: Crizotinib 100 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': '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 QD for up to 34 cycles (each cycle 28 days).'}, {'id': 'BG003', 'title': 'Low Dose Escalation Cohort: Crizotinib 200 mg BID', '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': 'BG004', 'title': 'Low Dose Escalation Cohort: Crizotinib 250 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': '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 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': 'BG006', 'title': 'High Dose Escalation Cohort: Crizotinib 300 mg QD', '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': 'BG007', 'title': 'High Dose Escalation Cohort: Crizotinib 400 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': 'BG008', 'title': 'High Dose Escalation Cohort: Crizotinib 500 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': 'BG009', 'title': 'High Dose Escalation Cohort: Crizotinib 650 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': 'BG010', 'title': 'High Dose Escalation Cohort: Crizotinib 800 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': '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 105 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 55 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 orally twice daily (BID) with or without food for up to 101 cycles (each cycle 28 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 twice daily (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 orally BID with or without food for up to 70 cycles (each cycle 21 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 twice daily (BID) with or without food for up to 133 cycles (each cycle 28 days).'}, {'id': 'BG017', 'title': 'RP2D Cohort: Enriched Other: 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': 'BG018', 'title': 'RP2D Cohort: Itraconazole Interaction: Crizotinib 250 mg +Itraconazole', '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': 'BG019', 'title': 'RP2D Cohort: Rifampin Interaction: Crizotinib 250 mg +Rifampin', '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': 'BG020', 'title': 'RP2D Cohort: Midazolam Interaction: Crizotinib 250 mg +Midazolam', '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': 'BG021', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'less than 65 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '5', 'groupId': 'BG010'}, {'value': '23', 'groupId': 'BG011'}, {'value': '18', 'groupId': 'BG012'}, {'value': '20', 'groupId': 'BG013'}, {'value': '30', 'groupId': 'BG014'}, {'value': '12', 'groupId': 'BG015'}, {'value': '131', 'groupId': 'BG016'}, {'value': '51', 'groupId': 'BG017'}, {'value': '9', 'groupId': 'BG018'}, {'value': '12', 'groupId': 'BG019'}, {'value': '9', 'groupId': 'BG020'}, {'value': '368', 'groupId': 'BG021'}]}]}, {'title': 'greater than or equals to 65 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '30', 'groupId': 'BG011'}, {'value': '67', 'groupId': 'BG012'}, {'value': '21', 'groupId': 'BG013'}, {'value': '18', 'groupId': 'BG014'}, {'value': '6', 'groupId': 'BG015'}, {'value': '23', 'groupId': 'BG016'}, {'value': '15', 'groupId': 'BG017'}, {'value': '9', 'groupId': 'BG018'}, {'value': '6', 'groupId': 'BG019'}, {'value': '3', 'groupId': 'BG020'}, {'value': '210', 'groupId': 'BG021'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '30', 'groupId': 'BG011'}, {'value': '48', 'groupId': 'BG012'}, {'value': '19', 'groupId': 'BG013'}, {'value': '24', 'groupId': 'BG014'}, {'value': '8', 'groupId': 'BG015'}, {'value': '80', 'groupId': 'BG016'}, {'value': '25', 'groupId': 'BG017'}, {'value': '11', 'groupId': 'BG018'}, {'value': '9', 'groupId': 'BG019'}, {'value': '8', 'groupId': 'BG020'}, {'value': '289', 'groupId': 'BG021'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '6', 'groupId': 'BG010'}, {'value': '23', 'groupId': 'BG011'}, {'value': '37', 'groupId': 'BG012'}, {'value': '22', 'groupId': 'BG013'}, {'value': '24', 'groupId': 'BG014'}, {'value': '10', 'groupId': 'BG015'}, {'value': '74', 'groupId': 'BG016'}, {'value': '41', 'groupId': 'BG017'}, {'value': '7', 'groupId': 'BG018'}, {'value': '9', 'groupId': 'BG019'}, {'value': '4', 'groupId': 'BG020'}, {'value': '289', 'groupId': 'BG021'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '8', 'groupId': 'BG010'}, {'value': '30', 'groupId': 'BG011'}, {'value': '60', 'groupId': 'BG012'}, {'value': '38', 'groupId': 'BG013'}, {'value': '35', 'groupId': 'BG014'}, {'value': '11', 'groupId': 'BG015'}, {'value': '98', 'groupId': 'BG016'}, {'value': '49', 'groupId': 'BG017'}, {'value': '13', 'groupId': 'BG018'}, {'value': '16', 'groupId': 'BG019'}, {'value': '11', 'groupId': 'BG020'}, {'value': '418', 'groupId': 'BG021'}]}, {'title': 'Black', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}, {'value': '2', 'groupId': 'BG013'}, {'value': '1', 'groupId': 'BG014'}, {'value': '3', 'groupId': 'BG015'}, {'value': '5', 'groupId': 'BG016'}, {'value': '4', 'groupId': 'BG017'}, {'value': '3', 'groupId': 'BG018'}, {'value': '2', 'groupId': 'BG019'}, {'value': '0', 'groupId': 'BG020'}, {'value': '27', 'groupId': 'BG021'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', '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': '1', 'groupId': 'BG010'}, {'value': '21', 'groupId': 'BG011'}, {'value': '15', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '9', 'groupId': 'BG014'}, {'value': '2', 'groupId': 'BG015'}, {'value': '43', 'groupId': 'BG016'}, {'value': '9', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}, {'value': '0', 'groupId': 'BG019'}, {'value': '0', 'groupId': 'BG020'}, {'value': '102', 'groupId': 'BG021'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', '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': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '8', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '3', 'groupId': 'BG014'}, {'value': '2', 'groupId': 'BG015'}, {'value': '8', 'groupId': 'BG016'}, {'value': '4', 'groupId': 'BG017'}, {'value': '2', 'groupId': 'BG018'}, {'value': '0', 'groupId': 'BG019'}, {'value': '1', 'groupId': 'BG020'}, {'value': '31', 'groupId': 'BG021'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety analysis (SA) set included all enrolled participants who received at least one dose of Crizotinib on Cycle 1 Day 1.