Viewing Study NCT01283516

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Ignite Creation Date: 2025-12-26 @ 11:50 AM
Ignite Modification Date: 2025-12-26 @ 11:50 AM
Study NCT ID: NCT01283516
Status: COMPLETED
Last Update Posted: 2019-03-15
First Post: 2011-01-24
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: A Dose Escalation/Expansion Study of LDK378 in Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Ireland', 'New Zealand']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C586847', 'term': 'ceritinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), at least 30 days following the last dose of study treatment . All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.', 'eventGroups': [{'id': 'EG000', 'title': 'LDK378 50 mg', 'description': 'Participants receiving 50 mg of LDK378', 'otherNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'LDK378 100 mg', 'description': 'Participants receiving 100 mg of LDK378', 'otherNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'LDK378 200 mg', 'description': 'Participants receiving 200 mg of LDK378', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'LDK378 300 mg', 'description': 'Participants receiving 300 mg of LDK378', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'LDK378 400 mg', 'description': 'Participants receiving 400 mg of LDK378', 'otherNumAtRisk': 14, 'otherNumAffected': 14, 'seriousNumAtRisk': 14, 'seriousNumAffected': 7}, {'id': 'EG005', 'title': 'LDK378 500 mg', 'description': 'Participants receiving 500 mg of LDK378', 'otherNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'seriousNumAffected': 4}, {'id': 'EG006', 'title': 'LDK378 600 mg', 'description': 'Participants receiving 600 mg of LDK378', 'otherNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'seriousNumAffected': 7}, {'id': 'EG007', 'title': 'LDK378 700 mg', 'description': 'Participants receiving 700 mg of LDK378', 'otherNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'seriousNumAffected': 3}, {'id': 'EG008', 'title': 'LDK378 750 mg', 'description': 'Participants receiving 750 mg of LDK378.', 'otherNumAtRisk': 255, 'otherNumAffected': 254, 'seriousNumAtRisk': 255, 'seriousNumAffected': 145}, {'id': 'EG009', 'title': 'All Participants', 'description': 'All participants enrolled in the study', 'otherNumAtRisk': 304, 'otherNumAffected': 303, 'seriousNumAtRisk': 304, 'seriousNumAffected': 169}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 255, 'numAffected': 32}, {'groupId': 'EG009', 'numAtRisk': 304, 'numAffected': 40}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 255, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 304, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 255, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 304, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 304, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 255, 'numAffected': 5}, {'groupId': 'EG009', 'numAtRisk': 304, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Sinus Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 255, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 304, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Sinus Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 304, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 255, 'numAffected': 6}, {'groupId': 'EG009', 'numAtRisk': 304, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 255, 'numAffected': 7}, {'groupId': 'EG009', 'numAtRisk': 304, 'numAffected': 8}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 255, 'numAffected': 7}, {'groupId': 'EG009', 'numAtRisk': 304, 'numAffected': 8}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Blepharospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 255, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 304, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 255, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 304, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Eyelid Ptosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 304, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Photopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 255, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 304, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Visual Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 255, 'numAffected': 17}, {'groupId': 'EG009', 'numAtRisk': 304, 'numAffected': 17}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Vitreous Floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 304, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 255, 'numAffected': 18}, {'groupId': 'EG009', 'numAtRisk': 304, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 255, 'numAffected': 9}, {'groupId': 'EG009', 'numAtRisk': 304, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 255, 'numAffected': 102}, {'groupId': 'EG009', 'numAtRisk': 304, 'numAffected': 111}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Abdominal Pain Lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 255, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 304, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 255, 'numAffected': 64}, {'groupId': 'EG009', 'numAtRisk': 304, 'numAffected': 68}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 255, 'numAffected': 2}, 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'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 255, 'numAffected': 9}, {'groupId': 'EG009', 'numAtRisk': 304, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 255, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 304, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 255, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 304, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Respiratory Distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 304, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 255, 'numAffected': 6}, {'groupId': 'EG009', 'numAtRisk': 304, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 255, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 304, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 304, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 304, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 304, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Dose Limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'LDK378 50 mg', 'description': 'Participants receiving 50 mg of LDK378'}, {'id': 'OG001', 'title': 'LDK378 100 mg', 'description': 'Participants receiving 100 mg of LDK378'}, {'id': 'OG002', 'title': 'LDK378 200 mg', 'description': 'Participants receiving 200 mg of LDK378'}, {'id': 'OG003', 'title': 'LDK378 300 mg', 'description': 'Participants receiving 300 mg of LDK378'}, {'id': 'OG004', 'title': 'LDK378 400 mg', 'description': 'Participants receiving 400 mg of LDK378'}, {'id': 'OG005', 'title': 'LDK378 500 mg', 'description': 'Participants receiving 500 mg of LDK378'}, {'id': 'OG006', 'title': 'LDK378 600 mg', 'description': 'Participants receiving 600 mg of LDK378'}, {'id': 'OG007', 'title': 'LDK378 700 mg', 'description': 'Participants receiving 700 mg of LDK378'}, {'id': 'OG008', 'title': 'LDK378 750 mg', 'description': 'Participants receiving 750 mg of LDK378.'}], 'classes': [{'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Alanine Aminotransferase Increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Transaminases Increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Dehydration', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Hypophosphataemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '33 months', 'description': 'The maximum tolerated dose (MTD) was defined as the highest dose for a given schedule that was expected to cause DLTs in no more than 33% of patients during the first cycle of treatment. A patient with multiple occurrences of a DLT under one treatment is counted only once in the AE category for that treatment. MTD was determined at 750mg.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Dose-determining Set (DDS) consists of all patients (NSCLC and non-NSCLC) from the safety set who either meet the minimum exposure criterion and have sufficient safety evaluations or have experienced a dose limiting toxicity (DLT) during Cycle 1 (including the PK run-in period). This constitutes all evaluable patients for the determination of MTD.'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR) Based on Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '246', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NSCLC With Prior ALKi (Arms 1A + 1B)', 'description': 'Patients with ALK-translocated NSCLC who were previously treated with an ALK inhibitor.'