Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2026-03-13 @ 11:21 AM
Study NCT ID:
NCT00501059
Status:
COMPLETED
Last Update Posted:
2018-10-26
First Post:
2007-07-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess the Efficacy and Safety of Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease
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': '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayer.com', 'title': 'Therapeutic Area Head', 'organization': 'BAYER'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The reported analyses are limited to endpoint events that met strict criteria. Further blinded review of events is ongoing to identify endpoints based on pragmatic criteria. Interpretations for clinical decision making should await future reporting.'}}, 'adverseEventsModule': {'timeFrame': 'Until follow-up (approximately 6 years)', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Subjects received 1 tablets of matching placebo orally once daily.', 'otherNumAtRisk': 6276, 'otherNumAffected': 5053, 'seriousNumAtRisk': 6276, 'seriousNumAffected': 1311}, {'id': 'EG001', 'title': 'Acetylsalicylic Acid', 'description': 'Subjects received 1 tablet of enteric-coated acetylsalicylic acid \\[100 milligram (mg)\\] orally one daily.', 'otherNumAtRisk': 6270, 'otherNumAffected': 5059, 'seriousNumAtRisk': 6270, 'seriousNumAffected': 1266}], 'otherEvents': [{'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 803, 'numAffected': 653}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 816, 'numAffected': 636}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 908, 'numAffected': 688}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 897, 'numAffected': 695}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 680, 'numAffected': 482}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 741, 'numAffected': 514}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 601, 'numAffected': 497}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 556, 'numAffected': 442}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 419, 'numAffected': 362}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 446, 'numAffected': 374}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 578, 'numAffected': 514}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 526, 'numAffected': 478}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 703, 'numAffected': 420}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 650, 'numAffected': 377}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 524, 'numAffected': 407}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 550, 'numAffected': 421}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 517, 'numAffected': 423}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 548, 'numAffected': 468}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 406, 'numAffected': 359}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 406, 'numAffected': 354}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 491, 'numAffected': 371}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 443, 'numAffected': 348}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 474, 'numAffected': 321}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 549, 'numAffected': 363}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'seriousEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Abdominal lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Abdominal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Abdominal wall abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Accident at work', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Acetabulum fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Acoustic neuroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Acute febrile neutrophilic dermatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 58, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 44, 'numAffected': 43}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Adenocarcinoma gastric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Adenocarcinoma pancreas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Adenolymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Adenoma benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Adjustment disorder with depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Adrenal adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Adrenal gland cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Adrenocortical carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Agitated depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Alcohol abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Alcohol poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Alcohol withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Alcoholic liver disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Alcoholism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Allergy to arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Amaurosis fugax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Ameloblastoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Amyotrophic lateral sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Anaemia postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Anal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Anal fistula infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Anal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 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'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Eye disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Eye haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Eyelid dermatochalasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 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intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Laryngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Laryngeal cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Laryngeal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Laryngeal squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Left ventricular hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lentigo maligna', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lentigo maligna recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Leriche syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Leukoplakia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Ligament rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lip squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Liposarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lower respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lower urinary tract symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lumbar radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lung adenocarcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lung adenocarcinoma stage I', 'stats': 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'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lung neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lung squamous cell carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lymphangiosis carcinomatosa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Macular fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Macular hole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Malignant hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Malignant neoplasm of ampulla of Vater', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Malignant neoplasm of pleura metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Malignant neoplasm of unknown primary site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Malignant nipple neoplasm', 'stats': 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'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Mantle cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Mechanical ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Mediastinal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 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{'term': "Morton's neuralgia", 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Motor neurone disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Multiple fractures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 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{'term': 'Vocal cord polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': "Wernicke's encephalopathy", 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'White blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Wound complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Yersinia infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to the First Occurrence of the Composite Outcome of MI (Myocardial Infarction), Stroke, Cardiovascular Death, UA (Unstable Angina) or TIA (Transient Ischemic Attack)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6270', 'groupId': 'OG000'}, {'value': '6276', 'groupId': 'OG001'}]}, {'units': 'Days', 'counts': [{'value': '1630', 'groupId': 'OG000'}, {'value': '1630', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylsalicylic Acid (Aspirin, BAYE4465)', 'description': 'Subjects received 1 tablet of enteric-coated acetylsalicylic acid \\[100 milligram (mg)\\] orally once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 1 tablets of matching placebo orally once daily.'}], 'classes': [{'title': 'Days until 1% subjects had an efficacy event', 'categories': [{'measurements': [{'value': '528', 'groupId': 'OG000'}, {'value': '381', 'groupId': 'OG001'}]}]}, {'title': 'Days until 2% subjects had an efficacy event', 'categories': [{'measurements': [{'value': '889', 'groupId': 'OG000'}, {'value': '796', 'groupId': 'OG001'}]}]}, {'title': 'Days until 3% subjects had an efficacy event', 'categories': [{'measurements': [{'value': '1225', 'groupId': 'OG000'}, {'value': '1134', 'groupId': 'OG001'}]}]}, {'title': 'Days until 4% subjects had an efficacy event', 'categories': [{'measurements': [{'value': '1630', 'groupId': 'OG000'}, {'value': '1582', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.597', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Primary efficacy analysis of time to the composite endpoint was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant and the primary objective of the study will have been met if the 2-sided P value is ≤0.05.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Until follow-up (approximate 6 years)', 'description': 'The primary efficacy endpoint was a composite outcome consisting of the first occurrence of confirmed MI, stroke, cardiovascular death, UA, TIA. The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.', 'unitOfMeasure': 'Days', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Days', 'denomUnitsSelected': 'Days', 'populationDescription': 'Intention-to-treat. The intent-to-treat (ITT) group (N=12546) consists of all patients who were randomized to the assigned study drug.'}, {'type': 'SECONDARY', 'title': 'Time to the First Occurrence of the Composite Outcome of Cardiovascular Death, MI, or Stroke (Ischemic, Hemorrhagic, or Unknown)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6270', 'groupId': 'OG000'}, {'value': '6276', 'groupId': 'OG001'}]}, {'units': 'Days', 'counts': [{'value': '1949', 'groupId': 'OG000'}, {'value': '1949', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylsalicylic Acid (Aspirin, BAYE4465)', 'description': 'Subjects received 1 tablet of enteric-coated acetylsalicylic acid \\[100 milligram (mg)\\] orally once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 1 tablets of matching placebo orally once daily.'