Viewing Study NCT00415194

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Ignite Creation Date: 2025-12-25 @ 2:00 AM

Ignite Modification Date: 2025-12-27 @ 2:43 AM

Study NCT ID: NCT00415194

Status: COMPLETED

Last Update Posted: 2011-06-28

First Post: 2006-12-20

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: A Study for Patients With Head and Neck Cancer

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Participants who received at least one dose of study drug were included in the safety population included here.', 'eventGroups': [{'id': 'EG000', 'title': 'Pemetrexed/Cisplatin', 'description': 'Pemetrexed 500 milligrams per meter square (mg/m2) administered intravenously (IV) plus cisplatin 75 mg/m2 IV on Day 1 every 21 days. Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.', 'otherNumAtRisk': 392, 'otherNumAffected': 343, 'seriousNumAtRisk': 392, 'seriousNumAffected': 185}, {'id': 'EG001', 'title': 'Placebo/Cisplatin', 'description': 'Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m2 on Day 1 every 21 days. Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.', 'otherNumAtRisk': 385, 'otherNumAffected': 316, 'seriousNumAtRisk': 385, 'seriousNumAffected': 132}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 133, 'numAffected': 118}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 88, 'numAffected': 79}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 57, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 35, 'numAffected': 24}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 105, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 48, 'numAffected': 35}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 33, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 22, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 63, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 65, 'numAffected': 53}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 50, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 35, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 23, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 199, 'numAffected': 118}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 153, 'numAffected': 106}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 81, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 104, 'numAffected': 79}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 41, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 35, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 88, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 57, 'numAffected': 53}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 30, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 23, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 44, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 21, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Creatinine renal clearance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 34, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 36, 'numAffected': 31}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 47, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 51, 'numAffected': 50}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 63, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 50, 'numAffected': 44}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 28, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 47, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 30, 'numAffected': 29}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 27, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 25, 'numAffected': 24}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 25, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 26, 'numAffected': 23}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 24, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 25, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 21, 'numAffected': 20}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Agranulocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 27, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Anaemia of malignant disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bone marrow toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Tracheo-oesophageal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Aphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Disbacteriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Duodenal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Duodenal ulcer perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastric ulcer perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastrointestinal necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Glossodynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 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'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Disorientation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bronchial secretion retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Laryngeal dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Laryngeal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lung infiltration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pharyngeal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Respiratory tract haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Stridor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Upper airway obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Subcutaneous emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Swelling face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Femoral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Haemodynamic instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Subclavian vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Superior vena caval occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '397', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemetrexed/Cisplatin', 'description': 'Pemetrexed 500 milligrams per meter square (mg/m\\^2) administered intravenously (IV) plus cisplatin 75 mg/m\\^2 IV on Day 1 every 21 days.\n\nPretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.\n\nVitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.