}, {'id': 'OG001', 'title': 'NSCLC ALKi Naive (Arm 2)', 'description': 'Patients with ALK-translocated NSCLC not previously treated with an ALK inhibitor.'}, {'id': 'OG002', 'title': 'All NSCLC', 'description': 'all NSCLC patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.4', 'groupId': 'OG000', 'lowerLimit': '48.5', 'upperLimit': '64.2'}, {'value': '73.5', 'groupId': 'OG001', 'lowerLimit': '62.7', 'upperLimit': '82.6'}, {'value': '62.2', 'groupId': 'OG002', 'lowerLimit': '55.8', 'upperLimit': '68.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '275 weeks', 'description': 'Overall response rate (ORR) was defined as the percentage of participants with a best overall complete response (CR) or partial response (PR) per RECIST 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI. Both CR and PR had to be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. CR was the disappearance of all target lesions. PR was at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. Both CR and PR had to be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. CR = at least two determinations of CR, at least 4 weeks apart before progression. PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR).', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - NSCLC: Subset of Full Analysis Set including ALK-positive NSCLC patients who received at least one dose of LDK378 in the 750 mg dose group.'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate Based on Blinded Independent Review Committee (BIRC) Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '246', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NSCLC With Prior ALKi (Arms 1A + 1B)', 'description': 'Patients with ALK-translocated NSCLC who were previously treated with an ALK inhibitor.'}, {'id': 'OG001', 'title': 'NSCLC ALKi Naive (Arm 2)', 'description': 'Patients with ALK-translocated NSCLC not previously treated with an ALK inhibitor.'}, {'id': 'OG002', 'title': 'All NCSLC', 'description': 'all NSCLC patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.1', 'groupId': 'OG000', 'lowerLimit': '41.2', 'upperLimit': '57.0'}, {'value': '65.1', 'groupId': 'OG001', 'lowerLimit': '53.8', 'upperLimit': '75.2'}, {'value': '54.5', 'groupId': 'OG002', 'lowerLimit': '48.0', 'upperLimit': '60.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '275 weeks', 'description': 'Overall response rate (ORR) was defined as the percentage of participants with a best overall complete response (CR) or partial response (PR) per RECIST 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI, CR was the disappearance of all target lesions. PR was at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. Both CR and PR had to be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. CR = at least two determinations of CR, at least 4 weeks apart before progression. PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - NSCLC: Subset of Full Analysis Set including ALK-positive NSCLC patients who received at least one dose of LDK378 in the 750 mg dose group.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) Based on Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NSCLC With Prior ALKi (Arms 1A + 1B)', 'description': 'Patients with ALK-translocated NSCLC who were previously treated with an ALK inhibitor.'}, {'id': 'OG001', 'title': 'NSCLC ALKi Naive (Arm 2)', 'description': 'Patients with ALK-translocated NSCLC not previously treated with an ALK inhibitor.'}, {'id': 'OG002', 'title': 'All NSCLC', 'description': 'all NSCLC patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.25', 'groupId': 'OG000', 'lowerLimit': '6.80', 'upperLimit': '9.69'}, {'value': '14.19', 'groupId': 'OG001', 'lowerLimit': '11.27', 'upperLimit': '22.11'}, {'value': '10.12', 'groupId': 'OG002', 'lowerLimit': '8.31', 'upperLimit': '11.63'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '275 weeks', 'description': 'Duration of response (DOR) was defined as the time from first documented response (partial response (PR) or complete response (CR)) to the date of first documented disease progression (PD) or death due to any cause, among patients with a confirmed PR or CR per RECIST 1.0.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - NSCLC: Subset of Full Analysis Set including ALK-positive NSCLC patients who received at least one dose of LDK378 in the 750 mg dose group and had a confirmed overall complete response or partial response after initiation of LDK378.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) Based on BIRC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NSCLC With Prior ALKi (Arms 1A + 1B)', 'description': 'Patients with ALK-translocated NSCLC who were previously treated with an ALK inhibitor.'}, {'id': 'OG001', 'title': 'NSCLC ALKi Naive (Arm 2)', 'description': 'Patients with ALK-translocated NSCLC not previously treated with an ALK inhibitor.'}, {'id': 'OG002', 'title': 'All NSCLC', 'description': 'all NSCLC patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.31', 'groupId': 'OG000', 'lowerLimit': '5.98', 'upperLimit': '12.42'}, {'value': '21.75', 'groupId': 'OG001', 'lowerLimit': '14.06', 'upperLimit': '31.11'}, {'value': '12.45', 'groupId': 'OG002', 'lowerLimit': '8.77', 'upperLimit': '16.56'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '275 weeks', 'description': 'Duration of response (DOR) was defined as the time from first documented response (partial response (PR) or complete response (CR)) to the date of first documented disease progression (PD) or death due to any cause, among patients with a confirmed PR or CR per RECIST 1.0.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - NSCLC: Subset of Full Analysis Set including ALK-positive NSCLC patients who received at least one dose of LDK378 in the 750 mg dose group and had a confirmed overall complete response or partial response after initiation of LDK378.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival Based on Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '246', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NSCLC With Prior ALKi (Arms 1A + 1B)', 'description': 'Patients with ALK-translocated NSCLC who were previously treated with an ALK inhibitor.'}, {'id': 'OG001', 'title': 'NSCLC ALKi Naive (Arm 2)', 'description': 'Patients with ALK-translocated NSCLC not previously treated with an ALK inhibitor.'}, {'id': 'OG002', 'title': 'All NSCLC', 'description': 'all NSCLC patients'}], 'classes': [{'categories': [{'measurements': [{'value': '6.93', 'groupId': 'OG000', 'lowerLimit': '5.55', 'upperLimit': '8.48'}, {'value': '15.21', 'groupId': 'OG001', 'lowerLimit': '12.12', 'upperLimit': '19.48'}, {'value': '8.74', 'groupId': 'OG002', 'lowerLimit': '6.93', 'upperLimit': '10.97'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '275 weeks', 'description': 'Progression-free survival (PFS) was defined as the time from the start date of study drug to the date of the first radiologically documented progressive disease (PD) per RECIST 1.0. or death due to any cause.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - NSCLC: Subset of Full Analysis Set including ALK-positive NSCLC patients who received at least one dose of LDK378 in the 750 mg dose group.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival Based on BIRC Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '246', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NSCLC With Prior ALKi (Arms 1A + 1B)', 'description': 'Patients with ALK-translocated NSCLC who were previously treated with an ALK inhibitor.'}, {'id': 'OG001', 'title': 'NSCLC ALKi Naive (Arm 2)', 'description': 'Patients with ALK-translocated NSCLC not previously treated with an ALK inhibitor'}, {'id': 'OG002', 'title': 'ALL NSCLC', 'description': 'all NSCLC patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.97', 'groupId': 'OG000', 'lowerLimit': '5.55', 'upperLimit': '8.57'}, {'value': '19.32', 'groupId': 'OG001', 'lowerLimit': '11.99', 'upperLimit': '29.01'}, {'value': '9.53', 'groupId': 'OG002', 'lowerLimit': '7.00', 'upperLimit': '11.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '275 weeks', 'description': 'Progression-free survival (PFS) was defined as the time from the start date of study drug to the date of the first radiologically documented progressive disease (PD) per RECIST 1.0. or death due to any cause.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - NSCLC: Subset of Full Analysis Set including ALK-positive NSCLC patients who received at least one dose of LDK378 in the 750 mg dose group.'