Viewing Study NCT01413204

Home

Certify Doc

Genes

Clinical Trials

CompTox

DrugMatrix

Open Targets

Products

Support

Bugs

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

Ignite Creation Date: 2025-12-24 @ 9:15 PM

Ignite Modification Date: 2025-12-29 @ 12:45 PM

Study NCT ID: NCT01413204

Status: COMPLETED

Last Update Posted: 2014-06-05

First Post: 2011-08-04

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Efficacy and Safety Study of TA-7284 in Patients With Type 2 Diabetes

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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cti-inq-ml@ml.mt-pharma.co.jp', 'title': 'Clinical Trials, Information Desk', 'organization': 'Mitsubishi Tanabe Pharma Corporation'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '26 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'TA-7284 Low', 'description': 'TA-7284 low dose, once daily for 24 weeks', 'otherNumAtRisk': 90, 'otherNumAffected': 59, 'seriousNumAtRisk': 90, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'TA-7284 High', 'description': 'TA-7284 high dose, once daily for 24 weeks', 'otherNumAtRisk': 89, 'otherNumAffected': 55, 'seriousNumAtRisk': 89, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Placebo', 'description': 'TA-7284 Placebo, once daily for 24 weeks', 'otherNumAtRisk': 93, 'otherNumAffected': 54, 'seriousNumAtRisk': 93, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Acute tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15'}, {'term': 'Asteatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bacteriuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Balanoposthitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood ketone body increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood parathyroid hormone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 4}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cervicobrachial syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chronic sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Colonic polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dizziness postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Eczema asteatotic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Enteritis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 15'}, {'term': 'Face injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fasciitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Forearm fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastritis atrophic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hangover', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Heat rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Herpes virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 15'}, {'term': 'Hunger', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypoglycaemia unawareness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Injury corneal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Mouth injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Myofascial pain syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Periarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Periodontal disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pharyngitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Polycythaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Post herpetic neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pulpitis dental', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Punctate keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Seborrhoeic dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Skeletal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Skin fissures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tenosynovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tinea pedis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Toxic skin eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 15'}, {'term': 'Trigger finger', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urine albumin/creatinine ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urine ketone body present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urine output increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vulvitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vulvovaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vulvovaginal mycotic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 15'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hepatic neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oropharyngeal cancer stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'TA-7284 Low', 'description': 'TA-7284 low dose, once daily for 24 weeks'}, {'id': 'OG001', 'title': 'TA-7284 High', 'description': 'TA-7284 high dose, once daily for 24 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'TA-7284 Placebo, once daily for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.74', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-0.76', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '0.29', 'spread': '0.07', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and 24 weeks', 'unitOfMeasure': 'percent HbA1C', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, last observation carried forward'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Plasma Glucose', 'timeFrame': 'Week 24', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight', 'timeFrame': 'Week 24', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Blood Pressure', 'timeFrame': 'Week 24', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Postprandial Plasma Glucose, Insulin and Urinary Glucose Excretion After a 75 g Oral Glucose Tolerance Test', 'timeFrame': 'Week 24', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events, Laboratory