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

Ignite Creation Date: 2025-12-24 @ 10:56 PM

Ignite Modification Date: 2026-03-11 @ 5:02 PM

Study NCT ID: NCT02801669

Status: COMPLETED

Last Update Posted: 2020-11-19

First Post: 2016-06-13

Is Gene Therapy: True

Has Adverse Events: True

Brief Title: Study of DU-176b Aged 80 Years or Older

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': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C552171', 'term': 'edoxaban'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CTRinfo@dsi.com', 'phone': '908-992-6400', 'title': 'Contact for Clinical Trial Information', 'organization': 'Daiichi Sankyo'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events (TEAEs) were collected from baseline up to 3 years 2 months postdose.', 'description': 'A treatment-emergent adverse event (TEAE) was defined as an adverse event that first appears during treatment, which is absent before treatment or which worsens relative to pre-treatment state. TEAEs are reported in the Safety Analysis Set.', 'eventGroups': [{'id': 'EG000', 'title': 'DU-176b 15 mg', 'description': 'Participants who were randomized to oral DU-176b administered at a dose of 15 mg once daily.', 'otherNumAtRisk': 492, 'deathsNumAtRisk': 492, 'otherNumAffected': 461, 'seriousNumAtRisk': 492, 'deathsNumAffected': 66, 'seriousNumAffected': 220}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants who were randomized to oral placebo administered once daily.', 'otherNumAtRisk': 490, 'deathsNumAtRisk': 490, 'otherNumAffected': 454, 'seriousNumAtRisk': 490, 'deathsNumAffected': 69, 'seriousNumAffected': 238}], 'otherEvents': [{'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 16}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Haemorrhage subcutaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 88}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 14}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 111}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 121}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 53}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 32}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 51}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 20}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 45}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 45}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 31}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 49}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 41}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vaginal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Thalamus haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diverticulum intestinal haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Duodenal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastritis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Mouth haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Oesophagitis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Small intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cystitis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Genital haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Subcutaneous haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Wound haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Traumatic haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Traumatic liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Craniocerebral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Traumatic haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 34}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Embolic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 28}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 30}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 16}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 15}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 13}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Brain stem infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hepatic encephalopathy', 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'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Foot deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Crowned dens syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Prerenal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Azotaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bladder tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Disuse syndrome', 'stats': [{'groupId': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Occult blood positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Heat illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acetabulum fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Stress fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Spinal column injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Removal of foreign body from joint', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cardiac pacemaker replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With a Composite Endpoint of Stroke and Systemic Embolic Events (SEE) in Participants Who Were Administered DU-176b Compared With Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '492', 'groupId': 'OG000'}, {'value': '492', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DU-176b 15 mg', 'description': 'Participants who were randomized to oral DU-176b administered at a dose of 15 mg once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who were randomized to oral placebo administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.339', 'ciLowerLimit': '0.188', 'ciUpperLimit': '0.608', 'groupDescription': 'This statistical analysis assesses the annual incidence of composite event of stroke and SEE between treatment groups.