Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-27 @ 11:16 PM
Study NCT ID:
NCT00762034
Status:
COMPLETED
Last Update Posted:
2015-12-21
First Post:
2008-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Pemetrexed, Carboplatin and Bevacizumab in Participants With Nonsquamous 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': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'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': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'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': {'description': 'Deaths due to progressive disease are not considered adverse events and reported in the participant flow. All randomized participants who received at least 1 dose of study drug during the specified treatment phase.', 'eventGroups': [{'id': 'EG000', 'title': 'Pem/Carbo/Bev', 'description': 'Induction:\n\nBevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m\\^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days\n\nMaintenance:\n\nPemetrexed: Maintenance therapy 500 mg/m\\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.', 'otherNumAtRisk': 442, 'otherNumAffected': 430, 'seriousNumAtRisk': 442, 'seriousNumAffected': 188}, {'id': 'EG001', 'title': 'Pac/Carbo/Bev', 'description': 'Induction:\n\nPaclitaxel: Induction therapy 200 milligram per meter squared (mg/m ²) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days\n\nMaintenance:\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.', 'otherNumAtRisk': 443, 'otherNumAffected': 433, 'seriousNumAtRisk': 443, 'seriousNumAffected': 181}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 1367, 'numAffected': 177}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 793, 'numAffected': 136}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 387, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 362, 'numAffected': 76}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 733, 'numAffected': 170}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 790, 'numAffected': 219}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 829, 'numAffected': 159}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 452, 'numAffected': 105}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 405, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 12, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 171, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 113, 'numAffected': 39}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 1380, 'numAffected': 181}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 931, 'numAffected': 166}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 536, 'numAffected': 100}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 338, 'numAffected': 118}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 419, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 155, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 249, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 178, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 1465, 'numAffected': 236}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 1157, 'numAffected': 223}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 321, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 159, 'numAffected': 44}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 369, 'numAffected': 114}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 310, 'numAffected': 108}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 230, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 178, 'numAffected': 29}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 2793, 'numAffected': 268}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 2273, 'numAffected': 257}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 229, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 110, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 466, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 249, 'numAffected': 40}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 87, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 196, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 104, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 57, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 111, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 53, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 103, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 53, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 84, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 108, 'numAffected': 42}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 291, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 47, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 207, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 52, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 163, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 29, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 322, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 102, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 106, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 39, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 464, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 470, 'numAffected': 68}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 865, 'numAffected': 133}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 912, 'numAffected': 145}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 194, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 155, 'numAffected': 54}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 251, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 236, 'numAffected': 45}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 70, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 76, 'numAffected': 33}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 169, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 186, 'numAffected': 30}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 272, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 967, 'numAffected': 107}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 299, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 441, 'numAffected': 64}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 83, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 204, 'numAffected': 33}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 197, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 141, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 273, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 246, 'numAffected': 31}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 150, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 394, 'numAffected': 60}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 200, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 413, 'numAffected': 44}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 404, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 298, 'numAffected': 63}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 551, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 283, 'numAffected': 47}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 516, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 343, 'numAffected': 67}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 413, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 1394, 'numAffected': 145}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 85, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 255, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 218, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 888, 'numAffected': 73}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 407, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 379, 'numAffected': 44}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 95, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 48, 'numAffected': 23}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 402, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 414, 'numAffected': 47}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 535, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 719, 'numAffected': 87}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 435, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 449, 'numAffected': 54}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 549, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 568, 'numAffected': 86}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 257, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 126, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 558, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 503, 'numAffected': 85}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 800, 'numAffected': 117}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 599, 'numAffected': 98}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 140, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 115, 'numAffected': 33}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 205, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 153, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 445, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 2024, 'numAffected': 193}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 72, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 91, 'numAffected': 30}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 239, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 177, 'numAffected': 56}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypertension', 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'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nephrotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Renal tubular necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Acquired tracheo-oesophageal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bronchial fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 30, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 22, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 14, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 18, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hydropneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 10, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 21, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 14, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Skin disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lung neoplasm surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Arterial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 16, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 34, 'numAffected': 14}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 7, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Intra-abdominal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Post thrombotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Superior vena cava syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 443, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '472', 'groupId': 'OG000'}, {'value': '467', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pem/Carbo/Bev', 'description': 'Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab\n\nBevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nPemetrexed: Induction therapy 500 milligram per meter squared (mg/m\\^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nPemetrexed: Maintenance therapy 500 mg/m\\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation\n\nCarboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}, {'id': 'OG001', 'title': 'Pac/Carbo/Bev', 'description': 'Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab\n\nPaclitaxel: Induction therapy 200 milligram per meter squared (mg/m\\^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nBevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nCarboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}], 'classes': [{'categories': [{'measurements': [{'value': '12.55', 'groupId': 