Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-01-03 @ 8:06 PM
Study NCT ID:
NCT01454934
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2011-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Treatment of Physician's Choice in Subjects With Advanced 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': 'C490954', 'term': 'eribulin'}, {'id': 'D000068437', 'term': 'Pemetrexed'}], 'ancestors': [{'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'esi_oncmedinfo@eisai.com', 'phone': '1-888-274-2378', 'title': 'Eisai Medical Information', 'organization': 'Eisai Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events (AEs) and serious adverse events (SAEs) were collected from the first dose of study treatment to thirty days after final dose of study medication. Participants were followed for approximately 37 months.', 'description': 'Safety analysis set included all randomized participants who received at least one dose of study treatment. AEs were graded on a 5-point scale according to Common Terminology for Adverse Events (CTCAE) version 4.0. All AEs graded 4 or 5 were considered serious.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A: Eribulin Mesylate', 'description': 'Eribulin mesylate (1.4 mg/m\\^2) was administered IV over 2 to 5 minutes on Day 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.', 'otherNumAtRisk': 269, 'deathsNumAtRisk': 269, 'otherNumAffected': 254, 'seriousNumAtRisk': 269, 'deathsNumAffected': 28, 'seriousNumAffected': 96}, {'id': 'EG001', 'title': 'Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed', 'description': 'TPC: Vinorelbine (30 mg/m\\^2) was administered IV on Day 1 every 7 days, Gemcitabine (1250 mg/m\\^2) was administered IV on Days 1 and 8 every 21 days (or 1000 mg/m\\^2 IV on Days 1, 8, and 15 every 28 days), Docetaxel (75 mg/m\\^2) was administered IV on Day 1 every 21 days, or Pemetrexed (500 mg/m\\^2) was administered IV on Day 1 every 21 days (nonsquamous histology only).', 'otherNumAtRisk': 268, 'deathsNumAtRisk': 268, 'otherNumAffected': 261, 'seriousNumAtRisk': 268, 'deathsNumAffected': 21, 'seriousNumAffected': 86}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 72}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 28}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 74}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 63}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 45}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 78}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 38}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 56}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 62}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 29}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 50}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 23}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 58}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 57}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 98}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 68}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Muscular Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 24}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 26}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 20}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 42}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 52}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 20}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 42}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 24}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Febrile bone marrow aplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Coronary artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Large intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Oesophageal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Oesophageal varices haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 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obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pharyngeal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Respiratory disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Superior vena cava syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Superior vena cava stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Eribulin Mesylate', 'description': 'Eribulin mesylate (1.4 mg/m\\^2) was administered IV over 2 to 5 minutes on Day 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.'}, {'id': 'OG001', 'title': 'Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed', 'description': 'TPC: Vinorelbine (30 mg/m\\^2) was administered IV on Day 1 every 7 days, Gemcitabine (1250 mg/m\\^2) was administered IV on Days 1 and 8 every 21 days (or 1000 mg/m\\^2 IV on Days 1, 8, and 15 every 28 days), Docetaxel (75 mg/m\\^2) was administered IV on Day 1 every 21 days, or Pemetrexed (500 mg/m\\^2) was administered IV on Day 1 every 21 days (nonsquamous histology only).'