Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-25 @ 8:42 PM
Study NCT ID:
NCT00379769
Status:
COMPLETED
Last Update Posted:
2017-03-23
First Post:
2006-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077154', 'term': 'Rosiglitazone'}, {'id': 'D013453', 'term': 'Sulfonylurea Compounds'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'In the RECORD study (RS), SAEs were collected from BL through End of Study (up to 7.5 years); non-serious AEs were collected only for the randomized treatment period. SAEs were collected from the end of the RS through the end of OFU (up to 4.0 years).', 'description': 'The Observational Follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. Other than bone fractures (tabulated in the Outcome Measure Module), no non-serious AEs were collected.', 'eventGroups': [{'id': 'EG000', 'title': 'RSG in Addition to Background MET', 'description': 'Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.', 'otherNumAtRisk': 1117, 'otherNumAffected': 1117, 'seriousNumAtRisk': 1117, 'seriousNumAffected': 424}, {'id': 'EG001', 'title': 'SU in Addition to Background MET', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.', 'otherNumAtRisk': 1105, 'otherNumAffected': 1105, 'seriousNumAtRisk': 1105, 'seriousNumAffected': 428}, {'id': 'EG002', 'title': 'RSG in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.', 'otherNumAtRisk': 1103, 'otherNumAffected': 1103, 'seriousNumAtRisk': 1103, 'seriousNumAffected': 427}, {'id': 'EG003', 'title': 'MET in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.', 'otherNumAtRisk': 1122, 'otherNumAffected': 1122, 'seriousNumAtRisk': 1122, 'seriousNumAffected': 431}, {'id': 'EG004', 'title': 'Combined RSG: Observational Follow-up', 'description': "Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.", 'otherNumAtRisk': 1280, 'otherNumAffected': 0, 'seriousNumAtRisk': 1280, 'seriousNumAffected': 99}, {'id': 'EG005', 'title': 'Combined MET/SU: Observational Follow-up', 'description': "Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.", 'otherNumAtRisk': 1250, 'otherNumAffected': 0, 'seriousNumAtRisk': 1250, 'seriousNumAffected': 76}], 'otherEvents': [{'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 345}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 372}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 302}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 319}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 216}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 202}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 121}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 122}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 236}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 144}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 193}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 120}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 153}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 143}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 95}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 105}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 139}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 128}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 136}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 122}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 119}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 126}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 98}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 70}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 190}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 162}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 144}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 110}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 129}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 106}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 88}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 121}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 78}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 155}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 64}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 144}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 133}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 41}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 81}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 44}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 135}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 79}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 61}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 51}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 105}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 55}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 38}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 97}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 49}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 68}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 66}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 59}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 49}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 35}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 61}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 58}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 47}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 67}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 54}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 42}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 81}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 57}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 66}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 56}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 67}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 35}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 46}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 42}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diabetic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 87}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 63}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 51}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 61}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 56}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 40}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 102}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 82}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 62}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 50}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 29}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 23}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac Failure Congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lung squamous cell carcinoma stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Malignant neoplasm of pleura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 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0}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rectal cancer stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'T-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Biliary cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Laryngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metastasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rectal cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Small cell lung cancer stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Forearm fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Comminuted fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Craniocerebral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pubis fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sternal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Subdural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hepatic lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1105, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1103, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1122, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1280, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1250, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Cardiovascular Death/Cardiovascular Hospitalisation Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2220', 'groupId': 'OG000'}, {'value': '2227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG', 'description': 'Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG001', 'title': 'Combined MET/SU', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'categories': [{'measurements': [{'value': '321', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.16', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority margin of 1.2 for the upper limit of the 95 percent confidence interval in time to event analysis comparing RSG to MET/SU stratified by background medication'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)', 'description': 'The number of participants with cardiovascular death events (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation events (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) was recorded.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cardiovascular Events and All-cause Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2220', 'groupId': 'OG000'}, {'value': '2227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG', 'description': 'Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG001', 'title': 'Combined MET/SU', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'title': 'CV death, acute MI, stroke', 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}]}, {'title': 'CV death, acute MI, stroke, unstable angina', 'categories': [{'measurements': [{'value': '171', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}]}, {'title': 'CV death, acute MI, stroke, unstable angina, CHF', 'categories': [{'measurements': [{'value': '204', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}]}, {'title': 'All-cause death,acuteMI,stroke,unstable angina,CHF', 'categories': [{'measurements': [{'value': '251', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}]}, {'title': 'Acute MI (fatal or non-fatal)', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}, {'title': 'Stroke (fatal or non-fatal)', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'CHF (fatal or non-fatal)', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Death from CV causes', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}, {'title': 'Death (all cause) during CV follow-up', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}]}, {'title': 'Death (all-cause) including survival status', 'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)', 'description': 'Composites of participants with first cardiovascular (CV) hospitalisations and CV death or all-cause death and individual first events of acute myocardial infarction (MI) , stroke, congestive heart failure (CHF), CV death, and all-cause death.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'SECONDARY', 'title': 'Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2220', 'groupId': 'OG000'}, {'value': '2227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG', 'description': 'Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG001', 'title': 'Combined MET/SU', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'title': 'CV deaths', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}, {'title': 'Death due to acute MI', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Death due to heart failure', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Sudden death', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Death due to acute vascular events', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Other CV mortality', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Death of presumed CV cause', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Cardiovascular hospitalisation', 'categories': [{'measurements': [{'value': '483', 'groupId': 'OG000'}, {'value': '490', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalisation for acute MI', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalisation for unstable angina', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalisation for congestive heart failure', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalisation for stroke', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalisation for transient ischaemic attack', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalisation for invasive CV procedure', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalisation for amputation of extremities', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Other CV hospitalisations', 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)', 'description': 'The total number of events for individual components of cardiovascular (CV) hospitalisations and cardiovascular deaths were recorded. MI, myocardial infarction.', 'unitOfMeasure': 'Number of events', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'SECONDARY', 'title': 'Number of Participants With First Cardiovascular Hospitalisations/Cardiovascular Deaths by Stratum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1117', 'groupId': 'OG000'}, {'value': '1105', 'groupId': 'OG001'}, {'value': '1103', 'groupId': 'OG002'}, {'value': '1122', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG in Addition to Background MET', 'description': 'Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG001', 'title': 'SU in Addition to Background MET', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG002', 'title': 'RSG in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG003', 'title': 'MET in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'categories': [{'measurements': [{'value': '158', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}, {'value': '169', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)', 'description': 'Participants with first cardiovascular death (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) were recorded by study stratum.', 'unitOfMeasure': 'partcipants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'SECONDARY', 'title': 'Number of Participants With CV/Microvascular Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2220', 'groupId': 'OG000'}, {'value': '2227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG', 'description': 'Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG001', 'title': 'Combined MET/SU', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'title': 'Participants with a CV/Microvascular event', 'categories': [{'measurements': [{'value': '363', 'groupId': 'OG000'}, {'value': '385', 'groupId': 'OG001'}]}]}, {'title': 'Participants with any microvascular event', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}, {'title': 'Participants with any eye event', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Participants with any foot event', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Participants with any renal event', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)', 'description': 'The number of participants with first cardiovascular or microvascular events (renal, foot, eye) were recorded.