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-11', 'size': 8204018, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-01-10T15:56', 'hasProtocol': True}, {'date': '2019-08-22', 'size': 3835620, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-07-30T10:28', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 596}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-10', 'studyFirstSubmitDate': '2007-12-29', 'resultsFirstSubmitDate': '2021-07-30', 'studyFirstSubmitQcDate': '2007-12-29', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-17', 'studyFirstPostDateStruct': {'date': '2008-01-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-Escalation Cohort: Maximum Tolerated Dose (MTD) of Crizotinib', 'timeFrame': 'Cycle 1 (28 days)', 'description': 'MTD: Dose level at which at most 1 of 6 participants experienced DLT within and including 28 days of treatment (during Cycle 1 \\[1 cycle=28 days\\]) with next higher dose having at least 2/3 or 2/6 participants experiencing a DLT. DLT was defined as any of following: Hematologic toxicities- 1) prolonged grade 4 neutropenia for \\>7 days. 2) Febrile neutropenia: grade 4 neutropenia with fever greater than (\\>) 38.5 degree Celsius, both sustained over a 24 hour period (3) neutropenic infection: greater than or equal to (\\>=) Grade 3 neutropenia with Grade \\>=3 infection. (4) Grade \\>=3 thrombocytopenia with bleeding/grade 4 lasting \\>=7 days. Other non-hematologic toxicity included: Grade 3/4 toxicities (except for alopecia, Grade 3/4 hypophosphatemia, grade 3 hypertension with controlled blood pressure \\[less than (\\<) 140/90 millimeter of mercury, and Grade 3/4 hyperuricemia without signs and symptoms of gout). Nausea, vomiting/diarrhea must persist at grade 3/4 despite maximal medical therapy.'}, {'measure': 'Dose-Escalation Cohort: Recommended Phase 2 Dose (RP2D) of Crizotinib', 'timeFrame': 'Cycle 1 (28 days)', 'description': 'RP2D was defined as a dose below or equal to MTD, at which crizotinib was unlikely to cause a significant inhibition of CYP3A4 activity.'}, {'measure': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Crizotinib on Day -7', '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', 'description': 'AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) extrapolated to infinite time (0-inf).'}, {'measure': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib on Day -7', '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', 'description': 'Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau), where dosing interval is 12 hours for BID dose and 24 hours for QD dose.'}, {'measure': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib on Cycle 1 Day 1', 'timeFrame': 'Pre-dose, 2, 4 and 6 hours post dose on Cycle 1 Day 1', 'description': 'Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau), where dosing interval is 12 hours for BID dose and 24 hours for QD dose.'}, {'measure': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib on Cycle 1 Day 15', 'timeFrame': 'Pre-dose, 1, 2, 4, 6, 8, 9 and 24 hours post dose on Cycle 1 Day 15', 'description': 'Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau), where dosing interval is 12 hours for BID dose and 24 hours for QD dose.'}, {'measure': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib on Cycle 2 Day 1', 'timeFrame': 'Pre-dose, 1, 2, 4, 6, 8, 9 and 24 hours post dose on Cycle 2 Day 1', 'description': 'Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau), where dosing interval is 12 hours for BID dose and 24 hours for QD dose.'}, {'measure': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Trough Concentration (Ctrough) of Crizotinib Cycle 1 Day 15', 'timeFrame': 'Pre-dose on Cycle 1 Day 15', 'description': 'Ctrough refers to plasma concentration of Crizotinib observed just before treatment administration.'}, {'measure': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Trough Concentration (Ctrough) of Crizotinib on Cycle 2 Day 1', 'timeFrame': 'Pre-dose on Cycle 2 Day 1', 'description': 'Ctrough refers to plasma concentration of Crizotinib observed just before treatment administration.'}, {'measure': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Maximum Observed Plasma Concentration (Cmax) of Crizotinib on Day -7', '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', 'description': 'Cmax is defined as the observed maximum plasma concentration post drug administration.'}, {'measure': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Maximum Observed Plasma Concentration (Cmax) of Crizotinib on Cycle 1 Day 1', 'timeFrame': 'Pre-dose, 2, 4 and 6 hours post dose on Cycle 1 Day 1', 'description': 'Cmax is defined as the observed maximum plasma concentration post drug administration.'}, {'measure': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Maximum Observed Plasma Concentration (Cmax) of Crizotinib on Cycle 1 Day 15', 'timeFrame': 'Pre-dose, 1, 2, 4, 6, 8, 9 and 24 hours post dose on Cycle 1 Day 15', 'description': 'Cmax is defined as the observed maximum plasma concentration post drug administration.'}, {'measure': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Maximum Observed Plasma Concentration (Cmax) of Crizotinib on Cycle 2 Day 1', 'timeFrame': 'Pre-dose, 1, 2, 4, 6, 8, 9 and 24 hours post dose on Cycle 2 Day 1', 'description': 'Cmax is defined as the observed maximum plasma concentration post drug administration.'}, {'measure': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Crizotinib on Day -7', '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', 'description': 'Tmax was defined as the time to reach the observed maximum plasma concentration (Cmax).'