'OG000', 'lowerLimit': '11.30', 'upperLimit': '14.03'}, {'value': '13.40', 'groupId': 'OG001', 'lowerLimit': '11.86', 'upperLimit': '14.91'}]}]}], 'analyses': [{'pValue': '0.94896', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.16', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to date of death from any cause (up to 37.06 months)', 'description': 'Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants using the intent-to-treat principle. Number of participants censored: n=131, 127 in Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Complete Response (CR) and Partial Response (PR) (Overall Response Rate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '472', 'groupId': 'OG000'}, {'value': '467', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pem/Carbo/Bev', 'description': 'Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab\n\nBevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nPemetrexed: Induction therapy 500 milligram per meter squared (mg/m\\^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nPemetrexed: Maintenance therapy 500 mg/m\\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation\n\nCarboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}, {'id': 'OG001', 'title': 'Pac/Carbo/Bev', 'description': 'Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab\n\nPaclitaxel: Induction therapy 200 milligram per meter squared (mg/m\\^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nBevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nCarboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}], 'classes': [{'categories': [{'measurements': [{'value': '34.1', 'groupId': 'OG000', 'lowerLimit': '29.8', 'upperLimit': '38.6'}, {'value': '33.0', 'groupId': 'OG001', 'lowerLimit': '28.7', 'upperLimit': '37.4'}]}]}], 'analyses': [{'pValue': '0.72997', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to measured progressive disease (up to 37.06 months)', 'description': 'Overall Response Rate (ORR) is the number of participants with a Complete Response (CR) and Partial Response (PR) divided by the total number of randomized participants per arm, then multiplied by 100. Response is based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions compared to baseline or the complete disappearance of target lesions, with persistence of 1 or more nontarget lesion(s) and no new lesions.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants using the intent-to-treat principle'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Complete Response (CR), Partial Response (PR), and Stable Disease (SD) (Disease Control Rate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '472', 'groupId': 'OG000'}, {'value': '467', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pem/Carbo/Bev', 'description': 'Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab\n\nBevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nPemetrexed: Induction therapy 500 milligram per meter squared (mg/m\\^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nPemetrexed: Maintenance therapy 500 mg/m\\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation\n\nCarboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}, {'id': 'OG001', 'title': 'Pac/Carbo/Bev', 'description': 'Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab\n\nPaclitaxel: Induction therapy 200 milligram per meter squared (mg/m\\^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nBevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nCarboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}], 'classes': [{'categories': [{'measurements': [{'value': '65.9', 'groupId': 'OG000', 'lowerLimit': '61.4', 'upperLimit': '70.2'}, {'value': '69.8', 'groupId': 'OG001', 'lowerLimit': '65.4', 'upperLimit': '73.9'}]}]}], 'analyses': [{'pValue': '0.20892', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to measured progressive disease (up to 37.06 months)', 'description': 'Disease Control Rate (DCR) is the number of participants with a Complete Response (CR), Partial Response (PR), and Stable Disease (SD) divided by the total number of randomized participants per arm, then multiplied by 100. Response is based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions compared with baseline or the complete disappearance of target lesions, with persistence of 1 or more nontarget lesion(s) and no new lesions. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions compared with the smallest sum of the longest diameter recorded since the start of treatment or the appearance of 1 or more new lesion(s). Stable Disease (SD) was defined as small changes that did not meet above criteria.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants using the intent-to-treat principle'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '472', 'groupId': 'OG000'}, {'value': '467', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pem/Carbo/Bev', 'description': 'Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab\n\nBevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nPemetrexed: Induction therapy 500 milligram per meter squared (mg/m\\^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nPemetrexed: Maintenance therapy 500 mg/m\\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation\n\nCarboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}, {'id': 'OG001', 'title': 'Pac/Carbo/Bev', 'description': 'Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab\n\nPaclitaxel: Induction therapy 200 milligram per meter squared (mg/m\\^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nBevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nCarboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}], 'classes': [{'categories': [{'measurements': [{'value': '6.04', 'groupId': 'OG000', 'lowerLimit': '5.55', 'upperLimit': '6.87'}, {'value': '5.55', 'groupId': 'OG001', 'lowerLimit': '5.39', 'upperLimit': '5.98'}]}]}], 'analyses': [{'pValue': '0.01206', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.71', 'ciUpperLimit': '0.96', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to measured progressive disease or date of death from any cause (up to 33.54 months)', 'description': 'Progression free survival (PFS) is defined as the time from date of randomization to the date of objective disease progression or death due to any cause. Participants were censored at date of last PFS assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy, whichever was earlier.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants using the intent-to-treat principle. Number of participants censored: n=127, 109 in Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively.'}, {'type': 'SECONDARY', 'title': 'Time to Progressive Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '472', 'groupId': 'OG000'}, {'value': '467', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pem/Carbo/Bev', 'description': 'Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab\n\nBevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nPemetrexed: Induction therapy 500 milligram per meter squared (mg/m\\^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nPemetrexed: Maintenance therapy 500 mg/m\\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation\n\nCarboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}, {'id': 'OG001', 'title': 'Pac/Carbo/Bev', 'description': 'Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab\n\nPaclitaxel: Induction therapy 200 milligram per meter squared (mg/m\\^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nBevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nCarboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}], 'classes': [{'categories': [{'measurements': [{'value': '7.03', 'groupId': 'OG000', 'lowerLimit': '6.24', 'upperLimit': '8.05'}, {'value': '6.04', 'groupId': 'OG001', 'lowerLimit': '5.58', 'upperLimit': '6.87'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.67', 'ciUpperLimit': '0.94', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to measured progressive disease (up to 37.06 months)', 'description': 'Time to progressive disease was defined as the time from randomization to the first date of objective disease progression. Participants were censored at date of last PFS assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy, whichever was earlier.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants using the intent-to-treat principle. Number of participants censored: n=198, 172 in Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively.'}, {'type': 'SECONDARY', 'title': 'Safety and Toxicity Profile of Study Treatments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}, {'value': '443', 'groupId': 'OG002'}, {'value': '298', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pem/Carbo/Bev; Induction Phase', 'description': 'Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab\n\nBevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nPemetrexed: Induction therapy 500 milligram per meter squared (mg/m\\^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nPemetrexed: Maintenance therapy 500 mg/m\\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation\n\nCarboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}, {'id': 'OG001', 'title': 'Pem/Carbo/Bev; Maintenance Phase', 'description': 'Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab\n\nBevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nPemetrexed: Induction therapy 500 milligram per meter squared (mg/m\\^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nPemetrexed: Maintenance therapy 500 mg/m\\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation\n\nCarboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}, {'id': 'OG002', 'title': 'Pac/Carbo/Bev; Induction Phase', 'description': 'Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab\n\nPaclitaxel: Induction therapy 200 milligram per meter squared (mg/m\\^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nBevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nCarboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}, {'id': 'OG003', 'title': 'Pac/Carbo/Bev; Maintenance Phase', 'description': 'Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab\n\nPaclitaxel: Induction therapy 200 milligram per meter squared (mg/m\\^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nBevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nCarboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}], 'classes': [{'title': 'Serious Adverse Events (SAEs)', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}]}, {'title': 'Other Adverse Events (AEs)', 'categories': [{'measurements': [{'value': '432', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}, {'value': '431', 'groupId': 'OG002'}, {'value': '296', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to study endpoint (up to 37.06 months)', 'description': 'Safety and toxicity profile was defined as serious and other non-serious adverse events. A summary of serious and all other non-serious adverse events is located in the Reported Adverse Event module.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug during the specified treatment phase.'}, {'type': 'SECONDARY', 'title': 'Duration of Hospitalizations Per Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pem/Carbo/Bev', 'description': 'Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab\n\nBevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nPemetrexed: Induction therapy 500 milligram per meter squared (mg/m\\^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nPemetrexed: Maintenance therapy 500 mg/m\\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation\n\nCarboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}, {'id': 'OG001', 'title': 'Pac/Carbo/Bev', 'description': 'Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab\n\nPaclitaxel: Induction therapy 200 milligram per meter squared (mg/m\\^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nBevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nCarboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}], 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '6.