Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-31 @ 11:36 AM
Study NCT ID:
NCT01685060
Status:
COMPLETED
Last Update Posted:
2017-06-19
First Post:
2012-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
LDK378 in Adult Patients With ALK-activated NSCLC Previously Treated With Chemotherapy and Crizotinib
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Belgium', 'Sweden']}, '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': {'email': 'trialandresults.registries@novartis.com', '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 pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Timeframe for AE', 'description': 'AE additional description', 'eventGroups': [{'id': 'EG000', 'title': 'LDK378 750 mg', 'description': 'Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.', 'otherNumAtRisk': 140, 'otherNumAffected': 139, 'seriousNumAtRisk': 140, 'seriousNumAffected': 67}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 25}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 45}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 42}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 115}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 115}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'STOMATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 92}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 54}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'NON-CARDIAC CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 65}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'ASPARTATE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 55}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'BLOOD ALKALINE PHOSPHATASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 23}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'BLOOD CREATININE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 27}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'ELECTROCARDIOGRAM QT PROLONGED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'GAMMA-GLUTAMYLTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 26}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'WEIGHT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 48}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 59}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'HYPOKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'HYPOPHOSPHATAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 28}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'MUSCULOSKELETAL CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'MUSCULOSKELETAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'NECK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'DYSGEUSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 31}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'PARAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 18}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 33}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 29}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'HAEMOPTYSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'ALOPECIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'DRY SKIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 24}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'seriousEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'FEBRILE NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'CORONARY ARTERY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'PERICARDIAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'PERICARDITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'ASCITES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'DYSPHAGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'FAECALOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'GASTROINTESTINAL DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'GASTROINTESTINAL TOXICITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'INTESTINAL PERFORATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'PANCREATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'RETROPERITONEAL FIBROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'DISEASE PROGRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'GENERAL PHYSICAL HEALTH DETERIORATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'MALAISE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'NON-CARDIAC CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'HEPATIC FUNCTION ABNORMAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'HEPATOCELLULAR INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'EMPYEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'ENTERITIS INFECTIOUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'LUNG INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'MENINGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'PLEURAL INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'SEPTIC SHOCK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'VIRAL PERICARDITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'HUMERUS FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'PUBIS FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'SPINAL COMPRESSION FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'ASPARTATE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'BLOOD CALCIUM INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'BLOOD CREATINE PHOSPHOKINASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'BLOOD CREATININE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'WEIGHT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'DEHYDRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'DIABETES MELLITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'HYPERGLYCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'BONE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'NECK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'COLON CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'METASTASES TO LIVER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'METASTASES TO LUNG', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'METASTASES TO MENINGES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'ALTERED STATE OF CONSCIOUSNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'APHASIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'BRAIN OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'CEREBROVASCULAR ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'DYSARTHRIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'ENCEPHALOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'HEPATIC ENCEPHALOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'HYPERAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'LETHARGY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'MOTOR DYSFUNCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'PARAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'PARAPARESIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'SEIZURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'SENSORY LOSS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'CONFUSIONAL STATE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'HYDRONEPHROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'POLLAKIURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'RENAL FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'RENAL IMPAIRMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'LUNG DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'PLEURAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'PLEURISY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'PNEUMONITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'PULMONARY EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'PULMONARY HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Response Rate (ORR) to LDK378 Per Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LDK378 750mg', 'description': 'Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.7', 'groupId': 'OG000', 'lowerLimit': '32.5', 'upperLimit': '49.