Viewing Study NCT00006392

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Ignite Creation Date: 2025-12-24 @ 3:32 PM
Ignite Modification Date: 2025-12-27 @ 7:43 PM
Study NCT ID: NCT00006392
Status: COMPLETED
Last Update Posted: 2015-11-20
First Post: 2000-10-04
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: S0000 Selenium and Vitamin E in Preventing Prostate Cancer
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Canada', 'Peru', 'Puerto Rico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014810', 'term': 'Vitamin E'}, {'id': 'D024502', 'term': 'alpha-Tocopherol'}, {'id': 'D012643', 'term': 'Selenium'}], 'ancestors': [{'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D024505', 'term': 'Tocopherols'}, {'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008903', 'term': 'Minerals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '2066674623', 'title': 'Study Statistician', 'organization': 'SWOG Statistical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'Study site visits, collected by CRA based on participant interview and annual limited physical exam', 'eventGroups': [{'id': 'EG000', 'title': 'Selenium Alone', 'description': 'Selenium + placebo for vitamin E', 'otherNumAtRisk': 8752, 'otherNumAffected': 2605, 'seriousNumAtRisk': 8752, 'seriousNumAffected': 96}, {'id': 'EG001', 'title': 'Combination', 'description': 'Selenium + vitamin E', 'otherNumAtRisk': 8702, 'otherNumAffected': 2550, 'seriousNumAtRisk': 8702, 'seriousNumAffected': 93}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo for selenium + placebo for vitamin E', 'otherNumAtRisk': 8696, 'otherNumAffected': 2421, 'seriousNumAtRisk': 8696, 'seriousNumAffected': 108}, {'id': 'EG003', 'title': 'Vitamin E Alone', 'description': 'Vitamin E + placebo for selenium', 'otherNumAtRisk': 8737, 'otherNumAffected': 2553, 'seriousNumAtRisk': 8737, 'seriousNumAffected': 99}], 'otherEvents': [{'term': 'Cardiac ischemia/infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 558}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 533}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 529}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 551}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Halitosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 523}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 555}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 447}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 517}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Fatigue/malaise/lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 698}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 657}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 632}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 660}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 647}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 593}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 554}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 627}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Nail changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 1129}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 1080}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 1072}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 1070}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}], 'seriousEvents': [{'term': 'Arrhythmia, NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Cardiac ischemia/infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 18}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Cardiovascular-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 14}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Conduction abnormality/block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'LVEF decrease/CHF', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Supraventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Ventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Eye-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Vision,NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Dyspepsia/heartburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'GI-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Melena/ GI bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Rectal bleeding/hematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Constitutional symptoms-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Hemorrhage w/o 3-4 thrombocyt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Pain-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Reportable adverse event, NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Liver-clinical', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Liver-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Respiratory infect w/o neutrop', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Respiratory infection, unk ANC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Urinary tr infect w/o neutrop', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Surgery-hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Myalgia/arthralgia, NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Second primary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'CNS hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Cerebrovascular ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Cranial neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Neuro-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Erectile impotence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'ARDS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Emphysema/COPD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and 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'numAtRisk': 