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to study endpoint (up to 37.06 months)', 'description': 'Length of hospitalization in participants hospitalized during the study or within 30 days of discontinuation regardless of whether the hospitalization was or was not due to study drug.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had at least one hospitalization while on study or within 30 days of discontinuation.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Received a Transfusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}, {'value': '443', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pem/Carbo/Bev', 'description': 'Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab\n\nBevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nPemetrexed: Induction therapy 500 milligram per meter squared (mg/m\\^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nPemetrexed: Maintenance therapy 500 mg/m\\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation\n\nCarboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}, {'id': 'OG001', 'title': 'Pac/Carbo/Bev', 'description': 'Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab\n\nPaclitaxel: Induction therapy 200 milligram per meter squared (mg/m\\^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nBevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nCarboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}], 'classes': [{'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to study endpoint (up to 37.06 months)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Receiving Concomitant Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '472', 'groupId': 'OG000'}, {'value': '467', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pem/Carbo/Bev', 'description': 'Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab\n\nBevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nPemetrexed: Induction therapy 500 milligram per meter squared (mg/m\\^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nPemetrexed: Maintenance therapy 500 mg/m\\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation\n\nCarboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}, {'id': 'OG001', 'title': 'Pac/Carbo/Bev', 'description': 'Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab\n\nPaclitaxel: Induction therapy 200 milligram per meter squared (mg/m\\^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nBevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nCarboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}], 'classes': [{'categories': [{'measurements': [{'value': '406', 'groupId': 'OG000'}, {'value': '421', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to study endpoint (up to 37.06 months)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy - General (FACT-G)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '472', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pem/Carbo/Bev', 'description': 'Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab\n\nBevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nPemetrexed: Induction therapy 500 milligram per meter squared (mg/m\\^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nPemetrexed: Maintenance therapy 500 mg/m\\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation\n\nCarboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}, {'id': 'OG001', 'title': 'Pac/Carbo/Bev', 'description': 'Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab\n\nPaclitaxel: Induction therapy 200 milligram per meter squared (mg/m\\^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nBevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nCarboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.51', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.54', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.667', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, up to first 10 cycles (4 induction and 6 maintenance cycles, cycle=21 days)', 'description': 'The FACT-G is a validated instrument used to measure quality of life (QOL) in participants with cancer consisting of the 27-item questionnaire and is organized into subscales, each designed to assess a QOL domain: physical well-being (PWB)-7 items; social/family well-being (SWB)-7 items; emotional well-being (EWB)-6 items; functional well-being (FWB)-7 items. Each item uses a 5 point rating scale (0="not at all" and 4=equals "very much"). FACT-G Total is the sum of the scores of all 4 subscales and ranges from 0 to 108. Higher scores indicate better QOL. Least squares mean (LSmean) change is calculated using the linear-mixed model (LMM) analysis controlled for treatment, baseline value, time point and treatment by time point interaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The LMM analysis includes data from all participants in each arm for whom a validated translation is available in a language in which the completer (participant) is fluent and have evaluable FACT-G data, using the intent-to-treat principle.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Lung (FACT-L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '472', 'groupId': 'OG000'}, {'value': '467', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pem/Carbo/Bev', 'description': 'Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab\n\nBevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nPemetrexed: Induction therapy 500 milligram per meter squared (mg/m\\^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nPemetrexed: Maintenance therapy 500 mg/m\\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation\n\nCarboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}, {'id': 'OG001', 'title': 'Pac/Carbo/Bev', 'description': 'Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab\n\nPaclitaxel: Induction therapy 200 milligram per meter squared (mg/m\\^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nBevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nCarboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}], 'classes': [{'title': 'FACT-L Total Score (n=397, 392)', 'categories': [{'measurements': [{'value': '1.88', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '1.66', 'spread': '0.66', 'groupId': 'OG001'}]}]}, {'title': 'Trial Outcome Index-Lung (TOI-L) (n=396, 394)', 'categories': [{'measurements': [{'value': '-0.38', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '-0.40', 'spread': '0.50', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.815', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'p-value for FACT-L Total; Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.978', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'p-value for FACT-L TOI; Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, up to first 10 cycles (4 induction and 6 maintenance cycles, cycle=21 days)', 'description': 'FACT-L is a valid instrument used to measure quality of life (QOL) in participants with cancer consisting of the 27-item FACT-General (G) and 9-item lung cancer subscale (LCS). FACT-G is organized into subscales: physical well-being (PWB)-7 items; social/family well-being (SWB)-7 items; emotional well-being (EWB)-6 items; functional well-being (FWB)-7 items. Each item uses a 5 point rating scale (0="not at all" and 4=equals "very much"). FACT-L Total Score=4 subscales + LCS and ranges from 0 to 144. Trial Outcome Index-Lung (TOI-L)=PWB+FWB+LCS and ranges from 0 to 92. Higher scores indicate better QOL. Least squares mean (LSmean) change is calculated using the linear-mixed model (LMM) analysis controlled for treatment, baseline value, time point and treatment by time point interaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The LMM analysis includes data from all participants in each arm for whom a validated translation is available in a language in which the completer (participant) is fluent and have evaluable FACT-L, using the intent-to-treat principle.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group- Neurotoxicity (FACT/GOG-Ntx)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '472', 'groupId': 'OG000'}, {'value': '467', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pem/Carbo/Bev', 'description': 'Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab\n\nBevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nPemetrexed: Induction therapy 500 milligram per meter squared (mg/m\\^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nPemetrexed: Maintenance therapy 500 mg/m\\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation\n\nCarboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}, {'id': 'OG001', 'title': 'Pac/Carbo/Bev', 'description': 'Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab\n\nPaclitaxel: Induction therapy 200 milligram per meter squared (mg/m\\^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nBevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nCarboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}], 'classes': [{'title': 'FACT/GOG-Ntx Total Score (n=393, 389)', 'categories': [{'measurements': [{'value': '-0.60', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '-5.48', 'spread': '0.70', 'groupId': 'OG001'}]}]}, {'title': 'Ntx Trial Outcome Index (TOI-Ntx)(n=393, 390)', 'categories': [{'measurements': [{'value': '-2.79', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '-7.60', 'spread': '0.55', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'p-value for FACT/GOG-Ntx Total; Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'p-value for FACT/GOG-Ntx TOI; Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, up to first 10 cycles (4 induction and 6 maintenance cycles, cycle=21 days)', 'description': 'FACT/GOG-Ntx is a validated instrument used to measure quality of life (QOL) in participants with cancer and neurotoxicity (Ntx) consisting of 27-item FACT-General (G) and 11-item Ntx subscale. FACT-G is organized into domain subscales: physical well-being (PWB)-7 items; social/family well-being (SWB)-7 items; emotional well-being (EWB)-6 items; functional well-being (FWB)-7 items; each uses a 5 point rating scale (0="not at all" and 4=equals "very much"). FACT/GOG-Ntx Total Score=sum 5 subscales and ranges from 0-152. Ntx Trial Outcome Index (TOI-Ntx)=PWB+FWB+NTX and range from 0-100. For all FACT scales, higher scores indicate better QOL. Least squares mean (LSmean) change is calculated using the linear-mixed model (LMM) analysis controlled for treatment, baseline value, time point and treatment by time point interaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The LMM analysis includes data from all participants in each arm for whom a validated translation is available in a language in which the completer (participant) is fluent and have evaluable FACT/GOG-Ntx data, using the intent-to-treat principle.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Pemetrexed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pem/Carbo/Bev', 'description': 'Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev)followed by pemetrexed and bevacizumab\n\nBevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nPemetrexed: Induction therapy 500 milligram per meter squared (mg/m\\^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nPemetrexed: Maintenance therapy 500 mg/m\\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation\n\nCarboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}], 'classes': [{'categories': [{'measurements': [{'value': '122', 'spread': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)', 'unitOfMeasure': 'micrograms per milliliter (μg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized to Pem/Carbo/Bev, who received study drug, and had evaluable Cmax data.