Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT00457002
Status:
COMPLETED
Last Update Posted:
2015-12-08
First Post:
2007-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Apixaban for the Prevention of Thrombosis-related Events in Patients With Acute Medical Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Romania']}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D011655', 'term': 'Pulmonary Embolism'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522181', 'term': 'apixaban'}, {'id': 'D017984', 'term': 'Enoxaparin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1, first dose of study drug, to last dose of study drug plus 2 days (AEs), plus 30 days (SAEs, Deaths).', 'description': 'No AE met or exceeded the 5% frequency threshold. Participants who received at least one dose of study drug were analyzed.', 'eventGroups': [{'id': 'EG000', 'title': 'Apix 2.5mg BID', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.', 'otherNumAtRisk': 3184, 'otherNumAffected': 0, 'seriousNumAtRisk': 3184, 'seriousNumAffected': 611}, {'id': 'EG001', 'title': 'Enox 40mg QD', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.', 'otherNumAtRisk': 3217, 'otherNumAffected': 0, 'seriousNumAtRisk': 3217, 'seriousNumAffected': 601}], 'seriousEvents': [{'term': 'Anuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Astrocytoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchiectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cachexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diabetic gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Drug intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hyperparathyroidism primary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypertrophic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Intestinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Malaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Metastatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Obstructive uropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oesophageal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pleural mesothelioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Polymyalgia rheumatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Porocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sarcoidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Small intestine carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Status asthmaticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Thoracic outlet syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urine uric acid abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Acute interstitial pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Aortic valve disease mixed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchial neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cancer pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cardiac 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumocystis test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 20}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Renal cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3217, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Composite of Adjudicated Total Venous Thromboembolism (VTE) and VTE-related Death During the Intended Treatment Period - Primary Efficacy Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2211', 'groupId': 'OG000'}, {'value': '2284', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'OG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.71', 'groupId': 'OG000', 'lowerLimit': '2.11', 'upperLimit': '3.49'}, {'value': '3.06', 'groupId': 'OG001', 'lowerLimit': '2.43', 'upperLimit': '3.86'}]}]}], 'analyses': [{'pValue': '0.4364', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.62', 'ciUpperLimit': '1.23', 'groupDescription': 'To conclude superiority of apixaban versus enoxaparin on the primary efficacy endpoint, the upper bound of the two-sided 95.004% confidence interval (CI) for the relative risk (pa/ pe) must be less than 1.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.39', 'ciLowerLimit': '-1.37', 'ciUpperLimit': '0.59', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Intended Treatment Period', 'description': 'VTE: nonfatal pulmonary embolism (PE), symptomatic deep vein thrombosis (DVT), or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE could not be excluded as a cause. Intended Treatment Period=period that started on day of randomization: period ended (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; period ended (for not treated) 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. All efficacy events were adjudicated by the Independent Central Adjudication Committee (ICAC). Event rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).', 'unitOfMeasure': 'Event rate (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Those randomized (without suspected VTE) who had an adjudicated and evaluable ultrasound at end of intended treatment; or (with suspected VTE) had VTE events adjudicated as non-events and had an adjudicated and evaluable ultrasound at end of intended treatment, or had an adjudicated total VTE-related death.'}, {'type': 'SECONDARY', 'title': 'Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Key Secondary Efficacy Evaluable Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2485', 'groupId': 'OG000'}, {'value': '2488', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'OG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.73', 'groupId': 'OG000', 'lowerLimit': '1.28', 'upperLimit': '2.33'}, {'value': '1.61', 'groupId': 'OG001', 'lowerLimit': '1.18', 'upperLimit': '2.19'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.63', 'groupDescription': 'Formal testing of noninferiority for the key secondary efficacy endpoint was not performed since the superiority of the primary efficacy endpoint was not demonstrated.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.61', 'ciUpperLimit': '0.81', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to last dose of parenteral study drug plus 1 day', 'description': 'Parenteral study drug=active or placebo enoxaparin. Parenteral treatment: started on the first dose of parenteral study drug and ended the day after the last dose of parenteral study drug. Key Secondary Efficacy population: all who received at least 1 dose of parenteral study drug and: (those without suspected VTE events during Parenteral Treatment) had an adjudicated evaluable ultrasound performed at the end of Parenteral Treatment; or (those with suspected VTE events during Parenteral Treatment) had those suspected VTE events adjudicated as non-events, and had an adjudicated evaluable ultrasound performed at the end of Parenteral Treatment; or had an adjudicated total VTE during Parenteral Treatment; or had an adjudicated VTE-related death during Parenteral Treatment. Event rate (%): n/N\\*100 (n=number with observation; N=total secondary efficacy evaluable participants).', 'unitOfMeasure': 'Event rate (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Those randomized (without suspected VTE) who had an adjudicated and evaluable ultrasound at end of parenteral treatment; or (with suspected VTE) had VTE events adjudicated as non-events and had adjudicated and evaluable ultrasound at end of parenteral treatment, or had an adjudicated VTE-related death during the Parenteral Treatment Period.'}, {'type': 'SECONDARY', 'title': 'Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Secondary Efficacy Evaluable Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2344', 'groupId': 'OG000'}, {'value': '2380', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'OG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.66', 'groupId': 'OG000', 'lowerLimit': '1.22', 'upperLimit': '2.28'}, {'value': '1.51', 'groupId': 'OG001', 'lowerLimit': '1.09', 'upperLimit': '2.10'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.71', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '0.85', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to last dose of parenteral study drug plus 1 day', 'description': 'Parenteral study drug=active or placebo enoxaparin. Parenteral treatment: started on the first dose of parenteral study drug and ended the day after the last dose of parenteral study drug. Secondary Efficacy Evaluable includes those who had an adjudicated, evaluable ultrasound at end of parenteral treatment and for those with a suspected symptomatic event, the result of the adjudication for the symptomatic event was not inadequate; or those with an adjudicated event that was part of the composite endpoint.. Event rate (%): n/N\\*100 (n=number with observation; N=total secondary efficacy evaluable participants).', 'unitOfMeasure': 'Event Rate (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Secondary Efficacy Evaluable includes those who have an adjudicated, evaluable ultrasound at end of parenteral treatment and for those with a suspected symptomatic event, the result of the adjudication for the symptomatic event is not inadequate; or those with an adjudicated event that is part of the composite endpoint.'