}], 'classes': [{'title': 'Days until 1% subjects had an efficacy event', 'categories': [{'measurements': [{'value': '678', 'groupId': 'OG000'}, {'value': '522', 'groupId': 'OG001'}]}]}, {'title': 'Days until 2% subjects had an efficacy event', 'categories': [{'measurements': [{'value': '1167', 'groupId': 'OG000'}, {'value': '1053', 'groupId': 'OG001'}]}]}, {'title': 'Days until 3% subjects had an efficacy event', 'categories': [{'measurements': [{'value': '1599', 'groupId': 'OG000'}, {'value': '1501', 'groupId': 'OG001'}]}]}, {'title': 'Days until 4% subjects had an efficacy event', 'categories': [{'measurements': [{'value': '1949', 'groupId': 'OG000'}, {'value': '1930', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6125', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Statistics for time to the composite endpoint was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Until follow-up (approximate 6 years)', 'description': 'The time to Composite outcome consisting of the first occurrence of cardiovascular death, MI, or stroke (ischemic, hemorrhagic, or unknown) was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.', 'unitOfMeasure': 'Days', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Days', 'denomUnitsSelected': 'Days', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Time to the First Occurrence of the Individual Components of the Primary: Non-fatal MI, Total MI, Non-fatal Stroke, Total Stroke, Cardiovascular Death, UA and TIA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6270', 'groupId': 'OG000'}, {'value': '6276', 'groupId': 'OG001'}]}, {'units': 'Days', 'counts': [{'value': '2128', 'groupId': 'OG000'}, {'value': '2128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylsalicylic Acid (Aspirin, BAYE4465)', 'description': 'Subjects received 1 tablet of enteric-coated acetylsalicylic acid \\[100 milligram (mg)\\] orally once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 1 tablets of matching placebo orally once daily.'}], 'classes': [{'title': 'Days until 1% subjects had non-fatal MI', 'categories': [{'measurements': [{'value': '1309', 'groupId': 'OG000'}, {'value': '1085', 'groupId': 'OG001'}]}]}, {'title': 'Days until 2% subjects had non-fatal MI', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable (NA) indicates that these milestones did not occur before completion of the study.', 'groupId': 'OG000'}, {'value': '2121', 'groupId': 'OG001'}]}]}, {'title': 'Days until 1% subjects had total MI', 'categories': [{'measurements': [{'value': '1216', 'groupId': 'OG000'}, {'value': '1014', 'groupId': 'OG001'}]}]}, {'title': 'Days until 2% subjects had total MI', 'categories': [{'measurements': [{'value': '2128', 'groupId': 'OG000'}, {'value': '1906', 'groupId': 'OG001'}]}]}, {'title': 'Days until 1% subjects had non-fatal stroke', 'categories': [{'measurements': [{'value': '1576', 'groupId': 'OG000'}, {'value': '1650', 'groupId': 'OG001'}]}]}, {'title': 'Days until 2% subjects had non-fatal stroke', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable (NA) indicates that these milestones did not occur before completion of the study.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not applicable (NA) indicates that these milestones did not occur before completion of the study.', 'groupId': 'OG001'}]}]}, {'title': 'Days until 1% subjects had total stroke', 'categories': [{'measurements': [{'value': '1543', 'groupId': 'OG000'}, {'value': '1627', 'groupId': 'OG001'}]}]}, {'title': 'Days until 2% subjects had total stroke', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable (NA) indicates that these milestones did not occur before completion of the study.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not applicable (NA) indicates that these milestones did not occur before completion of the study.', 'groupId': 'OG001'}]}]}, {'title': 'Days until 1% subjects had cardiovascular death', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable (NA) indicates that these milestones did not occur before completion of the study.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not applicable (NA) indicates that these milestones did not occur before completion of the study.', 'groupId': 'OG001'}]}]}, {'title': 'Days until 2% subjects had cardiovascular death', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable (NA) indicates that these milestones did not occur before completion of the study.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not applicable (NA) indicates that these milestones did not occur before completion of the study.', 'groupId': 'OG001'}]}]}, {'title': 'Days until 1% subjects had UA', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable (NA) indicates that these milestones did not occur before completion of the study.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not applicable (NA) indicates that these milestones did not occur before completion of the study.', 'groupId': 'OG001'}]}]}, {'title': 'Days until 2% subjects had UA', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable (NA) indicates that these milestones did not occur before completion of the study.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not applicable (NA) indicates that these milestones did not occur before completion of the study.', 'groupId': 'OG001'}]}]}, {'title': 'Days until 1% subjects had TIA', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable (NA) indicates that these milestones did not occur before completion of the study.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not applicable (NA) indicates that these milestones did not occur before completion of the study.', 'groupId': 'OG001'}]}]}, {'title': 'Days until 2% subjects had TIA', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable (NA) indicates that these milestones did not occur before completion of the study.