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Glycaemic Failure Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1117', 'groupId': 'OG000'}, {'value': '1105', 'groupId': 'OG001'}, {'value': '1103', 'groupId': 'OG002'}, {'value': '1122', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG in Addition to Background MET', 'description': 'Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG001', 'title': 'SU in Addition to Background MET', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG002', 'title': 'RSG in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG003', 'title': 'MET in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'categories': [{'measurements': [{'value': '281', 'groupId': 'OG000'}, {'value': '451', 'groupId': 'OG001'}, {'value': '365', 'groupId': 'OG002'}, {'value': '424', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through to end of randomised dual therapy', 'description': 'Failure of glycaemic control was defined as two consecutive HbA1c values of ≥8.5 percent, or HbA1c ≥8.5percent at a single visit, after which the subject was either moved to the post-randomised treatment phase or triple therapy was started.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Addition of Third Oral Agent/Switch to Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1117', 'groupId': 'OG000'}, {'value': '1105', 'groupId': 'OG001'}, {'value': '1103', 'groupId': 'OG002'}, {'value': '1122', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG in Addition to Background MET', 'description': 'Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG001', 'title': 'SU in Addition to Background MET', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG002', 'title': 'RSG in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG003', 'title': 'MET in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'title': 'Participants with an event', 'categories': [{'measurements': [{'value': '295', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '344', 'groupId': 'OG002'}, {'value': '171', 'groupId': 'OG003'}]}]}, {'title': 'First Event - Triple Therapy', 'categories': [{'measurements': [{'value': '257', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '296', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'First Event - Insulin', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '165', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)', 'description': 'The number of participants with addition of a third oral agent or switch to insulin from randomised dual combination treatment were recorded.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'SECONDARY', 'title': 'The Number of Participants Starting Insulin at Any Time During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1117', 'groupId': 'OG000'}, {'value': '1105', 'groupId': 'OG001'}, {'value': '1103', 'groupId': 'OG002'}, {'value': '1122', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG in Addition to Background MET', 'description': 'Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG001', 'title': 'SU in Addition to Background MET', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG002', 'title': 'RSG in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG003', 'title': 'MET in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}, {'value': '259', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)', 'description': 'The number of participants starting insulin at any time during the study was recorded.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'SECONDARY', 'title': 'Model Adjusted Change From Baseline in HbA1c at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1096', 'groupId': 'OG000'}, {'value': '1079', 'groupId': 'OG001'}, {'value': '1073', 'groupId': 'OG002'}, {'value': '1079', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG in Addition to Background MET', 'description': 'Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG001', 'title': 'SU in Addition to Background MET', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG002', 'title': 'RSG in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG003', 'title': 'MET in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.035', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.042', 'groupId': 'OG001'}, {'value': '-0.24', 'spread': '0.039', 'groupId': 'OG002'}, {'value': '-0.10', 'spread': '0.039', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 60 of randomised dual therapy treatment period', 'description': 'Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in HbA1c was calculated as the value at Month 60 minus the Baseline value.', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'SECONDARY', 'title': 'Model Adjusted Change From Baseline in Fasting Plasma Glucose at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1095', 'groupId': 'OG000'}, {'value': '1078', 'groupId': 'OG001'}, {'value': '1074', 'groupId': 'OG002'}, {'value': '1079', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG in Addition to Background MET', 'description': 'Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG001', 'title': 'SU in Addition to Background MET', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG002', 'title': 'RSG in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG003', 'title': 'MET in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.38', 'spread': '0.073', 'groupId': 'OG000'}, {'value': '-0.29', 'spread': '0.090', 'groupId': 'OG001'}, {'value': '-2.00', 'spread': '0.085', 'groupId': 'OG002'}, {'value': '-0.94', 'spread': '0.094', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment period', 'description': 'Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in fasting plasma glucose was calculated as the value at Month 60 minus the Baseline value.', 'unitOfMeasure': 'mmol/L (millimoles/Liter)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'SECONDARY', 'title': 'Model Adjusted Mean Change From Baseline in Insulin and Pro-insulin at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '931', 'groupId': 'OG000'}, {'value': '982', 'groupId': 'OG001'}, {'value': '882', 'groupId': 'OG002'}, {'value': '940', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG in Addition to Background MET', 'description': 'Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG001', 'title': 'SU in Addition to Background MET', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG002', 'title': 'RSG in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG003', 'title': 'MET in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'title': 'Insulin, Adjusted Change from Baseline', 'categories': [{'measurements': [{'value': '-18.6', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '1.77', 'groupId': 'OG001'}, {'value': '-16.9', 'spread': '1.65', 'groupId': 'OG002'}, {'value': '-12.1', 'spread': '1.91', 'groupId': 'OG003'}]}]}, {'title': 'Pro-insulin, Adjusted Change from Baseline', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '0.43', 'groupId': 'OG001'}, {'value': '-3.2', 'spread': '0.48', 'groupId': 'OG002'}, {'value': '-3.0', 'spread': '0.37', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment period', 'description': 'Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in insulin and pro-insulin was calculated as the value at Month 60 minus the Baseline value.', 'unitOfMeasure': 'picamoles/liter (pmol/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'SECONDARY', 'title': 'Number of HbA1c and Fasting Plasma Glucose (FPG) Responders at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1117', 'groupId': 'OG000'}, {'value': '1105', 'groupId': 'OG001'}, {'value': '1103', 'groupId': 'OG002'}, {'value': '1122', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG in Addition to Background MET', 'description': 'Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG001', 'title': 'SU in Addition to Background MET', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG002', 'title': 'RSG in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG003', 'title': 'MET in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'title': 'HbA1c Responders', 'categories': [{'measurements': [{'value': '265', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '235', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}]}, {'title': 'FPG Responders', 'categories': [{'measurements': [{'value': '300', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment period', 'description': 'Number of responders, i.e., participants meeting glycaemic targets (HbA1c less than or equal to 7 percent, FPG less than or equal to 7 mmol/L)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'SECONDARY', 'title': 'Model Adjusted Ratio to Baseline (Expressed as a Percentage) Homeostasis Model Assessment (HOMA) Beta Cell Function and Insulin Sensitivity at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '926', 'groupId': 'OG000'}, {'value': '977', 'groupId': 'OG001'}, {'value': '878', 'groupId': 'OG002'}, {'value': '933', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG in Addition to Background MET', 'description': 'Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG001', 'title': 'SU in Addition to Background MET', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG002', 'title': 'RSG in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG003', 'title': 'MET in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'title': 'Beta cell function', 'categories': [{'measurements': [{'value': '20.54', 'groupId': 'OG000', 'lowerLimit': '16.52', 'upperLimit': '24.70'}, {'value': '19.28', 'groupId': 'OG001', 'lowerLimit': '14.66', 'upperLimit': '24.09'}, {'value': '32.35', 'groupId': 'OG002', 'lowerLimit': '26.55', 'upperLimit': '38.41'}, {'value': '12.43', 'groupId': 'OG003', 'lowerLimit': '7.42', 'upperLimit': '17.67'}]}]}, {'title': 'Insulin sensitivity', 'categories': [{'measurements': [{'value': '42.57', 'groupId': 'OG000', 'lowerLimit': '37.57', 'upperLimit': '47.76'}, {'value': '-3.45', 'groupId': 'OG001', 'lowerLimit': '-7.21', 'upperLimit': '0.47'}, {'value': '42.07', 'groupId': 'OG002', 'lowerLimit': '36.39', 'upperLimit': '47.98'}, {'value': '23.90', 'groupId': 'OG003', 'lowerLimit': '19.36', 'upperLimit': '28.61'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment phase', 'description': 'The model adjusted (adjusted for any imbalances in the baseline \\[BL\\] values between within stratum treatment groups) ratio to BL in HOMA beta-cell function and insulin sensitivity was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100\\*\\[GM\\^-1\\]).', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'SECONDARY', 'title': 'Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC), Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Triglycerides, and Free Fatty Acids (FFAs) at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1117', 'groupId': 'OG000'}, {'value': '1105', 'groupId': 'OG001'}, {'value': '1103', 'groupId': 'OG002'}, {'value': '1122', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG in Addition to Background MET', 'description': 'Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG001', 'title': 'SU in Addition to Background MET', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG002', 'title': 'RSG in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG003', 'title': 'MET in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'title': 'Total cholesterol', 'categories': [{'measurements': [{'value': '-5.49', 'groupId': 'OG000', 'lowerLimit': '-6.99', 'upperLimit': '-3.96'}, {'value': '-9.09', 'groupId': 'OG001', 'lowerLimit': '-10.33', 'upperLimit': '-7.84'}, {'value': '-2.91', 'groupId': 'OG002', 'lowerLimit': '-4.62', 'upperLimit': '-1.17'}, {'value': '-9.68', 'groupId': 'OG003', 'lowerLimit': '-11.03', 'upperLimit': '-8.31'}]}]}, {'title': 'HDL-cholesterol', 'categories': [{'measurements': [{'value': '9.95', 'groupId': 'OG000', 'lowerLimit': '8.44', 'upperLimit': '11.49'}, {'value': '2.57', 'groupId': 'OG001', 'lowerLimit': '1.46', 'upperLimit': '3.68'}, {'value': '7.73', 'groupId': 'OG002', 'lowerLimit': '6.18', 'upperLimit': '9.30'}, {'value': '6.14', 'groupId': 'OG003', 'lowerLimit': '4.88', 'upperLimit': '7.42'}]}]}, {'title': 'LDL-cholesterol', 'categories': [{'measurements': [{'value': '-12.70', 'groupId': 'OG000', 'lowerLimit': '-15.03', 'upperLimit': '-10.30'}, {'value': '-17.68', 'groupId': 'OG001', 'lowerLimit': '-19.70', 'upperLimit': '-15.61'}, {'value': '-8.99', 'groupId': 'OG002', 'lowerLimit': '-11.42', 'upperLimit': '-6.49'}, {'value': '-17.80', 'groupId': 'OG003', 'lowerLimit': '-19.93', 'upperLimit': '-15.61'}]}]}, {'title': 'Triglycerides', 'categories': [{'measurements': [{'value': '-7.97', 'groupId': 'OG000', 'lowerLimit': '-10.72', 'upperLimit': '-5.15'}, {'value': '-1.95', 'groupId': 'OG001', 'lowerLimit': '-4.73', 'upperLimit': '0.91'}, {'value': '-2.68', 'groupId': 'OG002', 'lowerLimit': '-5.69', 'upperLimit': '0.43'}, {'value': '-2.50', 'groupId': 'OG003', 'lowerLimit': '-5.21', 'upperLimit': '0.28'}]}]}, {'title': 'Free fatty acids', 'categories': [{'measurements': [{'value': '-16.46', 'groupId': 'OG000', 'lowerLimit': '-19.13', 'upperLimit': '-13.71'}, {'value': '2.79', 'groupId': 'OG001', 'lowerLimit': '-0.23', 'upperLimit': '5.91'}, {'value': '-11.58', 'groupId': 'OG002', 'lowerLimit': '-14.65', 'upperLimit': '-8.41'}, {'value': '4.47', 'groupId': 'OG003', 'lowerLimit': '1.23', 'upperLimit': '7.81'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment phase', 'description': 'The model adjusted (adjusted for any imbalances in the baseline \\[BL\\] values between within stratum treatment groups) ratio to BL in TC, LDL cholesterol, HDL cholesterol, triglycerides, and FFAs was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100\\*\\[GM\\^-1\\]).', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'SECONDARY', 'title': 'Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC):High-density Lipoprotein (HDL) Cholesterol and Low-density Lipoprotein (LDL) Cholesterol:HDL Cholesterol Ratios at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1117', 'groupId': 'OG000'}, {'value': '1105', 'groupId': 'OG001'}, {'value': '1103', 'groupId': 'OG002'}, {'value': '1122', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG in Addition to Background MET', 'description': 'Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG001', 'title': 'SU in Addition to Background MET', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG002', 'title': 'RSG in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG003', 'title': 'MET in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'title': 'Total Cholesterol: HDL Cholesterol Ratio', 'categories': [{'measurements': [{'value': '-14.20', 'groupId': 'OG000', 'lowerLimit': '-15.98', 'upperLimit': '-12.39'}, {'value': '-11.33', 'groupId': 'OG001', 'lowerLimit': '-12.82', 'upperLimit': '-9.81'}, {'value': '-9.93', 'groupId': 'OG002', 'lowerLimit': '-11.83', 'upperLimit': '-7.98'}, {'value': '-15.01', 'groupId': 'OG003', 'lowerLimit': '-16.44', 'upperLimit': '-13.55'}]}]}, {'title': 'LDL Cholesterol: HDL-Cholesterol Ratio', 'categories': [{'measurements': [{'value': '-20.89', 'groupId': 'OG000', 'lowerLimit': '-23.24', 'upperLimit': '-18.46'}, {'value': '-20.04', 'groupId': 'OG001', 'lowerLimit': '-22.16', 'upperLimit': '-17.87'}, {'value': '-15.85', 'groupId': 'OG002', 'lowerLimit': '-18.26', 'upperLimit': '-13.37'}, {'value': '-22.53', 'groupId': 'OG003', 'lowerLimit': '-24.63', 'upperLimit': '-20.37'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment period', 'description': 'The model adjusted (adjusted for any imbalances in the baseline \\[BL\\] values between within stratum treatment groups) ratio to BL in TC:HDL cholesterol and LDL cholesterol:HDL cholesterol was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100\\*\\[GM\\^-1\\]).', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'SECONDARY', 'title': 'Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Apolipoprotein B (Apo-B) at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '949', 'groupId': 'OG000'}, {'value': '1007', 'groupId': 'OG001'}, {'value': '906', 'groupId': 'OG002'}, {'value': '970', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG in Addition to Background MET', 'description': 'Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG001', 'title': 'SU in Addition to Background MET', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG002', 'title': 'RSG in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG003', 'title': 'MET in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.77', 'groupId': 'OG000', 'lowerLimit': '-15.45', 'upperLimit': '-12.05'}, {'value': '-11.63', 'groupId': 'OG001', 'lowerLimit': '-13.10', 'upperLimit': '-10.14'}, {'value': '-9.68', 'groupId': 'OG002', 'lowerLimit': '-11.55', 'upperLimit': '-7.77'}, {'value': '-12.09', 'groupId': 'OG003', 'lowerLimit': '-13.67', 'upperLimit': '-10.47'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment period', 'description': 'The model adjusted (adjusted for any imbalances in the baseline \\[BL\\] values between within stratum treatment groups) ratio to BL in Apo-B was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100\\*\\[GM\\^-1\\]).', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'SECONDARY', 'title': 'Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Urinary Albumin Creatinine Ratio at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '899', 'groupId': 'OG000'}, {'value': '921', 'groupId': 'OG001'}, {'value': '891', 'groupId': 'OG002'}, {'value': '901', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG in Addition to Background MET', 'description': 'Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG001', 'title': 'SU in Addition to Background MET', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG002', 'title': 'RSG in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG003', 'title': 'MET in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.31', 'groupId': 'OG000', 'lowerLimit': '-0.70', 'upperLimit': '18.14'}, {'value': '15.17', 'groupId': 'OG001', 'lowerLimit': '6.73', 'upperLimit': '24.28'}, {'value': '-3.43', 'groupId': 'OG002', 'lowerLimit': '-11.91', 'upperLimit': '5.87'}, {'value': '11.91', 'groupId': 'OG003', 'lowerLimit': '3.10', 'upperLimit': '21.46'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment phase', 'description': 'The model adjusted (adjusted for any imbalances in the baseline \\[BL\\] values between within stratum treatment groups) ratio to BL in urinary albumin creatinine ratio was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100\\*\\[GM\\^-1\\]).', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'SECONDARY', 'title': 'Model Adjusted Change From Baseline in Body Weight at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1096', 'groupId': 'OG000'}, {'value': '1079', 'groupId': 'OG001'}, {'value': '1073', 'groupId': 'OG002'}, {'value': '1079', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG in Addition to Background MET', 'description': 'Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG001', 'title': 'SU in Addition to Background MET', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or miconizied equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG002', 'title': 'RSG in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG003', 'title': 'MET in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.93', 'spread': '0.263', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '0.192', 'groupId': 'OG001'}, {'value': '4.72', 'spread': '0.235', 'groupId': 'OG002'}, {'value': '-2.16', 'spread': '0.179', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment phase', 'description': 'Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in body weight was calculated as the value at Month 60 minus the Baseline value.', 'unitOfMeasure': 'kilograms', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'SECONDARY', 'title': 'Model Adjusted Change From Baseline in Alanine Aminotransferase at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1094', 'groupId': 'OG000'}, {'value': '1077', 'groupId': 'OG001'}, {'value': '1073', 'groupId': 'OG002'}, {'value': '1078', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG in Addition to Background MET', 'description': 'Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG001', 'title': 'SU in Addition to Background MET', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or miconizied equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG002', 'title': 'RSG in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG003', 'title': 'MET in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'categories': [{'measurements': [{'value': '-37.43', 'groupId': 'OG000', 'lowerLimit': '-39.22', 'upperLimit': '-35.59'}, {'value': '-21.73', 'groupId': 'OG001', 'lowerLimit': '-23.90', 'upperLimit': '-19.50'}, {'value': '-30.17', 'groupId': 'OG002', 'lowerLimit': '-31.98', 'upperLimit': '-28.31'}, {'value': '-24.00', 'groupId': 'OG003', 'lowerLimit': '-26.21', 'upperLimit': '-21.73'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment phase', 'description': 'Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in alanine aminotransferase was calculated as the value at Month 60 minus the Baseline value.', 'unitOfMeasure': 'U/L (Units/Liter)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'SECONDARY', 'title': 'Model Adjusted Change From Baseline in Waist Circumference at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '972', 'groupId': 'OG000'}, {'value': '1032', 'groupId': 'OG001'}, {'value': '926', 'groupId': 'OG002'}, {'value': '994', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG in Addition to Background MET', 'description': 'Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG001', 'title': 'SU in Addition to Background MET', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15mg per day or miconizied equivalent of 10.5mg per day; gliclazide 240mg per day and glimepiride 4mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG002', 'title': 'RSG in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG003', 'title': 'MET in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.70', 'spread': '0.266', 'groupId': 'OG000'}, {'value': '0.65', 'spread': '0.214', 'groupId': 'OG001'}, {'value': '3.00', 'spread': '0.263', 'groupId': 'OG002'}, {'value': '-0.60', 'spread': '0.215', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment phase', 'description': 'Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in waist circumference was calculated as the value at Month 60 minus the Baseline value.', 'unitOfMeasure': 'cm (centimeters)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'SECONDARY', 'title': 'Model Adjusted Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1096', 'groupId': 'OG000'}, {'value': '1079', 'groupId': 'OG001'}, {'value': '1074', 'groupId': 'OG002'}, {'value': '1079', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG in Addition to Background MET', 'description': 'Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG001', 'title': 'SU in Addition to Background MET', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15mg per day or miconizied equivalent of 10.5mg per day; gliclazide 240mg per day and glimepiride 4mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG002', 'title': 'RSG in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG003', 'title': 'MET in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'title': 'SBP', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '0.52', 'groupId': 'OG001'}, {'value': '-2.3', 'spread': '0.52', 'groupId': 'OG002'}, {'value': '-0.6', 'spread': '0.53', 'groupId': 'OG003'}]}]}, {'title': 'DBP', 'categories': [{'measurements': [{'value': '-3.6', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '-3.6', 'spread': '0.31', 'groupId': 'OG002'}, {'value': '-2.3', 'spread': '0.31', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment phase', 'description': 'Model adjusted (adjusted for any imbalances in the baseline values between within treatment groups) change from baseline in SBP and DBP was calculated as the value at Month 60 minus the Baseline value.', 'unitOfMeasure': 'mmHg (millimeters of mercury)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'SECONDARY', 'title': 'Model Adjusted Ratio to Baseline (Expressed as a Percentage) for C-Reactive Protein at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '942', 'groupId': 'OG000'}, {'value': '987', 'groupId': 'OG001'}, {'value': '887', 'groupId': 'OG002'}, {'value': '952', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG in Addition to Background MET', 'description': 'Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG001', 'title': 'SU in Addition to Background MET', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15mg per day or miconizied equivalent of 10.5mg per day; gliclazide 240mg per day and glimepiride 4mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG002', 'title': 'RSG in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG003', 'title': 'MET in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'categories': [{'measurements': [{'value': '-57.40', 'groupId': 'OG000', 'lowerLimit': '-60.41', 'upperLimit': '-54.15'}, {'value': '-28.92', 'groupId': 'OG001', 'lowerLimit': '-33.71', 'upperLimit': '-23.79'}, {'value': '-56.50', 'groupId': 'OG002', 'lowerLimit': '-61.56', 'upperLimit': '-55.21'}, {'value': '-36.29', 'groupId': 'OG003', 'lowerLimit': '-41.03', 'upperLimit': '-31.17'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment phase', 'description': 'The model adjusted (adjusted for any imbalances in the baseline \\[BL\\] values between within stratum treatment groups) ratio to BL in C-Reactive Protein was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100\\*\\[GM\\^-1\\]).', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'SECONDARY', 'title': 'Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Fibrinogen at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '918', 'groupId': 'OG000'}, {'value': '987', 'groupId': 'OG001'}, {'value': '875', 'groupId': 'OG002'}, {'value': '941', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG in Addition to Background MET', 'description': 'Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG001', 'title': 'SU in Addition to Background MET', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15mg per day or miconizied equivalent of 10.5mg per day; gliclazide 240mg per day and glimepiride 4mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG002', 'title': 'RSG in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG003', 'title': 'MET in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.12', 'groupId': 'OG000', 'lowerLimit': '0.54', 'upperLimit': '3.72'}, {'value': '5.74', 'groupId': 'OG001', 'lowerLimit': '4.22', 'upperLimit': '7.28'}, {'value': '-0.23', 'groupId': 'OG002', 'lowerLimit': '-1.79', 'upperLimit': '1.35'}, {'value': '3.14', 'groupId': 'OG003', 'lowerLimit': '1.38', 'upperLimit': '4.93'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment phase', 'description': 'The model adjusted (adjusted for any imbalances in the baseline \\[BL\\] values between within stratum treatment groups) ratio to BL in fibrinogen was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100\\*\\[GM\\^-1\\]).', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'SECONDARY', 'title': 'Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Plasminogen Activator Inhibitor-1 (PAI-1) Antigen at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '931', 'groupId': 'OG000'}, {'value': '991', 'groupId': 'OG001'}, {'value': '882', 'groupId': 'OG002'}, {'value': '939', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG in Addition to Background MET', 'description': 'Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG001', 'title': 'SU in Addition to Background MET', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15mg per day or miconizied equivalent of 10.5mg per day; gliclazide 240mg per day and glimepiride 4mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG002', 'title': 'RSG in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'OG003', 'title': 'MET in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.85', 'groupId': 'OG000', 'lowerLimit': '-14.42', 'upperLimit': '-5.02'}, {'value': '15.01', 'groupId': 'OG001', 'lowerLimit': '9.77', 'upperLimit': '20.50'}, {'value': '-7.79', 'groupId': 'OG002', 'lowerLimit': '-12.61', 'upperLimit': '-2.71'}, {'value': '-0.64', 'groupId': 'OG003', 'lowerLimit': '-5.82', 'upperLimit': '4.83'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment phase', 'description': 'The model adjusted (adjusted for any imbalances in the baseline \\[BL\\] values between within stratum treatment groups) ratio to BL in plasminogen activator inhibitor-1 (PAI-1) antigen was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100\\*\\[GM\\^-1\\]).', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'PRIMARY', 'title': 'Independent Re-adjudication Outcome: Number of Participants Who Died Due to Any Cause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2220', 'groupId': 'OG000'}, {'value': '2227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG', 'description': 'Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent'}, {'id': 'OG001', 'title': 'Combined MET/SU', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.68', 'ciUpperLimit': '1.08', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)', 'description': 'All deaths identified during the original record study and discovered after the re-adjudication efforts began were included.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'PRIMARY', 'title': 'Independent Re-adjudication (IR) Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Original RECORD Endpoint Definitions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2220', 'groupId': 'OG000'}, {'value': '2227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG', 'description': 'Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent'}, {'id': 'OG001', 'title': 'Combined MET/SU', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'categories': [{'measurements': [{'value': '181', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.17', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)', 'description': 'IR was based on original RECORD endpoint definitions. CV death= no unequivocal non-CV cause (sudden death, death from acute vascular events, heart failure, acute MI, other CV causes, and deaths adjudicated as unknown cause). MI event=hospitalization + elevation of specific cardiac biomarkers above the upper limit of normal + cardiac ischemia symptoms/new pathological electrocardiogram findings. Stroke event=hospitalization + rapidly developed clinical signs of focal/global disturbance of cerebral function for more than 24 hours, with no apparent cause other than a vascular origin.