Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2025-12-27 @ 5:08 PM
Study NCT ID:
NCT00787150
Status:
COMPLETED
Last Update Posted:
2013-05-01
First Post:
2008-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 2 Study To Evaluate The Safety Of Apixaban In Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522181', 'term': 'apixaban'}, {'id': 'D014859', 'term': 'Warfarin'}], 'ancestors': [{'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Warfarin', 'description': 'The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.', 'otherNumAtRisk': 75, 'otherNumAffected': 17, 'seriousNumAtRisk': 75, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Apixaban 2.5mg BID', 'description': 'One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.', 'otherNumAtRisk': 72, 'otherNumAffected': 24, 'seriousNumAtRisk': 72, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Apixaban 5.0 mg BID', 'description': 'One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.', 'otherNumAtRisk': 71, 'otherNumAffected': 22, 'seriousNumAtRisk': 71, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood creatine phophkinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood pressure inadequately controlled', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Arterial stenosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) or Clinically Relevant Non-major Bleeding Adjudicated by Clinical Event Committee During the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Warfarin', 'description': 'The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.'}, {'id': 'OG001', 'title': 'Apixaban 2.5mg BID', 'description': 'One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.'}, {'id': 'OG002', 'title': 'Apixaban 5.0 mg BID', 'description': 'One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 12', 'description': 'Major bleeding event was acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Total Bleeding Events During the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Warfarin', 'description': 'The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.'}, {'id': 'OG001', 'title': 'Apixaban 2.5mg BID', 'description': 'One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.'}, {'id': 'OG002', 'title': 'Apixaban 5.0 mg BID', 'description': 'One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 12', 'description': 'Total bleeding events consisted of major (per International Society on Thrombosis and Haemostasis \\[ISTH\\] Criteria), clinically relevant non-major and minor bleeding events. All acute clinically overt bleeding events not meeting the criteria for either major bleeding or clinically relevant non-major bleeding were classified as minor bleeding.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) Bleeding Events During the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Warfarin', 'description': 'The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.'}, {'id': 'OG001', 'title': 'Apixaban 2.5mg BID', 'description': 'One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.'}, {'id': 'OG002', 'title': 'Apixaban 5.0 mg BID', 'description': 'One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 12', 'description': 'Major bleeding event is acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding is also major bleeding event.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Relevant Non-major Bleeding Events During the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Warfarin', 'description': 'The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.'}, {'id': 'OG001', 'title': 'Apixaban 2.5mg BID', 'description': 'One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.'}, {'id': 'OG002', 'title': 'Apixaban 5.0 mg BID', 'description': 'One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 12', 'description': 'Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Stroke or Systemic Embolism During the Intended Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Warfarin', 'description': 'The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.'}, {'id': 'OG001', 'title': 'Apixaban 2.5mg BID', 'description': 'One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.'}, {'id': 'OG002', 'title': 'Apixaban 5.0 mg BID', 'description': 'One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 12', 'description': 'The definition of the "Intended Treatment Period" was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) was defined as all randomized participants. Participants were categorized to the group to which they were assigned by the randomization system, regardless of the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Stroke, Systemic Embolism, or All-Cause Death During the Intended Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Warfarin', 'description': 'The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.'}, {'id': 'OG001', 'title': 'Apixaban 2.5mg BID', 'description': 'One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.'