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The treatment groups were compared using a Cox proportional hazard model with the CHADS2 score (\\<= 2 or \\>= 3) as covariate.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization up to the time of onset of the initial composite event of stroke or systemic embolic event, or study discontinuation, or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)', 'description': 'Stroke was defined as an abrupt onset, over minutes to hours, of symptoms representing focal neurological deficit in the domain supplied by a single brain artery (including the retinal artery) and that was not due to an identifiable non-vascular cause (such as brain tumor or trauma). The deficit symptoms had to either last for more than 24 hours or result in death within 24 hours of symptom onset.\n\nA systemic embolic event (SEE) was defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms (eg, atherosclerosis and instrumentation).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary outcome was assessed in the Intent-to-Treat (ITT) analysis set.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Stroke and Systemic Embolic Events (SEE), Including Subcomponents of Stroke and Composite Event of Ischemic Stroke and SEE in Participants Who Were Administered DU-176b Compared With Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '492', 'groupId': 'OG000'}, {'value': '492', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DU-176b 15 mg', 'description': 'Participants who were randomized to oral DU-176b administered at a dose of 15 mg once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who were randomized to oral placebo administered once daily.'}], 'classes': [{'title': 'Stroke', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Systemic Embolic Events (SEE)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Ischaemic Stroke', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Hemorrhagic Stroke', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Ischemic Stroke/SEE', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.299', 'ciLowerLimit': '0.157', 'ciUpperLimit': '0.570', 'estimateComment': 'The treatment groups were compared using a Cox proportional hazard model with the CHADS2 score (\\<= 2 or \\>= 3) as covariate.', 'groupDescription': 'This statistical analysis assesses the annual incidence of stroke between treatment groups.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.503', 'ciLowerLimit': '0.126', 'ciUpperLimit': '2.011', 'estimateComment': 'The treatment groups were compared using a Cox proportional hazard model with the CHADS2 score (\\<= 2 or \\>= 3) as covariate.', 'groupDescription': 'This statistical analysis assesses the annual incidence of SEE between treatment groups.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.306', 'ciLowerLimit': '0.160', 'ciUpperLimit': '0.585', 'estimateComment': 'The treatment groups were compared using a Cox proportional hazard model with the CHADS2 score (\\<= 2 or \\>= 3) as covariate.', 'groupDescription': 'This statistical analysis assesses the annual incidence of ischemic stroke between treatment groups.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.347', 'ciLowerLimit': '0.193', 'ciUpperLimit': '0.624', 'estimateComment': 'The treatment groups were compared using a Cox proportional hazard model with the CHADS2 score (\\<= 2 or \\>= 3) as covariate.', 'groupDescription': 'This statistical analysis assesses the annual incidence of ischemic stroke/SEE between treatment groups.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization up to the time of onset of the initial composite event of stroke or systemic embolic event, or study discontinuation, or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)', 'description': 'Stroke was defined as an abrupt onset, over minutes to hours, of symptoms representing focal neurological deficit in the domain supplied by a single brain artery (including the retinal artery) and that was not due to an identifiable non-vascular cause (such as brain tumor or trauma). The deficit symptoms had to either last for more than 24 hours or result in death within 24 hours of symptom onset. Subcomponents of stroke (ischemic and hemorrhagic) were also reported.\n\nA systemic embolic event (SEE) was defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms (eg, atherosclerosis and instrumentation).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary outcome was assessed in the Intent-to-Treat (ITT) analysis set.