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'PRIMARY', 'title': 'Independent Re-adjudication Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Contemporary Endpoint Definitions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2220', 'groupId': 'OG000'}, {'value': '2227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG', 'description': 'Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent'}, {'id': 'OG001', 'title': 'Combined MET/SU', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'categories': [{'measurements': [{'value': '186', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.18', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)', 'description': 'Independent re-adjudication was based on the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions. CV death included death resulting from an acute MI; sudden cardiac death and death due to heart failure, stroke, and to other CV causes. Deaths of unknown cause were counted as CV deaths. MI was defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Stroke was defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'PRIMARY', 'title': 'Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Original RECORD Endpoint Definitions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2220', 'groupId': 'OG000'}, {'value': '2227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG', 'description': 'Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent'}, {'id': 'OG001', 'title': 'Combined MET/SU', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.68', 'ciUpperLimit': '1.21', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)', 'description': 'The number of participants with a CV death (or unknown) as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. CV death was defined as any death for which an unequivocal non-CV cause could not be established. CV death included death following heart failure, death following acute myocardial infarction (MI), sudden death, death due to acute vascular events, and other CV causes. Deaths due to unknown causes were classified as "unknown deaths," but were counted as CV deaths for the analysis of this endpoint.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'PRIMARY', 'title': 'Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Contemporary Endpoint Definitions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2220', 'groupId': 'OG000'}, {'value': '2227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG', 'description': 'Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent'}, {'id': 'OG001', 'title': 'Combined MET/SU', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.68', 'ciUpperLimit': '1.21', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)', 'description': 'The number of participants with a CV (or unknown) death as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. CV death included death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, and death due to other CV causes. Deaths of unknown cause were counted as CV deaths.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'PRIMARY', 'title': 'Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2220', 'groupId': 'OG000'}, {'value': '2227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG', 'description': 'Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent'}, {'id': 'OG001', 'title': 'Combined MET/SU', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.59', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)', 'description': 'The number of participants with an MI (fatal or non-fatal) event as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. An event of MI was defined as hospitalization plus elevation of cardiac biomarkers troponin (TN) I and/or TNT above the upper limit of normal (ULN) or creatinine kinase (CK) MB (M=muscle type; B=brain type) isoenzyme \\>= 2x the ULN or CK \\> 2x the ULN plus typical symptoms of cardiac ischemia or new pathological electrocardiogram findings, or cause of death adjudicated as MI.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'PRIMARY', 'title': 'Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2220', 'groupId': 'OG000'}, {'value': '2227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG', 'description': 'Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent'}, {'id': 'OG001', 'title': 'Combined MET/SU', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.62', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)', 'description': 'The number of participants with an MI (fatal or non-fatal) event as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. An event of MI was defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'PRIMARY', 'title': 'Independent Re-adjudication Outcome: Number of Participants (Par.) With an Event of Stroke (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2220', 'groupId': 'OG000'}, {'value': '2227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG', 'description': 'Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent'}, {'id': 'OG001', 'title': 'Combined MET/SU', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.54', 'ciUpperLimit': '1.14', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)', 'description': 'Par. with a stroke (fatal or non-fatal) event as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. A stroke event=hospitalization plus rapidly developed clinical signs of focal (or global) disturbance of cerebral function lasting more than 24 hours (unless interrupted by thrombolysis, surgery, or death), with no apparent cause other than a vascular origin, including par. presenting clinical signs/symptoms suggestive of subarachnoid haemorrhage/intracerebral haemorrhage/cerebral ischemic necrosis or cause of death adjudicated as stroke.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'PRIMARY', 'title': 'Independent Re-adjudication Outcome: Number of Participants With an Event of Stroke (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2220', 'groupId': 'OG000'}, {'value': '2227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG', 'description': 'Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent'}, {'id': 'OG001', 'title': 'Combined MET/SU', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.57', 'ciUpperLimit': '1.18', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)', 'description': 'The number of participants with a stroke (fatal or non-fatal) event as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. An event of stroke was defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Main Study + Observational Follow-up Combined', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2220', 'groupId': 'OG000'}, {'value': '2227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG: Main Study and Observational Follow-up', 'description': "Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}, {'id': 'OG001', 'title': 'Combined MET/SU: Main Study and Observational Follow-up', 'description': "Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}], 'classes': [{'title': 'All neoplasms/cancer (N/C) (benign/malignant)', 'categories': [{'measurements': [{'value': '196', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}]}, {'title': 'Malignant (Mal.) N/C', 'categories': [{'measurements': [{'value': '179', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}]}, {'title': 'Mal. N/C; excluding non-melanomatous skin cancers', 'categories': [{'measurements': [{'value': '164', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)', 'description': "The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Observational Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1280', 'groupId': 'OG000'}, {'value': '1250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG: Observational Follow-up', 'description': "Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}, {'id': 'OG001', 'title': 'Combined MET/SU: Observational Follow-up', 'description': "Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}], 'classes': [{'title': 'All neoplasms/cancer (N/C) (benign/malignant)', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Malignant (Mal.) N/C', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Mal. N/C; excluding non-melanomatous skin cancers', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)', 'description': "The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2220', 'groupId': 'OG000'}, {'value': '2227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG: Main Study and Observational Follow-up', 'description': "Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}, {'id': 'OG001', 'title': 'Combined MET/SU: Main Study and Observational Follow-up', 'description': "Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}], 'classes': [{'title': 'Any genitourinary', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'Prostate', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Renal', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Uterine', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Bladder', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Vaginal/vulvar', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Ovarian', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Any gastrointestinal', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': 'Colon/rectal cancer', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Colon', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Gastric', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Pancreatic', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Liver', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Gall bladder/biliary', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Gastrointestinal; not specified', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any hematologic', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Lung', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Skin (non-melanomatous)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Skin (melanomatous)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Metastases', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Breast', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Head and neck', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Neurologic', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Endocrine', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Not specified', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)', 'description': 'The observational follow-up (OFU) was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. The neoplasms/cancer events of bladder, breast, colon, liver, pancreatic, prostate cancer, and melanoma were pre-specified as cancers of interest for the OFU. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1280', 'groupId': 'OG000'}, {'value': '1250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG: Observational Follow-up', 'description': "Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}, {'id': 'OG001', 'title': 'Combined MET/SU: Observational Follow-up', 'description': "Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}], 'classes': [{'title': 'Any genitourinary', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Prostate', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Renal', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Uterine', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Bladder', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vaginal/vulvar', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Ovarian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any gastrointestinal', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Colon/rectal cancer', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Colon', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Gastric', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pancreatic', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Liver', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Gall bladder/biliary', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Gastrointestinal; not specified', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any hematologic', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Lung', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Skin (non-melanomatous)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Skin (melanomatous)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Metastases', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Breast', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Head and neck', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Neurologic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Endocrine', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Not specified', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)', 'description': 'The observational follow-up (OFU) was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. The neoplasms/cancer events of bladder, breast, colon, liver, pancreatic, prostate cancer, and melanoma were pre-specified as cancers of interest for the OFU. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2220', 'groupId': 'OG000'}, {'value': '2227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG: Main Study and Observational Follow-up', 'description': "Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}, {'id': 'OG001', 'title': 'Combined MET/SU: Main Study and Observational Follow-up', 'description': "Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}], 'classes': [{'title': 'Any cancer-related death', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}, {'title': 'Any gastrointestinal event', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Pancreatic', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Colon/rectal', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Gastric', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Liver', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Gall bladder/biliary', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Gastrointestinal event; not specified', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any genitourinary event', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Renal', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Uterine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Prostate', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Bladder', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Ovarian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Lung', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Any hematologic event', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Skin (melanoma)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Skin (non-melanomatous)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Metastases', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Breast', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Head and neck', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any neurologic event', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Endocrine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Not specified', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)', 'description': "The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1280', 'groupId': 'OG000'}, {'value': '1250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG: Observational Follow-up', 'description': "Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}, {'id': 'OG001', 'title': 'Combined MET/SU: Observational Follow-up', 'description': "Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}], 'classes': [{'title': 'Any cancer-related death', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Any gastrointestinal event', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Pancreatic', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Colon/rectal', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Gastric', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Liver', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Gall bladder/biliary', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Gastrointestinal event; not specified', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any genitourinary event', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Renal', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Uterine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Prostate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bladder', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ovarian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lung', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Any hematologic event', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Skin (melanoma)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Skin (non-melanomatous)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Metastases', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Breast', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Head