Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-26 @ 11:41 PM
Study NCT ID:
NCT01004250
Status:
COMPLETED
Last Update Posted:
2014-05-21
First Post:
2009-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Pemetrexed and Bevacizumab for Participants With Advanced Non-Small Cell 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': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000068258', 'term': 'Bevacizumab'}], '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'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Induction Therapy', 'description': 'Induction Therapy:\n\nBevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.\n\nPemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.\n\nCisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.', 'otherNumAtRisk': 109, 'otherNumAffected': 105, 'seriousNumAtRisk': 109, 'seriousNumAffected': 32}, {'id': 'EG001', 'title': 'Maintenance Therapy', 'description': 'Maintenance Therapy:\n\nBevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.\n\nPemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.', 'otherNumAtRisk': 72, 'otherNumAffected': 68, 'seriousNumAtRisk': 72, 'seriousNumAffected': 14}, {'id': 'EG002', 'title': 'Overall Study Treatment', 'description': 'Induction Therapy:\n\nBevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.\n\nPemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.\n\nCisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.\n\nMaintenance Therapy:\n\nBevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.\n\nPemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.', 'otherNumAtRisk': 109, 'otherNumAffected': 106, 'seriousNumAtRisk': 109, 'seriousNumAffected': 39}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 15, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 12, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 31, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 29, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 27, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 60, 'numAffected': 22}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 19, 'numAffected': 16}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 33, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 21, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 54, 'numAffected': 39}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 29, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 100, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 27, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 128, 'numAffected': 64}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 25, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 28, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 17, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 45, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 47, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 22, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 63, 'numAffected': 51}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 20, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 22, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 34, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 29, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 22, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 19, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 29, 'numAffected': 22}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 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'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Transient global amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Haemoptysis', 'notes': 'Event resulted in 1 death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Idiopathic pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Treatment', 'description': 'Induction Therapy:\n\nBevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.\n\nPemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.\n\nCisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.\n\nMaintenance Therapy:\n\nBevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.\n\nPemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000', 'lowerLimit': '5.7', 'upperLimit': '8.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From enrollment to the first date of objectively determined Progressive Disease (PD) or death from any cause (every other cycle during study treatment and then every 6 weeks during follow-up period)(Baseline up to 36.1 Months)', 'description': 'Progression-Free Survival (PFS) is defined as the time from the date of study enrollment to the first date of objectively determined PD or death from any cause. PD is defined using Response Evaluation Criteria in Solid Tumours (RECIST) Guidelines (Version 1.0), as at least a 20% increase in the sum of longest diameter (LD) of target lesions, taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. For participants not known to have died as of the data cut-off date and who do not have objective PD, PFS will be censored at the date of the last objective progression-free disease assessment. For participants who receive subsequent systemic anticancer therapy, PFS will be censored at the date of the last objective progression-free disease assessment prior to post-discontinuation systemic therapy.', 'unitOfMeasure': 'Months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '30 participants were censored. Participants qualified by the following criteria:\n\n* Confirmed histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV lung cancer\n* At least 1 unidimensionally measurable lesion\n* No concomitant curative anticancer therapy\n* Treated with at least one dose of study drug'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Treatment', 'description': 'Induction Therapy:\n\nBevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.\n\nPemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.\n\nCisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.\n\nMaintenance Therapy:\n\nBevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.\n\nPemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000', 'lowerLimit': '11.5', 'upperLimit': '19.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From enrollment to the date of death from any cause (every cycle during study treatment, every 6 weeks during follow-up period until PD, and then at least every 3 Months) (Baseline up to 36.3 Months)', 'description': 'Overall Survival (OS) is defined as the time from the date of study enrollment to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS will be censored at the last contact date.