Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT00102804
Status:
COMPLETED
Last Update Posted:
2014-12-29
First Post:
2005-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pemetrexed and Best Supportive Care Versus Placebo and Best Supportive Care in Non-Small Cell Lung Cancer (NSCLC)
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'}], 'ancestors': [{'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Four participants (pts) assigned to placebo received pemetrexed; pts analyzed for efficacy as randomized. Three treated pts did not sign ICF, 1 treated pt signed ICF but did not complete entire randomization process; pts excluded from all analyses.'}}, 'adverseEventsModule': {'description': 'Participants are reported under the treatment to which they received.', 'eventGroups': [{'id': 'EG000', 'title': 'Pemetrexed and BSC', 'description': 'Pemetrexed: 500 mg/m\\^2, IV administration, q 21 days, until disease progression.\n\nBSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.', 'otherNumAtRisk': 438, 'otherNumAffected': 386, 'seriousNumAtRisk': 438, 'seriousNumAffected': 83}, {'id': 'EG001', 'title': 'Placebo and BSC', 'description': 'Placebo: IV administration, q 21 days.\n\nBSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.', 'otherNumAtRisk': 218, 'otherNumAffected': 178, 'seriousNumAtRisk': 218, 'seriousNumAffected': 31}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 97, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Anaemia of malignant disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 64, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Lymph node pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 66, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Neutrophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Thrombocythaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 29, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Arrhythmia supraventricular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cyanosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cerumen impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Motion sickness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 24, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Eye swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Eyelid oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Keratoconjunctivitis sicca', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ocular surface disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pterygium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Visual disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 11, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 85, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 22, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diarrhoea', 'stats': 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{'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Faecal incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Faecaloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 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'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Paraparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Paraplegia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Balanitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 321, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bronchial obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pelvic venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Superior vena caval occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-Free Survival (PFS) Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemetrexed and BSC', 'description': 'Pemetrexed: 500 mg/m\\^2, IV administration, q 21 days, until disease progression.\n\nBSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.'}, {'id': 'OG001', 'title': 'Placebo and BSC', 'description': 'Placebo: IV administration, q 21 days.\n\nBSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.27', 'groupId': 'OG000', 'lowerLimit': '4.07', 'upperLimit': '4.73'}, {'value': '2.60', 'groupId': 'OG001', 'lowerLimit': '1.68', 'upperLimit': '2.83'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to measured PD or death from any cause (up to 41 months)', 'description': "PFS time was the elapsed time from the date of randomization to the first date of objective progression of disease or death from any cause. PFS was censored at the date of the participant's last tumor assessment for participants who were not known to have died or to have PD as of the data-inclusion cut-off date for analysis. PD, defined using Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0), was at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.", 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized. Participants censored: N = 123, 36 participants in the pemetrexed and placebo treatment arms, respectively.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemetrexed and BSC', 'description': 'Pemetrexed: 500 mg/m\\^2, IV administration, q 21 days, until disease progression.\n\nBSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.'