}, {'type': 'SECONDARY', 'title': 'Primary Pharmacokinetics (PK) Parameter: AUC0-last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '252', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'LDK378 50 mg', 'description': 'Participants receiving 50 mg of LDK378'}, {'id': 'OG001', 'title': 'LDK378 100 mg', 'description': 'Participants receiving 100 mg of LDK378'}, {'id': 'OG002', 'title': 'LDK378 200 mg', 'description': 'Participants receiving 200 mg of LDK378'}, {'id': 'OG003', 'title': 'LDK378 300 mg', 'description': 'Participants receiving 300 mg of LDK378'}, {'id': 'OG004', 'title': 'LDK378 400 mg', 'description': 'Participants receiving 400 mg of LDK378'}, {'id': 'OG005', 'title': 'LDK378 500 mg', 'description': 'Participants receiving 500 mg of LDK378'}, {'id': 'OG006', 'title': 'LDK378 600 mg', 'description': 'Participants receiving 600 mg of LDK378'}, {'id': 'OG007', 'title': 'LDK378 700 mg', 'description': 'Participants receiving 700 mg of LDK378'}, {'id': 'OG008', 'title': 'LDK378 750 mg', 'description': 'Participants receiving 750 mg of LDK378.'}], 'classes': [{'categories': [{'measurements': [{'value': '366', 'spread': 'NA', 'comment': 'N/A = not estimable', 'groupId': 'OG000'}, {'value': '938', 'spread': '24.3', 'groupId': 'OG001'}, {'value': '1460', 'spread': '62.9', 'groupId': 'OG002'}, {'value': '7470', 'spread': '46.5', 'groupId': 'OG003'}, {'value': '4070', 'spread': '81.8', 'groupId': 'OG004'}, {'value': '5140', 'spread': '141.7', 'groupId': 'OG005'}, {'value': '8180', 'spread': '57.4', 'groupId': 'OG006'}, {'value': '9210', 'spread': '111.7', 'groupId': 'OG007'}, {'value': '7870', 'spread': '127.3', 'groupId': 'OG008'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'PK run-in of Dose Escalation phase', 'description': 'The AUC from time zero to the last quantifiable concentration point (Tlast). Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set (PAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least 1 dose of LDK378 \\& had at least 1 evaluable PK sample'}, {'type': 'SECONDARY', 'title': 'Primary Pharmacokinetics (PK) Parameter: AUC0-24h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '252', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'LDK378 50 mg', 'description': 'Participants receiving 50 mg of LDK378'}, {'id': 'OG001', 'title': 'LDK378 100 mg', 'description': 'Participants receiving 100 mg of LDK378'}, {'id': 'OG002', 'title': 'LDK378 200 mg', 'description': 'Participants receiving 200 mg of LDK378'}, {'id': 'OG003', 'title': 'LDK378 300 mg', 'description': 'Participants receiving 300 mg of LDK378'}, {'id': 'OG004', 'title': 'LDK378 400 mg', 'description': 'Participants receiving 400 mg of LDK378'}, {'id': 'OG005', 'title': 'LDK378 500 mg', 'description': 'Participants receiving 500 mg of LDK378'}, {'id': 'OG006', 'title': 'LDK378 600 mg', 'description': 'Participants receiving 600 mg of LDK378'}, {'id': 'OG007', 'title': 'LDK378 700 mg', 'description': 'Participants receiving 700 mg of LDK378'}, {'id': 'OG008', 'title': 'LDK378 750 mg', 'description': 'Participants receiving 750 mg of LDK378.'}], 'classes': [{'title': 'PK Run-in dose escalation phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '226', 'spread': 'NA', 'comment': 'N/A = not estimable', 'groupId': 'OG000'}, {'value': '467', 'spread': '10.7', 'groupId': 'OG001'}, {'value': '703', 'spread': '55.6', 'groupId': 'OG002'}, {'value': '3440', 'spread': '44.7', 'groupId': 'OG003'}, {'value': '1920', 'spread': '78.0', 'groupId': 'OG004'}, {'value': '2350', 'spread': '87.9', 'groupId': 'OG005'}, {'value': '3590', 'spread': '53.4', 'groupId': 'OG006'}, {'value': '3450', 'spread': '137.9', 'groupId': 'OG007'}, {'value': '3390', 'spread': '121.4', 'groupId': 'OG008'}]}]}, {'title': 'C1D8: dose escalation phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '435', 'spread': '42.1', 'groupId': 'OG000'}, {'value': '1520', 'spread': '41.1', 'groupId': 'OG001'}, {'value': '4150', 'spread': '32.2', 'groupId': 'OG002'}, {'value': '7660', 'spread': '402.8', 'groupId': 'OG003'}, {'value': '7680', 'spread': '77.4', 'groupId': 'OG004'}, {'value': '12300', 'spread': '37.4', 'groupId': 'OG005'}, {'value': '14700', 'spread': '71.7', 'groupId': 'OG006'}, {'value': '35200', 'spread': '0.800', 'groupId': 'OG007'}, {'value': '13900', 'spread': '74.8', 'groupId': 'OG008'}]}]}, {'title': 'C1D1 dose escalation phase for 750mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '73', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '3340', 'spread': '111.9', 'groupId': 'OG008'}]}]}, {'title': 'C2D1 dose escalation & expansion phases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '23', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '376', 'spread': 'NA', 'comment': 'N/A = not estimable', 'groupId': 'OG000'}, {'value': '894', 'spread': 'NA', 'comment': 'N/A = not estimable', 'groupId': 'OG001'}, {'value': '22600', 'spread': '37.1', 'groupId': 'OG008'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'PK run-in of dose escalation phase, Cycle 1 Day 8 of dose escalation phase, Cycle 1, Day 1 of dose escalation phase, Cycle 2 Day 1 of dose escalation & dose expansion phases', 'description': 'Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. AUC0 - 24 is the AUC calculated to 24 hour. Cycle 1 Day 1 = C1D1; Cycle 1 Day 8 = C1D8; Cycle 2 Day 1 = C2D1. However, there was no PK sampling during C1D1 and C2D1 except for 750 mg dose to compute PK parameter AUC0-24.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set (PAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least 1 dose of LDK378 \\& had at least 1 evaluable PK sample'}, {'type': 'SECONDARY', 'title': 'Primary Pharmacokinetics (PK) Parameter: Tmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '252', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'LDK378 50 mg', 'description': 'Participants receiving 50 mg of LDK378'}, {'id': 'OG001', 'title': 'LDK378 100 mg', 'description': 'Participants receiving 100 mg of LDK378'}, {'id': 'OG002', 'title': 'LDK378 200 mg', 'description': 'Participants receiving 200 mg of LDK378'}, {'id': 'OG003', 'title': 'LDK378 300 mg', 'description': 'Participants receiving 300 mg of LDK378'}, {'id': 'OG004', 'title': 'LDK378 400 mg', 'description': 'Participants receiving 400 mg of LDK378'}, {'id': 'OG005', 'title': 'LDK378 500 mg', 'description': 'Participants receiving 500 mg of LDK378'}, {'id': 'OG006', 'title': 'LDK378 600 mg', 'description': 'Participants receiving 600 mg of LDK378'}, {'id': 'OG007', 'title': 'LDK378 700 mg', 'description': 'Participants receiving 700 mg of LDK378'}, {'id': 'OG008', 'title': 'LDK378 750 mg', 'description': 'Participants receiving 750 mg of LDK378.'}], 'classes': [{'title': 'PK run-in dose escalation phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '5.95', 'groupId': 'OG000', 'lowerLimit': '5.95', 'upperLimit': '5.95'}, {'value': '15.0', 'groupId': 'OG001', 'lowerLimit': '6.00', 'upperLimit': '24.0'}, {'value': '5.08', 'groupId': 'OG002', 'lowerLimit': '4.17', 'upperLimit': '6.00'}, {'value': '4.00', 'groupId': 'OG003', 'lowerLimit': '4.00', 'upperLimit': '5.95'}, {'value': '4.99', 'groupId': 'OG004', 'lowerLimit': '2.97', 'upperLimit': '6.73'}, {'value': '3.98', 'groupId': 'OG005', 'lowerLimit': '3.00', 'upperLimit': '23.5'}, {'value': '6.00', 'groupId': 'OG006', 'lowerLimit': '3.00', 'upperLimit': '24.1'}, {'value': '6.00', 'groupId': 'OG007', 'lowerLimit': '4.00', 'upperLimit': '25.0'}, {'value': '6.02', 'groupId': 'OG008', 'lowerLimit': '3.95', 'upperLimit': '23.8'}]}]}, {'title': 'C1D8 dose escalation phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '2.46', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '2.92'}, {'value': '3.49', 'groupId': 'OG001', 'lowerLimit': '3.00', 'upperLimit': '3.98'}, {'value': '3.00', 'groupId': 'OG002', 'lowerLimit': '2.98', 'upperLimit': '7.95'}, {'value': '4.00', 'groupId': 'OG003', 'lowerLimit': '3.00', 'upperLimit': '7.18'}, {'value': '6.08', 'groupId': 'OG004', 'lowerLimit': '2.98', 'upperLimit': '24.0'}, {'value': '3.95', 'groupId': 'OG005', 'lowerLimit': '1.93', 'upperLimit': '6.00'}, {'value': '4.00', 'groupId': 'OG006', 'lowerLimit': '0.00', 'upperLimit': '23.6'}, {'value': '5.97', 'groupId': 'OG007', 'lowerLimit': '2.00', 'upperLimit': '24.0'}, {'value': '5.03', 'groupId': 'OG008', 'lowerLimit': '3.00', 'upperLimit': '7.95'}]}]}, {'title': 'C1D1 dose escalation phase for 750mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '208', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '6.00', 'groupId': 'OG008', 'lowerLimit': '1.13', 'upperLimit': '24.0'}]}]}, {'title': 'C2D1 dose escalation & dose expansion phases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '133', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '6.00'}, {'value': '2.08', 'groupId': 'OG001', 'lowerLimit': '2.08', 'upperLimit': '2.08'}, {'value': '8.00', 'groupId': 'OG002', 'lowerLimit': '4.00', 'upperLimit': '23.9'}, {'value': '6.00', 'groupId': 'OG008', 'lowerLimit': '0.00', 'upperLimit': '22.