}, {'type': 'SECONDARY', 'title': 'Incidence of Adjudicated Total VTE or All-Cause Death With Onset During the Intended Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2297', 'groupId': 'OG000'}, {'value': '2369', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'OG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.44', 'groupId': 'OG000', 'lowerLimit': '5.51', 'upperLimit': '7.53'}, {'value': '6.63', 'groupId': 'OG001', 'lowerLimit': '5.69', 'upperLimit': '7.71'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.20', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.24', 'ciLowerLimit': '-1.65', 'ciUpperLimit': '1.17', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Intended Treatment Period', 'description': 'Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal (N-F) PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. All-Cause Death (A-C Death). Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).', 'unitOfMeasure': 'Event Rate (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Those randomized with adjudicated and evaluable ultrasound at the end of the intended treatment period; for those with a suspected symptomatic event, the adjudication result was not inadequate; includes all those randomized who have an adjudicated event associated with the endpoint during Intended Treatment.'}, {'type': 'SECONDARY', 'title': 'Incidence of Adjudicated Proximal DVT, Non-Fatal PE or All-Cause Death With Onset During the Intended Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2297', 'groupId': 'OG000'}, {'value': '2368', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'OG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.44', 'groupId': 'OG000', 'lowerLimit': '5.51', 'upperLimit': '7.53'}, {'value': '6.50', 'groupId': 'OG001', 'lowerLimit': '5.58', 'upperLimit': '7.58'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.22', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-1.52', 'ciUpperLimit': '1.29', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Intended Treatment Period', 'description': 'Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).', 'unitOfMeasure': 'Event Rate (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Those randomized with adjudicated and evaluable ultrasound at the end of the intended treatment period; for those with a suspected symptomatic event, the adjudication result was not inadequate; includes all those randomized who have an adjudicated event associated with the endpoint during Intended Treatment.'}, {'type': 'SECONDARY', 'title': 'Incidence of Adjudicated Proximal DVT, Non-Fatal PE or VTE-Related Death, With Onset During the Intended Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2211', 'groupId': 'OG000'}, {'value': '2283', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'OG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.71', 'groupId': 'OG000', 'lowerLimit': '2.11', 'upperLimit': '3.49'}, {'value': '2.93', 'groupId': 'OG001', 'lowerLimit': '2.32', 'upperLimit': '3.72'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.65', 'ciUpperLimit': '1.29', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-1.23', 'ciUpperLimit': '0.71', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Intended Treatment Period', 'description': 'Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).', 'unitOfMeasure': 'Event Rate (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Those randomized with adjudicated and evaluable ultrasound at the end of the intended treatment period; for those with a suspected symptomatic event, the adjudication result was not inadequate; includes all those randomized who have an adjudicated event associated with the endpoint during Intended Treatment.'}, {'type': 'SECONDARY', 'title': 'Incidence of Adjudicated VTE-Related Death With Onset During the Intended Treatment Period in Randomized Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3255', 'groupId': 'OG000'}, {'value': '3273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'OG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.24'}, {'value': '0.09', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.29'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.11', 'ciUpperLimit': '4.05', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.10', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Intended Treatment Period', 'description': 'Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).', 'unitOfMeasure': 'Event Rate (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized Participants.'}, {'type': 'SECONDARY', 'title': 'Incidence of Adjudicated Symptomatic VTE or All-Cause Death With Onset During the Intended Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3251', 'groupId': 'OG000'}, {'value': '3269', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'OG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.11', 'groupId': 'OG000', 'lowerLimit': '2.56', 'upperLimit': '3.77'}, {'value': '3.46', 'groupId': 'OG001', 'lowerLimit': '2.88', 'upperLimit': '4.14'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.68', 'ciUpperLimit': '1.16', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.38', 'ciLowerLimit': '-1.25', 'ciUpperLimit': '0.48', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Intended Treatment Period', 'description': 'Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).', 'unitOfMeasure': 'Event Rate (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment were analyzed.'}, {'type': 'SECONDARY', 'title': 'Symptomatic Adjudicated VTE or VTE-Related Death With Onset During the Intended Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3251', 'groupId': 'OG000'}, {'value': '3266', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'OG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.40', 'groupId': 'OG000', 'lowerLimit': '0.23', 'upperLimit': '0.69'}, {'value': '0.80', 'groupId': 'OG001', 'lowerLimit': '0.54', 'upperLimit': '1.17'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.50', 'ciLowerLimit': '0.26', 'ciUpperLimit': '0.96', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.40', 'ciLowerLimit': '-0.78', 'ciUpperLimit': '-0.03', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Intended Treatment Period', 'description': 'Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).', 'unitOfMeasure': 'Event Rate (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment were analyzed.'}, {'type': 'SECONDARY', 'title': 'Incidence of All VTE or Major Bleeding or All-Cause Death During the Intended Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2304', 'groupId': 'OG000'}, {'value': '2371', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'OG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.16', 'groupId': 'OG000', 'lowerLimit': '6.18', 'upperLimit': '8.29'}, {'value': '6.83', 'groupId': 'OG001', 'lowerLimit': '5.88', 'upperLimit': '7.93'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.28', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '-1.18', 'ciUpperLimit': '1.73', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Intended Treatment Period', 'description': 'Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).', 'unitOfMeasure': 'Event Rate (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Those randomized with adjudicated and evaluable ultrasound at the end of the intended treatment period; for those with a suspected symptomatic event, the adjudication result was not inadequate; includes all those randomized who have an adjudicated event associated with the endpoint during Intended Treatment.'}, {'type': 'SECONDARY', 'title': 'Incidence of Adjudicated PE With Onset During the Intended Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3251', 'groupId': 'OG000'}, {'value': '3266', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'OG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.22', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '0.46'}, {'value': '0.24', 'groupId': 'OG001', 'lowerLimit': '0.12', 'upperLimit': '0.50'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.32', 'ciUpperLimit': '2.43', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.20', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Intended Treatment Period', 'description': 'Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. PE: non-fatal or fatal. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).', 'unitOfMeasure': 'Event Rate (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment were analyzed.'