8752, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Rash/desquamation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Aortic Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Carotid stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Peripheral arterial ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Thrombosis/embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8752, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8702, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8696, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 8737, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Prostate Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8737', 'groupId': 'OG000'}, {'value': '8752', 'groupId': 'OG001'}, {'value': '8703', 'groupId': 'OG002'}, {'value': '8696', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin E', 'description': 'Vitamin E + matching placebo for selenium'}, {'id': 'OG001', 'title': 'Selenium', 'description': 'Selenium + matching placebo for vitamin E'}, {'id': 'OG002', 'title': 'Combination', 'description': 'Vitamin E + selenium'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Matching placebo for vitamin E + matching placebo for selenium'}], 'classes': [{'categories': [{'measurements': [{'value': '473', 'groupId': 'OG000'}, {'value': '432', 'groupId': 'OG001'}, {'value': '437', 'groupId': 'OG002'}, {'value': '416', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '< .01', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard 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power to detect a 25% reduction in prostate cancer for either agent vs. Placebo.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< .01', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '99', 'paramValue': '1.05', 'ciLowerLimit': '.88', 'ciUpperLimit': '1.25', 'pValueComment': 'The p-value was adjusted for multiple comparisons.', 'groupDescription': 'Per study design, with a sample size of 32,400 men, using a 1-sided alpha=.005 level (equivalent to a 2-sided alpha=.01 level) there was 99% power to detect a 44% reduction in prostate cancer for combination vs. Placebo.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Every six months for 7 to 12 years depending on when the participant was randomized.', 'description': 'Participants are seen at the study site every six month for an update of medical events. Prostate cancer diagnosis is based on participant report followed by the submission of a pathologic sample to central pathology review for confirmation.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized eligible men not at 2 sites for which the DSMC said the data could not be used due to participant and data management issues as well as regulatory problems.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Lung Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8737', 'groupId': 'OG000'}, {'value': '8752', 'groupId': 'OG001'}, {'value': '8703', 'groupId': 'OG002'}, {'value': '8696', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin E', 'description': 'Vitamin E + matching placebo for selenium'}, {'id': 'OG001', 'title': 'Selenium', 'description': 'Selenium + matching placebo for vitamin E'}, {'id': 'OG002', 'title': 'Combination', 'description': 'Vitamin E + selenium'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Matching placebo for vitamin E + matching placebo for selenium'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '> .05', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '99', 'paramValue': '1.0', 'ciLowerLimit': '.64', 'ciUpperLimit': '1.55', 'pValueComment': 'The trial was designed to study prostate cancer and lung cancer has a lower incidence rate, there was limited power to look at lung cancer incidence. A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.', 'estimateComment': 'The placebo was the denominator.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '> .01', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '1.12', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.72', 'pValueComment': 'The trial was designed to study prostate cancer and lung cancer has a lower incidence rate, there was limited power to look at lung cancer incidence. A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.', 'estimateComment': 'The placebo was the denominator.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '>.01', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '1.16', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.16', 'pValueComment': 'The trial was designed to study prostate cancer and lung cancer has a lower incidence rate, there was limited power to look at lung cancer incidence. A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.', 'estimateComment': 'The placebo was the denominator.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.', 'description': 'Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Colorectal Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8737', 'groupId': 'OG000'}, {'value': '8752', 'groupId': 'OG001'}, {'value': '8703', 'groupId': 'OG002'}, {'value': '8696', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin E', 'description': 'Vitamin E + matching placebo for selenium'}, {'id': 'OG001', 'title': 'Selenium', 'description': 'Selenium + matching placebo for vitamin E'}, {'id': 'OG002', 'title': 'Combination', 'description': 'Vitamin E + selenium'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Matching placebo for vitamin E + matching placebo for selenium'}], 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '> .05', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '1.09', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.73', 'pValueComment': 'A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.', 'estimateComment': 'The placebo was the denominator.', 'groupDescription': 'The trial was designed to study prostate cancer and colorectal cancer has a lower incidence rate, there was limited power to look at colorectal cancer incidence.