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not applicable (NA) indicates that these milestones did not occur before completion of the study..', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4505', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Statistics for time to non-fatal MI was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.229', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Statistics for time to total MI was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3947', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Statistics for time to total non-fatal stroke was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.5125', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Statistics for time to total stroke was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Until follow-up (approximately 6 years)', 'description': 'The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.', 'unitOfMeasure': 'Days', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Days', 'denomUnitsSelected': 'Days', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Time to All-cause Mortality, the First Occurrence of All Cancers Excluding Non-melanoma Skin Cancer (NMSC) and the First Occurrence of Colon Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6270', 'groupId': 'OG000'}, {'value': '6276', 'groupId': 'OG001'}]}, {'units': 'Days', 'counts': [{'value': '1970', 'groupId': 'OG000'}, {'value': '1970', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylsalicylic Acid (Aspirin, BAYE4465)', 'description': 'Subjects received 1 tablet of enteric-coated acetylsalicylic acid \\[100 milligram (mg)\\] orally once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 1 tablets of matching placebo orally once daily.'}], 'classes': [{'title': 'Days until 1% subjects had all-cause mortality', 'categories': [{'measurements': [{'value': '838', 'groupId': 'OG000'}, {'value': '938', 'groupId': 'OG001'}]}]}, {'title': 'Days until 2% subjects had all-cause mortality', 'categories': [{'measurements': [{'value': '1493', 'groupId': 'OG000'}, {'value': '1460', 'groupId': 'OG001'}]}]}, {'title': 'Days until 3% subjects had all-cause mortality', 'categories': [{'measurements': [{'value': '1970', 'groupId': 'OG000'}, {'value': '1963', 'groupId': 'OG001'}]}]}, {'title': 'Days until 4% subjects had all-cause mortality', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable (NA) indicates that these milestones did not occur before completion of the study.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not applicable (NA) indicates that these milestones did not occur before completion of the study.', 'groupId': 'OG001'}]}]}, {'title': 'Days until 1% subjects had all cancer excl. NMSC', 'categories': [{'measurements': [{'value': '374', 'groupId': 'OG000'}, {'value': '420', 'groupId': 'OG001'}]}]}, {'title': 'Days until 2% subjects had all cancer excl. NMSC', 'categories': [{'measurements': [{'value': '849', 'groupId': 'OG000'}, {'value': '805', 'groupId': 'OG001'}]}]}, {'title': 'Days until 3% subjects had all cancer excl. NMSC', 'categories': [{'measurements': [{'value': '1164', 'groupId': 'OG000'}, {'value': '1276', 'groupId': 'OG001'}]}]}, {'title': 'Days until 4% subjects had all cancer excl. NMSC', 'categories': [{'measurements': [{'value': '1542', 'groupId': 'OG000'}, {'value': '1751', 'groupId': 'OG001'}]}]}, {'title': 'Days until 1% subjects had colon cancer', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable (NA) indicates that these milestones did not occur before completion of the study.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not applicable (NA) indicates that these milestones did not occur before completion of the study.', 'groupId': 'OG001'}]}]}, {'title': 'Days until 2% subjects had colon cancer', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable (NA) indicates that these milestones did not occur before completion of the study.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not applicable (NA) indicates that these milestones did not occur before completion of the study..', 'groupId': 'OG001'}]}]}, {'title': 'Days until 3% subjects had colon cancer', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable (NA) indicates that these milestones did not occur before completion of the study.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not applicable (NA) indicates that these milestones did not occur before completion of the study.', 'groupId': 'OG001'}]}]}, {'title': 'Days until 4% subjects had colon cancer', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable (NA) indicates that these milestones did not occur before completion of the study.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not applicable (NA) indicates that these milestones did not occur before completion of the study..', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9544', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Analysis of time to all-cause mortality was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.4422', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Analysis of time to the first occurrence of all cancers excluding non-melanoma skin cancer was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.611', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Analysis of time to the first occurence colon cancer was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Until follow-up (approximately 6 years)', 'description': 'The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.', 'unitOfMeasure': 'Days', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Days', 'denomUnitsSelected': 'Days', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Incidence of All-cause Mortality, All Cancers Excluding Non-melanoma Skin Cancer and Colon Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6270', 'groupId': 'OG000'}, {'value': '6276', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylsalicylic Acid (Aspirin, BAYE4465)', 'description': 'Subjects received 1 tablet of enteric-coated acetylsalicylic acid \\[100 milligram (mg)\\] orally once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 1 tablets of matching placebo orally once daily.'