}, {'type': 'SECONDARY', 'title': 'Incidence of Adjudicated Non-Fatal PE With Onset During the Intended Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3251', 'groupId': 'OG000'}, {'value': '3266', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'OG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.22', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '0.46'}, {'value': '0.24', 'groupId': 'OG001', 'lowerLimit': '0.12', 'upperLimit': '0.50'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.32', 'ciUpperLimit': '2.43', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.20', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Intended Treatment Period', 'description': 'Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).', 'unitOfMeasure': 'Event Rate (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment were analyzed.'}, {'type': 'SECONDARY', 'title': 'Incidence of Adjudicated Symptomatic DVT With Onset During the Intended Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3255', 'groupId': 'OG000'}, {'value': '3273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'OG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.15', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '0.37'}, {'value': '0.49', 'groupId': 'OG001', 'lowerLimit': '0.30', 'upperLimit': '0.80'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.31', 'ciLowerLimit': '0.11', 'ciUpperLimit': '0.83', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-0.62', 'ciUpperLimit': '-0.07', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Intended Treatment Period', 'description': 'Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).', 'unitOfMeasure': 'Event Rate (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment were analyzed.'}, {'type': 'SECONDARY', 'title': 'Incidence of Adjudicated Proximal DVT With Onset During the Intended Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2207', 'groupId': 'OG000'}, {'value': '2276', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'OG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.40', 'groupId': 'OG000', 'lowerLimit': '1.84', 'upperLimit': '3.14'}, {'value': '2.50', 'groupId': 'OG001', 'lowerLimit': '1.94', 'upperLimit': '3.24'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.65', 'ciUpperLimit': '1.37', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-1.04', 'ciUpperLimit': '0.76', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Intended Treatment Period', 'description': 'Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).', 'unitOfMeasure': 'Event Rate (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Those randomized with adjudicated and evaluable ultrasound at the end of the intended treatment period; for those with a suspected symptomatic event, the adjudication result was not inadequate; includes all those randomized who have an adjudicated event associated with the endpoint during Intended Treatment.'}, {'type': 'SECONDARY', 'title': 'Incidence of Adjudicated Symptomatic Distal DVT With Onset During the Intended Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3255', 'groupId': 'OG000'}, {'value': '3273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'OG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.15'}, {'value': '0.15', 'groupId': 'OG001', 'lowerLimit': '0.06', 'upperLimit': '0.37'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '-0.02', 'groupDescription': 'Note: Relative risk was not estimable (0.0); only risk difference could be estimated.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Intended Treatment Period', 'description': 'Events were adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).', 'unitOfMeasure': 'Event Rate (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants, except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment period, were analyzed.'}, {'type': 'SECONDARY', 'title': 'Incidence of Adjudicated Symptomatic Proximal DVT With Onset During the Intended Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3255', 'groupId': 'OG000'}, {'value': '3273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'OG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.15', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '0.37'}, {'value': '0.37', 'groupId': 'OG001', 'lowerLimit': '0.20', 'upperLimit': '0.65'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.41', 'ciLowerLimit': '0.14', 'ciUpperLimit': '1.16', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '0.03', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Intended Treatment Period', 'description': 'Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).', 'unitOfMeasure': 'Event Rate (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants, except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment, were analyzed.'}, {'type': 'PRIMARY', 'title': 'Incidence of Major Bleeding During the Treatment Period in Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3184', 'groupId': 'OG000'}, {'value': '3217', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'OG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.47', 'groupId': 'OG000', 'lowerLimit': '0.28', 'upperLimit': '0.79'}, {'value': '0.19', 'groupId': 'OG001', 'lowerLimit': '0.08', 'upperLimit': '0.42'}]}]}], 'analyses': [{'pValue': '0.0437', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference of event rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.29', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.57', 'pValueComment': 'The Mantel-Haenszel test stratified by the stratification factors will be used at the one-sided alpha=0.025 level.', 'groupDescription': 'Adjusted difference of event rates takes the stratification factor into consideration: previous VTE (yes, no) and active or previous cancer (yes, no).', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1, first dose of study drug, to last dose of study drug plus 2 days', 'description': 'Major bleeding was adjudicated by an ICAC using criteria from the International Society on Thrombosis and Hemostasis (ISTH) and was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 grams per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 milliliters (mL) or more of whole blood, or bleeding in a critical site or bleeding which is fatal. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).', 'unitOfMeasure': 'Event Rate (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of study drug were analyzed (As Treated population). Participants were categorized to the group to which they were randomized, unless the same incorrect treatment was received throughout the study; in such case, the As Treated were equal to the treatment received.'}, {'type': 'PRIMARY', 'title': 'Incidence of Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3184', 'groupId': 'OG000'}, {'value': '3217', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'OG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.26', 'groupId': 'OG000', 'lowerLimit': '1.80', 'upperLimit': '2.84'}, {'value': '1.90', 'groupId': 'OG001', 'lowerLimit': '1.48', 'upperLimit': '2.43'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference of event rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.36', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '1.06', 'groupDescription': 'Adjusted difference of event rates takes the stratification factor into consideration: previous VTE (yes, no) and active or previous cancer (yes, no).', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1, first dose of study drug, to last dose of study drug plus 2 days', 'description': 'Bleeding was adjudicated by an ICAC using criteria from the ISTH. CRNM bleeding: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding; spontaneous hematuria; macroscopic gastrointestinal hemorrhage (including at least 1 episode of melena or hematemesis, if clinically apparent with positive results on a fecal occult-blood test); rectal blood loss. Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs for bleeding endpoints. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).', 'unitOfMeasure': 'Event Rate (%):', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of study drug were analyzed (As Treated population). Participants were categorized to the group to which they were randomized, unless the same incorrect treatment was received throughout the study; in such case, the As Treated were equal to the treatment received.'