Tests, 12-lead ECG and Vital Signs', 'timeFrame': 'Week 24', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TA-7284 Low', 'description': 'TA-7284 low dose, once daily for 24 weeks'}, {'id': 'FG001', 'title': 'TA-7284 High', 'description': 'TA-7284 high dose, once daily for 24 weeks'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'TA-7284 Placebo, once daily for 24 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}, {'groupId': 'FG001', 'numSubjects': '89'}, {'groupId': 'FG002', 'numSubjects': '93'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '83'}, {'groupId': 'FG002', 'numSubjects': '74'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Clearly not eligible for the study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Fasting plasma glucose level increased', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '10'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '272', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'TA-7284 Low', 'description': 'TA-7284 low dose, once daily for 24 weeks'}, {'id': 'BG001', 'title': 'TA-7284 High', 'description': 'TA-7284 high dose, once daily for 24 weeks'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'TA-7284 Placebo, once daily for 24 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.4', 'spread': '10.4', 'groupId': 'BG000'}, {'value': '57.3', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '58.2', 'spread': '11', 'groupId': 'BG002'}, {'value': '58', 'spread': '10.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '192', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 272}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-27', 'studyFirstSubmitDate': '2011-08-04', 'resultsFirstSubmitDate': '2014-03-26', 'studyFirstSubmitQcDate': '2011-08-08', 'lastUpdatePostDateStruct': {'date': '2014-06-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-27', 'studyFirstPostDateStruct': {'date': '2011-08-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value)', 'timeFrame': 'baseline and 24 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in Fasting Plasma Glucose', 'timeFrame': 'Week 24'}, {'measure': 'Change in Body Weight', 'timeFrame': 'Week 24'}, {'measure': 'Change in Blood Pressure', 'timeFrame': 'Week 24'}, {'measure': 'Change in Postprandial Plasma Glucose, Insulin and Urinary Glucose Excretion After a 75 g Oral Glucose Tolerance Test', 'timeFrame': 'Week 24'}, {'measure': 'Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events, Laboratory Tests, 12-lead ECG and Vital Signs', 'timeFrame': 'Week 24'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['TA-7284', 'JNJ-28431754', 'Canagliflozin', 'Sodium Glucose Co-transporter (SGLT2 inhibitor)'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '25010793', 'type': 'DERIVED', 'citation': 'Inagaki N, Kondo K, Yoshinari T, Takahashi N, Susuta Y, Kuki H. Efficacy and safety of canagliflozin monotherapy in Japanese patients with type 2 diabetes inadequately controlled with diet and exercise: a 24-week, randomized, double-blind, placebo-controlled, Phase III study. Expert Opin Pharmacother. 2014 Aug;15(11):1501-15. doi: 10.1517/14656566.2014.935764.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of TA-7284 as monotherapy in patients with type 2 Diabetes for 24 weeks administration.', 'detailedDescription': 'This is a randomized, 3-arm, parallel group, double blind study to evaluate the efficacy and safety of TA-7284 in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise. The patients will receive either TA-7284-Low, TA-7284-High or Placebo orally alone for 24 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women age ≥20 years old\n* Diagnosed with Type 2 diabetes mellitus at least 3 months before run-in period\n* HbA1c of ≥7.0% and ≤10.0%\n\nExclusion Criteria:\n\n* Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus\n* Past or current history of severe diabetic complications\n* Fasting plasma glucose \\> 270 mg/dL before treatment start\n* History of hereditary glucose-galactose malabsorption or primary renal glucosuria\n* Patients requiring insulin therapy'}, 'identificationModule': {'nctId': 'NCT01413204', 'briefTitle': 'Efficacy and Safety Study of TA-7284 in Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of TA-7284 as Monotherapy in the Treatment of Subjects With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'TA-7284-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TA-7284 Low', 'interventionNames': ['Drug: TA-7284 Low']}, {'type': 'EXPERIMENTAL', 'label': 'TA-7284 High', 'interventionNames': ['Drug: TA-7284 High']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'TA-7284 Low', 'type': 'DRUG', 'description': 'The patients will receive TA-7284-Low orally for 24 weeks.', 'armGroupLabels': ['TA-7284 Low']}, {'name': 'TA-7284 High', 'type': 'DRUG', 'description': 'The patients will receive TA-7284-High orally for 24 weeks.', 'armGroupLabels': ['TA-7284 High']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'The patients will receive Placebo orally for 24 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chūbu', 'country': 'Japan', 'facility': 'Reserch site', 'geoPoint': {'lat': 35.43379, 'lon': 140.2797}}, {'city': 'Kanto', 'country': 'Japan', 'facility': 'Reserch site'}, {'city': 'Kinki', 'country': 'Japan', 'facility': 'Reserch site'}, {'city': 'Shikoku', 'country': 'Japan', 'facility': 'Reserch site'}, {'city': 'Tōhoku', 'country': 'Japan', 'facility': 'Reserch site', 'geoPoint': {'lat': 35.81882, 'lon': 139.57138}}], 'overallOfficials': [{'name': 'Nobuya Inagaki, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kyoto University, Graduate School of Medicine'}, {'name': 'Kazuoki Kondo, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tanabe Pharma Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}