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Elimination Half-life (t1/2) for Pemetrexed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pem/Carbo/Bev', 'description': 'Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab\n\nBevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nPemetrexed: Induction therapy 500 milligram per meter squared (mg/m\\^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nPemetrexed: Maintenance therapy 500 mg/m\\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation\n\nCarboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}], 'classes': [{'categories': [{'measurements': [{'value': '2.88', 'spread': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)', 'unitOfMeasure': 'hours (hr)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized to Pem/Carbo/Bev, who received study drug, and had evaluable t1/2 data.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) for Pemetrexed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pem/Carbo/Bev', 'description': 'Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab\n\nBevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nPemetrexed: Induction therapy 500 milligram per meter squared (mg/m\\^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nPemetrexed: Maintenance therapy 500 mg/m\\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation\n\nCarboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}], 'classes': [{'categories': [{'measurements': [{'value': '203', 'spread': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)', 'unitOfMeasure': 'microgram*hour per milliliter (μg•hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized to Pem/Carbo/Bev, who received study drug, and had evaluable AUC(0-∞) data.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Pemetrexed Clearance (CL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pem/Carbo/Bev', 'description': 'Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab\n\nBevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nPemetrexed: Induction therapy 500 milligram per meter squared (mg/m\\^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nPemetrexed: Maintenance therapy 500 mg/m\\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation\n\nCarboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}], 'classes': [{'categories': [{'measurements': [{'value': '72.1', 'spread': '25', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)', 'unitOfMeasure': 'milliliters per minute (mL/min)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized to Pem/Carbo/Bev, who received study drug, and had evaluable CL data.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Total (Bound and Unbound) Platinum and Unbound Platinum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pem/Carbo/Bev', 'description': 'Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab\n\nBevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nPemetrexed: Induction therapy 500 milligram per meter squared (mg/m\\^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nPemetrexed: Maintenance therapy 500 mg/m\\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation\n\nCarboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}, {'id': 'OG001', 'title': 'Pac/Carbo/Bev', 'description': 'Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab\n\nPaclitaxel: Induction therapy 200 milligram per meter squared (mg/m\\^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nBevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nCarboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}], 'classes': [{'title': 'Total (Bound and Unbound)', 'categories': [{'measurements': [{'value': '18.4', 'spread': '24', 'groupId': 'OG000'}, {'value': '17.8', 'spread': '33', 'groupId': 'OG001'}]}]}, {'title': 'Unbound (n=18, 15)', 'categories': [{'measurements': [{'value': '21.1', 'spread': '31', 'groupId': 'OG000'}, {'value': '17.1', 'spread': '34', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)', 'description': 'Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.', 'unitOfMeasure': 'micrograms per milliliter (μg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received study drug and had evaluable Cmax data.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Elimination Half-life (t1/2) for Total (Bound and Unbound) Platinum and Unbound Platinum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pem/Carbo/Bev', 'description': 'Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab\n\nBevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nPemetrexed: Induction therapy 500 milligram per meter squared (mg/m\\^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nPemetrexed: Maintenance therapy 500 mg/m\\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation\n\nCarboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}, {'id': 'OG001', 'title': 'Pac/Carbo/Bev', 'description': 'Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab\n\nPaclitaxel: Induction therapy 200 milligram per meter squared (mg/m\\^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nBevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nCarboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}], 'classes': [{'title': 'Total (Bound and Unbound)', 'categories': [{'measurements': [{'value': '65.6', 'spread': '69', 'groupId': 'OG000'}, {'value': '86.4', 'spread': '21', 'groupId': 'OG001'}]}]}, {'title': 'Unbound (n=17, 13)', 'categories': [{'measurements': [{'value': '2.03', 'spread': '15', 'groupId': 'OG000'}, {'value': '1.95', 'spread': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)', 'description': 'Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.', 'unitOfMeasure': 'hours (hr)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received study drug and had evaluable t1/2 data.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) for Total (Bound and Unbound) Platinum and Unbound Platinum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pem/Carbo/Bev', 'description': 'Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab\n\nBevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nPemetrexed: Induction therapy 500 milligram per meter squared (mg/m\\^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nPemetrexed: Maintenance therapy 500 mg/m\\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation\n\nCarboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}, {'id': 'OG001', 'title': 'Pac/Carbo/Bev', 'description': 'Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab\n\nPaclitaxel: Induction therapy 200 milligram per meter squared (mg/m\\^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nBevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nCarboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}], 'classes': [{'title': 'Total (Bound and Unbound)', 'categories': [{'measurements': [{'value': '160', 'spread': '32', 'groupId': 'OG000'}, {'value': '182', 'spread': '24', 'groupId': 'OG001'}]}]}, {'title': 'Unbound (n=17, 13)', 'categories': [{'measurements': [{'value': '55.7', 'spread': '33', 'groupId': 'OG000'}, {'value': '62.9', 'spread': '34', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)', 'description': 'Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.', 'unitOfMeasure': 'microgram*hour per milliliter (μg•hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received study drug and had evaluable AUC(0-∞) data.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Platinum Clearance (CL) for Total (Bound and Unbound) and Unbound Forms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pem/Carbo/Bev', 'description': 'Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab\n\nBevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nPemetrexed: Induction therapy 500 milligram per meter squared (mg/m\\^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nPemetrexed: Maintenance therapy 500 mg/m\\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation\n\nCarboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}, {'id': 'OG001', 'title': 'Pac/Carbo/Bev', 'description': 'Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab\n\nPaclitaxel: Induction therapy 200 milligram per meter squared (mg/m\\^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nBevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nCarboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}], 'classes': [{'title': 'Total (Bound and Unbound)', 'categories': [{'measurements': [{'value': '2.02', 'spread': '39', 'groupId': 'OG000'}, {'value': '1.87', 'spread': '28', 'groupId': 'OG001'}]}]}, {'title': 'Unbound (n=17, 13)', 'categories': [{'measurements': [{'value': '5.81', 'spread': '35', 'groupId': 'OG000'}, {'value': '5.36', 'spread': '47', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)', 'description': 'Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.', 'unitOfMeasure': 'liters per hour (L/hr)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received study drug and had evaluable CL data.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Bevacizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pem/Carbo/Bev', 'description': 'Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab\n\nBevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nPemetrexed: Induction therapy 500 milligram per meter squared (mg/m\\^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nPemetrexed: Maintenance therapy 500 mg/m\\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation\n\nCarboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}, {'id': 'OG001', 'title': 'Pac/Carbo/Bev', 'description': 'Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab\n\nPaclitaxel: Induction therapy 200 milligram per meter squared (mg/m\\^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nBevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nCarboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}], 'classes': [{'categories': [{'measurements': [{'value': '276', 'spread': '18', 'groupId': 'OG000'}, {'value': '302', 'spread': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)', 'unitOfMeasure': 'micrograms per milliliter (μg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received study drug and had evaluable Cmax data.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Elimination Half-life (t1/2) for Bevacizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pem/Carbo/Bev', 'description': 'Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab\n\nBevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nPemetrexed: Induction therapy 500 milligram per meter squared (mg/m\\^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nPemetrexed: Maintenance therapy 500 mg/m\\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation\n\nCarboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}, {'id': 'OG001', 'title': 'Pac/Carbo/Bev', 'description': 'Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab\n\nPaclitaxel: Induction therapy 200 milligram per meter squared (mg/m\\^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nBevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nCarboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}], 'classes': [{'categories': [{'measurements': [{'value': '14.8', 'spread': '36', 'groupId': 'OG000'}, {'value': '12.8', 'spread': '46', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)', 'unitOfMeasure': 'days', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received study drug and had evaluable t1/2 data.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) Bevacizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pem/Carbo/Bev', 'description': 'Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab\n\nBevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nPemetrexed: Induction therapy 500 milligram per meter squared (mg/m\\^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nPemetrexed: Maintenance therapy 500 mg/m\\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation\n\nCarboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}, {'id': 'OG001', 'title': 'Pac/Carbo/Bev', 'description': 'Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab\n\nPaclitaxel: Induction therapy 200 milligram per meter squared (mg/m\\^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nBevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nCarboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}], 'classes': [{'categories': [{'measurements': [{'value': '3070', 'spread': '29', 'groupId': 'OG000'}, {'value': '3160', 'spread': '33', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)', 'unitOfMeasure': 'microgram*day per milliliter (μg•day/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received study drug and had evaluable AUC(0-∞) data.