}, {'type': 'PRIMARY', 'title': 'Incidence of Composite of Major or Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3184', 'groupId': 'OG000'}, {'value': '3217', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'OG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.67', 'groupId': 'OG000', 'lowerLimit': '2.16', 'upperLimit': '3.29'}, {'value': '2.08', 'groupId': 'OG001', 'lowerLimit': '1.64', 'upperLimit': '2.64'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjustted difference of event rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.59', 'ciLowerLimit': '-016', 'ciUpperLimit': '1.33', 'groupDescription': 'Adjusted difference of event rates takes the stratification factor into consideration: previous VTE (yes, no) and active or previous cancer (yes, no).', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1, first dose of study drug, to last dose of study drug plus 2 days', 'description': 'Bleeding was adjudicated by an ICAC using criteria from the ISTH. Major bleeding: acute clinically overt bleeding: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 mL or more of whole blood, or bleeding in a critical site or bleeding which is fatal. CRNM bleeding: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding; spontaneous hematuria; macroscopic gastrointestinal hemorrhage; rectal blood loss. Treatment Period=onset from first dose of study drug through 2 days after last dose of study drugs. Incidence: Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).', 'unitOfMeasure': 'Event Rate (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of study drug were analyzed (As Treated population). Participants were categorized to the group to which they were randomized, unless the same incorrect treatment was received throughout the study; in such case, the As Treated were equal to the treatment received.'}, {'type': 'PRIMARY', 'title': 'Incidence of All Bleeding During the Treatment Period in Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3184', 'groupId': 'OG000'}, {'value': '3217', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'OG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.73', 'groupId': 'OG000', 'lowerLimit': '6.85', 'upperLimit': '8.71'}, {'value': '6.81', 'groupId': 'OG001', 'lowerLimit': '5.99', 'upperLimit': '7.73'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference of Event Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '2.14', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1, first dose of drug to last dose of drug plus 2 days', 'description': 'Bleeding was adjudicated by an ICAC using criteria from the ISTH. Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs, for bleeding endpoints. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).', 'unitOfMeasure': 'Event Rate (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of study drug were analyzed (As Treated population). Participants were categorized to the group to which they were randomized, unless the same incorrect treatment was received throughout the study; in such case, the As Treated were equal to the treatment received.'}, {'type': 'SECONDARY', 'title': 'Incidence of Adjudicated Asymptomatic Proximal DVT With Onset During the Intended Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2206', 'groupId': 'OG000'}, {'value': '2269', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'OG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.36', 'groupId': 'OG000', 'lowerLimit': '1.80', 'upperLimit': '3.09'}, {'value': '2.12', 'groupId': 'OG001', 'lowerLimit': '1.60', 'upperLimit': '2.80'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.61', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.20', 'ciLowerLimit': '-0.66', 'ciUpperLimit': '1.07', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Intended Treatment Period', 'description': 'A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).', 'unitOfMeasure': 'Event Rate (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Those randomized with adjudicated and evaluable ultrasound at the end of the intended treatment period; for those with a suspected symptomatic event, the adjudication result was not inadequate; includes all those randomized who have an adjudicated event associated with the endpoint during Intended Treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Deaths, and Discontinuations Due to AEs During the Treatment Period in Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3184', 'groupId': 'OG000'}, {'value': '3217', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'OG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '1871', 'groupId': 'OG000'}, {'value': '1910', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '611', 'groupId': 'OG000'}, {'value': '601', 'groupId': 'OG001'}]}]}, {'title': 'Bleeding AEs', 'categories': [{'measurements': [{'value': '244', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}]}, {'title': 'Discontinuations Due to AE', 'categories': [{'measurements': [{'value': '290', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1, first dose of study drug, to last dose of study drug plus 2 days (AEs), plus 30 days (SAEs, Deaths)', 'description': 'Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs for AEs, and 30 days after last dose of study drugs for SAEs and deaths.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of study drug were analyzed (As Treated population).'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Diastolic Blood Pressure in Treated Participants During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2227', 'groupId': 'OG000'}, {'value': '2301', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'OG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'classes': [{'title': 'Day of Discharge from Hospital (N=1607, 1625)', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '12.69', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '12.32', 'groupId': 'OG001'}]}]}, {'title': 'Day 30 of Treatment + 2 (N=2227,2301)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '12.91', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '12.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to last dose of study drug plus 2 days', 'description': 'Diastolic blood pressure was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Blood pressure was measured in millimeters of mercury (mmHg) and could have been taken with the participant either sitting, standing, or supine.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of study drug, had a baseline value, and had a value on the day specified were analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Systolic Blood Pressure in Treated Participants During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2227', 'groupId': 'OG000'}, {'value': '2301', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'OG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'classes': [{'title': 'Discharge from Hospital (N=1607, 1625)', 'categories': [{'measurements': [{'value': '-3.0', 'spread': '19.12', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '19.80', 'groupId': 'OG001'}]}]}, {'title': 'Day 30 of Treatment + 2 (N=2227, 2301)', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '19.79', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '20.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to last dose of study drug plus 2 days', 'description': 'Systolic blood pressure was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Blood pressure was measured in millimeters of mercury (mmHg) and could have been taken either sitting, standing, or supine.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of study drug, had a baseline value, and had a value on the day specified were analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Heart Rate in Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2225', 'groupId': 'OG000'}, {'value': '2299', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'OG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'classes': [{'title': 'Hospital Discharge (N=1606,1622)', 'categories': [{'measurements': [{'value': '-5.4', 'spread': '14.08', 'groupId': 'OG000'}, {'value': '-5.1', 'spread': '14.07', 'groupId': 'OG001'}]}]}, {'title': 'Day 30 of treatment (N=2225,2299)', 'categories': [{'measurements': [{'value': '-4.0', 'spread': '15.62', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '14.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to last dose of study drug plus 2 days', 'description': 'Heart Rate was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Heart rate was measured in beats per minute (bpm) and could have been taken with participants either sitting, standing, or supine.', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of study drug, had a baseline value, and had a value on the day specified were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Marked Abnormalities in Hematology Laboratory Tests During Treatment Period in Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2835', 'groupId': 'OG000'}, {'value': '2871', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'OG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'classes': [{'title': 'Hemoglobin >2 g/dL decrease (N=2835, 2871)', 'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}, {'title': 'Hematocrit <0.75*PreRx (N=2688, 2722)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Platelet Count < 100*10^9 c/L (N=2761, 2799)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Erythrocytes <0.75*PreRx c/µL (N=2697, 2730)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes <0.75*LLN (N= 2835, 2869)', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes > 1.25*ULN (N=2835, 2869)', 'categories': [{'measurements': [{'value': '331', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}]}, {'title': 'Abs Eosinophils > 0.75*10^3 c/µL (N=20, 24)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Abs