Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-29 @ 3:24 PM
Study NCT ID:
NCT01011868
Status:
COMPLETED
Last Update Posted:
2014-09-30
First Post:
2009-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of BI 10773 in Combination With Insulin in Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': 'C570240', 'term': 'empagliflozin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'During the course of the study (82 weeks)', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Oral Placebo', 'otherNumAtRisk': 170, 'otherNumAffected': 115, 'seriousNumAtRisk': 170, 'seriousNumAffected': 28}, {'id': 'EG001', 'title': 'Empagliflozin 10 mg', 'description': 'Empagliflozin 10 mg orally once daily', 'otherNumAtRisk': 169, 'otherNumAffected': 110, 'seriousNumAtRisk': 169, 'seriousNumAffected': 28}, {'id': 'EG002', 'title': 'Empagliflozin 25 mg', 'description': 'Empagliflozin 25 mg orally once daily', 'otherNumAtRisk': 155, 'otherNumAffected': 95, 'seriousNumAtRisk': 155, 'seriousNumAffected': 28}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 56}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 55}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}], 'seriousEvents': [{'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Scrotal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Malignant fibrous histiocytoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Mycosis fungoides', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Prostatic adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Squamous cell carcinoma of the cervix', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Carotid artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Haemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Macular fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Femoral arterial stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Vocal cord polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Enterocutaneous fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Oesophageal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Costochondritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Joint contracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Joint instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Nephrotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Neurogenic bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Arnold-Chiari malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Device failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Accident at home', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Accident at work', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Limb crushing injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Skeletal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Carotid endarterectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 18 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Oral Placebo'}, {'id': 'OG001', 'title': 'Empagliflozin 10 mg', 'description': 'Empagliflozin 10 mg orally once daily'}, {'id': 'OG002', 'title': 'Empagliflozin 25 mg', 'description': 'Empagliflozin 25 mg orally once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-0.58', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '-0.75', 'spread': '0.08', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.56', 'ciLowerLimit': '-0.78', 'ciUpperLimit': '-0.33', 'pValueComment': 'Hypotheses were tested at significance level of 0.025, which is half of overall alpha of 0.05, split equally between 2 treatment comparisons. This maintained the overall type-I (alpha) at 5%. There was no a priori assumption on testing order.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'estimateComment': 'The primary analysis consisted of the pair-wise comparisons between each dose of empagliflozin versus placebo using the adjusted means from the model.', 'groupDescription': 'The null and alternative hypotheses to be tested:\n\n* H0,1: No difference in change from baseline to Week 18 in HbA1c between empagliflozin 10 mg and placebo\n* H1,1: A difference in change from baseline to Week 18 in HbA1c between empagliflozin 10 mg and placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA that included treatment group and geographic region as fixed effects along with baseline HbA1c as covariate.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.70', 'ciLowerLimit': '-0.93', 'ciUpperLimit': '-0.47', 'pValueComment': 'Hypotheses were tested at significance level of 0.025, which is half of overall alpha of 0.05, split equally between 2 treatment comparisons. This maintained the overall type-I (alpha) at 5%. There was no a priori assumption on testing order.