}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '7.4', 'upperLimit': '11.4'}, {'value': '9.5', 'groupId': 'OG001', 'lowerLimit': '8.5', 'upperLimit': '11.3'}]}]}], 'analyses': [{'pValue': '0.1343', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.41', 'pValueComment': 'P-value was calculated from a 2-sided long-rank test stratified by histology, TPC option, and geographic region.', 'estimateComment': 'Hazard Ratio was based on a Cox regression model including treatment as covariate, and histology, TPC option and geographic region as strata.', 'groupDescription': 'OS was compared between eribulin and TPC testing the following null hypothesis: H0: OS in Arm A (eribulin) is equal to OS in Arm B (TPC) against the alternative: H1: OS in Arm A (eribulin) is not equal to OS in Arm B (TPC).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization (Day 1) until date of death from any cause, or 37 months', 'description': 'The OS was defined as the time in months from the date of randomization to the date of death, regardless of cause. In the absence of confirmation of death, the participants were censored either at the date that participant was last known to be alive or the date of study cut-off, whichever was earlier. The two treatment arms were compared using the log-rank test, stratified by histology, TPC option, and geographic region; and the treatment difference between eribulin mesylate and TPC was tested at a significance level of 0.05 (2-sided). Kaplan-Meier (K-M) survival probabilities for each arm were plotted over time. The treatment effect was estimated by fitting a Cox Proportional Hazards model to the OS times including treatment arm as a factor and histology, TPC option and geographic region as strata.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Eribulin Mesylate', 'description': 'Eribulin mesylate (1.4 mg/m\\^2) was administered IV over 2 to 5 minutes on Day 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.'}, {'id': 'OG001', 'title': 'Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed', 'description': 'TPC: Vinorelbine (30 mg/m\\^2) was administered IV on Day 1 every 7 days, Gemcitabine (1250 mg/m\\^2) was administered IV on Days 1 and 8 every 21 days (or 1000 mg/m\\^2 IV on Days 1, 8, and 15 every 28 days), Docetaxel (75 mg/m\\^2) was administered IV on Day 1 every 21 days, or Pemetrexed (500 mg/m\\^2) was administered IV on Day 1 every 21 days (nonsquamous histology only).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '3.9'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '3.6'}]}]}], 'analyses': [{'pValue': '0.3946', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.32', 'pValueComment': 'P-value was calculated from a 2-sided long-rank test stratified by histology, TPC option, and geographic region.', 'estimateComment': 'The hazard ratio was based on a Cox regression model including treatment as covariate, and histology, TPC option, and geographic region as strata.', 'groupDescription': 'OS was compared between eribulin and TPC testing the following null hypothesis: H0: OS in Arm A (eribulin) is equal to OS in Arm B (TPC) against the alternative: H1: OS in Arm A (eribulin) is not equal to OS in Arm B (TPC).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization (Day 1) until date of disease progression or death (whichever occurred first), or 37 months', 'description': 'PFS was defined as the time from the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first. The difference in PFS (based on the tumor response evaluation as determined by the investigator) between eribulin mesylate and TPC was evaluated using the log rank test, stratified by histology, TPC option, and geographic region, tested at an alpha level of 0.05 (2-sided). PFS censoring rules will be defined in the SAP and follow Federal Department of Agriculture (FDA) guidance.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Eribulin Mesylate', 'description': 'Eribulin mesylate (1.4 mg/m\\^2) was administered IV over 2 to 5 minutes on Day 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.'}, {'id': 'OG001', 'title': 'Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed', 'description': 'TPC: Vinorelbine (30 mg/m\\^2) was administered IV on Day 1 every 7 days, Gemcitabine (1250 mg/m\\^2) was administered IV on Days 1 and 8 every 21 days (or 1000 mg/m\\^2 IV on Days 1, 8, and 15 every 28 days), Docetaxel (75 mg/m\\^2) was administered IV on Day 1 every 21 days, or Pemetrexed (500 mg/m\\^2) was administered IV on Day 1 every 21 days (nonsquamous histology only).'}], 'classes': [{'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000', 'lowerLimit': '8.6', 'upperLimit': '16.7'}, {'value': '15.2', 'groupId': 'OG001', 'lowerLimit': '11.1', 'upperLimit': '20.0'}]}]}], 'analyses': [{'pValue': '0.3034', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The P-value was stratified by histology, TPC option, and geographic region.', 'groupDescription': 'OS was compared between eribulin and TPC testing the following null hypothesis: H0: OS in Arm A (eribulin) is equal to OS in Arm B (TPC) against the alternative: H1: OS in Arm A (eribulin) is not equal to OS in Arm B (TPC).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization (Day 1) to CR or PR', 'description': 'The ORR was defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR) per RECIST criteria. The ORR was estimated by study arm based on the tumor response evaluation as determined by the investigator, according to RECIST 1.1. Participants with unknown response were treated as non-responders. The statistical difference in ORR between treatment arms was evaluated using the Cochran-Mantel-Haenszel (CMH) chi-square test with histology, TPC option, and geographic region as strata, tested at an alpha level of 0.05 (2-sided). The 95 percent confidence interval (CI) was calculated using Clopper Pearson method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A: Eribulin Mesylate', 'description': 'Eribulin mesylate (1.4 milligram per square meter \\[mg/m\\^2\\]) was administered intravenously (IV) over 2 to 5 minutes on Day 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.'