Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
Study NCT ID:
NCT00790205
Status:
COMPLETED
Last Update Posted:
2021-11-23
First Post:
2008-11-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Sitagliptin Cardiovascular Outcomes Study (MK-0431-082)
Sponsor:
Organization:
Raw JSON
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[{'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study at least 30 days prior to submission for publication/presentation or at least 14 calendar days prior to submission for abstracts.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 68 months (including up to 28 days after last dose of study drug)', 'description': 'All participants as treated (APaT) population includes participants who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years', 'otherNumAtRisk': 7266, 'otherNumAffected': 0, 'seriousNumAtRisk': 7266, 'seriousNumAffected': 928}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years', 'otherNumAtRisk': 7274, 'otherNumAffected': 0, 'seriousNumAtRisk': 7274, 'seriousNumAffected': 909}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 24, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Anaemia vitamin B12 deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Autoimmune haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Haemorrhagic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lymphadenopathy mediastinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Microcytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Normochromic normocytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pernicious anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 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'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Sinus arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Arteriovenous malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hamartoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hydrocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Phimosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pyloric stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Syringomyelia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vitello-intestinal duct remnant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Deafness bilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': "Meniere's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Sudden hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vertigo labyrinthine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vestibular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Adrenocortical insufficiency acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Inappropriate antidiuretic hormone secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Amaurosis fugax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Angle closure glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Corneal degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dacryostenosis acquired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Optic ischaemic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal hernia obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal wall haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abnormal faeces', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 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'sourceVocabulary': 'MedDRA 17.0'}, {'term': "Bowen's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Breast cancer in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Breast cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Breast cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Bronchial carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Carcinoid tumour of the small bowel', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Carcinoid tumour pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Central nervous system lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cervix carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cholangiocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cholesteatoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Chronic lymphocytic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Chronic lymphocytic leukaemia recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Chronic myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Clear cell renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Colon adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Colon cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Colon cancer stage I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Colon cancer stage IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Colon neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Colorectal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Colorectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diffuse large B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Endometrial adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Endometrial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gallbladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastric adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastric cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastric cancer stage IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastrointestinal cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastrointestinal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastrointestinal tract adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Glioblastoma multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and 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'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hepatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Intraductal papilloma of breast', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, 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ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Laryngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Laryngeal squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Leiomyosarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Leiomyosarcoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lentigo maligna', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lip and/or oral cavity cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lip squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lung adenocarcinoma metastatic', 'stats': 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lung carcinoma cell type unspecified stage IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lung neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lung squamous cell carcinoma stage III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lymphocytic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Malignant melanoma in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Malignant neoplasm of ampulla of Vater', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Malignant neoplasm of renal pelvis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Melanocytic naevus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Meningeal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Meningioma malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Metastases to bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Metastases to liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Metastases to spine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Metastatic bronchial carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Metastatic malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Metastatic renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Metastatic squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Metastatic uterine cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Mucinous adenocarcinoma of appendix', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nasal cavity cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nasopharyngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Neoplasm recurrence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Neuroendocrine carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Neuroendocrine tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Neurofibroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': "Non-Hodgkin's lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Non-small cell lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Oesophageal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Oesophageal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Oesophageal squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Oropharyngeal squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ovarian adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ovarian cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ovarian germ cell teratoma benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ovarian granulosa-theca cell tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ovarian neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pancreatic carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Parathyroid tumour benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Penile cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Penile squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Phaeochromocytoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pituitary tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pituitary tumour benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Plasma cell myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Plasmablastic lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Plasmacytoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pleomorphic liposarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pleural mesothelioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Polycythaemia vera', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 36, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 45, 'numAffected': 45}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Prostate cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Prostate cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Prostate cancer stage I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Prostatic adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Rectal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Rectal cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Rectosigmoid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Renal cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Renal cell carcinoma recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Renal cell carcinoma stage I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Renal cell carcinoma stage III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Renal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Renal oncocytoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Retroperitoneal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Sarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Skin cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 38, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 44, 'numAffected': 38}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Squamous cell carcinoma of head and neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Squamous cell carcinoma of lung', 'stats': [{'groupId': 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Squamous cell carcinoma of the tongue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'T-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'T-cell prolymphocytic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Testis cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Thymic cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Thyroid adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Tracheal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Tracheal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Neoplasms 