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'estimateComment': 'The primary analysis consisted of the pair-wise comparisons between each dose of empagliflozin versus placebo using the adjusted means from the model.', 'groupDescription': 'The null and alternative hypotheses to be tested:\n\n* H0,2: No difference in change from baseline to Week 18 in HbA1c between empagliflozin 25 mg and placebo\n* H1,2: A difference in change from baseline to Week 18 in HbA1c between empagliflozin 25 mg and placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA that included treatment group and geographic region as fixed effects along with baseline HbA1c as covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 18 weeks', 'description': 'Change from baseline in Glycosylated haemoglobin A1c (HbA1c) after 18 weeks of treatment', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Error', 'populationDescription': 'FAS18-completers-included FAS patients not prematurely discontinue prior to Week 18, completed required minimum treatment duration, and had an on treatment HbA1c value within Week 18 time window. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF-18) was used for imputation.\n\n(LOCF-18)'}, {'type': 'SECONDARY', 'title': 'Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5%) After 18, 54 and 78 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Oral Placebo'}, {'id': 'OG001', 'title': 'Empagliflozin 10 mg', 'description': 'Empagliflozin 10 mg orally once daily'}, {'id': 'OG002', 'title': 'Empagliflozin 25 mg', 'description': 'Empagliflozin 25 mg orally once daily'}], 'classes': [{'title': '18 weeks', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}]}, {'title': '54 weeks', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}]}, {'title': '78 weeks', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.518', 'ciLowerLimit': '3.262', 'ciUpperLimit': '9.334', 'groupDescription': 'Empagliflozin 10 mg vs Placebo at 18 weeks', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression includes treatment, geographical region and baseline HbA1c.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.883', 'ciLowerLimit': '2.859', 'ciUpperLimit': '8.338', 'groupDescription': 'Empagliflozin 25 mg vs Placebo at 18 weeks', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression includes treatment, geographical region and baseline HbA1c', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.471', 'ciLowerLimit': '2.077', 'ciUpperLimit': '5.802', 'groupDescription': 'Empagliflozin 10 mg vs Placebo at 54 weeks', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression includes treatment, geographical region and baseline HbA1c', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.825', 'ciLowerLimit': '2.268', 'ciUpperLimit': '6.451', 'groupDescription': 'Empagliflozin 25 mg vs Placebo at 54 weeks', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression includes treatment, geographical region and baseline HbA1c', 'testedNonInferiority': False}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.802', 'ciLowerLimit': '1.639', 'ciUpperLimit': '4.789', 'groupDescription': 'Empagliflozin 10 mg vs Placebo at 78 weeks', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression includes treatment, geographical region and baseline HbA1c', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.527', 'ciLowerLimit': '2.051', 'ciUpperLimit': '6.066', 'groupDescription': 'Empagliflozin 25 mg vs Placebo at 78 weeks', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression includes treatment, geographical region and baseline HbA1c', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 18, 54 and 78 weeks', 'description': 'Patients that had a reduction in HbA1c of at least 0.5% from baseline to 18, 54 and 78 weeks of treatment', 'unitOfMeasure': 'participants', 'populationDescription': 'FAS with non-completers considered failure (NCF)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Oral Placebo'}, {'id': 'OG001', 'title': 'Empagliflozin 10 mg', 'description': 'Empagliflozin 10 mg orally once daily'}, {'id': 'OG002', 'title': 'Empagliflozin 25 mg', 'description': 'Empagliflozin 25 mg orally once daily'}], 'classes': [{'title': 'week 18 Change from BL', 'categories': [{'measurements': [{'value': '9.81', 'spread': '5.48', 'groupId': 'OG000'}, {'value': '-14.79', 'spread': '3.93', 'groupId': 'OG001'}, {'value': '-27.03', 'spread': '3.92', 'groupId': 'OG002'}]}]}, {'title': 'week 54 Change from BL (N=103,111,99)', 'categories': [{'measurements': [{'value': '0.91', 'spread': '5.08', 'groupId': 'OG000'}, {'value': '-9.59', 'spread': '4.69', 'groupId': 'OG001'}, {'value': '-23.75', 'spread': '4.62', 'groupId': 'OG002'}]}]}, {'title': 'week 78 Change from BL (N=92,104,92)', 'categories': [{'measurements': [{'value': '-5.53', 'spread': '4.95', 'groupId': 'OG000'}, {'value': '-7.75', 'spread': '4.66', 'groupId': 'OG001'}, {'value': '-21.62', 'spread': '5.13', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-28.40', 'ciLowerLimit': '-37.54', 'ciUpperLimit': '-19.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.65', 'groupDescription': 'Change from BL at week 18 - Empagliflozin 10 mg vs Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-34.21', 'ciLowerLimit': '-43.67', 'ciUpperLimit': '-24.76', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.81', 'groupDescription': 'Change from BL at week 18 - Empagliflozin 25 mg vs Placebo at 18 weeks', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects', 'testedNonInferiority': False}, {'pValue': '0.0328', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.75', 'ciLowerLimit': '-20.62', 'ciUpperLimit': '-0.89', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.02', 'groupDescription': 'Change from BL at week 54 - Empagliflozin 10 mg vs Placebo at 18 weeks', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects', 'testedNonInferiority': False}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.16', 'ciLowerLimit': '-29.31', 'ciUpperLimit': '-9.