and neck', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any neurologic event', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Endocrine', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Not specified', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)', 'description': "The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Bone Fracture Event - Overall and by Gender: Main Study and Observational Follow-up Combined', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2220', 'groupId': 'OG000'}, {'value': '2227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG: Main Study and Observational Follow-up', 'description': "Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}, {'id': 'OG001', 'title': 'Combined MET/SU: Main Study and Observational Follow-up', 'description': "Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}], 'classes': [{'title': 'Overall, n=2220, 2227', 'categories': [{'measurements': [{'value': '238', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}]}, {'title': 'Male, n=1142, 1152', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'Female, n=1078, 1075', 'categories': [{'measurements': [{'value': '156', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)', 'description': "The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Bone Fracture Event - Overall and by Gender: Observational Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1280', 'groupId': 'OG000'}, {'value': '1250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG: Observational Follow-up', 'description': "Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}, {'id': 'OG001', 'title': 'Combined MET/SU: Observational Follow-up', 'description': "Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}], 'classes': [{'title': 'Overall, n=1280, 1250', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Male, n=665, 635', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Female, n=615, 615', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)', 'description': "The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Main Study + Observational Follow-up Combined', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2220', 'groupId': 'OG000'}, {'value': '2227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG: Main Study and Observational Follow-up', 'description': "Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}, {'id': 'OG001', 'title': 'Combined MET/SU: Main Study and Observational Follow-up', 'description': "Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}], 'classes': [{'title': 'Any event', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'Upper limb', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Distal lower limb', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Femur/hip', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Spinal', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Pelvic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)', 'description': 'The OFU was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Observational Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1280', 'groupId': 'OG000'}, {'value': '1250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG: Observational Follow-up', 'description': "Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}, {'id': 'OG001', 'title': 'Combined MET/SU: Observational Follow-up', 'description': "Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}], 'classes': [{'title': 'Any event', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Upper limb', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Distal lower limb', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Femur/hip', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Spinal', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Pelvic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)', 'description': 'The OFU was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Event of Death Due to a Bone Fracture-related Event: Main Study + Observational Follow-up Combined', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2220', 'groupId': 'OG000'}, {'value': '2227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG: Main Study and Observational Follow-up', 'description': "Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}, {'id': 'OG001', 'title': 'Combined MET/SU: Main Study and Observational Follow-up', 'description': "Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)', 'description': "The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2220', 'groupId': 'OG000'}, {'value': '2227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG: Main Study and Observational Follow-up', 'description': "Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}, {'id': 'OG001', 'title': 'Combined MET/SU: Main Study and Observational Follow-up', 'description': "Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}], 'classes': [{'title': 'Any event, overall; n=2220, 2227', 'categories': [{'measurements': [{'value': '238', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}]}, {'title': 'Any event, male; n=1142, 1152', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'Any event, female; n=1078, 1075', 'categories': [{'measurements': [{'value': '156', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}, {'title': 'Upper limb, any event, overall; n=2220, 2227', 'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}, {'title': 'Upper limb, any event, male; n=1142, 1152', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Upper limb, any event, female; n=1078, 1075', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Distal lower limb, any event, overall; n=2220, 222', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Distal lower limb, any event, male; n=1142, 1152', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Distal lower limb, any event, female; n=1078, 1075', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Femur/hip, any event, overall; n=2220, 2227', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Femur/hip, any event, male; n=1142, 1152', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Femur/hip, any event, female; n=1078, 1075', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Spinal, any event, overall; n=2220, 2227', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Spinal, any event, male; n=1142, 1152', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Spinal, any event, female; n=1078, 1075', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Pelvic, any event, overall; n=2220, 2227', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Pelvic, any event, male; n=1142, 1152', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Pelvic, any event, female; n=1078, 1075', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Unclassified, any event, overall; n=2220, 2227', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Unclassified, any event, male; n=1142, 1152', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Unclassified, any event, female; n=1078, 1075', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other, any event, overall; n=2220, 2227', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Other, any event, male; n=1142, 1152', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Other, any event, female; n=1078, 1075', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)', 'description': "The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date that had the same Higher Level Group Term (HLGT) for fracture location, per participant.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1280', 'groupId': 'OG000'}, {'value': '1250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG: Observational Follow-up', 'description': "Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}, {'id': 'OG001', 'title': 'Combined MET/SU: Observational Follow-up', 'description': "Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}], 'classes': [{'title': 'Any event, overall; n=1280, 1250', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Any event, male; n=665, 635', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Any event, female; n=615, 615', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Upper limb, any event, overall; n=1280, 1250', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Upper limb, any event, male; n=665, 635', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Upper limb, any event, female; n=615, 615', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Distal lower limb, any event, overall; n=1280,1250', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Distal lower limb, any event, male; n=665, 635', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Distal lower limb, any event, female; n=615, 615', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Femur/hip, any event, overall; n=1280, 1250', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Femur/hip, any event, male; n=665, 635', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Femur/hip, any event, female; n=615, 615', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Spinal, any event, overall; n=1280, 1250', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Spinal, any event, male; n=665, 635', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Spinal, any event, female; n=615, 615', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pelvic, any event, overall; n=1280, 1250', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pelvic, any event, male; n=665, 635', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pelvic, any event, female; n=615, 615', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Unclassified, any event, overall; n=1280, 1250', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Unclassified, any event, male; n=665, 635', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Unclassified, any event, female; n=615, 615', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other, any event, overall; n=1280, 1250', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Other, any event, male; n=665, 635', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Other, any event, female; n=615, 615', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)', 'description': "The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date that had the same Higher Level Group Term (HLGT) for fracture location, per participant.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2220', 'groupId': 'OG000'}, {'value': '2227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG: Main Study and Observational Follow-up', 'description': "Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}, {'id': 'OG001', 'title': 'Combined MET/SU: Main Study and Observational Follow-up', 'description': "Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}], 'classes': [{'title': 'Any event, overall, n=2220, 2227', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Any event, male, n=1142, 1152', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Any event, female, n=1078, 1075', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Hip, overall, n=2220, 2227', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Hip, male, n=1142, 1152', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hip, female, n=1078, 1075', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Pelvis, overall, n=2220, 2227', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Pelvis, male, n=1142, 1152', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Pelvis, female, n=1078, 1075', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Upper leg, overall, n=2220, 2227', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Upper leg, male, n=1142, 1152', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Upper leg, female, n=1078, 1075', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Any vertebral event, overall, n=2220, 2227', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Any vertebral event, male, n=1142, 1152', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Any vertebral event, female, n=1078, 1075', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Lumbar spine, overall, n=2220, 2227', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Lumbar spine, male, n=1142, 1152', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Lumbar spine, female, n=1078, 1075', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Thoracic spine, overall, n=2220, 2227', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Thoracic spine, male, n=1142, 1152', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Thoracic spine, female, n=1078, 1075', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Cervical spine, overall, n=2220, 2227', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Cervical spine, male, n=1142, 1152', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Cervical spine, female, n=1078, 1075', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)', 'description': "The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The following bone fractures were grouped and were identified as potentially high morbidity bone fractures: hip, pelvis, upper leg, vertebral (lumbar spine, thoracic spine, cervical spine, spine - site unknown).", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Potentially High Morbidity Fracture Events and Non-high Morbidity Fracture Events, in Participants With Prior Hand/Upper Arm/Foot Fractures (H/UA/FF): Main Study + Observational Follow-up Combined', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2220', 'groupId': 'OG000'}, {'value': '2227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG: Main Study and Observational Follow-up', 'description': "Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}, {'id': 'OG001', 'title': 'Combined MET/SU: Main Study and Observational Follow-up', 'description': "Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}], 'classes': [{'title': 'Any H/UA/FF event, overall, n=2220, 2227', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Any H/UA/FF event, male, n=1142, 1152', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Any H/UA/FF event, female, n=1078, 1075', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'High morbidity fractures, overall, n=2220, 2227', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'High morbidity fractures, male, n=1142, 1152', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'High morbidity fractures, female, n=1078, 1075', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Non-high morbidity fractures, overall, n=2220, 222', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Non-high morbidity fractures, male, n=1142, 1152', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Non-high morbidity fractures, female, n=1078, 1075', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)', 'description': "The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The following bone fractures were grouped and were identified as potentially high morbidity bone fractures: hip, pelvis, upper leg, vertebral (lumbar spine, thoracic spine, cervical spine, spine - site unknown).", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Bone Fracture Events of the Indicated Cause: Main Study + Observational Follow-up Combined', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2220', 'groupId': 'OG000'}, {'value': '2227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG: Main Study and Observational Follow-up', 'description': "Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}, {'id': 'OG001', 'title': 'Combined MET/SU: Main Study and Observational Follow-up', 'description': "Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}], 'classes': [{'title': 'Any event', 'categories': [{'measurements': [{'value': '238', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}]}, {'title': 'Non-traumatic event', 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Traumatic event', 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}, {'title': 'Pathologic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Data unavailable', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)', 'description': "The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Bone Fracture Events of the Indicated Cause: Observational Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1280', 'groupId': 'OG000'}, {'value': '1250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG: Observational Follow-up', 'description': "Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}, {'id': 'OG001', 'title': 'Combined MET/SU: Observational Follow-up', 'description': "Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}], 'classes': [{'title': 'Any event', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Non-traumatic event,', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Traumatic event', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Pathologic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Data unavailable', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)', 'description': 'The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator\'s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included "Unknown" as a category. Fracture events with missing outcome data were reported as "Data unavailable."', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).'