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'PK run-in of dose escalation phase, Cycle 1 Day 8 of dose escalation phase, Cycle 1, Day 1 of dose escalation phase, Cycle 2 Day 1 of dose escalation & dose expansion phases', 'description': 'Tmax is the time to reach Cmax. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. Cycle 1 Day 1 = C1D1; Cycle 1 Day 8 = C1D8; Cycle 2 Day 1 = C2D1. However, there was no PK sampling during C1D1 and C2D1 except for 750 mg dose to compute PK parameter Tmax.', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set (PAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least 1 dose of LDK378 \\& had at least 1 evaluable PK sample'}, {'type': 'SECONDARY', 'title': 'Primary Pharmacokinetics (PK) Parameter: Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '252', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'LDK378 50 mg', 'description': 'Participants receiving 50 mg of LDK378'}, {'id': 'OG001', 'title': 'LDK378 100 mg', 'description': 'Participants receiving 100 mg of LDK378'}, {'id': 'OG002', 'title': 'LDK378 200 mg', 'description': 'Participants receiving 200 mg of LDK378'}, {'id': 'OG003', 'title': 'LDK378 300 mg', 'description': 'Participants receiving 300 mg of LDK378'}, {'id': 'OG004', 'title': 'LDK378 400 mg', 'description': 'Participants receiving 400 mg of LDK378'}, {'id': 'OG005', 'title': 'LDK378 500 mg', 'description': 'Participants receiving 500 mg of LDK378'}, {'id': 'OG006', 'title': 'LDK378 600 mg', 'description': 'Participants receiving 600 mg of LDK378'}, {'id': 'OG007', 'title': 'LDK378 700 mg', 'description': 'Participants receiving 700 mg of LDK378'}, {'id': 'OG008', 'title': 'LDK378 750 mg', 'description': 'Participants receiving 750 mg of LDK378.'}], 'classes': [{'title': 'PK Run-in dose escalation phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '13.1', 'spread': 'NA', 'comment': 'N/A = not estimable', 'groupId': 'OG000'}, {'value': '29.3', 'spread': '10.1', 'groupId': 'OG001'}, {'value': '40.2', 'spread': '88.5', 'groupId': 'OG002'}, {'value': '198', 'spread': '41.5', 'groupId': 'OG003'}, {'value': '120', 'spread': '80.9', 'groupId': 'OG004'}, {'value': '153', 'spread': '86.5', 'groupId': 'OG005'}, {'value': '212', 'spread': '59.7', 'groupId': 'OG006'}, {'value': '206', 'spread': '145.6', 'groupId': 'OG007'}, {'value': '186', 'spread': '126.9', 'groupId': 'OG008'}]}]}, {'title': 'C1D8 dose escalation phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '25.1', 'spread': '37.5', 'groupId': 'OG000'}, {'value': '76.7', 'spread': '20.9', 'groupId': 'OG001'}, {'value': '212', 'spread': '18.0', 'groupId': 'OG002'}, {'value': '381', 'spread': '167.5', 'groupId': 'OG003'}, {'value': '419', 'spread': '69.7', 'groupId': 'OG004'}, {'value': '641', 'spread': '40.0', 'groupId': 'OG005'}, {'value': '688', 'spread': '68.3', 'groupId': 'OG006'}, {'value': '1140', 'spread': '37.7', 'groupId': 'OG007'}, {'value': '674', 'spread': '76.2', 'groupId': 'OG008'}]}]}, {'title': 'C1D1 dose escalation phase for 750mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '208', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '203', 'spread': '100.9', 'groupId': 'OG008'}]}]}, {'title': 'C2D1 dose escalation & dose expansion phases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '133', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '21.9', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '53.5', 'spread': 'NA', 'comment': 'N/A = not estimable', 'groupId': 'OG001'}, {'value': '229', 'spread': '120.7', 'groupId': 'OG002'}, {'value': '1010', 'spread': '44.8', 'groupId': 'OG008'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'PK run-in of dose escalation phase, Cycle 1 Day 8 of dose escalation phase, Cycle 1, Day 1 of dose escalation ion phase, Cycle 2 Day 1 of dose escalation & expansion phases', 'description': 'Cmax is the maximum observed concentration. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. However, there was no PK sampling during C1D1 and C2D1 except for 750 mg dose to compute PK parameter Cmax.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set (PAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least 1 dose of LDK378 \\& had at least 1 evaluable PK sample'}, {'type': 'SECONDARY', 'title': 'Secondary Pharmacokinetics (PK) Parameter: T1/2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'LDK378 50 mg', 'description': 'Participants receiving 50 mg of LDK378'}, {'id': 'OG001', 'title': 'LDK378 100 mg', 'description': 'Participants receiving 100 mg of LDK378'}, {'id': 'OG002', 'title': 'LDK378 200 mg', 'description': 'Participants receiving 200 mg of LDK378'}, {'id': 'OG003', 'title': 'LDK378 300 mg', 'description': 'Participants receiving 300 mg of LDK378'}, {'id': 'OG004', 'title': 'LDK378 400 mg', 'description': 'Participants receiving 400 mg of LDK378'}, {'id': 'OG005', 'title': 'LDK378 500 mg', 'description': 'Participants receiving 500 mg of LDK378'}, {'id': 'OG006', 'title': 'LDK378 600 mg', 'description': 'Participants receiving 600 mg of LDK378'}, {'id': 'OG007', 'title': 'LDK378 700 mg', 'description': 'Participants receiving 700 mg of LDK378'}, {'id': 'OG008', 'title': 'LDK378 750 mg', 'description': 'Participants receiving 750 mg of LDK378.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.5', 'spread': 'NA', 'comment': 'N/A = not estimable', 'groupId': 'OG000'}, {'value': '19.4', 'spread': 'NA', 'comment': 'N/A = not estimable', 'groupId': 'OG001'}, {'value': '33.2', 'spread': 'NA', 'comment': 'N/A = not estimable', 'groupId': 'OG002'}, {'value': '30.1', 'spread': '10.0', 'groupId': 'OG003'}, {'value': '30.7', 'spread': '39.1', 'groupId': 'OG004'}, {'value': '31.1', 'spread': '11.1', 'groupId': 'OG005'}, {'value': '37.6', 'spread': '24.6', 'groupId': 'OG006'}, {'value': '38.9', 'spread': '98.4', 'groupId': 'OG007'}, {'value': '40.6', 'spread': '34.7', 'groupId': 'OG008'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'PK Run-in dose escalation phase', 'description': 'T1/2 is the elimination half-life associated with the terminal slope (λz) of a semi logarithmic concentration-time curve (time). Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378.', 'unitOfMeasure': 'hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set (PAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least 1 dose of LDK378 \\& had at least 1 evaluable PK sample'}, {'type': 'SECONDARY', 'title': 'Secondary Pharmacokinetics (PK) Parameter: CL/F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'LDK378 50 mg', 'description': 'Participants receiving 50 mg of LDK378'}, {'id': 'OG001', 'title': 'LDK378 100 mg', 'description': 'Participants receiving 100 mg of LDK378'}, {'id': 'OG002', 'title': 'LDK378 200 mg', 'description': 'Participants receiving 200 mg of LDK378'}, {'id': 'OG003', 'title': 'LDK378 300 mg', 'description': 'Participants receiving 300 mg of LDK378'}, {'id': 'OG004', 'title': 'LDK378 400 mg', 'description': 'Participants receiving 400 mg of LDK378'}, {'id': 'OG005', 'title': 'LDK378 500 mg', 'description': 'Participants receiving 500 mg of LDK378'}, {'id': 'OG006', 'title': 'LDK378 600 mg', 'description': 'Participants receiving 600 mg of LDK378'}, {'id': 'OG007', 'title': 'LDK378 700 mg', 'description': 'Participants receiving 700 mg of LDK378'}, {'id': 'OG008', 'title': 'LDK378 750 mg', 'description': 'Participants receiving 750 mg of LDK378.'}], 'classes': [{'categories': [{'measurements': [{'value': '126', 'spread': 'NA', 'comment': 'N/A = not estimable', 'groupId': 'OG000'}, {'value': '116', 'spread': 'NA', 'comment': 'N/A = not estimable', 'groupId': 'OG001'}, {'value': '77.5', 'spread': 'NA', 'comment': 'N/A = not estimable', 'groupId': 'OG002'}, {'value': '44.5', 'spread': '36.8', 'groupId': 'OG003'}, {'value': '95.9', 'spread': '58.6', 'groupId': 'OG004'}, {'value': '147.0', 'spread': '170.3', 'groupId': 'OG005'}, {'value': '46.3', 'spread': '9.6', 'groupId': 'OG006'}, {'value': '66.6', 'spread': '35.8', 'groupId': 'OG007'}, {'value': '88.5', 'spread': '162.5', 'groupId': 'OG008'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'PK Run-in dose escalation phase', 'description': 'CL/F is the apparent total body clearance of drug from the plasma', 'unitOfMeasure': 'Litres/hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set (PAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least 1 dose of LDK378 \\& had at least 1 evaluable PK sample'}, {'type': 'SECONDARY', 'title': 'Secondary Pharmacokinetics (PK) Parameter: Vz/F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'LDK378 50 mg', 'description': 'Participants receiving 50 mg of LDK378'}, {'id': 'OG001', 'title': 'LDK378 100 mg', 'description': 'Participants receiving 100 mg of LDK378'}, {'id': 'OG002', 'title': 'LDK378 200 mg', 'description': 'Participants receiving 200 mg of LDK378'}, {'id': 'OG003', 'title': 'LDK378 300 mg', 'description': 'Participants receiving 300 mg of LDK378'}, {'id': 'OG004', 'title': 'LDK378 400 mg', 'description': 'Participants receiving 400 mg of LDK378'}, {'id': 'OG005', 'title': 'LDK378 500 mg', 'description': 'Participants receiving 500 mg of LDK378'}, {'id': 'OG006', 'title': 'LDK378 600 mg', 'description': 'Participants receiving 600 mg of LDK378'}, {'id': 'OG007', 'title': 'LDK378 700 mg', 'description': 'Participants receiving 700 mg of LDK378'}, {'id': 'OG008', 'title': 'LDK378 750 mg', 'description': 'Participants receiving 750 mg of LDK378.'