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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-25 @ 1:47 AM

Ignite Modification Date: 2025-12-26 @ 4:38 AM

Study NCT ID: NCT01204294

Status: COMPLETED

Last Update Posted: 2014-03-28

First Post: 2010-09-16

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Comprehensive Add on Study in Japan

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

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': 'D000069476', 'term': 'Linagliptin'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'The first drug administration through 7 days after the last drug administration, up to 382 days', 'eventGroups': [{'id': 'EG000', 'title': 'Bigu+Lina', 'description': 'biguanide plus linagliptin', 'otherNumAtRisk': 82, 'otherNumAffected': 55, 'seriousNumAtRisk': 82, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Glin+Lina', 'description': 'glinide plus linagliptin', 'otherNumAtRisk': 66, 'otherNumAffected': 41, 'seriousNumAtRisk': 66, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Glit+Lina', 'description': 'glitazone plus linagliptin', 'otherNumAtRisk': 74, 'otherNumAffected': 37, 'seriousNumAtRisk': 74, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'SU+Lina', 'description': 'sulfonylurea plus linagliptin', 'otherNumAtRisk': 143, 'otherNumAffected': 83, 'seriousNumAtRisk': 143, 'seriousNumAffected': 7}, {'id': 'EG004', 'title': 'A-GI+Lina', 'description': 'alpha-glucosidase inhibitor plus linagliptin', 'otherNumAtRisk': 85, 'otherNumAffected': 54, 'seriousNumAtRisk': 85, 'seriousNumAffected': 7}, {'id': 'EG005', 'title': 'SU+Met', 'description': 'sulfonylurea plus metformin', 'otherNumAtRisk': 63, 'otherNumAffected': 31, 'seriousNumAtRisk': 63, 'seriousNumAffected': 5}, {'id': 'EG006', 'title': 'A-GI+Met', 'description': 'alpha-glucosidase inhibitor plus metformin', 'otherNumAtRisk': 61, 'otherNumAffected': 33, 'seriousNumAtRisk': 61, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 45}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 35}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 13}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 10}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Periodontal disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Infectious peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Haemangioma of liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lip and/or oral cavity cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Metastases to lymph nodes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Sudden hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Colonic polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Haemorrhage subcutaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Clavicle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '143', 'groupId': 'OG003'}, {'value': '85', 'groupId': 'OG004'}, {'value': '63', 'groupId': 'OG005'}, {'value': '61', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Bigu+Lina', 'description': 'biguanide plus linagliptin'}, {'id': 'OG001', 'title': 'Glin+Lina', 'description': 'glinide plus linagliptin'}, {'id': 'OG002', 'title': 'Glit+Lina', 'description': 'glitazone plus linagliptin'}, {'id': 'OG003', 'title': 'SU+Lina', 'description': 'sulfonylurea plus linagliptin'}, {'id': 'OG004', 'title': 'A-GI+Lina', 'description': 'alpha-glucosidase inhibitor plus linagliptin'}, {'id': 'OG005', 'title': 'SU+Met', 'description': 'sulfonylurea plus metformin'}, {'id': 'OG006', 'title': 'A-GI+Met', 'description': 'alpha-glucosidase inhibitor plus metformin'}], 'classes': [{'title': 'Patients with any AE', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '114', 'groupId': 'OG003'}, {'value': '71', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}]}]}, {'title': 'Patients with severe AE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Patients with AEs leading to discontinuation', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Patients with Hypoglycaemic events', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'The first drug administration through 7 days after the last drug administration, up to 382 days', 'description': 'The number of patient with any AEs, patients with severe AE, patients with AEs leading to discontinuation of trial drug, and patients with Hypoglycaemic events', 'unitOfMeasure': 'Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'The treated set (TS) comprised all patients who received at least one dose of randomised study medication in the 52-week treatment period'}, {'type': 'SECONDARY', 'title': 'Glycosylated Haemoglobin A1c (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '140', 'groupId': 'OG003'}, {'value': '85', 'groupId': 'OG004'}, {'value': '62', 'groupId': 'OG005'}, {'value': '61', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Bigu+Lina', 'description': 'biguanide plus linagliptin'}, {'id': 'OG001', 'title': 'Glin+Lina', 'description': 'glinide plus linagliptin'}, {'id': 'OG002', 'title': 'Glit+Lina', 'description': 'glitazone plus linagliptin'}, {'id': 'OG003', 'title': 'SU+Lina', 'description': 'sulfonylurea plus linagliptin'}, {'id': 'OG004', 'title': 'A-GI+Lina', 'description': 'alpha-glucosidase inhibitor plus linagliptin'}, {'id': 'OG005', 'title': 'SU+Met', 'description': 'sulfonylurea plus metformin'}, {'id': 'OG006', 'title': 'A-GI+Met', 'description': 'alpha-glucosidase inhibitor plus metformin'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.98', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '7.92', 'spread': '0.82', 'groupId': 'OG001'}, {'value': '7.86', 'spread': '0.83', 'groupId': 'OG002'}, {'value': '8.12', 'spread': '0.78', 'groupId': 'OG003'}, {'value': '7.87', 'spread': '0.75', 'groupId': 'OG004'}, {'value': '8.01', 'spread': '0.64', 'groupId': 'OG005'}, {'value': '8.07', 'spread': '1.04', 'groupId': 'OG006'}]}]}, {'title': 'At 52 weeks', 'categories': [{'measurements': [{'value': '7.10', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '7.19', 'spread': '0.75', 'groupId': 'OG001'}, {'value': '7.07', 'spread': '0.74', 'groupId': 'OG002'}, {'value': '7.42', 'spread': '0.91', 'groupId': 'OG003'}, {'value': '6.96', 'spread': '0.75', 'groupId': 'OG004'}, {'value': '7.19', 'spread': '0.72', 'groupId': 'OG005'}, {'value': '6.98', 'spread': '0.75', 'groupId': 'OG006'}]}]}, {'title': 'Change from baseline to 52 weeks', 'categories': [{'measurements': [{'value': '-0.88', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '-0.73', 'spread': '0.65', 'groupId': 'OG001'}, {'value': '-0.79', 'spread': '0.50', 'groupId': 'OG002'}, {'value': '-0.70', 'spread': '0.70', 'groupId': 'OG003'}, {'value': '-0.91', 'spread': '0.61', 'groupId': 'OG004'}, {'value': '-0.82', 'spread': '0.78', 'groupId': 'OG005'}, {'value': '-1.09', 'spread': '0.87', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 52 weeks', 'description': 'The change from baseline in HbA1c after 52 weeks of treatment. When the HbA1c after 52 weeks treatment was missing, the value from the measurements at the closest preceding visit replaced the missing value.', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) comprised all treated patients who had baseline HbA1c measurement and at least one on-treatment HbA1c measurement available'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bigu+Lina', 'description': 'biguanide plus linagliptin'}, {'id': 'FG001', 'title': 'Glin+Lina', 'description': 'glinide plus linagliptin'}, {'id': 'FG002', 'title': 'Glit+Lina', 'description': 'glitazone plus linagliptin'}, {'id': 'FG003', 'title': 'SU+Lina', 'description': 'sulfonylurea plus linagliptin'}, {'id': 'FG004', 'title': 'A-GI+Lina', 'description': 'alpha-glucosidase inhibitor plus linagliptin'}, {'id': 'FG005', 'title': 'SU+Met', 'description': 'sulfonylurea plus metformin'}, {'id': 'FG006', 'title': 'A-GI+Met', 'description': 'alpha-glucosidase inhibitor plus metformin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '74'}, {'groupId': 'FG003', 'numSubjects': '143'}, {'groupId': 'FG004', 'numSubjects': '85'}, {'groupId': 'FG005', 'numSubjects': '63'}, {'groupId': 'FG006', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '69'}, {'groupId': 'FG003', 'numSubjects': '132'}, {'groupId': 'FG004', 'numSubjects': '83'}, {'groupId': 'FG005', 'numSubjects': '58'}, {'groupId': 'FG006', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Other (house moving)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 618 patients were enrolled in the trial at 43 trial sites, and 37 patients were withdrawn from the trial because of screening failure. 