}, {'id': 'OG002', 'title': 'Apixaban 5.0 mg BID', 'description': 'One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 12', 'description': 'The definition of the "Intended Treatment Period" was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) was defined as all randomized participants. Participants were categorized to the group to which they were assigned by the randomization system, regardless of the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Myocardial Infarction or All-Cause Death During the Intended Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Warfarin', 'description': 'The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.'}, {'id': 'OG001', 'title': 'Apixaban 2.5mg BID', 'description': 'One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.'}, {'id': 'OG002', 'title': 'Apixaban 5.0 mg BID', 'description': 'One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 12', 'description': 'The definition of the "Intended Treatment Period" was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) was defined as all randomized participants. Participants were categorized to the group to which they were assigned by the randomization system, regardless of the treatment actually received.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Plasma Apixaban Concentration at Each Time Point in Participants Treated With Apixaban', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5mg BID', 'description': 'One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.'}, {'id': 'OG001', 'title': 'Apixaban 5.0 mg BID', 'description': 'One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.'}], 'classes': [{'title': '0 hour post dose at Week 1 (n=68, 70)', 'categories': [{'measurements': [{'value': '53.31', 'spread': '28.55', 'groupId': 'OG000'}, {'value': '119.34', 'spread': '50.83', 'groupId': 'OG001'}]}]}, {'title': '2 hours post dose at Week 1 (n=68, 70)', 'categories': [{'measurements': [{'value': '99.43', 'spread': '44.65', 'groupId': 'OG000'}, {'value': '201.80', 'spread': '95.58', 'groupId': 'OG001'}]}]}, {'title': '4 hours post dose at Week 1 (n=38, 35)', 'categories': [{'measurements': [{'value': '104.09', 'spread': '44.48', 'groupId': 'OG000'}, {'value': '224.40', 'spread': '77.06', 'groupId': 'OG001'}]}]}, {'title': '0 hour post dose at Week 8 (n=67, 66)', 'categories': [{'measurements': [{'value': '62.83', 'spread': '37.27', 'groupId': 'OG000'}, {'value': '137.79', 'spread': '54.91', 'groupId': 'OG001'}]}]}, {'title': '2 hours post dose at Week 8 (n=67, 66)', 'categories': [{'measurements': [{'value': '120.16', 'spread': '57.79', 'groupId': 'OG000'}, {'value': '250.53', 'spread': '81.35', 'groupId': 'OG001'}]}]}, {'title': '4 hours post dose at Week 8 (n=35, 29)', 'categories': [{'measurements': [{'value': '110.58', 'spread': '49.96', 'groupId': 'OG000'}, {'value': '244.55', 'spread': '84.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 2, 4 hours postdose at Week 1 and Week 8', 'description': 'Sample at 4 hours postdose was to be taken if possible.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic analysis set was defined as participants treated with apixaban, who were not assessed as major protocol violators, and in whom at least one observation of plasma apixaban concentration. n=number of participants with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Prothrombin Time (PT) at Each Time Point in Participants Treated With Apixaban', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5mg BID', 'description': 'One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.'}, {'id': 'OG001', 'title': 'Apixaban 5.0 mg BID', 'description': 'One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.'}], 'classes': [{'title': 'Week 0 (n=72, 71)', 'categories': [{'measurements': [{'value': '14.54', 'spread': '2.20', 'groupId': 'OG000'}, {'value': '14.41', 'spread': '2.06', 'groupId': 'OG001'}]}]}, {'title': '0 hour post dose at Week 1 (n=67, 70)', 'categories': [{'measurements': [{'value': '12.22', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '12.54', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': '2 hours post dose at Week 1 (n=68, 70)', 'categories': [{'measurements': [{'value': '12.46', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '13.28', 'spread': '1.05', 'groupId': 'OG001'}]}]}, {'title': '4 hours post dose at Week 1 (n=38, 35)', 'categories': [{'measurements': [{'value': '12.36', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '13.48', 'spread': '0.82', 'groupId': 'OG001'}]}]}, {'title': '0 hour post dose at Week 8 (n=67, 66)', 'categories': [{'measurements': [{'value': '12.09', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '12.74', 'spread': '0.87', 'groupId': 'OG001'}]}]}, {'title': '2 hours post dose at Week 8 (n=67, 66)', 'categories': [{'measurements': [{'value': '12.68', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '13.83', 'spread': '1.03', 'groupId': 'OG001'}]}]}, {'title': '4 hours post dose at Week 8 (n=35, 29)', 'categories': [{'measurements': [{'value': '12.47', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '13.85', 'spread': '1.