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Composite Endpoint of Stroke, Systemic Embolic Events (SEE), and Death Due to Cardiovascular in Participants Who Were Administered DU-176b Compared With Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '492', 'groupId': 'OG000'}, {'value': '492', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DU-176b 15 mg', 'description': 'Participants who were randomized to oral DU-176b administered at a dose of 15 mg once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who were randomized to oral placebo administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization up to the time of onset of the initial composite event of stroke, systemic embolic event, or death due to CV, or study discontinuation, or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)', 'description': 'Stroke was defined as an abrupt onset, over minutes to hours, of symptoms representing focal neurological deficit in the domain supplied by a single brain artery (including the retinal artery) and that was not due to an identifiable non-vascular cause (such as brain tumor or trauma). The deficit symptoms had to either last for more than 24 hours or result in death within 24 hours of symptom onset.\n\nA systemic embolic event (SEE) was defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms (eg, atherosclerosis and instrumentation).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Secondary outcomes were assessed in the Intent-to-Treat (ITT) analysis set.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Composite Endpoint of a Major Adverse Cardiovascular Event (MACE) in Participants Who Were Administered DU-176b Compared With Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '492', 'groupId': 'OG000'}, {'value': '492', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DU-176b 15 mg', 'description': 'Participants who were randomized to oral DU-176b administered at a dose of 15 mg once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who were randomized to oral placebo administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization up to the time of onset of the initial MACE event, or study discontinuation, or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)', 'description': 'Major adverse cardiovascular events (MACE) included a composite of non-fatal myocardial infarction (MI), non-fatal stroke, non-fatal systemic embolic events (SEE), and deaths due to cardiovascular (CV) or bleeding.\n\nStroke was defined as an abrupt onset, over minutes to hours, of symptoms representing focal neurological deficit in the domain supplied by a single brain artery (including the retinal artery) and that was not due to an identifiable non-vascular cause (such as brain tumor or trauma). The deficit symptoms had to either last for more than 24 hours or result in death within 24 hours of symptom onset.\n\nA SEE was defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms (eg, atherosclerosis and instrumentation).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Secondary outcomes were assessed in the Intent-to-Treat (ITT) analysis set.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Composite Endpoint of Stroke, Systemic Embolic Events (SEE), and All-Cause Mortality in Participants Who Were Administered DU-176b Compared With Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '492', 'groupId': 'OG000'}, {'value': '492', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DU-176b 15 mg', 'description': 'Participants who were randomized to oral DU-176b administered at a dose of 15 mg once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who were randomized to oral placebo administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization up to the time of onset of the initial composite event of stroke, SEE, all-cause mortality, or study discontinuation, or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)', 'description': 'Stroke was defined as an abrupt onset, over minutes to hours, of symptoms representing focal neurological deficit in the domain supplied by a single brain artery (including the retinal artery) and that was not due to an identifiable non-vascular cause (such as brain tumor or trauma). The deficit symptoms had to either last for more than 24 hours or result in death within 24 hours of symptom onset.\n\nA systemic embolic event (SEE) was defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms (eg, atherosclerosis and instrumentation).\n\nAll-cause mortality was defined as death due to cardiovascular and mortality due to all other causes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Secondary outcomes were assessed in the Intent-to-Treat (ITT) analysis set.