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.16', 'groupDescription': 'Change from BL at week 54 - Empagliflozin 25 mg vs Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects', 'testedNonInferiority': False}, {'pValue': '0.3216', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.03', 'ciLowerLimit': '-15.01', 'ciUpperLimit': '4.94', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.07', 'groupDescription': 'Change from BL at week 78 - Empagliflozin 10 mg vs Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects', 'testedNonInferiority': False}, {'pValue': '0.0229', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.95', 'ciLowerLimit': '-22.24', 'ciUpperLimit': '-1.67', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.23', 'groupDescription': 'Change from BL at week 78 - Empagliflozin 25 mg vs Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 18, 54 and 78 weeks', 'description': 'Change from baseline in fasting plasma glucose (FPG) after 18, 54 and 78 weeks of treatment', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'populationDescription': 'FAS observed cases (OC)'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Oral Placebo'}, {'id': 'OG001', 'title': 'Empagliflozin 10 mg', 'description': 'Empagliflozin 10 mg orally once daily'}, {'id': 'OG002', 'title': 'Empagliflozin 25 mg', 'description': 'Empagliflozin 25 mg orally once daily'}], 'classes': [{'title': 'week 18 % CHG', 'categories': [{'measurements': [{'value': '19.02', 'spread': '6.32', 'groupId': 'OG000'}, {'value': '-2.80', 'spread': '3.17', 'groupId': 'OG001'}, {'value': '-13.43', 'spread': '2.39', 'groupId': 'OG002'}]}]}, {'title': 'week 54 % CHG (N=103,111,99)', 'categories': [{'measurements': [{'value': '9.67', 'spread': '5.58', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '4.05', 'groupId': 'OG001'}, {'value': '-11.59', 'spread': '3.04', 'groupId': 'OG002'}]}]}, {'title': 'week 78 % CHG (N=92,104,92)', 'categories': [{'measurements': [{'value': '4.75', 'spread': '5.67', 'groupId': 'OG000'}, {'value': '2.43', 'spread': '4.18', 'groupId': 'OG001'}, {'value': '-9.52', 'spread': '3.40', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-25.12', 'ciLowerLimit': '-35.38', 'ciUpperLimit': '-14.86', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.22', 'groupDescription': 'Change from BL at week 18 - Empagliflozin 10 mg vs Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-31.01', 'ciLowerLimit': '-41.62', 'ciUpperLimit': '-20.39', 'groupDescription': 'Change from BL at week 18 - Empagliflozin 25 mg vs Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects', 'testedNonInferiority': False}, {'pValue': '<0.0484', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.20', 'ciLowerLimit': '-20.33', 'ciUpperLimit': '-0.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.15', 'groupDescription': 'Change from BL at week 54 - Empagliflozin 10 mg vs Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects', 'testedNonInferiority': False}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.42', 'ciLowerLimit': '-29.84', 'ciUpperLimit': '-8.99', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.30', 'groupDescription': 'Change from BL at week 54 - Empagliflozin 25 mg vs Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects', 'testedNonInferiority': False}, {'pValue': '0.3517', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciPctValue': '95', 'paramValue': '-4.73', 'ciLowerLimit': '-14.71', 'ciUpperLimit': '5.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.07', 'groupDescription': 'Change from BL at week 78 - Empagliflozin 10 mg vs Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects', 'testedNonInferiority': False}, {'pValue': '0.0185', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.39', 'ciLowerLimit': '-22.69', 'ciUpperLimit': '-2.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.23', 'groupDescription': 'Change from BL at week 78 - Empagliflozin 25 mg vs Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 18, 54 and 78 weeks', 'description': 'Percent change from baseline in fasting plasma glucose (FPG) after 18, 54 and 78 weeks of treatment', 'unitOfMeasure': 'percentage of Change from BL in FPG', 'dispersionType': 'Standard Error', 'populationDescription': 'FAS (OC)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Basal Insulin Dose/Day After 54 and 78 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Oral Placebo'}, {'id': 'OG001', 'title': 'Empagliflozin 10 mg', 'description': 'Empagliflozin 10 mg orally once daily'}, {'id': 'OG002', 'title': 'Empagliflozin 25 mg', 'description': 'Empagliflozin 25 mg orally once daily'}], 'classes': [{'title': 'week 54 (N=112,122,104)', 'categories': [{'measurements': [{'value': '5.39', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '-1.20', 