}], 'classes': [{'title': 'all-cause mortality', 'categories': [{'measurements': [{'value': '2.55', 'groupId': 'OG000'}, {'value': '2.57', 'groupId': 'OG001'}]}]}, {'title': 'all cancers excluding non-melanoma skin cancer', 'categories': [{'measurements': [{'value': '4.02', 'groupId': 'OG000'}, {'value': '3.76', 'groupId': 'OG001'}]}]}, {'title': 'colon cancer', 'categories': [{'measurements': [{'value': '0.48', 'groupId': 'OG000'}, {'value': '0.41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9459', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.24', 'groupDescription': 'Analysis of incidence of all-cause mortality was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Until follow-up (approximately 6 years)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Incidence of Confirmed MI, Stroke, Cardiovascular Death, UA, and TIA Separately', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6270', 'groupId': 'OG000'}, {'value': '6276', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylsalicylic Acid (Aspirin, BAYE4465)', 'description': 'Subjects received 1 tablet of enteric-coated acetylsalicylic acid \\[100 milligram (mg)\\] orally once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 1 tablets of matching placebo orally once daily.'}], 'classes': [{'title': 'MI', 'categories': [{'measurements': [{'value': '1.52', 'groupId': 'OG000'}, {'value': '1.78', 'groupId': 'OG001'}]}]}, {'title': 'stroke', 'categories': [{'measurements': [{'value': '1.20', 'groupId': 'OG000'}, {'value': '1.07', 'groupId': 'OG001'}]}]}, {'title': 'CV death*', 'categories': [{'measurements': [{'value': '0.61', 'groupId': 'OG000'}, {'value': '0.62', 'groupId': 'OG001'}]}]}, {'title': 'UA', 'categories': [{'measurements': [{'value': '0.32', 'groupId': 'OG000'}, {'value': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'TIA', 'categories': [{'measurements': [{'value': '0.67', 'groupId': 'OG000'}, {'value': '0.72', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2325', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.11', 'groupDescription': 'Analysis of incidence of MI was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.5072', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.55', 'groupDescription': 'Analysis of incidence of stroke was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.9010', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.62', 'ciUpperLimit': '1.52', 'groupDescription': 'Analysis of incidence of cardiovascular death was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.9979', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.54', 'ciUpperLimit': '1.86', 'groupDescription': 'Analysis of incidence of UA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.7455', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.61', 'ciUpperLimit': '1.42', 'groupDescription': 'Analysis of incidence of TIA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Until follow-up (approximately 6 years)', 'description': 'The percentages of subjects with the efficacy endpoints of confirmed MI, stroke, cardiovascular death, UA and TIA are reported separately. \\*all other CV death without fatal MI and fatal stroke', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Subjects With Adjudicated GI Bleeding by Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6270', 'groupId': 'OG000'}, {'value': '6276', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylsalicylic Acid (Aspirin, BAYE4465)', 'description': 'Subjects received 1 tablet of enteric-coated acetylsalicylic acid \\[100 milligram (mg)\\] orally once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 1 tablets of matching placebo orally once daily.'}], 'classes': [{'title': 'Total', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Until follow-up (approximate 6 years)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Incidence of Composite Outcomes and Non-fatal MI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6270', 'groupId': 'OG000'}, {'value': '6276', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylsalicylic Acid (Aspirin, BAYE4465)', 'description': 'Subjects received 1 tablet of enteric-coated acetylsalicylic acid \\[100 milligram (mg)\\] orally once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 1 tablets of matching placebo orally once daily.'}], 'classes': [{'title': 'MI, stroke, CV death, UA or TIA', 'categories': [{'measurements': [{'value': '4.29', 'groupId': 'OG000'}, {'value': '4.48', 'groupId': 'OG001'}]}]}, {'title': 'MI, stroke or CV death', 'categories': [{'measurements': [{'value': '3.32', 'groupId': 'OG000'}, {'value': '3.47', 'groupId': 'OG001'}]}]}, {'title': 'non-fatal MI', 'categories': [{'measurements': [{'value': '1.40', 'groupId': 'OG000'}, {'value': '1.56', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6038', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.13', 'groupDescription': 'Analysis of incidence of composite outcome of MI, stroke, CV death, UA or TIA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.6190', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.15', 'groupDescription': 'Analysis of incidence of composite outcome of MI, stroke or CV death was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.4562', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.67', 'ciUpperLimit': '1.20', 'groupDescription': 'Analysis of incidence of non-fatal MI was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Until follow-up (approximate 6 years)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Incidence of Composite Outcomes and Individual Outcomes in Per-protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3790', 'groupId': 'OG000'}, {'value': '3912', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetylsalicylic Acid (Aspirin, BAYE4465) Per-protocol', 'description': 'Subjects received 1 tablet of enteric-coated acetylsalicylic acid \\[100 milligram (mg)\\] orally once daily.'