}, {'id': 'OG001', 'title': 'Placebo and BSC', 'description': 'Placebo: IV administration, q 21 days.\n\nBSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.37', 'groupId': 'OG000', 'lowerLimit': '11.93', 'upperLimit': '15.87'}, {'value': '10.58', 'groupId': 'OG001', 'lowerLimit': '8.74', 'upperLimit': '12.02'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to date of death from any cause (up to 41 months)', 'description': 'OS time was the elapsed time from the date of randomization to the date of death from any cause. OS was censored at the last date of contact for participants who were not known to have died as of the data-inclusion cut-off date for analysis.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized. Participants censored: N = 138, 48 participants in the pemetrexed and placebo treatment arms, respectively.'}, {'type': 'SECONDARY', 'title': 'Time to Objective Progressive Disease (TPD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemetrexed and BSC', 'description': 'Pemetrexed: 500 mg/m\\^2, IV administration, q 21 days, until disease progression.\n\nBSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.'}, {'id': 'OG001', 'title': 'Placebo and BSC', 'description': 'Placebo: IV administration, q 21 days.\n\nBSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.27', 'groupId': 'OG000', 'lowerLimit': '4.11', 'upperLimit': '4.73'}, {'value': '2.60', 'groupId': 'OG001', 'lowerLimit': '1.68', 'upperLimit': '2.83'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to measured PD (up to 41 months)', 'description': "TPD was the elapsed time from the date of randomization to the first date of objective PD. TPD was censored at the date of the participant's last tumor assessment for participants who were not known to have PD as of the data-inclusion cut-off date for analysis or who died without objective PD. PD, defined using RECIST v1.0, was at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.", 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized. Participants censored: N = 145, 40 participants in the pemetrexed and placebo treatment arms, respectively.'}, {'type': 'SECONDARY', 'title': 'Time to Worsening of Symptoms (TWS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemetrexed and BSC', 'description': 'Pemetrexed: 500 mg/m\\^2, IV administration, q 21 days, until disease progression.\n\nBSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.'}, {'id': 'OG001', 'title': 'Placebo and BSC', 'description': 'Placebo: IV administration, q 21 days.\n\nBSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.'}], 'classes': [{'title': 'Loss of appetite', 'categories': [{'measurements': [{'value': '3.78', 'groupId': 'OG000', 'lowerLimit': '2.86', 'upperLimit': '4.44'}, {'value': '4.40', 'groupId': 'OG001', 'lowerLimit': '2.96', 'upperLimit': '15.61'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '3.06', 'groupId': 'OG000', 'lowerLimit': '2.63', 'upperLimit': '5.29'}, {'value': '3.09', 'groupId': 'OG001', 'lowerLimit': '2.43', 'upperLimit': '3.98'}]}]}, {'title': 'Cough', 'categories': [{'measurements': [{'value': '6.05', 'groupId': 'OG000', 'lowerLimit': '4.21', 'upperLimit': '7.82'}, {'value': '4.67', 'groupId': 'OG001', 'lowerLimit': '3.06', 'upperLimit': '15.61'}]}]}, {'title': 'Dyspnea', 'categories': [{'measurements': [{'value': '5.36', 'groupId': 'OG000', 'lowerLimit': '4.21', 'upperLimit': '10.87'}, {'value': '4.40', 'groupId': 'OG001', 'lowerLimit': '2.83', 'upperLimit': '15.61'}]}]}, {'title': 'Hemoptysis', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median (95% confidence interval) TWS for hemoptysis was not calculated due to the high level of censoring.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median (95% confidence interval) TWS for hemoptysis was not calculated due to the high level of censoring.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '6.11', 'groupId': 'OG000', 'lowerLimit': '4.57', 'upperLimit': '9.56'}, {'value': '4.63', 'groupId': 'OG001', 'lowerLimit': '3.32', 'upperLimit': '5.98'}]}]}, {'title': 'Symptomatic distress', 'categories': [{'measurements': [{'value': '4.21', 'groupId': 'OG000', 'lowerLimit': '3.58', 'upperLimit': '5.55'}, {'value': '3.78', 'groupId': 'OG001', 'lowerLimit': '2.99', 'upperLimit': '18.53'}]}]}, {'title': 'Interference with activity level', 'categories': [{'measurements': [{'value': '6.51', 'groupId': 'OG000', 'lowerLimit': '4.34', 'upperLimit': '8.18'}, {'value': '3.98', 'groupId': 'OG001', 'lowerLimit': '2.83', 'upperLimit': '15.61'}]}]}, {'title': 'Global quality of life', 'categories': [{'measurements': [{'value': '5.75', 'groupId': 'OG000', 'lowerLimit': '4.37', 'upperLimit': '8.41'}, {'value': '3.71', 'groupId': 'OG001', 'lowerLimit': '2.99', 'upperLimit': '5.49'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to worsening of each LCSS item (up to 39 months)', 'description': 'TWS was the elapsed time from the date of randomization to the first date of worsening \\[defined as a 15-millimeter (mm) increase from baseline based on a 100-mm scale\\] of each symptom and summary item in the Lung Cancer Symptom Scale (LCSS). The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant (pt) responses to each item were measured using visual analogue scales (VAS) from 0 (for best outcome) to 100 (for worst outcome). TWS was censored at the date of the last LCSS assessment for pts who were not known to have LCSS worsening.