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'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Basal ganglia haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Brain injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system 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'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Arterial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Arteriovenous fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Bleeding varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Femoral artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Intra-abdominal haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lymphocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7266, 'numEvents': 0, 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'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With First Confirmed Cardiovascular (CV) Event of Major Adverse Cardiovascular Event (MACE) Plus (Per Protocol Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7257', 'groupId': 'OG000'}, {'value': '7266', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years'}], 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000'}, {'value': '9.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 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['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.14', 'groupDescription': 'Hazard Ratio of Sitagliptin/Placebo: The between-treatment difference in mortality due to all causes was assessed by the hazard ratio between the Sitagliptin and Placebo groups.', 'statisticalMethod': 'Cox proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years', 'description': 'Percent incidence of all-cause mortality is reported as the percentage of participants who died due to any cause.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.'}, {'type': 'SECONDARY', 'title': 'Percent Incidence of Congestive Heart 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Incidence of CHF Requiring Hospitalization (Intent to Treat Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7332', 'groupId': 'OG000'}, {'value': '7339', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '1.53'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '0.84', 'upperLimit': '1.33'}]}]}], 'analyses': [{'pValue': '0.983', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.20', 'groupDescription': 'Hazard Ratio of Sitagliptin/Placebo: The between-treatment difference in CHF cases requiring hospitalization was assessed by the hazard ratio between the Sitagliptin and Placebo groups.', 'statisticalMethod': 'Cox proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model stratified by region with treatment group and history of CHF at baseline as explanatory variables.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years', 'description': 'Percent incidence of CHF requiring hospitalization was reported as the percentage of participants who were admitted to the hospital for CHF.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Renal Function Over Time (Per Protocol Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7182', 'groupId': 'OG000'}, {'value': '7203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years'}], 'classes': [{'title': 'Month 4; Sitagliptin, n= 3859; Placebo, n= 3864', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '14.2', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '14.3', 'groupId': 'OG001'}]}]}, {'title': 'Month 8; Sitagliptin, n= 3562; Placebo, n= 3501', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '14.9', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '15.1', 'groupId': 'OG001'}]}]}, {'title': 'Month 12; Sitagliptin, n=4912, Placebo, n=4778', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '15.8', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '16.2', 'groupId': 'OG001'}]}]}, {'title': 'Month 24; Sitagliptin, n=4782, Placebo, n=4637', 'categories': [{'measurements': [{'value': '-3.1', 'spread': '17.9', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '17.5', 'groupId': 'OG001'}]}]}, {'title': 'Month 36; Sitagliptin, n=2776, Placebo, n=2614', 'categories': [{'measurements': [{'value': '-3.7', 'spread': '18.0', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '18.8', 'groupId': 'OG001'}]}]}, {'title': 'Month 48; Sitagliptin, n=1096, Placebo, n=1056', 'categories': [{'measurements': [{'value': '-3.7', 'spread': '18.3', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '18.4', 'groupId': 'OG001'}]}]}, {'title': 'Month 60; Sitagliptin, n=79, Placebo, n=88', 'categories': [{'measurements': [{'value': '-3.5', 'spread': '18.2', 'groupId': 'OG000'}, {'value': '-6.4', 'spread': '17.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 5 years', 'description': 'Change in renal function based on estimated glomerular filtration rate \\[eGFR\\] using the Modification of Diet in Renal Disease \\[MDRD\\] method.', 'unitOfMeasure': 'mL/min/1.73 m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data. Number of participants analyzed consists of those participants with a baseline value.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Renal Function Over Time (Intent to Treat Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7254', 'groupId': 'OG000'}, {'value': '7274', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years'}], 'classes': [{'title': 'Month 4; Sitagliptin, n=3949; Placebo, n=3977', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '14.3', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '14.3', 'groupId': 'OG001'}]}]}, {'title': 'Month 8; Sitagliptin, n=3687; Placebo, n=3648', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '14.8', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '15.2', 'groupId': 'OG001'}]}]}, {'title': 'Month 12; Sitagliptin, n=5082; Placebo, n=5015', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '15.8', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '16.3', 'groupId': 'OG001'}]}]}, {'title': 'Month 24; Sitagliptin, n=5157; Placebo, n=5071', 'categories': [{'measurements': [{'value': '-3.2', 'spread': '17.9', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '17.7', 'groupId': 'OG001'}]}]}, {'title': 'Month 36; Sitagliptin, n=3037; Placebo, n=2942', 'categories': [{'measurements': [{'value': '-3.8', 'spread': '18.1', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '18.7', 'groupId': 'OG001'}]}]}, {'title': 'Month 48; Sitagliptin, n=1237; Placebo, n=1210', 'categories': [{'measurements': [{'value': '-4.0', 'spread': '18.4', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '18.3', 'groupId': 'OG001'}]}]}, {'title': 'Month 60; Sitagliptin, n=93; Placebo, n=106', 'categories': [{'measurements': [{'value': '-4.2', 'spread': '17.4', 'groupId': 'OG000'}, {'value': '-5.7', 'spread': '17.