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8', 'description': 'Sample at 4 hours postdose was to be taken if possible.', 'unitOfMeasure': 'second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Prothrombin Time-International Normalized Ratio (PT-INR) at Each Time Point in Participants Treated With Apixaban', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5mg BID', 'description': 'One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.'}, {'id': 'OG001', 'title': 'Apixaban 5.0 mg BID', 'description': 'One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.'}], 'classes': [{'title': 'Week 0 (n=72, 71)', 'categories': [{'measurements': [{'value': '1.76', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '1.72', 'spread': '0.43', 'groupId': 'OG001'}]}]}, {'title': '0 hour post dose at Week 1 (n=67, 70)', 'categories': [{'measurements': [{'value': '1.30', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '1.34', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': '2 hours post dose at Week 1 (n=68, 70)', 'categories': [{'measurements': [{'value': '1.33', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '1.48', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': '4 hours post dose at Week 1 (n=38, 35)', 'categories': [{'measurements': [{'value': '1.30', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '1.51', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': '0 hour post dose at Week 8 (n=67, 66)', 'categories': [{'measurements': [{'value': '1.27', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '1.38', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': '2 hours post dose at Week 8 (n=67, 66)', 'categories': [{'measurements': [{'value': '1.37', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '1.61', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': '4 hours post dose at Week 8 (n=35, 29)', 'categories': [{'measurements': [{'value': '1.34', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '1.59', 'spread': '0.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8', 'description': 'Blood sample at 4 hours postdose was collected if possible. PT-INR is a standardized measure derived from prothrombin time (PT). The systematic variations in PT assay results are corrected in PT-INR in order to optimize measurements of vitamin K antagonists.', 'unitOfMeasure': 'International normalized ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Activated Partial Thromboplastin Time (aPTT) at Each Time Point in Participants Treated With Apixaban', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5mg BID', 'description': 'One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.'}, {'id': 'OG001', 'title': 'Apixaban 5.0 mg BID', 'description': 'One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.'}], 'classes': [{'title': 'Week 0 (n=72, 71)', 'categories': [{'measurements': [{'value': '34.51', 'spread': '5.05', 'groupId': 'OG000'}, {'value': '32.98', 'spread': '4.39', 'groupId': 'OG001'}]}]}, {'title': '0 hour post dose at Week 1 (n=67, 70)', 'categories': [{'measurements': [{'value': '33.26', 'spread': '10.24', 'groupId': 'OG000'}, {'value': '33.24', 'spread': '4.28', 'groupId': 'OG001'}]}]}, {'title': '2 hours post dose at Week 1 (n=68, 70)', 'categories': [{'measurements': [{'value': '33.04', 'spread': '3.57', 'groupId': 'OG000'}, {'value': '35.19', 'spread': '4.42', 'groupId': 'OG001'}]}]}, {'title': '4 hours oist dose at Week 1 (n=38, 35)', 'categories': [{'measurements': [{'value': '32.00', 'spread': '3.49', 'groupId': 'OG000'}, {'value': '35.36', 'spread': '5.44', 'groupId': 'OG001'}]}]}, {'title': '0 hour post dose at Week 8 (n=67, 66)', 'categories': [{'measurements': [{'value': '33.83', 'spread': '5.18', 'groupId': 'OG000'}, {'value': '35.65', 'spread': '4.32', 'groupId': 'OG001'}]}]}, {'title': '2 hours post dose at Week 8 (n=67, 66)', 'categories': [{'measurements': [{'value': '34.67', 'spread': '4.39', 'groupId': 'OG000'}, {'value': '37.92', 'spread': '4.78', 'groupId': 'OG001'}]}]}, {'title': '4 hours post dose at Week 8 (n=35, 29)', 'categories': [{'measurements': [{'value': '32.75', 'spread': '3.86', 'groupId': 'OG000'}, {'value': '36.46', 'spread': '5.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8', 'description': 'Blood Sample at 4 hours postdose was collected if possible. The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V, VIII, IX, X, XI and XII. Higher values than the baseline indicate anticoagulant effects.', 'unitOfMeasure': 'Second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Anti-Xa Activity (Apixaban Units) at Each Time Point in Participants Treated With Apixaban', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban 2.5mg BID', 'description': 'One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.'}, {'id': 'OG001', 'title': 'Apixaban 5.0 mg BID', 'description': 'One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.'