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Net Clinical Benefit in Participants Who Were Administered DU-176b Compared With Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '492', 'groupId': 'OG000'}, {'value': '492', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DU-176b 15 mg', 'description': 'Participants who were randomized to oral DU-176b administered at a dose of 15 mg once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who were randomized to oral placebo administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization up to the time of onset of the initial composite event of stroke, SEE, major bleeding, all-cause mortality, or study discontinuation, or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)', 'description': 'Net clinical benefit included a composite of stroke, systemic embolic events (SEE), major bleeding, and all-cause mortality. Stroke was defined as an abrupt onset of symptoms representing focal neurological deficit in the domain supplied by a single brain artery that was not due to an identifiable non-vascular cause. The deficit symptoms had to either last \\>24 hours or result in death within 24 hours of symptom onset. A SEE was defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms. Major bleeding was defined as overt bleeding that met at least 1 of the following criteria: fatal bleeding; retroperitoneal, intracranial, intraocular, intrathecal, intraarticular, or pericardial bleeding, or symptomatic intramuscular bleeding accompanied by compartment syndrome; or clinically overt bleeding that decreased hemoglobin by at least 2.0 g/dL and required blood transfusion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Secondary outcomes were assessed in the Intent-to-Treat (ITT) analysis set.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All-Cause Mortality in Participants Who Were Administered DU-176b Compared With Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '492', 'groupId': 'OG000'}, {'value': '492', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DU-176b 15 mg', 'description': 'Participants who were randomized to oral DU-176b administered at a dose of 15 mg once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who were randomized to oral placebo administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization up to death (due to any cause), or study discontinuation, or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)', 'description': 'All-cause mortality was defined as death due to cardiovascular and mortality due to all other causes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Secondary outcomes were assessed in the Intent-to-Treat (ITT) analysis set.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Major Bleeding During On-Treatment Period in Participants Who Were Administered DU-176b Compared With Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '492', 'groupId': 'OG000'}, {'value': '490', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DU-176b 15 mg', 'description': 'Participants who were randomized to oral DU-176b administered at a dose of 15 mg once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who were randomized to oral placebo administered once daily.'}], 'classes': [{'title': 'Major bleeding', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Major bleeding, Intracranial haemorrhage', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Fatal bleeding', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Fatal bleeding, Intracranial haemorrhage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Fatal bleeding, Non-Intracranial haemorrhage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Life-threatening bleeding', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to study discontinuation or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)', 'description': 'Major bleeding was defined as overt bleeding that met at least 1 of the following criteria: fatal bleeding; retroperitoneal, intracranial, intraocular, intrathecal, intraarticular, or pericardial bleeding, or symptomatic intramuscular bleeding accompanied by compartment syndrome; or clinically overt bleeding that decreased hemoglobin by at least 2.0 g/dL and required blood transfusion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety outcomes were assessed in the Safety analysis set.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Major Bleeding or Clinically Relevant Non-major Bleedings During On-Treatment Period in Participants Who Were Administered DU-176b Compared With Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '492', 'groupId': 'OG000'}, {'value': '490', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DU-176b 15 mg', 'description': 'Participants who were randomized to oral DU-176b administered at a dose of 15 mg once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who were randomized to oral placebo administered once daily.'}], 'classes': [{'title': 'Major or clinically relevant non-major bleeding', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': 'Clinically relevant non-major bleeding', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to study discontinuation or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)', 'description': 'Major bleeding was defined as overt bleeding that met at least 1 of the following criteria: fatal bleeding; retroperitoneal, intracranial, intraocular, intrathecal, intraarticular, or pericardial bleeding, or symptomatic intramuscular bleeding accompanied by compartment syndrome; or clinically overt bleeding that decreased hemoglobin by at least 2.0 g/dL and required blood transfusion. Clinically overt bleeding that required treatment was taken to be clinically relevant non-major bleeding, including for example (but was not limited to) the bleeding that led to the diagnostic tests and treatments as specified in the protocol. The clinically overt bleeding requiring treatment did not include outpatient examinations that did not involve any of the medical procedures (diagnostic tests or treatments) as specified in the protocol.