Lymphocytes < 0.750*10*3 c/ µL (N=20, 24)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Abs Monocytes > 2000/MM^3 (N= 19, 25)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to last dose of study drug plus 2 days', 'description': 'Lower limit of normal (LLN). Upper limit of normal (ULN). Pre-therapy (PreRx). Absolute (Abs) neutrophil count, bands + neutrophils (ANC). Cells per microliter (c/µL). Grams per deciliter (g/dL). Cells per Liter (c/L). Millimeter (MM). Absolute (Abs). Hemoglobin: \\>2 g/dL decrease compared to PreRx value or value \\<=8 g/dL; Hematocrit: \\<0.75\\*PreRx; Erythrocytes: \\<0.75\\*PreRx c/µL; Leukocytes: \\<0.75\\*LLN or \\> 1.25\\*ULN, if PreRx \\<LLN then use \\<0.8\\*PreRx or \\>ULN, if PreRx \\>ULN then use \\>1.2\\*PreRx or \\< LLN; Platelet count: \\< 100\\*10\\^9 c/L; ANC: \\< 1.00\\*10\\^3 c/µL; Abs eosinophils: \\> 0.75\\*10\\^3 c/µL; Abs Basophils: \\> 400/MM\\^3; Abs Monocytes \\> 2000/MM\\^3; Abs Lymphocytes: \\< 0.750\\*10\\*3 c/ µL or \\> 7.5\\*10\\^3 c/ µL. Samples were obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of study drug, had a pre-therapy value, and had a value on the day specified were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Marked Abnormalities in Electrolyte Laboratory Tests During Treatment Period in Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2862', 'groupId': 'OG000'}, {'value': '2893', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'OG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'classes': [{'title': 'Calcium < 0.8*LLN (N=2861, 2893)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Calcium > 1.2*ULN (N=2861, 2893)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Chloride < 0.9*LLN (N=2861, 2886)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Chloride > 1.1*ULN (N=2861, 2886)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Bicarbonate < 0.75*LLN (N=2831, 2855)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Bicarbonate > 1.25*ULN (N=2831, 2855)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Potassium < 0.9*LLN (N=2851, 2878)', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}, {'title': 'Potassium > 1.1*ULN (N=2851, 2878)', 'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}]}, {'title': 'Sodium < 0.95*LLN (N=2862, 2888)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Sodium > 1.05*ULN (N=2862, 2888)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to last dose of study drug plus 2 days', 'description': 'Bicarbonate milliequivalents/Liter (mEq/L) Low/High: \\< 0.75\\*LLN or \\> 1.25\\*ULN, or if PreRx \\< LLN then use \\< 0.75\\* PreRx or \\> ULN if PreRx \\> ULN then use \\> 1.25\\*PreRx or \\< LLN; Serum Calcium mg/dL Low/High: \\< 0.8\\*LLN or \\> 1.2\\*ULN, or if PreRx \\< LLN then use \\< 0.75\\*PreRx or \\> ULN if PreRx \\> ULN then use \\> 1.25\\*PreRx or \\< LLN; Serum Chloride mEq/L: \\< 0.9\\*LLN or \\> 1.1\\*ULN, or if PreRx \\< LLN then use \\< 0.9\\*PreRx or \\> ULN if PreRx \\> ULN then use \\> 1.1\\*PreRx or \\< LLN; Serum Potassium mEq/L: \\< 0.9\\*LLN or \\> 1.1\\*ULN, or if PreRx \\< LLN then use \\< 0.9\\*PreRx or \\> ULN if PreRx \\> ULN then use \\> 1.1\\*PreRx or \\< LLN; Serum Sodium mEq/L: \\< 0.95\\*LLN or \\> 1.05\\*ULN, or if PreRx \\< LLN then use \\< 0.95\\*PreRx or \\> ULN if PreRx \\> ULN then use \\> 1.05\\*PreRx or \\< LLN. Samples obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of study drug, had a pre-therapy value, and had a value on the day specified were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests During the Treatment Period in Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2866', 'groupId': 'OG000'}, {'value': '2895', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'OG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'classes': [{'title': 'Alkaline phosphatase U/L > 2*ULN(N=2866, 2895)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'ALT U/L > 3*ULN (N=2827, 2861)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'AST U/L > 3*ULN (N=2831, 2863)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin Direct mg/dL > 1.5*ULN (N=2782, 2821)', 'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin Total mg/dL > 2*ULN (N=2853, 2884)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'BUN mg/dL > 1.5*ULN (N=2864, 2891)', 'categories': [{'measurements': [{'value': '194', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine mg/dL > 1.5*ULN (N=2862, 2892)', 'categories': [{'measurements': [{'value': '150', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to last dose of study drug plus 2 days', 'description': 'Blood urea nitrogen (BUN), milligrams/deciliter (mg/dL), units per liter (U/L). BUN mg/dL \\> 1.5\\*ULN; Creatinine mg/dL: \\> 1.5\\*ULN; Alanine aminotransferase (ALT) U/L: \\> 3\\*ULN; Aspartate aminotransferase (AST) U/L: \\> 3\\*ULN; Alkaline phosphatase U/L: \\> 2\\*ULN; Bilirubin Direct mg/dL: \\> 1.5\\*ULN; Bilirubin Total mg/dL: \\> 2\\*ULN. Samples for laboratories obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of study drug, had a pre-therapy value, and had a value on the day specified were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Marked Abnormalities in Glucose, Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests During the Treatment Period in Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2864', 'groupId': 'OG000'}, {'value': '2890', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'OG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'classes': [{'title': 'Glucose Fasting <0.9*LLN (N=284,287)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Glucose Fasting > 1.5*ULN (N=284,287)', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Total Protein < 0.9 *LLN (N=2864, 2890)', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Total Protein > 1.1*ULN (N=2864, 2890)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Creatine kinase >5*ULN U/L(N=2856, 2888)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Uric acid > 1.5* ULN (N=2862, 2889)', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to last dose of study drug plus 2 days', 'description': 'Creatine kinase High: \\>5\\*ULN Units/Liter (U/L); Total Protein High/Low: \\< 0.9 \\*LLN or \\> 1.1\\*ULN, or if PreRx \\< LLN then use 0.9\\* PreRx or \\> ULN if PreRx \\> ULN then use 1.1 \\*PreRx or \\<LLN; Uric acid High: \\> 1.5\\* ULN, or if PreRx \\> ULN then use \\> 2 \\*PreRx. Glucose Fasting: \\<0.9\\*LLN or \\> 1.5\\*ULN or if PreRx \\< LLN then use \\< 0.8\\*PreRx or \\> ULN, if PreRx \\> ULN then use \\>2.0\\*PreRx. Samples obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) ± 2days.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of study drug, had a pre-therapy value, and had a value on the day specified were analyzed.'}, {'type': 'SECONDARY', 'title': 'Incidence of Events of Special Interest of Adjudicated Myocardial Infarction, Stroke, and Thrombocytopenia During the Treatment Period in Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3184', 'groupId': 'OG000'}, {'value': '3217', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'OG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'classes': [{'title': 'MI or stoke (N=3183, 3216)', 'categories': [{'measurements': [{'value': '0.38', 'groupId': 'OG000', 'lowerLimit': '0.21', 'upperLimit': '0.67'}, {'value': '0.37', 'groupId': 'OG001', 'lowerLimit': '0.21', 'upperLimit': '0.66'}]}]}, {'title': 'MI (N=3184, 3217)', 'categories': [{'measurements': [{'value': '0.22', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '0.47'}, {'value': '0.12', 'groupId': 'OG001', 'lowerLimit': '0.04', 'upperLimit': '0.34'}]}]}, {'title': 'Stroke (N=3183, 3216)', 'categories': [{'measurements': [{'value': '0.16', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '0.38'}, {'value': '0.25', 'groupId': 'OG001', 'lowerLimit': '0.12', 'upperLimit': '0.50'}]}]}, {'title': 'Thrombocytopenia (N=3184, 3217)', 'categories': [{'measurements': [{'value': '0.19', 'groupId': 'OG000', 'lowerLimit': '0.08', 'upperLimit': '0.42'}, {'value': '0.09', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.29'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Event rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.00', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '0.29', 'estimateComment': 'stratification factor: previous VTE (yes, no), and active or previous cancer (yes, no).', 'groupDescription': 'Adjusted difference in event rates in MI or stroke.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted difference of event rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.30', 'estimateComment': 'stratification factor: previous VTE (yes, no), and active or previous cancer (yes, no).', 'groupDescription': 'Adjusted difference of event rates for myocardial infarction.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted difference in event rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.12', 'groupDescription': 'Adjusted difference in event rates for stroke.