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '> .05', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '1.05', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.67', 'pValueComment': 'A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.', 'estimateComment': 'The placebo was the denominator.', 'groupDescription': 'The trial was designed to study prostate cancer and colorectal cancer has a lower incidence rate, there was limited power to look at colorectal cancer incidence.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '> .05', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '1.28', 'ciLowerLimit': '0.82', 'ciUpperLimit': '2.00', 'pValueComment': 'A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.', 'estimateComment': 'The placebo was the denominator.', 'groupDescription': 'The trial was designed to study prostate cancer and colorectal cancer has a lower incidence rate, there was limited power to look at colorectal cancer incidence.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.', 'description': 'Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Diagnosis of Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8737', 'groupId': 'OG000'}, {'value': '8752', 'groupId': 'OG001'}, {'value': '8703', 'groupId': 'OG002'}, {'value': '8696', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin E', 'description': 'Vitamin E + matching placebo for selenium'}, {'id': 'OG001', 'title': 'Selenium', 'description': 'Selenium + matching placebo for vitamin E'}, {'id': 'OG002', 'title': 'Combination', 'description': 'Vitamin E + selenium'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Matching placebo for vitamin E + matching placebo for selenium'}], 'classes': [{'categories': [{'measurements': [{'value': '856', 'groupId': 'OG000'}, {'value': '837', 'groupId': 'OG001'}, {'value': '846', 'groupId': 'OG002'}, {'value': '824', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '> .05', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '1.03', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.17', 'pValueComment': 'A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.', 'estimateComment': 'The placebo was the denominator.', 'groupDescription': 'The power to look at all cancer incidence is greater than 90%.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '> .05', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '1.01', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.15', 'pValueComment': 'A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.', 'estimateComment': 'The placebo was the denominator.', 'groupDescription': 'The power to look at all cancer incidence is greater than 90%.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '> .05', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '99', 'paramValue': '1.02', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.16', 'pValueComment': 'A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.', 'estimateComment': 'The placebo was the denominator.', 'groupDescription': 'The power to look at all cancer incidence is greater than 90%.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.', 'description': 'Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues.'}, {'type': 'SECONDARY', 'title': 'Prostate Cancer Free Survival; Lung Cancer-free Survival, Colorectal Cancer-free Survival, Cancer-free Survival, Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8737', 'groupId': 'OG000'}, {'value': '8752', 'groupId': 'OG001'}, {'value': '8703', 'groupId': 'OG002'}, {'value': '8696', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin E', 'description': 'Vitamin E + matching placebo for selenium'}, {'id': 'OG001', 'title': 'Selenium', 'description': 'Selenium + matching placebo for vitamin E'}, {'id': 'OG002', 'title': 'Combination', 'description': 'Vitamin E + selenium'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Matching placebo for vitamin E + matching placebo for selenium'}], 'classes': [{'title': 'All deaths', 'categories': [{'measurements': [{'value': '358', 'groupId': 'OG000'}, {'value': '378', 'groupId': 'OG001'}, {'value': '359', 'groupId': 'OG002'}, {'value': '382', 'groupId': 'OG003'}]}]}, {'title': 'All cancer deaths', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}, {'value': '125', 'groupId': 'OG003'}]}]}, {'title': 'Prostate cancer deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Lung cancer deaths', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}]}, {'title': 'Colorectal cancer deaths', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '> .05', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '99', 'paramValue': '0.93', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.13', 'pValueComment': 'A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.', 'estimateComment': 'The placebo is the denominator.', 'groupDescription': 'Only results from overall survival are presented as the number of cancer-specific deaths is too few to be meaningful.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '> .05', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '0.99', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.19', 'pValueComment': 'A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.', 'estimateComment': 'The placebo was the denominator.', 'groupDescription': 'Only results from overall survival are presented as the number of cancer-specific deaths is too few to be meaningful.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '> .05', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '0.94', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.13', 'pValueComment': 'A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.', 'groupDescription': 'Only results from overall survival are presented as the number of cancer-specific deaths is too few to be meaningful.