}, {'measure': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Crizotinib on Cycle 1 Day 1', 'timeFrame': 'Pre-dose, 2, 4 and 6 hours post dose on Cycle 1 Day 1', 'description': 'Tmax was defined as the time to reach the observed maximum plasma concentration (Cmax).'}, {'measure': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Crizotinib on Cycle 1 Day 15', 'timeFrame': 'Pre-dose, 1, 2, 4, 6, 8, 9 and 24 hours post dose on Cycle 1 Day 15', 'description': 'Tmax was defined as the time to reach the observed maximum plasma concentration (Cmax).'}, {'measure': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Crizotinib Cycle 2 Day 1', 'timeFrame': 'Pre-dose, 1, 2, 4, 6, 8, 9 and 24 hours post dose on Cycle 2 Day 1', 'description': 'Tmax was defined as the time to reach the observed maximum plasma concentration (Cmax).'}, {'measure': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Plasma Decay Half-Life (t1/2) of Crizotinib on Day -7', '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', 'description': 'Plasma decay half-life is the time measured for the plasma concentration of Crizotinib to decrease by one half.'}, {'measure': 'Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Number of Participants With Treatment Emergent Adverse Events (TEAES) and Serious Adverse Events (SAEs)', 'timeFrame': 'up to 189 Months', '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.'}, {'measure': 'Dose-Escalation Cohort: Number of Participants With Dose-limiting Toxicities (DLT)', 'timeFrame': 'Cycle 1 (28 days)', 'description': 'Dose-limiting toxicity (DLT) was defined as any of the following: Hematologic- prolonged grade 4 neutropenia for \\>7 days. Febrile neutropenia, defined as grade 4 neutropenia with fever greater than (\\>)38.5 degree Celsius, both sustained over a 24 hour period, neutropenic infection: greater than or equal to (\\>=)Grade 3 neutropenia with Grade \\>=3 infection. Grade \\>=3 thrombocytopenia with bleeding or grade 4 lasting \\>=7 days Lymphopenia was not considered a DLT unless accompanied by infection. Other non-hematologic toxicity: Grade 3 or 4 toxicities (except for alopecia, Grade 3/4 hypophosphatemia, grade 3 hypertension with controlled blood pressure \\[less than (\\<) 140/90\\], and Grade 3/4 hyperuricemia without signs and symptoms of gout). Nausea, vomiting or diarrhea must persist at grade 3 or 4 despite maximal medical therapy.'}, {'measure': 'Midazolam Interaction Cohort: Maximum Observed Plasma Concentration (Cmax) of Midazolam When Taken Alone or Taken With Crizotinib', 'timeFrame': 'pre-dose, 0.5, 1, 2, 4, 6, 8, 9, and 24 hours post dose on Day -7 (midazolam alone arm), pre-dose, 0.5, 1, 2, 4, 6, 8, 9, and 24 hours post dose on Cycle 2 Day 1 (midazolam with crizotinib arm)', 'description': 'Cmax is defined as the observed maximum plasma concentration post drug administration.'}, {'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Midazolam When Taken Alone or Taken With Crizotinib', 'timeFrame': 'pre-dose, 0.5, 1, 2, 4, 6, 8, 9, and 24 hours post dose on Day -7 (midazolam alone arm), pre-dose, 0.5, 1, 2, 4, 6, 8, 9, and 24 hours post dose on Cycle 2 Day 1 (midazolam with crizotinib arm)', 'description': 'AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).'}, {'measure': 'RP2D Cohort: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Crizotinib When Taken With Food', 'timeFrame': 'pre-dose, 1, 2, 4, 6, 8, 9, and 24 hours post-dose on Day -7', 'description': 'AUC0-24 of Crizotinib was defined as the area under the free plasma concentration time curve from time 0 to 24 hours post-dose.'}, {'measure': 'RP2D Cohort: Maximum Observed Plasma Concentration (Cmax) of Crizotinib When Taken With Food', 'timeFrame': 'pre-dose, 1, 2, 4, 6, 8, 9, and 24 hours post-dose on Day -7', 'description': 'Cmax is defined as the observed maximum plasma concentration post drug administration.'}, {'measure': 'Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib Alone and When Taken With Rifampin', 'timeFrame': 'pre-dose, 2, 4, 6, 8 and 10 hours on Cycle 1 Day 15 (Crizotinib alone arm) and Cycle 2 Day 1 (Crizotinib with Rifampin arm)', 'description': 'Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau).'}, {'measure': 'Rifampin Cohort: Maximum Observed Plasma Concentration (Cmax) of Crizotinib Alone and When Taken With Rifampin', 'timeFrame': 'pre-dose, 2, 4, 6, 8 and 10 hours on Cycle 1 Day 15 (Crizotinib alone) and Cycle 2 Day 1 (Crizotinib with Rifampin)'}, {'measure': 'Rifampin Cohort: Ctrough of Crizotinib Alone and When Taken With Rifampin', 'timeFrame': 'pre-dose on Cycle 1 Day 15 (Crizotinib alone arm) and Cycle 2 Day 1 (Crizotinib with Rifampin arm)', 'description': 'Ctrough refers to plasma concentration of Crizotinib observed just before treatment administration.'}, {'measure': 'Itraconazole Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib When Taken Alone and When Taken With Itraconazole', 'timeFrame': 'pre-dose, 1, 2, 4, 6, 8, 9 and 24 hours post dose on Cycle 1 Day 15 (Crizotinib with itraconazole) and Cycle 2 Day 1 (itraconazole alone)', 'description': 'Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau), where dosing interval is 24 hours.'}, {'measure': 'Itraconazole Cohort: Maximum Observed Plasma Concentration (Cmax) of Crizotinib When Taken Alone and When Taken With Itraconazole', 'timeFrame': 'pre-dose, 1, 2, 4, 6, 8, 9 and 24 hours post dose on Cycle 1 Day 15 (Crizotinib with itraconazole) and Cycle 2 Day 1 (itraconazole alone)'}, {'measure': 'Itraconazole Cohort: Trough Plasma Concentration (Ctrough) of Crizotinib When Taken Alone and When Taken With Itraconazole', 'timeFrame': 'pre-dose on Cycle 1 Day 15 (crizotinib with itraconazole) and Cycle 2 Day 1 (itraconazole alone)', 'description': 'Ctrough refers to plasma concentration of Crizotinib observed just before treatment administration.'