'spread': '1.40', 'groupId': 'OG001'}, {'value': '-1.12', 'spread': '1.27', 'groupId': 'OG002'}]}]}, {'title': 'week 78', 'categories': [{'measurements': [{'value': '4.79', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '-0.70', 'spread': '1.85', 'groupId': 'OG001'}, {'value': '-0.39', 'spread': '1.06', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0213', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.58', 'ciLowerLimit': '-10.32', 'ciUpperLimit': '-0.84', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.40', 'estimateComment': 'Week 54 model includes, baseline basal insulin, baseline HbA1c as linear covariate(s), geographical region, treatment, visit and visit by treatment interaction as fixed effects.', 'groupDescription': 'Empagliflozin versus Placebo 10 mg at 54 weeks', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0237', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.69', 'ciLowerLimit': '-10.62', 'ciUpperLimit': '-0.77', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.49', 'estimateComment': 'Week 54 model includes, baseline basal insulin, baseline HbA1c as linear covariate(s), geographical region, treatment, visit and visit by treatment interaction as fixed effect(s).', 'groupDescription': 'Empagliflozin versus Placebo 25 mg at 54 weeks', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0024', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-6.66', 'ciLowerLimit': '-11.56', 'ciUpperLimit': '-1.77', 'pValueComment': 'Hierarchical testing approach was applied to Empagliflozin 10 mg vs Placebo. If null hypothesis is rejected for the primary endpoint, at 0.025 (2-sided), testing of the key secondary endpoints continued in a hierarchical fashion for the same dose.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.18', 'groupDescription': 'Empagliflozin versus Placebo 10 mg at 78 weeks\n\nH0,1a: No difference in change from baseline to Week 78 in basal insulin dose between Empagliflozin 10 mg and placebo H1,1a: A difference in change from baseline to Week 78 in basal insulin dose between Empagliflozin 10 mg and placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model for Week 78 includes baseline basal insulin, baseline HbA1c as linear covariate(s) and geographical region, treatment as fixed effect(s)', 'testedNonInferiority': False}, {'pValue': '0.0090', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-5.92', 'ciLowerLimit': '-11.00', 'ciUpperLimit': '-0.85', 'pValueComment': 'Hierarchical testing approach was applied to Empagliflozin 25 mg vs Placebo. If null hypothesis is rejected for the primary endpoint, at 0.025 (2-sided), testing of the key secondary endpoints continued in a hierarchical fashion for the same dose.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.25', 'groupDescription': 'Empagliflozin versus Placebo 25 mg at 78 weeks\n\nH0,1a: No difference in change from baseline to Week 78 in basal insulin dose between Empagliflozin 25 mg and placebo H1,1a: A difference in change from baseline to Week 78 in basal insulin dose between Empagliflozin 25 mg and placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model for Week 78 includes baseline basal insulin, baseline HbA1c as linear covariate(s) and geographical region, treatment as fixed effect(s)', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 54 and 78 weeks', 'description': 'Change from baseline in basal insulin dose/day after 54 and 78 weeks of treatment', 'unitOfMeasure': 'IU', 'dispersionType': 'Standard Error', 'populationDescription': 'FAS (OC-78) for week 54 FAS78-completers (LOCF-78) for week 78 - Values after start of antidiabetic rescue therapy except changes in basal insulin dose were set to missing and last observation carried forward (LOCF) was used for imputation of missing values'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight After 18, 54 and 78 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Oral Placebo'}, {'id': 'OG001', 'title': 'Empagliflozin 10 mg', 'description': 'Empagliflozin 10 mg orally once daily'}, {'id': 'OG002', 'title': 'Empagliflozin 25 mg', 'description': 'Empagliflozin 25 mg orally once daily'}], 'classes': [{'title': '18 weeks', 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-2.06', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '-0.91', 'spread': '1.27', 'groupId': 'OG002'}]}]}, {'title': '54 weeks (N=114,120,106)', 'categories': [{'measurements': [{'value': '-0.52', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '-2.28', 'spread': '0.33', 'groupId': 'OG001'}, {'value': '-2.23', 'spread': '0.35', 'groupId': 'OG002'}]}]}, {'title': '78 weeks (N=100,113,96)', 'categories': [{'measurements': [{'value': '1.12', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '-2.61', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '-1.99', 'spread': '0.32', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0320', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.04', 'ciLowerLimit': '-3.90', 'ciUpperLimit': '-0.