}], 'classes': [{'categories': [{'measurements': [{'value': '3540', 'spread': 'NA', 'comment': 'N/A = not estimable', 'groupId': 'OG000'}, {'value': '3250', 'spread': 'NA', 'comment': 'N/A = not estimable', 'groupId': 'OG001'}, {'value': '3720', 'spread': 'NA', 'comment': 'N/A = not estimable', 'groupId': 'OG002'}, {'value': '1880', 'spread': '50.7', 'groupId': 'OG003'}, {'value': '3470', 'spread': '74.4', 'groupId': 'OG004'}, {'value': '6230', 'spread': '218.9', 'groupId': 'OG005'}, {'value': '1990', 'spread': '4.3', 'groupId': 'OG006'}, {'value': '2340', 'spread': '56.5', 'groupId': 'OG007'}, {'value': '4230', 'spread': '164.4', 'groupId': 'OG008'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'PK Run-in dose escalation phase', 'description': 'Vz/F is the apparent volume of distribution during terminal phase (associated with Lambda\\_z)', 'unitOfMeasure': 'Litre', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set (PAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least 1 dose of LDK378 \\& had at least 1 evaluable PK sample'}, {'type': 'SECONDARY', 'title': 'Secondary Pharmacokinetics (PK) Parameter: CLss/F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '252', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'LDK378 50 mg', 'description': 'Participants receiving 50 mg of LDK378'}, {'id': 'OG001', 'title': 'LDK378 100 mg', 'description': 'Participants receiving 100 mg of LDK378'}, {'id': 'OG002', 'title': 'LDK378 200 mg', 'description': 'Participants receiving 200 mg of LDK378'}, {'id': 'OG003', 'title': 'LDK378 300 mg', 'description': 'Participants receiving 300 mg of LDK378'}, {'id': 'OG004', 'title': 'LDK378 400 mg', 'description': 'Participants receiving 400 mg of LDK378'}, {'id': 'OG005', 'title': 'LDK378 500 mg', 'description': 'Participants receiving 500 mg of LDK378'}, {'id': 'OG006', 'title': 'LDK378 600 mg', 'description': 'Participants receiving 600 mg of LDK378'}, {'id': 'OG007', 'title': 'LDK378 700 mg', 'description': 'Participants receiving 700 mg of LDK378'}, {'id': 'OG008', 'title': 'LDK378 750 mg', 'description': 'Participants receiving 750 mg of LDK378.'}], 'classes': [{'title': 'C1D8: dose escalation phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '115', 'spread': '42.1', 'groupId': 'OG000'}, {'value': '65.8', 'spread': '41.1', 'groupId': 'OG001'}, {'value': '48.2', 'spread': '32.2', 'groupId': 'OG002'}, {'value': '39.2', 'spread': '402.8', 'groupId': 'OG003'}, {'value': '52.1', 'spread': '77.4', 'groupId': 'OG004'}, {'value': '40.7', 'spread': '37.4', 'groupId': 'OG005'}, {'value': '40.8', 'spread': '71.7', 'groupId': 'OG006'}, {'value': '19.9', 'spread': '0.8', 'groupId': 'OG007'}, {'value': '53.9', 'spread': '74.8', 'groupId': 'OG008'}]}]}, {'title': 'C2D1:dose escalation & dose expansion phases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '23', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '133', 'spread': 'NA', 'comment': 'N/A = not estimable', 'groupId': 'OG000'}, {'value': '112', 'spread': 'NA', 'comment': 'N/A = not estimable', 'groupId': 'OG001'}, {'value': '33.2', 'spread': '37.1', 'groupId': 'OG008'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 8 of dose escalation phase, Cycle 2 Day 1 of dose escalation & dose expansion phases', 'description': 'CLss/F is the apparent total body clearance of drug from the plasma. There was no PK sampling during C1D1 and C2D1 except for 750 mg dose to compute PK parameter CLss/F.', 'unitOfMeasure': 'Litres/hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set (PAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least 1 dose of LDK378 \\& had at least 1 evaluable PK sample'}, {'type': 'SECONDARY', 'title': 'Secondary Pharmacokinetics (PK) Parameter: Racc', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '252', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'LDK378 50 mg', 'description': 'Participants receiving 50 mg of LDK378'}, {'id': 'OG001', 'title': 'LDK378 100 mg', 'description': 'Participants receiving 100 mg of LDK378'}, {'id': 'OG002', 'title': 'LDK378 200 mg', 'description': 'Participants receiving 200 mg of LDK378'}, {'id': 'OG003', 'title': 'LDK378 300 mg', 'description': 'Participants receiving 300 mg of LDK378'}, {'id': 'OG004', 'title': 'LDK378 400 mg', 'description': 'Participants receiving 400 mg of LDK378'}, {'id': 'OG005', 'title': 'LDK378 500 mg', 'description': 'Participants receiving 500 mg of LDK378'}, {'id': 'OG006', 'title': 'LDK378 600 mg', 'description': 'Participants receiving 600 mg of LDK378'}, {'id': 'OG007', 'title': 'LDK378 700 mg', 'description': 'Participants receiving 700 mg of LDK378'}, {'id': 'OG008', 'title': 'LDK378 750 mg', 'description': 'Participants receiving 750 mg of LDK378.'}], 'classes': [{'title': 'C1D8: dose escalation phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '2.56', 'spread': 'NA', 'comment': 'N/A = not estimable', 'groupId': 'OG000'}, {'value': '3.25', 'spread': '53.5', 'groupId': 'OG001'}, {'value': '6.62', 'spread': '17.6', 'groupId': 'OG002'}, {'value': '1.83', 'spread': '215.9', 'groupId': 'OG003'}, {'value': '3.80', 'spread': '124.7', 'groupId': 'OG004'}, {'value': '6.08', 'spread': '71.5', 'groupId': 'OG005'}, {'value': '3.55', 'spread': '51.7', 'groupId': 'OG006'}, {'value': '6.84', 'spread': '89.4', 'groupId': 'OG007'}, {'value': '4.68', 'spread': '72.1', 'groupId': 'OG008'}]}]}, {'title': 'C2D1: dose escalation & dose expansion phases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '1.67', 'spread': 'NA', 'comment': 'N/A = not estimable', 'groupId': 'OG000'}, {'value': '1.77', 'spread': 'NA', 'comment': 'N/A = not estimable', 'groupId': 'OG001'}, {'value': '6.20', 'spread': '58.5', 'groupId': 'OG008'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 8 of dose escalation phase, Cycle 2 Day 1 of dose escalation & dose expansion phases', 'description': 'Racc is the accumulation ratio calculated using AUCtau values obtained from a dosing interval at steady-state divided by AUCtau at day 1 or PK run-in phase. AUCtau is the AUC calculated to the end of the dosing interval, tau. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. However, there was no PK sampling during C1D1 and C2D1 except for 750 mg dose to compute PK parameter Racc.', 'unitOfMeasure': 'unitless', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set (PAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least 1 dose of LDK378 \\& had at least 1 evaluable PK sample'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LDK378 50 mg', 'description': 'Participants receiving 50 mg of LDK378'}, {'id': 'FG001', 'title': 'LDK378 100 mg', 'description': 'Participants receiving 100 mg of LDK378'}, {'id': 'FG002', 'title': 'LDK378 200 mg', 'description': 'Participants receiving 200 mg of LDK378'}, {'id': 'FG003', 'title': 'LDK378 300 mg', 'description': 'Participants receiving 300 mg of LDK378'}, {'id': 'FG004', 'title': 'LDK378 400 mg', 'description': 'Participants receiving 400 mg of LDK378'}, {'id': 'FG005', 'title': 'LDK378 500 mg', 'description': 'Participants receiving 500 mg of LDK378'}, {'id': 'FG006', 'title': 'LDK378 600 mg', 'description': 'Participants receiving 600 mg of LDK378'}, {'id': 'FG007', 'title': 'LDK378 700 mg', 'description': 'Participants receiving 700 mg of LDK378'}, {'id': 'FG008', 'title': 'LDK378 750 mg', 'description': 'Participants receiving 750 mg of LDK378.