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 cycles of 28 days up to 24 weeks', 'description': 'ORR per RECIST 1.1 calculated as the percentage of patients with a best overall confirmed response defined as complete response or partial response (CR+PR) as assessed by investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib.'}, {'type': 'SECONDARY', 'title': 'ORR Per Blinded Independent Review Committee (BIRC) Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LDK378 750mg', 'description': 'Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000', 'lowerLimit': '27.8', 'upperLimit': '44.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 cycles of 28 days up to 24 weeks', 'description': 'ORR (CR+PR) by BIRC is calculated as the percentage of patients with a best overall confirmed response defined as complete response or partial response (CR+PR) as assessed by BIRC. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) by Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LDK378 750mg', 'description': 'Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000', 'lowerLimit': '7.4', 'upperLimit': '14.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 cycles of 28 days up to 24 weeks', 'description': 'DOR, calculated as the time from the date of the first confirmed CR or PR to the first documented progression or death due to any cause, by investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib. Only patients with confirmed complete response/partial response (CR/PR) per Investigator were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) by BIRC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LDK378 750mg', 'description': 'Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000', 'lowerLimit': '9.3', 'upperLimit': '18.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 cycles of 28 days up to 24 weeks', 'description': 'DOR, calculated as the time from the date of the first documented CR or PR to the first documented progression or death due to underlying cancer, by BIRC (Blinded Imaging Review Committee). CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib. Only patients with confirmed complete response/partial response (CR/PR) per BIRC were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate (DCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LDK378 750mg', 'description': 'Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.'}], 'classes': [{'title': 'DCR per Investigator', 'categories': [{'measurements': [{'value': '76.4', 'groupId': 'OG000', 'lowerLimit': '68.5', 'upperLimit': '83.2'}]}]}, {'title': 'DCR per BIRC', 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000', 'lowerLimit': '72.4', 'upperLimit': '86.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 cycles of 28 days up to 24 weeks', 'description': 'DCR was calculated as the percentage of patients with best overall response of CR, PR, SD, or non-CR non-PD (NCRNPD), per RECIST 1.1 by investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. Non-CR/Non-PD (NCRNPD): refers to best overall responses that are neither CR nor PD per RECIST 1.1 criteria for patients with non-measurable disease only at baseline.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib.'}, {'type': 'SECONDARY', 'title': 'Time to Response (TTR) Per Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LDK378 750mg', 'description': 'Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '3.54', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '18.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 cycles of 28 days up to 24 weeks', 'description': 'TTR is the time from date of start of treatment to the first CR or PR observed which were confirmed afterwards.', 'unitOfMeasure': 'Months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib. Only patients with confirmed complete response/partial response (CR/PR) were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Time to Response (TTR) Per BIRC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LDK378 750mg', 'description': 'Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '1.44', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '10.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 cycles of 28 days up to 24 weeks', 'description': 'TTR is the time from date of start of treatment to the first CR or PR observed which are confirmed afterwards.', 'unitOfMeasure': 'Months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib. Only patients with confirmed complete response/partial response (CR/PR) were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS) Per Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LDK378 750mg', 'description': 'Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000', 'lowerLimit': '5.4', 'upperLimit': '7.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 cycles of 28 days up to 24 weeks', 'description': 'PFS, defined as the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient had no event or when the patient received any further anticancer therapy in the absence of disease progression, progression-free survival was censored at the date of last adequate tumor assessment.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS) Per BIRC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LDK378 750mg', 'description': 'Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '10.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 cycles of 28 days up to 24 weeks', 'description': 'PFS, defined as the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient had no event or when the patient received any further anticancer therapy in the absence of disease progression, progression-free survival was censored at the date of last adequate tumor assessment.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib.'}, {'type': 'SECONDARY', 'title': 'Overall Intracranial Response Rate (OIRR) Per Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LDK378 750mg', 'description': 'Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.0', 'groupId': 'OG000', 'lowerLimit': '23.1', 'upperLimit': '68.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 cycles of 28 days up to 24 weeks', 'description': 'OIRR calculated as the ORR (CR+PR) of lesions in the brain for patients who had measureable disease in the brain at baseline.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib. Only patients with measurable disease in brain at baseline selected by Investigator were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Overall Intracranial Response Rate (OIRR) Per BIRC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LDK378 750mg', 'description': 'Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000', 'lowerLimit': '18.6', 'upperLimit': '55.