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.95', 'estimateComment': 'Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects', 'groupDescription': 'Change from BL at week 18 - Empagliflozin 10 mg vs Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3818', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.87', 'ciLowerLimit': '-2.81', 'ciUpperLimit': '1.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.99', 'estimateComment': 'Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects', 'groupDescription': 'Change from BL at week 18 - Empagliflozin 25 mg vs Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.97', 'ciLowerLimit': '-2.89', 'ciUpperLimit': '-1.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.47', 'estimateComment': 'Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects', 'groupDescription': 'Change from BL at week 54 - Empagliflozin 10 mg vs Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.17', 'ciLowerLimit': '-3.13', 'ciUpperLimit': '-1.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.49', 'estimateComment': 'Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects', 'groupDescription': 'Change from BL at week 54 - Empagliflozin 25 mg vs Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.63', 'ciLowerLimit': '-5.81', 'ciUpperLimit': '-1.45', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.10', 'estimateComment': 'Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects', 'groupDescription': 'Change from BL at week 78 - Empagliflozin 10 mg vs Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0073', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.12', 'ciLowerLimit': '-5.39', 'ciUpperLimit': '-0.85', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.15', 'estimateComment': 'Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects', 'groupDescription': 'Change from BL at week 78 - Empagliflozin 25 mg vs Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes, baseline weight, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 18, 54, 78 weeks', 'description': 'Change from baseline in body weight after 18, 54 and 78 weeks of treatment', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'populationDescription': 'FAS (OC)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight at Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Oral Placebo'}, {'id': 'OG001', 'title': 'Empagliflozin 10 mg', 'description': 'Empagliflozin 10 mg orally once daily'}, {'id': 'OG002', 'title': 'Empagliflozin 25 mg', 'description': 'Empagliflozin 25 mg orally once daily'}], 'classes': [{'title': 'Follow-up', 'categories': [{'measurements': [{'value': '90.56', 'spread': '25.87', 'groupId': 'OG000'}, {'value': '90.44', 'spread': '19.35', 'groupId': 'OG001'}, {'value': '93.98', 'spread': '20.87', 'groupId': 'OG002'}]}]}, {'title': 'Follow-up change from baseline', 'categories': [{'measurements': [{'value': '0.92', 'spread': '12.20', 'groupId': 'OG000'}, {'value': '-2.02', 'spread': '4.04', 'groupId': 'OG001'}, {'value': '-1.05', 'spread': '3.96', 'groupId': 'OG002'}]}]}, {'title': 'Change from last value on treatment N=111,118,109', 'categories': [{'measurements': [{'value': '-0.23', 'spread': '16.84', 'groupId': 'OG000'}, {'value': '0.62', 'spread': '2.11', 'groupId': 'OG001'}, {'value': '1.34', 'spread': '1.90', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 82 weeks', 'description': 'Change from baseline in body weight at follow up (82 weeks)', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'populationDescription': 'FAS-FU (OR)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c After 54 and 78 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Oral Placebo'}, {'id': 'OG001', 'title': 'Empagliflozin 10 mg', 'description': 'Empagliflozin 10 mg orally once daily'}, {'id': 'OG002', 'title': 'Empagliflozin 25 mg', 'description': 'Empagliflozin 25 mg orally once daily'}], 'classes': [{'title': 'Week 54 (N=113,121,107)', 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '-0.84', 'spread': '0.09', 'groupId': 'OG002'}]}]}, {'title': 'Week 78 (N=112,127,110)', 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '-0.68', 'spread': '0.09', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '-0.26', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'estimateComment': 'Model includes baseline HbA1c as linear covariate(s), geographical region, treatment, visit and visit by treatment interaction as fixed effect(s).', 'groupDescription': 'Change from BL at week 54 - Empagliflozin 10 mg vs Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.74', 'ciLowerLimit': '-0.95', 'ciUpperLimit': '-0.52', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'estimateComment': 'Model includes baseline HbA1c as linear covariate(s), geographical region, treatment, visit and visit by treatment interaction as fixed effect(s).', 'groupDescription': 'Change from BL at week 54 - Empagliflozin 25 mg vs Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.46', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '-0.19', 'pValueComment': 'Hierarchical testing approach was applied to Empagliflozin 10 mg vs Placebo. If null hypothesis is rejected for the primary endpoint, at 0.025 (2-sided), testing of the key secondary endpoints continued in a hierarchical fashion for the same dose.