Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT00968812
Status:
COMPLETED
Last Update Posted:
2017-01-30
First Post:
2009-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'Portugal', 'South Africa']}, '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': 'C057619', 'term': 'glimepiride'}, {'id': 'D013453', 'term': 'Sulfonylurea Compounds'}, {'id': 'D000068896', 'term': 'Canagliflozin'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-800-526-7736', 'title': 'Vice President, Franchise Medical Leader, Cardiovascular & Metabolism Franchise', 'organization': 'Janssen Research & Development, LLC'}, 'certainAgreement': {'otherDetails': 'A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'No notable study limitations were identified by the Sponsor.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected for the duration of the study (104 weeks).', 'description': 'The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.\n\nMEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.', 'eventGroups': [{'id': 'EG000', 'title': 'Canagliflozin 100 mg: Baseline to Week 52', 'description': 'Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 52.', 'otherNumAtRisk': 483, 'otherNumAffected': 138, 'seriousNumAtRisk': 483, 'seriousNumAffected': 24}, {'id': 'EG001', 'title': 'Canagliflozin 300 mg: Baseline to Week 52', 'description': 'Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 52.', 'otherNumAtRisk': 485, 'otherNumAffected': 150, 'seriousNumAtRisk': 485, 'seriousNumAffected': 26}, {'id': 'EG002', 'title': 'Glimepiride: Baseline to Week 52', 'description': 'Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 52.', 'otherNumAtRisk': 482, 'otherNumAffected': 175, 'seriousNumAtRisk': 482, 'seriousNumAffected': 39}, {'id': 'EG003', 'title': 'Canagliflozin 100 mg: Baseline to Week 104', 'description': 'Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 104.', 'otherNumAtRisk': 483, 'otherNumAffected': 198, 'seriousNumAtRisk': 483, 'seriousNumAffected': 47}, {'id': 'EG004', 'title': 'Canagliflozin 300 mg: Baseline to Week 104', 'description': 'Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 104.', 'otherNumAtRisk': 485, 'otherNumAffected': 204, 'seriousNumAtRisk': 485, 'seriousNumAffected': 47}, {'id': 'EG005', 'title': 'Glimepiride: Baseline to Week 104', 'description': 'Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 104.', 'otherNumAtRisk': 482, 'otherNumAffected': 242, 'seriousNumAtRisk': 482, 'seriousNumAffected': 69}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 29}, {'groupId': 'EG003', 'numAtRisk': 482, 'numAffected': 25}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 39}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 27}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 37}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 47}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 55}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 51}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 41}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 36}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 38}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 56}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 44}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 33}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 61}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 86}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 34}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 28}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 26}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 21}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 29}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 33}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 30}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 25}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 23}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 26}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 24}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Diabetic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Ventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Angle closure glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Duodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Small intestinal perforation', 'notes': 'This event was re-coded as "Small bowel perforation"; it was subsequently re-mapped to the "Surgical and medical procedures".', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Hepatic cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Endometritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Localised infection', 'notes': 'In the Week 52 study report, this event was coded as "infection"; it was subsequently re-coded in the Week 104 study report as "localised infection".', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Eye injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Incisional hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Meniscus lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Muscle injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Muscle rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Skull fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Endometrial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Renal cancer stage I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Squamous cell carcinoma of the cervix', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Carotid arterial embolus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Hemiplegic migraine', 'notes': 'In the Week 52 study report, this event was coded as "Hemiplegic migraine"; it was subsequently re-coded in the Week 104 study report as "Hemiparesis".', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Vertebrobasilar insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 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'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Dysfunctional uterine bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 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'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Intermittent claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Arnold-Chiari malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Philmosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 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0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Complex regional pain syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Hemiparesis', 'notes': 'In the Week 52 study report, this event was coded as "Hemiplegic migraine"; it was subsequently re-coded in the Week 104 study report as "Hemiparesis".', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Anxiety', 'notes': 'In the Week 52 study report, this event was coded as "stress"; it was subsequently re-coded in the Week 104 study report as "anxiety".', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Urethral stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Prostatomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Familial risk factor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Infection', 'notes': 'In the Week 52 study report, this event was coded as "infection"; it was subsequently re-coded in the Week 104 study report as "localised infection".', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}, {'term': 'Small bowel perforation', 'notes': 'In Week 52 study report this event was coded as "small intestinal perforation" and was mapped under "Gastrointestinal disorders ".', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 485, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 483, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 485, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1 / 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in HbA1c From Baseline to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'OG000'}, {'value': '474', 'groupId': 'OG001'}, {'value': '473', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Canagliflozin 100 mg', 'description': 'Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.'}, {'id': 'OG001', 'title': 'Canagliflozin 300 mg', 'description': 'Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.'}, {'id': 'OG002', 'title': 'Glimepiride', 'description': 'Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.039', 'groupId': 'OG000'}, {'value': '-0.93', 'spread': '0.039', 'groupId': 'OG001'}, {'value': '-0.81', 'spread': '0.039', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.109', 'ciUpperLimit': '0.085', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.050', 'groupDescription': 'If the hypothesis of non-inferiority of canagliflozin to glimepiride at Week 52 was demonstrated (ie, upper bound of the 95% Confidence Interval of the treatment difference \\[canagliflozin minus glimepiride\\] was less than 0.3) and the upper bound was less than 0.0, the superiority of the canagliflozin dose relative to glimepiride would be concluded.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Power calculation: assuming a difference between canagliflozin and glimepiride of 0.0% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.0125, and assuming a drop-out rate of 35% in 52 weeks, it was estimated that approximately 427 patients per group would provide 90% power to demonstrate non-inferiority with the non-inferiority margin of 0.3, comparing canagliflozin with glimepiride.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.217', 'ciUpperLimit': '-0.023', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.050', 'groupDescription': 'If the hypothesis of non-inferiority of canagliflozin to glimepiride at Week 52 was demonstrated (ie, upper bound of the 95% Confidence Interval of the treatment difference \\[canagliflozin minus glimepiride\\] was less than 0.3) and the upper bound was less than 0.0, the superiority of the canagliflozin dose relative to glimepiride would be concluded.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Power calculation: assuming a difference between canagliflozin and glimepiride of 0.0% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.0125, and assuming a drop-out rate of 35% in 52 weeks, it was estimated that approximately 427 patients per group would provide 90% power to demonstrate non-inferiority with the non-inferiority margin of 0.3, comparing canagliflozin with glimepiride'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (Baseline) and Week 52', 'description': 'The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change.', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Experiencing at Least 1 Hypoglycemic Event From Baseline to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '483', 'groupId': 'OG000'}, {'value': '485', 'groupId': 'OG001'}, {'value': '482', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Canagliflozin 100 mg', 'description': 'Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.'}, {'id': 'OG001', 'title': 'Canagliflozin 300 mg', 'description': 'Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.'}, {'id': 'OG002', 'title': 'Glimepiride', 'description': 'Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000'}, {'value': '4.9', 'groupId': 'OG001'}, {'value': '34.