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 5 years', 'description': 'Change in renal function based on eGFR using the MDRD method.', 'unitOfMeasure': 'mL/min/1.73 m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation. Number of participants analyzed consists of those participants with a baseline value.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c Over Time (Per Protocol Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7250', 'groupId': 'OG000'}, {'value': '7258', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years'}], 'classes': [{'title': 'Month 4; Sitagliptin, n=6632, Placebo, n=6588', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Month 8; Sitagliptin, n=6294, Placebo, n=6197', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Month 12; Sitagliptin, n=6217, Placebo, n=6092', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Month 24; Sitagliptin, n=5668, Placebo, n=5475', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Month 36; Sitagliptin, n=3227, Placebo, n=3083', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Month 48; Sitagliptin, n=1271, Placebo, n=1224', 'categories': [{'measurements': [{'value': '0.0', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Month 60; Sitagliptin, n=106, Placebo, n=108', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 4 years', 'description': 'HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Estimated mean difference between sitagliptin and placebo controlling for baseline HbA1c and region.', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data. Number of participants analyzed consists of those participants with a baseline value.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c Over Time (Intent to Treat Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7325', 'groupId': 'OG000'}, {'value': '7331', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years'}], 'classes': [{'title': 'Month 4: Sitagliptin, n= 6772; Placebo, n= 6738', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Month 8: Sitagliptin, n= 6478; Placebo, n= 6414', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Month 12: Sitagliptin, n= 6448; Placebo, n= 6384', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Month 24: Sitagliptin, n= 6105; Placebo, n= 5975', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Month 36: Sitagliptin, n= 3521; Placebo, n= 3439', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Month 48: Sitagliptin, n= 1432; Placebo, n= 1383', 'categories': [{'measurements': [{'value': '0.0', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Month 60: Sitagliptin, n= 123; Placebo, n= 128', 'categories': [{'measurements': [{'value': '0.0', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 4 years', 'description': 'HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Estimated mean difference between sitagliptin and placebo controlling for baseline HbA1c and region.', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation. Number of participants analyzed consists of those participants in the intent to treat population with a baseline value.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Per Protocol Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2590', 'groupId': 'OG000'}, {'value': '2522', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years'}], 'classes': [{'title': 'Month 4; Sitagliptin, n=664; Placebo, n=688', 'categories': [{'measurements': [{'value': '-2.2', 'spread': '27.7', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '24.6', 'groupId': 'OG001'}]}]}, {'title': 'Month 8; Sitagliptin, n=635; Placebo, n=597', 'categories': [{'measurements': [{'value': '1.7', 'spread': '38.5', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '45.3', 'groupId': 'OG001'}]}]}, {'title': 'Month 12; Sitagliptin, n=1126; Placebo, n=1059', 'categories': [{'measurements': [{'value': '0.8', 'spread': '27.7', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '33.1', 'groupId': 'OG001'}]}]}, {'title': 'Month 24; Sitagliptin, n=930; Placebo, n=892', 'categories': [{'measurements': [{'value': '0.7', 'spread': '34.0', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '31.6', 'groupId': 'OG001'}]}]}, {'title': 'Month 36; Sitagliptin, n=488; Placebo, n=513', 'categories': [{'measurements': [{'value': '2.5', 'spread': '24.0', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '31.0', 'groupId': 'OG001'}]}]}, {'title': 'Month 48; Sitagliptin, n=238; Placebo, n=233', 'categories': [{'measurements': [{'value': '1.3', 'spread': '15.2', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '25.5', 'groupId': 'OG001'}]}]}, {'title': 'Month 60; Sitagliptin, n=13; Placebo, n=17', 'categories': [{'measurements': [{'value': '-2.7', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '15.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 5 years', 'description': 'Change from baseline reflects the difference between the urine albumin:creatinine ratio reported time point and baseline value.', 'unitOfMeasure': 'g/mol Creatinine', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data. Number of participants analyzed consists of those participants with a baseline value.