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety outcomes were assessed in the Safety analysis set.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All Bleeding Events and Minor Bleeding Events During On-Treatment Period in Participants Who Were Administered DU-176b Compared With Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '492', 'groupId': 'OG000'}, {'value': '490', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DU-176b 15 mg', 'description': 'Participants who were randomized to oral DU-176b administered at a dose of 15 mg once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who were randomized to oral placebo administered once daily.'}], 'classes': [{'title': 'All bleeding', 'categories': [{'measurements': [{'value': '241', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}]}, {'title': 'Minor bleeding', 'categories': [{'measurements': [{'value': '190', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to study discontinuation or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)', 'description': 'All bleeding events include major and clinically relevant non-major bleeding events.\n\nOther overt bleeding events that did not meet the criteria for major bleeding or clinically relevant non-major bleeding were taken to be minor bleeding (for example, epistaxis that did not require treatment). All events other than the above (such as a decrease in hemoglobin without overt bleeding) were classified as "non-bleeding event."', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety outcomes were assessed in the Safety analysis set.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of DU-176 in Participants Who Were Administered DU-176b', 'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DU-176b 15 mg', 'description': 'Participants who were randomized to oral DU-176b administered at a dose of 15 mg once daily.'}], 'classes': [{'title': 'Week 8: Predose (trough)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.3', 'spread': '13.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 8: 1-3 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.3', 'spread': '57.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 8: 4-8 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.4', 'spread': '37.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8: Predose,1-3 hours (h) and 4-8 h postdose', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Plasma concentration was assessed in the Pharmacokinetic Analysis Set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DU-176b 15 mg', 'description': 'Participants who were randomized to oral DU-176b administered at a dose of 15 mg once daily.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants who were randomized to oral placebo administered once daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '492'}, {'groupId': 'FG001', 'numSubjects': '492'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '492'}, {'groupId': 'FG001', 'numSubjects': '490'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '341'}, {'groupId': 'FG001', 'numSubjects': '340'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '152'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '69'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '77'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'A total of 984 participants who met all inclusion criteria and no exclusion criteria were randomized to treatment at 164 clinic centers in Japan. Of the 984 participants, 982 received treatment.', 'preAssignmentDetails': 'Participants were assigned to the DU-176b or placebo group in a 1:1 ratio using a stratified randomization method with the CHADS2 index score (≤2, ≥3) as a stratification factor.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '492', 'groupId': 'BG000'}, {'value': '492', 'groupId': 'BG001'}, {'value': '984', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DU-176b 15 mg', 'description': 'Participants who were randomized to oral DU-176b administered at a dose of 15 mg once daily.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants who were randomized to oral placebo administered once daily.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '86.7', 'spread': '4.22', 'groupId': 'BG000'}, {'value': '86.4', 'spread': '4.27', 'groupId': 'BG001'}, {'value': '86.6', 'spread': '4.24', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<85 years', 'categories': [{'measurements': [{'value': '173', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '354', 'groupId': 'BG002'}]}]}, {'title': '85 to <90 years', 'categories': [{'measurements': [{'value': '190', 'groupId': 'BG000'}, {'value': '184', 'groupId': 'BG001'}, {'value': '374', 'groupId': 'BG002'}]}]}, {'title': '90 to <95 years', 'categories': [{'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}]}]}, {'title': '95 years or older', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '280', 'groupId': 'BG000'}, {'value': '285', 'groupId': 'BG001'}, {'value': '565', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '212', 'groupId': 'BG000'}, {'value': '207', 'groupId': 'BG001'}, {'value': '419', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '492', 'groupId': 'BG000'}, {'value': '492', 'groupId': 'BG001'}, {'value': '984', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '492', 'groupId': 'BG000'}, {'value': '492', 'groupId': 'BG001'}, {'value': '984', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline demographics were assessed in the intent-to-treat (ITT) population.