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'estimateComment': 'Model includes baseline HbA1c as linear covariate(s), geographical region, treatment as fixed effect(s).', 'groupDescription': 'Change from BL at week 78 - Empagliflozin 10 mg vs Placebo\n\nH0,1b: The change from baseline to Week 78 in HbA1c between empagliflozin 10 mg and placebo ≥0.3% H1,1b: The change from baseline to Week 78 in HbA1c between empagliflozin 10 mg and placebo \\<0.3%', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'For non-inferiority, a one-sided test at the significance level of 0.0125 was performed using a chosen margin of 0.3% difference between each dose of empagliflozin and placebo.\n\nIf the non-inferiority of empagliflozin to placebo with respect to change from baseline in HbA1c after 78 weeks of treatment could be concluded for a specific dose, subsequent testing of superiority was performed at the significance level of 0.025 for the relevant empagliflozin dose versus placebo comparison.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.62', 'ciLowerLimit': '-0.90', 'ciUpperLimit': '-0.34', 'pValueComment': 'Hierarchical testing approach was applied to Empagliflozin 25 mg vs Placebo. If null hypothesis is rejected for the primary endpoint, at 0.025 (2-sided), testing of the key secondary endpoints continued in a hierarchical fashion for the same dose.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'estimateComment': 'Model includes baseline HbA1c as linear covariate(s), geographical region, treatment as fixed effect(s).', 'groupDescription': 'Change from BL at week 78 - Empagliflozin 25 mg vs Placebo\n\nH0,1b: The change from baseline to Week 78 in HbA1c between empagliflozin 25 mg and placebo ≥0.3% H1,1b: The change from baseline to Week 78 in HbA1c between empagliflozin 25 mg and placebo \\<0.3%', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'For non-inferiority, a one-sided test at the significance level of 0.0125 was performed using a chosen margin of 0.3% difference between each dose of empagliflozin and placebo.\n\nIf the non-inferiority of empagliflozin to placebo with respect to change from baseline in HbA1c after 78 weeks of treatment could be concluded for a specific dose, subsequent testing of superiority was performed at the significance level of 0.025 for the relevant empagliflozin dose versus placebo comparison.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 54 and 78 weeks', 'description': 'Change from baseline in HbA1c after 54 and 78 weeks of treatment', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Error', 'populationDescription': 'Week 54 - FAS (OC-78) Week 78 - FAS78-completers (LOCF-78)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Confirmed Hypoglycemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Oral Placebo'}, {'id': 'OG001', 'title': 'Empagliflozin 10 mg', 'description': 'Empagliflozin 10 mg orally once daily'}, {'id': 'OG002', 'title': 'Empagliflozin 25 mg', 'description': 'Empagliflozin 25 mg orally once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the course of the study (82 weeks)', 'description': "Confirmed hypoglycemic events refer to all hypoglycemic events that had a glucose value ≤70 ml/dL or where assistance was required. Symptomatic hypoglycemic events were to be reported as adverse events. Investigator-defined hypoglycaemia adverse events include all events that investigator marked as 'Hypoglycaemic event' in CRFs, regardless of the reported term or blood glucose value. It may include hypoglycemia itself as reported term or any other symptoms that that investigator may have attributed to hypoglycemia (e.g. dizziness, hyperhidrosis, and asthenia).", 'unitOfMeasure': 'participants', 'populationDescription': 'Treated set (TS). Treatment assignment as first medication taken.'}, {'type': 'SECONDARY', 'title': 'The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 18, 54, and 78 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Oral Placebo'}, {'id': 'OG001', 'title': 'Empagliflozin 10 mg', 'description': 'Empagliflozin 10 mg orally once daily'}, {'id': 'OG002', 'title': 'Empagliflozin 25 mg', 'description': 'Empagliflozin 25 mg orally once daily'}], 'classes': [{'title': '18 weeks', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}, {'title': '54 weeks', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}, {'title': '78 weeks', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.096', 'ciLowerLimit': '1.846', 'ciUpperLimit': '9.088', 'groupDescription': 'Empagliflozin 10 mg vs Placebo at 18 weeks', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression includes treatment, geographical region and baseline HbA1c', 'testedNonInferiority': False}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.636', 'ciLowerLimit': '2.083', 'ciUpperLimit': '10.321', 'groupDescription': 'Empagliflozin 25 mg vs Placebo at 18 weeks', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression includes treatment, geographical region and baseline HbA1c', 'testedNonInferiority': False}, {'pValue': '0.1248', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.750', 