\n\nFolic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.'}, {'id': 'OG001', 'title': 'Placebo/Cisplatin', 'description': 'Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m\\^2 on Day 1 every 21 days.\n\nPretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.\n\nVitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.\n\nFolic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.33', 'groupId': 'OG000', 'lowerLimit': '6.34', 'upperLimit': '8.38'}, {'value': '6.28', 'groupId': 'OG001', 'lowerLimit': '5.52', 'upperLimit': '7.06'}]}]}], 'analyses': [{'pValue': '0.082', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.02', 'statisticalMethod': 'Stratified Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to date of death from any cause up to 36 months', 'description': "OS duration is defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date, OS duration will be censored at the date of the participant's last contact prior to that cut-off date.", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) Population - defines the treatment group as those to which participants were assigned by random allocation, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '397', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemetrexed/Cisplatin', 'description': 'Pemetrexed 500 milligrams per meter square (mg/m\\^2) administered intravenously (IV) plus cisplatin 75 mg/m\\^2 IV on Day 1 every 21 days.\n\nPretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.\n\nVitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.\n\nFolic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.'}, {'id': 'OG001', 'title': 'Placebo/Cisplatin', 'description': 'Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m\\^2 on Day 1 every 21 days.\n\nPretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.\n\nVitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.\n\nFolic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.61', 'groupId': 'OG000', 'lowerLimit': '3.15', 'upperLimit': '4.07'}, {'value': '2.79', 'groupId': 'OG001', 'lowerLimit': '2.69', 'upperLimit': '3.22'}]}]}], 'analyses': [{'pValue': '0.166', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.03', 'statisticalMethod': 'Stratified Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline to measured progressive disease up to 33 months', 'description': 'Objective PFS is defined as the time from date of randomization to date of objectively determined progressive disease (PD) or death from any cause, whichever comes first. PD was defined by Response Evaluation Criteria in Solid Tumors (RECIST). PD=at least a 20% increase in sum of longest diameter of target lesions. For participants who are not known to have died as of the data-inclusion cut-off date, and who do not have progressive disease, PFS will be censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systemic anticancer therapy.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) Population - defines the treatment group as those to which participants were assigned by random allocation, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol.'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With a Tumor Response (Response Rate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '397', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemetrexed/Cisplatin', 'description': 'Pemetrexed 500 milligrams per meter square (mg/m\\^2) administered intravenously (IV) plus cisplatin 75 mg/m\\^2 IV on Day 1 every 21 days.\n\nPretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.\n\nVitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.\n\nFolic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.'}, {'id': 'OG001', 'title': 'Placebo/Cisplatin', 'description': 'Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m\\^2 on Day 1 every 21 days.\n\nPretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.\n\nVitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.\n\nFolic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000'}, {'value': '8.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.061', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Unadjusted normal distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value is based on an unadjusted, normal distribution approximation for differences in rates.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to progressive disease or discontinuation of study treatment up to 11 months', 'description': 'Tumor Response is evaluated as CR (Complete Response) or PR (Partial Response) per Response Evaluation Criteria in Solid Tumors (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions. Response rate (%) = (number of participants with CR+PR/number of participants)\\*100', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) Population - defines the treatment group as those to which participants were assigned by random allocation, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DoR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemetrexed/Cisplatin', 'description': 'Pemetrexed 500 milligrams per meter square (mg/m\\^2) administered intravenously (IV) plus cisplatin 75 mg/m\\^2 IV on Day 1 every 21 days.\n\nPretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.\n\nVitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.\n\nFolic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.'}, {'id': 'OG001', 'title': 'Placebo/Cisplatin', 'description': 'Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m\\^2 on Day 1 every 21 days.\n\nPretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.\n\nVitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.\n\nFolic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.29', 'groupId': 'OG000', 'lowerLimit': '4.21', 'upperLimit': '5.98'}, {'value': '4.37', 'groupId': 'OG001', 'lowerLimit': '3.58', 'upperLimit': '6.44'}]}]}], 'analyses': [{'pValue': '0.811', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.56', 'ciUpperLimit': '1.53', 'statisticalMethod': 'Stratified Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'time of response to progressive disease up to 24 months', 'description': 'DoR is time from first observation of complete response (CR) or partial response (PR) to first observation of PD or death. Response is objective status of CR or PR using RECIST criteria. CR is disappearance of lesions. PR is \\>30% decrease in size of lesions. Responder is any participant with CR or PR. PD is at least 20% increase in sum of longest diameter of target lesions. For participants alive as of data-inclusion cut-off date and who do not have PD, DoR will be censored at date of last objective progression-free disease assessment before date of any subsequent systemic anticancer therapy.