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '32 participants were censored. All enrolled participants receiving at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Confirmed Complete Response or Partial Response During Study Treatment (Induction and Maintenance)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Treatment', 'description': 'Induction Therapy:\n\nBevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.\n\nPemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.\n\nCisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.\n\nMaintenance Therapy:\n\nBevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.\n\nPemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.2', 'groupId': 'OG000', 'lowerLimit': '32.8', 'upperLimit': '52.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From enrollment to objectively determined PD (assessment during study treatment completed at every other cycle till PD and at 30 day follow-up)(Baseline up to 104.1 Weeks)', 'description': 'Overall Response Rate (ORR) is defined as the percentage of participants whose best response is complete response (CR) or partial response (PR) per RECIST Guidelines, Version 1.0. CR is disappearance of all tumor lesions. PR is either a) at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LDs, or b) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants qualified by the following criteria:\n\n* Confirmed histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV lung cancer\n* At least 1 unidimensionally measurable lesion\n* No concomitant curative anticancer therapy\n* Treated with at least one dose of study drug'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Confirmed Response Complete or Partial Response During the Induction Treatment Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Treatment', 'description': 'Induction Therapy:\n\nBevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.\n\nPemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.\n\nCisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.9', 'groupId': 'OG000', 'lowerLimit': '26.0', 'upperLimit': '44.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the time of study enrollment to the first date of objectively determined PD during the induction therapy (assessment during study treatment completed at every other cycle up to four cycles) (Baseline up to 4 cycles)', 'description': 'CR and PR defined per RECIST Guidelines, Version 1.0. CR is disappearance of all tumor lesions. PR is either a) at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LDs, or b) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants qualified by the following criteria:\n\n* Confirmed histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV lung cancer\n* At least 1 unidimensionally measurable lesion\n* No concomitant curative anticancer therapy\n* Treated with at least one dose of study drug'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Confirmed Complete Response or Partial Response During the Maintenance Therapy Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Treament', 'description': 'Induction Therapy:\n\nBevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.\n\nPemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.\n\nCisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.\n\nMaintenance Therapy:\n\nBevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.\n\nPemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '20.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the start of the maintenance to the first date of objectively determined PD during the maintenance therapy (assessment during maintenance treatment completed at every other cycle till PD and at 30 day follow-up)(Cycle 5 up to 104.1 Weeks)', 'description': 'CR and PR defined per RECIST Guidelines, Version 1.0. CR is disappearance of all tumor lesions. PR is either a) at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LDs, or b) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants qualified by the following criteria:\n\n* Confirmed histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV lung cancer\n* At least 1 unidimensionally measurable lesion\n* No concomitant curative anticancer therapy\n* Treated with at least one dose of study drug'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Study Treatment', 'description': 'Induction Therapy:\n\nBevacizumab: 7.5 milligram per kilogram (mg/kg) given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.\n\nPemetrexed: 500 milligram per square meter (mg/m²) given intravenously on Day 1 for four cycles of Induction Therapy.\n\nCisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.\n\nMaintenance Therapy:\n\nBevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle (cycle=21 days) and continued until progression or unacceptable toxicity.\n\nPemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.'}], 'periods': [{'title': 'Induction Therapy Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}]}, {'type': 'Death (Any Cause) or Disease Progression', 'achievements': [{'comment': 'Participants (pts) with death or disease progression considered to have completed phase.', 'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Entry Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}, {'title': 'Maintenance Therapy Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Did not enter Maint: 21 pts due to death or disease progression; 1 pts had performance status 2.', 'groupId': 'FG000', 'numSubjects': '72'}]}, {'type': 'Death (Any Cause) or Disease Progression', 'achievements': [{'comment': 'Pts with death or disease progression considered to have completed phase.', 'groupId': 'FG000', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}, {'title': 'Follow-Up (FU) Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Did not enter FU:Death-4pts Ind,1pts Maint; Pt Withdrew-1 pts Ind,1pts Maint; Lost to FU-1 pts Maint', 'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'The study had 3 periods: a baseline period; a study treatment period, including both induction (Ind) and maintenance (Maint) treatment; and a follow-up period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Study Treatment', 'description': 'Induction Therapy:\n\nBevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.\n\nPemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.\n\nCisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.\n\nMaintenance Therapy:\n\nBevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.