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted difference in event rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.28', 'estimateComment': 'stratification factor: previous VTE (yes, no), and active or previous cancer (yes, no).', 'groupDescription': 'Adjusted difference of event rates in thrombocytopenia.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to last dose of study drug plus 2 days', 'description': 'Events of Special Interest include: adjudicated thrombocytopenia, adjudicated myocardial infarction (MI), adjudicated stroke, and adjudicated MI or stroke. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants). Treatment Period includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs.', 'unitOfMeasure': 'Event Rate (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'MI and thrombocytopenia categories: participants who received at least one dose of study drug. MI or stroke category: treated participants except those who did not have MI and had an inadequate assessment for stroke. Stroke category: treated participants except those with an inadequate assessment for stroke during the treatment period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Events of Special Interest for Liver Function and Neurology During Treatment Period in Treated Participants With Available Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3184', 'groupId': 'OG000'}, {'value': '3217', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'OG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'classes': [{'title': 'Neurologic AEs', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Neurologic SAEs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Liver-related AEs', 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}]}, {'title': 'Liver-related SAEs', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to last dose of study drug plus 2 days (AEs) and plus 30 days (SAEs)', 'description': 'Special interest include: liver function test increases, AEs related to liver function, and neurologic AEs. Treatment Period includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drug when summarizing AEs and through 30 days after the last dose when summarizing SAEs.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of study drug, and had available laboratory results associated with the event and treatment group.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Liver-Related Elevations During the Treatment Period in Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2853', 'groupId': 'OG000'}, {'value': '2884', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'OG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'classes': [{'title': 'AST Elevation >3*ULN (N=2831, 2863)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'ALT Elevation >3*ULN (N=2827, 2861)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'AST + ALT >3*ULN on same date (N= 2827, 2861)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'TBili >2*ULN (N= 2853, 2884)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'ALT or AST >3*ULN + TBili >2*ULN (N=2818,2855)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'ALT>3*ULN + TBili >2*ULN (N=2817, 2853)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to last dose of study drug plus 2 days', 'description': 'Liver function tests: Alanine aminotransferase (ALT) U/L; Aspartate aminotransferase (AST) U/L; Alkaline phosphatase U/L; Total Bilirubin (TBili) mg/dL. Elevations consist of \\>3\\*Upper Limit of Normal (ULN) for ALT and AST and elevation of \\>2\\*ULN for Bilirubin.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of study drug and had available laboratory measurements.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Apixaban 2.5 mg Oral', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'FG001', 'title': 'Enoxaparin 40 mg Subcutaneous', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3255'}, {'groupId': 'FG001', 'numSubjects': '3273'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2442'}, {'groupId': 'FG001', 'numSubjects': '2516'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '813'}, {'groupId': 'FG001', 'numSubjects': '757'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '284'}, {'groupId': 'FG001', 'numSubjects': '260'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '299'}, {'groupId': 'FG001', 'numSubjects': '271'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'Poor/Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'No longer met criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'Administrative reason by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'non-specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'treated for 1 day; missing status/reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'First patient, first visit was June 2007 and last patient, last visit was May 2011. Acutely ill patients who had been hospitalized and had an expected hospitalization of an additional 3 or more days after randomization were enrolled.', 'preAssignmentDetails': '6758 enrolled; 6528 randomized to treatment. Reasons for non-randomization: 2 Adverse event (AE); 34 withdrew consent; 1 death; 3 poor/non-compliance; 162 no longer met study criteria; 2 administrative reason by Sponsor; 26 other reasons.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3255', 'groupId': 'BG000'}, {'value': '3273', 'groupId': 'BG001'}, {'value': '6528', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Apixaban 2.5 mg', 'description': 'Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.'}, {'id': 'BG001', 'title': 'Enoxaparin 40 mg', 'description': 'Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.0', 'groupId': 'BG000', 'lowerLimit': '40', 'upperLimit': '101'}, {'value': '67.0', 'groupId': 'BG001', 'lowerLimit': '40', 'upperLimit': '98'}, {'value': '67.0', 'groupId': 'BG002', 'lowerLimit': '40', 'upperLimit': '101'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': 'Less than (<) 65 years', 'categories': [{'measurements': [{'value': '1401', 'groupId': 'BG000'}, {'value': '1411', 'groupId': 'BG001'}, {'value': '2812', 'groupId': 'BG002'}]}]}, {'title': 'Greater than, equal to (>=) 65 and < 75 years', 'categories': [{'measurements': [{'value': '890', 'groupId': 'BG000'}, {'value': '884', 'groupId': 'BG001'}, {'value': '1774', 'groupId': 'BG002'}]}]}, {'title': '>= 75 years', 'categories': [{'measurements': [{'value': '964', 'groupId': 'BG000'}, {'value': '978', 'groupId': 'BG001'}, {'value': '1942', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1629', 'groupId': 'BG000'}, {'value': '1696', 'groupId': 'BG001'}, {'value': '3325', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1626', 'groupId': 'BG000'}, {'value': '1577', 'groupId': 'BG001'}, {'value': '3203', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '625', 'groupId': 'BG000'}, {'value': '620', 'groupId': 'BG001'}, {'value': '1245', 'groupId': 'BG002'}]}]}, {'title': 'Philippines', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': 'Hong Kong', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '270', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '546', 'groupId': 'BG002'}]}]}, {'title': 'Chile', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '336', 'groupId': 'BG002'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '632', 'groupId': 'BG000'}, {'value': '632', 'groupId': 'BG001'}, {'value': '1264', 'groupId': 'BG002'}]}]}, {'title': 'Colombia', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '198', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '203', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '403', 'groupId': 'BG002'}]}]}, {'title': 'Malaysia', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}, {'title': 'Peru', 'categories': [{'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}, {'title': 'Turkey', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '195', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '389', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}, {'title': 'Argentina', 'categories': [{'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}]}, {'title': 'Singapore', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Norway', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Randomized Participants.', 'unitOfMeasure': 'participants'}, {'title': 'Participants with Risk Factors', 'classes': [{'title': 'Previous Venous Thromboembolism (VTE)', 'categories': [{'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '265', 'groupId': 'BG002'}]}]}, {'title': 'Estrogenic Hormone Therapy', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}, {'title': 'History of Malignancy', 'categories': [{'measurements': [{'value': '312', 'groupId': 'BG000'}, {'value': '320', 'groupId': 'BG001'}, {'value': '632', 'groupId': 'BG002'}]}]}, {'title': 'Chronic Heart Failure', 'categories': [{'measurements': [{'value': '1531', 'groupId': 'BG000'}, {'value': '1537', 'groupId': 'BG001'}, {'value': '3068', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'This baseline measures randomized participants.', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Randomized Participants'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6758}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-07', 'studyFirstSubmitDate': '2007-04-04', 'resultsFirstSubmitDate': '2014-04-14', 'studyFirstSubmitQcDate': '2007-04-04', 'lastUpdatePostDateStruct': {'date': '2015-12-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-14', 'studyFirstPostDateStruct': {'date': '2007-04-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Composite of Adjudicated Total Venous Thromboembolism (VTE) and VTE-related Death During the Intended Treatment Period - Primary Efficacy Population', 'timeFrame': 'Intended Treatment Period', 'description': 'VTE: nonfatal pulmonary embolism (PE), symptomatic deep vein thrombosis (DVT), or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE could not be excluded as a cause. Intended Treatment Period=period that started on day of randomization: period ended (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; period ended (for not treated) 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. All efficacy events were adjudicated by the Independent Central Adjudication Committee (ICAC). Event rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).'