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Bevacizumab Clearance (CL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pem/Carbo/Bev', 'description': 'Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab\n\nBevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nPemetrexed: Induction therapy 500 milligram per meter squared (mg/m\\^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nPemetrexed: Maintenance therapy 500 mg/m\\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation\n\nCarboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}, {'id': 'OG001', 'title': 'Pac/Carbo/Bev', 'description': 'Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab\n\nPaclitaxel: Induction therapy 200 milligram per meter squared (mg/m\\^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nBevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nCarboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.341', 'spread': '31', 'groupId': 'OG000'}, {'value': '0.376', 'spread': '38', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)', 'unitOfMeasure': 'liters per day (L/day)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received study drug and had evaluable CL data.'}, {'type': 'SECONDARY', 'title': 'Translational Research: Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pem or Pac Plus Carbo/Bev', 'description': 'Participants who received either Pem/Carbo/Bev or Pac/Carbo/Bev treatment.\n\nPem/Carbo/Bev Treatment-500 mg per meter squared (mg/m\\^2) Pem IV every 21 days, plus Carbo AUC 6 IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21.\n\nOR\n\nPac/Carbo/Bev Treatment-200 mg/m\\^2 Pac IV and AUC 6 Carbo IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21 days.'}], 'classes': [{'title': 'EGFR mutation positive', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'EGFR mutation negative', 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Epidermal Growth Factor Receptor (EGFR) mutations were measured by polymerase chain reaction (PCR).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with EGFR data regardless of study treatment.'}, {'type': 'SECONDARY', 'title': 'Translational Research: Overall Survival (OS) Based on Nuclear Thyroid Transcription Factor-1 (TTF-1) Expression Regardless of Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TTF-1 Positive (H Score > 0)', 'description': 'Participants who were TTF-1 Positive (H score \\> 0) and received either Pem/Carbo/Bev or Pac/Carbo/Bev treatment.\n\nPem/Carbo/Bev Treatment-500 mg per meter squared (mg/m\\^2) Pem IV every 21 days, plus Carbo AUC 6 IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21.\n\nOR\n\nPac/Carbo/Bev Treatment-200 mg/m\\^2 Pac IV and AUC 6 Carbo IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21 days.'}, {'id': 'OG001', 'title': 'TTF-1 Negative (H Score = 0)', 'description': 'Participants who were TTF-1 Negative (H score = 0) and received either Pem/Carbo/Bev or Pac/Carbo/Bev treatment.\n\nPem/Carbo/Bev Treatment-500 mg per meter squared (mg/m\\^2) Pem IV every 21 days, plus Carbo AUC 6 IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21.\n\nOR\n\nPac/Carbo/Bev Treatment-200 mg/m\\^2 Pac IV and AUC 6 Carbo IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000', 'lowerLimit': '12.8', 'upperLimit': '17.6'}, {'value': '8.7', 'groupId': 'OG001', 'lowerLimit': '6.4', 'upperLimit': '10.5'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.480', 'ciLowerLimit': '0.338', 'ciUpperLimit': '0.681', 'pValueComment': 'p-value was not adjusted for multiple comparisons.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to date of death from any cause (up to 37.06 months)', 'description': 'Nuclear Thyroid Transcription Factor-1 (TTF-1) expression was measured using an Immunohistochemistry (IHC) assay which were scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system, and H score is a calculated using formula: 1x(percentage of cells stained 1+) + 2x(percentage of cells stained 2+) + 3x(percentage of cells stained 3+). TTF-1 Positive have an H score \\>0 and TTF-1 Negative have an H score=0. Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with TTF-1 H scores regardless of study treatment. Participants censored: n=38, 11 in the TTF-1 Nuclear Positive and Negative arms, respectively.'}, {'type': 'SECONDARY', 'title': 'Translational Research: Overall Survival (OS) Based on Cytoplasmic and Nuclear Thymidylate Synthase (TS) Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pem/Carbo/Bev', 'description': 'Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab\n\nBevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nPemetrexed: Induction therapy 500 milligram per meter squared (mg/m\\^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nPemetrexed: Maintenance therapy 500 mg/m\\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation\n\nCarboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}, {'id': 'OG001', 'title': 'Pac/Carbo/Bev', 'description': 'Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab\n\nPaclitaxel: Induction therapy 200 milligram per meter squared (mg/m\\^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nBevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nCarboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}], 'classes': [{'title': 'TS Cytoplasm Positive (H score > 0; n=90, 83)', 'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000', 'lowerLimit': '10.8', 'upperLimit': '16.9'}, {'value': '12.4', 'groupId': 'OG001', 'lowerLimit': '10.9', 'upperLimit': '15.5'}]}]}, {'title': 'TS Cytoplasm Negative (H score = 0; n=10, 6)', 'categories': [{'measurements': [{'value': '18.2', 'comment': 'Not calculable due to the low number of participants reaching endpoint event of death.', 'groupId': 'OG000', 'lowerLimit': '12.5', 'upperLimit': 'NA'}, {'value': '11.6', 'groupId': 'OG001', 'lowerLimit': '9.1', 'upperLimit': '14.7'}]}]}, {'title': 'TS Nucleus Positive (H score > 0; n=68, 51)', 'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000', 'lowerLimit': '9.7', 'upperLimit': '15.4'}, {'value': '12.4', 'groupId': 'OG001', 'lowerLimit': '8.4', 'upperLimit': '15.5'}]}]}, {'title': 'TS Nucleus Negative (H score = 0; n=32, 38)', 'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000', 'lowerLimit': '12.5', 'upperLimit': '24.1'}, {'value': '12.4', 'groupId': 'OG001', 'lowerLimit': '10.1', 'upperLimit': '17.1'}]}]}], 'analyses': [{'pValue': '0.673', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.927', 'ciLowerLimit': '0.654', 'ciUpperLimit': '1.316', 'pValueComment': 'p-value is for TS Cytoplasm Positive (H score \\> 0) comparing treatment arms and was not adjusted for multiple comparisons.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.287', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.521', 'ciLowerLimit': '0.157', 'ciUpperLimit': '1.729', 'pValueComment': 'p-value is for TS Cytoplasm Negative (H score = 0) comparing treatment arms and was not adjusted for multiple comparisons.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.759', 'ciLowerLimit': '0.498', 'ciUpperLimit': '1.157', 'pValueComment': 'p-value is for TS Nucleus Positive (H score \\> 0) comparing treatment arms and was not adjusted for multiple comparisons.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.915', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.969', 'ciLowerLimit': '0.540', 'ciUpperLimit': '1.738', 'pValueComment': 'p-value is for TS Nucleus Negative (H score = 0) comparing treatment arms and was not adjusted for multiple comparisons.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to date of death from any cause (up to 37.06 months)', 'description': 'Cytoplasmic and nuclear Thymidylate Synthase (TS) expression was measured using an Immunohistochemistry (IHC) assay which were scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system for cytoplasmic and nuclear staining, and H score was calculated using formula: 1x(percentage of cells stained 1+) + 2x(percentage of cells stained 2+) + 3x(percentage of cells stained 3+). TS Positive have an H score \\>0 and TS Negative have an H score=0. Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with TS Cytoplasm and Nucleus H scores. Participants censored: TS Cytoplasm Positive n=23, 20 and Negative n=4, 1; TS Nucleus Positive n=17, 9 and Negative n=10, 12 for the Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively.'}, {'type': 'SECONDARY', 'title': 'Translational Research: Overall Survival (OS) Based on Cytoplasmic and Membrane Folate Receptor Alpha (FR-α) Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pem/Carbo/Bev', 'description': 'Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab\n\nBevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nPemetrexed: Induction therapy 500 milligram per meter squared (mg/m\\^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nPemetrexed: Maintenance therapy 500 mg/m\\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation\n\nCarboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}, {'id': 'OG001', 'title': 'Pac/Carbo/Bev', 'description': 'Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab\n\nPaclitaxel: Induction therapy 200 milligram per meter squared (mg/m\\^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nBevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nCarboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}], 'classes': [{'title': 'FR-α Cytoplasm Positive (H score > 0; n=64, 53)', 'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000', 'lowerLimit': '11.4', 'upperLimit': '22.2'}, {'value': '14.3', 'groupId': 'OG001', 'lowerLimit': '11.2', 'upperLimit': '18.2'}]}]}, {'title': 'FR-α Cytoplasm Negative (H score = 0; n=34, 29)', 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000', 'lowerLimit': '9.6', 'upperLimit': '16.9'}, {'value': '11.2', 'groupId': 'OG001', 'lowerLimit': '5.7', 'upperLimit': '14.4'}]}]}, {'title': 'FR-α Membrane Positive (H score > 0; n=39, 22)', 'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000', 'lowerLimit': '10.5', 'upperLimit': '30.8'}, {'value': '15.5', 'comment': 'Not calculable due to the low number of participants reaching endpoint event of death.', 'groupId': 'OG001', 'lowerLimit': '11.2', 'upperLimit': 'NA'}]}]}, {'title': 'FR-α Membrane Negative (H score = 0; n=59, 60)', 'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000', 'lowerLimit': '9.6', 'upperLimit': '16.7'}, {'value': '11.3', 'groupId': 'OG001', 'lowerLimit': '8.8', 'upperLimit': '14.7'}]}]}], 'analyses': [{'pValue': '0.891', 'groupIds': ['OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.970', 'ciLowerLimit': '0.622', 'ciUpperLimit': '1.511', 'pValueComment': 'p-value for FR-α Cytoplasm Positive (H score \\> 0) comparing treatment arms and was not adjusted for multiple comparisons.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.060', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.592', 'ciLowerLimit': '0.342', 'ciUpperLimit': '1.023', 'pValueComment': 'p-value for FR-α Cytoplasm Negative (H score = 0) comparing treatment arms and was not adjusted for multiple comparisons.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.905', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.960', 'ciLowerLimit': '0.490', 'ciUpperLimit': '1.880', 'pValueComment': 'p-value for FR-α Membrane Positive (H score \\> 0) comparing treatment arms and was not adjusted for multiple comparisons.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.455', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.859', 'ciLowerLimit': '0.575', 'ciUpperLimit': '1.281', 'pValueComment': 'p-value for FR-α Membrane Negative (H score = 0) comparing treatment arms and was not adjusted for multiple comparisons.