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.', 'description': 'Participants are seen at the study site every six month for an update of medical events. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Prostate cancer diagnosis is based on participant report followed by the submission of a pathologic sample to central pathology review for confirmation. Other cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. Follow-up was planned for seven to 12 years depending on when the participant was randomized.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues. Deaths include those reported as SAEs as well as non-SAE deaths as this was a prevention trial with older generally healthy men at baseline who were followed for a long time.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Cardiovascular Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8737', 'groupId': 'OG000'}, {'value': '8752', 'groupId': 'OG001'}, {'value': '8703', 'groupId': 'OG002'}, {'value': '8696', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin E', 'description': 'Vitamin E + matching placebo for selenium'}, {'id': 'OG001', 'title': 'Selenium', 'description': 'Selenium + matching placebo for vitamin E'}, {'id': 'OG002', 'title': 'Combination', 'description': 'Vitamin E + selenium'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Matching placebo for vitamin E + matching placebo for selenium'}], 'classes': [{'categories': [{'measurements': [{'value': '1034', 'groupId': 'OG000'}, {'value': '1080', 'groupId': 'OG001'}, {'value': '1041', 'groupId': 'OG002'}, {'value': '1050', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '> .05', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '0.98', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.09', 'pValueComment': 'A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.', 'estimateComment': 'The placebo was the denominator.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '> .05', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '1.02', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.13', 'pValueComment': 'A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.', 'estimateComment': 'The placebo was the denominator.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '> .05', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '0.99', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.10', 'pValueComment': 'A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.', 'estimateComment': 'The placebo was the denominator.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.', 'description': 'Participants are seen at the study site every six month for an update of medical events. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Cardiovascular events are based on self-report and are not confirmed. Follow-up was planned for seven to 12 years depending on when the participant was randomized.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vitamin E', 'description': 'Vitamin E + matching placebo for selenium'}, {'id': 'FG001', 'title': 'Selenium', 'description': 'Selenium + matching placebo for vitamin E'}, {'id': 'FG002', 'title': 'Combination', 'description': 'Vitamin E + selenium'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Matching placebo for vitamin E + matching placebo for selenium'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8904'}, {'groupId': 'FG001', 'numSubjects': '8910'}, {'groupId': 'FG002', 'numSubjects': '8863'}, {'groupId': 'FG003', 'numSubjects': '8856'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8737'}, {'groupId': 'FG001', 'numSubjects': '8752'}, {'groupId': 'FG002', 'numSubjects': '8703'}, {'groupId': 'FG003', 'numSubjects': '8696'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '167'}, {'groupId': 'FG001', 'numSubjects': '158'}, {'groupId': 'FG002', 'numSubjects': '160'}, {'groupId': 'FG003', 'numSubjects': '160'}]}], 'dropWithdraws': [{'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Poor data/ppt mgmt, regulatory problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '156'}, {'groupId': 'FG001', 'numSubjects': '155'}, {'groupId': 'FG002', 'numSubjects': '155'}, {'groupId': 'FG003', 'numSubjects': '155'}]}]}], 'recruitmentDetails': 'Men were randomized at 427 study sites in the US, Puerto Rico and Canada between August 22, 2001 and June 24, 2004.', 'preAssignmentDetails': 'Prior to randomization, there was a three month formal pre-randomization period with no placebo run-in capsules to give potential participants to decide if they would agree to stop disallowed over-the-counter supplements of selenium or vitamin E. By returning for randomization, they exhibited their willingness to adhere to the trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8737', 'groupId': 'BG000'}, {'value': '8752', 'groupId': 'BG001'}, {'value': '8703', 'groupId': 'BG002'}, {'value': '8696', 'groupId': 'BG003'}, {'value': '34888', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Vitamin E', 'description': 'Vitamin E + matching placebo for selenium'}, {'id': 'BG001', 'title': 'Selenium', 'description': 'Selenium + matching placebo for vitamin E'}, {'id': 'BG002', 'title': 'Combination', 'description': 'Vitamin E + selenium'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Matching placebo for vitamin E + matching placebo for selenium'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.4', 'groupId': 'BG000', 'lowerLimit': '58.1', 'upperLimit': '67.8'}, {'value': '62.6', 'groupId': 'BG001', 'lowerLimit': '58.1', 'upperLimit': '67.8'}, {'value': '62.3', 'groupId': 'BG002', 'lowerLimit': '58.0', 'upperLimit': '67.8'}, {'value': '62.6', 'groupId': 