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pts who signed ICF and completed randomization, according to treatment randomized. Pts censored: Loss of appetite 236,140; fatigue 237,130; cough 274,146; dyspnea 271,143, hemoptysis 404,198; pain 271,135; symptom distress 247,141; interference with activity level 267,141, global quality of life 262,137 pts in pemetrexed, placebo arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Tumor Response Rate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemetrexed and BSC', 'description': 'Pemetrexed: 500 mg/m\\^2, IV administration, q 21 days, until disease progression.\n\nBSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.'}, {'id': 'OG001', 'title': 'Placebo and BSC', 'description': 'Placebo: IV administration, q 21 days.\n\nBSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '10'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to measured PD (up to 41 months)', 'description': 'Response was defined using RECIST v1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined either A) at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LDs or B) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared. The percentage of participants with CR or PR=(Number of participants with CR or PR)/(Number of participants assessed)\\*100.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemetrexed and BSC', 'description': 'Pemetrexed: 500 mg/m\\^2, IV administration, q 21 days, until disease progression.\n\nBSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.'}, {'id': 'OG001', 'title': 'Placebo and BSC', 'description': 'Placebo: IV administration, q 21 days.\n\nBSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.'}], 'classes': [{'title': 'SAEs', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Other Non-Serious AEs', 'categories': [{'measurements': [{'value': '386', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to study completion (up to 41 Months)', 'description': 'Clinically significant events were defined as serious adverse events (SAEs) and other non-serious AEs regardless of causality. A summary of serious and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who signed the ICF, completed the randomized process and received at least 1 dose of study drug are reported according to the treatment to which they were received.'}, {'type': 'SECONDARY', 'title': 'Maximum Improvement Over Baseline in Individual Symptom Scores and Quality of Life Using the LCSS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemetrexed and BSC', 'description': 'Pemetrexed: 500 mg/m\\^2, IV administration, q 21 days, until disease progression.\n\nBSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.'}, {'id': 'OG001', 'title': 'Placebo and BSC', 'description': 'Placebo: IV administration, q 21 days.\n\nBSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.'}], 'classes': [{'title': 'Loss of appetite (n=403, 197)', 'categories': [{'measurements': [{'value': '7.3', 'spread': '25.90', 'groupId': 'OG000'}, {'value': '10.6', 'spread': '25.25', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue (n=403, 197)', 'categories': [{'measurements': [{'value': '10.2', 'spread': '27.10', 'groupId': 'OG000'}, {'value': '10.4', 'spread': '23.92', 'groupId': 'OG001'}]}]}, {'title': 'Cough (n=402, 197)', 'categories': [{'measurements': [{'value': '7.6', 'spread': '20.09', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '23.81', 'groupId': 'OG001'}]}]}, {'title': 'Dyspnea (n=400, 196)', 'categories': [{'measurements': [{'value': '7.6', 'spread': '22.50', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '20.44', 'groupId': 'OG001'}]}]}, {'title': 'Pain (n=401, 197)', 'categories': [{'measurements': [{'value': '5.4', 'spread': '20.96', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '21.93', 'groupId': 'OG001'}]}]}, {'title': 'Hemoptysis (n=402, 196)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '9.41', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '9.23', 'groupId': 'OG001'}]}]}, {'title': 'Symptom distress (n=401, 196)', 'categories': [{'measurements': [{'value': '6.5', 'spread': '21.13', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '22.5', 'groupId': 'OG001'}]}]}, {'title': 'Interference with activity level (n=400, 197)', 'categories': [{'measurements': [{'value': '10.8', 'spread': '27.08', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '25.50', 'groupId': 'OG001'}]}]}, {'title': 'Global quality of life (n=401, 195)', 'categories': [{'measurements': [{'value': '10.7', 'spread': '24.94', 'groupId': 'OG000'}, {'value': '10.5', 'spread': '22.98', 'groupId': 'OG001'}]}]}, {'title': 'ASBI (n=392, 195)', 'categories': [{'measurements': [{'value': '3.7', 'spread': '12.34', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '13.24', 'groupId': 'OG001'}]}]}, {'title': 'Total LCSS (n=388, 193)', 'categories': [{'measurements': [{'value': '4.07', 'spread': '12.76', 'groupId': 'OG000'}, {'value': '4.04', 'spread': '13.