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to date of death from any cause (up to 37.06 months)', 'description': 'Cytoplasmic and membrane Folate Receptor Alpha (FR-α) expression was measured using an Immunohistochemistry (IHC) assay which were scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system for cytoplasmic or membrane staining, and H score is a calculated using formula: 1x(percentage of cells stained 1+) + 2x(percentage of cells stained 2+) + 3x(percentage of cells stained 3+). FR-α Positive have an H score \\>0 and FR-α Negative have an H score=0. Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with FR-α Cytoplasm or Membrane H scores. Participants censored: FR-α Positive Cytoplasm n=21, 15 and Negative n=4, 3; FR-α Membrane Positive n=16, 8 and Negative n=9, 10 for Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pem/Carbo/Bev', 'description': 'Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab\n\nBevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nPemetrexed: Induction therapy 500 milligram per meter squared (mg/m\\^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nPemetrexed: Maintenance therapy 500 mg/m\\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation\n\nCarboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}, {'id': 'FG001', 'title': 'Pac/Carbo/Bev', 'description': 'Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab\n\nPaclitaxel: Induction therapy 200 milligram per meter squared (mg/m\\^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nBevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nCarboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}], 'periods': [{'title': 'Induction Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '472'}, {'groupId': 'FG001', 'numSubjects': '467'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '442'}, {'groupId': 'FG001', 'numSubjects': '443'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '294'}, {'groupId': 'FG001', 'numSubjects': '298'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '178'}, {'groupId': 'FG001', 'numSubjects': '169'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Entry Criterion Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'Deaths Not Due to Study Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Deaths Due to Study Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}, {'title': 'Maintenance Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '294'}, {'groupId': 'FG001', 'numSubjects': '298'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '294'}, {'groupId': 'FG001', 'numSubjects': '298'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '294'}, {'groupId': 'FG001', 'numSubjects': '298'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Entry Criterion Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '186'}, {'groupId': 'FG001', 'numSubjects': '224'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Death not due to study disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Death due to study disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '472', 'groupId': 'BG000'}, {'value': '467', 'groupId': 'BG001'}, {'value': '939', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pem/Carbo/Bev', 'description': 'Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab\n\nBevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nPemetrexed: Induction therapy 500 milligram per meter squared (mg/m\\^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nPemetrexed: Maintenance therapy 500 mg/m\\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation\n\nCarboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}, {'id': 'BG001', 'title': 'Pac/Carbo/Bev', 'description': 'Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab\n\nPaclitaxel: Induction therapy 200 milligram per meter squared (mg/m\\^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days\n\nBevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days\n\nBevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.\n\nCarboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<=65 years', 'categories': [{'measurements': [{'value': '249', 'groupId': 'BG000'}, {'value': '236', 'groupId': 'BG001'}, {'value': '485', 'groupId': 'BG002'}]}]}, {'title': '>65 years', 'categories': [{'measurements': [{'value': '223', 'groupId': 'BG000'}, {'value': '231', 'groupId': 'BG001'}, {'value': '454', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '221', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '439', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '251', 'groupId': 'BG000'}, {'value': '249', 'groupId': 'BG001'}, {'value': '500', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '409', 'groupId': 'BG000'}, {'value': '396', 'groupId': 'BG001'}, {'value': '805', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Multiple race/ethnicities', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Information not provided', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '472', 'groupId': 'BG000'}, {'value': '467', 'groupId': 'BG001'}, {'value': '939', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Previously Treated Brain Metastasis', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '420', 'groupId': 'BG000'}, {'value': '415', 'groupId': 'BG001'}, {'value': '835', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Histological Subtype', 'classes': [{'title': 'Adenocarcinoma, Lung', 'categories': [{'measurements': [{'value': '367', 'groupId': 'BG000'}, {'value': '360', 'groupId': 'BG001'}, {'value': '727', 'groupId': 'BG002'}]}]}, {'title': 'Bronchioalveolar Carcinoma', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Large Cell Lung Carcinoma', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'NSCLC Not Otherwise Specified', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}, {'title': 'NSCLC Poorly Differentiated', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}, {'title': 'Predominantly Adenocarcinoma', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Non-small Cell Lung Carcinoma (NSCLC)', 'unitOfMeasure': 'participants'}, {'title': 'Histological Category for Subgroup Analyses', 'classes': [{'title': 'Adenocarcinoma', 'categories': [{'measurements': [{'value': '378', 'groupId': 'BG000'}, {'value': '365', 'groupId': 'BG001'}, {'value': '743', 'groupId': 'BG002'}]}]}, {'title': 'Large Cell Carcinoma', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Other or Indeterminant', 'categories': [{'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 939}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-16', 'studyFirstSubmitDate': '2008-09-26', 'resultsFirstSubmitDate': '2013-03-28', 'studyFirstSubmitQcDate': '2008-09-26', 'lastUpdatePostDateStruct': {'date': '2015-12-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-09-26', 'studyFirstPostDateStruct': {'date': '2008-09-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Baseline to date of death from any cause (up to 37.06 months)', 'description': 'Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With a Complete Response (CR) and Partial Response (PR) (Overall Response Rate)', 'timeFrame': 'Baseline to measured progressive disease (up to 37.06 months)', 'description': 'Overall Response Rate (ORR) is the number of participants with a Complete Response (CR) and Partial Response (PR) divided by the total number of randomized participants per arm, then multiplied by 100. Response is based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions compared to baseline or the complete disappearance of target lesions, with persistence of 1 or more nontarget lesion(s) and no new lesions.'}, {'measure': 'Percentage of Participants With a Complete Response (CR), Partial Response (PR), and Stable Disease (SD) (Disease Control Rate)', 'timeFrame': 'Baseline to measured progressive disease (up to 37.06 months)', 'description': 'Disease Control Rate (DCR) is the number of participants with a Complete Response (CR), Partial Response (PR), and Stable Disease (SD) divided by the total number of randomized participants per arm, then multiplied by 100. Response is based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions compared with baseline or the complete disappearance of target lesions, with persistence of 1 or more nontarget lesion(s) and no new lesions. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions compared with the smallest sum of the longest diameter recorded since the start of treatment or the appearance of 1 or more new lesion(s). Stable Disease (SD) was defined as small changes that did not meet above criteria.'}, {'measure': 'Progression Free Survival Time', 'timeFrame': 'Baseline to measured progressive disease or date of death from any cause (up to 33.54 months)', 'description': 'Progression free survival (PFS) is defined as the time from date of randomization to the date of objective disease progression or death due to any cause. Participants were censored at date of last PFS assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy, whichever was earlier.'}, {'measure': 'Time to Progressive Disease', 'timeFrame': 'Baseline to measured progressive disease (up to 37.06 months)', 'description': 'Time to progressive disease was defined as the time from randomization to the first date of objective disease progression. Participants were censored at date of last PFS assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy, whichever was earlier.'}, {'measure': 'Safety and Toxicity Profile of Study Treatments', 'timeFrame': 'Baseline to study endpoint (up to 37.06 months)', 'description': 'Safety and toxicity profile was defined as serious and other non-serious adverse events. A summary of serious and all other non-serious adverse events is located in the Reported Adverse Event module.'}, {'measure': 'Duration of Hospitalizations Per Participant', 'timeFrame': 'Baseline to study endpoint (up to 37.06 months)', 'description': 'Length of hospitalization in participants hospitalized during the study or within 30 days of discontinuation regardless of whether the hospitalization was or was not due to study drug.'}, {'measure': 'Number of Participants Who Received a Transfusion', 'timeFrame': 'Baseline to study endpoint (up to 37.06 months)'}, {'measure': 'Number of Participants Receiving Concomitant Medication', 'timeFrame': 'Baseline to study endpoint (up to 37.06 months)'}, {'measure': 'Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy - General (FACT-G)', 'timeFrame': 'Baseline, up to first 10 cycles (4 induction and 6 maintenance cycles, cycle=21 days)', 'description': 'The FACT-G is a validated instrument used to measure quality of life (QOL) in participants with cancer consisting of the 27-item questionnaire and is organized into subscales, each designed to assess a QOL domain: physical well-being (PWB)-7 items; social/family well-being (SWB)-7 items; emotional well-being (EWB)-6 items; functional well-being (FWB)-7 items. Each item uses a 5 point rating scale (0="not at all" and 4=equals "very much"). FACT-G Total is the sum of the scores of all 4 subscales and ranges from 0 to 108. Higher scores indicate better QOL. Least squares mean (LSmean) change is calculated using the linear-mixed model (LMM) analysis controlled for treatment, baseline value, time point and treatment by time point interaction.'}, {'measure': 'Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Lung (FACT-L)', 'timeFrame': 'Baseline, up to first 10 cycles (4 induction and 6 maintenance cycles, cycle=21 days)', 'description': 'FACT-L is a valid instrument used to measure quality of life (QOL) in participants with cancer consisting of the 27-item FACT-General (G) and 9-item lung cancer subscale (LCS). FACT-G is organized into subscales: physical well-being (PWB)-7 items; social/family well-being (SWB)-7 items; emotional well-being (EWB)-6 items; functional well-being (FWB)-7 items. Each item uses a 5 point rating scale (0="not at all" and 4=equals "very much"). FACT-L Total Score=4 subscales + LCS and ranges from 0 to 144. Trial Outcome Index-Lung (TOI-L)=PWB+FWB+LCS and ranges from 0 to 92. Higher scores indicate better QOL. Least squares mean (LSmean) change is calculated using the linear-mixed model (LMM) analysis controlled for treatment, baseline value, time point and treatment by time point interaction.'