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Started = Full Analysis Set and Safety Set', 'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '14'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '10'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '255'}]}, {'type': 'Non-Small Cell Lung Cancer (NSCLC)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '9'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '246'}]}, {'type': 'Dose-Determining Set (DDS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '14'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '10'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '8'}]}, {'type': 'Non-NSCLC', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'comment': 'Small number of patients at 750 mg - non-NSCLC, assessment limited, not included in efficacy tables', 'groupId': 'FG008', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed - see explanation in Recruitment Details.', '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'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '14'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '10'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '255'}]}], 'dropWithdraws': [{'type': 'Adverse Event', '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': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '28'}]}, {'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': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '12'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '13'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '139'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '36'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '39'}]}, {'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': '1'}]}]}], 'recruitmentDetails': 'Study was considered completed when all patients discontinued ceritinib treatment, \\& all required follow-up was completed or patient died, was lost to follow-up or withdrew their consent to further participate in study or last patient on treatment was enrolled to a separate protocol to continue receiving ceritinib treatment, whichever came first.', 'preAssignmentDetails': 'A total of 304 patients were treated with LDK378 in the study, including 59 patients from the dose-escalation phase (including 10 patients at 750 mg) and 245 patients from the expansion phase treated at LDK378 750 mg.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '255', 'groupId': 'BG008'}, {'value': '304', 'groupId': 'BG009'}]}], 'groups': [{'id': 'BG000', 'title': 'LDK378 50 mg', 'description': 'Participants receiving 50 mg of LDK378'}, {'id': 'BG001', 'title': 'LDK378 100 mg', 'description': 'Participants receiving 100 mg of LDK378'}, {'id': 'BG002', 'title': 'LDK378 200 mg', 'description': 'Participants receiving 200 mg of LDK378'}, {'id': 'BG003', 'title': 'LDK378 300 mg', 'description': 'Participants receiving 300 mg of LDK378'}, {'id': 'BG004', 'title': 'LDK378 400 mg', 'description': 'Participants receiving 400 mg of LDK378'}, {'id': 'BG005', 'title': 'LDK378 500 mg', 'description': 'Participants receiving 500 mg of LDK378'}, {'id': 'BG006', 'title': 'LDK378 600 mg', 'description': 'Participants receiving 600 mg of LDK378'}, {'id': 'BG007', 'title': 'LDK378 700 mg', 'description': 'Participants receiving 700 mg of LDK378'}, {'id': 'BG008', 'title': 'LDK378 750 mg', 'description': 'Participants receiving 750 mg of LDK378.'}, {'id': 'BG009', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '255', 'groupId': 'BG008'}, {'value': '304', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '46.5', 'spread': '23.33', 'groupId': 'BG000'}, {'value': '30.5', 'spread': '12.02', 'groupId': 'BG001'}, {'value': '53.7', 'spread': '10.69', 'groupId': 'BG002'}, {'value': '58.7', 'spread': '5.03', 'groupId': 'BG003'}, {'value': '48.7', 'spread': '15.62', 'groupId': 'BG004'}, {'value': '55.0', 'spread': '15.99', 'groupId': 'BG005'}, {'value': '54.6', 'spread': '13.22', 'groupId': 'BG006'}, {'value': '56.4', 'spread': '4.67', 'groupId': 'BG007'}, {'value': '51.9', 'spread': '12.08', 'groupId': 'BG008'}, {'value': '52.0', 'spread': '12.41', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '255', 'groupId': 'BG008'}, {'value': '304', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '215', 'groupId': 'BG008'}, {'value': '255', 'groupId': 'BG009'}]}]}, {'title': '>=65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '255', 'groupId': 'BG008'}, {'value': '304', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '40', 'groupId': 'BG008'}, {'value': '49', 'groupId': 'BG009'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '255', 'groupId': 'BG008'}, {'value': '304', 'groupId': 'BG009'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '136', 'groupId': 'BG008'}, {'value': '170', 'groupId': 'BG009'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '119', 'groupId': 'BG008'}, {'value': '134', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '255', 'groupId': 'BG008'}, {'value': '304', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}, {'value': '32', 'groupId': 'BG009'}]}]}, {'title': 'Chinese', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '255', 'groupId': 'BG008'}, {'value': '304', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '17', 'groupId': 'BG008'}, {'value': '19', 'groupId': 'BG009'}]}]}, {'title': 'Indian (Indian subcontinent)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '255', 'groupId': 'BG008'}, {'value': '304', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '0', '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': '0', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}]}]}, {'title': 'Mixed Ethnicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '255', 'groupId': 'BG008'}, {'value': '304', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '255', 'groupId': 'BG008'}, {'value': '304', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '205', 'groupId': 'BG008'}, {'value': '244', 'groupId': 'BG009'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Predominant Race', 'classes': [{'title': 'Caucasian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '255', 'groupId': 'BG008'}, {'value': '304', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '160', 'groupId': 'BG008'}, {'value': '199', 'groupId': 'BG009'}]}]}, {'title': 'Black', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '255', 'groupId': 'BG008'}, {'value': '304', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '0', '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': '0', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '255', 'groupId': 'BG008'}, {'value': '304', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '87', 'groupId': 'BG008'}, {'value': '95', 'groupId': 'BG009'}]}]}, {'title': 'Native American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '255', 'groupId': 'BG008'}, {'value': '304', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '0', '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': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}]}]}, {'title': 'Pacific Islander', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '255', 'groupId': 'BG008'}, {'value': '304', 'groupId': 'BG009'}]}], 'categories': [{'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': '1', 'groupId': 'BG009'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '255', 'groupId': 'BG008'}, {'value': '304', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '0', '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': '3', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '255', 'groupId': 'BG008'}, {'value': '304', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '60.8', 'spread': '19.80', 'groupId': 'BG000'}, {'value': '67.8', 'spread': '5.94', 'groupId': 'BG001'}, {'value': '69.2', 'spread': '17.20', 'groupId': 'BG002'}, {'value': '54.1', 'spread': '9.70', 'groupId': 'BG003'}, {'value': '69.2', 'spread': '15.91', 'groupId': 'BG004'}, {'value': '72.2', 'spread': '18.74', 'groupId': 'BG005'}, {'value': '63.8', 'spread': '13.23', 'groupId': 'BG006'}, {'value': '61.6', 'spread': '16.05', 'groupId': 'BG007'}, {'value': '69.2', 'spread': '15.64', 'groupId': 'BG008'}, {'value': '68.8', 'spread': '15.61', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilograms (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '254', 'groupId': 'BG008'}, {'value': '302', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '169.0', 'spread': '7.07', 'groupId': 'BG000'}, {'value': '178.0', 'spread': '14.14', 'groupId': 'BG001'}, {'value': '161.3', 'spread': '3.04', 'groupId': 'BG002'}, {'value': '164.6', 'spread': '5.82', 'groupId': 'BG003'}, {'value': '169.9', 'spread': '9.35', 'groupId': 'BG004'}, {'value': '166.4', 'spread': '12.24', 'groupId': 'BG005'}, {'value': '165.1', 'spread': '8.67', 'groupId': 'BG006'}, {'value': '163.6', 'spread': '5.05', 'groupId': 'BG007'}, {'value': '167.5', 'spread': '9.87', 'groupId': 'BG008'}, {'value': '167.5', 'spread': '9.78', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimenters (cm)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Full Analysis Set (FAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least one dose of LDK378. Height was not collected for 1 patient each in the 700 mg arm and the 750 mg arm.'