}, {'measure': 'Recommended Phase 2 Dose (RP2D) Cohort: Percentage of Participants With Objective Response (OR)', 'timeFrame': 'Baseline up to 172 months', 'description': 'ORR was defined as participants with a best overall response of complete response (CR) or partial response (PR) divided by the total number of evaluable participants per RECIST version 1.0 (RECIST1.1 for ALK-negative NSCLC cohort 1 and ALK-negative NSCLC cohort 2). CR: Disappearance of all target and non-target lesions, normalization of tumor marker levels, and no appearance of new lesions indicated complete response. PR: At least a 30% decrease in the sum of the longest diameters of target lesions (taking as reference the baseline sum), without progression of non-target lesions and no appearance of new lesions indicated partial response.'}, {'measure': 'Recommended Phase 2 Dose (RP2D) Cohort: Duration of Response (DOR)', 'timeFrame': 'From first documentation of response to date of PD or death due to any cause (up to 172 months)', 'description': 'Duration of response (DoR) was the time from first documentation of PR or CR to date of first documentation of progressive disease (PD) or death due to any cause. PR: At least a 30% decrease in the sum of the longest diameters of target lesions (taking as reference the baseline sum), without progression of non-target lesions and no appearance of new lesions indicated partial response. CR: Disappearance of all target and non-target lesions, normalization of tumor marker levels, and no appearance of new lesions indicated complete response. PD: \\>=20% increase in the sum of the longest diameter of target lesions taking as references the smallest sum longest diameter recorded since the treatment started, unequivocal progression of existing non-target lesions, or the appearance of 1 or more new lesions.'}, {'measure': 'Recommended Phase 2 Dose (RP2D) Cohort: Time to Response (TTR)', 'timeFrame': 'From first dose until first documented response of PR or CR (up to 172 months)', 'description': 'TTR: time between first dose until first documented response of PR or CR. PR: At least a 30% decrease in the sum of the longest diameters of target lesions (taking as reference the baseline sum), without progression of non-target lesions and no appearance of new lesions indicated partial response. CR: Disappearance of all target and non-target lesions, normalization of tumor marker levels, and no appearance of new lesions indicated complete response.'}, {'measure': 'Recommended Phase 2 Dose (RP2D) Cohort: Percentage of Participants With Disease Control at Week 8', 'timeFrame': 'Week 8', 'description': 'Disease control was defined as the percentage of participants with a confirmed CR, PR, or stable disease (SD) per RECIST version 1.0 (RECIST1.1 for ALK-negative NSCLC cohort 1 and ALK-negative NSCLC cohort 2). PR: At least a 30% decrease in the sum of the longest diameters of target lesions (taking as reference the baseline sum), without progression of non-target lesions and no appearance of new lesions indicated partial response. CR: Disappearance of all target and non-target lesions, normalization of tumor marker levels, and no appearance of new lesions indicated complete response. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.'}, {'measure': 'Recommended Phase 2 Dose (RP2D) Cohort: Percentage of Participants With Disease Control at Week 16', 'timeFrame': 'Week 16', 'description': 'Disease control was defined as the percentage of participants with a confirmed CR, PR, or stable disease (SD) per RECIST version 1.0 (RECIST1.1 for ALK-negative NSCLC cohort 1 and ALK-negative NSCLC cohort 2). PR: At least a 30% decrease in the sum of the longest diameters of target lesions (taking as reference the baseline sum), without progression of non-target lesions and no appearance of new lesions indicated partial response. CR: Disappearance of all target and non-target lesions, normalization of tumor marker levels, and no appearance of new lesions indicated complete response. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.'}, {'measure': 'Recommended Phase 2 Dose (RP2D) Cohort: Progression Free Survival (PFS)', 'timeFrame': 'From randomization until PD or death, whichever occurred first (up to 172 months)', 'description': 'Progression free survival (PFS) was the time from randomization date to date of first documentation of PD or death due to any cause RECIST version 1.0 (RECIST1.1 for ALK-negative NSCLC cohort 1 and ALK-negative NSCLC cohort 2). PD: \\>=20% increase in the sum of the longest diameter of target lesions taking as references the smallest sum longest diameter recorded since the treatment started, unequivocal progression of existing non-target lesions, or the appearance of 1 or more new lesions.'}, {'measure': 'Recommended Phase 2 Dose (RP2D) Cohort: Probability of Being Event Free at Month 6', 'timeFrame': 'From randomization to 6 months', 'description': 'Probability of being event free (event defined as PD or death due to any cause) at 6 months after the first dose of crizotinib was reported. PD: \\>=20% increase in the sum of the longest diameter of target lesions taking as references the smallest sum longest diameter recorded since the treatment started, unequivocal progression of existing non-target lesions, or the appearance of 1 or more new lesions.'}, {'measure': 'Recommended Phase 2 Dose (RP2D) Cohort: Overall Survival (OS)', 'timeFrame': 'From randomization date to the date of death (up to 172 Months)', 'description': 'OS was defined as the time from randomization to death due to any cause.'}, {'measure': 'Probability of Participant Survival at Month 6', 'timeFrame': 'Month 6', 'description': 'Probability of survival was defined as the probability of being alive at Month 6.'