Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT00311402
Status:
COMPLETED
Last Update Posted:
2014-02-14
First Post:
2006-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
JASAP: Japanese Aggrenox Stroke Prevention vs. Aspirin Programme
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068342', 'term': 'Aspirin, Dipyridamole Drug Combination'}, {'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004176', 'term': 'Dipyridamole'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From day of first drug dose until 6 days after last dose, up to 874 days', 'eventGroups': [{'id': 'EG000', 'title': 'Aggrenox Capsule', 'description': 'Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily', 'otherNumAtRisk': 655, 'otherNumAffected': 634, 'seriousNumAtRisk': 655, 'seriousNumAffected': 178}, {'id': 'EG001', 'title': 'Acetylsalicylic Acid (ASA) 81 mg Tablet', 'description': 'ASA 81 mg, 1 tablet once daily', 'otherNumAtRisk': 639, 'otherNumAffected': 604, 'seriousNumAtRisk': 639, 'seriousNumAffected': 167}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 281}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 261}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 293}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 187}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 55}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 53}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 42}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 60}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 42}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 42}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 59}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 39}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 69}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 60}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 43}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Acute tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Bronchopulmonary aspergillosis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Peritonsillar abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pleurisy viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hepatic neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Large intestine carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Colon adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastrointestinal stromal tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Intestinal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Laryngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Leiomyosarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Malignant pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Oesophageal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Ovarian neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Rectosigmoid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Salivary gland neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Small cell lung cancer stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hyperadrenalism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Anxiety disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 32}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cerebellar haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Thalamus haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Basilar migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cerebellar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Haemorrhagic cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypertensive encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Mental impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nystagmus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Putamen haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Spondylitic myelopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Maculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Eyelid ptosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Retinal artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Retinal vein occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Auricular perichondritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Vertigo labyrinthine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Ischaemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Aortic aneurysm rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hyperventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Colonic polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Acute abdomen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Diverticulum intestinal haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastric polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastritis atrophic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastritis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Intestinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Mallory-Weiss syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Oesophageal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Oesophageal rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Oesophageal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Oesophagitis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Subileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gallbladder polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hepatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypoaesthesia facial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cervical spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': "Dupuytren's contracture", 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Foot deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Calculus bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Diabetic nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Renal failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pelvic haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Implant site inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Oedema due to renal disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Prostatic specific antigen increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cerebral haemorrhage traumatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Meniscus lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Blast injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Brain contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Burns first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Burns second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Clavicle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Diffuse axonal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Fat embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Limb traumatic amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Neck injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pubic rami fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Scapula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Subdural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '652', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aggrenox Capsule', 'description': 'Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily'}, {'id': 'OG001', 'title': 'Acetylsalicylic Acid (ASA) 81 mg Tablet', 'description': 'ASA 81 mg, 1 tablet once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.097', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciPctValue': '95', 'paramValue': '1.47', 'ciLowerLimit': '0.93', 'ciUpperLimit': '2.31', 'groupDescription': 'Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The non-event rates after 1 year in the Aggrenox group and ASA group are estimated at 94.0% and 91.5%, respectively. The non-inferiority margin was set to 2%. Under these conditions, 500 patients per group were supposed to be enough to detect the non-inferiority of Aggrenox with over 80% power.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 124 weeks', 'description': 'All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.', 'unitOfMeasure': 'patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Brain (Cerebral) Haemorrhage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '652', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aggrenox Capsule', 'description': 'Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily'}, {'id': 'OG001', 'title': 'Acetylsalicylic Acid (ASA) 81 mg Tablet', 'description': 'ASA 81 mg, 1 tablet once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.223', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciPctValue': '95', 'paramValue': '1.79', 'ciLowerLimit': '0.70', 'ciUpperLimit': '4.54', 'groupDescription': 'Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 124 weeks', 'description': 'All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.', 'unitOfMeasure': 'patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Subarachnoid Haemorrhage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '652', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aggrenox Capsule', 'description': 'Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily'}, {'id': 'OG001', 'title': 'Acetylsalicylic Acid (ASA) 81 mg Tablet', 'description': 'ASA 81 mg, 1 tablet once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.998', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '0', 'groupDescription': 'Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 124 weeks', 'description': 'All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.', 'unitOfMeasure': 'patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Transient Ischemic Attack (TIA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '652', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aggrenox Capsule', 'description': 'Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily'}, {'id': 'OG001', 'title': 'Acetylsalicylic Acid (ASA) 81 mg Tablet', 'description': 'ASA 81 mg, 1 tablet once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.977', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.21', 'ciUpperLimit': '5.07', 'groupDescription': 'Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 124 weeks', 'description': 'All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.', 'unitOfMeasure': 'patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Acute Coronary Syndrome (ACS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '652', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aggrenox Capsule', 'description': 'Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily'}, {'id': 'OG001', 'title': 'Acetylsalicylic Acid (ASA) 81 mg Tablet', 'description': 'ASA 81 mg, 1 tablet once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.192', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciPctValue': '95', 'paramValue': '0.58', 'ciLowerLimit': '0.26', 'ciUpperLimit': '1.31', 'groupDescription': 'Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 124 weeks', 'description': 'ACS contains acute myocardial infarction (MI), unstable angina and sudden cardiac death. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.', 'unitOfMeasure': 'patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Other Vascular Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '652', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aggrenox Capsule', 'description': 'Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily'}, {'id': 'OG001', 'title': 'Acetylsalicylic Acid (ASA) 81 mg Tablet', 'description': 'ASA 81 mg, 1 tablet once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.215', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciPctValue': '95', 'paramValue': '1.88', 'ciLowerLimit': '0.69', 'ciUpperLimit': '5.07', 'groupDescription': 'Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 124 weeks', 'description': 'This endpoints were defined as pulmonary embolism, retinal vascular disorder, deep vein thrombosis, peripheral artery obstruction and vascular intervention. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.', 'unitOfMeasure': 'patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Ischemic Vascular Event Composite Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '652', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aggrenox Capsule', 'description': 'Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily'}, {'id': 'OG001', 'title': 'Acetylsalicylic Acid (ASA) 81 mg Tablet', 'description': 'ASA 81 mg, 1 tablet once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.443', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.69', 'groupDescription': 'Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 124 weeks', 'description': 'This is a composite endpoint of cerebral infarction, transient ischemic attack (TIA), acute myocardial infarction (MI), unstable angina and sudden death attributable to thromboembolism. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.', 'unitOfMeasure': 'patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.'}, {'type': 'POST_HOC', 'title': 'Number of Patients With Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '652', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aggrenox Capsule', 'description': 'Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily'}, {'id': 'OG001', 'title': 'Acetylsalicylic Acid (ASA) 81 mg Tablet', 'description': 'ASA 81 mg, 1 tablet once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.043', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciPctValue': '95', 'paramValue': '1.52', 'ciLowerLimit': '1.01', 'ciUpperLimit': '2.29', 'groupDescription': 'Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 124 weeks', 'description': 'This is a composite endpoint of cerebral infarction, brain (cerebral) hemorrhage and subarachnoid haemorrhage. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.', 'unitOfMeasure': 'patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.'}, {'type': 'POST_HOC', 'title': 'Number of Patients With Intracranial Haemorrhage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '652', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aggrenox Capsule', 'description': 'Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily'}, {'id': 'OG001', 'title': 'Acetylsalicylic Acid (ASA) 81 mg Tablet', 'description': 'ASA 81 mg, 1 tablet once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.919', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.48', 'ciUpperLimit': '2.25', 'groupDescription': 'Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 124 weeks', 'description': 'All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.', 'unitOfMeasure': 'patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.'}, {'type': 'POST_HOC', 'title': 'Number of Patients With Composite Endpoint of Stroke or Major Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '652', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aggrenox Capsule', 'description': 'Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily'}, {'id': 'OG001', 'title': 'Acetylsalicylic Acid (ASA) 81 mg Tablet', 'description': 'ASA 81 mg, 1 tablet once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.101', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciPctValue': '95', 'paramValue': '1.34', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.91', 'groupDescription': 'Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 124 weeks', 'description': 'This is a composite endpoint of cerebral infarction, brain (cerebral) hemorrhage, subarachnoid haemorrhage and major bleeding. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.', 'unitOfMeasure': 'patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aggrenox Capsule', 'description': 'Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily'}, {'id': 'FG001', 'title': 'Acetylsalicylic Acid (ASA) 81 mg Tablet', 'description': 'ASA 81 mg, 1 tablet once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '655'}, {'groupId': 'FG001', 'numSubjects': '639'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '445'}, {'groupId': 'FG001', 'numSubjects': '462'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '210'}, {'groupId': 'FG001', 'numSubjects': '177'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '105'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': "IRB's rejection etc.", 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Patient recruitment initiated from June 2006 and completed in December 2007.