581 patients were entered into the 2-week placebo run-in period, and 7 patients were withdrawn. 574 patients completed the 2-week placebo run-in period and took linagliptin 5 mg or metformin.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}, {'value': '85', 'groupId': 'BG004'}, {'value': '63', 'groupId': 'BG005'}, {'value': '61', 'groupId': 'BG006'}, {'value': '574', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Bigu+Lina', 'description': 'biguanide plus linagliptin'}, {'id': 'BG001', 'title': 'Glin+Lina', 'description': 'glinide plus linagliptin'}, {'id': 'BG002', 'title': 'Glit+Lina', 'description': 'glitazone plus linagliptin'}, {'id': 'BG003', 'title': 'SU+Lina', 'description': 'sulfonylurea plus linagliptin'}, {'id': 'BG004', 'title': 'A-GI+Lina', 'description': 'alpha-glucosidase inhibitor plus linagliptin'}, {'id': 'BG005', 'title': 'SU+Met', 'description': 'sulfonylurea plus metformin'}, {'id': 'BG006', 'title': 'A-GI+Met', 'description': 'alpha-glucosidase inhibitor plus metformin'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '58.4', 'spread': '9.9', 'groupId': 'BG000'}, {'value': '62.6', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '60.4', 'spread': '9.4', 'groupId': 'BG002'}, {'value': '61.8', 'spread': '10.8', 'groupId': 'BG003'}, {'value': '62.0', 'spread': '10.4', 'groupId': 'BG004'}, {'value': '61.2', 'spread': '10.6', 'groupId': 'BG005'}, {'value': '59.3', 'spread': '10.3', 'groupId': 'BG006'}, {'value': '60.9', 'spread': '10.2', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}, {'value': '173', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}, {'value': '44', 'groupId': 'BG005'}, {'value': '42', 'groupId': 'BG006'}, {'value': '401', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 574}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-27', 'studyFirstSubmitDate': '2010-09-16', 'resultsFirstSubmitDate': '2012-12-18', 'studyFirstSubmitQcDate': '2010-09-16', 'lastUpdatePostDateStruct': {'date': '2014-03-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-12-18', 'studyFirstPostDateStruct': {'date': '2010-09-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Events (AEs)', 'timeFrame': 'The first drug administration through 7 days after the last drug administration, up to 382 days', 'description': 'The number of patient with any AEs, patients with severe AE, patients with AEs leading to discontinuation of trial drug, and patients with Hypoglycaemic events'}], 'secondaryOutcomes': [{'measure': 'Glycosylated Haemoglobin A1c (HbA1c)', 'timeFrame': 'Baseline and 52 weeks', 'description': 'The change from baseline in HbA1c after 52 weeks of treatment. When the HbA1c after 52 weeks treatment was missing, the value from the measurements at the closest preceding visit replaced the missing value.'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The objective of the current study is to investigate the safety and efficacy of linagliptin (5mg / once daily) given for 52 weeks as add-on therapy to patients with type 2 diabetes mellitus and insufficient glycaemic control despite diet, exercise, and treatment with one approved antidiabetic drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Diagnosis of type 2 diabetes mellitus\n2. Male and female patients on diet and exercise regimen who are treated with one antidiabetic drug\n\nExclusion criteria:\n\n1. Myocardial infarction, stroke, transient ischemic attack, or pulmonary embolism\n2. Impaired