}, {'measure': 'Incidence of Major Bleeding During the Treatment Period in Treated Participants', 'timeFrame': 'Day 1, first dose of study drug, to last dose of study drug plus 2 days', 'description': 'Major bleeding was adjudicated by an ICAC using criteria from the International Society on Thrombosis and Hemostasis (ISTH) and was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 grams per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 milliliters (mL) or more of whole blood, or bleeding in a critical site or bleeding which is fatal. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).'}, {'measure': 'Incidence of Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants', 'timeFrame': 'Day 1, first dose of study drug, to last dose of study drug plus 2 days', 'description': 'Bleeding was adjudicated by an ICAC using criteria from the ISTH. CRNM bleeding: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding; spontaneous hematuria; macroscopic gastrointestinal hemorrhage (including at least 1 episode of melena or hematemesis, if clinically apparent with positive results on a fecal occult-blood test); rectal blood loss. Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs for bleeding endpoints. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).'}, {'measure': 'Incidence of Composite of Major or Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants', 'timeFrame': 'Day 1, first dose of study drug, to last dose of study drug plus 2 days', 'description': 'Bleeding was adjudicated by an ICAC using criteria from the ISTH. Major bleeding: acute clinically overt bleeding: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 mL or more of whole blood, or bleeding in a critical site or bleeding which is fatal. CRNM bleeding: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding; spontaneous hematuria; macroscopic gastrointestinal hemorrhage; rectal blood loss. Treatment Period=onset from first dose of study drug through 2 days after last dose of study drugs. Incidence: Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).'}, {'measure': 'Incidence of All Bleeding During the Treatment Period in Treated Participants', 'timeFrame': 'Day 1, first dose of drug to last dose of drug plus 2 days', 'description': 'Bleeding was adjudicated by an ICAC using criteria from the ISTH. Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs, for bleeding endpoints. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).'}], 'secondaryOutcomes': [{'measure': 'Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Key Secondary Efficacy Evaluable Participants', 'timeFrame': 'Day 1 to last dose of parenteral study drug plus 1 day', 'description': 'Parenteral study drug=active or placebo enoxaparin. Parenteral treatment: started on the first dose of parenteral study drug and ended the day after the last dose of parenteral study drug. Key Secondary Efficacy population: all who received at least 1 dose of parenteral study drug and: (those without suspected VTE events during Parenteral Treatment) had an adjudicated evaluable ultrasound performed at the end of Parenteral Treatment; or (those with suspected VTE events during Parenteral Treatment) had those suspected VTE events adjudicated as non-events, and had an adjudicated evaluable ultrasound performed at the end of Parenteral Treatment; or had an adjudicated total VTE during Parenteral Treatment; or had an adjudicated VTE-related death during Parenteral Treatment. Event rate (%): n/N\\*100 (n=number with observation; N=total secondary efficacy evaluable participants).'}, {'measure': 'Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Secondary Efficacy Evaluable Participants', 'timeFrame': 'Day 1 to last dose of parenteral study drug plus 1 day', 'description': 'Parenteral study drug=active or placebo enoxaparin. Parenteral treatment: started on the first dose of parenteral study drug and ended the day after the last dose of parenteral study drug. Secondary Efficacy Evaluable includes those who had an adjudicated, evaluable ultrasound at end of parenteral treatment and for those with a suspected symptomatic event, the result of the adjudication for the symptomatic event was not inadequate; or those with an adjudicated event that was part of the composite endpoint.. Event rate (%): n/N\\*100 (n=number with observation; N=total secondary efficacy evaluable participants).'}, {'measure': 'Incidence of Adjudicated Total VTE or All-Cause Death With Onset During the Intended Treatment Period', 'timeFrame': 'Intended Treatment Period', 'description': 'Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal (N-F) PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. All-Cause Death (A-C Death). Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).'}, {'measure': 'Incidence of Adjudicated Proximal DVT, Non-Fatal PE or All-Cause Death With Onset During the Intended Treatment Period', 'timeFrame': 'Intended Treatment Period', 'description': 'Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).'}, {'measure': 'Incidence of Adjudicated Proximal DVT, Non-Fatal PE or VTE-Related Death, With Onset During the Intended Treatment Period', 'timeFrame': 'Intended Treatment Period', 'description': 'Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).'}, {'measure': 'Incidence of Adjudicated VTE-Related Death With Onset During the Intended Treatment Period in Randomized Participants', 'timeFrame': 'Intended Treatment Period', 'description': 'Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).'}, {'measure': 'Incidence of Adjudicated Symptomatic VTE or All-Cause Death With Onset During the Intended Treatment Period', 'timeFrame': 'Intended Treatment Period', 'description': 'Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).'}, {'measure': 'Symptomatic Adjudicated VTE or VTE-Related Death With Onset During the Intended Treatment Period', 'timeFrame': 'Intended Treatment Period', 'description': 'Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).'}, {'measure': 'Incidence of All VTE or Major Bleeding or All-Cause Death During the Intended Treatment Period', 'timeFrame': 'Intended Treatment Period', 'description': 'Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).'}, {'measure': 'Incidence of Adjudicated PE With Onset During the Intended Treatment Period', 'timeFrame': 'Intended Treatment Period', 'description': 'Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. PE: non-fatal or fatal. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).'}, {'measure': 'Incidence of Adjudicated Non-Fatal PE With Onset During the Intended Treatment Period', 'timeFrame': 'Intended Treatment Period', 'description': 'Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).'}, {'measure': 'Incidence of Adjudicated Symptomatic DVT With Onset During the Intended Treatment Period', 'timeFrame': 'Intended Treatment Period', 'description': 'Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).'}, {'measure': 'Incidence of Adjudicated Proximal DVT With Onset During the Intended Treatment Period', 'timeFrame': 'Intended Treatment Period', 'description': 'Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).'}, {'measure': 'Incidence of Adjudicated Symptomatic Distal DVT With Onset During the Intended Treatment Period', 'timeFrame': 'Intended Treatment Period', 'description': 'Events were adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).'}, {'measure': 'Incidence of Adjudicated Symptomatic Proximal DVT With Onset During the Intended Treatment Period', 'timeFrame': 'Intended Treatment Period', 'description': 'Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).'