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-17', 'size': 13495925, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-10-24T15:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 984}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2019-12-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-17', 'studyFirstSubmitDate': '2016-06-13', 'resultsFirstSubmitDate': '2020-10-26', 'studyFirstSubmitQcDate': '2016-06-15', 'lastUpdatePostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-17', 'studyFirstPostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With a Composite Endpoint of Stroke and Systemic Embolic Events (SEE) in Participants Who Were Administered DU-176b Compared With Placebo', 'timeFrame': 'Randomization up to the time of onset of the initial composite event of stroke or systemic embolic event, or study discontinuation, or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)', 'description': 'Stroke was defined as an abrupt onset, over minutes to hours, of symptoms representing focal neurological deficit in the domain supplied by a single brain artery (including the retinal artery) and that was not due to an identifiable non-vascular cause (such as brain tumor or trauma). The deficit symptoms had to either last for more than 24 hours or result in death within 24 hours of symptom onset.\n\nA systemic embolic event (SEE) was defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms (eg, atherosclerosis and instrumentation).'}, {'measure': 'Number of Participants With Stroke and Systemic Embolic Events (SEE), Including Subcomponents of Stroke and Composite Event of Ischemic Stroke and SEE in Participants Who Were Administered DU-176b Compared With Placebo', 'timeFrame': 'Randomization up to the time of onset of the initial composite event of stroke or systemic embolic event, or study discontinuation, or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)', 'description': 'Stroke was defined as an abrupt onset, over minutes to hours, of symptoms representing focal neurological deficit in the domain supplied by a single brain artery (including the retinal artery) and that was not due to an identifiable non-vascular cause (such as brain tumor or trauma). The deficit symptoms had to either last for more than 24 hours or result in death within 24 hours of symptom onset. Subcomponents of stroke (ischemic and hemorrhagic) were also reported.\n\nA systemic embolic event (SEE) was defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms (eg, atherosclerosis and instrumentation).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With a Composite Endpoint of Stroke, Systemic Embolic Events (SEE), and Death Due to Cardiovascular in Participants Who Were Administered DU-176b Compared With Placebo', 'timeFrame': 'Randomization up to the time of onset of the initial composite event of stroke, systemic embolic event, or death due to CV, or study discontinuation, or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)', 'description': 'Stroke was defined as an abrupt onset, over minutes to hours, of symptoms representing focal neurological deficit in the domain supplied by a single brain artery (including the retinal artery) and that was not due to an identifiable non-vascular cause (such as brain tumor or trauma). The deficit symptoms had to either last for more than 24 hours or result in death within 24 hours of symptom onset.\n\nA systemic embolic event (SEE) was defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms (eg, atherosclerosis and instrumentation).'}, {'measure': 'Number of Participants With a Composite Endpoint of a Major Adverse Cardiovascular Event (MACE) in Participants Who Were Administered DU-176b Compared With Placebo', 'timeFrame': 'Randomization up to the time of onset of the initial MACE event, or study discontinuation, or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)', 'description': 'Major adverse cardiovascular events (MACE) included a composite of non-fatal myocardial infarction (MI), non-fatal stroke, non-fatal systemic embolic events (SEE), and deaths due to cardiovascular (CV) or bleeding.\n\nStroke was defined as an abrupt onset, over minutes to hours, of symptoms representing focal neurological deficit in the domain supplied by a single brain artery (including the retinal artery) and that was not due to an identifiable non-vascular cause (such as brain tumor or trauma). The deficit symptoms had to either last for more than 24 hours or result in death within 24 hours of symptom onset.\n\nA SEE was defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms (eg, atherosclerosis and instrumentation).'