}, {'type': 'SECONDARY', 'title': 'Number of Bone Fracture Events With the Indicated Outcome: Main Study + Observational Follow-up Combined', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2220', 'groupId': 'OG000'}, {'value': '2227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG: Main Study and Observational Follow-up', 'description': "Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}, {'id': 'OG001', 'title': 'Combined MET/SU: Main Study and Observational Follow-up', 'description': "Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}], 'classes': [{'title': 'Number of bone fracture events', 'categories': [{'measurements': [{'value': '299', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Normal healing with standard management', 'categories': [{'measurements': [{'value': '250', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}]}, {'title': 'Complication', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Additional therapeutic measures required', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Data unavailable', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)', 'description': 'The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator\'s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included "Unknown" as a category. Fracture events with missing outcome data were reported as "Data unavailable."', 'unitOfMeasure': 'bone fracture events', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).'}, {'type': 'SECONDARY', 'title': 'Number of Bone Fracture Events With the Indicated Outcome: Observational Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1280', 'groupId': 'OG000'}, {'value': '1250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG: Observational Follow-up', 'description': "Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}, {'id': 'OG001', 'title': 'Combined MET/SU: Observational Follow-up', 'description': "Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}], 'classes': [{'title': 'Number of bone fracture events', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Normal healing with standard management', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Complication', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Additional therapeutic measures required', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Data unavailable', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)', 'description': 'The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator\'s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included "Unknown" as a category. Fracture events with missing outcome data were reported as "Data unavailable."', 'unitOfMeasure': 'bone fracture events', 'reportingStatus': 'POSTED', 'populationDescription': 'Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1280', 'groupId': 'OG000'}, {'value': '1250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined RSG: Observational Follow-up', 'description': "Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}, {'id': 'OG001', 'title': 'Combined MET/SU: Observational Follow-up', 'description': "Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}], 'classes': [{'title': 'Any event', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}, {'title': 'Ankle fracture', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Prostate cancer', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Lung neoplasm malignant', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Breast cancer', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Basal cell carcinoma', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Pancreatic carcinoma', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Colon cancer', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Humerus fracture', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Upper limb fracture', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Malignant melanoma', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Uterine cancer', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Gastric cancer', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Wrist fracture', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hip fracture', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Radius fracture', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Forearm fracture', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hepatic neoplasm malignant', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Rectal cancer', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Renal cancer', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Foot fracture', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Renal cell carcinoma', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Femur fracture', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Femoral neck fracture', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Lumbar vertebral fracture', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Metastases to bone', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Metastases to liver', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Bladder cancer', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Fall', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Metastases to central nervous system', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rib fracture', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Squamous cell carcinoma', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Acute myocardial infarction', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Brain neoplasm', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Gastric neoplasm', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Metastases to lung', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Patella fracture', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Acute myeloid leukaemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Acute respiratory failure', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Anaemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Benign salivary gland neoplasm', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Biliary colic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Biliary neoplasm', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bone neoplasm malignant', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bronchial carcinoma', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cardiac failure acute', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Chest pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Chronic lymphocytic leukaemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Colon neoplasm', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Contusion', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Drowning', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dysplasia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Endometrial cancer stage I', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Leukaemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lower limb fracture', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lung squamous cell carcinoma stage unspecified', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymphoma', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Malignant neoplasm of pleura', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Metastases to skin', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Metastases to testicle', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Metastatic renal cell carcinoma', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Oesophageal carcinoma', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Osteoarthritis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pancreatic necrosis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rectal cancer stage II', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Spinal fracture', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'T-cell lymphoma', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Urinary tract infection', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Uterine leiomyosarcoma', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Biliary cancer metastatic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Cervix carcinoma', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Chronic obstructive pulmonary disease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Comminuted fracture', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Craniocerebral injury', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Gastrointestinal neoplasm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hepatic lesion', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Joint dislocation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Laryngeal cancer', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Lip neoplasm malignant stage unspecified', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Lung neoplasm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Metastases to lymph nodes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Metastasis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Musculoskeletal chest pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Myocardial infarction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': "Non-Hodgkin's lymphoma", 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pubis fracture', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pulmonary embolism', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Rectal cancer recurrent', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Rectal neoplasm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Skin cancer', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Skin ulcer', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Small cell lung cancer stage unspecified', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Sternal fracture', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Subdural haemorrhage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Sudden death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Thoracic vertebral fracture', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Thyroid cancer', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Vulval cancer', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)', 'description': "The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RSG in Addition to Background MET', 'description': 'Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'FG001', 'title': 'SU in Addition to Background MET', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'FG002', 'title': 'RSG in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'FG003', 'title': 'MET in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'FG004', 'title': 'Combined RSG: Observational Follow-up', 'description': "Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}, {'id': 'FG005', 'title': 'Combined MET/SU: Observational Follow-up', 'description': "Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion."}], 'periods': [{'title': 'Main Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1117'}, {'groupId': 'FG001', 'numSubjects': '1105'}, {'groupId': 'FG002', 'numSubjects': '1103'}, {'groupId': 'FG003', 'numSubjects': '1122'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '939'}, {'groupId': 'FG001', 'numSubjects': '906'}, {'groupId': 'FG002', 'numSubjects': '896'}, {'groupId': 'FG003', 'numSubjects': '892'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '178'}, {'groupId': 'FG001', 'numSubjects': '199'}, {'groupId': 'FG002', 'numSubjects': '207'}, {'groupId': 'FG003', 'numSubjects': '230'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '67'}, {'groupId': 'FG002', 'numSubjects': '54'}, {'groupId': 'FG003', 'numSubjects': '72'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '26'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '72'}, {'groupId': 'FG003', 'numSubjects': '70'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Moved to survival status follow-up only', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '36'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Participant moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Poor compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Prohibited glucose lowering medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Site closed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Entry criteria violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Participant did not take study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Participant completed study at visit 27', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Personal reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Risk of heart failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Investigator refused to log temperature', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Reason unspecified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Observational Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'comment': '665 from "RSG in Addition to Background MET" arm; 615 from "RGS in Addition to Background SU" arm.', 'groupId': 'FG004', 'numSubjects': '1280'}, {'comment': '647 from "SU in Addition to Background MET" arm; 603 from "MET in Addition to Background SU" arm.', 'groupId': 'FG005', 'numSubjects': '1250'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1131'}, {'groupId': 'FG005', 'numSubjects': '1102'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '149'}, {'groupId': 'FG005', 'numSubjects': '148'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '78'}, {'groupId': 'FG005', 'numSubjects': '70'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '25'}, {'groupId': 'FG005', 'numSubjects': '27'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '12'}]}, {'type': 'Entered into Another Clinical Trial', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '18'}, {'groupId': 'FG005', 'numSubjects': '22'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'Site Closed Early', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'Participant Moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Unknown; Reason Not Provided', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The RECORD study ran from April 2001 through December 2008. Results are presented in the non-re-adjudicated outcome measures (OMs). An independent patient-level re-adjudication of mortality, non-fatal myocardial infarction, and non-fatal stroke began on January 2011 and ran through March 2012. The results are presented in the re-adjudicated OMs.', 'preAssignmentDetails': 'The RECORD observational follow-up (OFU) started at the end of the RECORD study and ran through December 2012. OFU was designed to collect cancer and bone fracture data. Participants were not provided with study medication in the OFU. Data are presented for the entire study (RECORD + OBF) and for OFU alone in the observational OMs.