}, {'measure': 'Incidence of Adjudicated Asymptomatic Proximal DVT With Onset During the Intended Treatment Period', 'timeFrame': 'Intended Treatment Period', 'description': 'A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants).'}, {'measure': 'Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Deaths, and Discontinuations Due to AEs During the Treatment Period in Treated Participants', 'timeFrame': 'Day 1, first dose of study drug, to last dose of study drug plus 2 days (AEs), plus 30 days (SAEs, Deaths)', 'description': 'Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs for AEs, and 30 days after last dose of study drugs for SAEs and deaths.'}, {'measure': 'Mean Change From Baseline in Diastolic Blood Pressure in Treated Participants During Treatment Period', 'timeFrame': 'Day 1 to last dose of study drug plus 2 days', 'description': 'Diastolic blood pressure was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Blood pressure was measured in millimeters of mercury (mmHg) and could have been taken with the participant either sitting, standing, or supine.'}, {'measure': 'Mean Change From Baseline in Systolic Blood Pressure in Treated Participants During Treatment Period', 'timeFrame': 'Day 1 to last dose of study drug plus 2 days', 'description': 'Systolic blood pressure was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Blood pressure was measured in millimeters of mercury (mmHg) and could have been taken either sitting, standing, or supine.'}, {'measure': 'Mean Change From Baseline in Heart Rate in Treated Participants', 'timeFrame': 'Day 1 to last dose of study drug plus 2 days', 'description': 'Heart Rate was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Heart rate was measured in beats per minute (bpm) and could have been taken with participants either sitting, standing, or supine.'}, {'measure': 'Number of Participants With Marked Abnormalities in Hematology Laboratory Tests During Treatment Period in Treated Participants', 'timeFrame': 'Day 1 to last dose of study drug plus 2 days', 'description': 'Lower limit of normal (LLN). Upper limit of normal (ULN). Pre-therapy (PreRx). Absolute (Abs) neutrophil count, bands + neutrophils (ANC). Cells per microliter (c/µL). Grams per deciliter (g/dL). Cells per Liter (c/L). Millimeter (MM). Absolute (Abs). Hemoglobin: \\>2 g/dL decrease compared to PreRx value or value \\<=8 g/dL; Hematocrit: \\<0.75\\*PreRx; Erythrocytes: \\<0.75\\*PreRx c/µL; Leukocytes: \\<0.75\\*LLN or \\> 1.25\\*ULN, if PreRx \\<LLN then use \\<0.8\\*PreRx or \\>ULN, if PreRx \\>ULN then use \\>1.2\\*PreRx or \\< LLN; Platelet count: \\< 100\\*10\\^9 c/L; ANC: \\< 1.00\\*10\\^3 c/µL; Abs eosinophils: \\> 0.75\\*10\\^3 c/µL; Abs Basophils: \\> 400/MM\\^3; Abs Monocytes \\> 2000/MM\\^3; Abs Lymphocytes: \\< 0.750\\*10\\*3 c/ µL or \\> 7.5\\*10\\^3 c/ µL. Samples were obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.'}, {'measure': 'Number of Participants With Marked Abnormalities in Electrolyte Laboratory Tests During Treatment Period in Treated Participants', 'timeFrame': 'Day 1 to last dose of study drug plus 2 days', 'description': 'Bicarbonate milliequivalents/Liter (mEq/L) Low/High: \\< 0.75\\*LLN or \\> 1.25\\*ULN, or if PreRx \\< LLN then use \\< 0.75\\* PreRx or \\> ULN if PreRx \\> ULN then use \\> 1.25\\*PreRx or \\< LLN; Serum Calcium mg/dL Low/High: \\< 0.8\\*LLN or \\> 1.2\\*ULN, or if PreRx \\< LLN then use \\< 0.75\\*PreRx or \\> ULN if PreRx \\> ULN then use \\> 1.25\\*PreRx or \\< LLN; Serum Chloride mEq/L: \\< 0.9\\*LLN or \\> 1.1\\*ULN, or if PreRx \\< LLN then use \\< 0.9\\*PreRx or \\> ULN if PreRx \\> ULN then use \\> 1.1\\*PreRx or \\< LLN; Serum Potassium mEq/L: \\< 0.9\\*LLN or \\> 1.1\\*ULN, or if PreRx \\< LLN then use \\< 0.9\\*PreRx or \\> ULN if PreRx \\> ULN then use \\> 1.1\\*PreRx or \\< LLN; Serum Sodium mEq/L: \\< 0.95\\*LLN or \\> 1.05\\*ULN, or if PreRx \\< LLN then use \\< 0.95\\*PreRx or \\> ULN if PreRx \\> ULN then use \\> 1.05\\*PreRx or \\< LLN. Samples obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.'}, {'measure': 'Number of Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests During the Treatment Period in Treated Participants', 'timeFrame': 'Day 1 to last dose of study drug plus 2 days', 'description': 'Blood urea nitrogen (BUN), milligrams/deciliter (mg/dL), units per liter (U/L). BUN mg/dL \\> 1.5\\*ULN; Creatinine mg/dL: \\> 1.5\\*ULN; Alanine aminotransferase (ALT) U/L: \\> 3\\*ULN; Aspartate aminotransferase (AST) U/L: \\> 3\\*ULN; Alkaline phosphatase U/L: \\> 2\\*ULN; Bilirubin Direct mg/dL: \\> 1.5\\*ULN; Bilirubin Total mg/dL: \\> 2\\*ULN. Samples for laboratories obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.'}, {'measure': 'Number of Participants With Marked Abnormalities in Glucose, Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests During the Treatment Period in Treated Participants', 'timeFrame': 'Day 1 to last dose of study drug plus 2 days', 'description': 'Creatine kinase High: \\>5\\*ULN Units/Liter (U/L); Total Protein High/Low: \\< 0.9 \\*LLN or \\> 1.1\\*ULN, or if PreRx \\< LLN then use 0.9\\* PreRx or \\> ULN if PreRx \\> ULN then use 1.1 \\*PreRx or \\<LLN; Uric acid High: \\> 1.5\\* ULN, or if PreRx \\> ULN then use \\> 2 \\*PreRx. Glucose Fasting: \\<0.9\\*LLN or \\> 1.5\\*ULN or if PreRx \\< LLN then use \\< 0.8\\*PreRx or \\> ULN, if PreRx \\> ULN then use \\>2.0\\*PreRx. Samples obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) ± 2days.'}, {'measure': 'Incidence of Events of Special Interest of Adjudicated Myocardial Infarction, Stroke, and Thrombocytopenia During the Treatment Period in Treated Participants', 'timeFrame': 'Day 1 to last dose of study drug plus 2 days', 'description': 'Events of Special Interest include: adjudicated thrombocytopenia, adjudicated myocardial infarction (MI), adjudicated stroke, and adjudicated MI or stroke. Incidence determined by Event Rate (%): n/N\\*100 (n=number with observation; N=total efficacy evaluable participants). Treatment Period includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs.'}, {'measure': 'Number of Participants With Events of Special Interest for Liver Function and Neurology During Treatment Period in Treated Participants With Available Measurements', 'timeFrame': 'Day 1 to last dose of study drug plus 2 days (AEs) and plus 30 days (SAEs)', 'description': 'Special interest include: liver function test increases, AEs related to liver function, and neurologic AEs. Treatment Period includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drug when summarizing AEs and through 30 days after the last dose when summarizing SAEs.'}, {'measure': 'Number of Participants With Liver-Related Elevations During the Treatment Period in Treated Participants', 'timeFrame': 'Day 1 to last dose of study drug plus 2 days', 'description': 'Liver function tests: Alanine aminotransferase (ALT) U/L; Aspartate aminotransferase (AST) U/L; Alkaline phosphatase U/L; Total Bilirubin (TBili) mg/dL. Elevations consist of \\>3\\*Upper Limit of Normal (ULN) for ALT and AST and elevation of \\>2\\*ULN for Bilirubin.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prevention of deep vein thrombosis and pulmonary embolism with acutely ill hospitalized patients'], 'conditions': ['Venous Thrombosis', 'Pulmonary Embolism']}, 'referencesModule': {'references': [{'pmid': '28762617', 'type': 'DERIVED', 'citation': 'Chi G, Goldhaber SZ, Kittelson JM, Turpie AGG, Hernandez AF, Hull RD, Gold A, Curnutte JT, Cohen AT, Harrington RA, Gibson CM. Effect of extended-duration thromboprophylaxis on venous thromboembolism and major bleeding among acutely ill hospitalized medical patients: a bivariate analysis. J Thromb Haemost. 2017 Oct;15(10):1913-1922. doi: 10.1111/jth.13783. Epub 2017 Sep 4.'}, {'pmid': '28617144', 'type': 'DERIVED', 'citation': 'Marszalek J, Mehrsefat S, Chi G. The risk of stroke among acutely ill hospitalized medical patients: lessons from recent trials on extended-duration thromboprophylaxis. Expert Rev Hematol. 2017 Aug;10(8):679-684. doi: 10.1080/17474086.2017.1343662. Epub 2017 Jun 21.'}, {'pmid': '22863355', 'type': 'DERIVED', 'citation': 'Sharma A, Chatterjee S, Lichstein E, Mukherjee D. Extended thromboprophylaxis for medically ill patients with decreased mobility: does it improve outcomes? J Thromb Haemost. 2012 Oct;10(10):2053-60. doi: 10.1111/j.1538-7836.2012.04874.x.'}, {'pmid': '22077144', 'type': 'DERIVED', 'citation': 'Goldhaber SZ, Leizorovicz A, Kakkar AK, Haas SK, Merli G, Knabb RM, Weitz JI; ADOPT Trial Investigators. Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients. N Engl J Med. 2011 Dec 8;365(23):2167-77. doi: 10.1056/NEJMoa1110899. Epub 2011 Nov 13.'}], 'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein thrombosis \\[DVT\\]) and lung (pulmonary embolism \\[PE\\]) that sometimes occur within patients hospitalized for acute medical illness, and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. 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