'BG003', 'lowerLimit': '58.2', 'upperLimit': '68.0'}, {'value': '62.3', 'groupId': 'BG004', 'lowerLimit': '58.1', 'upperLimit': '67.8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '8737', 'groupId': 'BG000'}, {'value': '8752', 'groupId': 'BG001'}, {'value': '8703', 'groupId': 'BG002'}, {'value': '8696', 'groupId': 'BG003'}, {'value': '34888', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '6890', 'groupId': 'BG000'}, {'value': '6942', 'groupId': 'BG001'}, {'value': '6874', 'groupId': 'BG002'}, {'value': '6863', 'groupId': 'BG003'}, {'value': '27569', 'groupId': 'BG004'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '1107', 'groupId': 'BG000'}, {'value': '1053', 'groupId': 'BG001'}, {'value': '1076', 'groupId': 'BG002'}, {'value': '1078', 'groupId': 'BG003'}, {'value': '4314', 'groupId': 'BG004'}]}]}, {'title': 'Hispanic (non-African American)', 'categories': [{'measurements': [{'value': '477', 'groupId': 'BG000'}, {'value': '481', 'groupId': 'BG001'}, {'value': '484', 'groupId': 'BG002'}, {'value': '492', 'groupId': 'BG003'}, {'value': '1934', 'groupId': 'BG004'}]}]}, {'title': 'Hispanic (African American)', 'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}, {'value': '360', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}, {'value': '187', 'groupId': 'BG003'}, {'value': '711', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participant'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7463', 'groupId': 'BG000'}, {'value': '7471', 'groupId': 'BG001'}, {'value': '7427', 'groupId': 'BG002'}, {'value': '7428', 'groupId': 'BG003'}, {'value': '29789', 'groupId': 'BG004'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '909', 'groupId': 'BG000'}, {'value': '915', 'groupId': 'BG001'}, {'value': '911', 'groupId': 'BG002'}, {'value': '904', 'groupId': 'BG003'}, {'value': '3639', 'groupId': 'BG004'}]}]}, {'title': 'Puerto Rico', 'categories': [{'measurements': [{'value': '365', 'groupId': 'BG000'}, {'value': '366', 'groupId': 'BG001'}, {'value': '365', 'groupId': 'BG002'}, {'value': '364', 'groupId': 'BG003'}, {'value': '1460', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Age (categorical)', 'classes': [{'title': '50 - 54 years', 'categories': [{'measurements': [{'value': '402', 'groupId': 'BG000'}, {'value': '337', 'groupId': 'BG001'}, {'value': '385', 'groupId': 'BG002'}, {'value': '355', 'groupId': 'BG003'}, {'value': '1479', 'groupId': 'BG004'}]}]}, {'title': '55 - 64 years', 'categories': [{'measurements': [{'value': '5143', 'groupId': 'BG000'}, {'value': '5076', 'groupId': 'BG001'}, {'value': '5052', 'groupId': 'BG002'}, {'value': '5078', 'groupId': 'BG003'}, {'value': '20349', 'groupId': 'BG004'}]}]}, {'title': '65 - 74 years', 'categories': [{'measurements': [{'value': '2641', 'groupId': 'BG000'}, {'value': '2733', 'groupId': 'BG001'}, {'value': '2731', 'groupId': 'BG002'}, {'value': '2702', 'groupId': 'BG003'}, {'value': '10807', 'groupId': 'BG004'}]}]}, {'title': '>= 75 years', 'categories': [{'measurements': [{'value': '551', 'groupId': 'BG000'}, {'value': '606', 'groupId': 'BG001'}, {'value': '535', 'groupId': 'BG002'}, {'value': '561', 'groupId': 'BG003'}, {'value': '2253', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Education (highest)', 'classes': [{'title': '<= High school graduate or GED', 'categories': [{'measurements': [{'value': '1875', 'groupId': 'BG000'}, {'value': '1917', 'groupId': 'BG001'}, {'value': '1898', 'groupId': 'BG002'}, {'value': '1993', 'groupId': 'BG003'}, {'value': '7683', 'groupId': 'BG004'}]}]}, {'title': 'Some college/vocational school', 'categories': [{'measurements': [{'value': '2387', 'groupId': 'BG000'}, {'value': '2327', 'groupId': 'BG001'}, {'value': '2348', 'groupId': 'BG002'}, {'value': '2291', 'groupId': 'BG003'}, {'value': '9353', 'groupId': 'BG004'}]}]}, {'title': '>= College graduate', 'categories': [{'measurements': [{'value': '4394', 'groupId': 'BG000'}, {'value': '4430', 'groupId': 'BG001'}, {'value': '4372', 'groupId': 'BG002'}, {'value': '4317', 'groupId': 'BG003'}, {'value': '17513', 'groupId': 'BG004'}]}]}, {'title': 'Unknown/missing', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}, {'value': '95', 'groupId': 'BG003'}, {'value': '339', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participant'}, {'title': 'PSA (ng/ml)', 'classes': [{'title': '0.1 - 1.0', 'categories': [{'measurements': [{'value': '4208', 'groupId': 'BG000'}, {'value': '4218', 'groupId': 'BG001'}, {'value': '4213', 'groupId': 'BG002'}, {'value': '4122', 'groupId': 'BG003'}, {'value': '16761', 'groupId': 'BG004'}]}]}, {'title': '1.1 - 2.0', 'categories': [{'measurements': [{'value': '2653', 'groupId': 'BG000'}, {'value': '2661', 'groupId': 'BG001'}, {'value': '2666', 'groupId': 'BG002'}, {'value': '2728', 'groupId': 'BG003'}, {'value': '10708', 'groupId': 'BG004'}]}]}, {'title': '2.1 - 3.0', 'categories': [{'measurements': [{'value': '1228', 'groupId': 'BG000'}, {'value': '1211', 'groupId': 'BG001'}, {'value': '1149', 'groupId': 'BG002'}, {'value': '1168', 'groupId': 'BG003'}, {'value': '4756', 'groupId': 'BG004'}]}]}, {'title': '3.1 - 4.0', 'categories': [{'measurements': [{'value': '634', 'groupId': 'BG000'}, {'value': '652', 'groupId': 'BG001'}, {'value': '659', 'groupId': 'BG002'}, {'value': '666', 'groupId': 'BG003'}, {'value': '2611', 'groupId': 'BG004'}]}]}, {'title': '> 4.0', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}, {'title': 'Unknown/missing', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participant'}, {'title': 'Smoking status', 'classes': [{'title': 'Never', 'categories': [{'measurements': [{'value': '3752', 'groupId': 'BG000'}, {'value': '3780', 'groupId': 'BG001'}, {'value': '3666', 'groupId': 'BG002'}, {'value': '3682', 'groupId': 'BG003'}, {'value': '14880', 'groupId': 'BG004'}]}]}, {'title': 