}, {'measure': 'Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group- Neurotoxicity (FACT/GOG-Ntx)', 'timeFrame': 'Baseline, up to first 10 cycles (4 induction and 6 maintenance cycles, cycle=21 days)', 'description': 'FACT/GOG-Ntx is a validated instrument used to measure quality of life (QOL) in participants with cancer and neurotoxicity (Ntx) consisting of 27-item FACT-General (G) and 11-item Ntx subscale. FACT-G is organized into domain subscales: physical well-being (PWB)-7 items; social/family well-being (SWB)-7 items; emotional well-being (EWB)-6 items; functional well-being (FWB)-7 items; each uses a 5 point rating scale (0="not at all" and 4=equals "very much"). FACT/GOG-Ntx Total Score=sum 5 subscales and ranges from 0-152. Ntx Trial Outcome Index (TOI-Ntx)=PWB+FWB+NTX and range from 0-100. For all FACT scales, higher scores indicate better QOL. Least squares mean (LSmean) change is calculated using the linear-mixed model (LMM) analysis controlled for treatment, baseline value, time point and treatment by time point interaction.'}, {'measure': 'Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Pemetrexed', 'timeFrame': 'Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)'}, {'measure': 'Pharmacokinetics (PK): Elimination Half-life (t1/2) for Pemetrexed', 'timeFrame': 'Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)'}, {'measure': 'Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) for Pemetrexed', 'timeFrame': 'Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)'}, {'measure': 'Pharmacokinetics (PK): Pemetrexed Clearance (CL)', 'timeFrame': 'Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)'}, {'measure': 'Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Total (Bound and Unbound) Platinum and Unbound Platinum', 'timeFrame': 'Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)', 'description': 'Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.'}, {'measure': 'Pharmacokinetics (PK): Elimination Half-life (t1/2) for Total (Bound and Unbound) Platinum and Unbound Platinum', 'timeFrame': 'Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)', 'description': 'Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.'}, {'measure': 'Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) for Total (Bound and Unbound) Platinum and Unbound Platinum', 'timeFrame': 'Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)', 'description': 'Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.'}, {'measure': 'Pharmacokinetics (PK): Platinum Clearance (CL) for Total (Bound and Unbound) and Unbound Forms', 'timeFrame': 'Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)', 'description': 'Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.'}, {'measure': 'Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Bevacizumab', 'timeFrame': 'Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)'}, {'measure': 'Pharmacokinetics (PK): Elimination Half-life (t1/2) for Bevacizumab', 'timeFrame': 'Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)'}, {'measure': 'Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) Bevacizumab', 'timeFrame': 'Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)'}, {'measure': 'Pharmacokinetics (PK): Bevacizumab Clearance (CL)', 'timeFrame': 'Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)'}, {'measure': 'Translational Research: Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations', 'timeFrame': 'Baseline', 'description': 'Epidermal Growth Factor Receptor (EGFR) mutations were measured by polymerase chain reaction (PCR).'}, {'measure': 'Translational Research: Overall Survival (OS) Based on Nuclear Thyroid Transcription Factor-1 (TTF-1) Expression Regardless of Study Treatment', 'timeFrame': 'Baseline to date of death from any cause (up to 37.06 months)', 'description': 'Nuclear Thyroid Transcription Factor-1 (TTF-1) expression was measured using an Immunohistochemistry (IHC) assay which were scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system, and H score is a calculated using formula: 1x(percentage of cells stained 1+) + 2x(percentage of cells stained 2+) + 3x(percentage of cells stained 3+). TTF-1 Positive have an H score \\>0 and TTF-1 Negative have an H score=0. Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.'}, {'measure': 'Translational Research: Overall Survival (OS) Based on Cytoplasmic and Nuclear Thymidylate Synthase (TS) Expression', 'timeFrame': 'Baseline to date of death from any cause (up to 37.06 months)', 'description': 'Cytoplasmic and nuclear Thymidylate Synthase (TS) expression was measured using an Immunohistochemistry (IHC) assay which were scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system for cytoplasmic and nuclear staining, and H score was calculated using formula: 1x(percentage of cells stained 1+) + 2x(percentage of cells stained 2+) + 3x(percentage of cells stained 3+). TS Positive have an H score \\>0 and TS Negative have an H score=0. Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.'}, {'measure': 'Translational Research: Overall Survival (OS) Based on Cytoplasmic and Membrane Folate Receptor Alpha (FR-α) Expression', 'timeFrame': 'Baseline to date of death from any cause (up to 37.06 months)', 'description': 'Cytoplasmic and membrane Folate Receptor Alpha (FR-α) expression was measured using an Immunohistochemistry (IHC) assay which were scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system for cytoplasmic or membrane staining, and H score is a calculated using formula: 1x(percentage of cells stained 1+) + 2x(percentage of cells stained 2+) + 3x(percentage of cells stained 3+). FR-α Positive have an H score \\>0 and FR-α Negative have an H score=0. Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Non-small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '25611228', 'type': 'DERIVED', 'citation': 'Spigel DR, Patel JD, Reynolds CH, Garon EB, Hermann RC, Govindan R, Olsen MR, Winfree KB, Chen J, Liu J, Guba SC, Socinski MA, Bonomi P. Quality of life analyses from the randomized, open-label, phase III PointBreak study of pemetrexed-carboplatin-bevacizumab followed by maintenance pemetrexed-bevacizumab versus paclitaxel-carboplatin-bevacizumab followed by maintenance bevacizumab in patients with stage IIIB or IV nonsquamous non-small-cell lung cancer. J Thorac Oncol. 2015 Feb;10(2):353-9. doi: 10.1097/JTO.0000000000000277.'}, {'pmid': '25516338', 'type': 'DERIVED', 'citation': 'Reynolds CH, Patel JD, Garon EB, Olsen MR, Bonomi P, Govindan R, Pennella EJ, Liu J, Guba SC, Li S, Spigel DR, Hermann RC, Socinski MA, Obasaju CK. Exploratory Subset Analysis of African Americans From the PointBreak Study: Pemetrexed-Carboplatin-Bevacizumab Followed by Maintenance Pemetrexed-Bevacizumab Versus Paclitaxel-Carboplatin-Bevacizumab Followed by Maintenance Bevacizumab in Patients With Stage IIIB/IV Nonsquamous Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2015 May;16(3):200-8. doi: 10.1016/j.cllc.2014.11.004. Epub 2014 Nov 18.'}, {'pmid': '24145346', 'type': 'DERIVED', 'citation': 'Patel JD, Socinski MA, Garon EB, Reynolds CH, Spigel DR, Olsen MR, Hermann RC, Jotte RM, Beck T, Richards DA, Guba SC, Liu J, Frimodt-Moller B, John WJ, Obasaju CK, Pennella EJ, Bonomi P, Govindan R. PointBreak: a randomized phase III study of pemetrexed plus carboplatin and bevacizumab followed by maintenance pemetrexed and bevacizumab versus paclitaxel plus carboplatin and bevacizumab followed by maintenance bevacizumab in patients with stage IIIB or IV nonsquamous non-small-cell lung cancer. J Clin Oncol. 2013 Dec 1;31(34):4349-57. doi: 10.1200/JCO.2012.47.9626. Epub 2013 Oct 21.'}, {'pmid': '19632943', 'type': 'DERIVED', 'citation': 'Patel JD, Bonomi P, Socinski MA, Govindan R, Hong S, Obasaju C, Pennella EJ, Girvan AC, Guba SC. Treatment rationale and study design for the pointbreak study: a randomized, open-label phase III study of pemetrexed/carboplatin/bevacizumab followed by maintenance pemetrexed/bevacizumab versus paclitaxel/carboplatin/bevacizumab followed by maintenance bevacizumab in patients with stage IIIB or IV nonsquamous non-small-cell lung cancer. Clin Lung Cancer. 2009 Jul;10(4):252-6. doi: 10.3816/CLC.2009.n.035.'}]}, 'descriptionModule': {'briefSummary': 'This study will compare overall survival in participants with Stage IIIB or IV nonsquamous non-small cell lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* You must sign an informed consent document for clinical research.\n* You must have Stage IIIB or Stage IV nonsquamous non-small cell lung cancer.\n* You must not have received any prior treatment for your disease.\n* Prior radiation therapy is allowed to \\< 25% of the bone marrow; however, prior radiation to the whole pelvis is not allowed. If you have had radiation therapy to the chest, you are not eligible to participate.\n* You must be at least 18 years of age or older.\n* You must have measureable tumor lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) or disease can be evaluated on computed tomography (CT) scan.\n* Your test results assessing the function of blood forming tissue, kidneys and liver must be satisfactory.\n* Women must be sterile, postmenopausal or on contraception and men must be sterile (for example post-vasectomy) or on contraception.\n\nExclusion Criteria:\n\n* You cannot have clinically significant third-space fluid collections (e.g. ascites or pleural effusions that cannot be controlled by drainage or other procedures).\n* You cannot have Non-small Cell Lung Carcinoma (NSCLC) of predominantly squamous cell histology.\n* You cannot have known central nervous system (CNS) disease, other than stable, treated brain metastasis.\n* You cannot have undergone a surgical procedure, open biopsy, open pleurodesis, or significant traumatic injury within 28 days of starting the study treatment, or have an anticipated need for major surgery during the study.\n* You cannot have a history of gastrointestinal fistula, perforation, or abscess, inflammatory bowel disease, or diverticulitis.\n* You are currently receiving ongoing treatment with full-dose warfarin or equivalent.\n* You cannot have significant vascular disease, serious cardiac conditions (such as heart attack), stroke or transient ischemic attack within 6 months of the trial.\n* You cannot have evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation).\n* You cannot have inadequately controlled hypertension, or a history of hypertensive crisis or hypertensive encephalopathy.\n* You cannot have a serious, nonhealing wound, active ulcer, or untreated bone fracture.\n* You cannot have another form of cancer, other than superficial basal cell and superficial squamous (skin) cell, or carcinoma in situ of the cervix within the last 5 years.\n* You cannot have received an investigational treatment within 30 days prior to the trial.\n* You cannot have previously received treatment with paclitaxel, carboplatin, pemetrexed, or bevacizumab.\n* You cannot be pregnant or breast-feeding.\n* You cannot have a known sensitivity to any component of paclitaxel, carboplatin, pemetrexed, or bevacizumab.\n* You cannot have a history of hemoptysis (coughing blood) within 3 months prior to the trial.\n* You are unable to stop taking aspirin more than 1.3 grams per day or other nonsteroidal anti-inflammatory drugs (NSAIDs).\n* You are unable or unwilling to take folic acid or vitamin B12 supplementation.\n* You are unable to take corticosteroids.\n* You have any other on-going illnesses including active infections that may not allow you to adhere to the requirements of the trial.'