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '655', 'groupId': 'BG000'}, {'value': '639', 'groupId': 'BG001'}, {'value': '1294', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Aggrenox Capsule', 'description': 'Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily'}, {'id': 'BG001', 'title': 'Acetylsalicylic Acid (ASA) 81 mg Tablet', 'description': 'ASA 81 mg, 1 tablet once daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.2', 'spread': '8.1', 'groupId': 'BG000'}, {'value': '66.0', 'spread': '8.6', 'groupId': 'BG001'}, {'value': '66.1', 'spread': '8.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '369', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '472', 'groupId': 'BG000'}, {'value': '453', 'groupId': 'BG001'}, {'value': '925', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1295}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'lastUpdateSubmitDate': '2014-01-21', 'studyFirstSubmitDate': '2006-03-28', 'resultsFirstSubmitDate': '2010-02-16', 'studyFirstSubmitQcDate': '2006-04-04', 'lastUpdatePostDateStruct': {'date': '2014-02-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-02-16', 'studyFirstPostDateStruct': {'date': '2006-04-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal)', 'timeFrame': 'Up to 124 weeks', 'description': 'All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Brain (Cerebral) Haemorrhage', 'timeFrame': 'Up to 124 weeks', 'description': 'All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.'}, {'measure': 'Number of Patients With Subarachnoid Haemorrhage', 'timeFrame': 'Up to 124 weeks', 'description': 'All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.'}, {'measure': 'Number of Patients With Transient Ischemic Attack (TIA)', 'timeFrame': 'Up to 124 weeks', 'description': 'All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.'}, {'measure': 'Number of Patients With Acute Coronary Syndrome (ACS)', 'timeFrame': 'Up to 124 weeks', 'description': 'ACS contains acute myocardial infarction (MI), unstable angina and sudden cardiac death. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.'}, {'measure': 'Number of Patients With Other Vascular Events', 'timeFrame': 'Up to 124 weeks', 'description': 'This endpoints were defined as pulmonary embolism, retinal vascular disorder, deep vein thrombosis, peripheral artery obstruction and vascular intervention. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.'}, {'measure': 'Number of Patients With Ischemic Vascular Event Composite Endpoint', 'timeFrame': 'Up to 124 weeks', 'description': 'This is a composite endpoint of cerebral infarction, transient ischemic attack (TIA), acute myocardial infarction (MI), unstable angina and sudden death attributable to thromboembolism. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.'}]}, 'conditionsModule': {'conditions': ['Cerebrovascular Accident']}, 'referencesModule': {'references': [{'pmid': '21502757', 'type': 'DERIVED', 'citation': 'Uchiyama S, Ikeda Y, Urano Y, Horie Y, Yamaguchi T. The Japanese aggrenox (extended-release dipyridamole plus aspirin) stroke prevention versus aspirin programme (JASAP) study: a randomized, double-blind, controlled trial. Cerebrovasc Dis. 2011;31(6):601-13. doi: 10.1159/000327035. Epub 2011 Apr 19.'}]}, 'descriptionModule': {'briefSummary': 'Phase III study to compare the preventive effect of recurrent brain infarction and safety of Aggrenox (combination drug containing sustained-release dipyridamole 200 mg/acetylsalicylic acid 25 mg) twice daily vs. acetylsalicylic acid 81 mg once daily'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients with a diagnosis of cerebral infarction (excluding cardiogenic cerebral embolism) who meet the diagnostic criteria based on the National Institute of Neurological Disorders and Stroke (NINDS) ad hoc committee's classification of cerebrovascular disease III.\n\n1. Patients who have had an onset of cerebral infarction, the time of which is known, between 1 week and 6 months before the time of enrolment (including first and recurrent cerebral infarctions)\n2. Patients who are 50 years or older\n3. Patients whose neurological signs and symptoms are considered to be stable by the investigator or sub-investigator\n4. Patients with a finding corresponding to the responsible focus confirmed by head X-ray computerised tomography (CT) or magnetic resonance imaging (MRI)\n5. Patients who have at least two of the following risk factors:\n\n * diabetes\n * hypertension (systolic blood pressure is 140 mmHg or higher or diastolic blood pressure is 90 mmHg or higher) or under treatment of hypertension\n * smoker (at the time of onset of cerebral infarction)\n * obesity (Body mass index (BMI) is more than 25 kg/m2)\n * previous vascular disease (stroke, acute myocardial infarction or peripheral arterial disease before the onset of cerebral infarction)\n * end-organ damage (retinopathy, left ventricular hypertrophy (LVH) or microalbuminuria)\n * hyperlipidaemia\n\nExclusion