Viewing Study NCT00252694

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Ignite Creation Date: 2025-12-25 @ 1:34 AM
Ignite Modification Date: 2025-12-25 @ 11:48 PM
Study NCT ID: NCT00252694
Status: COMPLETED
Last Update Posted: 2014-06-06
First Post: 2005-11-10
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: DIabetic Retinopathy Candesartan Trials
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': 'C081643', 'term': 'candesartan'}, {'id': 'C077793', 'term': 'candesartan cilexetil'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'phone': '+46 31 7766310', 'title': 'Niklas Berglind, GPS Atacand', 'organization': 'AstraZeneca'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During treatment.', 'description': 'The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.', 'eventGroups': [{'id': 'EG000', 'title': 'Candesartan', 'description': 'Candesartan cilexetil 32 mg once daily', 'otherNumAtRisk': 949, 'otherNumAffected': 50, 'seriousNumAtRisk': 949, 'seriousNumAffected': 301}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo Comparator', 'otherNumAtRisk': 953, 'otherNumAffected': 18, 'seriousNumAtRisk': 953, 'seriousNumAffected': 267}], 'otherEvents': [{'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 18}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Disseminated Intravascular Coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Iron Deficiency Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 18}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 14}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Myocardial Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Acute Coronary Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Arteriosclerosis Coronary Artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cardiac Failure Congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Coronary Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Supraventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Aortic Valve Incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Aortic Valve Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Arrhythmia Supraventricular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Atrioventricular Block Complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cardiac Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cardiogenic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cardiovascular Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Congestive Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Coronary Artery Insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Coronary Artery Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Intracardiac Thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ischaemic Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Left Ventricular Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Mitral Valve Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Mitral Valve Incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nodal Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hydrocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ventricular Septal Defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vertigo Positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Deafness Neurosensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sudden Hearing Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tympanic Membrane Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': "Basedow's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': "Cushing's Syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Thyroid Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Thyroiditis Chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Angle Closure Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Eye Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Open Angle Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Optic Ischaemic Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Optic Nerve Cupping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Retinal Artery Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Retinal Detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Retinal Tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Retinal Vein Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Anal Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastroduodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Inguinal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pancreatitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal Adhesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Colonic Polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Duodenal Polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Duodenal Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Epigastric Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Chondrocalcinosis Pyrophosphate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': "Dupuytren's Contracture", 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Foot Deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 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'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Osteitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rheumatoid Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue 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953, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Adrenal Adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Adrenal Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'B-Cell Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 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unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Chronic Lymphocytic Leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Chronic Myeloid Leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Colorectal Cancer Recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gallbladder Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastric Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Glioblastoma Multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hepatic Neoplasm Malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': "Hodgkin's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': "Kaposi's Sarcoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Laryngeal Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Lipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Lung Squamous Cell Carcinoma Stage Unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 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'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Metastases To Bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Myeloproliferative Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nasal Cavity Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Neoplasm Prostate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Peripheral T-Cell Lymphoma Unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Prostatic Adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rectal Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Renal Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Renal Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Renal Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Skin Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Thyroid Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Carpal Tunnel Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cerebral Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ischaemic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Loss Of Consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 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{'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Extremity Necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Microangiopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Peripheral Arterial Occlusive Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Peripheral Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Varicose Vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Venous Thrombosis Limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 949, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 953, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '951', 'groupId': 'OG000'}, {'value': '954', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Candesartan', 'description': 'Candesartan cilexetil 32 mg once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Comparator'}], 'classes': [{'categories': [{'measurements': [{'value': '161', 'spread': '0.045', 'groupId': 'OG000'}, {'value': '182', 'spread': '0.052', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1994', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.870', 'ciLowerLimit': '0.704', 'ciUpperLimit': '1.076', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Generalized', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.', 'description': '3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11). A generlized log-rank test was used to test difference between treatments.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least a 3 Step Improvement or a Persistent 2-step Improvement in the ETDRS Severity Scale.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '951', 'groupId': 'OG000'}, {'value': '954', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Candesartan', 'description': 'Candesartan cilexetil 32 mg once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Comparator'}], 'classes': [{'categories': [{'measurements': [{'value': '180', 'spread': '0.054', 'groupId': 'OG000'}, {'value': '136', 'spread': '0.040', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to end of study, i.e. 5 years.', 'description': '3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Incident Clinically Significant Macular Edema (CSME) and/or Proliferative Diabetic Retinopathy (PDR).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '951', 'groupId': 'OG000'}, {'value': '954', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Candesartan', 'description': 'Candesartan cilexetil 32 mg once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Comparator'}], 'classes': [{'categories': [{'measurements': [{'value': '192', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '193', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to end of study, i.e. 5 years.', 'description': 'Clinically Significant Macular Edema (CSME) and Proliferative Diabetic Retinopathy (PDR) are diagnosed via retinal photographs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.'}, {'type': 'SECONDARY', 'title': 'Rate of Change in Urinary Albumin Excretion Rate (UAER).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '951', 'groupId': 'OG000'}, {'value': '954', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Candesartan', 'description': 'Candesartan cilexetil 32 mg once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Comparator'}], 'classes': [{'categories': [{'measurements': [{'value': '656', 'groupId': 'OG000', 'lowerLimit': '605', 'upperLimit': '708'}, {'value': '718', 'groupId': 'OG001', 'lowerLimit': '666', 'upperLimit': '770'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to end of study, i.e. 5 years.', 'description': 'An estimate of the slope from fitting a linear regression of log(UAER) over time (post-randomisation, yearly assessments) for each patient.', 'unitOfMeasure': 'log (µg/min)/1000 year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Candesartan', 'description': 'Candesartan cilexetil 32 mg once daily'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo Comparator'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '951'}, {'groupId': 'FG001', 'numSubjects': '954'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '807'}, {'groupId': 'FG001', 'numSubjects': '800'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '144'}, {'groupId': 'FG001', 'numSubjects': '154'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '91'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'Mostly Lost to Follow Up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Patient Moving', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}]}]}], 'recruitmentDetails': 'First subject enrolled in the DIRECT Programme 8 June 2001 and last subject completed the DIRECT Programme 16 April 2008 mainly in hospital based clinics. A total of 4717 patients enrolled into the programme of whom 1905 patients proceeded to randomization into Study 47.', 'preAssignmentDetails': 'The most common reason for not being randomized was that all eligibility criteria were not fulfilled, followed by withdrawn informed consent.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '951', 'groupId': 'BG000'}, {'value': '954', 'groupId': 'BG001'}, {'value': '1905', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Candesartan', 'description': 'Candesartan cilexetil 32 mg once daily'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo Comparator'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '809', 'groupId': 'BG000'}, {'value': '808', 'groupId': 'BG001'}, {'value': '1617', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.9', 'spread': '7.6', 'groupId': 'BG000'}, {'value': '56.8', 'spread': '7.9', 'groupId': 'BG001'}, {'value': '56.8', 'spread': '7.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '485', 'groupId': 'BG000'}, {'value': '472', 'groupId': 'BG001'}, {'value': '957', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '466', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '948', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '327', 'groupId': 'BG002'}]}]}, {'title': 'Europe', 'categories': [{'measurements': [{'value': '419', 'groupId': 'BG000'}, {'value': '438', 'groupId': 'BG001'}, {'value': '857', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '188', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '361', 'groupId': 'BG002'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '360', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4717}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-09', 'studyFirstSubmitDate': '2005-11-10', 'resultsFirstSubmitDate': '2012-03-22', 'studyFirstSubmitQcDate': '2005-11-14', 'lastUpdatePostDateStruct': {'date': '2014-06-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-09', 'studyFirstPostDateStruct': {'date': '2005-11-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale', 'timeFrame': 'From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.', 'description': '3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11). A generlized log-rank test was used to test difference between treatments.