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '0.06', 'ciUpperLimit': '0.16', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '0.05', 'ciUpperLimit': '0.14', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Baseline) and Week 52', 'description': 'The table below shows the percentage of patients who experienced at least 1 documented hypoglycemic event from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in percentages.', 'unitOfMeasure': 'Percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Body Weight From Baseline to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '479', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}, {'value': '478', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Canagliflozin 100 mg', 'description': 'Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.'}, {'id': 'OG001', 'title': 'Canagliflozin 300 mg', 'description': 'Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.'}, {'id': 'OG002', 'title': 'Glimepiride', 'description': 'Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.2', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '-4.7', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '0.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.2', 'ciLowerLimit': '-5.7', 'ciUpperLimit': '-4.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.7', 'ciLowerLimit': '-6.2', 'ciUpperLimit': '-5.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (Baseline) and Week 52', 'description': 'The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean percent change.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.'}, {'type': 'SECONDARY', 'title': 'Change in HbA1c From Baseline to Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'OG000'}, {'value': '474', 'groupId': 'OG001'}, {'value': '474', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Canagliflozin 100 mg', 'description': 'Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.'}, {'id': 'OG001', 'title': 'Canagliflozin 300 mg', 'description': 'Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.'}, {'id': 'OG002', 'title': 'Glimepiride', 'description': 'Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.65', 'spread': '0.042', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '0.22'}, {'value': '-0.74', 'spread': '0.042', 'groupId': 'OG001', 'lowerLimit': '0.10', 'upperLimit': '0.21'}, {'value': '-0.55', 'spread': '0.043', 'groupId': 'OG002', 'lowerLimit': '0.31', 'upperLimit': '0.43'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.200', 'ciUpperLimit': '0.010', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.054', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-0.289', 'ciUpperLimit': '-0.078', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.054', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 104', 'description': 'The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 104 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change.', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Canagliflozin 100 mg: Baseline to Week 104', 'description': 'Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.'}, {'id': 'FG001', 'title': 'Canagliflozin 300 mg: Baseline to Week 104', 'description': 'Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.'}, {'id': 'FG002', 'title': 'Glimepiride: Baseline to Week 104', 'description': 'Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '483'}, {'groupId': 'FG001', 'numSubjects': '485'}, {'groupId': 'FG002', 'numSubjects': '482'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '343'}, {'groupId': 'FG001', 'numSubjects': '323'}, {'groupId': 'FG002', 'numSubjects': '314'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '140'}, {'groupId': 'FG001', 'numSubjects': '162'}, {'groupId': 'FG002', 'numSubjects': '168'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '33'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '25'}]}, {'type': 'Creatinine or eGFR withdrawal criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Noncompliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Unable to take rescue therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '40'}]}]}], 'recruitmentDetails': 'This study evaluated the efficacy and safety of canagliflozin (JNJ-28431754) compared with glimepiride in participants with type 2 diabetes mellitus with inadequate glycemic control despite metformin treatment. The study was conducted between 28 August 2009 and 25 January 2013 and included 157 study centers in 19 countries worldwide.', 'preAssignmentDetails': '1,452 participants were randomly allocated to the 3 treatment arms. 1450 participants received at least 1 dose of study drug and were included in the modified intent-to-treat (mITT) analysis set and safety analysis set. Participant flow is presented for Baseline to Week 104.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '483', 'groupId': 'BG000'}, {'value': '485', 'groupId': 'BG001'}, {'value': '482', 'groupId': 'BG002'}, {'value': '1450', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Canagliflozin 100 mg', 'description': 'Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.'}, {'id': 'BG001', 'title': 'Canagliflozin 300 mg', 'description': 'Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.'