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Intent to Treat Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2606', 'groupId': 'OG000'}, {'value': '2542', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years'}], 'classes': [{'title': 'Month 4; n=677, n=713', 'categories': [{'measurements': [{'value': '-2.1', 'spread': '27.5', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '24.1', 'groupId': 'OG001'}]}]}, {'title': 'Month 8; n=658, n=624', 'categories': [{'measurements': [{'value': '2.1', 'spread': '39.4', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '44.5', 'groupId': 'OG001'}]}]}, {'title': 'Month 12; n=1167, n=1115', 'categories': [{'measurements': [{'value': '1.3', 'spread': '30.2', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '32.3', 'groupId': 'OG001'}]}]}, {'title': 'Month 24; n=1011, n=964', 'categories': [{'measurements': [{'value': '0.5', 'spread': '33.1', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '30.7', 'groupId': 'OG001'}]}]}, {'title': 'Month 36; n=537, n=553', 'categories': [{'measurements': [{'value': '2.6', 'spread': '25.8', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '30.3', 'groupId': 'OG001'}]}]}, {'title': 'Month 48; n=265, n=256', 'categories': [{'measurements': [{'value': '1.9', 'spread': '16.3', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '24.5', 'groupId': 'OG001'}]}]}, {'title': 'Month 60; n=14, n=18', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '16.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 5 years', 'description': 'Change from baseline reflects the difference between the urine albumin:creatinine ratio reported time point and baseline value.', 'unitOfMeasure': 'g/mol Creatinine', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation. Number of participants analyzed consists of those participants in the intent to treat population with a baseline value for the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Initiated Chronic Insulin Therapy (Per Protocol Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5554', 'groupId': 'OG000'}, {'value': '5601', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years'}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000'}, {'value': '11.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.61', 'ciUpperLimit': '0.77', 'statisticalMethod': 'Cox proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model stratified by region with treatment group only as explanatory variable.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years', 'description': 'Chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Initiated Chronic Insulin Therapy (Intent to Treat Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5608', 'groupId': 'OG000'}, {'value': '5655', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years'}], 'classes': [{'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000'}, {'value': '13.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.63', 'ciUpperLimit': '0.79', 'statisticalMethod': 'Cox proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model stratified by region with treatment group only as explanatory variable.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years', 'description': 'Chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Initiation of Co-interventional Agent (Per Protocol Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7257', 'groupId': 'OG000'}, {'value': '7266', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years'}], 'classes': [{'categories': [{'measurements': [{'value': '18.9', 'groupId': 'OG000'}, {'value': '24.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.65', 'ciUpperLimit': '0.75', 'statisticalMethod': 'Cox proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model stratified by region with treatment group only as explanatory variable.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years', 'description': 'In participants not receiving insulin at baseline, time to addition of first co-interventional agent (i.e., next oral antihyperglycemic agent \\[AHA\\] or chronic insulin, where chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Initiation of Co-interventional Agent (Intent to Treat Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7332', 'groupId': 'OG000'}, {'value': '7339', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years'}], 'classes': [{'categories': [{'measurements': [{'value': '21.7', 'groupId': 'OG000'}, {'value': '27.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.68', 'ciUpperLimit': '0.77', 'statisticalMethod': 'Cox proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model stratified by region with treatment group only as explanatory variable.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years', 'description': 'In participants not receiving insulin at baseline, time to addition of first co-interventional agent (i.e., next oral AHA or chronic insulin, where chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7332'}, {'groupId': 'FG001', 'numSubjects': '7339'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7266'}, {'groupId': 'FG001', 'numSubjects': '7274'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6972'}, {'groupId': 'FG001', 'numSubjects': '6905'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '360'}, {'groupId': 'FG001', 'numSubjects': '434'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '299'}, {'groupId': 'FG001', 'numSubjects': '363'}]}]}], 'preAssignmentDetails': 'A total of 14,671 participants were randomized to treatment, provided consent and did not have any Good Clinical Practice (GCP) deviations.