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 cycles of 28 days up to 24 weeks', 'description': 'OIRR calculated as the ORR (CR+PR) of lesions in the brain for patients who had measureable disease in the brain at baseline.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib. Only patients with measurable disease in brain at baseline selected by BIRC were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LDK378 750mg', 'description': 'Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000', 'lowerLimit': '13.6', 'upperLimit': '24.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 cycles of 28 days up to 24 weeks', 'description': 'OS, defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last known date patient alive.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LDK378 750mg', 'description': 'Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '140'}]}, {'type': 'Entered Post-treatment Efficacy f/u', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Entered Survival Follow up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}]}, {'type': 'Discontinued From Study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '140'}]}], 'dropWithdraws': [{'type': 'Rollover patients', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '69'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'Subject/guardian decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}]}], 'preAssignmentDetails': 'Approximately 137 patients were planned to be enrolled. A total of 140 patients were enrolled and treated with ceritinib.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'LDK378 750mg', 'description': 'Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.2', 'spread': '11.62', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '70', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '70', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-25', 'studyFirstSubmitDate': '2012-09-04', 'resultsFirstSubmitDate': '2017-03-27', 'studyFirstSubmitQcDate': '2012-09-12', 'lastUpdatePostDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-27', 'studyFirstPostDateStruct': {'date': '2012-09-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate (ORR) to LDK378 Per Investigator Assessment', 'timeFrame': '6 cycles of 28 days up to 24 weeks', 'description': 'ORR per RECIST 1.1 calculated as the percentage of patients with a best overall confirmed response defined as complete response or partial response (CR+PR) as assessed by investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.'}], 'secondaryOutcomes': [{'measure': 'ORR Per Blinded Independent Review Committee (BIRC) Assessment', 'timeFrame': '6 cycles of 28 days up to 24 weeks', 'description': 'ORR (CR+PR) by BIRC is calculated as the percentage of patients with a best overall confirmed response defined as complete response or partial response (CR+PR) as assessed by BIRC. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.'}, {'measure': 'Duration of Response (DOR) by Investigator', 'timeFrame': '6 cycles of 28 days up to 24 weeks', 'description': 'DOR, calculated as the time from the date of the first confirmed CR or PR to the first documented progression or death due to any cause, by investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.'}, {'measure': 'Duration of Response (DOR) by BIRC', 'timeFrame': '6 cycles of 28 days up to 24 weeks', 'description': 'DOR, calculated as the time from the date of the first documented CR or PR to the first documented progression or death due to underlying cancer, by BIRC (Blinded Imaging Review Committee). CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': '6 cycles of 28 days up to 24 weeks', 'description': 'DCR was calculated as the percentage of patients with best overall response of CR, PR, SD, or non-CR non-PD (NCRNPD), per RECIST 1.1 by investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. Non-CR/Non-PD (NCRNPD): refers to best overall responses that are neither CR nor PD per RECIST 1.1 criteria for patients with non-measurable disease only at baseline.'}, {'measure': 'Time to Response (TTR) Per Investigator', 'timeFrame': '6 cycles of 28 days up to 24 weeks', 'description': 'TTR is the time from date of start of treatment to the first CR or PR observed which were confirmed afterwards.'}, {'measure': 'Time to Response (TTR) Per BIRC', 'timeFrame': '6 cycles of 28 days up to 24 weeks', 'description': 'TTR is the time from date of start of treatment to the first CR or PR observed which are confirmed afterwards.'}, {'measure': 'Progression-free Survival (PFS) Per Investigator', 'timeFrame': '6 cycles of 28 days up to 24 weeks', 'description': 'PFS, defined as the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient had no event or when the patient received any further anticancer therapy in the absence of disease progression, progression-free survival was censored at the date of last adequate tumor assessment.'}, {'measure': 'Progression-free Survival (PFS) Per BIRC', 'timeFrame': '6 cycles of 28 days up to 24 weeks', 'description': 'PFS, defined as the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient had no event or when the patient received any further anticancer therapy in the absence of disease progression, progression-free survival was censored at the date of last adequate tumor assessment.'}, {'measure': 'Overall Intracranial Response Rate (OIRR) Per Investigator', 'timeFrame': '6 cycles of 28 days up to 24 weeks', 'description': 'OIRR calculated as the ORR (CR+PR) of lesions in the brain for patients who had measureable disease in the brain at baseline.'}, {'measure': 'Overall Intracranial Response Rate (OIRR) Per BIRC', 'timeFrame': '6 cycles of 28 days up to 24 weeks', 'description': 'OIRR calculated as the ORR (CR+PR) of lesions in the brain for patients who had measureable disease in the brain at baseline.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': '6 cycles of 28 days up to 24 weeks', 'description': 'OS, defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last known date patient alive.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Non-Small Cell Lung Cancer', 'NSCLC', 'ALK', 'LDK378', 'Ceritinib'], 'conditions': ['Non-Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '28369553', 'type': 'DERIVED', 'citation': 'Hida T, Satouchi M, Nakagawa K, Seto T, Matsumoto S, Kiura K, Nokihara H, Murakami H, Tokushige K, Hatano B, Nishio M. Ceritinib in patients with advanced, crizotinib-treated, anaplastic lymphoma kinase-rearranged NSCLC: Japanese subset. Jpn J Clin Oncol. 2017 Jul 1;47(7):618-624. doi: 10.1093/jjco/hyx045.'}, {'pmid': '27432917', 'type': 'DERIVED', 'citation': 'Crino L, Ahn MJ, De Marinis F, Groen HJ, Wakelee H, Hida T, Mok T, Spigel D, Felip E, Nishio M, Scagliotti G, Branle F, Emeremni C, Quadrigli M, Zhang J, Shaw AT. Multicenter Phase II Study of Whole-Body and Intracranial Activity With Ceritinib in Patients With ALK-Rearranged Non-Small-Cell Lung Cancer Previously Treated With Chemotherapy and Crizotinib: Results From ASCEND-2. J Clin Oncol. 