}, {'id': 'BG002', 'title': 'Glimepiride', 'description': 'Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '397', 'groupId': 'BG000'}, {'value': '411', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}, {'value': '1207', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '243', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.4', 'spread': '9.49', 'groupId': 'BG000'}, {'value': '55.8', 'spread': '9.17', 'groupId': 'BG001'}, {'value': '56.3', 'spread': '9.01', 'groupId': 'BG002'}, {'value': '56.2', 'spread': '9.22', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '231', 'groupId': 'BG000'}, {'value': '244', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}, {'value': '694', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '252', 'groupId': 'BG000'}, {'value': '241', 'groupId': 'BG001'}, {'value': '263', 'groupId': 'BG002'}, {'value': '756', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region Enroll', 'classes': [{'title': 'ARGENTINA', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}]}, {'title': 'BULGARIA', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}, {'title': 'CANADA', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}]}]}, {'title': 'COSTA RICA', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}]}, {'title': 'DENMARK', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}]}]}, {'title': 'FINLAND', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}]}, {'title': 'GERMANY', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}, {'title': 'INDIA', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}]}]}, {'title': 'ISRAEL', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}]}, {'title': 'MEXICO', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}]}]}, {'title': 'NORWAY', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}]}, {'title': 'PHILIPPINES', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}]}, {'title': 'POLAND', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}]}, {'title': 'ROMANIA', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '130', 'groupId': 'BG003'}]}]}, {'title': 'RUSSIAN FEDERATION', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}]}]}, {'title': 'SLOVAKIA', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}]}, {'title': 'SOUTH KOREA', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}]}]}, {'title': 'UKRAINE', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}]}]}, {'title': 'UNITED STATES', 'categories': [{'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '350', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1452}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'dispFirstSubmitDate': '2012-06-27', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-01', 'studyFirstSubmitDate': '2009-08-28', 'dispFirstSubmitQcDate': '2012-06-27', 'resultsFirstSubmitDate': '2013-04-17', 'studyFirstSubmitQcDate': '2009-08-28', 'dispFirstPostDateStruct': {'date': '2012-07-02', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-04-17', 'studyFirstPostDateStruct': {'date': '2009-08-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c From Baseline to Week 52', 'timeFrame': 'Day 1 (Baseline) and Week 52', 'description': 'The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients Experiencing at Least 1 Hypoglycemic Event From Baseline to Week 52', 'timeFrame': 'Day 1 (Baseline) and Week 52', 'description': 'The table below shows the percentage of patients who experienced at least 1 documented hypoglycemic event from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in percentages.'}, {'measure': 'Percent Change in Body Weight From Baseline to Week 52', 'timeFrame': 'Day 1 (Baseline) and Week 52', 'description': 'The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean percent change.'}, {'measure': 'Change in HbA1c From Baseline to Week 104', 'timeFrame': 'Baseline, Week 104', 'description': 'The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 104 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes', 'Metformin', 'Glimepiride', 'Hemoglobin A1c', 'Type 2 diabetes mellitus', 'Canagliflozin'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '38770818', 'type': 'DERIVED', 'citation': 'Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.'}, {'pmid': '31001673', 'type': 'DERIVED', 'citation': 'Heerspink HJL, Perco P, Mulder S, Leierer J, Hansen MK, Heinzel A, Mayer G. Canagliflozin reduces inflammation and fibrosis biomarkers: a potential mechanism of action for beneficial effects of SGLT2 inhibitors in diabetic kidney disease. Diabetologia. 2019 Jul;62(7):1154-1166. doi: 10.1007/s00125-019-4859-4. Epub 2019 Apr 17.'}, {'pmid': '29452178', 'type': 'DERIVED', 'citation': 'Garvey WT, Van Gaal L, Leiter LA, Vijapurkar U, List J, Cuddihy R, Ren J, Davies MJ. Effects of canagliflozin versus glimepiride on adipokines and inflammatory biomarkers in type 2 diabetes. Metabolism. 2018 Aug;85:32-37. doi: 10.1016/j.metabol.2018.02.002. Epub 2018 Feb 13.'}, {'pmid': '27977934', 'type': 'DERIVED', 'citation': 'Qiu R, Balis D, Xie J, Davies MJ, Desai M, Meininger G. Longer-term safety and tolerability of canagliflozin in patients with type 2 diabetes: a pooled analysis. Curr Med Res Opin. 2017 Mar;33(3):553-562. doi: 10.1080/03007995.2016.1271780. Epub 2017 Jan 4.'}, {'pmid': '27600862', 'type': 'DERIVED', 'citation': 'John M, Cerdas S, Violante R, Deerochanawong C, Hassanein M, Slee A, Canovatchel W, Hamilton G. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus living in hot climates. Int J Clin Pract. 2016 Sep;70(9):775-85. doi: 10.1111/ijcp.12868.'}, {'pmid': '27495291', 'type': 'DERIVED', 'citation': 'Patel CA, Bailey RA, Vijapurkar U, Meininger G, Blonde L. A post-hoc analysis of the comparative efficacy of canagliflozin and glimepiride in the attainment of type 2 diabetes-related quality measures. BMC Health Serv Res. 2016 Aug 5;16(a):356. doi: 10.1186/s12913-016-1607-z.'}, {'pmid': '27002421', 'type': 'DERIVED', 'citation': 'Blonde L, Stenlof K, Fung A, Xie J, Canovatchel W, Meininger G. Effects of canagliflozin on body weight and body composition in patients with type 2 diabetes over 104 weeks. Postgrad Med. 2016 May;128(4):371-80. doi: 10.1080/00325481.2016.1169894. Epub 2016 Apr 7.'}, {'pmid': '26984361', 'type': 'DERIVED', 'citation': 'Leiter LA, Langslet G, Vijapurkar U, Davies MJ, Canovatchel W. Simultaneous Reduction in Both HbA1c and Body Weight with Canagliflozin Versus Glimepiride in Patients with Type 2 Diabetes on Metformin. Diabetes Ther. 2016 Jun;7(2):269-78. doi: 10.1007/s13300-016-0163-1. Epub 2016 Mar 16.'