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with a confirmed best response of complete response (CR) or partial response (PR).'}, {'type': 'SECONDARY', 'title': 'Time to Treatment Worsening in Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemetrexed/Cisplatin', 'description': 'Pemetrexed 500 milligrams per meter square (mg/m\\^2) administered intravenously (IV) plus cisplatin 75 mg/m\\^2 IV on Day 1 every 21 days.\n\nPretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.\n\nVitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.\n\nFolic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.'}, {'id': 'OG001', 'title': 'Placebo/Cisplatin', 'description': 'Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m\\^2 on Day 1 every 21 days.\n\nPretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.\n\nVitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.\n\nFolic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.29', 'groupId': 'OG000', 'lowerLimit': '2.76', 'upperLimit': '4.11'}, {'value': '2.89', 'groupId': 'OG001', 'lowerLimit': '2.40', 'upperLimit': '3.19'}]}]}], 'analyses': [{'pValue': '0.20', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.07', 'statisticalMethod': 'Stratified Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (</=Day 1 of first dose) and Day 1 of every subsequent cycle to 30-day post-study completion up to 33 months', 'description': "FACT-H\\&N consists of 39 items with 5-point rating scale from 0 (not at all) to 4 (very much). FACT-H\\&N Total score ranges from 0 to 148. Higher score represents a better quality of life. Time to worsening was defined as the first date of worsening in the FACT H\\&N Total score that was considered at least the prospectively defined minimally important difference (MID) as compared with participant's baseline score, or date of death from any cause. The MID for FACT H\\&N Total score was a decrease of 12 points.", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) population with at least Baseline data.'}, {'type': 'SECONDARY', 'title': 'Correlation Between Biomarkers and Treatment Effect', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemetrexed/Cisplatin', 'description': 'Pemetrexed 500 milligrams per meter square (mg/m\\^2) administered intravenously (IV) plus cisplatin 75 mg/m\\^2 IV on Day 1 every 21 days.\n\nPretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.\n\nVitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.\n\nFolic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.'}, {'id': 'OG001', 'title': 'Placebo/Cisplatin', 'description': 'Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m\\^2 on Day 1 every 21 days.\n\nPretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.\n\nVitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.\n\nFolic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Correlation between highly up/downregulated genes and clinical response (Overall Survival (OS) and Progression-Free Survival (PFS)). OS is is defined as the time from the date of randomization to the date of death from any cause. PFS is defined as the time from the date of randomization to the date of objectively determined progressive disease or death from any cause, whichever comes first.\n\n0 participants were analyzed; Reason: The relatively low number of samples collected would not have yielded a meaningful genomic analysis and the decision was made to not analyze the data.', 'unitOfMeasure': 'correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed because the relatively low number of samples collected would not have yielded a meaningful genomic analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pemetrexed/Cisplatin', 'description': 'Pemetrexed 500 milligrams per meter square (mg/m\\^2) administered intravenously (IV) plus cisplatin 75 mg/m\\^2 IV on Day 1 every 21 days.\n\nPretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.\n\nVitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.\n\nFolic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.'}, {'id': 'FG001', 'title': 'Placebo/Cisplatin', 'description': 'Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m\\^2 on Day 1 every 21 days.\n\nPretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.\n\nVitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.\n\nFolic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '398'}, {'groupId': 'FG001', 'numSubjects': '397'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '392'}, {'groupId': 'FG001', 'numSubjects': '385'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '328'}, {'groupId': 'FG001', 'numSubjects': '342'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'Entry Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '180'}, {'groupId': 'FG001', 'numSubjects': '217'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Death Due to Study Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'Death Due to Study Drug Related AE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death Due to Procedural Related AE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death Due to AE (Other Causes)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '15'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'BG000'}, {'value': '397', 'groupId': 'BG001'}, {'value': '795', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pemetrexed/Cisplatin', 'description': 'Pemetrexed 500 milligrams per meter square (mg/m\\^2) administered intravenously (IV) plus cisplatin 75 mg/m\\^2 IV on Day 1 every 21 days.\n\nPretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.\n\nVitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.\n\nFolic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.'}, {'id': 'BG001', 'title': 'Placebo/Cisplatin', 'description': 'Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m\\^2 on Day 1 every 21 days.