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7332', 'groupId': 'BG000'}, {'value': '7339', 'groupId': 'BG001'}, {'value': '14671', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Adults 18 - 64 years', 'categories': [{'measurements': [{'value': '3315', 'spread': '7.9', 'groupId': 'BG000'}, {'value': '3301', 'spread': '8.0', 'groupId': 'BG001'}, {'value': '65.5', 'spread': '8.0', 'groupId': 'BG002'}]}]}, {'title': 'From 65 - 84 years', 'categories': [{'measurements': [{'value': '3813', 'groupId': 'BG000'}, {'value': '3821', 'groupId': 'BG001'}, {'value': '7634', 'groupId': 'BG002'}]}]}, {'title': '85 years and over', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}, {'title': 'Unknown age', 'categories': [{'measurements': [{'value': '158', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '320', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Age is unknown for 320 participants', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2134', 'groupId': 'BG000'}, {'value': '2163', 'groupId': 'BG001'}, {'value': '4297', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5198', 'groupId': 'BG000'}, {'value': '5176', 'groupId': 'BG001'}, {'value': '10374', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Estimated Glomerular Filtration Rate (eGFR)', 'classes': [{'categories': [{'measurements': [{'value': '74.9', 'spread': '21.3', 'groupId': 'BG000'}, {'value': '74.9', 'spread': '20.9', 'groupId': 'BG001'}, {'value': '74.9', 'spread': '21.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Sitagliptin, n= 7254; Placebo, n= 7274; Total, n=14528', 'unitOfMeasure': 'mL/min/1.73 m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hemoglobin A1c (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'spread': '0.5', 'groupId': 'BG000'}, {'value': '7.2', 'spread': '0.5', 'groupId': 'BG001'}, {'value': '7.2', 'spread': '0.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Sitagliptin, n= 7330; Placebo, n= 7336; Total, n= 14666', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Urine albumin creatinine ratio', 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'spread': '37.4', 'groupId': 'BG000'}, {'value': '8.4', 'spread': '36.0', 'groupId': 'BG001'}, {'value': '8.5', 'spread': '36.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Sitagliptin, n= 2606; Placebo, n= 2542; Total, n= 5148', 'unitOfMeasure': 'g/mol Creatinine', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14671}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2015-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-27', 'studyFirstSubmitDate': '2008-11-11', 'resultsFirstSubmitDate': '2016-03-15', 'studyFirstSubmitQcDate': '2008-11-11', 'lastUpdatePostDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-03-15', 'studyFirstPostDateStruct': {'date': '2008-11-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With First Confirmed Cardiovascular (CV) Event of Major Adverse Cardiovascular Event (MACE) Plus (Per Protocol Population)', 'timeFrame': 'Up to 5 years', 'description': 'Primary composite CV endpoint of MACE plus which includes CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization.'}, {'measure': 'Percentage of Participants With First Confirmed CV Event of Major Adverse Cardiovascular Event (MACE) Plus (Intent to Treat Population)', 'timeFrame': 'Up to 5 years', 'description': 'Primary composite CV endpoint of MACE plus which includes CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With First Confirmed CV Event of MACE (Per Protocol Population)', 'timeFrame': 'Up to 5 years', 'description': 'CV composite endpoint of MACE which includes CV-related death, nonfatal MI, or nonfatal stroke.'}, {'measure': 'Percentage of Participants With First Confirmed CV Event of MACE (Intent to Treat Population)', 'timeFrame': 'Up to 5 years', 'description': 'CV composite endpoint of MACE which includes CV-related death, nonfatal MI, or nonfatal stroke.'}, {'measure': 'Percent Incidence of All-cause Mortality (Per Protocol Population)', 'timeFrame': 'Up to 5 years', 'description': 'Percent incidence of all-cause mortality is reported as the percentage of participants who died due to any cause.'}, {'measure': 'Percent Incidence of All-cause Mortality (Intent to Treat Population)', 'timeFrame': 'Up to 5 years', 'description': 'Percent incidence of all-cause mortality is reported as the percentage of participants who died due to any cause.'}, {'measure': 'Percent Incidence of Congestive Heart Failure (CHF) Requiring Hospitalization (Per Protocol Population)', 'timeFrame': 'Up to 5 years', 'description': 'Percent incidence of CHF requiring hospitalization was reported as the percentage of participants who were admitted to the hospital for CHF.'}, {'measure': 'Percent Incidence of CHF Requiring Hospitalization (Intent to Treat Population)', 'timeFrame': 'Up to 5 years', 'description': 'Percent incidence of CHF requiring hospitalization was reported as the percentage of participants who were admitted to the hospital for CHF.'}, {'measure': 'Change From Baseline in Renal Function Over Time (Per Protocol Population)', 'timeFrame': 'Baseline and up to 5 years', 'description': 'Change in renal function based on estimated glomerular filtration rate \\[eGFR\\] using the Modification of Diet in Renal Disease \\[MDRD\\] method.'}, {'measure': 'Change From Baseline in Renal Function Over Time (Intent to Treat Population)', 'timeFrame': 'Baseline and up to 5 years', 'description': 'Change in renal function based on eGFR using the MDRD method.'}, {'measure': 'Change From Baseline in HbA1c Over Time (Per Protocol Population)', 'timeFrame': 'Baseline and up to 4 years', 'description': 'HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Estimated mean difference between sitagliptin and placebo controlling for baseline HbA1c and region.'}, {'measure': 'Change From Baseline in HbA1c Over Time (Intent to Treat Population)', 'timeFrame': 'Baseline and up to 4 years', 'description': 'HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Estimated mean difference between sitagliptin and placebo controlling for baseline HbA1c and region.'}, {'measure': 'Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Per Protocol Population)', 'timeFrame': 'Baseline and up to 5 years', 'description': 'Change from baseline reflects the difference between the urine albumin:creatinine ratio reported time point and baseline value.'}, {'measure': 'Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Intent to Treat Population)', 'timeFrame': 'Baseline and up to 5 years', 'description': 'Change from baseline reflects the difference between the urine albumin:creatinine ratio reported time point and baseline value.'