}], 'classes': [{'title': 'Week 0 (n=72, 71)', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': '0 hour post dose at Week 1 (n=68, 69)', 'categories': [{'measurements': [{'value': '45.29', 'spread': '26.77', 'groupId': 'OG000'}, {'value': '111.19', 'spread': '49.02', 'groupId': 'OG001'}]}]}, {'title': '2 hours post dose at Week 1 (n=68, 70)', 'categories': [{'measurements': [{'value': '94.90', 'spread': '45.23', 'groupId': 'OG000'}, {'value': '187.58', 'spread': '85.72', 'groupId': 'OG001'}]}]}, {'title': '4 hours post dose at Week 1 (n=38, 35)', 'categories': [{'measurements': [{'value': '99.07', 'spread': '44.46', 'groupId': 'OG000'}, {'value': '213.24', 'spread': '67.54', 'groupId': 'OG001'}]}]}, {'title': '0 hour post dose at Week 8 (n=67, 65)', 'categories': [{'measurements': [{'value': '56.81', 'spread': '37.34', 'groupId': 'OG000'}, {'value': '130.12', 'spread': '52.20', 'groupId': 'OG001'}]}]}, {'title': '2 hours post dose at Week 8 (n=67, 66)', 'categories': [{'measurements': [{'value': '114.97', 'spread': '56.25', 'groupId': 'OG000'}, {'value': '236.36', 'spread': '88.08', 'groupId': 'OG001'}]}]}, {'title': '4 hours post dose at Week 8 (n=35, 29)', 'categories': [{'measurements': [{'value': '103.61', 'spread': '44.54', 'groupId': 'OG000'}, {'value': '237.78', 'spread': '78.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8', 'description': 'Blood sample at 4 hours postdose was collected if possible. Below the limit of quantification (BLQ) was assigned the value 0 for calculation. If 50% or more of the data was BLQ, statistics was not be calculated. Therefore, 0 means not calculated.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Prothrombin Fragment 1+2 (F1+2) at Each Time Point in Participants Treated With Warfarin or Apixaban', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Warfarin', 'description': 'The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.'}, {'id': 'OG001', 'title': 'Apixaban 2.5mg BID', 'description': 'One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.'}, {'id': 'OG002', 'title': 'Apixaban 5.0 mg BID', 'description': 'One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.'}], 'classes': [{'title': 'Week 0 (n=75, 72, 71)', 'categories': [{'measurements': [{'value': '144.0', 'spread': '345.2', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '91.4', 'spread': '115.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 1 (n=75, 68, 70)', 'categories': [{'measurements': [{'value': '100.4', 'spread': '139.0', 'groupId': 'OG000'}, {'value': '133.8', 'spread': '105.5', 'groupId': 'OG001'}, {'value': '137.0', 'spread': '255.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 (n=68, 67, 66)', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '152.9', 'spread': '79.7', 'groupId': 'OG001'}, {'value': '121.1', 'spread': '56.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, Week 1, Week 8', 'description': 'Below the limit of quantification (BLQ) was assigned the value 0 for calculation. If 50% or more of the data was BLQ, statistics was not calculated. Therefore, 0 indicates not calculated.', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Warfarin, Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean D-Dimer at Each Time Point in Participants Treated With Warfarin or Apixaban', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Warfarin', 'description': 'The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.'}, {'id': 'OG001', 'title': 'Apixaban 2.5mg BID', 'description': 'One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.'}, {'id': 'OG002', 'title': 'Apixaban 5.0 mg BID', 'description': 'One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.'}], 'classes': [{'title': 'Week 0 (n=75, 72, 71)', 'categories': [{'measurements': [{'value': '240.4', 'spread': '333.5', 'groupId': 'OG000'}, {'value': '297.8', 'spread': '634.6', 'groupId': 'OG001'}, {'value': '196.4', 'spread': '181.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 1 (n=75, 68, 70)', 'categories': [{'measurements': [{'value': '245.2', 'spread': '325.7', 'groupId': 'OG000'}, {'value': '209.9', 'spread': '202.6', 'groupId': 'OG001'}, {'value': '237.0', 'spread': '314.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 (n=68, 67, 66)', 'categories': [{'measurements': [{'value': '209.9', 'spread': '201.1', 'groupId': 'OG000'}, {'value': '227.0', 'spread': '253.5', 'groupId': 'OG001'}, {'value': '203.5', 'spread': '190.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, Week 1, Week 8', 'description': 'Below the limit of quantification (BLQ) was assigned the value 0 for calculation.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of participants with evaluable data in Warfarin, Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Warfarin', 'description': 'The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.'}, {'id': 'FG001', 'title': 'Apixaban 2.5mg BID', 'description': 'One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.'}, {'id': 'FG002', 'title': 'Apixaban 5.0 mg BID', 'description': 'One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Of 222 participants enrolled 4 discontinued before dosing, made a total of 218 participants started.', 'groupId': 'FG000', 'numSubjects': '75'}, {'comment': 'Of 222 participants enrolled 4 discontinued before dosing, made a total of 218 participants started.', 'groupId': 'FG001', 'numSubjects': '72'}, {'comment': 'Of 222 participants enrolled 4 discontinued before dosing, made a total of 218 participants started.', 'groupId': 'FG002', 'numSubjects': '71'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Dosing incorrect study durg', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '222', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Warfarin', 'description': 'The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.'