}, {'measure': 'Number of Participants With a Composite Endpoint of Stroke, Systemic Embolic Events (SEE), and All-Cause Mortality in Participants Who Were Administered DU-176b Compared With Placebo', 'timeFrame': 'Randomization up to the time of onset of the initial composite event of stroke, SEE, all-cause mortality, or study discontinuation, or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)', 'description': 'Stroke was defined as an abrupt onset, over minutes to hours, of symptoms representing focal neurological deficit in the domain supplied by a single brain artery (including the retinal artery) and that was not due to an identifiable non-vascular cause (such as brain tumor or trauma). The deficit symptoms had to either last for more than 24 hours or result in death within 24 hours of symptom onset.\n\nA systemic embolic event (SEE) was defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms (eg, atherosclerosis and instrumentation).\n\nAll-cause mortality was defined as death due to cardiovascular and mortality due to all other causes.'}, {'measure': 'Number of Participants With Net Clinical Benefit in Participants Who Were Administered DU-176b Compared With Placebo', 'timeFrame': 'Randomization up to the time of onset of the initial composite event of stroke, SEE, major bleeding, all-cause mortality, or study discontinuation, or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)', 'description': 'Net clinical benefit included a composite of stroke, systemic embolic events (SEE), major bleeding, and all-cause mortality. Stroke was defined as an abrupt onset of symptoms representing focal neurological deficit in the domain supplied by a single brain artery that was not due to an identifiable non-vascular cause. The deficit symptoms had to either last \\>24 hours or result in death within 24 hours of symptom onset. A SEE was defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms. Major bleeding was defined as overt bleeding that met at least 1 of the following criteria: fatal bleeding; retroperitoneal, intracranial, intraocular, intrathecal, intraarticular, or pericardial bleeding, or symptomatic intramuscular bleeding accompanied by compartment syndrome; or clinically overt bleeding that decreased hemoglobin by at least 2.0 g/dL and required blood transfusion.'}, {'measure': 'Number of Participants With All-Cause Mortality in Participants Who Were Administered DU-176b Compared With Placebo', 'timeFrame': 'Randomization up to death (due to any cause), or study discontinuation, or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)', 'description': 'All-cause mortality was defined as death due to cardiovascular and mortality due to all other causes.'}, {'measure': 'Number of Participants With Major Bleeding During On-Treatment Period in Participants Who Were Administered DU-176b Compared With Placebo', 'timeFrame': 'Baseline up to study discontinuation or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)', 'description': 'Major bleeding was defined as overt bleeding that met at least 1 of the following criteria: fatal bleeding; retroperitoneal, intracranial, intraocular, intrathecal, intraarticular, or pericardial bleeding, or symptomatic intramuscular bleeding accompanied by compartment syndrome; or clinically overt bleeding that decreased hemoglobin by at least 2.0 g/dL and required blood transfusion.'}, {'measure': 'Number of Participants With Major Bleeding or Clinically Relevant Non-major Bleedings During On-Treatment Period in Participants Who Were Administered DU-176b Compared With Placebo', 'timeFrame': 'Baseline up to study discontinuation or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)', 'description': 'Major bleeding was defined as overt bleeding that met at least 1 of the following criteria: fatal bleeding; retroperitoneal, intracranial, intraocular, intrathecal, intraarticular, or pericardial bleeding, or symptomatic intramuscular bleeding accompanied by compartment syndrome; or clinically overt bleeding that decreased hemoglobin by at least 2.0 g/dL and required blood transfusion. Clinically overt bleeding that required treatment was taken to be clinically relevant non-major bleeding, including for example (but was not limited to) the bleeding that led to the diagnostic tests and treatments as specified in the protocol. The clinically overt bleeding requiring treatment did not include outpatient examinations that did not involve any of the medical procedures (diagnostic tests or treatments) as specified in the protocol.'}, {'measure': 'Number of Participants With All Bleeding Events and Minor Bleeding Events During On-Treatment Period in Participants Who Were Administered DU-176b Compared With Placebo', 'timeFrame': 'Baseline up to study discontinuation or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)', 'description': 'All bleeding events include major and clinically relevant non-major bleeding events.\n\nOther overt bleeding events that did not meet the criteria for major bleeding or clinically relevant non-major bleeding were taken to be minor bleeding (for example, epistaxis that did not require treatment). All events other than the above (such as a decrease in hemoglobin without overt bleeding) were classified as "non-bleeding event."'