}, {'measure': 'Probability of Participant Survival at Month 12', 'timeFrame': 'Month 12', 'description': 'Probability of survival was defined as the probability of being alive at Month 12.'}, {'measure': 'Geometric Mean of Ratio of Total Testosterone, Free Testosterone, Sex Hormone Binding Globulin (SHBG), Luteinizing Hormone, Follicle Stimulating Hormone, Dihydroepiandrosterone Sulfate, Estradiol and Prolactin Levels in Males at Cycle 1 Day 15', 'timeFrame': 'Baseline, Cycle 1 Day 15', 'description': 'Geometric mean of ratio (Cycle1Day15/Baseline) of hypogonadism parameters (total testosterone, free testosterone, sex hormone binding globulin, luteinizing hormone, follicle stimulating hormone, dihydroepiandrosterone sulfate, estradiol and prolactin) levels in males was analyzed. Data for this outcome measure was planned to be collected for combined RP2D Cohort only, excluding arms of low and high dose escalation cohorts.'}, {'measure': 'Geometric Mean of Ratio of Total Testosterone, Free Testosterone, Sex Hormone Binding Globulin (SHBG), Luteinizing Hormone, Follicle Stimulating Hormone, Dihydroepiandrosterone Sulfate, Estradiol and Prolactin Levels in Males at Cycle 2 Day 1', 'timeFrame': 'Baseline, Cycle 2 Day 1', 'description': 'Geometric mean of ratio (Cycle 2 Day 1/Baseline) of hypogonadism parameters (total testosterone, free testosterone, sex hormone binding globulin, luteinizing hormone, follicle stimulating hormone, dihydroepiandrosterone sulfate, estradiol and prolactin) levels in males was analyzed. Data for this outcome measure was planned to be collected for combined RP2D Cohort only, excluding arms of low and high dose escalation cohorts.'}, {'measure': 'Geometric Mean of Ratio of Total Testosterone, Free Testosterone, Sex Hormone Binding Globulin (SHBG), Luteinizing Hormone, Follicle Stimulating Hormone, Dihydroepiandrosterone Sulfate, Estradiol and Prolactin Levels in Males at Cycle 4 Day 1', 'timeFrame': 'Baseline, Cycle 4 Day 1', 'description': 'Geometric mean of ratio (Cycle 4 Day 1/Baseline) of hypogonadism parameters (total testosterone, free testosterone, sex hormone binding globulin, luteinizing hormone, follicle stimulating hormone, dihydroepiandrosterone sulfate, estradiol and prolactin) levels in males was analyzed. Data for this outcome measure was planned to be collected for combined RP2D Cohort only, excluding arms of low and high dose escalation cohorts.'}, {'measure': 'Geometric Mean of Ratio of Total Testosterone, Free Testosterone, Sex Hormone Binding Globulin (SHBG), Luteinizing Hormone, Follicle Stimulating Hormone, Dihydroepiandrosterone Sulfate, Estradiol and Prolactin Levels in Males at Cycle 6 Day 1', 'timeFrame': 'Baseline, Cycle 6 Day 1', 'description': 'Geometric mean of ratio (Cycle 6 Day 1/Baseline) of hypogonadism parameters (total testosterone, free testosterone, sex hormone binding globulin, luteinizing hormone, follicle stimulating hormone, dihydroepiandrosterone sulfate, estradiol and prolactin) levels in males was analyzed. Data for this outcome measure was planned to be collected for combined RP2D Cohort only, excluding arms of low and high dose escalation cohorts.'}, {'measure': 'Geometric Mean of Ratio of Total Testosterone, Free Testosterone, Sex Hormone Binding Globulin (SHBG), Luteinizing Hormone, Follicle Stimulating Hormone, Dihydroepiandrosterone Sulfate, Estradiol and Prolactin Levels in Males at Cycle 9 Day 1', 'timeFrame': 'Baseline, Cycle 9 Day 1', 'description': 'Geometric mean of ratio (Cycle 9 Day 1/Baseline) of hypogonadism parameters (total testosterone, free testosterone, sex hormone binding globulin, luteinizing hormone, follicle stimulating hormone, dihydroepiandrosterone sulfate, estradiol and prolactin) levels in males was analyzed. Data for this outcome measure was planned to be collected for combined RP2D Cohort only, excluding arms of low and high dose escalation cohorts. 95% CI should be interpreted with cautions due to the limited sample size at this time point.'}, {'measure': 'Geometric Mean of Ratio of Total Testosterone, Free Testosterone, Sex Hormone Binding Globulin (SHBG), Luteinizing Hormone, Follicle Stimulating Hormone, Dihydroepiandrosterone Sulfate, Estradiol and Prolactin Levels in Males at Cycle 12 Day 1', 'timeFrame': 'Baseline, Cycle 12 Day 1', 'description': 'Geometric mean of ratio (Cycle 12 Day 1/Baseline) of hypogonadism parameters (total testosterone, free testosterone, sex hormone binding globulin, luteinizing hormone, follicle stimulating hormone, dihydroepiandrosterone sulfate, estradiol and prolactin) levels in males was analyzed. Data for this outcome measure was planned to be collected for combined RP2D Cohort only, excluding arms of low and high dose escalation cohorts. 95% CI should be interpreted with cautions due to the limited sample size at this time point.'}, {'measure': 'Geometric Mean of Ratio of Total Testosterone, Free Testosterone, Sex Hormone Binding Globulin (SHBG), Luteinizing Hormone, Follicle Stimulating Hormone, Dihydroepiandrosterone Sulfate, Estradiol and Prolactin Levels in Males at Cycle 15 Day 1', 'timeFrame': 'Baseline, Cycle 15 Day 1', 'description': 'Geometric mean of ratio (Cycle 15 Day 1/Baseline) of hypogonadism parameters (total testosterone, free testosterone, sex hormone binding globulin, luteinizing hormone, follicle stimulating hormone, dihydroepiandrosterone sulfate, estradiol and prolactin) levels in males was analyzed. Data for this outcome measure was planned to be collected for combined RP2D Cohort only, excluding arms of low and high dose escalation cohorts. 95% CI should be interpreted with cautions due to the limited sample size at this time point.'