Criteria:\n\n1. Patients with a diagnosis of brain disorders with a bleeding risk such as brain haemorrhage, subarachnoid haemorrhage, cerebral arteriovenous (AV) malformation, cerebral AV aneurysms and brain tumours\n2. Patients with complications of cardiac disorders (atrial fibrillation, mitral valve stenosis, severe cardiac valve disorders) that may provide an embolic source for cerebral embolism\n3. Patients having had acute coronary syndromes (acute myocardial infarction, unstable angina) within 6 months after enrolment in this study\n4. Patient with hypersensitivity to dipyridamole preparations\n5. Patients with a history of drug allergy to acetylsalicylic acid (ASA) or aspirin asthma\n6. Patients with a history of peptic ulcer\n7. Patients having undergone arterial reconstruction after development of cerebral infarction\n8. Patients with very severe impairment (4 or 5 on Modified Rankin Scale)\n9. Patients with bleeding or bleeding tendencies (haemophilia, haemorrhage urinary tract, vitreous haemorrhage, etc.)\n10. Patients with severe hypertension (systolic blood pressure is 180 mmHg or higher or diastolic blood pressure is 110 mmHg or higher)\n11. Patients with complications such as serious cardiac, renal and hepatic disorders\n12. Patients with a malignant tumour or having had a tumour treatment in the past 5 years\n13. Women who are or may be pregnant or lactating women"}, 'identificationModule': {'nctId': 'NCT00311402', 'briefTitle': 'JASAP: Japanese Aggrenox Stroke Prevention vs. Aspirin Programme', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'JASAP: Japanese Aggrenox Stroke Prevention vs. Aspirin Programme, Phase III Study to Compare the Preventive Effect of Recurrent Brain Infarction and Safety of Aggrenox (Combination Drug Containing Sustained-release Dipyridamole 200 mg/Acetylsalicylic Acid 25 mg) Twice Daily vs. Acetylsalicylic Acid 81 mg Once Daily', 'orgStudyIdInfo': {'id': '9.178'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Aggrenox Capsule', 'interventionNames': ['Drug: Aggrenox capsule']}, {'type': 'OTHER', 'label': 'Acetylsalicylic Acid (ASA) 81 mg Tablet', 'interventionNames': ['Other: Acetylsalicylic Acid (ASA)']}], 'interventions': [{'name': 'Aggrenox capsule', 'type': 'DRUG', 'description': 'extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule, 2 capsules twice daily', 'armGroupLabels': ['Aggrenox Capsule']}, {'name': 'Acetylsalicylic Acid (ASA)', 'type': 'OTHER', 'description': 'Acetylsalicylic Acid (ASA) 81 mg, 1 tablet once daily', 'armGroupLabels': ['Acetylsalicylic Acid (ASA) 81 mg Tablet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Adachi-ku, Tokyo', 'country': 'Japan', 'facility': '9.178.060 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Adumino, Nagano', 'country': 'Japan', 'facility': '9.178.017 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 36.65, 'lon': 138.18333}}, {'city': 'Akashi, Hyogo', 'country': 'Japan', 'facility': '9.178.032 Boehringer Ingelheim Investigational Site'}, {'city': 'Akashi, Hyogo', 'country': 'Japan', 'facility': '9.178.074 Boehringer Ingelheim Investigational Site'}, {'city': 'Ako, Hyogo', 'country': 'Japan', 'facility': '9.178.062 Boehringer Ingelheim Investigational Site'}, {'city': 'Aoba-ku, Yokohama, Kanagawa', 'country': 'Japan', 'facility': '9.178.064 Boehringer Ingelheim Investigational Site'}, {'city': 'Aoi-ku, Shizuoka, Shizuoka', 'country': 'Japan', 'facility': '9.178.097 Boehringer Ingelheim Investigational Site'}, {'city': 'Asahi, Chiba', 'country': 'Japan', 'facility': '9.178.056 Boehringer Ingelheim Investigational Site'}, {'city': 'Asahikawa, Hokkaido', 'country': 'Japan', 'facility': '9.178.067 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.77063, 'lon': 142.36489}}, {'city': 'Asahikawa, Hokkaido', 'country': 'Japan', 'facility': '9.178.117 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.77063, 'lon': 142.36489}}, {'city': 'Atsugi, Kanagawa', 'country': 'Japan', 'facility': '9.178.166 Boehringer Ingelheim Investigational Site'}, {'city': 'Bunkyo-ku, Tokyo', 'country': 'Japan', 'facility': '9.178.089 Boehringer Ingelheim Investigational Site'}, {'city': 'Chitose, Hokkaido', 'country': 'Japan', 'facility': '9.178.054 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 42.81944, 'lon': 141.65222}}, {'city': 'Chuo-ku, Chiba, Chiba', 'country': 'Japan', 'facility': '9.178.133 Boehringer Ingelheim Investigational Site'}, {'city': 'Chuo-ku, Kobe, Hyogo', 'country': 'Japan', 'facility': '9.178.030 Boehringer Ingelheim Investigational Site'}, {'city': 'Chuo-ku, Sapporo, Hokkaido', 'country': 'Japan', 'facility': '9.178.077 Boehringer Ingelheim Investigational Site'}, {'city': 'Chuo-Ku, Sappro, Hokkaido', 'country': 'Japan', 'facility': '9.178.002 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 33.63867, 'lon': 130.67068}}, {'city': 'Chuo-ku, Sappro, Hokkaido', 'country': 'Japan', 'facility': '9.178.119 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 33.63867, 'lon': 130.67068}}, {'city': 'Daito, Osaka', 'country': 'Japan', 'facility': '9.178.161 Boehringer Ingelheim Investigational Site'}, {'city': 'Fuchu, Tokyo', 'country': 'Japan', 'facility': '9.178.112 Boehringer Ingelheim Investigational Site'}, {'city': 'Fujieda, Shizuoka', 'country': 'Japan', 'facility': '9.178.098 Boehringer Ingelheim Investigational Site'}, {'city': 'Fukaya, Saitama', 