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '254', 'groupId': 'BG008'}, {'value': '302', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '21.1', 'spread': '5.16', 'groupId': 'BG000'}, {'value': '21.8', 'spread': '5.30', 'groupId': 'BG001'}, {'value': '26.5', 'spread': '5.69', 'groupId': 'BG002'}, {'value': '20.2', 'spread': '5.08', 'groupId': 'BG003'}, {'value': '24.0', 'spread': '5.38', 'groupId': 'BG004'}, {'value': '25.9', 'spread': '5.41', 'groupId': 'BG005'}, {'value': '23.1', 'spread': '2.78', 'groupId': 'BG006'}, {'value': '24.3', 'spread': '6.06', 'groupId': 'BG007'}, {'value': '24.5', 'spread': '4.40', 'groupId': 'BG008'}, {'value': '24.4', 'spread': '4.48', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Full Analysis Set (FAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least one dose of LDK378. Body Mass Index was not collected for 1 patient each in the 700 mg arm and the 750 mg arm.'}, {'title': 'WHO/ECOG Performance status', 'classes': [{'title': '0:Fully active,in line with pre-disease activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '255', 'groupId': 'BG008'}, {'value': '304', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '65', 'groupId': 'BG008'}, {'value': '76', 'groupId': 'BG009'}]}]}, {'title': '1: Able to carry out light work', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '255', 'groupId': 'BG008'}, {'value': '304', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '161', 'groupId': 'BG008'}, {'value': '193', 'groupId': 'BG009'}]}]}, {'title': '2:Capable of self-care up & about >50% of the time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '255', 'groupId': 'BG008'}, {'value': '304', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '28', 'groupId': 'BG008'}, {'value': '34', 'groupId': 'BG009'}]}]}, {'title': '3: Limited self-care, confined to bed/chair >50%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '255', 'groupId': 'BG008'}, {'value': '304', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '0', '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': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}]}]}], 'paramType': 'NUMBER', 'description': "The ECOG performance status is a scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis.", 'unitOfMeasure': 'Participants'}, {'title': 'Smoking History', 'classes': [{'title': 'Never Smoked', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '255', 'groupId': 'BG008'}, {'value': '304', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '159', 'groupId': 'BG008'}, {'value': '192', 'groupId': 'BG009'}]}]}, {'title': 'Ex-Smoker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '255', 'groupId': 'BG008'}, {'value': '304', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '88', 'groupId': 'BG008'}, {'value': '104', 'groupId': 'BG009'}]}]}, {'title': 'Current Smoker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '255', 'groupId': 'BG008'}, {'value': '304', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '0', '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': '0', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set (FAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least one dose of LDK378. Patients were classified according to the intended treatment dose group.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 304}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2016-05-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-28', 'studyFirstSubmitDate': '2011-01-24', 'resultsFirstSubmitDate': '2014-05-29', 'studyFirstSubmitQcDate': '2011-01-24', 'lastUpdatePostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-07-18', 'studyFirstPostDateStruct': {'date': '2011-01-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Dose Limiting Toxicities (DLTs)', 'timeFrame': '33 months', 'description': 'The maximum tolerated dose (MTD) was defined as the highest dose for a given schedule that was expected to cause DLTs in no more than 33% of patients during the first cycle of treatment. A patient with multiple occurrences of a DLT under one treatment is counted only once in the AE category for that treatment. MTD was determined at 750mg.'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate (ORR) Based on Investigator Assessment', 'timeFrame': '275 weeks', 'description': 'Overall response rate (ORR) was defined as the percentage of participants with a best overall complete response (CR) or partial response (PR) per RECIST 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI. Both CR and PR had to be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. CR was the disappearance of all target lesions. PR was at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. Both CR and PR had to be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. CR = at least two determinations of CR, at least 4 weeks apart before progression. PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR).'}, {'measure': 'Overall Response Rate Based on Blinded Independent Review Committee (BIRC) Assessment', 'timeFrame': '275 weeks', 'description': 'Overall response rate (ORR) was defined as the percentage of participants with a best overall complete response (CR) or partial response (PR) per RECIST 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI, CR was the disappearance of all target lesions. PR was at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. Both CR and PR had to be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. CR = at least two determinations of CR, at least 4 weeks apart before progression. PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR).'}, {'measure': 'Duration of Response (DOR) Based on Investigator Assessment', 'timeFrame': '275 weeks', 'description': 'Duration of response (DOR) was defined as the time from first documented response (partial response (PR) or complete response (CR)) to the date of first documented disease progression (PD) or death due to any cause, among patients with a confirmed PR or CR per RECIST 1.0.'}, {'measure': 'Duration of Response (DOR) Based on BIRC', 'timeFrame': '275 weeks', 'description': 'Duration of response (DOR) was defined as the time from first documented response (partial response (PR) or complete response (CR)) to the date of first documented disease progression (PD) or death due to any cause, among patients with a confirmed PR or CR per RECIST 1.0.'}, {'measure': 'Progression-free Survival Based on Investigator Assessment', 'timeFrame': '275 weeks', 'description': 'Progression-free survival (PFS) was defined as the time from the start date of study drug to the date of the first radiologically documented progressive disease (PD) per RECIST 1.0. or death due to any cause.'}, {'measure': 'Progression-free Survival Based on BIRC Assessment', 'timeFrame': '275 weeks', 'description': 'Progression-free survival (PFS) was defined as the time from the start date of study drug to the date of the first radiologically documented progressive disease (PD) per RECIST 1.0. or death due to any cause.'}, {'measure': 'Primary Pharmacokinetics (PK) Parameter: AUC0-last', 'timeFrame': 'PK run-in of Dose Escalation phase', 'description': 'The AUC from time zero to the last quantifiable concentration point (Tlast). Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378.'}, {'measure': 'Primary Pharmacokinetics (PK) Parameter: AUC0-24h', 'timeFrame': 'PK run-in of dose escalation phase, Cycle 1 Day 8 of dose escalation phase, Cycle 1, Day 1 of dose escalation phase, Cycle 2 Day 1 of dose escalation & dose expansion phases', 'description': 'Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. AUC0 - 24 is the AUC calculated to 24 hour. Cycle 1 Day 1 = C1D1; Cycle 1 Day 8 = C1D8; Cycle 2 Day 1 = C2D1. However, there was no PK sampling during C1D1 and C2D1 except for 750 mg dose to compute PK parameter AUC0-24.'}, {'measure': 'Primary Pharmacokinetics (PK) Parameter: Tmax', 'timeFrame': 'PK run-in of dose escalation phase, Cycle 1 Day 8 of dose escalation phase, Cycle 1, Day 1 of dose escalation phase, Cycle 2 Day 1 of dose escalation & dose expansion phases', 'description': 'Tmax is the time to reach Cmax. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. Cycle 1 Day 1 = C1D1; Cycle 1 Day 8 = C1D8; Cycle 2 Day 1 = C2D1. However, there was no PK sampling during C1D1 and C2D1 except for 750 mg dose to compute PK parameter Tmax.'