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1117', 'groupId': 'BG000'}, {'value': '1105', 'groupId': 'BG001'}, {'value': '1103', 'groupId': 'BG002'}, {'value': '1122', 'groupId': 'BG003'}, {'value': '4447', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'RSG in Addition to Background MET', 'description': 'Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'BG001', 'title': 'SU in Addition to Background MET', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'BG002', 'title': 'RSG in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'BG003', 'title': 'MET in Addition to Background SU', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.0', 'spread': '8.02', 'groupId': 'BG000'}, {'value': '57.2', 'spread': '8.14', 'groupId': 'BG001'}, {'value': '59.8', 'spread': '8.26', 'groupId': 'BG002'}, {'value': '59.7', 'spread': '8.23', 'groupId': 'BG003'}, {'value': '58.4', 'spread': '8.27', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '516', 'groupId': 'BG000'}, {'value': '521', 'groupId': 'BG001'}, {'value': '562', 'groupId': 'BG002'}, {'value': '554', 'groupId': 'BG003'}, {'value': '2153', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '601', 'groupId': 'BG000'}, {'value': '584', 'groupId': 'BG001'}, {'value': '541', 'groupId': 'BG002'}, {'value': '568', 'groupId': 'BG003'}, {'value': '2294', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '1105', 'groupId': 'BG000'}, {'value': '1087', 'groupId': 'BG001'}, {'value': '1095', 'groupId': 'BG002'}, {'value': '1112', 'groupId': 'BG003'}, {'value': '4399', 'groupId': 'BG004'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}]}, {'title': 'Oriental', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}]}, {'title': 'Aboriginal', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'African', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}, {'title': 'Egyptian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Gipsy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Indian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Maori', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Middle East Hible', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Polynesian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Sri Lankan', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'Tahitian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4447}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-21', 'studyFirstSubmitDate': '2006-09-21', 'resultsFirstSubmitDate': '2009-08-24', 'studyFirstSubmitQcDate': '2006-09-21', 'lastUpdatePostDateStruct': {'date': '2017-03-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-10-07', 'studyFirstPostDateStruct': {'date': '2006-09-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Cardiovascular Death/Cardiovascular Hospitalisation Events', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)', 'description': 'The number of participants with cardiovascular death events (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation events (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) was recorded.'}, {'measure': 'Independent Re-adjudication Outcome: Number of Participants Who Died Due to Any Cause', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)', 'description': 'All deaths identified during the original record study and discovered after the re-adjudication efforts began were included.'}, {'measure': 'Independent Re-adjudication (IR) Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Original RECORD Endpoint Definitions', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)', 'description': 'IR was based on original RECORD endpoint definitions. CV death= no unequivocal non-CV cause (sudden death, death from acute vascular events, heart failure, acute MI, other CV causes, and deaths adjudicated as unknown cause). MI event=hospitalization + elevation of specific cardiac biomarkers above the upper limit of normal + cardiac ischemia symptoms/new pathological electrocardiogram findings. Stroke event=hospitalization + rapidly developed clinical signs of focal/global disturbance of cerebral function for more than 24 hours, with no apparent cause other than a vascular origin.'}, {'measure': 'Independent Re-adjudication Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Contemporary Endpoint Definitions', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)', 'description': 'Independent re-adjudication was based on the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions. CV death included death resulting from an acute MI; sudden cardiac death and death due to heart failure, stroke, and to other CV causes. Deaths of unknown cause were counted as CV deaths. MI was defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Stroke was defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury.'}, {'measure': 'Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Original RECORD Endpoint Definitions', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)', 'description': 'The number of participants with a CV death (or unknown) as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. CV death was defined as any death for which an unequivocal non-CV cause could not be established. CV death included death following heart failure, death following acute myocardial infarction (MI), sudden death, death due to acute vascular events, and other CV causes. Deaths due to unknown causes were classified as "unknown deaths," but were counted as CV deaths for the analysis of this endpoint.'}, {'measure': 'Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Contemporary Endpoint Definitions', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)', 'description': 'The number of participants with a CV (or unknown) death as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. CV death included death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, and death due to other CV causes. Deaths of unknown cause were counted as CV deaths.'}, {'measure': 'Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)', 'description': 'The number of participants with an MI (fatal or non-fatal) event as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. An event of MI was defined as hospitalization plus elevation of cardiac biomarkers troponin (TN) I and/or TNT above the upper limit of normal (ULN) or creatinine kinase (CK) MB (M=muscle type; B=brain type) isoenzyme \\>= 2x the ULN or CK \\> 2x the ULN plus typical symptoms of cardiac ischemia or new pathological electrocardiogram findings, or cause of death adjudicated as MI.'}, {'measure': 'Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)', 'description': 'The number of participants with an MI (fatal or non-fatal) event as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. An event of MI was defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.'}, {'measure': 'Independent Re-adjudication Outcome: Number of Participants (Par.) With an Event of Stroke (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)', 'description': 'Par. with a stroke (fatal or non-fatal) event as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. A stroke event=hospitalization plus rapidly developed clinical signs of focal (or global) disturbance of cerebral function lasting more than 24 hours (unless interrupted by thrombolysis, surgery, or death), with no apparent cause other than a vascular origin, including par. presenting clinical signs/symptoms suggestive of subarachnoid haemorrhage/intracerebral haemorrhage/cerebral ischemic necrosis or cause of death adjudicated as stroke.'}, {'measure': 'Independent Re-adjudication Outcome: Number of Participants With an Event of Stroke (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)', 'description': 'The number of participants with a stroke (fatal or non-fatal) event as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. An event of stroke was defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Cardiovascular Events and All-cause Deaths', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)', 'description': 'Composites of participants with first cardiovascular (CV) hospitalisations and CV death or all-cause death and individual first events of acute myocardial infarction (MI) , stroke, congestive heart failure (CHF), CV death, and all-cause death.'}, {'measure': 'Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)', 'description': 'The total number of events for individual components of cardiovascular (CV) hospitalisations and cardiovascular deaths were recorded. MI, myocardial infarction.'}, {'measure': 'Number of Participants With First Cardiovascular Hospitalisations/Cardiovascular Deaths by Stratum', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)', 'description': 'Participants with first cardiovascular death (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) were recorded by study stratum.'}, {'measure': 'Number of Participants With CV/Microvascular Events', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)', 'description': 'The number of participants with first cardiovascular or microvascular events (renal, foot, eye) were recorded.'}, {'measure': 'Number of Participants With Glycaemic Failure Events', 'timeFrame': 'Baseline through to end of randomised dual therapy', 'description': 'Failure of glycaemic control was defined as two consecutive HbA1c values of ≥8.5 percent, or HbA1c ≥8.5percent at a single visit, after which the subject was either moved to the post-randomised treatment phase or triple therapy was started.'}, {'measure': 'Number of Participants With Addition of Third Oral Agent/Switch to Insulin', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)', 'description': 'The number of participants with addition of a third oral agent or switch to insulin from randomised dual combination treatment were recorded.'}, {'measure': 'The Number of Participants Starting Insulin at Any Time During the Study', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)', 'description': 'The number of participants starting insulin at any time during the study was recorded.'}, {'measure': 'Model Adjusted Change From Baseline in HbA1c at Month 60', 'timeFrame': 'Baseline and Month 60 of randomised dual therapy treatment period', 'description': 'Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in HbA1c was calculated as the value at Month 60 minus the Baseline value.'}, {'measure': 'Model Adjusted Change From Baseline in Fasting Plasma Glucose at Month 60', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment period', 'description': 'Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in fasting plasma glucose was calculated as the value at Month 60 minus the Baseline value.'}, {'measure': 'Model Adjusted Mean Change From Baseline in Insulin and Pro-insulin at Month 60', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment period', 'description': 'Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in insulin and pro-insulin was calculated as the value at Month 60 minus the Baseline value.'}, {'measure': 'Number of HbA1c and Fasting Plasma Glucose (FPG) Responders at Month 60', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment period', 'description': 'Number of responders, i.e., participants meeting glycaemic targets (HbA1c less than or equal to 7 percent, FPG less than or equal to 7 mmol/L)'}, {'measure': 'Model Adjusted Ratio to Baseline (Expressed as a Percentage) Homeostasis Model Assessment (HOMA) Beta Cell Function and Insulin Sensitivity at Month 60', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment phase', 'description': 'The model adjusted (adjusted for any imbalances in the baseline \\[BL\\] values between within stratum treatment groups) ratio to BL in HOMA beta-cell function and insulin sensitivity was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100\\*\\[GM\\^-1\\]).'}, {'measure': 'Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC), Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Triglycerides, and Free Fatty Acids (FFAs) at Month 60', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment phase', 'description': 'The model adjusted (adjusted for any imbalances in the baseline \\[BL\\] values between within stratum treatment groups) ratio to BL in TC, LDL cholesterol, HDL cholesterol, triglycerides, and FFAs was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100\\*\\[GM\\^-1\\]).'}, {'measure': 'Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC):High-density Lipoprotein (HDL) Cholesterol and Low-density Lipoprotein (LDL) Cholesterol:HDL Cholesterol Ratios at Month 60', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment period', 'description': 'The model adjusted (adjusted for any imbalances in the baseline \\[BL\\] values between within stratum treatment groups) ratio to BL in TC:HDL cholesterol and LDL cholesterol:HDL cholesterol was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100\\*\\[GM\\^-1\\]).'}, {'measure': 'Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Apolipoprotein B (Apo-B) at Month 60', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment period', 'description': 'The model adjusted (adjusted for any imbalances in the baseline \\[BL\\] values between within stratum treatment groups) ratio to BL in Apo-B was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100\\*\\[GM\\^-1\\]).'}, {'measure': 'Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Urinary Albumin Creatinine Ratio at Month 60', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment phase', 'description': 'The model adjusted (adjusted for any imbalances in the baseline \\[BL\\] values between within stratum treatment groups) ratio to BL in urinary albumin creatinine ratio was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100\\*\\[GM\\^-1\\]).'}, {'measure': 'Model Adjusted Change From Baseline in Body Weight at Month 60', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment phase', 'description': 'Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in body weight was calculated as the value at Month 60 minus the Baseline value.'}, {'measure': 'Model Adjusted Change From Baseline in Alanine Aminotransferase at Month 60', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment phase', 'description': 'Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in alanine aminotransferase was calculated as the value at Month 60 minus the Baseline value.'}, {'measure': 'Model Adjusted Change From Baseline in Waist Circumference at Month 60', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment phase', 'description': 'Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in waist circumference was calculated as the value at Month 60 minus the Baseline value.'}, {'measure': 'Model Adjusted Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Month 60', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment phase', 'description': 'Model adjusted (adjusted for any imbalances in the baseline values between within treatment groups) change from baseline in SBP and DBP was calculated as the value at Month 60 minus the Baseline value.'