}, {'id': 'FG001', 'title': 'Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed', 'description': "Treatment of Physician's Choice (TPC): Vinorelbine (30 mg/m\\^2) was administered IV on Day 1 every 7 days, Gemcitabine (1250 mg/m\\^2) was administered IV on Days 1 and 8 every 21 days (or 1000 mg/m\\^2 IV on Days 1, 8, and 15 every 28 days), Docetaxel (75 mg/m\\^2) was administered IV on Day 1 every 21 days, or Pemetrexed (500 mg/m\\^2) was administered IV on Day 1 every 21 days (nonsquamous histology only)."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '270'}, {'groupId': 'FG001', 'numSubjects': '270'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '270'}, {'groupId': 'FG001', 'numSubjects': '270'}]}], 'dropWithdraws': [{'type': 'Clinical progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'Withdrawn consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '194'}, {'groupId': 'FG001', 'numSubjects': '181'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'A total of 735 participants were screened. Of these, 195 screen failed due to failure to meet inclusion/exclusion criteria, adverse events, withdrawal of consent, or other reason and were not randomized into the study. A total of 540 participants were randomized into the study. Of these, 3 were discontinued prior to treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'BG000'}, {'value': '270', 'groupId': 'BG001'}, {'value': '540', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A: Eribulin Mesylate', 'description': 'Eribulin mesylate (1.4 mg/m\\^2) was administered IV over 2 to 5 minutes on Day 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.'}, {'id': 'BG001', 'title': 'Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed', 'description': 'TPC: Vinorelbine (30 mg/m\\^2) was administered IV on Day 1 every 7 days, Gemcitabine (1250 mg/m\\^2) was administered IV on Days 1 and 8 every 21 days (or 1000 mg/m\\^2 IV on Days 1, 8, and 15 every 28 days), Docetaxel (75 mg/m\\^2) was administered IV on Day 1 every 21 days, or Pemetrexed (500 mg/m\\^2) was administered IV on Day 1 every 21 days (nonsquamous histology only).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.4', 'spread': '9.62', 'groupId': 'BG000'}, {'value': '60.8', 'spread': '9.32', 'groupId': 'BG001'}, {'value': '61.1', 'spread': '9.47', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '163', 'groupId': 'BG000'}, {'value': '169', 'groupId': 'BG001'}, {'value': '332', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set included all randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 540}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-05-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-16', 'studyFirstSubmitDate': '2011-10-13', 'resultsFirstSubmitDate': '2017-01-11', 'studyFirstSubmitQcDate': '2011-10-17', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-11', 'studyFirstPostDateStruct': {'date': '2011-10-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Randomization (Day 1) until date of death from any cause, or 37 months', 'description': 'The OS was defined as the time in months from the date of randomization to the date of death, regardless of cause. In the absence of confirmation of death, the participants were censored either at the date that participant was last known to be alive or the date of study cut-off, whichever was earlier. The two treatment arms were compared using the log-rank test, stratified by histology, TPC option, and geographic region; and the treatment difference between eribulin mesylate and TPC was tested at a significance level of 0.05 (2-sided). Kaplan-Meier (K-M) survival probabilities for each arm were plotted over time. The treatment effect was estimated by fitting a Cox Proportional Hazards model to the OS times including treatment arm as a factor and histology, TPC option and geographic region as strata.'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST)', 'timeFrame': 'Randomization (Day 1) until date of disease progression or death (whichever occurred first), or 37 months', 'description': 'PFS was defined as the time from the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first. The difference in PFS (based on the tumor response evaluation as determined by the investigator) between eribulin mesylate and TPC was evaluated using the log rank test, stratified by histology, TPC option, and geographic region, tested at an alpha level of 0.05 (2-sided). PFS censoring rules will be defined in the SAP and follow Federal Department of Agriculture (FDA) guidance.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Randomization (Day 1) to CR or PR', 'description': 'The ORR was defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR) per RECIST criteria. The ORR was estimated by study arm based on the tumor response evaluation as determined by the investigator, according to RECIST 1.1. Participants with unknown response were treated as non-responders. The statistical difference in ORR between treatment arms was evaluated using the Cochran-Mantel-Haenszel (CMH) chi-square test with histology, TPC option, and geographic region as strata, tested at an alpha level of 0.05 (2-sided). The 95 percent confidence interval (CI) was calculated using Clopper Pearson method.