\n\nPemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.1', 'spread': '8.80', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '64', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '108', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Spain', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'ECOG Performance Status', 'classes': [{'title': 'ECOG 0', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}]}]}, {'title': 'ECOG 1', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Eastern Cooperative Oncology Group (ECOG) Performance Status Classifies participants according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death):\n\n0 - Fully Active\n\n1. \\- Ambulatory, Restricted Strenuous Activity\n2. \\- Ambulatory, No Work Activities\n3. \\- Partially Confined to Bed, Limited Self Care\n4. \\- Completely Disabled\n5. \\- Death', 'unitOfMeasure': 'Participants'}, {'title': 'Initial Pathological Diagnosis', 'classes': [{'title': 'Adenocarcinoma', 'categories': [{'measurements': [{'value': '99', 'groupId': 'BG000'}]}]}, {'title': 'Large Cell Lung Carcinoma', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Poorly Differentiated NSCLC', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Non-Small Cell Lung Cancer (NSCLC)', 'unitOfMeasure': 'Participants'}, {'title': 'Stage of Disease', 'classes': [{'title': 'Stage IIIB', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Stage IV', 'categories': [{'measurements': [{'value': '99', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'According to American Joint Committee on Cancer (AJCC) Cancer Staging Manual, sixth edition (2002), stage of disease means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body).\n\nStage IIIB - the cancer has spread to nearby tissue or spread to far away lymph nodes but not spread to other organs\n\nStage IV - the cancer has spread to other organs of the body such as the other lung, brain, or liver', 'unitOfMeasure': 'Participants'}, {'title': 'Tobacco Use', 'classes': [{'title': 'Never Smoked', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'Ex-Smoker', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}]}]}, {'title': 'Current Smoker', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participant'}], 'populationDescription': 'Intent To Treat population who receive at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-23', 'studyFirstSubmitDate': '2009-10-28', 'resultsFirstSubmitDate': '2013-11-07', 'studyFirstSubmitQcDate': '2009-10-28', 'lastUpdatePostDateStruct': {'date': '2014-05-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-11-07', 'studyFirstPostDateStruct': {'date': '2009-10-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival', 'timeFrame': 'From enrollment to the first date of objectively determined Progressive Disease (PD) or death from any cause (every other cycle during study treatment and then every 6 weeks during follow-up period)(Baseline up to 36.1 Months)', 'description': 'Progression-Free Survival (PFS) is defined as the time from the date of study enrollment to the first date of objectively determined PD or death from any cause. PD is defined using Response Evaluation Criteria in Solid Tumours (RECIST) Guidelines (Version 1.0), as at least a 20% increase in the sum of longest diameter (LD) of target lesions, taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. For participants not known to have died as of the data cut-off date and who do not have objective PD, PFS will be censored at the date of the last objective progression-free disease assessment. For participants who receive subsequent systemic anticancer therapy, PFS will be censored at the date of the last objective progression-free disease assessment prior to post-discontinuation systemic therapy.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'From enrollment to the date of death from any cause (every cycle during study treatment, every 6 weeks during follow-up period until PD, and then at least every 3 Months) (Baseline up to 36.3 Months)', 'description': 'Overall Survival (OS) is defined as the time from the date of study enrollment to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS will be censored at the last contact date.'}, {'measure': 'Percentage of Participants With Confirmed Complete Response or Partial Response During Study Treatment (Induction and Maintenance)', 'timeFrame': 'From enrollment to objectively determined PD (assessment during study treatment completed at every other cycle till PD and at 30 day follow-up)(Baseline up to 104.1 Weeks)', 'description': 'Overall Response Rate (ORR) is defined as the percentage of participants whose best response is complete response (CR) or partial response (PR) per RECIST Guidelines, Version 1.0. CR is disappearance of all tumor lesions. PR is either a) at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LDs, or b) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared.'}, {'measure': 'Percentage of Participants With Confirmed Response Complete or Partial Response During the Induction Treatment Only', 'timeFrame': 'From the time of study enrollment to the first date of objectively determined PD during the induction therapy (assessment during study treatment completed at every other cycle up to four cycles) (Baseline up to 4 cycles)', 'description': 'CR and PR defined per RECIST Guidelines, Version 1.0. CR is disappearance of all tumor lesions. PR is either a) at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LDs, or b) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared.'}, {'measure': 'Percentage of Participants With Confirmed Complete Response or Partial Response During the Maintenance Therapy Only', 'timeFrame': 'From the start of the maintenance to the first date of objectively determined PD during the maintenance therapy (assessment during maintenance treatment completed at every other cycle till PD and at 30 day follow-up)(Cycle 5 up to 104.1 Weeks)', 'description': 'CR and PR defined per RECIST Guidelines, Version 1.0. CR is disappearance of all tumor lesions. PR is either a) at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LDs, or b) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Participants with advanced non-small cell lung cancer (NSCLC) will receive a first-line treatment of Pemetrexed, Cisplatin and Bevacizumab as induction therapy followed by a maintenance treatment of Pemetrexed and Bevacizumab. Treatment will continue until disease progression or unacceptable toxicity occurs. The primary objective of this study is to measure how long this treatment could prevent the disease progression.', 'detailedDescription': 'The study will have 3 periods: a baseline period; a study treatment period, including both induction and maintenance treatment; and a follow-up period. Approximately 110 participants will be enrolled into the study, with the aim of having 100 evaluable participants. Eligible participants will first receive 4 cycles of induction chemotherapy with pemetrexed-cisplatin-bevacizumab. Participants who achieve a response or do not progress after completion of induction chemotherapy and have an adequate performance status will receive maintenance therapy with pemetrexed-bevacizumab. Treatment will continue until disease progression or unacceptable toxicity occurs. When treatment is discontinued, the participants health status will be monitored till death, loss to follow-up or data cut-off date.