}, {'measure': 'Model Adjusted Ratio to Baseline (Expressed as a Percentage) for C-Reactive Protein at Month 60', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment phase', 'description': 'The model adjusted (adjusted for any imbalances in the baseline \\[BL\\] values between within stratum treatment groups) ratio to BL in C-Reactive Protein was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100\\*\\[GM\\^-1\\]).'}, {'measure': 'Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Fibrinogen at Month 60', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment phase', 'description': 'The model adjusted (adjusted for any imbalances in the baseline \\[BL\\] values between within stratum treatment groups) ratio to BL in fibrinogen was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100\\*\\[GM\\^-1\\]).'}, {'measure': 'Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Plasminogen Activator Inhibitor-1 (PAI-1) Antigen at Month 60', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment phase', 'description': 'The model adjusted (adjusted for any imbalances in the baseline \\[BL\\] values between within stratum treatment groups) ratio to BL in plasminogen activator inhibitor-1 (PAI-1) antigen was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100\\*\\[GM\\^-1\\]).'}, {'measure': 'Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Main Study + Observational Follow-up Combined', 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)', 'description': "The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE."}, {'measure': 'Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Observational Follow-up', 'timeFrame': 'From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)', 'description': "The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE."}, {'measure': 'Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined', 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)', 'description': 'The observational follow-up (OFU) was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. The neoplasms/cancer events of bladder, breast, colon, liver, pancreatic, prostate cancer, and melanoma were pre-specified as cancers of interest for the OFU. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.'}, {'measure': 'Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up', 'timeFrame': 'From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)', 'description': 'The observational follow-up (OFU) was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. The neoplasms/cancer events of bladder, breast, colon, liver, pancreatic, prostate cancer, and melanoma were pre-specified as cancers of interest for the OFU. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.'}, {'measure': 'Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined', 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)', 'description': "The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE."}, {'measure': 'Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up', 'timeFrame': 'From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)', 'description': "The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE."}, {'measure': 'Number of Participants With a Bone Fracture Event - Overall and by Gender: Main Study and Observational Follow-up Combined', 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)', 'description': "The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant."}, {'measure': 'Number of Participants With a Bone Fracture Event - Overall and by Gender: Observational Follow-up', 'timeFrame': 'From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)', 'description': "The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant."}, {'measure': 'Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Main Study + Observational Follow-up Combined', 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)', 'description': 'The OFU was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.'}, {'measure': 'Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Observational Follow-up', 'timeFrame': 'From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)', 'description': 'The OFU was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.'}, {'measure': 'Number of Participants With an Event of Death Due to a Bone Fracture-related Event: Main Study + Observational Follow-up Combined', 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)', 'description': "The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant."}, {'measure': 'Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined', 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)', 'description': "The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date that had the same Higher Level Group Term (HLGT) for fracture location, per participant."}, {'measure': 'Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up', 'timeFrame': 'From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)', 'description': "The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date that had the same Higher Level Group Term (HLGT) for fracture location, per participant."}, {'measure': 'Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined', 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)', 'description': "The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The following bone fractures were grouped and were identified as potentially high morbidity bone fractures: hip, pelvis, upper leg, vertebral (lumbar spine, thoracic spine, cervical spine, spine - site unknown)."}, {'measure': 'Number of Participants With Potentially High Morbidity Fracture Events and Non-high Morbidity Fracture Events, in Participants With Prior Hand/Upper Arm/Foot Fractures (H/UA/FF): Main Study + Observational Follow-up Combined', 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)', 'description': "The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The following bone fractures were grouped and were identified as potentially high morbidity bone fractures: hip, pelvis, upper leg, vertebral (lumbar spine, thoracic spine, cervical spine, spine - site unknown)."}, {'measure': 'Number of Participants With Bone Fracture Events of the Indicated Cause: Main Study + Observational Follow-up Combined', 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)', 'description': "The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant."}, {'measure': 'Number of Participants With Bone Fracture Events of the Indicated Cause: Observational Follow-up', 'timeFrame': 'From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)', 'description': 'The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator\'s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included "Unknown" as a category. Fracture events with missing outcome data were reported as "Data unavailable."'}, {'measure': 'Number of Bone Fracture Events With the Indicated Outcome: Main Study + Observational Follow-up Combined', 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)', 'description': 'The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator\'s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included "Unknown" as a category. Fracture events with missing outcome data were reported as "Data unavailable."'}, {'measure': 'Number of Bone Fracture Events With the Indicated Outcome: Observational Follow-up', 'timeFrame': 'From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)', 'description': 'The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator\'s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included "Unknown" as a category. Fracture events with missing outcome data were reported as "Data unavailable."'}, {'measure': 'Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up', 'timeFrame': 'From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)', 'description': "The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diabetes', 'CV outcomes', 'rosiglitazone', 'Type II diabetes', 'sulfonylurea', 'RECORD', 'metformin'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'availIpds': [{'id': 'BRL-049653/231', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'BRL-049653/231', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'BRL-049653/231', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'BRL-049653/231', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'BRL-049653/231', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'BRL-049653/231', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'BRL-049653/231', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '17517066', 'type': 'BACKGROUND', 'citation': 'Home PD, Jones NP, Pocock SJ, Beck-Nielsen H, Gomis R, Hanefeld M, Komajda M, Curtis P; RECORD Study Group. Rosiglitazone RECORD study: glucose control outcomes at 18 months. Diabet Med. 2007 Jun;24(6):626-34. doi: 10.1111/j.1464-5491.2007.02160.x.'}, {'pmid': '16025252', 'type': 'BACKGROUND', 'citation': 'Home PD, Pocock SJ, Beck-Nielsen H, Gomis R, Hanefeld M, Dargie H, Komajda M, Gubb J, Biswas N, Jones NP. Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes (RECORD): study design and protocol. Diabetologia. 2005 Sep;48(9):1726-35. doi: 10.1007/s00125-005-1869-1. Epub 2005 Jul 16.'}, {'pmid': '17551159', 'type': 'BACKGROUND', 'citation': 'Home PD, Pocock SJ, Beck-Nielsen H, Gomis R, Hanefeld M, Jones NP, Komajda M, McMurray JJ; RECORD Study Group. Rosiglitazone evaluated for cardiovascular outcomes--an interim analysis. N Engl J Med. 2007 Jul 5;357(1):28-38. doi: 10.1056/NEJMoa073394. Epub 2007 Jun 5.'}, {'pmid': '19501900', 'type': 'BACKGROUND', 'citation': 'Home PD, Pocock SJ, Beck-Nielsen H, Curtis PS, Gomis R, Hanefeld M, Jones NP, Komajda M, McMurray JJ; RECORD Study Team. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. Lancet. 2009 Jun 20;373(9681):2125-35. doi: 10.1016/S0140-6736(09)60953-3. Epub 2009 Jun 6.'}, {'pmid': '18435852', 'type': 'BACKGROUND', 'citation': 'Komajda M, Curtis P, Hanefeld M, Beck-Nielsen H, Pocock SJ, Zambanini A, Jones NP, Gomis R, Home PD; RECORD Study Group. Effect of the addition of rosiglitazone to metformin or sulfonylureas versus metformin/sulfonylurea combination therapy on ambulatory blood pressure in people with type 2 diabetes: a randomized controlled trial (the RECORD study). Cardiovasc Diabetol. 2008 Apr 24;7:10. doi: 10.1186/1475-2840-7-10.'}, {'pmid': '25524432', 'type': 'DERIVED', 'citation': 'Jones NP, Curtis PS, Home PD. Cancer and bone fractures in observational follow-up of the RECORD study. Acta Diabetol. 2015 Jun;52(3):539-46. doi: 10.1007/s00592-014-0691-y. Epub 2014 Dec 19.'}, {'pmid': '21562320', 'type': 'DERIVED', 'citation': 'MacDonald MR, Petrie MC, Home PD, Komajda M, Jones NP, Beck-Nielsen H, Gomis R, Hanefeld M, Pocock SJ, Curtis PS, McMurray JJ. Incidence and prevalence of unrecognized myocardial infarction in people with diabetes: a substudy of the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) study. Diabetes Care. 2011 Jun;34(6):1394-6. doi: 10.2337/dc10-2398. Epub 2011 May 11.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'This study is a phase 3b, multicentre, randomised, open label, parallel group study. A 4-week run-in period will be followed by a median of 6 years of treatment with study medication in addition to continuation of background glucose lowering therapy. Patients inadequately controlled on background metformin will be randomised to receive, in addition to metformin, either rosiglitazone or a sulfonylurea(glibenclamide, gliclazide or glimepiride) in a ratio of 1:1. Patients inadequately controlled on background SU will be randomised to receive, in addition to SU, either rosiglitazone or metformin in a ratio of 1:1. Equal numbers of patients receiving background metformin and SU at entry will be entered into the study.', 'detailedDescription': 'A RECORD follow-up study is being performed to monitor the incidence of cancer and bone fractures in RECORD patients for a period of 4 years after the end of the main RECORD study (2008 - 2012).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with type II diabetes mellitus as defined by 1999 World Health Organisation criteria.\n* Glycated haemoglobin (HbA1c) \\>7.0 % to = 9.0 % at visit 1.\n* Use of an oral glucose lowering agent for a minimum of 6 months prior to screening and unchanged for 2 months prior to screening.\n* Body mass index \\>25.0 kg/m2.\n\nExclusion Criteria:\n\n* Patients receiving any other glucose lowering therapy which is not metformin or a sulfonylurea.\n* Patients with systolic blood pressure \\>180 mmHg or diastolic blood pressure \\>105 mmHg.\n* Patients who have required the use of insulin for glycaemic control at any time in the past.\n* Hospitalisation for any major cardiovascular event in the last 3 months.'}, 'identificationModule': {'nctId': 'NCT00379769', 'acronym': 'RECORD', 'briefTitle': 'RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Long Term, Open Label, Randomised Study in Patients With Type 2 Diabetes, Comparing the Combination of Rosiglitazone and Either Metformin or Sulfonylurea With Metformin Plus Sulfonylurea on Cardiovascular Endpoints and Glycaemia', 'orgStudyIdInfo': {'id': 'BRL-049653/231'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rosiglitazone in addition to background metformin', 'description': 'Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.', 'interventionNames': ['Drug: Rosiglitazone', 'Drug: Metformin']}, {'type': 'EXPERIMENTAL', 'label': 'rosiglitazone in addition to background sulfonylurea', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.', 'interventionNames': ['Drug: Rosiglitazone', 'Drug: Sulfonylurea']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sulfonylurea in addition to background metformin', 'description': 'Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or miconizied equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.', 'interventionNames': ['Drug: Sulfonylurea', 'Drug: Metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin in addition to background sulfonylurea', 'description': 'Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.', 'interventionNames': ['Drug: Sulfonylurea', 'Drug: Metformin']}], 'interventions': [{'name': 'Rosiglitazone', 'type': 'DRUG', 'description': 'Rosiglitazone maximum 8 mg per day', 'armGroupLabels': ['rosiglitazone in addition to background metformin', 'rosiglitazone in addition to background sulfonylurea']}, {'name': 'Sulfonylurea', 'type': 'DRUG', 'description': 'Sulfonylurea (SU) maximum permitted daily dose', 'armGroupLabels': ['Metformin in addition to background sulfonylurea', 'Sulfonylurea in addition to background metformin', 'rosiglitazone in addition to background sulfonylurea']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'Metformin maximum permitted daily dose .', 'armGroupLabels': ['Metformin in addition to background sulfonylurea', 'Sulfonylurea in addition to background metformin', 'rosiglitazone in addition to background metformin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2228', 'city': 'Miranda', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -34.03857, 'lon': 151.10005}}, {'zip': '2031', 'city': 'Randwick', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'zip': '2500', 'city': 'Wollongong', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -34.424, 'lon': 150.89345}}, {'zip': '4152', 'city': 'Carina Heights', 'state': 'Queensland', 'country': 'Australia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -27.50721, 'lon': 153.09126}}, {'zip': '4021', 'city': 'Kippa-Ring', 'state': 'Queensland', 'country': 'Australia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -27.22586, 'lon': 153.0835}}, {'zip': '4075', 'city': 'Sherwood', 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