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through 30 days post discontinuation of study treatment (up to 39 Months)', 'description': 'The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant responses to each item were measured using VAS from 0 (for best outcome) to 100 (for worst outcome). The average symptom burden index (ASBI) was the mean of the 6 symptom-specific items. The LCSS total score was the mean of the 9 items.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who signed the ICF, completed the randomization process, had LCSS data at baseline and at least once postdose are reported according to the treatment arm to which they were randomized.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pemetrexed and BSC', 'description': 'Pemetrexed: 500 milligrams per square meter (mg/m\\^2), intravenous (IV) administration, every (q) 21 days, until disease progression.\n\nBest Supportive Care (BSC): Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.'}, {'id': 'FG001', 'title': 'Placebo and BSC', 'description': 'Placebo: IV administration, q 21 days, until disease progression.\n\nBSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '441'}, {'groupId': 'FG001', 'numSubjects': '222'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '434'}, {'comment': 'Four participants randomized to placebo received pemetrexed.', 'groupId': 'FG001', 'numSubjects': '222'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '441'}, {'groupId': 'FG001', 'numSubjects': '222'}]}], 'dropWithdraws': [{'type': 'Progressive Disease (PD)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '307'}, {'groupId': 'FG001', 'numSubjects': '196'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Enrollment Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Satisfactory Response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Alive, Receiving Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'Participants who signed the informed consent form (ICF) and completed the randomized process are presented in the participant flow by the treatment arm to which they were randomized. Participants who did not sign the ICF or complete the randomization process were removed from the database and excluded from all analyses.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'BG000'}, {'value': '222', 'groupId': 'BG001'}, {'value': '663', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pemetrexed and BSC', 'description': 'Pemetrexed: 500 mg/m\\^2, IV administration, q 21 days, until disease progression.\n\nBSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.'}, {'id': 'BG001', 'title': 'Placebo and BSC', 'description': 'Placebo: IV administration, q 21 days.\n\nBSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.6', 'groupId': 'BG000', 'lowerLimit': '54.3', 'upperLimit': '67.5'}, {'value': '60.4', 'groupId': 'BG001', 'lowerLimit': '53.8', 'upperLimit': '67.0'}, {'value': '60.6', 'groupId': 'BG002', 'lowerLimit': '54.1', 'upperLimit': '67.4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '322', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '483', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Aboriginal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'African', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '279', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '428', 'groupId': 'BG002'}]}]}, {'title': 'East Asian', 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'West Asian', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Greece', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}, {'title': 'Turkey', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'Croatia', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}, {'title': 'China', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}, {'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 663}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-17', 'studyFirstSubmitDate': '2005-02-01', 'resultsFirstSubmitDate': '2014-12-17', 'studyFirstSubmitQcDate': '2005-02-01', 'lastUpdatePostDateStruct': {'date': '2014-12-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-17', 'studyFirstPostDateStruct': {'date': '2005-02-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS) Time', 'timeFrame': 'Randomization to measured PD or death from any cause (up to 41 months)', 'description': "PFS time was the elapsed time from the date of randomization to the first date of objective progression of disease or death from any cause. PFS was censored at the date of the participant's last tumor assessment for participants who were not known to have died or to have PD as of the data-inclusion cut-off date for analysis. PD, defined using Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0), was at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions."}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS) Time', 'timeFrame': 'Randomization to date of death from any cause (up to 41 months)', 'description': 'OS time was the elapsed time from the date of randomization to the date of death from any cause. OS was censored at the last date of contact for participants who were not known to have died as of the data-inclusion cut-off date for analysis.'