\n\nPretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.\n\nVitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.\n\nFolic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.45', 'spread': '9.54', 'groupId': 'BG000'}, {'value': '57.78', 'spread': '9.36', 'groupId': 'BG001'}, {'value': '57.62', 'spread': '9.44', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '342', 'groupId': 'BG000'}, {'value': '344', 'groupId': 'BG001'}, {'value': '686', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '243', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '476', 'groupId': 'BG002'}]}]}, {'title': 'East Asian', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'West Asian (Indian sub-continent)', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Argentina', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'China', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Previously Treated for Head and Neck Cancer (HNC)', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '363', 'groupId': 'BG000'}, {'value': '358', 'groupId': 'BG001'}, {'value': '721', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Prior Treatment with Platinum-Based Therapy', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '213', 'groupId': 'BG000'}, {'value': '228', 'groupId': 'BG001'}, {'value': '441', 'groupId': 'BG002'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '185', 'groupId': 'BG000'}, {'value': '169', 'groupId': 'BG001'}, {'value': '354', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Distant Metastasis', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '320', 'groupId': 'BG002'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '233', 'groupId': 'BG000'}, {'value': '242', 'groupId': 'BG001'}, {'value': '475', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) Performance Status', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '257', 'groupId': 'BG000'}, {'value': '253', 'groupId': 'BG001'}, {'value': '510', 'groupId': 'BG002'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}]}, {'title': 'Missing Data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': "These scales and criteria are used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis:\n\n1. Fully active, able to carry on all pre-disease performance without restriction\n2. Restricted in strenuous activity,able to carry out work of a light or sedentary nature\n3. Ambulatory, but unable to carry out any work activities. Capable of only limited selfcare\n4. Completely disabled. Cannot carry on any selfcare.\n5. Dead", 'unitOfMeasure': 'Participants'}, {'title': 'Primary Site of Disease', 'classes': [{'title': 'Hypopharynx', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}]}, {'title': 'Larynx', 'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '205', 'groupId': 'BG002'}]}]}, {'title': 'Oral Cavity', 'categories': [{'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '261', 'groupId': 'BG002'}]}]}, {'title': 'Oropharynx', 'categories': [{'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, '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': 795}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-23', 'studyFirstSubmitDate': '2006-12-20', 'resultsFirstSubmitDate': '2011-03-10', 'studyFirstSubmitQcDate': '2006-12-21', 'lastUpdatePostDateStruct': {'date': '2011-06-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-03-10', 'studyFirstPostDateStruct': {'date': '2006-12-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Baseline to date of death from any cause up to 36 months', 'description': "OS duration is defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date, OS duration will be censored at the date of the participant's last contact prior to that cut-off date."}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'baseline to measured progressive disease up to 33 months', 'description': 'Objective PFS is defined as the time from date of randomization to date of objectively determined progressive disease (PD) or death from any cause, whichever comes first. PD was defined by Response Evaluation Criteria in Solid Tumors (RECIST). PD=at least a 20% increase in sum of longest diameter of target lesions. For participants who are not known to have died as of the data-inclusion cut-off date, and who do not have progressive disease, PFS will be censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systemic anticancer therapy.'}, {'measure': 'Percent of Participants With a Tumor Response (Response Rate)', 'timeFrame': 'Baseline to progressive disease or discontinuation of study treatment up to 11 months', 'description': 'Tumor Response is evaluated as CR (Complete Response) or PR (Partial Response) per Response Evaluation Criteria in Solid Tumors (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions. Response rate (%) = (number of participants with CR+PR/number of participants)\\*100'}, {'measure': 'Duration of Response (DoR)', 'timeFrame': 'time of response to progressive disease up to 24 months', 'description': 'DoR is time from first observation of complete response (CR) or partial response (PR) to first observation of PD or death. Response is objective status of CR or PR using RECIST criteria. CR is disappearance of lesions. PR is \\>30% decrease in size of lesions. Responder is any participant with CR or PR. PD is at least 20% increase in sum of longest diameter of target lesions. For participants alive as of data-inclusion cut-off date and who do not have PD, DoR will be censored at date of last objective progression-free disease assessment before date of any subsequent systemic anticancer therapy.'}, {'measure': 'Time to Treatment Worsening in Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Total Score', 'timeFrame': 'Baseline (</=Day 1 of first dose) and Day 1 of every subsequent cycle to 30-day post-study completion up to 33 months', 'description': "FACT-H\\&N consists of 39 items with 5-point rating scale from 0 (not at all) to 4 (very much). FACT-H\\&N Total score ranges from 0 to 148. Higher score represents a better quality of life. Time to worsening was defined as the first date of worsening in the FACT H\\&N Total score that was considered at least the prospectively defined minimally important difference (MID) as compared with participant's baseline score, or date of death from any cause. The MID for FACT H\\&N Total score was a decrease of 12 points."