'Current', 'categories': [{'measurements': [{'value': '659', 'groupId': 'BG000'}, {'value': '631', 'groupId': 'BG001'}, {'value': '670', 'groupId': 'BG002'}, {'value': '655', 'groupId': 'BG003'}, {'value': '2615', 'groupId': 'BG004'}]}]}, {'title': 'Former', 'categories': [{'measurements': [{'value': '4194', 'groupId': 'BG000'}, {'value': '4214', 'groupId': 'BG001'}, {'value': '4242', 'groupId': 'BG002'}, {'value': '4208', 'groupId': 'BG003'}, {'value': '16858', 'groupId': 'BG004'}]}]}, {'title': 'Ever (unknown status)', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '235', 'groupId': 'BG004'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}, {'value': '300', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participant'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35533}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-23', 'studyFirstSubmitDate': '2000-10-04', 'resultsFirstSubmitDate': '2012-06-12', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-10-05', 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Prostate Cancer', 'timeFrame': 'Every six months for 7 to 12 years depending on when the participant was randomized.', 'description': 'Participants are seen at the study site every six month for an update of medical events. Prostate cancer diagnosis is based on participant report followed by the submission of a pathologic sample to central pathology review for confirmation.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Lung Cancer', 'timeFrame': 'Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.', 'description': 'Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized.'}, {'measure': 'Number of Participants With Colorectal Cancer', 'timeFrame': 'Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.', 'description': 'Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized.'}, {'measure': 'Number of Participants With Any Diagnosis of Cancer', 'timeFrame': 'Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.', 'description': 'Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized.'}, {'measure': 'Prostate Cancer Free Survival; Lung Cancer-free Survival, Colorectal Cancer-free Survival, Cancer-free Survival, Overall Survival', 'timeFrame': 'Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.', 'description': 'Participants are seen at the study site every six month for an update of medical events. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Prostate cancer diagnosis is based on participant report followed by the submission of a pathologic sample to central pathology review for confirmation. Other cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. Follow-up was planned for seven to 12 years depending on when the participant was randomized.'}, {'measure': 'Number of Participants With Serious Cardiovascular Events', 'timeFrame': 'Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.', 'description': 'Participants are seen at the study site every six month for an update of medical events. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Cardiovascular events are based on self-report and are not confirmed. Follow-up was planned for seven to 12 years depending on when the participant was randomized.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['prostate cancer'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '11552710', 'type': 'BACKGROUND', 'citation': 'Hoque A, Albanes D, Lippman SM, Spitz MR, Taylor PR, Klein EA, Thompson IM, Goodman P, Stanford JL, Crowley JJ, Coltman CA, Santella RM. Molecular epidemiologic studies within the Selenium and Vitamin E Cancer Prevention Trial (SELECT). Cancer Causes Control. 2001 Sep;12(7):627-33. doi: 10.1023/a:1011277600059.'}, {'pmid': '19373601', 'type': 'BACKGROUND', 'citation': 'El-Bayoumy K. The negative results of the SELECT study do not necessarily discredit the selenium-cancer prevention hypothesis. Nutr Cancer. 2009;61(3):285-6. doi: 10.1080/01635580902892829. No abstract available.'}, {'pmid': '16315648', 'type': 'BACKGROUND', 'citation': 'Cook ED, Moody-Thomas S, Anderson KB, Campbell R, Hamilton SJ, Harrington JM, Lippman SM, Minasian LM, Paskett ED, Craine S, Arnold KB, Probstfield JL. Minority recruitment to the Selenium and Vitamin E Cancer Prevention Trial (SELECT). Clin Trials. 2005;2(5):436-42. doi: 10.1191/1740774505cn111oa.'}, {'pmid': '15767358', 'type': 'BACKGROUND', 'citation': 'Kristal AR, King IB, Albanes D, Pollak MN, Stanzyk FZ, Santella RM, Hoque A. Centralized blood processing for the selenium and vitamin E cancer prevention trial: effects of delayed processing on carotenoids, tocopherols, insulin-like growth factor-I, insulin-like growth factor binding protein 3, steroid hormones, and lymphocyte viability. Cancer Epidemiol Biomarkers Prev. 2005 Mar;14(3):727-30. doi: 10.1158/1055-9965.EPI-04-0596.'}, {'pmid': '15657339', 'type': 'BACKGROUND', 'citation': 'Lippman SM, Goodman PJ, Klein EA, Parnes HL, Thompson IM Jr, Kristal AR, Santella RM, Probstfield JL, Moinpour CM, Albanes D, Taylor PR, Minasian LM, Hoque A, Thomas SM, Crowley JJ, Gaziano JM, Stanford JL, Cook ED, Fleshner NE, Lieber MM, Walther PJ, Khuri FR, Karp DD, Schwartz GG, Ford LG, Coltman CA Jr. Designing the Selenium and Vitamin E Cancer Prevention Trial (SELECT). J Natl Cancer Inst. 2005 Jan 19;97(2):94-102. doi: 10.1093/jnci/dji009.'}, {'pmid': '19066370', 'type': 'RESULT', 'citation': 'Lippman SM, Klein EA, Goodman PJ, Lucia MS, Thompson IM, Ford LG, Parnes HL, Minasian LM, Gaziano JM, Hartline JA, Parsons JK, Bearden JD 3rd, Crawford ED, Goodman GE, Claudio J, Winquist E, Cook ED, Karp DD, Walther P, Lieber MM, Kristal AR, Darke AK, Arnold KB, Ganz PA, Santella RM, Albanes D, Taylor PR, Probstfield JL, Jagpal TJ, Crowley JJ, Meyskens FL Jr, Baker LH, Coltman CA Jr. Effect of selenium and vitamin E on risk of prostate cancer and other cancers: the Selenium and Vitamin E Cancer Prevention Trial (SELECT). JAMA. 2009 Jan 7;301(1):39-51. doi: 10.1001/jama.2008.864. Epub 2008 Dec 9.'