}, {'measure': 'Time to Objective Progressive Disease (TPD)', 'timeFrame': 'Randomization to measured PD (up to 41 months)', 'description': "TPD was the elapsed time from the date of randomization to the first date of objective PD. TPD was censored at the date of the participant's last tumor assessment for participants who were not known to have PD as of the data-inclusion cut-off date for analysis or who died without objective PD. PD, defined using RECIST v1.0, was at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions."}, {'measure': 'Time to Worsening of Symptoms (TWS)', 'timeFrame': 'Randomization to worsening of each LCSS item (up to 39 months)', 'description': 'TWS was the elapsed time from the date of randomization to the first date of worsening \\[defined as a 15-millimeter (mm) increase from baseline based on a 100-mm scale\\] of each symptom and summary item in the Lung Cancer Symptom Scale (LCSS). The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant (pt) responses to each item were measured using visual analogue scales (VAS) from 0 (for best outcome) to 100 (for worst outcome). TWS was censored at the date of the last LCSS assessment for pts who were not known to have LCSS worsening.'}, {'measure': 'Percentage of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Tumor Response Rate)', 'timeFrame': 'Baseline to measured PD (up to 41 months)', 'description': 'Response was defined using RECIST v1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined either A) at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LDs or B) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared. The percentage of participants with CR or PR=(Number of participants with CR or PR)/(Number of participants assessed)\\*100.'}, {'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Baseline to study completion (up to 41 Months)', 'description': 'Clinically significant events were defined as serious adverse events (SAEs) and other non-serious AEs regardless of causality. A summary of serious and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.'}, {'measure': 'Maximum Improvement Over Baseline in Individual Symptom Scores and Quality of Life Using the LCSS', 'timeFrame': 'Baseline through 30 days post discontinuation of study treatment (up to 39 Months)', 'description': 'The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant responses to each item were measured using VAS from 0 (for best outcome) to 100 (for worst outcome). The average symptom burden index (ASBI) was the mean of the 6 symptom-specific items. The LCSS total score was the mean of the 9 items.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Non-Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '22336221', 'type': 'DERIVED', 'citation': 'Belani CP, Brodowicz T, Ciuleanu TE, Krzakowski M, Yang SH, Franke F, Cucevic B, Madhavan J, Santoro A, Ramlau R, Liepa AM, Visseren-Grul C, Peterson P, John WJ, Zielinski CC. Quality of life in patients with advanced non-small-cell lung cancer given maintenance treatment with pemetrexed versus placebo (H3E-MC-JMEN): results from a randomised, double-blind, phase 3 study. Lancet Oncol. 2012 Mar;13(3):292-9. doi: 10.1016/S1470-2045(11)70339-4. Epub 2012 Feb 14.'}, {'pmid': '22266043', 'type': 'DERIVED', 'citation': 'Gridelli C, Brodowicz T, Langer CJ, Peterson P, Islam M, Guba SC, Moore P, Visseren-Grul CM, Scagliotti G. Pemetrexed therapy in elderly patients with good performance status: analysis of two phase III trials of patients with nonsquamous non-small-cell lung cancer. Clin Lung Cancer. 2012 Sep;13(5):340-6. doi: 10.1016/j.cllc.2011.12.002. Epub 2012 Jan 23.'}, {'pmid': '19767093', 'type': 'DERIVED', 'citation': 'Ciuleanu T, Brodowicz T, Zielinski C, Kim JH, Krzakowski M, Laack E, Wu YL, Bover I, Begbie S, Tzekova V, Cucevic B, Pereira JR, Yang SH, Madhavan J, Sugarman KP, Peterson P, John WJ, Krejcy K, Belani CP. Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study. Lancet. 2009 Oct 24;374(9699):1432-40. doi: 10.1016/S0140-6736(09)61497-5. Epub 2009 Sep 18.'}], 'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'This study is a randomized Phase 3, double-blind study of maintenance pemetrexed plus best supportive care versus placebo plus best supportive care in NSCLC. Participants must have received 1 of 6 induction regimens for 4 cycles and did not have progressive disease prior to randomization (enrollment) into this trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologic or cytologic diagnosis of NSCLC Stage IIIB (with pleural effusion and/or positive supraclavicular lymph nodes) or Stage IV prior to induction therapy.\n* Participants must have had 1 of the following induction therapies for treatment for Stage IIIB (with pleural effusion and/or positive supraclavicular lymph nodes) or IV NSCLC: Gemcitabine plus carboplatin, paclitaxel plus carboplatin, or docetaxel plus carboplatin, gemcitabine plus cisplatin, paclitaxel plus cisplatin or docetaxel plus cisplatin.\n* Participants must have received only 1 chemotherapeutic doublet lasting precisely 4 cycles.\n* Induction regimens must be based on 21-day cycles.