}, {'measure': 'Correlation Between Biomarkers and Treatment Effect', 'timeFrame': 'Baseline', 'description': 'Correlation between highly up/downregulated genes and clinical response (Overall Survival (OS) and Progression-Free Survival (PFS)). OS is is defined as the time from the date of randomization to the date of death from any cause. PFS is defined as the time from the date of randomization to the date of objectively determined progressive disease or death from any cause, whichever comes first.\n\n0 participants were analyzed; Reason: The relatively low number of samples collected would not have yielded a meaningful genomic analysis and the decision was made to not analyze the data.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Head and Neck Neoplasms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'This study will compare the effects of pemetrexed plus cisplatin versus cisplatin alone in head and neck cancer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* You must have head and neck cancer that has returned and cannot be treated with surgery or other types of treatment. OR You must have head and neck cancer that was just found and has spread to other parts of your body.\n* You must have a performance status of 0,1 or 2. This means that you must at least be able to get around, be able to take care of yourself and must be up and about most of the day.\n* Your test results must show that your liver, kidneys and blood cells are working normally.\n* You must understand and sign the form that gives your agreement to willingly be part of the study.\n* You must be at least 18 years of age.\n\nExclusion Criteria:\n\n* You cannot have previously been given other treatment for cancer that has spread to other parts of your body.\n* You cannot have a serious sickness that might keep you from finishing the study (for example a bad infection).\n* You cannot have any extra fluid in your chest or bowel area unless your doctor tells you it can be drained before you join the study.\n* You cannot have any cancer called nasopharyngeal cancer, paranasal sinus cancer, lip cancer, or salivary gland cancer.\n* If you are taking high dose aspirin or other medicines called non-steroidal anti-inflammatory drugs and cannot stop taking them for at least 5 days, you cannot be in the study. Your doctor or a member of the study team can explain which drugs are non-steroidal anti-inflammatory drugs.'}, 'identificationModule': {'nctId': 'NCT00415194', 'briefTitle': 'A Study for Patients With Head and Neck Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Randomized Phase 3 Study of Pemetrexed in Combination With Cisplatin Versus Cisplatin Monotherapy in Patients With Recurrent or Metastatic Head and Neck Cancer', 'orgStudyIdInfo': {'id': '8431'}, 'secondaryIdInfos': [{'id': 'H3E-MC-JMHR', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pemetrexed/Cisplatin', 'description': 'Pemetrexed 500 milligrams per meter square (mg/m\\^2) administered intravenously (IV) plus cisplatin 75 mg/m\\^2 IV on Day 1 every 21 days. Pretreatment, Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.\n\nVitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.', 'interventionNames': ['Drug: pemetrexed', 'Drug: cisplatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo/Cisplatin', 'description': 'Placebo (approximately 100 mL normal saline) administered intravenously (IV) plus cisplatin 75 mg/m\\^2 on Day 1 every 21 days.\n\nPretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.\n\nFolic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.', 'interventionNames': ['Drug: cisplatin', 'Drug: placebo']}], 'interventions': [{'name': 'pemetrexed', 'type': 'DRUG', 'otherNames': ['Alimta', 'LY231514'], 'description': '500 mg/m\\^2, IV, every 21 days, six 21 day cycles', 'armGroupLabels': ['Pemetrexed/Cisplatin']}, {'name': 'cisplatin', 'type': 'DRUG', 'description': '75 mg/m\\^2, administered IV, every 21 days, six 21 day cycles', 'armGroupLabels': ['Pemetrexed/Cisplatin', 'Placebo/Cisplatin']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Approximately 100 mL normal saline administered IV, every 21 days, six 21 day cycles', 'armGroupLabels': ['Placebo/Cisplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33708', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46107', 'city': 'Beech Grove', 'state': 'Indiana', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.72199, 'lon': -86.08998}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'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': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '02896', 'city': 'North Smithfield', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.96677, 'lon': -71.54951}}, {'zip': 'C1185AAT', 'city': 'Buenos Aires', 'country': 'Argentina', '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': -34.61315, 'lon': -58.37723}}, {'zip': '4000', 'city': 'S.M. de Tucuman', 'country': 'Argentina', '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': '3000', 'city': 'Santa Fé', 'country': 'Argentina', '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': '4000', 'city': 'Tucumain', 'country': 'Argentina', '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': '2020', 'city': 'Antwerp', 'country': 'Belgium', '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': 51.22047, 'lon': 4.40026}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', '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': 51.15662, 'lon': 4.44504}}, {'zip': '30140-083', 'city': 'Belo Horizonte', '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': -19.92083, 'lon': -43.93778}}, {'zip': '20231050', 'city': 'Rio de Janeiro', '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': -22.90642, 'lon': -43.18223}}, {'zip': '510060', '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': '530000', 'city': 'Nanning', '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': 22.81667, 'lon': 108.31667}}, {'zip': '200032', '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': '430030', 'city': 'Wuhan', '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': 