}, {'measure': 'Plasma Concentration of DU-176 in Participants Who Were Administered DU-176b', 'timeFrame': 'Week 8: Predose,1-3 hours (h) and 4-8 h postdose'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['anticoagulants', 'DU-176b', 'edoxaban', 'factor Xa', 'oral', 'prevention', 'atrial fibrillation'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '38240204', 'type': 'DERIVED', 'citation': 'Akao M, Yamashita T, Fukuzawa M, Hayashi T, Okumura K. Efficacy and Safety of Low-Dose Edoxaban by Body Weight in Very Elderly Patients With Atrial Fibrillation: A Subanalysis of the Randomized ELDERCARE-AF Trial. J Am Heart Assoc. 2024 Feb 6;13(3):e031506. doi: 10.1161/JAHA.123.031506. Epub 2024 Jan 19.'}, {'pmid': '36700520', 'type': 'DERIVED', 'citation': 'Cochrane A, Chen C, Stephen J, Ronning OM, Anderson CS, Hankey GJ, Al-Shahi Salman R. Antithrombotic treatment after stroke due to intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Jan 26;1(1):CD012144. doi: 10.1002/14651858.CD012144.pub3.'}, {'pmid': '36056729', 'type': 'DERIVED', 'citation': 'Mikami T, Hirabayashi K, Okawa K, Betsuyaku T, Watanabe S, Imamura Y, Tanizawa K, Hayashi T, Akao M, Yamashita T, Okumura K. Laboratory Test Predictors for Major Bleeding in Elderly (>/=80 Years) Patients With Nonvalvular Atrial Fibrillation Treated With Edoxaban 15 mg: Sub-Analysis of the ELDERCARE-AF Trial. J Am Heart Assoc. 2022 Sep 6;11(17):e024970. doi: 10.1161/JAHA.122.024970. Epub 2022 Sep 3.'}, {'pmid': '35416910', 'type': 'DERIVED', 'citation': 'Kuroda M, Tamiya E, Nose T, Ogimoto A, Taura J, Imamura Y, Fukuzawa M, Hayashi T, Akao M, Yamashita T, Lip GYH, Okumura K. Effect of 15-mg Edoxaban on Clinical Outcomes in 3 Age Strata in Older Patients With Atrial Fibrillation: A Prespecified Subanalysis of the ELDERCARE-AF Randomized Clinical Trial. JAMA Cardiol. 2022 Jun 1;7(6):583-590. doi: 10.1001/jamacardio.2022.0480.'}, {'pmid': '35226559', 'type': 'DERIVED', 'citation': 'Yoshida T, Nakamura A, Funada J, Amino M, Shimizu W, Fukuzawa M, Watanabe S, Hayashi T, Yamashita T, Okumura K, Akao M. Efficacy and Safety of Edoxaban 15 mg According to Renal Function in Very Elderly Patients With Atrial Fibrillation: A Subanalysis of the ELDERCARE-AF Trial. Circulation. 2022 Mar;145(9):718-720. doi: 10.1161/CIRCULATIONAHA.121.057190. Epub 2022 Feb 28. No abstract available.'}, {'pmid': '32865374', 'type': 'DERIVED', 'citation': 'Okumura K, Akao M, Yoshida T, Kawata M, Okazaki O, Akashi S, Eshima K, Tanizawa K, Fukuzawa M, Hayashi T, Akishita M, Lip GYH, Yamashita T; ELDERCARE-AF Committees and Investigators. Low-Dose Edoxaban in Very Elderly Patients with Atrial Fibrillation. N Engl J Med. 2020 Oct 29;383(18):1735-1745. doi: 10.1056/NEJMoa2012883. Epub 2020 Aug 30.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of edoxaban in patients with non-valvular NVAF aged 80 years or older who are ineligible for available oral anticoagulation therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '80 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Nonvalvular Atrial Fibrillation (NVAF) aged 80 years or older who are ineligible for available oral anticoagulation therapy\n\nExclusion Criteria:\n\n* Patients with active bleeding\n* Patients who have poorly controlled hypertension\n* Patients who have liver dysfunction accompanied with disorder of blood coagulation'}, 'identificationModule': {'nctId': 'NCT02801669', 'briefTitle': 'Study of DU-176b Aged 80 Years or Older', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study of DU-176b in Patients With NVAF Aged 80 Years or Older Who Are Ineligible for Available Oral Anticoagulation Therapy', 'orgStudyIdInfo': {'id': 'DU176b-C-J316'}, 'secondaryIdInfos': [{'id': '163266', 'type': 'REGISTRY', 'domain': 'JAPIC CTI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DU-176b 15 mg group', 'description': 'DU-176b orally administered at a dose of 15 mg once daily.', 'interventionNames': ['Drug: Du-176b']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Placebo orally administered once daily.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Du-176b', 'type': 'DRUG', 'otherNames': ['edoxaban'], 'description': 'DU-176b orally administered at a dose of 15 mg once daily.', 'armGroupLabels': ['DU-176b 15 mg group']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Placebo orally administered once daily.', 'armGroupLabels': ['Placebo 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'facility': 'Tokai University Hospital', 'geoPoint': {'lat': 35.39932, 'lon': 139.31019}}, {'zip': '372-0841', 'city': 'Isesaki', 'country': 'Japan', 'facility': 'Kubo Clinic', 'geoPoint': {'lat': 36.31667, 'lon': 139.2}}, {'zip': '693-8501', 'city': 'Izumo', 'country': 'Japan', 'facility': 'Shimane University Hospital', 'geoPoint': {'lat': 35.36667, 'lon': 132.76667}}, {'zip': '892-0853', 'city': 'Kagoshima', 'country': 'Japan', 'facility': 'National Hospital Organization Kagoshima Medical Center', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '920-8650', 'city': 'Kanazawa', 'country': 'Japan', 'facility': 'National Hospital Organization Kanazawa Medical Center', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'zip': '486-8510', 'city': 'Kasugai', 'country': 'Japan', 'facility': 'Kasugai Municipal Hospital', 'geoPoint': {'lat': 35.24762, 'lon': 136.97229}}, {'zip': '125-0041', 'city': 'Katsushikachō', 'country': 'Japan', 'facility': 'Asano Kanamachi Clinic', 'geoPoint': 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