}, {'id': 'OG001', 'title': 'Placebo Per-protocol', 'description': 'Subjects received 1 tablets of matching placebo orally once daily.'}], 'classes': [{'title': 'MI, stroke, CV death, UA or TIA', 'categories': [{'measurements': [{'value': '3.40', 'groupId': 'OG000'}, {'value': '4.19', 'groupId': 'OG001'}]}]}, {'title': 'MI, stroke or CV death', 'categories': [{'measurements': [{'value': '2.72', 'groupId': 'OG000'}, {'value': '3.45', 'groupId': 'OG001'}]}]}, {'title': 'MI', 'categories': [{'measurements': [{'value': '0.98', 'groupId': 'OG000'}, {'value': '1.84', 'groupId': 'OG001'}]}]}, {'title': 'Non-fatal MI', 'categories': [{'measurements': [{'value': '0.84', 'groupId': 'OG000'}, {'value': '1.53', 'groupId': 'OG001'}]}]}, {'title': 'Stroke', 'categories': [{'measurements': [{'value': '1.06', 'groupId': 'OG000'}, {'value': '0.95', 'groupId': 'OG001'}]}]}, {'title': 'CV death*', 'categories': [{'measurements': [{'value': '0.69', 'groupId': 'OG000'}, {'value': '0.66', 'groupId': 'OG001'}]}]}, {'title': 'UA', 'categories': [{'measurements': [{'value': '0.21', 'groupId': 'OG000'}, {'value': '0.28', 'groupId': 'OG001'}]}]}, {'title': 'TIA', 'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG000'}, {'value': '0.49', 'groupId': 'OG001'}]}]}, {'title': 'All-cause mortality', 'categories': [{'measurements': [{'value': '2.85', 'groupId': 'OG000'}, {'value': '2.58', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0756', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.81', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.02', 'groupDescription': 'Analysis of incidence of composite outcome of MI, stroke, CV death, UA or TIA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0661', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.61', 'ciUpperLimit': '1.02', 'groupDescription': 'Analysis of incidence of composite outcome of MI, stroke or CV death was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.53', 'ciLowerLimit': '0.36', 'ciUpperLimit': '0.79', 'groupDescription': 'Analysis of incidence of MI was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0056', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '0.36', 'ciUpperLimit': '0.84', 'groupDescription': 'Analysis of incidence of non-fatal MI was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.6291', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.75', 'groupDescription': 'Analysis of incidence of stroke was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.9161', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.60', 'ciUpperLimit': '1.77', 'groupDescription': 'Analysis of incidence of CV death was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.5380', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.30', 'ciUpperLimit': '1.87', 'groupDescription': 'Analysis of incidence of UA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.9181', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.55', 'ciUpperLimit': '1.95', 'groupDescription': 'Analysis of incidence of TIA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.4796', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.45', 'groupDescription': 'Analysis of incidence of all-cause mortality was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Until follow-up (approximate 6 years)', 'description': '\\*all other CV death without fatal MI and fatal stroke.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol (PP) group (N=7702) consists of all patients who had no protocol violation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Acetylsalicylic Acid (Aspirin, BAYE4465)', 'description': 'Subjects received 1 tablet of enteric-coated acetylsalicylic acid \\[100 milligram (mg)\\] orally once daily.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Subjects received 1 tablets of matching placebo orally once daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6270'}, {'groupId': 'FG001', 'numSubjects': '6276'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4402'}, {'groupId': 'FG001', 'numSubjects': '4384'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1868'}, {'groupId': 'FG001', 'numSubjects': '1892'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '69'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '140'}, {'groupId': 'FG001', 'numSubjects': '137'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '236'}, {'groupId': 'FG001', 'numSubjects': '239'}]}, {'type': 'Missing end-of-study page', 'reasons': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '92'}]}, {'type': 'Clinical endpoint reached', 'reasons': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '123'}]}, {'type': 'Insufficient therapeutic effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Consent withdrawn by subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '817'}, {'groupId': 'FG001', 'numSubjects': '873'}]}, {'type': 'Non-compliant with study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Reason not given', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '122'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '210'}, {'groupId': 'FG001', 'numSubjects': '198'}]}, {'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '17'}]}]}], 'recruitmentDetails': 'Overall, 15823 subjects were screened. Of these, 3277 subjects were screening failures. The remaining 12546 subjects were randomized to treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6270', 'groupId': 'BG000'}, {'value': '6276', 'groupId': 'BG001'}, {'value': '12546', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Acetylsalicylic Acid (Aspirin, BAYE4465)', 'description': 'Subjects received 1 tablet of enteric-coated acetylsalicylic acid \\[100 milligram (mg)\\] orally once daily.