'country': 'Japan', 'facility': '9.178.046 Boehringer Ingelheim Investigational Site'}, {'city': 'Fukui, Fukui', 'country': 'Japan', 'facility': '9.178.145 Boehringer Ingelheim Investigational Site'}, {'city': 'Fukuroi, Shizuoka', 'country': 'Japan', 'facility': '9.178.099 Boehringer Ingelheim Investigational Site'}, {'city': 'Funabashi, Chiba', 'country': 'Japan', 'facility': '9.178.165 Boehringer Ingelheim Investigational Site'}, {'city': 'Fushimi-ku, Kyoto, Kyoto', 'country': 'Japan', 'facility': '9.178.072 Boehringer Ingelheim Investigational Site'}, {'city': 'Gifu, Gifu', 'country': 'Japan', 'facility': '9.178.081 Boehringer Ingelheim Investigational Site'}, {'city': 'Habikino, Osaka', 'country': 'Japan', 'facility': '9.178.024 Boehringer Ingelheim Investigational Site'}, {'city': 'Hachioji, Tokyo', 'country': 'Japan', 'facility': '9.178.136 Boehringer Ingelheim Investigational Site'}, {'city': 'Hakodate, Hokkaido', 'country': 'Japan', 'facility': '9.178.082 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 41.77583, 'lon': 140.73667}}, {'city': 'Hakodate, Hokkaido', 'country': 'Japan', 'facility': '9.178.118 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 41.77583, 'lon': 140.73667}}, {'city': 'Hamada, Shimane', 'country': 'Japan', 'facility': '9.178.052 Boehringer Ingelheim Investigational Site'}, {'city': 'Hashima-gun, Gifu', 'country': 'Japan', 'facility': '9.178.138 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'city': 'Hidaka, Saitama', 'country': 'Japan', 'facility': '9.178.169 Boehringer Ingelheim Investigational Site'}, {'city': 'Higashi-ku, Sappro, Hokkaido', 'country': 'Japan', 'facility': '9.178.001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 32.40781, 'lon': 130.56341}}, {'city': 'Higashi-osaka, Osaka', 'country': 'Japan', 'facility': '9.178.026 Boehringer Ingelheim Investigational Site'}, {'city': 'Higashidakawa-gun, Yamagata', 'country': 'Japan', 'facility': '9.178.163 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 38.23333, 'lon': 140.36667}}, {'city': 'Higashimatsushima, Miyagi', 'country': 'Japan', 'facility': '9.178.120 Boehringer Ingelheim Investigational Site'}, {'city': 'Higashinari-ku, Osaka, Osaka', 'country': 'Japan', 'facility': '9.178.028 Boehringer Ingelheim Investigational Site'}, {'city': 'Higashiosaka, Osaka', 'country': 'Japan', 'facility': '9.178.140 Boehringer Ingelheim Investigational Site'}, {'city': 'Higashisonogi-gun, Nagasaki', 'country': 'Japan', 'facility': '9.178.122 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'city': 'Higashiyodogawa-ku, Osaka, Osaka', 'country': 'Japan', 'facility': '9.178.101 Boehringer Ingelheim Investigational Site'}, {'city': 'Himeji, Hyogo', 'country': 'Japan', 'facility': '9.178.093 Boehringer Ingelheim Investigational Site'}, {'city': 'Hitachi, Ibaraki', 'country': 'Japan', 'facility': '9.178.153 Boehringer Ingelheim Investigational Site'}, {'city': 'Hitachinaka, Ibaraki', 'country': 'Japan', 'facility': '9.178.005 Boehringer Ingelheim Investigational Site'}, {'city': 'Ibusuki, Kagoshima', 'country': 'Japan', 'facility': '9.178.079 Boehringer Ingelheim Investigational Site'}, {'city': 'Ichikawa, Chiba', 'country': 'Japan', 'facility': '9.178.143 Boehringer Ingelheim Investigational Site'}, {'city': 'Iida, Nagano', 'country': 'Japan', 'facility': '9.178.019 Boehringer Ingelheim Investigational Site'}, {'city': 'Inashiki-gun, Ibaraki', 'country': 'Japan', 'facility': '9.178.129 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}, {'city': 'Isesaki, Gunma', 'country': 'Japan', 'facility': '9.178.011 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 36.31667, 'lon': 139.2}}, {'city': 'Isesaki, Gunma', 'country': 'Japan', 'facility': '9.178.045 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 36.31667, 'lon': 139.2}}, {'city': 'Itami, Hyogo', 'country': 'Japan', 'facility': '9.178.031 Boehringer Ingelheim Investigational Site'}, {'city': 'Iwanuma, Miyagi', 'country': 'Japan', 'facility': '9.178.135 Boehringer Ingelheim Investigational Site'}, {'city': 'Iwata, Shizuoka', 'country': 'Japan', 'facility': '9.178.104 Boehringer Ingelheim Investigational Site'}, {'city': 'Izuka, Fukuoka', 'country': 'Japan', 'facility': '9.178.095 Boehringer Ingelheim Investigational Site'}, {'city': 'Izumisano, Osaka', 'country': 'Japan', 'facility': '9.178.080 Boehringer Ingelheim Investigational Site'}, {'city': 'Izumo, Shimane', 'country': 'Japan', 'facility': '9.178.139 Boehringer Ingelheim Investigational Site'}, {'city': 'Izunokuni, Shizuoka', 'country': 'Japan', 'facility': '9.178.113 Boehringer Ingelheim Investigational Site'}, {'city': 'Kahoku-gun, Ishikawa', 'country': 'Japan', 'facility': '9.178.115 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 26.42333, 'lon': 127.82139}}, {'city': 'Kameda-gun, Hokkaido', 'country': 'Japan', 'facility': '9.178.147 Boehringer Ingelheim Investigational Site'}, {'city': 'Kamigyo-ku, Kyoto, Kyoto', 'country': 'Japan', 'facility': '9.178.092 Boehringer Ingelheim Investigational Site'}, {'city': 'Kasama, Ibaraki', 'country': 'Japan', 'facility': '9.178.008 Boehringer Ingelheim Investigational Site'}, {'city': 'Kasuga, Fukuoka', 'country': 'Japan', 'facility': '9.178.035 Boehringer Ingelheim Investigational Site'}, {'city': 'Kasuga, Fukuoka', 'country': 'Japan', 'facility': '9.178.037 Boehringer Ingelheim Investigational Site'}, {'city': 