}, {'measure': 'Percentage of Participants Who Initiated Chronic Insulin Therapy (Per Protocol Population)', 'timeFrame': 'Up to 5 years', 'description': 'Chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.'}, {'measure': 'Percentage of Participants Who Initiated Chronic Insulin Therapy (Intent to Treat Population)', 'timeFrame': 'Up to 5 years', 'description': 'Chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.'}, {'measure': 'Percentage of Participants With Initiation of Co-interventional Agent (Per Protocol Population)', 'timeFrame': 'Up to 5 years', 'description': 'In participants not receiving insulin at baseline, time to addition of first co-interventional agent (i.e., next oral antihyperglycemic agent \\[AHA\\] or chronic insulin, where chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.)'}, {'measure': 'Percentage of Participants With Initiation of Co-interventional Agent (Intent to Treat Population)', 'timeFrame': 'Up to 5 years', 'description': 'In participants not receiving insulin at baseline, time to addition of first co-interventional agent (i.e., next oral AHA or chronic insulin, where chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '24268212', 'type': 'RESULT', 'citation': 'Green JB, Bethel MA, Paul SK, Ring A, Kaufman KD, Shapiro DR, Califf RM, Holman RR. Rationale, design, and organization of a randomized, controlled Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) in patients with type 2 diabetes and established cardiovascular disease. Am Heart J. 2013 Dec;166(6):983-989.e7. doi: 10.1016/j.ahj.2013.09.003. Epub 2013 Oct 23.'}, {'pmid': '25600421', 'type': 'RESULT', 'citation': 'Bethel MA, Green JB, Milton J, Tajar A, Engel SS, Califf RM, Holman RR; TECOS Executive Committee. Regional, age and sex differences in baseline characteristics of patients enrolled in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS). Diabetes Obes Metab. 2015 Apr;17(4):395-402. doi: 10.1111/dom.12441. Epub 2015 Feb 13.'}, {'pmid': '26052984', 'type': 'RESULT', 'citation': 'Green JB, Bethel MA, Armstrong PW, Buse JB, Engel SS, Garg J, Josse R, Kaufman KD, Koglin J, Korn S, Lachin JM, McGuire DK, Pencina MJ, Standl E, Stein PP, Suryawanshi S, Van de Werf F, Peterson ED, Holman RR; TECOS Study Group. Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2015 Jul 16;373(3):232-42. doi: 10.1056/NEJMoa1501352. Epub 2015 Jun 8.'}, {'pmid': '38922488', 'type': 'DERIVED', 'citation': 'Gao N, Dakin HA, Holman RR, Lim LL, Leal J, Clarke P. Estimating Risk Factor Time Paths Among People with Type 2 Diabetes and QALY Gains from Risk Factor Management. Pharmacoeconomics. 2024 Sep;42(9):1017-1028. doi: 10.1007/s40273-024-01398-4. Epub 2024 Jun 26.'}, {'pmid': '36978066', 'type': 'DERIVED', 'citation': 'Bethel MA, Sourij H, Stevens SR, Hannan K, Lokhnygina Y, Adler AI, Peterson ED, Holman RR, Lopes RD. Time-dependent event accumulation in a cardiovascular outcome trial of patients with type 2 diabetes and established atherosclerotic cardiovascular disease. Cardiovasc Diabetol. 2023 Mar 28;22(1):72. doi: 10.1186/s12933-023-01802-x.'}, {'pmid': '34716214', 'type': 'DERIVED', 'citation': 'Sharma A, Zheng Y, Ezekowitz JA, Westerhout CM, Udell JA, Goodman SG, Armstrong PW, Buse JB, Green JB, Josse RG, Kaufman KD, McGuire DK, Ambrosio G, Chuang LM, Lopes RD, Peterson ED, Holman RR. Cluster Analysis of Cardiovascular Phenotypes in Patients With Type 2 Diabetes and Established Atherosclerotic Cardiovascular Disease: A Potential Approach to Precision Medicine. Diabetes Care. 2022 Jan 1;45(1):204-212. doi: 10.2337/dc20-2806.'}, {'pmid': '32621557', 'type': 'DERIVED', 'citation': 'McAlister FA, Zheng Y, Westerhout CM, Buse JB, Standl E, McGuire DK, Van de Werf F, Green JB, Armstrong PW, Holman RR; TECOS Study Group. Association between glycated haemoglobin levels and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease: a secondary analysis of the TECOS randomized clinical trial. Eur J Heart Fail. 2020 Nov;22(11):2026-2034. doi: 10.1002/ejhf.1958. Epub 2020 Jul 28.'}, {'pmid': '31790905', 'type': 'DERIVED', 'citation': 'De Ferrari GM, Stevens SR, Ambrosio G, Leonardi S, Armstrong PW, Green JB, Wamil M, Holman RR, Peterson ED; TECOS Study Group. Low-density lipoprotein cholesterol treatment and outcomes in patients with type 2 diabetes and established cardiovascular disease: Insights from TECOS. Am Heart J. 2020 Feb;220:82-88. doi: 10.1016/j.ahj.2019.11.005. Epub 2019 Nov 13.'}, {'pmid': '31715435', 'type': 'DERIVED', 'citation': 'Shavadia JS, Zheng Y, Green JB, Armstrong PW, Westerhout CM, McGuire DK, Cornel JH, Holman RR, Peterson ED. Associations between beta-blocker therapy and cardiovascular outcomes in patients with diabetes and established cardiovascular disease. Am Heart J. 2019 Dec;218:92-99. doi: 10.1016/j.ahj.2019.09.013. Epub 2019 Oct 20.'}, {'pmid': '31481069', 'type': 'DERIVED', 'citation': 'Nauck MA, McGuire DK, Pieper KS, Lokhnygina Y, Strandberg TE, Riefflin A, Delibasi T, Peterson ED, White HD, Scott R, Holman RR. Sitagliptin does not reduce the risk of cardiovascular death or hospitalization for heart failure following myocardial infarction in patients with diabetes: observations from TECOS. Cardiovasc Diabetol. 2019 Sep 3;18(1):116. doi: 10.1186/s12933-019-0921-2.'}, {'pmid': '31079973', 'type': 'DERIVED', 'citation': 'Guimaraes PO, Peterson ED, Stevens SR, Lokhnygina Y, Green JB, McGuire DK, Holman RR, Lopes RD. Antithrombotic treatment gap among patients with atrial fibrillation and type 2 diabetes. Int J Cardiol. 2019 Aug 15;289:58-62. doi: 10.1016/j.ijcard.2019.04.085. Epub 2019 Apr 30.'}, {'pmid': '29573215', 'type': 'DERIVED', 'citation': 'Reed SD, Li Y, Leal J, Radican L, Adler AI, Alfredsson J, Buse JB, Green JB, Kaufman KD, Riefflin A, Van de Werf F, Peterson ED, Gray AM, Holman RR; TECOS Study Group. Longitudinal medical resources and costs among type 2 diabetes patients participating in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS). Diabetes Obes Metab. 