}, 'identificationModule': {'nctId': 'NCT00762034', 'briefTitle': 'A Study of Pemetrexed, Carboplatin and Bevacizumab in Participants With Nonsquamous Non-Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Randomized, Open-Label, Phase 3 Study of Pemetrexed Plus Carboplatin and Bevacizumab Followed by Maintenance Pemetrexed and Bevacizumab Versus Paclitaxel Plus Carboplatin and Bevacizumab Followed by Maintenance Bevacizumab in Patients With Stage IIIB or IV Nonsquamous Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '9707'}, 'secondaryIdInfos': [{'id': 'H3E-MC-JMHD', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pem/Carbo/Bev', 'description': 'Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab', 'interventionNames': ['Drug: Pemetrexed', 'Drug: Carboplatin', 'Biological: Bevacizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pac/Carbo/Bev', 'description': 'Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab', 'interventionNames': ['Drug: Paclitaxel', 'Drug: Carboplatin', 'Biological: Bevacizumab']}], 'interventions': [{'name': 'Pemetrexed', 'type': 'DRUG', 'otherNames': ['Alimta', 'LY231514'], 'description': 'Induction therapy 500 milligram per meter squared (mg/m\\^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days', 'armGroupLabels': ['Pem/Carbo/Bev']}, {'name': 'Pemetrexed', 'type': 'DRUG', 'otherNames': ['Alimta', 'LY231514'], 'description': 'Maintenance therapy 500 mg/m\\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation', 'armGroupLabels': ['Pem/Carbo/Bev']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'Induction therapy 200 mg/m\\^2 IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days', 'armGroupLabels': ['Pac/Carbo/Bev']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Induction therapy area under the concentration curve (AUC) 6 IV every 21 days for up to 4 cycles of 21 days', 'armGroupLabels': ['Pac/Carbo/Bev', 'Pem/Carbo/Bev']}, {'name': 'Bevacizumab', 'type': 'BIOLOGICAL', 'description': 'Induction therapy 15 milligrams per kilogram (mg/kg) IV every 21 days for up to 4 cycles of 21 days', 'armGroupLabels': ['Pac/Carbo/Bev', 'Pem/Carbo/Bev']}, {'name': 'Bevacizumab', 'type': 'BIOLOGICAL', 'description': 'Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.', 'armGroupLabels': ['Pac/Carbo/Bev', 'Pem/Carbo/Bev']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72703', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', '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': 36.06258, 'lon': -94.15743}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', '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': 35.8423, 'lon': -90.70428}}, {'zip': '91801', 'city': 'Alhambra', 'state': 'California', 'country': 'United States', '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': 34.09529, 'lon': -118.12701}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', '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': 35.37329, 'lon': -119.01871}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', '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': 34.13945, 'lon': -117.97729}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', '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': 33.70918, 'lon': -117.95367}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', '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': 33.87029, 'lon': -117.92534}}, {'zip': '91750', 'city': 'La Verne', 'state': 'California', 'country': 'United States', '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': 34.10084, 'lon': -117.76784}}, {'zip': '90813', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', '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': 33.76696, 'lon': -118.18923}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', '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': 34.05223, 'lon': -118.24368}}, {'zip': '91325', 'city': 'Northridge', 'state': 'California', 'country': 'United States', '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': 34.22834, 'lon': -118.53675}}, {'zip': '92270', 'city': 'Rancho Mirage', 'state': 'California', 'country': 'United States', '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': 33.73974, 'lon': -116.41279}}, {'zip': '90277', 'city': 'Redondo Beach', 'state': 'California', 'country': 'United States', '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': 33.84918, 'lon': -118.38841}}, {'zip': '93105', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', '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': 34.42083, 'lon': -119.69819}}, {'zip': '93454', 'city': 'Santa Maria', 'state': 'California', 'country': 'United States', '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': 34.95303, 'lon': -120.43572}}, {'zip': '95403', 'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', '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': 38.44047, 'lon': -122.71443}}, {'zip': '81501', 'city': 'Grand Junction', 'state': 'Colorado', 'country': 'United States', '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': 39.06387, 'lon': -108.55065}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', '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': 26.35869, 'lon': -80.0831}}, {'zip': '33065', 'city': 'Coral Springs', 'state': 'Florida', 'country': 'United States', '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': 26.27119, 'lon': -80.2706}}, {'zip': '33916', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', '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': 26.62168, 'lon': -81.84059}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', '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': 30.33218, 'lon': -81.65565}}, {'zip': '33467', 'city': 'Lake Worth', 'state': 'Florida', 'country': 'United States', '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': 26.61708, 'lon': -80.07231}}, {'zip': '32901', 'city': 'Melbourne', 'state': 'Florida', 'country': 'United States', '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': 28.08363, 'lon': -80.60811}}, {'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', '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': 28.53834, 'lon': -81.37924}}, {'zip': '33028', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', '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': 26.00315, 'lon': -80.22394}}, {'zip': '34952', 'city': 'Port Saint Lucie', 'state': 'Florida', 'country': 'United States', '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': 27.29393, 'lon': -80.35033}}, {'zip': '34994', 'city': 'Stuart', 'state': 'Florida', 'country': 'United States', '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': 27.19755, 'lon': -80.25283}}, {'zip': '30607', 'city': 'Athens', 'state': 'Georgia', 'country': 'United States', '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': 33.96095, 'lon': -83.37794}}, {'zip': '30901', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', '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': 33.47097, 'lon': -81.97484}}, {'zip': '30905', 'city': 'Fort Gordon', 'state': 'Georgia', 'country': 'United States', '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': 33.42097, 'lon': -82.16206}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', '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': 41.85003, 'lon': -87.65005}}, {'zip': '60031', 'city': 'Gurnee', 'state': 'Illinois', 'country': 'United States', '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 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'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '21237', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', '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': 39.29038, 'lon': -76.61219}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', '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': 38.98067, 'lon': -77.10026}}, {'zip': '20815', 'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', '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': 39.00287, 'lon': -77.07115}}, {'zip': '21701', 'city': 'Frederick', 'state': 'Maryland', 'country': 'United States', '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': 39.41427, 'lon': -77.41054}}, {'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', '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': 39.084, 'lon': -77.15276}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', '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': 42.35843, 'lon': -71.05977}}, {'zip': '01701', 'city': 'Framingham', 'state': 'Massachusetts', 'country': 'United States', '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': 42.27926, 'lon': -71.41617}}, {'zip': '48144', 'city': 'Lambertville', 'state': 'Michigan', 'country': 'United States', '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': 41.76588, 'lon': -83.62799}}, {'zip': '55805', 'city': 'Duluth', 'state': 'Minnesota', 'country': 'United States', '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': 46.78327, 'lon': -92.10658}}, {'zip': '55417', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', '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': 44.97997, 'lon': -93.26384}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', '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': 38.62727, 'lon': -90.19789}}, {'zip': '89502', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', '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': 39.52963, 'lon': -119.8138}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', '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': 40.92565, 'lon': -73.14094}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', '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': 40.84985, 'lon': -73.86641}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', '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': 35.9132, 'lon': -79.05584}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', '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': 39.12711, 'lon': -84.51439}}, {'zip': '43219', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', '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': 39.96118, 'lon': -82.99879}}, {'zip': '73120', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', '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': 35.46756, 'lon': -97.51643}}, {'zip': '74136', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', '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': 36.15398, 'lon': -95.99277}}, {'zip': '16201', 'city': 'Kittanning', 'state': 'Pennsylvania', 'country': 'United States', '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': 40.81645, 'lon': -79.52199}}, {'zip': '19090', 'city': 'Willow Grove', 'state': 'Pennsylvania', 'country': 'United States', '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': 40.144, 'lon': -75.11573}}, {'zip': '29210', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', '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': 34.00071, 'lon': -81.03481}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', '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': 35.96064, 'lon': -83.92074}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', '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': 35.14953, 'lon': -90.04898}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', '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': 29.42412, 'lon': -98.49363}}, {'zip': '77380', 'city': 'The Woodlands', 'state': 'Texas', 'country': 'United States', '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': 30.15799, 'lon': -95.48938}}, {'zip': '24211', 'city': 'Abingdon', 'state': 'Virginia', 'country': 'United States', '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': 36.70983, 'lon': -81.97735}}, {'zip': '23230', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', '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': 37.55376, 'lon': -77.46026}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', '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': 47.25288, 'lon': -122.44429}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', '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': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMC - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}