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Subjects received 1 tablets of matching placebo orally once daily.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.9', 'spread': '7.10', 'groupId': 'BG000'}, {'value': '63.9', 'spread': '7.05', 'groupId': 'BG001'}, {'value': '63.9', 'spread': '7.08', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1851', 'groupId': 'BG000'}, {'value': '1857', 'groupId': 'BG001'}, {'value': '3708', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4419', 'groupId': 'BG000'}, {'value': '4419', 'groupId': 'BG001'}, {'value': '8838', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12546}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'dispFirstSubmitDate': '2017-09-19', 'completionDateStruct': {'date': '2016-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-26', 'studyFirstSubmitDate': '2007-07-12', 'dispFirstSubmitQcDate': '2017-09-19', 'resultsFirstSubmitDate': '2017-11-15', 'studyFirstSubmitQcDate': '2007-07-12', 'dispFirstPostDateStruct': {'date': '2017-09-27', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2018-10-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-04', 'studyFirstPostDateStruct': {'date': '2007-07-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Subjects With Adjudicated GI Bleeding by Severity', 'timeFrame': 'Until follow-up (approximate 6 years)'}, {'measure': 'Incidence of Composite Outcomes and Non-fatal MI', 'timeFrame': 'Until follow-up (approximate 6 years)'}, {'measure': 'Incidence of Composite Outcomes and Individual Outcomes in Per-protocol Population', 'timeFrame': 'Until follow-up (approximate 6 years)', 'description': '\\*all other CV death without fatal MI and fatal stroke.'}], 'primaryOutcomes': [{'measure': 'Time to the First Occurrence of the Composite Outcome of MI (Myocardial Infarction), Stroke, Cardiovascular Death, UA (Unstable Angina) or TIA (Transient Ischemic Attack)', 'timeFrame': 'Until follow-up (approximate 6 years)', 'description': 'The primary efficacy endpoint was a composite outcome consisting of the first occurrence of confirmed MI, stroke, cardiovascular death, UA, TIA. The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.'}], 'secondaryOutcomes': [{'measure': 'Time to the First Occurrence of the Composite Outcome of Cardiovascular Death, MI, or Stroke (Ischemic, Hemorrhagic, or Unknown)', 'timeFrame': 'Until follow-up (approximate 6 years)', 'description': 'The time to Composite outcome consisting of the first occurrence of cardiovascular death, MI, or stroke (ischemic, hemorrhagic, or unknown) was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.'}, {'measure': 'Time to the First Occurrence of the Individual Components of the Primary: Non-fatal MI, Total MI, Non-fatal Stroke, Total Stroke, Cardiovascular Death, UA and TIA', 'timeFrame': 'Until follow-up (approximately 6 years)', 'description': 'The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.'}, {'measure': 'Time to All-cause Mortality, the First Occurrence of All Cancers Excluding Non-melanoma Skin Cancer (NMSC) and the First Occurrence of Colon Cancer', 'timeFrame': 'Until follow-up (approximately 6 years)', 'description': 'The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.'}, {'measure': 'Incidence of All-cause Mortality, All Cancers Excluding Non-melanoma Skin Cancer and Colon Cancer', 'timeFrame': 'Until follow-up (approximately 6 years)'}, {'measure': 'Incidence of Confirmed MI, Stroke, Cardiovascular Death, UA, and TIA Separately', 'timeFrame': 'Until follow-up (approximately 6 years)', 'description': 'The percentages of subjects with the efficacy endpoints of confirmed MI, stroke, cardiovascular death, UA and TIA are reported separately. \\*all other CV death without fatal MI and fatal stroke'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Primary prevention of coronary heart disease', 'Stroke and cardiovascular death', 'Aspirin'], 'conditions': ['Moderate Risk of CVD']}, 'referencesModule': {'references': [{'pmid': '30158069', 'type': 'RESULT', 'citation': 'Gaziano JM, Brotons C, Coppolecchia R, Cricelli C, Darius H, Gorelick PB, Howard G, Pearson TA, Rothwell PM, Ruilope LM, Tendera M, Tognoni G; ARRIVE Executive Committee. Use of aspirin to reduce risk of initial vascular events in patients at moderate risk of cardiovascular disease (ARRIVE): a randomised, double-blind, placebo-controlled trial. Lancet. 2018 Sep 22;392(10152):1036-1046. doi: 10.1016/S0140-6736(18)31924-X. Epub 2018 Aug 26.'}], 'seeAlsoLinks': [{'url': 'http://www.clinicaltrialsregister.eu/', 'label': 'Click here to find information about studies related to Bayer Healthcare products conducted in Europe'}]}, 'descriptionModule': {'briefSummary': 'The use of acetylsalicylic acid in the primary prevention of cardiovascular events has been extensively studied but to a lesser extent in patients with moderate levels of cardiovascular risk. The current study is designed to prove the efficacy and tolerability of 100 mg enteric-coated Aspirin versus placebo in the prevention of cardiovascular disease (CVD) events, which include fatal and nonfatal myocardial infarction, fatal and nonfatal stroke and CV death, in a population with no history of known CVD who are at moderate risk of major CHD events (approximately 10-20% 10 year CHD risk). This corresponds to a patient population mean 10-year CVD risk of approximately 30%. Subjects are treated in a standard care setting and may receive treatment for the underlying risk factors as defined by the treating physician. Outcome events will be adjudicated by an Endpoint Adjudication Committee and the study will be monitored by an independent Data Safety Monitoring Board.', 'detailedDescription': 'Summary of substantial Protocol amendments\n\nAmendment #2 from 09-APR-2008:\n\n* Systolic blood pressure (SBP) limit of 170 mmHg has been added to the exclusion criteria\n* Exclusion of patients currently taking anticoagulant medication\n* A longer interval between the daily dose of study drug and ibuprofen\n* Revised wording in moderate risk definitions for coronary heart disease (CHD) and cerebrovascular disease (CVD): "To evaluate the clinical effects of a 100 mg/day enteric-coated acetylsalicylic acid versus placebo in the reduction of CVD events in patients at moderate risk of major CHD events (approximately 10 to 20% 10-year CHD risk; approximately 20 to 30% 10-year risk of CVD). This corresponds to a patient population mean 10-year CVD risk of approximately 30%."