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Non-Small Cell Lung Cancer (NSCLC)']}, 'referencesModule': {'references': [{'pmid': '28911085', 'type': 'DERIVED', 'citation': "Katakami N, Felip E, Spigel DR, Kim JH, Olivo M, Guo M, Nokihara H, Yang JC, Iannotti N, Satouchi M, Barlesi F. A randomized, open-label, multicenter, phase 3 study to compare the efficacy and safety of eribulin to treatment of physician's choice in patients with advanced non-small cell lung cancer. Ann Oncol. 2017 Sep 1;28(9):2241-2247. doi: 10.1093/annonc/mdx284."}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, open-label, multicenter, Phase 3 study, comparing efficacy and safety of eribulin with TPC in subjects with advanced and disease progression following at least two prior regimens for advanced disease, which should have included a platinum-based regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\nSubjects must meet all of the following criteria to be included in this study:\n\n1. Histologically or cytologically confirmed diagnosis of NSCLC.\n2. Documented evidence of advanced NSCLC not amenable to surgery or radiotherapy.\n3. Confirmation of the presence or absence of EGFR mutations prior to study enrolment in all subjects.\n4. Subjects must have received at least two prior regimens for advanced NSCLC, which should have included a platinum-based regimen and, in all subjects with tumors harbouring EGFR mutations, an EGFR TKI.\n5. Radiographic evidence of disease progression on, or after, the last anti-cancer regimen prior to study entry.\n6. Presence of measurable disease.\n7. ECOG performance status of 0, 1, or 2.\n8. Adequate bone marrow\n9. Adequate renal function.\n10. Adequate liver function.\n11. Female subjects of child-bearing potential must agree to use two forms of highly effective contraception.\n12. Male subjects and their female partners who are of child-bearing potential must agree to use two forms of highly effective contraception.\n13. Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.\n14. Males or females aged at least 18 years (or any age greater than 18 years as determined by country legislation) at the time of informed consent.\n\nExclusion:\n\nSubjects who meet any of the following criteria will be excluded from this study:\n\n1. Subjects who have received any anti-cancer therapy within 14 days, or five half-lives of the drug (whichever is longer), prior to randomization.\n2. Subjects who have not recovered from toxicities as a result of prior anti-cancer therapy to less than Grade 2.\n3. Subjects who have previously been treated, or participated in a study with eribulin, whether treated with eribulin or not. The TPC option must not include the same agent which the subject received in a prior regimen.\n4. Peripheral neuropathy more than CTCAE Grade 2.\n5. Significant cardiovascular impairment.\n6. Subjects with a high probability of Long QT Syndrome, or QTc interval \\>500 ms.\n7. Subjects with brain or subdural metastases are not eligible, unless the metastases are asymptomatic and do not require treatment or have been adequately treated by local therapy.\n8. Any serious concomitant illness.\n9. Known HIV positive, or have an infection requiring treatment.\n10. Any malignancy that required treatment, or has shown evidence of recurrence (except for NSCLC, non-melanoma skin cancer, or histologically confirmed complete excision of carcinoma in-situ) during the 5 years prior to study entry.\n11. Female subjects must not be pregnant, and must not be breastfeeding.\n12. Hypersensitivity to either HalB or HalB chemical derivatives or both, or to any of the excipients of the eribulin formulation.'}, 'identificationModule': {'nctId': 'NCT01454934', 'briefTitle': "A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Treatment of Physician's Choice in Subjects With Advanced Non-Small Cell Lung Cancer", 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'orgStudyIdInfo': {'id': 'E7389-G000-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'interventionNames': ['Drug: Eribulin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B', 'interventionNames': ['Drug: TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed']}], 'interventions': [{'name': 'Eribulin', 'type': 'DRUG', 'description': 'Administration of eribulin mesylate at a dose of 1.4 mg/m2 i.v. over 2 to 5 minutes on Days 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.', 'armGroupLabels': ['Arm A']}, {'name': 'TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed', 'type': 'DRUG', 'description': '* Vinorelbine 30 mg/m2 i.v. on Day 1, every 7 days\n* Gemcitabine 1250 mg/m2 i.v. on Days 1 and 8, every 21 days\n* Docetaxel 75 mg/m2 i.v. on Day 1 every 21 days\n* Pemetrexed 500 mg/m2 i.v. on Day 1 every 21 days (nonsquamous histology only).', 'armGroupLabels': ['Arm B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Pleasant Hill', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.94798, 'lon': -122.0608}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'city': 'Washington D.C.', 'state': 'District of 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