'ciLowerLimit': '0.856', 'ciUpperLimit': '3.575', 'groupDescription': 'Empagliflozin 10 mg vs Placebo at 54 weeks', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression includes treatment, geographical region and baseline HbA1c', 'testedNonInferiority': False}, {'pValue': '0.0132', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.423', 'ciLowerLimit': '1.203', 'ciUpperLimit': '4.879', 'groupDescription': 'Empagliflozin 25 mg vs Placebo at 54 weeks', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression includes treatment, geographical region and baseline HbA1c', 'testedNonInferiority': False}, {'pValue': '0.0986', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.939', 'ciLowerLimit': '0.884', 'ciUpperLimit': '4.256', 'groupDescription': 'Empagliflozin 10 mg vs Placebo at 78 weeks', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression includes treatment, geographical region and baseline HbA1c', 'testedNonInferiority': False}, {'pValue': '0.0024', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.239', 'ciLowerLimit': '1.518', 'ciUpperLimit': '6.911', 'groupDescription': 'Empagliflozin 25 mg vs Placebo at 78 weeks', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression includes treatment, geographical region and baseline HbA1c', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 18, 54 and 78 weeks', 'description': 'The occurrence of treat to target efficacy response, that is an HbA1c under treatment of \\<7.0% After 18, 54, and 78 weeks of treatment', 'unitOfMeasure': 'participants', 'populationDescription': 'FAS (NCF)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Oral Placebo'}, {'id': 'FG001', 'title': 'Empagliflozin 10 mg', 'description': 'Empagliflozin 10 mg orally once daily'}, {'id': 'FG002', 'title': 'Empagliflozin 25 mg', 'description': 'Empagliflozin 25 mg orally once daily'}], 'periods': [{'title': 'After Week 18 Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '170'}, {'groupId': 'FG001', 'numSubjects': '169'}, {'groupId': 'FG002', 'numSubjects': '155'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '147'}, {'groupId': 'FG001', 'numSubjects': '153'}, {'groupId': 'FG002', 'numSubjects': '129'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other reason not defined above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '12'}]}]}, {'title': 'After Week 78 Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '170'}, {'groupId': 'FG001', 'numSubjects': '169'}, {'groupId': 'FG002', 'numSubjects': '155'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '131'}, {'groupId': 'FG002', 'numSubjects': '111'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '44'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other reason not defined above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '16'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'BG000'}, {'value': '169', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '494', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Oral Placebo'}, {'id': 'BG001', 'title': 'Empagliflozin 10 mg', 'description': 'Empagliflozin 10 mg orally once daily'}, {'id': 'BG002', 'title': 'Empagliflozin 25 mg', 'description': 'Empagliflozin 25 mg orally once daily'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.1', 'spread': '9.4', 'groupId': 'BG000'}, {'value': '58.6', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '59.9', 'spread': '10.5', 'groupId': 'BG002'}, {'value': '58.8', 'spread': '9.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '218', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '276', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS) - including all randomized and treated patients who had a baseline HbA1c value. Treatment assignment as randomized.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 494}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'lastUpdateSubmitDate': '2014-09-24', 'studyFirstSubmitDate': '2009-11-10', 'resultsFirstSubmitDate': '2014-05-16', 'studyFirstSubmitQcDate': '2009-11-10', 'lastUpdatePostDateStruct': {'date': '2014-09-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-09-24', 'studyFirstPostDateStruct': {'date': '2009-11-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Confirmed Hypoglycemic Events', 'timeFrame': 'During the course of the study (82 weeks)', 'description': "Confirmed hypoglycemic events refer to all hypoglycemic events that had a glucose value ≤70 ml/dL or where assistance was required. Symptomatic hypoglycemic events were to be reported as adverse events. Investigator-defined hypoglycaemia adverse events include all events that investigator marked as 'Hypoglycaemic event' in CRFs, regardless of the reported term or blood glucose value. It may include hypoglycemia itself as reported term or any other symptoms that that investigator may have attributed to hypoglycemia (e.g. dizziness, hyperhidrosis, and asthenia)."