}, {'pmid': '21990298', 'type': 'RESULT', 'citation': 'Klein EA, Thompson IM Jr, Tangen CM, Crowley JJ, Lucia MS, Goodman PJ, Minasian LM, Ford LG, Parnes HL, Gaziano JM, Karp DD, Lieber MM, Walther PJ, Klotz L, Parsons JK, Chin JL, Darke AK, Lippman SM, Goodman GE, Meyskens FL Jr, Baker LH. Vitamin E and the risk of prostate cancer: the Selenium and Vitamin E Cancer Prevention Trial (SELECT). JAMA. 2011 Oct 12;306(14):1549-56. doi: 10.1001/jama.2011.1437.'}, {'pmid': '27998216', 'type': 'DERIVED', 'citation': 'Tangen CM, Goodman PJ, Till C, Schenk JM, Lucia MS, Thompson IM Jr. Biases in Recommendations for and Acceptance of Prostate Biopsy Significantly Affect Assessment of Prostate Cancer Risk Factors: Results From Two Large Randomized Clinical Trials. J Clin Oncol. 2016 Dec 20;34(36):4338-4344. doi: 10.1200/JCO.2016.68.1965. Epub 2016 Oct 28.'}, {'pmid': '27519183', 'type': 'DERIVED', 'citation': 'Goodman PJ, Tangen CM, Darke AK, Arnold KB, Hartline J, Yee M, Anderson K, Caban-Holt A, Christen WG, Cassano PA, Lance P, Klein EA, Crowley JJ, Minasian LM, Meyskens FL. Opportunities and challenges in incorporating ancillary studies into a cancer prevention randomized clinical trial. Trials. 2016 Aug 12;17:400. doi: 10.1186/s13063-016-1524-9.'}, {'pmid': '27197287', 'type': 'DERIVED', 'citation': 'Chan JM, Darke AK, Penney KL, Tangen CM, Goodman PJ, Lee GM, Sun T, Peisch S, Tinianow AM, Rae JM, Klein EA, Thompson IM Jr, Kantoff PW, Mucci LA. Selenium- or Vitamin E-Related Gene Variants, Interaction with Supplementation, and Risk of High-Grade Prostate Cancer in SELECT. Cancer Epidemiol Biomarkers Prev. 2016 Jul;25(7):1050-1058. doi: 10.1158/1055-9965.EPI-16-0104. Epub 2016 May 6.'}, {'pmid': '23171483', 'type': 'DERIVED', 'citation': "Abner EL, Dennis BC, Mathews MJ, Mendiondo MS, Caban-Holt A, Kryscio RJ, Schmitt FA; PREADViSE Investigators; Crowley JJ; SELECT Investigators. Practice effects in a longitudinal, multi-center Alzheimer's disease prevention clinical trial. Trials. 2012 Nov 20;13:217. doi: 10.1186/1745-6215-13-217."}, {'pmid': '23064404', 'type': 'DERIVED', 'citation': 'Goodman PJ, Hartline JA, Tangen CM, Crowley JJ, Minasian LM, Klein EA, Cook ED, Darke AK, Arnold KB, Anderson K, Yee M, Meyskens FL, Baker LH. Moving a randomized clinical trial into an observational cohort. Clin Trials. 2013 Feb;10(1):131-42. doi: 10.1177/1740774512460345. Epub 2012 Oct 12.'}, {'pmid': '20833684', 'type': 'DERIVED', 'citation': 'Chlebowski RT, Menon R, Chaisanguanthum RM, Jackson DM. Prospective evaluation of two recruitment strategies for a randomized controlled cancer prevention trial. Clin Trials. 2010 Dec;7(6):744-8. doi: 10.1177/1740774510383886. Epub 2010 Sep 10.'}, {'pmid': '20156960', 'type': 'DERIVED', 'citation': 'Cook ED, Arnold KB, Hermos JA, McCaskill-Stevens W, Moody-Thomas S, Probstfield JL, Hamilton SJ, Campbell RD, Anderson KB, Minasian LM. Impact of supplemental site grants to increase African American accrual for the Selenium and Vitamin E Cancer Prevention Trial. Clin Trials. 2010 Feb;7(1):90-9. doi: 10.1177/1740774509357227.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. It is not yet known which regimen of selenium and/or vitamin E may be more effective in preventing prostate cancer.\n\nPURPOSE: Randomized phase III trial to determine the effectiveness of selenium and vitamin E, either alone or together, in preventing prostate cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the effect of selenium and vitamin E administered alone vs in combination on the clinical incidence of prostate cancer.\n* Compare the effect of these prevention regimens on the incidence of lung cancer, colorectal cancer, and all cancers combined in participants on this study.\n* Compare the effect of these prevention regimens on prostate cancer-free survival, lung cancer-free survival, colorectal cancer-free survival, cancer-free survival, overall survival, and serious cardiovascular events in these participants.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Healthy male volunteers\n* Digital rectal examination (DRE) deemed not suspicious for prostate cancer performed within 364 days prior to study entry\n\n * Participants with a suspicious DRE are ineligible even if a recent or subsequent biopsy is negative for cancer\n* Total prostate-specific antigen ≤ 4.0 ng/mL within 364 days prior to study entry\n* No prior prostate cancer or high-grade (grade 2-3) prostatic intraepithelial neoplasia\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* See Disease Characteristics\n\nPerformance status:\n\n* Not specified\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* Not specified\n\nRenal:\n\n* Not specified\n\nCardiovascular:\n\n* Systolic blood pressure \\< 160 mm Hg\n* Diastolic blood pressure \\< 90 mm Hg\n* No history of hemorrhagic stroke\n\nOther:\n\n* No malignancies within the past 5 years except basal cell or squamous cell skin cancer\n* No uncontrolled medical illness\n* No retinitis pigmentosa\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* Not specified\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* Not specified\n\nOther\n\n* At least 7 years since prior randomization to SWOG-9217, with completion of end-of-study biopsy requirement\n* No additional concurrent selenium or vitamin E (contained in individual supplements, antioxidant mix, or multivitamin)\n* Concurrent multivitamins allowed (supplied on study)\n* No concurrent anticoagulation therapy (e.g., warfarin)\n* Concurrent prophylactic aspirin (average daily dose no greater than 175 mg/day) allowed\n\n * Concurrent