Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 5:32 AM
Study NCT ID:
NCT00050960
Status:
COMPLETED
Last Update Posted:
2012-07-13
First Post:
2002-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D000077610', 'term': 'Bexarotene'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '888-422-4743', 'title': 'Eisai, Inc.', 'organization': 'Eisai Call Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Bexarotene With Carboplatin and Paclitaxel', 'description': 'bexarotene capsules (400 mg/m\\^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\\^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.', 'otherNumAtRisk': 293, 'otherNumAffected': 293, 'seriousNumAtRisk': 293, 'seriousNumAffected': 256}, {'id': 'EG001', 'title': 'Carboplatin and Paclitaxel', 'description': 'carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\\^2) every 3 weeks.', 'otherNumAtRisk': 295, 'otherNumAffected': 295, 'seriousNumAtRisk': 295, 'seriousNumAffected': 242}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 147}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 112}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 138}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 71}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 42}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Hypotriglyceridemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 168}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 48}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypercholesterolemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyperlipidemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 56}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 27}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 31}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 70}], 'organSystem': 'Nervous system disorders'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 32}], 'organSystem': 'Nervous system disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 28}], 'organSystem': 'Nervous system disorders'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 34}], 'organSystem': 'Nervous system disorders'}, {'term': 'Polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 31}], 'organSystem': 'Nervous system disorders'}, {'term': 'Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 19}], 'organSystem': 'Nervous system disorders'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 23}], 'organSystem': 'Nervous system disorders'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 52}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 47}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Dyspnoea exacerbated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 23}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Hoarseness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 10}], 'organSystem': 'Vascular disorders'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 9}], 'organSystem': 'Vascular disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 147}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 140}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 108}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 68}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 78}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 84}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 147}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 154}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 22}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 20}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Dermatitis exfoliative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Skin desquamation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 68}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 55}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 32}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 35}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 156}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 137}], 'organSystem': 'General disorders'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 49}], 'organSystem': 'General disorders'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 56}], 'organSystem': 'General disorders'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 38}], 'organSystem': 'General disorders'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 30}], 'organSystem': 'General disorders'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 47}], 'organSystem': 'General disorders'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 30}], 'organSystem': 'Investigations'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 2}], 'organSystem': 'Endocrine disorders'}], 'seriousEvents': [{'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 219}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 213}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Non-small cell lung cancer Stage IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Non-small cell lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Dyspnoea exacerbated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Chronic obstructive airways disease exacerbated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 4}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 4}], 'organSystem': 'Cardiac disorders'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 3}], 'organSystem': 'Cardiac disorders'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 8}], 'organSystem': 'General disorders'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 4}], 'organSystem': 'General disorders'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 7}], 'organSystem': 'General disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 6}], 'organSystem': 'Infections and infestations'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 3}], 'organSystem': 'Nervous system disorders'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 295, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 4}, 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Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.'}, {'id': 'BG001', 'title': 'Carboplatin and Paclitaxel', 'description': 'carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\\^2) every 3 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '166', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '340', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.5', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '61.7', 'spread': '10.3', 'groupId': 'BG001'}, {'value': '62.1', 'spread': '10.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '203', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '406', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '304', 'groupId': 'BG000'}, {'value': '297', 'groupId': 'BG001'}, {'value': '601', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '269', 'groupId': 'BG000'}, {'value': '272', 'groupId': 'BG001'}, {'value': '541', 'groupId': 'BG002'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Counts are correct as reported. The BL measure title of "race" does not include counts of Hispanic or Latino population- which are reported in the BL measure title of "Ethnicity."', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 612}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-07', 'studyFirstSubmitDate': '2002-12-31', 'resultsFirstSubmitDate': '2010-07-23', 'studyFirstSubmitQcDate': '2003-01-02', 'lastUpdatePostDateStruct': {'date': '2012-07-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-07-23', 'studyFirstPostDateStruct': {'date': '2003-01-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'From date of randomization to date of death'}]}, 'conditionsModule': {'keywords': ['NSCLC', 'Targretin', 'Retinoid', 'Bexarotene'], 'conditions': ['Non-small Cell Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.Ligand.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have not yet received chemotherapy for their lung cancer.', 'detailedDescription': 'This study evaluates the use of Targretin capsules (bexarotene) in combination with Carboplatin and Paclitaxel for the treatment of metastatic non-small cell lung cancer in patients who have not yet received chemotherapy for their lung cancer. Every patient receives a platinum-containing chemotherapy every three weeks for at least four chemotherapy cycles (approximately four months). Half of the patients are randomly assigned to receive Targretin capsules once daily in addition to the chemotherapy. The other half is randomized to receive a standard platinum-containing chemotherapy without Targretin capsules.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Patients must have:\n\n* Pathologic (histologic or cytologic) confirmation of NSCLC\n* Stage IIIB with malignant pleural effusion or Stage IV disease\n* At least one measurable or evaluable NSCLC lesion that has not been previously irradiated unless radiation therapy was more than three weeks prior to entry in the study and the lesion has been shown to have progressed subsequent to the radiation therapy\n* ECOG performance status 0 or 1\n* Adequate organ system function\n* Fasting serum triglycerides that are within the age-adjusted normal range (or normalized with appropriate intervention such as antilipid therapy prior to the initiation of Targretin capsule therapy).\n\nPatients must be able to complete at least four cycles of combination chemotherapy (i.e., approximately four months)\n\nPatients must not have had:\n\n* Brain metastasis\n* Prior chemotherapy for NSCLC\n* Prior platinum-based chemotherapy for any indication'}, 'identificationModule': {'nctId': 'NCT00050960', 'briefTitle': 'Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer', 'nctIdAliases': ['NCT00036907'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'Randomized Phase III Trial Comparing Targretin Capsules/Carboplatin/Paclitaxel Versus Carboplatin/Paclitaxel in Chemotherapy-Naïve Patients With Advanced or Metastatic Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'L1069-48'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bexarotene with carboplatin and paclitaxel', 'interventionNames': ['Drug: bexarotene with carboplatin and paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'carboplatin and paclitaxel', 'interventionNames': ['Drug: carboplatin and paclitaxel']}], 'interventions': [{'name': 'bexarotene with carboplatin and paclitaxel', 'type': 'DRUG', 'description': 'bexarotene capsules (400 mg/m\\^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\\^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.', 'armGroupLabels': ['bexarotene with carboplatin and paclitaxel']}, {'name': 'carboplatin and paclitaxel', 'type': 'DRUG', 'description': 'carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\\^2) every 3 weeks.', 'armGroupLabels': ['carboplatin and paclitaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36106', 'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'facility': 'Montgomery Cancer Center, L.L.C.', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Clinical Research Center, Inc.', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'Bay Area Cancer Research Group, LLC', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Compassionate Cancer Care Medical Group, Inc.', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Coast Hematology/Oncology Medical Group, Inc.', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '94909', 'city': 'Greenbrae', 'state': 'California', 'country': 'United States', 'facility': 'California Cancer Care, Inc.', 'geoPoint': {'lat': 37.94854, 'lon': -122.5247}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Coast Hematology and Oncology Associates', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Metropolitan Hematology/Oncology Medical Group', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90067', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Sant P. 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