2018 Jul;20(7):1732-1739. doi: 10.1111/dom.13292. Epub 2018 Apr 20.'}, {'pmid': '29311155', 'type': 'DERIVED', 'citation': 'Standl E, Stevens SR, Armstrong PW, Buse JB, Chan JCN, Green JB, Lachin JM, Scheen A, Travert F, Van de Werf F, Peterson ED, Holman RR; TECOS Study Group. Increased Risk of Severe Hypoglycemic Events Before and After Cardiovascular Outcomes in TECOS Suggests an At-Risk Type 2 Diabetes Frail Patient Phenotype. Diabetes Care. 2018 Mar;41(3):596-603. doi: 10.2337/dc17-1778. Epub 2018 Jan 8.'}, {'pmid': '28986504', 'type': 'DERIVED', 'citation': 'Sharma A, Green JB, Dunning A, Lokhnygina Y, Al-Khatib SM, Lopes RD, Buse JB, Lachin JM, Van de Werf F, Armstrong PW, Kaufman KD, Standl E, Chan JCN, Distiller LA, Scott R, Peterson ED, Holman RR; TECOS Study Group. Causes of Death in a Contemporary Cohort of Patients With Type 2 Diabetes and Atherosclerotic Cardiovascular Disease: Insights From the TECOS Trial. Diabetes Care. 2017 Dec;40(12):1763-1770. doi: 10.2337/dc17-1091. Epub 2017 Oct 6.'}, {'pmid': '28626088', 'type': 'DERIVED', 'citation': 'Pagidipati NJ, Navar AM, Pieper KS, Green JB, Bethel MA, Armstrong PW, Josse RG, McGuire DK, Lokhnygina Y, Cornel JH, Halvorsen S, Strandberg TE, Delibasi T, Holman RR, Peterson ED; TECOS Study Group. Secondary Prevention of Cardiovascular Disease in Patients With Type 2 Diabetes Mellitus: International Insights From the TECOS Trial (Trial Evaluating Cardiovascular Outcomes With Sitagliptin). Circulation. 2017 Sep 26;136(13):1193-1203. doi: 10.1161/CIRCULATIONAHA.117.027252. Epub 2017 Jun 16.'}, {'pmid': '28057693', 'type': 'DERIVED', 'citation': 'Bethel MA, Engel SS, Green JB, Huang Z, Josse RG, Kaufman KD, Standl E, Suryawanshi S, Van de Werf F, McGuire DK, Peterson ED, Holman RR; TECOS Study Group. Assessing the Safety of Sitagliptin in Older Participants in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS). Diabetes Care. 2017 Apr;40(4):494-501. doi: 10.2337/dc16-1135. Epub 2017 Jan 5.'}, {'pmid': '27742728', 'type': 'DERIVED', 'citation': 'Cornel JH, Bakris GL, Stevens SR, Alvarsson M, Bax WA, Chuang LM, Engel SS, Lopes RD, McGuire DK, Riefflin A, Rodbard HW, Sinay I, Tankova T, Wainstein J, Peterson ED, Holman RR; TECOS Study Group. Effect of Sitagliptin on Kidney Function and Respective Cardiovascular Outcomes in Type 2 Diabetes: Outcomes From TECOS. Diabetes Care. 2016 Dec;39(12):2304-2310. doi: 10.2337/dc16-1415. Epub 2016 Oct 14.'}, {'pmid': '27630212', 'type': 'DERIVED', 'citation': 'Buse JB, Bethel MA, Green JB, Stevens SR, Lokhnygina Y, Aschner P, Grado CR, Tankova T, Wainstein J, Josse R, Lachin JM, Engel SS, Patel K, Peterson ED, Holman RR; TECOS Study Group. Pancreatic Safety of Sitagliptin in the TECOS Study. Diabetes Care. 2017 Feb;40(2):164-170. doi: 10.2337/dc15-2780. Epub 2016 Sep 14.'}, {'pmid': '27437883', 'type': 'DERIVED', 'citation': 'McGuire DK, Van de Werf F, Armstrong PW, Standl E, Koglin J, Green JB, Bethel MA, Cornel JH, Lopes RD, Halvorsen S, Ambrosio G, Buse JB, Josse RG, Lachin JM, Pencina MJ, Garg J, Lokhnygina Y, Holman RR, Peterson ED; Trial Evaluating Cardiovascular Outcomes With Sitagliptin (TECOS) Study Group. Association Between Sitagliptin Use and Heart Failure Hospitalization and Related Outcomes in Type 2 Diabetes Mellitus: Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2016 May 1;1(2):126-35. doi: 10.1001/jamacardio.2016.0103.'}]}, 'descriptionModule': {'briefSummary': 'This is a clinical trial designed to assess the cardiovascular outcome of long-term treatment with sitagliptin used as part of usual care compared to usual care without sitagliptin in participants with type 2 diabetes mellitus (T2DM) having a history of cardiovascular (CV) disease and a hemoglobin A1c (HbA1c) of 6.5% to 8.0%.\n\nPrimary hypothesis A is that sitagliptin, when used as part of usual care, is non-inferior to usual care without sitagliptin with regard to the risk of developing a confirmed event in the primary CV composite endpoint of Major Adverse Cardiovascular Event (MACE) plus. If hypothesis A is satisfied: hypothesis B is that sitagliptin, when used as part of usual care, is superior to usual care without sitagliptin with regard to the risk of developing a confirmed event in the primary CV composite endpoint.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has T2DM\n* Has HbA1c between 6.5% (48 mmol/mol) and 8.0% (64 mmol/mol) on stable dose(s) of antihyperglycemic agent(s), including insulin\n* Has pre-existing cardiovascular disease\n\nExclusion Criteria:\n\n* Has a history of type 1 diabetes mellitus or ketoacidosis.\n* Is not able to take sitagliptin'}, 'identificationModule': {'nctId': 'NCT00790205', 'acronym': 'TECOS', 'briefTitle': 'Sitagliptin Cardiovascular Outcomes Study (MK-0431-082)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'TECOS: A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes After Treatment With Sitagliptin in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control', 'orgStudyIdInfo': {'id': '0431-082'}, 'secondaryIdInfos': [{'id': '2008_523', 'type': 'OTHER', 'domain': 'Merck study number'}, {'id': '2008-006719-20', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sitagliptin', 'description': 'Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years.', 'interventionNames': ['Drug: Sitagliptin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo to sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Sitagliptin', 'type': 'DRUG', 'otherNames': ['MK-0431', 'Januvia®'], 'description': 'Sitagliptin, one 50 mg or one 100 mg tablet (dose dependant on renal function) orally, once daily.', 'armGroupLabels': ['Sitagliptin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablet matching the 50 mg or 100 mg sitagliptin tablet, orally, once daily.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Duke Clinical Research Institute, Oxford Diabetes Trials Unit', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}