}], 'primaryOutcomes': [{'measure': 'Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 18 Weeks of Treatment', 'timeFrame': 'Baseline and 18 weeks', 'description': 'Change from baseline in Glycosylated haemoglobin A1c (HbA1c) after 18 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5%) After 18, 54 and 78 Weeks of Treatment', 'timeFrame': 'Baseline and 18, 54 and 78 weeks', 'description': 'Patients that had a reduction in HbA1c of at least 0.5% from baseline to 18, 54 and 78 weeks of treatment'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment', 'timeFrame': 'Baseline, 18, 54 and 78 weeks', 'description': 'Change from baseline in fasting plasma glucose (FPG) after 18, 54 and 78 weeks of treatment'}, {'measure': 'Percent Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment', 'timeFrame': 'Baseline, 18, 54 and 78 weeks', 'description': 'Percent change from baseline in fasting plasma glucose (FPG) after 18, 54 and 78 weeks of treatment'}, {'measure': 'Change From Baseline in Basal Insulin Dose/Day After 54 and 78 Weeks of Treatment', 'timeFrame': 'Baseline, 54 and 78 weeks', 'description': 'Change from baseline in basal insulin dose/day after 54 and 78 weeks of treatment'}, {'measure': 'Change From Baseline in Body Weight After 18, 54 and 78 Weeks of Treatment', 'timeFrame': 'Baseline, 18, 54, 78 weeks', 'description': 'Change from baseline in body weight after 18, 54 and 78 weeks of treatment'}, {'measure': 'Change From Baseline in Body Weight at Follow-up', 'timeFrame': 'Baseline and 82 weeks', 'description': 'Change from baseline in body weight at follow up (82 weeks)'}, {'measure': 'Change From Baseline in HbA1c After 54 and 78 Weeks of Treatment', 'timeFrame': 'Baseline, 54 and 78 weeks', 'description': 'Change from baseline in HbA1c after 54 and 78 weeks of treatment'}, {'measure': 'The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 18, 54, and 78 Weeks of Treatment', 'timeFrame': 'Baseline, 18, 54 and 78 weeks', 'description': 'The occurrence of treat to target efficacy response, that is an HbA1c under treatment of \\<7.0% After 18, 54, and 78 weeks of treatment'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '35472672', 'type': 'DERIVED', 'citation': 'Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 at two different doses compared to placebo during long term treatment (78 weeks) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n1. Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation\n2. Male and female patients with a diagnosis of Type 2 Diabetes Mellitus treated with a stable dose of basal insulin with or without concomitant metformin and / or sulfonylurea.\n3. Glycosylated hemoglobin A1c (Type A, subtype 1c) of \\>7.0% and \\< or = 10% at Visit 1 (screening)\n4. Suitability for trial participation according to investigator's judgment (evaluating all alternative treatment options and in consideration of the patient completing the study)\n5. Age \\> or =18 years at Visit 1 (screening)\n6. BMI \\< or = 45 kg/m2 (Body Mass Index) at Visit 1 (screening)\n\nExclusion criteria:\n\n1. Patients with poorly controlled hyperglycemia\n2. Frequent (at the discretion of the investigator) episodes of hypoglycemic events on basal insulin therapy\n3. MI, stroke, or TIA within 3 months prior to obtaining informed consent\n4. Impaired hepatic or renal function; gastric surgery; cancer within the last 5 years; blood dyscrasias\n\n6\\. Treatment with other anti-diabetics, anti-obesity medications, steroids or thyroid hormones, participation in another trial with an investigational drug 7. Pre-menopausal women on insufficient birth control 8. Alcohol or drug abuse"}, 'identificationModule': {'nctId': 'NCT01011868', 'briefTitle': 'Efficacy and Safety of BI 10773 in Combination With Insulin in Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Phase IIb, Randomized, Double-blind, Placebo-controlled, Parallel Group, Safety and Efficacy Study of BI 10773 (10 mg and 25 mg) Administered Orally, Once Daily Over 78 Weeks in Type 2 Diabetic Patients Receiving Treatment With Basal Insulin (Glargine, Detemir, or NPH Insulin Only) With or Without Concomitant Metformin and/or Sulfonylurea Therapy and Insufficient Glycemic Control', 'orgStudyIdInfo': {'id': '1245.33'}, 'secondaryIdInfos': [{'id': '2009-013668-38', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BI 10773 low dose', 'description': 'Patients receive BI 10773 low dose daily', 'interventionNames': ['Drug: BI 10773 low dose']}, {'type': 'EXPERIMENTAL', 'label': 'BI 10773 high dose', 'description': 'Patients receive BI 10773 high dose daily', 'interventionNames': ['Drug: BI 10773 placebo', 'Drug: BI 10773 high dose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Patients receive placebo to match BI 10773 daily', 'interventionNames': ['Drug: BI 10773 placebo']}], 'interventions': [{'name': 'BI 10773 placebo', 'type': 'DRUG', 'description': 'BI 10773 placebo', 'armGroupLabels': ['BI 10773 high dose']}, {'name': 'BI 10773 low dose', 'type': 'DRUG', 'description': 'BI 10773 low dose', 'armGroupLabels': ['BI 10773 low dose']}, {'name': 'BI 10773 high dose', 'type': 'DRUG', 'description': 'BI 10773 high dose', 'armGroupLabels': ['BI 10773 high dose']}, {'name': 'BI 10773 placebo', 'type': 'DRUG', 'description': 'BI 10773 placebo', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 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