}, {'measure': 'Geometric Mean of Ratio of Total Testosterone, Free Testosterone, Sex Hormone Binding Globulin (SHBG), Luteinizing Hormone, Follicle Stimulating Hormone, Dihydroepiandrosterone Sulfate, Estradiol and Prolactin Levels in Males at Cycle 18 Day 1', 'timeFrame': 'Baseline, Cycle 18 Day 1', 'description': 'Geometric mean of ratio (Cycle 18 Day 1/Baseline) of hypogonadism parameters (total testosterone, free testosterone, sex hormone binding globulin, luteinizing hormone, follicle stimulating hormone, dihydroepiandrosterone sulfate, estradiol and prolactin) levels in males was analyzed. Data for this outcome measure was planned to be collected for combined RP2D Cohort only, excluding arms of low and high dose escalation cohorts. 95% CI should be interpreted with cautions due to the limited sample size at this time point.'}, {'measure': 'Geometric Mean of Ratio of Total Testosterone, Free Testosterone, Sex Hormone Binding Globulin (SHBG), Luteinizing Hormone, Follicle Stimulating Hormone, Dihydroepiandrosterone Sulfate, Estradiol and Prolactin Levels in Males at Cycle 21 Day 1', 'timeFrame': 'Baseline, Cycle 21 Day 1', 'description': 'Geometric mean of ratio (Cycle 21 Day 1/Baseline) of hypogonadism parameters (total testosterone, free testosterone, sex hormone binding globulin, luteinizing hormone, follicle stimulating hormone, dihydroepiandrosterone sulfate, estradiol and prolactin) levels in males was analyzed. Data for this outcome measure was planned to be collected for combined RP2D Cohort only, excluding arms of low and high dose escalation cohorts. 95% CI should be interpreted with cautions due to the limited sample size at this time point.'}, {'measure': 'Geometric Mean of Ratio of Total Testosterone, Free Testosterone, Sex Hormone Binding Globulin (SHBG), Luteinizing Hormone, Follicle Stimulating Hormone, Dihydroepiandrosterone Sulfate, Estradiol and Prolactin Levels in Males at Cycle 24 Day 1', 'timeFrame': 'Baseline, Cycle 24 Day 1', 'description': 'Geometric mean of ratio (Cycle 24 Day 1/Baseline) of hypogonadism parameters (total testosterone, free testosterone, sex hormone binding globulin, luteinizing hormone, follicle stimulating hormone, dihydroepiandrosterone sulfate, estradiol and prolactin) levels in males was analyzed. Data for this outcome measure was planned to be collected for combined RP2D Cohort only, excluding arms of low and high dose escalation cohorts. 95% CI should be interpreted with cautions due to the limited sample size at this time point.'}, {'measure': 'Geometric Mean of Ratio of Total Testosterone, Free Testosterone, Sex Hormone Binding Globulin (SHBG), Luteinizing Hormone, Follicle Stimulating Hormone, Dihydroepiandrosterone Sulfate, Estradiol and Prolactin Levels in Males at Cycle 27 Day 1', 'timeFrame': 'Baseline, Cycle 27 Day 1', 'description': 'Geometric mean of ratio (Cycle 27 Day 1/Baseline) of hypogonadism parameters (total testosterone, free testosterone, sex hormone binding globulin, luteinizing hormone, follicle stimulating hormone, dihydroepiandrosterone sulfate, estradiol and prolactin) levels in males was analyzed. Data for this outcome measure was planned to be collected for combined RP2D Cohort only, excluding arms of low and high dose escalation cohorts. 95% CI should be interpreted with cautions due to the limited sample size at this time point.'}, {'measure': 'Geometric Mean of Ratio of Total Testosterone, Free Testosterone, Sex Hormone Binding Globulin (SHBG), Luteinizing Hormone, Follicle Stimulating Hormone, Dihydroepiandrosterone Sulfate, Estradiol and Prolactin Levels in Males at Cycle 30 Day 1', 'timeFrame': 'Baseline, Cycle 30 Day 1', 'description': 'Geometric mean of ratio (Cycle 30 Day 1/Baseline) of hypogonadism parameters (total testosterone, free testosterone, sex hormone binding globulin, luteinizing hormone, follicle stimulating hormone, dihydroepiandrosterone sulfate, estradiol and prolactin) levels in males was analyzed. Data for this outcome measure was planned to be collected for combined RP2D Cohort only, excluding arms of low and high dose escalation cohorts. 95% CI should be interpreted with cautions due to the limited sample size at this time point.'}, {'measure': 'Geometric Mean of Ratio of Total Testosterone, Free Testosterone, Sex Hormone Binding Globulin (SHBG), Luteinizing Hormone, Follicle Stimulating Hormone, Dihydroepiandrosterone Sulfate, Estradiol and Prolactin Levels in Males at End of Treatment', 'timeFrame': 'Baseline, End of Treatment (28 days post last dose)', 'description': 'Geometric mean of ratio (End of treatment/Baseline) of hypogonadism parameters (total testosterone, free testosterone, sex hormone binding globulin, luteinizing hormone, follicle stimulating hormone, dihydroepiandrosterone sulfate, estradiol and prolactin) levels in males was analyzed. Data for this outcome measure was planned to be collected for combined RP2D Cohort only, excluding arms of low and high dose escalation cohorts. 95% CI should be interpreted with cautions due to the limited sample size at this time point.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Crizotinib', 'dose-finding', 'drug-drug interaction', 'ALK rearrangements', 'c-Met mutations or amplifications', 'c-Met dependent tumors', 'ROS1 rearrangements', 'c-Met exon 14 deletion', 'c-Met exon 14 skipping', 'c-Met exon 14 alterations'], 'conditions': ['Non-Small Cell Lung Cancer ALK-positive', 'Non-Small Cell Lung Cancer c-Met Dependent', 'Non-Small Cell Lung Cancer ROS Marker Positive', 'Systemic Anaplastic Large-Cell Lymphoma', 'Advanced Malignancies Except Leukemia']}, 'referencesModule': {'references': [{'pmid': '35510711', 'type': 'DERIVED', 'citation': 'Ng TL, Tsui DCC, Wang S, Usari T, Patil T, Wilner K, Camidge DR. Association of anticoagulant use with clinical outcomes from crizotinib in ALK- and ROS1-rearranged advanced non-small cell lung cancers: A retrospective analysis of PROFILE 1001. Cancer Med. 2022 Dec;11(23):4422-4429. doi: 10.1002/cam4.4789. Epub 2022 May 5.'}, {'pmid': '33676017', 'type': 'DERIVED', 'citation': 'Camidge DR, Otterson GA, Clark JW, Ignatius Ou SH, Weiss J, Ades S, Shapiro GI, Socinski MA, Murphy DA, Conte U, Tang Y, Wang SC, Wilner KD, Villaruz LC. Crizotinib in Patients With MET-Amplified NSCLC. J Thorac Oncol. 