'Kawachinagano, Osaka', 'country': 'Japan', 'facility': '9.178.051 Boehringer Ingelheim Investigational Site'}, {'city': 'Kisarazu, Chiba', 'country': 'Japan', 'facility': '9.178.086 Boehringer Ingelheim Investigational Site'}, {'city': 'Kishiwada, Osaka', 'country': 'Japan', 'facility': '9.178.162 Boehringer Ingelheim Investigational Site'}, {'city': 'Kita-ku, Nagoya, Aichi', 'country': 'Japan', 'facility': '9.178.102 Boehringer Ingelheim Investigational Site'}, {'city': 'Kita-ku, Osaka, Osaka', 'country': 'Japan', 'facility': '9.178.023 Boehringer Ingelheim Investigational Site'}, {'city': 'Kita-ku, Osaka, Osaka', 'country': 'Japan', 'facility': '9.178.127 Boehringer Ingelheim Investigational Site'}, {'city': 'Kita-ku, Sappro, Hokkaido', 'country': 'Japan', 'facility': '9.178.004 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 35.75264, 'lon': 139.73348}}, {'city': 'Kitami, Hokkaido', 'country': 'Japan', 'facility': '9.178.154 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.80306, 'lon': 143.89083}}, {'city': 'Kitami, Hokkaido', 'country': 'Japan', 'facility': '9.178.155 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.80306, 'lon': 143.89083}}, {'city': 'Kiyose, Tokyo', 'country': 'Japan', 'facility': '9.178.069 Boehringer Ingelheim Investigational Site'}, {'city': 'Kiyose, Tokyo', 'country': 'Japan', 'facility': '9.178.070 Boehringer Ingelheim Investigational Site'}, {'city': 'Kochi, Kochi', 'country': 'Japan', 'facility': '9.178.121 Boehringer Ingelheim Investigational Site'}, {'city': 'Kochi, Kochi', 'country': 'Japan', 'facility': '9.178.141 Boehringer Ingelheim Investigational Site'}, {'city': 'Koriyama, Fukushima', 'country': 'Japan', 'facility': '9.178.061 Boehringer Ingelheim Investigational Site'}, {'city': 'Koriyama, Fukushima', 'country': 'Japan', 'facility': '9.178.085 Boehringer Ingelheim Investigational Site'}, {'city': 'Koshi, Kumamoto', 'country': 'Japan', 'facility': '9.178.075 Boehringer Ingelheim Investigational Site'}, {'city': 'Kurashiki, Okayama', 'country': 'Japan', 'facility': '9.178.107 Boehringer Ingelheim Investigational Site'}, {'city': 'Kushiro', 'country': 'Japan', 'facility': '9.178.063 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 42.975, 'lon': 144.37472}}, {'city': 'Kushiro', 'country': 'Japan', 'facility': '9.178.083 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 42.975, 'lon': 144.37472}}, {'city': 'Kushiro', 'country': 'Japan', 'facility': '9.178.126 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 42.975, 'lon': 144.37472}}, {'city': 'Marugame, Kagawa', 'country': 'Japan', 'facility': '9.178.150 Boehringer Ingelheim Investigational Site'}, {'city': 'Matsudo, Chiba', 'country': 'Japan', 'facility': '9.178.164 Boehringer Ingelheim Investigational Site'}, {'city': 'Matsumoto, Nagano', 'country': 'Japan', 'facility': '9.178.015 Boehringer Ingelheim Investigational Site'}, {'city': 'Meguro-ku, Tokyo', 'country': 'Japan', 'facility': '9.178.130 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Meito-ku, Nagoya, Aichi', 'country': 'Japan', 'facility': '9.178.057 Boehringer Ingelheim Investigational Site'}, {'city': 'Midori-ku, Yokohama, Kanagawa', 'country': 'Japan', 'facility': '9.178.013 Boehringer Ingelheim Investigational Site'}, {'city': 'Minami-ku, Hiroshima, Hiroshima', 'country': 'Japan', 'facility': '9.178.043 Boehringer Ingelheim Investigational Site'}, {'city': 'Miyagino-ku, Sendai, Miyagi', 'country': 'Japan', 'facility': '9.178.068 Boehringer Ingelheim Investigational Site'}, {'city': 'Miyazaki, Miyazaki', 'country': 'Japan', 'facility': '9.178.116 Boehringer Ingelheim Investigational Site'}, {'city': 'Moriguchi, Osaka', 'country': 'Japan', 'facility': '9.178.142 Boehringer Ingelheim Investigational Site'}, {'city': 'Morioka, Iwate', 'country': 'Japan', 'facility': '9.178.078 Boehringer Ingelheim Investigational Site'}, {'city': 'Morioka, Iwate', 'country': 'Japan', 'facility': '9.178.084 Boehringer Ingelheim Investigational Site'}, {'city': 'Moriya, Ibaraki', 'country': 'Japan', 'facility': '9.178.009 Boehringer Ingelheim Investigational Site'}, {'city': 'Moriya, Ibaraki', 'country': 'Japan', 'facility': '9.178.149 Boehringer Ingelheim Investigational Site'}, {'city': 'Musashimurayama, Tokyo', 'country': 'Japan', 'facility': '9.178.071 Boehringer Ingelheim Investigational Site'}, {'city': 'Musashino, Tokyo', 'country': 'Japan', 'facility': '9.178.012 Boehringer Ingelheim Investigational Site'}, {'city': 'Naka-ku, Hamamatsu, Shizuoka', 'country': 'Japan', 'facility': '9.178.100 Boehringer Ingelheim Investigational Site'}, {'city': 'Naka-ku, Hamamatsu, Shizuoka', 'country': 'Japan', 'facility': '9.178.110 Boehringer Ingelheim Investigational Site'}, {'city': 'Naka-ku, Nagoya, Aichi', 'country': 'Japan', 'facility': '9.178.020 Boehringer Ingelheim Investigational Site'}, {'city': 'Nakagawa-ku, Nagoya, Aichi', 'country': 'Japan', 'facility': '9.178.053 Boehringer Ingelheim Investigational Site'}, {'city': 'Nakagawa-ku, Nagoya, Nagoya', 'country': 'Japan', 'facility': '9.178.132 Boehringer Ingelheim Investigational Site'}, {'city': 'Namegata, Ibaraki', 'country': 'Japan', 'facility': '9.178.124 Boehringer Ingelheim Investigational Site'}, {'city': 'Nanao, Ishikawa', 'country': 'Japan', 'facility': '9.178.158 Boehringer Ingelheim Investigational Site'}, {'city': 'Nishi-yodogawa-ku, Osaka, Osaka', 