2016 Aug 20;34(24):2866-73. doi: 10.1200/JCO.2015.65.5936. Epub 2016 Jul 18.'}]}, 'descriptionModule': {'briefSummary': 'A single-arm, open-label, multicenter, phase II study. Treatment with LDK378 750 mg qd continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the investigator or patient, started a new anti-cancer therapy and/or died. LDK378 could be continued beyond RECIST-defined progressive disease (PD) as assessed by the investigator if, in the judgment of the investigator, there was evidence of clinical benefit. In these patients tumor assessment would continue as per the schedule of assessments until treatment with LDK378 was permanently discontinued. Patients who discontinued the study medication in the absence of progression continued to be followed for tumor assessment until the time of PD as assessed by the investigator'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion critieria:\n\n* Histologically or cytologically confirmed diagnosis of stage IIIB or IV NSCLC that carries an ALK rearrangement, as per the FDA-approved FISH assay (Abbott Molecular Inc.).\n* Age 18 years or older at the time of informed consent.\n* Patients must have NSCLC that has progressed during therapy with crizotinib or within 30 days of the last dose\n* Patients must have received 1-3 lines of cytotoxic chemotherapy (of which 1 must have been a platinum doublet) to treat their locally advanced or metastatic NSCLC\n* Patients must have a tumor tissue sample available, collected either at the time of diagnosis of NSCLC or any time since.\n* Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 2, except for patients with grade 2 nausea/vomiting and/or grade 2 diarrhea despite optimal supportive therapy who will not be allowed to participate in the study.\n\nExclusion criteria:\n\n* Patients with known hypersensitivity to any of the excipients of LDK378.\n* Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.\n* History of carcinomatous meningitis.\n* Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years.\n* Clinically significant, uncontrolled heart disease\n* Systemic anti-cancer therapy given after the last dose of crizotinib and prior to starting study drug.'}, 'identificationModule': {'nctId': 'NCT01685060', 'briefTitle': 'LDK378 in Adult Patients With ALK-activated NSCLC Previously Treated With Chemotherapy and Crizotinib', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase II, Multicenter, Single-arm Study of Oral LDK378 in Adult Patients With ALK-activated Non-small Cell Lung Cancer Previously Treated With Chemotherapy and Crizotinib', 'orgStudyIdInfo': {'id': 'CLDK378A2201'}, 'secondaryIdInfos': [{'id': '2012-003432-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LDK378', 'description': 'Patients treated with ceritinib/LDK378 750 mg once-daily, fasted', 'interventionNames': ['Drug: LDK378']}], 'interventions': [{'name': 'LDK378', 'type': 'DRUG', 'otherNames': ['Ceritinib'], 'description': 'Ceritinib/LDK378 was supplied as 150 mg hard gelatin capsules and were administered orally, once-daily at a dose of 750 mg on a continuous dosing schedule (5 x 150 mg capsules).', 'armGroupLabels': ['LDK378']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72703', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Highlands Oncology Group Dept of Highlands Oncology Grp', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '91010-3000', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope National Medical Center Dept of Oncology 2', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California at Los Angeles Reg-5', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California at San Diego, Moores Cancer Ctr SC', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94304', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center Stanford Cancer Center(2)', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital SC', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University School of Medicine/Winship Cancer Institute Dept of Oncology', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center SC', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Cancer Center DeptofUofKansas CancerCenter-2', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '67214-3728', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas Dept of CCK', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Maryland Oncology Hematology, P.A. SC', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital Mass General', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Levine Cancer Institute SC 1', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute Drug Ship - 4', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle Cancer Care Alliance SC-1', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Univ Wisc 2', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'L1G 2B9', 'city': 'Oshawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.90012, 'lon': -78.84957}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '13915', 'city': 'Marseille', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '75970', 'city': 'Paris', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '50937', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': '83100', 'city': 'Avellino', 'state': 'AV', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.91494, 'lon': 14.79103}}, {'zip': '57124', 'city': 'Livorno', 'state': 'LI', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.54427, 'lon': 10.32615}}, {'zip': '20900', 'city': 'Monza', 'state': 'MB', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '20141', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '06129', 'city': 'Perugia', 'state': 'PG', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'zip': '43100', 'city': 'Parma', 'state': 'PR', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'zip': '464-8681', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '277-8577', 'city': 'Kashiwa', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.86224, 'lon': 139.97732}}, {'zip': '673-8558', 'city': 'Akashi', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.65524, 'lon': 135.00687}}, {'zip': '700-8558', 'city': 'Okayama', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '589-8511', 'city': 'Sayama', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.51685, 'lon': 135.56298}}, {'zip': '411-8777', 'city': 'Sunto-gun', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '104-0045', 'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '135-8550', 'city': 'Koto', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '811-1395', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '1081 HV', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '9713 GZ', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '5800', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'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': '03722', 'city': 'Seoul', 'state': 'Korea', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'state': 'Korea', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '41013', 'city': 'Seville', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '15006', 'city': 'A Coruña', 'state': 'Galicia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'SE1 9RT', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}