2021 Jun;16(6):1017-1029. doi: 10.1016/j.jtho.2021.02.010. Epub 2021 Mar 4.'}, {'pmid': '32460197', 'type': 'DERIVED', 'citation': 'Solomon BJ, Kim EE, Winter M, Monti K, Tang Y, Wilner KD, Wang S, Ou SI. Ophthalmological assessment of crizotinib in advanced non-small-cell lung cancer. Lung Cancer. 2020 Jul;145:167-172. doi: 10.1016/j.lungcan.2020.04.010. Epub 2020 Apr 28.'}, {'pmid': '31778074', 'type': 'DERIVED', 'citation': 'Clark JW, Camidge DR, Kwak EL, Maki RG, Shapiro GI, Chen I, Tan W, Randolph S, Christensen JG, Ozeck M, Tang Y, Wilner KD, Salgia R. Dose-escalation trial of the ALK, MET & ROS1 inhibitor, crizotinib, in patients with advanced cancer. Future Oncol. 2020 Jan;16(1):4289-4301. doi: 10.2217/fon-2019-0653. Epub 2019 Nov 28.'}, {'pmid': '30980071', 'type': 'DERIVED', 'citation': 'Shaw AT, Riely GJ, Bang YJ, Kim DW, Camidge DR, Solomon BJ, Varella-Garcia M, Iafrate AJ, Shapiro GI, Usari T, Wang SC, Wilner KD, Clark JW, Ou SI. Crizotinib in ROS1-rearranged advanced non-small-cell lung cancer (NSCLC): updated results, including overall survival, from PROFILE 1001. Ann Oncol. 2019 Jul 1;30(7):1121-1126. doi: 10.1093/annonc/mdz131.'}, {'pmid': '30822515', 'type': 'DERIVED', 'citation': 'Camidge DR, Kim EE, Usari T, Polli A, Lewis I, Wilner KD. Renal Effects of Crizotinib in Patients With ALK-Positive Advanced NSCLC. J Thorac Oncol. 2019 Jun;14(6):1077-1085. doi: 10.1016/j.jtho.2019.02.015. Epub 2019 Feb 26.'}, {'pmid': '28373069', 'type': 'DERIVED', 'citation': 'Yoneda KY, Scranton JR, Cadogan MA, Tassell V, Nadanaciva S, Wilner KD, Stollenwerk NS. Interstitial Lung Disease Associated With Crizotinib in Patients With Advanced Non-Small Cell Lung Cancer: Independent Review of Four PROFILE Trials. Clin Lung Cancer. 2017 Sep;18(5):472-479. doi: 10.1016/j.cllc.2017.03.004. Epub 2017 Mar 14.'}, {'pmid': '25264305', 'type': 'DERIVED', 'citation': 'Shaw AT, Ou SH, Bang YJ, Camidge DR, Solomon BJ, Salgia R, Riely GJ, Varella-Garcia M, Shapiro GI, Costa DB, Doebele RC, Le LP, Zheng Z, Tan W, Stephenson P, Shreeve SM, Tye LM, Christensen JG, Wilner KD, Clark JW, Iafrate AJ. Crizotinib in ROS1-rearranged non-small-cell lung cancer. N Engl J Med. 2014 Nov 20;371(21):1963-71. doi: 10.1056/NEJMoa1406766. Epub 2014 Sep 27.'}, {'pmid': '24128715', 'type': 'DERIVED', 'citation': 'Go H, Kim DW, Kim D, Keam B, Kim TM, Lee SH, Heo DS, Bang YJ, Chung DH. Clinicopathologic analysis of ROS1-rearranged non-small-cell lung cancer and proposal of a diagnostic algorithm. J Thorac Oncol. 2013 Nov;8(11):1445-50. doi: 10.1097/JTO.0b013e3182a4dd6e.'}, {'pmid': '23724914', 'type': 'DERIVED', 'citation': 'Awad MM, Katayama R, McTigue M, Liu W, Deng YL, Brooun A, Friboulet L, Huang D, Falk MD, Timofeevski S, Wilner KD, Lockerman EL, Khan TM, Mahmood S, Gainor JF, Digumarthy SR, Stone JR, Mino-Kenudson M, Christensen JG, Iafrate AJ, Engelman JA, Shaw AT. Acquired resistance to crizotinib from a mutation in CD74-ROS1. N Engl J Med. 2013 Jun 20;368(25):2395-401. doi: 10.1056/NEJMoa1215530. Epub 2013 Jun 1.'}, {'pmid': '22954507', 'type': 'DERIVED', 'citation': 'Camidge DR, Bang YJ, Kwak EL, Iafrate AJ, Varella-Garcia M, Fox SB, Riely GJ, Solomon B, Ou SH, Kim DW, Salgia R, Fidias P, Engelman JA, Gandhi L, Janne PA, Costa DB, Shapiro GI, Lorusso P, Ruffner K, Stephenson P, Tang Y, Wilner K, Clark JW, Shaw AT. Activity and safety of crizotinib in patients with ALK-positive non-small-cell lung cancer: updated results from a phase 1 study. Lancet Oncol. 2012 Oct;13(10):1011-9. doi: 10.1016/S1470-2045(12)70344-3. Epub 2012 Sep 4.'}, {'pmid': '22088989', 'type': 'DERIVED', 'citation': 'Ou SH, Azada M, Dy J, Stiber JA. Asymptomatic profound sinus bradycardia (heart rate </=45) in non-small cell lung cancer patients treated with crizotinib. J Thorac Oncol. 2011 Dec;6(12):2135-7. doi: 10.1097/JTO.0b013e3182307e06.'}, {'pmid': '21933749', 'type': 'DERIVED', 'citation': 'Shaw AT, Yeap BY, Solomon BJ, Riely GJ, Gainor J, Engelman JA, Shapiro GI, Costa DB, Ou SH, Butaney M, Salgia R, Maki RG, Varella-Garcia M, Doebele RC, Bang YJ, Kulig K, Selaru P, Tang Y, Wilner KD, Kwak EL, Clark JW, Iafrate AJ, Camidge DR. Effect of crizotinib on overall survival in patients with advanced non-small-cell lung cancer harbouring ALK gene rearrangement: a retrospective analysis. Lancet Oncol. 2011 Oct;12(11):1004-12. doi: 10.1016/S1470-2045(11)70232-7. Epub 2011 Sep 18.'}, {'pmid': '21767331', 'type': 'DERIVED', 'citation': 'Kijima T, Takeuchi K, Tetsumoto S, Shimada K, Takahashi R, Hirata H, Nagatomo I, Hoshino S, Takeda Y, Kida H, Goya S, Tachibana I, Kawase I. Favorable response to crizotinib in three patients with echinoderm microtubule-associated protein-like 4-anaplastic lymphoma kinase fusion-type oncogene-positive non-small cell lung cancer. Cancer Sci. 2011 Aug;102(8):1602-4. doi: 10.1111/j.1349-7006.2011.01970.x.'}, {'pmid': '21623265', 'type': 'DERIVED', 'citation': 'Ou SH, Kwak EL, Siwak-Tapp C, Dy J, Bergethon K, Clark JW, Camidge DR, Solomon BJ, Maki RG, Bang YJ, Kim DW, Christensen J, Tan W, Wilner KD, Salgia R, Iafrate AJ. Activity of crizotinib (PF02341066), a dual mesenchymal-epithelial transition (MET) and anaplastic lymphoma kinase (ALK) inhibitor, in a non-small cell lung cancer patient with de novo MET amplification. J Thorac Oncol. 2011 May;6(5):942-6. doi: 10.1097/JTO.0b013e31821528d3.'}, {'pmid': '21422405', 'type': 'DERIVED', 'citation': 'Costa DB, Kobayashi S, Pandya SS, Yeo WL, Shen Z, Tan W, Wilner KD. CSF concentration of the anaplastic lymphoma kinase inhibitor crizotinib. J Clin Oncol. 2011 May 20;29(15):e443-5. doi: 10.1200/JCO.2010.34.1313. Epub 2011 Mar 21. No abstract available.'