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With at Least a 3 Step Improvement or a Persistent 2-step Improvement in the ETDRS Severity Scale.', 'timeFrame': 'From baseline to end of study, i.e. 5 years.', 'description': '3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11).'}, {'measure': 'Number of Participants With Incident Clinically Significant Macular Edema (CSME) and/or Proliferative Diabetic Retinopathy (PDR).', 'timeFrame': 'From baseline to end of study, i.e. 5 years.', 'description': 'Clinically Significant Macular Edema (CSME) and Proliferative Diabetic Retinopathy (PDR) are diagnosed via retinal photographs.'}, {'measure': 'Rate of Change in Urinary Albumin Excretion Rate (UAER).', 'timeFrame': 'From Baseline to end of study, i.e. 5 years.', 'description': 'An estimate of the slope from fitting a linear regression of log(UAER) over time (post-randomisation, yearly assessments) for each patient.'}]}, 'conditionsModule': {'keywords': ['Diabetes mellitus type 2'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '38682786', 'type': 'DERIVED', 'citation': 'Natale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2.'}, {'pmid': '21602709', 'type': 'DERIVED', 'citation': 'Tillin T, Orchard T, Malm A, Fuller J, Chaturvedi N. The role of antihypertensive therapy in reducing vascular complications of type 2 diabetes. Findings from the DIabetic REtinopathy Candesartan Trials-Protect 2 study. J Hypertens. 2011 Jul;29(7):1457-62. doi: 10.1097/HJH.0b013e3283480db9.'}, {'pmid': '21309844', 'type': 'DERIVED', 'citation': 'Sjolie AK, Klein R, Porta M, Orchard T, Fuller J, Parving HH, Bilous R, Aldington S, Chaturvedi N. Retinal microaneurysm count predicts progression and regression of diabetic retinopathy. Post-hoc results from the DIRECT Programme. Diabet Med. 2011 Mar;28(3):345-51. doi: 10.1111/j.1464-5491.2010.03210.x.'}, {'pmid': '21225239', 'type': 'DERIVED', 'citation': 'Porta M, Hainer JW, Jansson SO, Malm A, Bilous R, Chaturvedi N, Fuller JH, Klein R, Orchard T, Parving HH, Sjolie AK; DIRECT Study Group. Exposure to candesartan during the first trimester of pregnancy in type 1 diabetes: experience from the placebo-controlled DIabetic REtinopathy Candesartan Trials. Diabetologia. 2011 Jun;54(6):1298-303. doi: 10.1007/s00125-010-2040-1. Epub 2011 Jan 12.'}, {'pmid': '19451554', 'type': 'DERIVED', 'citation': 'Bilous R, Chaturvedi N, Sjolie AK, Fuller J, Klein R, Orchard T, Porta M, Parving HH. Effect of candesartan on microalbuminuria and albumin excretion rate in diabetes: three randomized trials. Ann Intern Med. 2009 Jul 7;151(1):11-20, W3-4. doi: 10.7326/0003-4819-151-1-200907070-00120. Epub 2009 May 18.'}, {'pmid': '18823658', 'type': 'DERIVED', 'citation': 'Sjolie AK, Klein R, Porta M, Orchard T, Fuller J, Parving HH, Bilous R, Chaturvedi N; DIRECT Programme Study Group. Effect of candesartan on progression and regression of retinopathy in type 2 diabetes (DIRECT-Protect 2): a randomised placebo-controlled trial. Lancet. 2008 Oct 18;372(9647):1385-93. doi: 10.1016/S0140-6736(08)61411-7. Epub 2008 Sep 25.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1912&filename=CSR-D2453C00047.pdf', 'label': 'CSR-D2453C00047.pdf'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to determine whether candesartan, compared to placebo reduces the progression of diabetic retinopathy in normoalbuminuric type 2 diabetic patients with retinopathy.\n\nThe secondary objective is to determine whether candesartan, compared to placebo, reduces the incidence of clinically significant macular oedema (CSME) and/or proliferative diabetic retinopathy (PDR) and beneficially influences the rate change in urinary albumin excretion rate (UAER).\n\nThis study is part of the DIRECT Programme also including a primary prevention study of diabetic retinopathy in type 1 diabetes and a secondary prevention study in type 1 diabetes. The primary objective for all three pooled studies is to determine whether candesartan, compared to placebo, reduces the incidence of microalbuminuria in type 1 and type 2 diabetic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '37 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 37 - 75 years with type 2 diabetes diagnosed at age of 36 years or thereafter.\n* Duration of diabetes for \\> 1 year and \\< 20 years with stable diabetic therapy within last 6 months.\n* Patients with untreated resting mean sitting SBP \\< 130 mmHg and mean sitting DBP \\< 85 or treated resting mean SBP \\< 160 mmHg and mean sitting DBP \\< 90 mmHg with retinal photograph grading level \\>20/10 up to \\< 47/47 (on ETDRS severity scale).\n\nExclusion Criteria:\n\n* Patients with the following conditions are excluded from participation in the study:\n* Cataract or media opacity of a degree which precludes taking gradable retinal photographs\n* Angle closure glaucoma, which precludes pharmacological dilatation of the pupil\n* History of or presence of proliferative retinopathy\n* History or presence of clinical significant macular oedema (CSME)\n* History or evidence of photocoagulation of the retina\n* Other retinal conditions which may mask assessment, eg, retinal vein occlusion\n* Positive micral dipstick test\n* Presence of secondary diabetes\n* Pregnant or lactating women or women of child bearing potential not practicing an adequate method of contraception\n* Need of treatment with ACE-inhibitor\n* Haemodynamically significant aortic or mitral valve stenosis\n* Known renal artery stenosis or kidney transplantation\n* Hypersensitivity to study drug\n* Severe concomitant disease which may interfere with the assessment of the patient, eg, malignancy, as judged by the investigator'}, 'identificationModule': {'nctId': 'NCT00252694', 'acronym': 'DIRECT', 'briefTitle': 'DIabetic Retinopathy Candesartan Trials', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 2 Diabetic Patients With Retinopathy.', 'orgStudyIdInfo': {'id': 'D2453C00047'}, 'secondaryIdInfos': [{'id': 'DIRECT'}, {'id': 'SH-AHM-0047'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'candesartan', 'description': 'candesartan cilexetil 32 mg once daily', 'interventionNames': ['Drug: candesartan']}, {'type': 'NO_INTERVENTION', 'label': 'placebo', 'description': 'control'}], 'interventions': [{'name': 'candesartan', 'type': 'DRUG', 'otherNames': ['ATACAND'], 'description': '32 mg oral tablet', 'armGroupLabels': ['candesartan']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'AstraZeneca Atacand Medical Science Director, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Takeda', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}