hepatic function\n3. Glitazone, glinide, and sulfonylurea group: renal failure or renal impairment defined as estimated glomerular filtration rate \\<30 ml/min (severe renal impairment) at Visit 1, Biguanide group: renal failure or renal impairment defined as estimated glomerular filtration rate \\<60 ml/min (moderate renal impairment) at Visit 1\n4. Treatment with anti-obesity drugs'}, 'identificationModule': {'nctId': 'NCT01204294', 'briefTitle': 'Comprehensive Add on Study in Japan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'An Open Label, Randomised, Parallel Group Safety and Efficacy Study of Linagliptin (5 mg Administered Orally Once Daily) Over 52 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Background Mono-therapy With an Approved Antidiabetic Drug', 'orgStudyIdInfo': {'id': '1218.78'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bigu+Lina', 'description': 'biguanide plus linagliptin', 'interventionNames': ['Drug: Linagliptin']}, {'type': 'EXPERIMENTAL', 'label': 'Glin+Lina', 'description': 'glinide plus linagliptin', 'interventionNames': ['Drug: Linagliptin']}, {'type': 'EXPERIMENTAL', 'label': 'Glit+Lina', 'description': 'glitazone plus linagliptin', 'interventionNames': ['Drug: Linagliptin']}, {'type': 'EXPERIMENTAL', 'label': 'SU+Lina', 'description': 'sulfonylurea plus linagliptin', 'interventionNames': ['Drug: Linagliptin']}, {'type': 'EXPERIMENTAL', 'label': 'A-GI+Lina', 'description': 'alpha-glucosidase inhibitor plus linagliptin', 'interventionNames': ['Drug: Linagliptin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SU+Met', 'description': 'sulfonylurea plus metformin', 'interventionNames': ['Drug: Metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'A-GI+Met', 'description': 'alpha-glucosidase inhibitor plus metformin', 'interventionNames': ['Drug: Metformin']}], 'interventions': [{'name': 'Linagliptin', 'type': 'DRUG', 'description': 'Linagliptin once daily', 'armGroupLabels': ['Glin+Lina']}, {'name': 'Linagliptin', 'type': 'DRUG', 'description': 'Linagliptin once daily', 'armGroupLabels': ['Glit+Lina']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'Metformin twice or three time per day', 'armGroupLabels': ['A-GI+Met']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'Metformin twice or three time per day', 'armGroupLabels': ['SU+Met']}, {'name': 'Linagliptin', 'type': 'DRUG', 'description': 'Linagliptin once daily', 'armGroupLabels': ['A-GI+Lina']}, {'name': 'Linagliptin', 'type': 'DRUG', 'description': 'Linagliptin once daily', 'armGroupLabels': ['Bigu+Lina']}, {'name': 'Linagliptin', 'type': 'DRUG', 'description': 'Linagliptin once daily', 'armGroupLabels': ['SU+Lina']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Akishima, Tokyo', 'country': 'Japan', 'facility': '1218.78.008 Boehringer Ingelheim Investigational Site'}, {'city': 'Amagasaki, Hyogo', 'country': 'Japan', 'facility': '1218.78.030 Boehringer Ingelheim Investigational Site'}, {'city': 'Annaka, Gunma', 'country': 'Japan', 'facility': '1218.78.017 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 36.33011, 'lon': 138.89585}}, {'city': 'Aomori, Aomori', 'country': 'Japan', 'facility': '1218.78.006 Boehringer Ingelheim Investigational Site'}, {'city': 'Aomori, Aomori', 'country': 'Japan', 'facility': '1218.78.007 Boehringer Ingelheim Investigational Site'}, {'city': 'Chuo-ku, Tokyo', 'country': 'Japan', 'facility': '1218.78.009 Boehringer Ingelheim Investigational Site'}, {'city': 'Chuo-ku, Tokyo', 'country': 'Japan', 'facility': '1218.78.013 Boehringer Ingelheim Investigational Site'}, {'city': 'Fukuoka, Fukuoka', 'country': 'Japan', 'facility': '1218.78.032 Boehringer Ingelheim Investigational Site'}, {'city': 'Fukuoka, Fukuoka', 'country': 'Japan', 'facility': '1218.78.040 Boehringer Ingelheim Investigational Site'}, {'city': 'Higashi Osaka, Osaka', 'country': 'Japan', 'facility': '1218.78.037 Boehringer Ingelheim Investigational Site'}, {'city': 'Hitachinaka, Ibaraki', 'country': 'Japan', 