\n\nParticipants who continue to receive benefit from treatment at the time of data cut-off may receive continued access to pemetrexed and bevacizumab until disease progression, unacceptable toxicity, or any other reason at investigator or participants decision.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV NSCLC that is not amenable to curative therapy\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* At least 1 unidimensionally measurable lesion meeting the Response Evaluation Criteria In Solid Tumors (RECIST) criteria\n* Adequate organ function, including the following:\n\n * Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ≥1.5 x 10\\^9 per Liter (10\\^9/L), platelets ≥100 x 10\\^9/L, and hemoglobin ≥10 gram per deciliter (g/dL)\n * Hepatic: bilirubin ≤1.5 times the upper limit of normal (ULN); alkaline phosphatase (AP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤3.0 x ULN (AP, AST, and ALT ≤5 x ULN is acceptable if liver has tumor involvement)\n * Renal: calculated creatinine clearance (CrCl) ≥45 milliliter per minute (mL/min) based on the original weight-based Cockcroft and Gault formula, and serum creatinine ≤1.5 x ULN\n * At the time of enrollment, if the urinalysis dipstick result is ≥2+ for protein, a 24-hour urine collection should be taken. In these cases, participants must have ≤1g protein/24 hours to be eligible for study participation\n* Participants must sign an Informed Consent Document (ICD)\n\nExclusion Criteria:\n\n* Have received prior systemic anticancer therapy for lung cancer (including adjuvant early-stage treatment for NSCLC)\n* Have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV\n* Have a second primary malignancy that is clinically detectable at the time of consideration for study enrollment\n* Have known central nervous system (CNS) disease, other than stable, treated brain metastasis. Stable, treated brain metastasis is defined as metastasis having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and post-treatment brain imaging (Computed Tomography \\[CT\\] scan or magnetic resonance imaging \\[MRI\\])\n* Are receiving concurrent administration of any other antitumor therapy\n* Have a history of gastrointestinal fistula, perforation, or abscess, inflammatory bowel disease, or diverticulitis\n* Have had significant weight loss (that is, ≥10%) over the previous 6 weeks before study entry\n* Have a history of gross hemoptysis (bright red blood of ≥½ teaspoon per episode of coughing) \\<3 months prior to enrollment or history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding\n* Are taking or have recently taken (within 10 days of enrollment) full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes. Prophylactic use of anticoagulants is allowed; international normalized ratio (INR) should be \\<1.5 at study enrollment\n* Have a history of hypertension, unless hypertension is well controlled upon study entry (≤150/90 millimeter of mercury \\[mm Hg\\]) and the participant is on a stable regimen of antihypertensive therapy. Participants should not have any prior history of hypertensive crisis or hypertensive encephalopathy\n* Have had major surgery, open biopsy, or significant traumatic injury within 28 days prior to study enrollment, or anticipate the need for major surgical procedure during the course of the study\n* History of thrombotic disorders within the last 6 months prior to entry'}, 'identificationModule': {'nctId': 'NCT01004250', 'briefTitle': 'A Study of Pemetrexed and Bevacizumab for Participants With Advanced Non-Small Cell Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Single-Arm, Phase 2 Trial of Pemetrexed, Cisplatin,and Bevacizumab as Induction, Followed by Pemetrexed and Bevacizumab as Maintenance, in First-Line Treatment of Nonsquamous Advanced NSCLC', 'orgStudyIdInfo': {'id': '13034'}, 'secondaryIdInfos': [{'id': 'H3E-EW-S125', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Treatment', 'interventionNames': ['Drug: Pemetrexed', 'Drug: Cisplatin', 'Drug: Bevacizumab']}], 'interventions': [{'name': 'Pemetrexed', 'type': 'DRUG', 'otherNames': ['Alimta', 'LY231514'], 'description': '500 milligram per square meter (mg/m²) given intravenously on Day 1 of each 21-day cycle for four cycles of Induction Therapy, and continued in Maintenance Therapy until progression or unacceptable toxicity.', 'armGroupLabels': ['Study Treatment']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': '75 mg/m² given intravenously on Day 1 of 21-day cycle for a maximum of 4 cycles', 'armGroupLabels': ['Study Treatment']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'description': '7.5 milligram per kilogram (mg/kg) given intravenously on Day 1 of 21-day cycle for four cycles of Induction Therapy, and continued in Maintenance Therapy until progression or unacceptable toxicity', 'armGroupLabels': ['Study Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2200', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'zip': '01640', 'city': 'Coswig', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.13204, 'lon': 13.58312}}, {'zip': '60431', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '22087', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '59071', 'city': 'Hamm', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.68033, 'lon': 7.82089}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': 'D-39120', 'city': 'Magdeburg', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '68167', 'city': 'Mannheim', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '73100', 'city': 'Lecce', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.35481, 'lon': 18.17244}}, {'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '00144', 'city': 'Rome', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '20089', 'city': 'Rozzano', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'zip': '38100', 'city': 'Trento', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 46.06787, 'lon': 11.12108}}, {'zip': '23007', 'city': 'Jaén', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.76922, 'lon': -3.79028}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28223', 'city': 'Pozuelo de Alarcón', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.43293, 'lon': -3.81338}}, {'zip': '205 02', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'zip': '17176', 'city': 'Solna', 'country': 'Sweden', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 59.36004, 'lon': 18.00086}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}