30.58333, 'lon': 114.26667}}, {'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '84082', 'city': 'Avignon', 'country': 'France', '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': 43.94834, 'lon': 4.80892}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', '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': 47.39484, 'lon': 0.70398}}, {'zip': '13125', 'city': 'Berlin', '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': 52.52437, 'lon': 13.41053}}, {'zip': 'D-91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '45122', 'city': 'Essen', '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': 51.45657, 'lon': 7.01228}}, {'zip': 'D-65929', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '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': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '04103', 'city': 'Leipzig', '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': 51.33962, 'lon': 12.37129}}, {'zip': '23538', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '1122', 'city': 'Budapest', 'country': 'Hungary', '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': 47.49835, 'lon': 19.04045}}, {'zip': 'H-4400', 'city': 'Nyíregyháza', 'country': 'Hungary', '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': 47.95539, 'lon': 21.71671}}, {'zip': '560 029', 'city': 'Bangalore', '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': 12.97194, 'lon': 77.59369}}, {'zip': '462001', 'city': 'Bhopal', '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 - 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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': 25.59408, 'lon': 85.13563}}, {'zip': '411004', 'city': 'Pune', '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': 18.51957, 'lon': 73.85535}}, {'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': '12100', 'city': 'Confreria', '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.'}, {'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': '20133', 'city': 'Milan', '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': 42.78235, 'lon': 12.59836}}, {'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 - 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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': 16.14944, 'lon': -92.06361}}, {'city': 'Monterrey', 'country': 'Mexico', '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': 25.68435, 'lon': -100.31721}}, {'zip': '06760', 'city': 'Roma Sur', 'country': 'Mexico', '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': 19.40582, 'lon': -99.16265}}, {'zip': 'CP50180', 'city': 'Toluca', 'country': 'Mexico', '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': 19.28786, 'lon': -99.65324}}, {'zip': '1081 HV', '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': '6500 HB', 'city': 'Nijmegen', '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': 51.8425, 'lon': 5.85278}}, {'zip': '80-211', 'city': 'Gdansk', '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': 54.35227, 'lon': 18.64912}}, {'zip': '31-531', 'city': 'Krakow', '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': 50.06143, 'lon': 19.93658}}, {'zip': '10-228', 'city': 'Olsztyn', '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': 53.78376, 'lon': 20.49272}}, {'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': '00935', 'city': 'San Juan', 'country': 'Puerto Rico', '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': 18.46633, 'lon': -66.10572}}, {'zip': '022328', 'city': 'Bucharest', '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': 44.43225, 'lon': 26.10626}}, {'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': '540136', 'city': 'Târgu Mureş', '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': 46.54245, 'lon': 24.55747}}, {'zip': '656049', 'city': 'Barnaul', 'country': 'Russia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 53.36199, 'lon': 83.72786}}, {'zip': '454087', 'city': 'Chelyabinsk', 'country': 'Russia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 55.1611, 'lon': 61.42877}}, {'zip': '115478', 'city': 'Moscow', 'country': 'Russia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '183047', 'city': 'Murmansk', 'country': 'Russia', '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': 68.96778, 'lon': 33.09922}}, {'zip': '198255', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '9300', 'city': 'Bloemfontein', 'country': 'South Africa', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -29.12107, 'lon': 26.214}}, {'zip': '4091', 'city': 'Durban', 'country': 'South Africa', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'zip': '2193', 'city': 'Parktown', 'country': 'South Africa', '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': -26.18205, 'lon': 28.02671}}, {'zip': '700-721', 'city': 'Daegu', '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': 35.87028, 'lon': 128.59111}}, {'zip': '519-809', 'city': 'Hwasun-Gun', '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.'}, {'zip': '609 735', 'city': 'Pusan', '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': 36.3809, 'lon': 128.3681}}, {'zip': '134-791', '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': '08036', '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': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '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': '31008', 'city': 'Pamplona', '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': 42.81687, 'lon': -1.64323}}, {'zip': '41013', 'city': 'Seville', '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': 37.38283, 'lon': -5.97317}}, {'zip': '46014', 'city': 'Valencia', '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': 39.47391, 'lon': -0.37966}}, {'zip': '500', 'city': 'Changhua', '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': 24.0692, 'lon': 120.5512}}, {'zip': '970', 'city': 'Hualien City', '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': 23.97694, 'lon': 121.60444}}, {'zip': '736', 'city': 'Liouying/Tainan', '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.'}, {'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}}], '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': {'oldNameTitle': 'Chief Medical Officer', 'oldOrganization': 'Eli Lilly'}}}}