\n* Documented evidence of a tumor response of complete response (CR), partial response (PR), or stable disease (SD). Tumor assessment must occur between Cycle 4 (Day 1) of induction therapy and the date of randomization. This response does not have to be confirmed in order for the participant to be randomized. Positron emission tomography (PET) scans and ultrasounds may not be used for lesion measurements for response determination.\n\nExclusion Criteria:\n\n* With the exception of those chemotherapies listed as inclusion criterion, participants will not be included if they have received prior systemic anticancer therapy (including adjuvant early-stage treatment for NSCLC) or any systemic treatment for any other cancer.\n* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.\n* Inability to comply with protocol or study procedures.\n* A serious concomitant systemic disorder that would compromise the participant's ability to complete the study.\n* A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV."}, 'identificationModule': {'nctId': 'NCT00102804', 'briefTitle': 'Pemetrexed and Best Supportive Care Versus Placebo and Best Supportive Care in Non-Small Cell Lung Cancer (NSCLC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed Plus Best Supportive Care Versus Best Supportive Care Immediately Following Induction Treatment for Advanced Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '5122'}, 'secondaryIdInfos': [{'id': 'H3E-MC-JMEN', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pemetrexed and Best Supportive Care', 'interventionNames': ['Drug: Pemetrexed', 'Other: Best Supportive Care']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo and Best Supportive Care', 'interventionNames': ['Drug: Placebo', 'Other: Best Supportive Care']}], 'interventions': [{'name': 'Pemetrexed', 'type': 'DRUG', 'otherNames': ['LY231514', 'Alimta'], 'description': '500 milligrams per square meter (mg/m\\^2), intravenous (IV) administration, every (q) 21 days, until disease progression', 'armGroupLabels': ['Pemetrexed and Best Supportive Care']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'IV administration, q 21 days', 'armGroupLabels': ['Placebo and Best Supportive Care']}, {'name': 'Best Supportive Care', 'type': 'OTHER', 'description': 'Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.', 'armGroupLabels': ['Pemetrexed and Best Supportive Care', 'Placebo and Best Supportive Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', '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': '03801', 'city': 'Portsmouth', 'state': 'New Hampshire', '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': 43.07704, 'lon': -70.75766}}, {'zip': '15213', 'city': 'Pittsburgh', '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': 40.44062, 'lon': -79.99589}}, {'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': '75204', 'city': 'Dallas', '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': 32.78306, 'lon': -96.80667}}, {'zip': '54449', 'city': 'Marshfield', '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': 44.66885, 'lon': -90.1718}}, {'zip': '2200', 'city': 'Bankstown', 'state': 'New South Wales', 'country': 'Australia', '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': -33.91667, 'lon': 151.03333}}, {'zip': '2450', 'city': 'Coffs Harbour', 'state': 'New South Wales', 'country': 'Australia', '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': -30.29626, 'lon': 153.11351}}, {'zip': '2217', 'city': 'Kogarah', 'state': 'New South Wales', 'country': 'Australia', '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': -33.9681, 'lon': 151.13564}}, {'zip': '2444', 'city': 'Port Macquarie', 'state': 'New South Wales', 'country': 'Australia', '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': -31.43084, 'lon': 152.90894}}, {'zip': '4560', 'city': 'Nambour', 'state': 'Queensland', 'country': 'Australia', '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': -26.62613, 'lon': 152.95941}}, {'zip': '4810', 'city': 'Townsville', 'state': 'Queensland', 'country': 'Australia', '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': -19.26639, 'lon': 146.80569}}, {'zip': '5035', 'city': 'Ashford', 'state': 'South Australia', 'country': 'Australia', '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': -34.94859, 'lon': 138.57457}}, {'zip': 'VIC 3199', 'city': 'Frankston', 'state': 'Victoria', 'country': 'Australia', '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': -38.14458, 'lon': 145.12291}}, {'zip': '1130', 'city': 'Vienna', 'country': 'Austria', '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': 48.20849, 'lon': 16.37208}}, {'zip': '98700 000', 'city': 'Ijuí', 'country': 'Brazil', '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': -28.38778, 'lon': -53.91472}}, {'zip': '01277-900', 'city': 'São Paulo', 'country': 'Brazil', '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': -23.5475, 'lon': -46.63611}}, {'zip': '1527', 'city': 'Sofia', 'country': 'Bulgaria', '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': 42.69751, 'lon': 23.32415}}, {'zip': '9010', 'city': 'Varna', 'country': 'Bulgaria', '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': 43.21912, 'lon': 27.91024}}, {'zip': '100730', 'city': 