}, {'pmid': '20979472', 'type': 'DERIVED', 'citation': "Butrynski JE, D'Adamo DR, Hornick JL, Dal Cin P, Antonescu CR, Jhanwar SC, Ladanyi M, Capelletti M, Rodig SJ, Ramaiya N, Kwak EL, Clark JW, Wilner KD, Christensen JG, Janne PA, Maki RG, Demetri GD, Shapiro GI. Crizotinib in ALK-rearranged inflammatory myofibroblastic tumor. N Engl J Med. 2010 Oct 28;363(18):1727-33. doi: 10.1056/NEJMoa1007056."}, {'pmid': '20979469', 'type': 'DERIVED', 'citation': 'Kwak EL, Bang YJ, Camidge DR, Shaw AT, Solomon B, Maki RG, Ou SH, Dezube BJ, Janne PA, Costa DB, Varella-Garcia M, Kim WH, Lynch TJ, Fidias P, Stubbs H, Engelman JA, Sequist LV, Tan W, Gandhi L, Mino-Kenudson M, Wei GC, Shreeve SM, Ratain MJ, Settleman J, Christensen JG, Haber DA, Wilner K, Salgia R, Shapiro GI, Clark JW, Iafrate AJ. Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N Engl J Med. 2010 Oct 28;363(18):1693-703. doi: 10.1056/NEJMoa1006448.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8081001&StudyName=A%20Study%20Of%20Oral%20PF-02341066%2C%20A%20c-Met/Hepatocyte%20Growth%20Factor%20Tyrosine%20Kinase%20Inhibitor%2C%20In%20Patients%20With%20Advanced%20Cancer', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'PF-02341066 may work in cancer by blocking the cell growth, migration and invasion of tumor cells. PF-02341066 is a new class of drugs called c-Met/Hepatocyte growth factor receptor tyrosine kinase inhibitors. This compound is also an inhibitor of the anaplastic lymphoma kinase (called ALK) tyrosine kinase and ROS receptor tyrosine kinases. This research study is the first time PF-02341066 will be given to people. PF-02341066 is taken by mouth daily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced malignancies (except leukemias), histologically proven at diagnosis; Histologically confirmed advanced malignancies that are known to be sensitive to PF-03241066 inhibition, e.g. ALK, c-MET and ROS\n* Solid tumors must have measurable disease (Recommended Phase 2 Dose Cohort patients with non-measurable disease may enter on a case-by-case basis); not required for DDI sub-studies.\n* Adequate blood cell counts, kidney function, liver function and Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 (for the Recommended Phase 2 Cohort, a ECOG score of 2 may be allowed on a case-by-case basis)\n\nExclusion Criteria:\n\n* Major surgery, radiation therapy or anti-cancer therapy within 2 to 4 weeks of starting study treatment, depending on the patient cohort\n* Prior stem cell transplant except of patients with neuroblastoma, lymphoma or myeloma\n* Active or unstable cardiac disease or heart attack within 3 months of starting study treatment'}, 'identificationModule': {'nctId': 'NCT00585195', 'acronym': 'PROFILE 1001', 'briefTitle': 'A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'PHASE 1 SAFETY, PHARMACOKINETIC AND PHARMACODYNAMIC STUDY OF PF-02341066, A MET/HGFR SELECTIVE TYROSINE KINASE INHIBITOR, ADMINISTERED ORALLY TO PATIENTS WITH ADVANCED CANCER', 'orgStudyIdInfo': {'id': 'A8081001'}, 'secondaryIdInfos': [{'id': 'PROFILE 1001', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: PF-02341066', 'Drug: Rifampin', 'Drug: Itraconazole']}], 'interventions': [{'name': 'PF-02341066', 'type': 'DRUG', 'description': 'Escalating doses of PF-02341066 will be administered orally on a continuous dosing schedule. Doses to be evaluated will range from 50 mg to 2000 mg/day administered either once or twice a day. A treatment cycle is considered to be 28 days (or 21 days depending on the cohort).', 'armGroupLabels': ['1']}, {'name': 'Rifampin', 'type': 'DRUG', 'description': '600 mg QD administered from Cycle 1, Day 16 to Cycle 2, Day 1 (14 days of dosing) in combination with PF-02341066.', 'armGroupLabels': ['1']}, {'name': 'Itraconazole', 'type': 'DRUG', 'description': 'Multiple Dose Design: 200 mg QD administered from Cycle 1, Day 1 to Cycle 1, Day 16 (16 days) in combination with PF-02341066.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868-3201', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Irvine Medical Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital/ Anschutz Cancer Pavilion', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Ophthalmic Consultants of Boston Inc.', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel 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'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center: Breast and Imaging Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599-7600', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Hospitals', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The James Cancer Hospital and Solove Research Institute', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43212', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State Eye and Ear Institute', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43221', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Martha Morehouse Medical Plaza', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Hillman Cancer Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Henry-Joyce Cancer Clinic', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Eye Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'The University of Vermont Medical Center', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': '05405', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'The University of Vermont Cancer Center', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': '3000', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Centre', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '464-8681', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Aichi cancer center central hospital', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '673-8558', 'city': 'Akashi', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Hyogo Cancer Center', 'geoPoint': {'lat': 34.65524, 'lon': 135.00687}}, {'zip': '589-8511', 'city': 'Sayama', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Kindai University Hospital', 'geoPoint': {'lat': 34.51685, 'lon': 135.56298}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}