daily aspirin dose ≤ 81 mg for participants receiving clopidogrel\n* Concurrent anti-hypertension medication allowed\n* No concurrent participation in another study involving a medical, surgical, nutritional, or life-style intervention (unless no longer receiving the intervention and are in the follow-up phase only)'}, 'identificationModule': {'nctId': 'NCT00006392', 'acronym': 'SELECT', 'briefTitle': 'S0000 Selenium and Vitamin E in Preventing Prostate Cancer', 'nctIdAliases': ['NCT00076128'], 'organization': {'class': 'NETWORK', 'fullName': 'SWOG Cancer Research Network'}, 'officialTitle': 'Selenium and Vitamin E Cancer Prevention Trial (SELECT) for Prostate Cancer', 'orgStudyIdInfo': {'id': 'CDR0000068277'}, 'secondaryIdInfos': [{'id': 'S0000', 'type': 'OTHER', 'domain': 'SWOG'}, {'id': 'U10CA037429', 'link': 'https://reporter.nih.gov/quickSearch/U10CA037429', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin E + selenium placebo', 'description': 'vitamin E and selenium placebo daily for 7-12 years', 'interventionNames': ['Drug: Vitamin E', 'Other: selenium placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Selenium + vitamin E placebo', 'description': 'selenium and vitamin E placebo daily for 7-12 years', 'interventionNames': ['Drug: Selenium', 'Other: Vitamin E placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Vitamin E + selenium', 'description': 'vitamin E and selenium placebo daily for 7-12 years', 'interventionNames': ['Drug: Vitamin E', 'Drug: Selenium']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vitamin E placebo + selenium placebo', 'description': 'vitamine E placebo and selenium placebo daily for 7-12 years', 'interventionNames': ['Other: Vitamin E placebo', 'Other: selenium placebo']}], 'interventions': [{'name': 'Vitamin E', 'type': 'DRUG', 'otherNames': ['alpha tocopherol'], 'description': '400 IU daily by mouth for 7-12 years', 'armGroupLabels': ['Vitamin E + selenium', 'Vitamin E + selenium placebo']}, {'name': 'Selenium', 'type': 'DRUG', 'otherNames': ['L-selenomethionine'], 'description': '200 mcg daily for 7-12 years', 'armGroupLabels': ['Selenium + vitamin E placebo', 'Vitamin E + selenium']}, {'name': 'Vitamin E placebo', 'type': 'OTHER', 'otherNames': ['placebo'], 'description': 'daily for 7-12 years', 'armGroupLabels': ['Selenium + vitamin E placebo', 'Vitamin E placebo + selenium placebo']}, {'name': 'selenium placebo', 'type': 'OTHER', 'otherNames': ['placebo'], 'description': 'daily for 7-12 years', 'armGroupLabels': ['Vitamin E + selenium placebo', 'Vitamin E placebo + selenium placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611-3013', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Robert H. Lurie Comprehensive Cancer Center at Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60432', 'city': 'Joliet', 'state': 'Illinois', 'country': 'United States', 'facility': 'Midwest Center for Hematology/Oncology', 'geoPoint': {'lat': 41.52519, 'lon': -88.0834}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Cardinal Bernardin Cancer Center at Loyola University Medical Center', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '65802', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'CCOP - Cancer Research for the Ozarks', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '65804', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': "St. John's Regional Health Center", 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Good Samaritan Hospital Cancer Treatment Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Bethesda North Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44501', 'city': 'Youngstown', 'state': 'Ohio', 'country': 'United States', 'facility': "Tod Children's Hospital", 'geoPoint': {'lat': 41.09978, 'lon': -80.64952}}, {'zip': '74104', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'LaFortune Cancer Center at St. John Medical Center', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '17822-0001', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger Medical Center', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}, {'zip': '16801', 'city': 'State College', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger Medical Group - Scenery Park', 'geoPoint': {'lat': 40.79339, 'lon': -77.86}}, {'zip': '18711', 'city': 'Wilkes-Barre', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center', 'geoPoint': {'lat': 41.24591, 'lon': -75.88131}}, {'zip': '37920-6999', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'U.T. Cancer Institute at University of Tennessee Medical Center', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}], 'overallOfficials': [{'name': 'Eric Klein, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The Cleveland Clinic'}, {'name': 'Philip J. Walther, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Duke University'}, {'name': 'Laurence H. Klotz, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Toronto Sunnybrook Regional Cancer Centre'}, {'name': 'Scott M. Lippman, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'MD Anderson'}, {'name': 'Ian M. Thompson, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Texas'}, {'name': 'J. Michael Gaziano, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'MAVERIC'}, {'name': 'Daniel D Karp, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Beth Israel Deaconess'}, {'name': 'Fadlo R. Khuri, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'MD Anderson'}, {'name': 'Michael M Lieber, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SWOG Cancer Research Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Eastern Cooperative Oncology Group', 'class': 'NETWORK'}, {'name': 'Cancer and Leukemia Group B', 'class': 'NETWORK'}, {'name': 'NCIC Clinical Trials Group', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}