}, {'id': 'BG001', 'title': 'Apixaban 2.5mg BID', 'description': 'One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.'}, {'id': 'BG002', 'title': 'Apixaban 5.0 mg BID', 'description': 'One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.7', 'spread': '7.0', 'groupId': 'BG000'}, {'value': '69.3', 'spread': '8.4', 'groupId': 'BG001'}, {'value': '70.0', 'spread': '8.1', 'groupId': 'BG002'}, {'value': '70.3', 'spread': '7.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '184', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 222}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-23', 'studyFirstSubmitDate': '2008-11-05', 'resultsFirstSubmitDate': '2013-01-29', 'studyFirstSubmitQcDate': '2008-11-05', 'lastUpdatePostDateStruct': {'date': '2013-05-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-01-29', 'studyFirstPostDateStruct': {'date': '2008-11-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mean Plasma Apixaban Concentration at Each Time Point in Participants Treated With Apixaban', 'timeFrame': '0, 2, 4 hours postdose at Week 1 and Week 8', 'description': 'Sample at 4 hours postdose was to be taken if possible.'}, {'measure': 'Mean Prothrombin Time (PT) at Each Time Point in Participants Treated With Apixaban', 'timeFrame': 'Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8', 'description': 'Sample at 4 hours postdose was to be taken if possible.'}, {'measure': 'Mean Prothrombin Time-International Normalized Ratio (PT-INR) at Each Time Point in Participants Treated With Apixaban', 'timeFrame': 'Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8', 'description': 'Blood sample at 4 hours postdose was collected if possible. PT-INR is a standardized measure derived from prothrombin time (PT). The systematic variations in PT assay results are corrected in PT-INR in order to optimize measurements of vitamin K antagonists.'}, {'measure': 'Mean Activated Partial Thromboplastin Time (aPTT) at Each Time Point in Participants Treated With Apixaban', 'timeFrame': 'Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8', 'description': 'Blood Sample at 4 hours postdose was collected if possible. The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V, VIII, IX, X, XI and XII. Higher values than the baseline indicate anticoagulant effects.'}, {'measure': 'Mean Anti-Xa Activity (Apixaban Units) at Each Time Point in Participants Treated With Apixaban', 'timeFrame': 'Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8', 'description': 'Blood sample at 4 hours postdose was collected if possible. Below the limit of quantification (BLQ) was assigned the value 0 for calculation. If 50% or more of the data was BLQ, statistics was not be calculated. Therefore, 0 means not calculated.'}, {'measure': 'Mean Prothrombin Fragment 1+2 (F1+2) at Each Time Point in Participants Treated With Warfarin or Apixaban', 'timeFrame': 'Week 0, Week 1, Week 8', 'description': 'Below the limit of quantification (BLQ) was assigned the value 0 for calculation. If 50% or more of the data was BLQ, statistics was not calculated. Therefore, 0 indicates not calculated.'}, {'measure': 'Mean D-Dimer at Each Time Point in Participants Treated With Warfarin or Apixaban', 'timeFrame': 'Week 0, Week 1, Week 8', 'description': 'Below the limit of quantification (BLQ) was assigned the value 0 for calculation.'}], 'primaryOutcomes': [{'measure': 'Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) or Clinically Relevant Non-major Bleeding Adjudicated by Clinical Event Committee During the Treatment Period', 'timeFrame': 'Baseline to Week 12', 'description': 'Major bleeding event was acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Total Bleeding Events During the Treatment Period', 'timeFrame': 'Baseline to Week 12', 'description': 'Total bleeding events consisted of major (per International Society on Thrombosis and Haemostasis \\[ISTH\\] Criteria), clinically relevant non-major and minor bleeding events. All acute clinically overt bleeding events not meeting the criteria for either major bleeding or clinically relevant non-major bleeding were classified as minor bleeding.'}, {'measure': 'Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) Bleeding Events During the Treatment Period', 'timeFrame': 'Baseline to Week 12', 'description': 'Major bleeding event is acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding is also major bleeding event.'}, {'measure': 'Number of Participants With Clinically Relevant Non-major Bleeding Events During the Treatment Period', 'timeFrame': 'Baseline to Week 12', 'description': 'Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.'