'facility': '1218.78.043 Boehringer Ingelheim Investigational Site'}, {'city': 'Isesaki, Gunma', 'country': 'Japan', 'facility': '1218.78.019 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 36.31667, 'lon': 139.2}}, {'city': 'Kashiwara, Osaka', 'country': 'Japan', 'facility': '1218.78.036 Boehringer Ingelheim Investigational Site'}, {'city': 'Kasugai, Aichi', 'country': 'Japan', 'facility': '1218.78.026 Boehringer Ingelheim Investigational Site'}, {'city': 'Kawachinagano, Osaka', 'country': 'Japan', 'facility': '1218.78.038 Boehringer Ingelheim Investigational Site'}, {'city': 'Kitaazumi-gun, Nagano', 'country': 'Japan', 'facility': '1218.78.021 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 36.65, 'lon': 138.18333}}, {'city': 'Matsumoto, Nagano', 'country': 'Japan', 'facility': '1218.78.022 Boehringer Ingelheim Investigational Site'}, {'city': 'Matsumoto, Nagano', 'country': 'Japan', 'facility': '1218.78.033 Boehringer Ingelheim Investigational Site'}, {'city': 'Meguro-ku, Tokyo', 'country': 'Japan', 'facility': '1218.78.012 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Meguro-ku, Tokyo', 'country': 'Japan', 'facility': '1218.78.041 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Morioka, Iwate', 'country': 'Japan', 'facility': '1218.78.034 Boehringer Ingelheim Investigational Site'}, {'city': 'Morioka, Iwate', 'country': 'Japan', 'facility': '1218.78.035 Boehringer Ingelheim Investigational Site'}, {'city': 'Moriya, Ibaraki', 'country': 'Japan', 'facility': '1218.78.018 Boehringer Ingelheim Investigational Site'}, {'city': 'Nagoya, Aichi', 'country': 'Japan', 'facility': '1218.78.024 Boehringer Ingelheim Investigational Site'}, {'city': 'Nagoya, Aichi', 'country': 'Japan', 'facility': '1218.78.025 Boehringer Ingelheim Investigational Site'}, {'city': 'Nagoya, Aichi', 'country': 'Japan', 'facility': '1218.78.027 Boehringer Ingelheim Investigational Site'}, {'city': 'Nagoya, Aichi', 'country': 'Japan', 'facility': '1218.78.028 Boehringer Ingelheim Investigational Site'}, {'city': 'Nagoya, Aichi', 'country': 'Japan', 'facility': '1218.78.031 Boehringer Ingelheim Investigational Site'}, {'city': 'Oita, Oita', 'country': 'Japan', 'facility': '1218.78.039 Boehringer Ingelheim Investigational Site'}, {'city': 'Okinawa, Okinawa', 'country': 'Japan', 'facility': '1218.78.004 Boehringer Ingelheim Investigational Site'}, {'city': 'Sagae, Yamagata', 'country': 'Japan', 'facility': '1218.78.016 Boehringer Ingelheim Investigational Site'}, {'city': 'Sapporo, Hokkaido', 'country': 'Japan', 'facility': '1218.78.001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Sapporo, Hokkaido', 'country': 'Japan', 'facility': '1218.78.020 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Sapporo, Hokkaido', 'country': 'Japan', 'facility': '1218.78.042 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Shimajiri-gun, Okinawa', 'country': 'Japan', 'facility': '1218.78.005 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 26.33583, 'lon': 127.80139}}, {'city': 'Shinjuku-ku, Tokyo', 'country': 'Japan', 'facility': '1218.78.014 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Shinjyuku-ku. Tokyo', 'country': 'Japan', 'facility': '1218.78.002 Boehringer Ingelheim Investigational Site'}, {'city': 'Shizuoka, Shizuoka', 'country': 'Japan', 'facility': '1218.78.011 Boehringer Ingelheim Investigational Site'}, {'city': 'Suita, Osaka', 'country': 'Japan', 'facility': '1218.78.003 Boehringer Ingelheim Investigational Site'}, {'city': 'Tokorozawa, Saitama', 'country': 'Japan', 'facility': '1218.78.023 Boehringer Ingelheim Investigational Site'}, {'city': 'Tokorozawa, Saitama', 'country': 'Japan', 'facility': '1218.78.029 Boehringer Ingelheim Investigational Site'}, {'city': 'Tsuchiura, Ibaraki', 'country': 'Japan', 'facility': '1218.78.010 Boehringer Ingelheim Investigational Site'}, {'city': 'Yamagata, Yamagata', 'country': 'Japan', 'facility': '1218.78.015 Boehringer Ingelheim Investigational Site'}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}