'Beijing', 'country': 'China', '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': 39.9075, 'lon': 116.39723}}, {'zip': '116023', 'city': 'Dalian', 'country': 'China', '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': 38.91222, 'lon': 121.60222}}, {'zip': '510080', 'city': 'Guangzhou', 'country': 'China', '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': 23.11667, 'lon': 113.25}}, {'zip': '310016', 'city': 'Hangzhou', 'country': 'China', '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': 30.29365, 'lon': 120.16142}}, {'zip': '250012', 'city': 'Jinan', 'country': 'China', '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': 36.66833, 'lon': 116.99722}}, {'zip': '210009', 'city': 'Nanjing', 'country': 'China', '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': 32.06167, 'lon': 118.77778}}, {'zip': '200025', 'city': 'Shanghai', 'country': 'China', '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': 31.22222, 'lon': 121.45806}}, {'zip': '10000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '656 91', 'city': 'Brno', 'country': 'Czechia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '59071', 'city': 'Hamm', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.68033, 'lon': 7.82089}}, {'zip': 'D-30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': 'D-39120', 'city': 'Magdeburg', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': 'D-89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '11527', 'city': 'Athens', 'country': 'Greece', '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': 37.98376, 'lon': 23.72784}}, {'zip': '73300', 'city': 'Chania', 'country': 'Greece', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': '302017', 'city': 'Jaipur', 'country': 'India', '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': 26.91962, 'lon': 75.78781}}, {'zip': '400 026', 'city': 'Mumbai', 'country': 'India', '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': 19.07283, 'lon': 72.88261}}, {'zip': '682304', 'city': 'P.O Ernakulam', 'country': 'India', '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.'}, {'zip': '695 011', 'city': 'Trivandrum', 'country': 'India', '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': 8.4855, 'lon': 76.94924}}, {'zip': '70126', 'city': 'Bari', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '40100', 'city': 'Bologna', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '16132', 'city': 'Genova', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '57128', 'city': 'Livorno', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.54427, 'lon': 10.32615}}, {'zip': '98122', 'city': 'Messina', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}, {'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '56100', 'city': 'Pisa', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '00168', 'city': 'Rome', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '20089', 'city': 'Rozzano', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '6716 RP', 'city': 'Ede', 'country': 'Netherlands', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.03333, 'lon': 5.65833}}, {'zip': '7207 BA', 'city': 'Zutphen', 'country': 'Netherlands', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.13833, 'lon': 6.20139}}, {'zip': '80211 JW', 'city': 'Zwolle', 'country': 'Netherlands', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}, {'zip': '60-569', 'city': 'Poznan', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '02-781', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '3400', 'city': 'Cluj-Napoca', 'country': 'Romania', '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': 46.76667, 'lon': 23.6}}, {'zip': '3700', 'city': 'Oradea', 'country': 'Romania', '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': 47.0458, 'lon': 21.91833}}, {'zip': '139-706', 'city': 'Seoul', 'country': 'South Korea', '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': 37.566, 'lon': 126.9784}}, {'zip': '28922', 'city': 'Alcorcón', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.34582, 'lon': -3.82487}}, {'zip': '03804', 'city': 'Alcoy', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 38.70545, 'lon': -0.47432}}, {'zip': '08003', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '18014', 'city': 'Granada', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '08304', 'city': 'Mataró', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.54211, 'lon': 2.4445}}, {'zip': '30008', 'city': 'Murcia', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'zip': '07198', 'city': 'Palma de Mallorca', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '38320', 'city': 'Santa Cruz de Tenerife', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 28.46824, 'lon': -16.25462}}, {'zip': '112', 'city': 'Taipei', 'country': 'Taiwan', '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': 25.05306, 'lon': 121.52639}}, {'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', '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': 39.91987, 'lon': 32.85427}}, {'zip': '35100', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', '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': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}