}, {'measure': 'Number of Participants With Stroke or Systemic Embolism During the Intended Treatment Period', 'timeFrame': 'Baseline to Week 12', 'description': 'The definition of the "Intended Treatment Period" was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.'}, {'measure': 'Number of Participants With Stroke, Systemic Embolism, or All-Cause Death During the Intended Treatment Period', 'timeFrame': 'Baseline to Week 12', 'description': 'The definition of the "Intended Treatment Period" was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.'}, {'measure': 'Number of Participants With Myocardial Infarction or All-Cause Death During the Intended Treatment Period', 'timeFrame': 'Baseline to Week 12', 'description': 'The definition of the "Intended Treatment Period" was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '21670542', 'type': 'DERIVED', 'citation': 'Ogawa S, Shinohara Y, Kanmuri K. Safety and efficacy of the oral direct factor xa inhibitor apixaban in Japanese patients with non-valvular atrial fibrillation. -The ARISTOTLE-J study-. Circ J. 2011;75(8):1852-9. doi: 10.1253/circj.cj-10-1183. Epub 2011 Jun 14.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0661003&StudyName=A%20Phase%202%20Study%20To%20Evaluate%20The%20Safety%20Of%20Apixaban%20In%20Atrial%20Fibrillation', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To assess the effect of two doses of Apixaban (2.5 mg BID and 5 mg BID) versus Warfarin on the composite endpoint of major and clinically relevant non-major bleeding during the treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 20 years outpatient (regardless of sex)\n* Patients diagnosed as non-valvular atrial fibrillation (NVAF)\n* One or more following risks of stroke.\n\nExclusion Criteria:\n\n* Recent cerebral infarction (includes TIA) within 4 weeks of week 0.\n* Subjects who have or are suspected to have a serious/hereditary bleeding tendency, such as disseminated intravascular coagulation syndrome (DIC), congenital platelet dysfunction and von Willebrand disease (those suspected from the family history are included).\n* Subjects who have or are suspected to have a serious/hereditary thrombogenic tendency (those suspected from the family history are included) or those who require continuation of the Warfarin therapy.'}, 'identificationModule': {'nctId': 'NCT00787150', 'briefTitle': 'A Phase 2 Study To Evaluate The Safety Of Apixaban In Atrial Fibrillation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 2b, Randomized, Partially Blind (Open Label Warfarin), Active-Controlled (Warfarin), Multicenter Study, To Evaluate The Safety And Efficacy In 2 Doses Of Apixaban In Comparison To Warfarin, Administered For 12 Weeks In Subjects With NVAF', 'orgStudyIdInfo': {'id': 'B0661003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Apixaban 5mg BID', 'interventionNames': ['Drug: Apixaban']}, {'type': 'EXPERIMENTAL', 'label': 'Apixaban 2.5mg BID', 'interventionNames': ['Drug: Apixaban']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Warfarin', 'interventionNames': ['Drug: Warfarin sodium']}], 'interventions': [{'name': 'Apixaban', 'type': 'DRUG', 'description': 'Apixaban 5 mg tablet BID for 12 weeks', 'armGroupLabels': ['Apixaban 5mg BID']}, {'name': 'Apixaban', 'type': 'DRUG', 'description': 'Apixaban 2.5 mg tablet BID for 12 weeks', 'armGroupLabels': ['Apixaban 2.5mg BID']}, {'name': 'Warfarin sodium', 'type': 'DRUG', 'description': "At each visit, the subject to take appropriate Warfarin tablet (on investigator's order) once a day every morning for 12 weeks", 'armGroupLabels': ['Warfarin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Seto', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.23333, 'lon': 137.1}}, {'city': 'Touon', 'state': 'Ehime', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}, {'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Kitakyushu', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'city': 'Ōgaki', 'state': 'Gifu', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.35, 'lon': 136.61667}}, {'city': 'Isesaki', 'state': 'Gunma', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 36.31667, 'lon': 139.2}}, {'city': 'Shibukawa', 'state': 'Gunma', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 36.48333, 'lon': 139.0}}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Higashiibaraki-gunn Ibarakimachi', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}, {'city': 'Zentsujichó', 'state': 'Kagawa-ken', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.22699, 'lon': 133.77791}}, {'city': 'Kawasaki', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'city': 'Kumamoto', 'state': 'Kumamoto', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'city': 'Tsu', 'state': 'Mie-ken', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.73333, 'lon': 136.51667}}, {'city': 'Minato-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}, {'city': 'Shinagawa-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}, {'city': 'Shinjuku-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}, {'city': 'Iwakuni', 'state': 'Yamaguchi', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.16297, 'lon': 132.22}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}