}, {'pmid': '26580237', 'type': 'DERIVED', 'citation': 'Watts NB, Bilezikian JP, Usiskin K, Edwards R, Desai M, Law G, Meininger G. Effects of Canagliflozin on Fracture Risk in Patients With Type 2 Diabetes Mellitus. J Clin Endocrinol Metab. 2016 Jan;101(1):157-66. doi: 10.1210/jc.2015-3167. Epub 2015 Nov 18.'}, {'pmid': '26579834', 'type': 'DERIVED', 'citation': 'Lavalle-Gonzalez FJ, Eliaschewitz FG, Cerdas S, Chacon Mdel P, Tong C, Alba M. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America. Curr Med Res Opin. 2016;32(3):427-39. doi: 10.1185/03007995.2015.1121865. Epub 2016 Jan 14.'}, {'pmid': '25205142', 'type': 'DERIVED', 'citation': 'Leiter LA, Yoon KH, Arias P, Langslet G, Xie J, Balis DA, Millington D, Vercruysse F, Canovatchel W, Meininger G. Canagliflozin provides durable glycemic improvements and body weight reduction over 104 weeks versus glimepiride in patients with type 2 diabetes on metformin: a randomized, double-blind, phase 3 study. Diabetes Care. 2015 Mar;38(3):355-64. doi: 10.2337/dc13-2762. Epub 2014 Sep 9.'}, {'pmid': '24517339', 'type': 'DERIVED', 'citation': 'Nyirjesy P, Sobel JD, Fung A, Mayer C, Capuano G, Ways K, Usiskin K. Genital mycotic infections with canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. Curr Med Res Opin. 2014 Jun;30(6):1109-19. doi: 10.1185/03007995.2014.890925. Epub 2014 Feb 21.'}, {'pmid': '23850055', 'type': 'DERIVED', 'citation': 'Cefalu WT, Leiter LA, Yoon KH, Arias P, Niskanen L, Xie J, Balis DA, Canovatchel W, Meininger G. Efficacy and safety of canagliflozin versus glimepiride in patients with type 2 diabetes inadequately controlled with metformin (CANTATA-SU): 52 week results from a randomised, double-blind, phase 3 non-inferiority trial. Lancet. 2013 Sep 14;382(9896):941-50. doi: 10.1016/S0140-6736(13)60683-2. Epub 2013 Jul 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the efficacy, safety, and tolerability of canagliflozin (JNJ-28431754) compared with glimepiride in patients with type 2 diabetes mellitus with inadequate control despite treatment with metformin.', 'detailedDescription': 'Type 2 diabetes mellitus (T2DM) is well recognized as a major public health problem that presents patients with a significant risk of complications including heart disease, retinopathy, nephropathy, and neuropathy. Various classes of orally administered antihyperglycemic agents have been developed for the treatment of diabetes and although individual agents may be highly effective for some patients, it is still difficult to maintain optimal glycemic control in most patients, thereby resulting in high rates of morbidity and mortality in the diabetic population. This is a randomized, double-blind, active comparator-controlled, 3-arm, parallel-group, multicenter study to demonstrate the efficacy, safety, and tolerability of canagliflozin compared with a sulfonylurea (glimepiride) in patients with T2DM, 18 to 80 years of age, inclusive, who are not optimally controlled on metformin monotherapy. The primary study hypothesis is that the study drug will be non-inferior to glimepiride as assessed by the change in hemoglobin A1c (HbA1c) from baseline. The patients will receive capsules taken by mouth of canagliflozin (either 100 or 300 mg), or glimepiride with a starting dosage of 1 mg, which will be increased to a maximum dose of 6 or 8 mg once daily for a total duration of 104 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have a diagnosis of type 2 diabetes\n* Body mass index (BMI) \\>=22 to \\<=45 kg/m2, at screening\n* Patients must be taking a stable dosage of metformin as monotherapy at screening\n* Patients must have a HbA1c between \\>=7% and \\<=9.5% at Week 2\n* Patients must have a fasting plasma glucose (FPG) \\<=270 mg/dL (15 mmol/L) at Week -2\n\nExclusion Criteria:\n\n* Patients having prior exposure or known contraindication or suspected hypersensitivity to JNJ-28431754, glimepiride, or metformin\n* History of diabetic ketoacidosis or type 1 diabetes mellitus\n* History of pancreas or beta-cell transplantation\n* History of active proliferative diabetic retinopathy\n* History of hereditary glucose-galactose malabsorption or primary renal glucosuria\n* Renal disease requiring treatment with immunosuppressive therapy within the past 12 months before screening or a history of dialysis or renal transplant\n* Taken thiazolidinedione therapy in the past 16 weeks before screening'}, 'identificationModule': {'nctId': 'NCT00968812', 'briefTitle': 'CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'A Randomized, Double-Blind, 3-Arm Parallel-Group, 2-Year (104-Week), Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-28431754 Compared With Glimepiride in the Treatment of Subjects With Type 2 Diabetes Mellitus Not Optimally Controlled on Metformin Monotherapy', 'orgStudyIdInfo': {'id': 'CR016480'}, 'secondaryIdInfos': [{'id': '28431754DIA3009', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}, {'id': '2009-009320-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Glimepiride', 'description': 'Each patient will receive glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.', 'interventionNames': ['Drug: Glimepiride', 'Drug: Metformin']}, {'type': 'EXPERIMENTAL', 'label': 'Canagliflozin 100 mg', 'description': 'Each patient will receive 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.', 'interventionNames': ['Drug: Canagliflozin (JNJ-28431754)', 'Drug: Metformin']}, {'type': 'EXPERIMENTAL', 'label': 'Canagliflozin 300 mg', 'description': 'Each volunteer will receive 300 mg of canagliflozin (JNJ-28431754) once 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