'country': 'Japan', 'facility': '9.178.029 Boehringer Ingelheim Investigational Site'}, {'city': 'Nishisonogi-gun, Nagasaki', 'country': 'Japan', 'facility': '9.178.096 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'city': 'Noda, Chiba', 'country': 'Japan', 'facility': '9.178.087 Boehringer Ingelheim Investigational Site'}, {'city': 'Obu, Aichi', 'country': 'Japan', 'facility': '9.178.058 Boehringer Ingelheim Investigational Site'}, {'city': 'Ohnojo, Fukuoka', 'country': 'Japan', 'facility': '9.178.034 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Okayama, Okayama', 'country': 'Japan', 'facility': '9.178.157 Boehringer Ingelheim Investigational Site'}, {'city': 'Okinawa, Okinawa', 'country': 'Japan', 'facility': '9.178.167 Boehringer Ingelheim Investigational Site'}, {'city': 'Sagamihara, Kanagawa', 'country': 'Japan', 'facility': '9.178.137 Boehringer Ingelheim Investigational Site'}, {'city': 'Sakai, Osaka', 'country': 'Japan', 'facility': '9.178.027 Boehringer Ingelheim Investigational Site'}, {'city': 'Sakai, Osaka', 'country': 'Japan', 'facility': '9.178.073 Boehringer Ingelheim Investigational Site'}, {'city': 'Saku, Nagano', 'country': 'Japan', 'facility': '9.178.018 Boehringer Ingelheim Investigational Site'}, {'city': 'Sapporo, Hokkaido', 'country': 'Japan', 'facility': '9.178.160 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Setagaya-ku, Tokyo', 'country': 'Japan', 'facility': '9.178.041 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Shibuya-ku, Tokyo', 'country': 'Japan', 'facility': '9.178.088 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Shimogyo-ku, Kyoto, Kyoto', 'country': 'Japan', 'facility': '9.178.022 Boehringer Ingelheim Investigational Site'}, {'city': 'Shimotsuke, Tochigi', 'country': 'Japan', 'facility': '9.178.076 Boehringer Ingelheim Investigational Site'}, {'city': 'Shiroishi, Miyagi', 'country': 'Japan', 'facility': '9.178.055 Boehringer Ingelheim Investigational Site'}, {'city': 'Simizu-ku, Shizuoka, Shizuoka', 'country': 'Japan', 'facility': '9.178.111 Boehringer Ingelheim Investigational Site'}, {'city': 'Suminoe-ku, Osaka, Osaka', 'country': 'Japan', 'facility': '9.178.151 Boehringer Ingelheim Investigational Site'}, {'city': 'Susono, Shizuoka', 'country': 'Japan', 'facility': '9.178.156 Boehringer Ingelheim Investigational Site'}, {'city': 'Suwa, Nagano', 'country': 'Japan', 'facility': '9.178.014 Boehringer Ingelheim Investigational Site'}, {'city': 'Takasaki, Gunma', 'country': 'Japan', 'facility': '9.178.039 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 36.33333, 'lon': 139.01667}}, {'city': 'Takatsuki, Osaka', 'country': 'Japan', 'facility': '9.178.146 Boehringer Ingelheim Investigational Site'}, {'city': 'Takayama, Gifu', 'country': 'Japan', 'facility': '9.178.144 Boehringer Ingelheim Investigational Site'}, {'city': 'Takikawa, Hokkaido', 'country': 'Japan', 'facility': '9.178.003 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.55278, 'lon': 141.90639}}, {'city': 'Tatebayashi, Gunma', 'country': 'Japan', 'facility': '9.178.040 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 36.25, 'lon': 139.53333}}, {'city': 'Teine-ku, Sapporo, Hokkaido', 'country': 'Japan', 'facility': '9.178.066 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Tenri, Nara', 'country': 'Japan', 'facility': '9.178.134 Boehringer Ingelheim Investigational Site'}, {'city': 'Tonami, Toyama', 'country': 'Japan', 'facility': '9.178.159 Boehringer Ingelheim Investigational Site'}, {'city': 'Toride, Ibaraki', 'country': 'Japan', 'facility': '9.178.007 Boehringer Ingelheim Investigational Site'}, {'city': 'Toyama, Toyama', 'country': 'Japan', 'facility': '9.178.047 Boehringer Ingelheim Investigational Site'}, {'city': 'Toyohashi, Aichi', 'country': 'Japan', 'facility': '9.178.090 Boehringer Ingelheim Investigational Site'}, {'city': 'Toyota, Aichi', 'country': 'Japan', 'facility': '9.178.131 Boehringer Ingelheim Investigational Site'}, {'city': 'Tsuchiura, Ibaraki', 'country': 'Japan', 'facility': '9.178.006 Boehringer Ingelheim Investigational Site'}, {'city': 'Ueda, Nagano', 'country': 'Japan', 'facility': '9.178.016 Boehringer Ingelheim Investigational Site'}, {'city': 'Uji, Kyoto', 'country': 'Japan', 'facility': '9.178.091 Boehringer Ingelheim Investigational Site'}, {'city': 'Ukyo-ku, Kyoto, Kyoto', 'country': 'Japan', 'facility': '9.178.050 Boehringer Ingelheim Investigational Site'}, {'city': 'Urayasu, Chiba', 'country': 'Japan', 'facility': '9.178.106 Boehringer Ingelheim Investigational Site'}, {'city': 'Wakayama, Wakayama', 'country': 'Japan', 'facility': '9.178.148 Boehringer Ingelheim Investigational Site'}, {'city': 'Wko, Saitama', 'country': 'Japan', 'facility': '9.178.114 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'city': 'Yaizu, Shizuoka', 'country': 'Japan', 'facility': '9.178.152 Boehringer Ingelheim Investigational Site'}, {'city': 'Yamashina, Kyoto, Kyoto', 'country': 'Japan', 'facility': '9.178.125 Boehringer Ingelheim Investigational Site'}, {'city': 'Yanai, Yamaguchi', 'country': 'Japan', 'facility': '9.178.108 Boehringer Ingelheim Investigational Site'}, {'city': 'Yao, Osaka', 'country': 'Japan', 'facility': '9.178.103 Boehringer Ingelheim Investigational Site'}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Boehringer Ingelheim, Study Chair', 'oldOrganization': 'Boehringer Ingelheim'}}}}