\n\nAmendment #3 from 02-JAN-2009\n\n• Increase in the number of allowed risk factors for males, age is no longer a risk factor\n\nAmendment #4 from 02-OCT-2013\n\n* The primary endpoint is changed to include confirmed UA and TIA.\n* The estimated event rate is changed to 1.5% per year due to new information.\n* Effect size (risk reduction) changed from 14.9% to 17 to 18%.\n* Achieving 60,000 person-years instead of 1488 primary endpoint events\n* Additional treatment and follow-up for a maximum of another 12 months.\n* Change to reduced adverse event and concomitant therapy reporting'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males aged 55 years and above with 2 to 4 risk factors. Male Risk Factors:\n\n * Elevated cholesterol (Tchol\\>200 mg/dL or LDL\\>130 mg/dL; as measured at screening) irrespective of current treatment\n * Current smoking: defined as any cigarette smoking in the past 12 months\n * Low HDL cholesterol (HDL\\<40 mg/dL; as measured at screening)\n * Elevated blood pressure (SBP\\>140 mmHg; as measured at screening)\n * Currently on any medication to treat high blood pressure\n * Positive family history of early CHD (a first-degree relative \\[father, mother, brother, sister, son, daughter\\] suffered a heart attack \\[myocardial infarction\\] before the age of 60 years)\n* Females aged 60 and above with 3 or more risk factors. Female Risk Factors:\n\n * Elevated cholesterol (Tchol\\>240 mg/dL or LDL\\>160 mg/dL; as measured at screening) irrespective of current treatment\n * Current smoking: defined as any cigarette smoking in the past 12 months\n * Low HDL cholesterol (HDL\\<40 mg/dL; as measured at screening)\n * Elevated blood pressure (SBP\\>140 mmHg; as measured at screening)\n * Currently on any medication to treat high blood pressure\n * Positive family history of early CHD (a first-degree relative \\[father, mother, brother, sister, son, daughter\\] suffered a heart attack \\[myocardial infarction\\] before the age of 60 years)\n* An understanding and willingness to comply with trial procedures and has given written informed consent to participate in the trial\n\nExclusion Criteria:\n\n* History of a documented vascular event, such as MI, stroke, coronary artery angioplasty or stenting, coronary artery bypass graft, relevant arrhythmias, or congestive heart failure or vascular intervention\n* Patients who are at higher than moderate risk on the basis of their diabetes status, other factors known to the investigator, or the currently used national risk score\n* Known contraindications to the study drug, e.g. hypersensitivity to acetylsalicylic acid\n* Recent (in the past year) history of gastrointestinal or genitourinary bleeding or other bleeding disorders\n* Active diagnosed and documented reflux esophagitis\n* Patients presenting with any medical condition, or psychiatric or substance abuse disorder, that, in the opinion of the investigator, is likely to affect the patient's ability to complete the study or precludes the patient's participation in the study\n* Lactating women or women of childbearing potential\n* Severe liver disease or damage based on the clinical judgment of the investigator\n* Severe renal disease or damage based on the clinical judgement of the investigator\n* A definite indication for acetylsalicylic acid therapy, other antiplatelet drug, or anticoagulant in the opinion of the physician\n* A history of asthma induced by administration of salicylates or substances with a similar action, notably NSAIDS\n* Chronic, frequent (\\> 5 days/month) use of NSAIDs (including aspirin, or aspirin containing products), COX-2 inhibitors or metamizole\n* Current participation in any other trials involving investigational products within 30 days prior to the Screening Visit\n* Current use of an anticoagulant medication\n* Sitting systolic blood pressure greater than 170 mmHg"}, 'identificationModule': {'nctId': 'NCT00501059', 'acronym': 'ARRIVE', 'briefTitle': 'A Study to Assess the Efficacy and Safety of Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group Study to Assess the Efficacy (Reduction of Cardiovascular Disease Events) and Safety of 100 mg Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease', 'orgStudyIdInfo': {'id': '12198'}, 'secondaryIdInfos': [{'id': '2006-003622-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acetylsalicylic acid (Aspirin, BAYE4465)', 'description': 'Participants received 1 tablet of enteric-coated acetylsalicylic acid \\[100 milligram (mg)\\] orally once daily.', 'interventionNames': ['Drug: Aspirin (Acetylsalicylic acid, BAYE4465)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received 1 tablets of matching placebo orally once daily.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Aspirin (Acetylsalicylic acid, BAYE4465)', 'type': 'DRUG', 'description': '100mg enteric coated Aspirin, taken daily', 'armGroupLabels': ['Acetylsalicylic acid (Aspirin, BAYE4465)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo, taken daily', 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