}, {'measure': 'Primary Pharmacokinetics (PK) Parameter: Cmax', 'timeFrame': 'PK run-in of dose escalation phase, Cycle 1 Day 8 of dose escalation phase, Cycle 1, Day 1 of dose escalation ion phase, Cycle 2 Day 1 of dose escalation & expansion phases', 'description': 'Cmax is the maximum observed concentration. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. However, there was no PK sampling during C1D1 and C2D1 except for 750 mg dose to compute PK parameter Cmax.'}, {'measure': 'Secondary Pharmacokinetics (PK) Parameter: T1/2', 'timeFrame': 'PK Run-in dose escalation phase', 'description': 'T1/2 is the elimination half-life associated with the terminal slope (λz) of a semi logarithmic concentration-time curve (time). Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378.'}, {'measure': 'Secondary Pharmacokinetics (PK) Parameter: CL/F', 'timeFrame': 'PK Run-in dose escalation phase', 'description': 'CL/F is the apparent total body clearance of drug from the plasma'}, {'measure': 'Secondary Pharmacokinetics (PK) Parameter: Vz/F', 'timeFrame': 'PK Run-in dose escalation phase', 'description': 'Vz/F is the apparent volume of distribution during terminal phase (associated with Lambda\\_z)'}, {'measure': 'Secondary Pharmacokinetics (PK) Parameter: CLss/F', 'timeFrame': 'Cycle 1 Day 8 of dose escalation phase, Cycle 2 Day 1 of dose escalation & dose expansion phases', 'description': 'CLss/F is the apparent total body clearance of drug from the plasma. There was no PK sampling during C1D1 and C2D1 except for 750 mg dose to compute PK parameter CLss/F.'}, {'measure': 'Secondary Pharmacokinetics (PK) Parameter: Racc', 'timeFrame': 'Cycle 1 Day 8 of dose escalation phase, Cycle 2 Day 1 of dose escalation & dose expansion phases', 'description': 'Racc is the accumulation ratio calculated using AUCtau values obtained from a dosing interval at steady-state divided by AUCtau at day 1 or PK run-in phase. AUCtau is the AUC calculated to the end of the dosing interval, tau. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. However, there was no PK sampling during C1D1 and C2D1 except for 750 mg dose to compute PK parameter Racc.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ALK inhibitor,', 'NSCLC,', 'LDK378,', 'ceritinib,', 'genetic abnormalities'], 'conditions': ['Tumors Characterized by Genetic Abnormalities of ALK']}, 'referencesModule': {'references': [{'pmid': '34890832', 'type': 'DERIVED', 'citation': 'Tan DS, Thomas M, Kim DW, Szpakowski S, Urban P, Mehra R, Chow LQM, Sharma S, Solomon BJ, Felip E, Camidge DR, Vansteenkiste J, Petruzzelli L, Pantano S, Shaw AT. Genetic landscape of patients with ALK-rearranged non-small-cell lung cancer (NSCLC) and response to ceritinib in ASCEND-1 study. Lung Cancer. 2022 Jan;163:7-13. doi: 10.1016/j.lungcan.2021.11.007. Epub 2021 Nov 20.'}, {'pmid': '26973324', 'type': 'DERIVED', 'citation': 'Kim DW, Mehra R, Tan DSW, Felip E, Chow LQM, Camidge DR, Vansteenkiste J, Sharma S, De Pas T, Riely GJ, Solomon BJ, Wolf J, Thomas M, Schuler M, Liu G, Santoro A, Sutradhar S, Li S, Szczudlo T, Yovine A, Shaw AT. Activity and safety of ceritinib in patients with ALK-rearranged non-small-cell lung cancer (ASCEND-1): updated results from the multicentre, open-label, phase 1 trial. Lancet Oncol. 2016 Apr;17(4):452-463. doi: 10.1016/S1470-2045(15)00614-2. Epub 2016 Mar 11.'}, {'pmid': '26337354', 'type': 'DERIVED', 'citation': 'Richly H, Kim TM, Schuler M, Kim DW, Harrison SJ, Shaw AT, Boral AL, Yovine A, Solomon B. Ceritinib in patients with advanced anaplastic lymphoma kinase-rearranged anaplastic large-cell lymphoma. Blood. 2015 Sep 3;126(10):1257-8. doi: 10.1182/blood-2014-12-617779. No abstract available.'}, {'pmid': '24670165', 'type': 'DERIVED', 'citation': 'Shaw AT, Kim DW, Mehra R, Tan DS, Felip E, Chow LQ, Camidge DR, Vansteenkiste J, Sharma S, De Pas T, Riely GJ, Solomon BJ, Wolf J, Thomas M, Schuler M, Liu G, Santoro A, Lau YY, Goldwasser M, Boral AL, Engelman JA. Ceritinib in ALK-rearranged non-small-cell lung cancer. N Engl J Med. 2014 Mar 27;370(13):1189-97. doi: 10.1056/NEJMoa1311107.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/26272586', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study assessed the safety and efficacy of LDK378 in adult patients with genetic abnormalities in anaplastic lymphoma kinase (ALK).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ECOG Performance Status of ≤ 2 and life expectancy of ≥ 12 weeks.\n* Diagnosed with a locally advanced or metastatic malignancy that has progressed despite standard therapy, or for which no effective standard therapy exists. Only patients with tumors characterized by genetic abnormalities in ALK were enrolled.\n* For NSCLC, an ALK translocation must be detected by FISH in ≥ 15% of tumor cells.\n* In patients with diseases other than NSCLC, ALK translocation is not required and overexpression of ALK protein may be considered indicative of a genetic abnormality in ALK.\n* Patients with measurable or non-measurable disease as determined by modified RECIST version 1.0 in dose-escalation phase, and patients with at least one measurable lesion as determined by RECIST 1.0 in expansion phase.\n\nExclusion Criteria:\n\n* Patients with symptomatic central nervous system (CNS) metastases who were neurologically unstable or required increasing doses of steroids to control their CNS disease were excluded.\n* Patients with a prior or current history of a second malignancy, impaired GI function, history of pancreatitis or increased amylase or lipase, known diagnosis of HIV, and clinically significant cardiac disease were excluded.\n* Patients treated with chemotherapy or biologic therapy or other investigational agent \\< 2 weeks prior to starting study drug for compounds with a half-life ≤ 3 days, and \\< 4 weeks prior to starting study drug for compounds with a prolonged half-life were excluded.\n* Further, patients treated with medications that were known to be strong inhibitors or inducers of CYP3A4/5 that could not be discontinued at least a week prior to start of treatment with LDK378 and for the duration of the study were also excluded.\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01283516', 'briefTitle': 'A Dose Escalation/Expansion Study of LDK378 in Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase I, Multi-center, Open Label Dose Escalation Study of LDK378, Administered Orally in Adult Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase (ALK)', 'orgStudyIdInfo': {'id': 'CLDK378X2101'}, 'secondaryIdInfos': [{'id': '2010-019827-70', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LDK378 750 mg: Arm 1A and Arm 1B', 'description': 'NSCLC patients previously treated with an ALK inhibitor', 'interventionNames': ['Drug: LDK378']}, {'type': 'EXPERIMENTAL', 'label': 'LDK378 750 mg: Arm 2', 'description': 'NSCLC patients not previously treated with an ALK inhibitor', 'interventionNames': ['Drug: LDK378']}, {'type': 'EXPERIMENTAL', 'label': 'LDK378 750 mg: Arm 3', 'description': 'Patients with other tumors that are ALK positive other than NSCLC', 'interventionNames': ['Drug: LDK378']}], 'interventions': [{'name': 'LDK378', 'type': 'DRUG', 'description': 'LDK378 is a selective and a potent inhibitor of anaplastic lymphoma kinase (ALK) activity, is a capsule and is administered orally.', 'armGroupLabels': ['LDK378 750 mg: Arm 1A and Arm 1B', 'LDK378 750 mg: Arm 2', 'LDK378 750 mg: Arm 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado School of Medicine Colorado Univ', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital Mass General', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10017', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering MSK', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center Fox Chase Cancer (2)', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '84103', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah / Huntsman Cancer Institute Huntsman', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle Cancer Care Alliance', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '3000', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': 'M5G 1Z6', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '50937', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '20141', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20089', 'city': 'Rozzano', 'state': 'MI', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'zip': '1066 CX', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '169610', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '03080', 'city': 'Seoul', 'state': 'Korea', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': 'G12 0YN', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'LE1 5WW', 'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}