Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-01-01 @ 3:57 PM
Study NCT ID:
NCT04435769
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2020-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Non-Interventional Study Describing Direct Costs Related to Anti-coagulation Treatment
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'}]}}, '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': {'timeFrame': '6 Months (from retrospective data retrieved in the study)', 'description': "An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. FAS population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents. No medical dictionary was utilized in this study.", 'eventGroups': [{'id': 'EG000', 'title': 'Apixaban', 'description': 'Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 4, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Warfarin', 'description': 'Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 0, 'seriousNumAtRisk': 67, 'deathsNumAffected': 1, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle hematomas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Feeling sick', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Cardiac ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke/TIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intracranial bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'GI bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intraparenchymal hematoma of the lower lobe', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'CHA2-DS2-VASc Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban', 'description': 'Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (from retrospective data retrieved in the study)', 'description': 'CHA2DS2-VASc scoring scale was used to estimate the risk of stroke and systemic emboli in participants with NVAF. CHA2DS2-VASc score was calculated based on 8 risk factors (age 65-74 years, age \\>=75 years, sex category, i.e. female sex, congestive heart failure history, hypertension history, stroke/TIA/thromboembolism history, vascular disease history and diabetes mellitus history). Total CHA2DS2-VASc score ranged from 0-9 where 0= low risk and 9= high risk of stroke.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.'}, {'type': 'PRIMARY', 'title': 'HAS-BLED Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban', 'description': 'Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (from retrospective data retrieved in the study)', 'description': 'HAS-BLED scoring scale was used to estimate the risk of bleeding. HAS-BLED score was calculated based on 9 risk factors (hypertension, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age \\>65 years, medication usage predisposing to bleeding and alcohol use). Total HAS-BLED score ranged from 0 to 9 where 0 = low risk and \\>=3 = high risk of bleed.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.'}, {'type': 'PRIMARY', 'title': 'CHA2-DS2-VASc Score at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban', 'description': 'Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6 (from retrospective data retrieved in the study)', 'description': 'CHA2DS2-VASc scoring scale was used to estimate the risk of stroke and systemic emboli in participants with NVAF. CHA2DS2-VASc score was calculated based on 8 risk factors (age 65-74 years, age \\>=75 years, sex category i.e. female sex, congestive heart failure history, hypertension history, stroke/TIA/thromboembolism history, vascular disease history and diabetes mellitus history). Total CHA2DS2-VASc score ranged from 0-9 where 0= low risk and 9= high risk of stroke.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.'}, {'type': 'PRIMARY', 'title': 'HAS-BLED Score at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban', 'description': 'Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6 (from retrospective data retrieved in the study)', 'description': 'HAS-BLED scoring scale was used to estimate the risk of bleeding. HAS-BLED score was calculated based on 9 risk factors (hypertension, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age \\>65 years, medication usage predisposing to bleeding and alcohol use). Total HAS-BLED score ranged from 0 to 9 where 0 = low risk and \\>=3 = high risk of bleed.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Categorized According to Number of Outpatient Visits During First 6 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban', 'description': 'Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}], 'classes': [{'title': '0 visit', 'categories': [{'measurements': [{'value': '55.0', 'groupId': 'OG000'}, {'value': '44.4', 'groupId': 'OG001'}]}]}, {'title': '1 visit', 'categories': [{'measurements': [{'value': '32.5', 'groupId': 'OG000'}, {'value': '36.5', 'groupId': 'OG001'}]}]}, {'title': '2 visits', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '9.5', 'groupId': 'OG001'}]}]}, {'title': '3 visits', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}, {'title': '4 visits', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '4.8', 'groupId': 'OG001'}]}]}, {'title': '5 visits', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': 'In this outcome measure, percentage of participants were categorized according to number of outpatient visits from 0 to 5.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.'}, {'type': 'PRIMARY', 'title': 'Cost of Outpatient Visits During First 6 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban', 'description': 'Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '258.8', 'spread': '320.4', 'groupId': 'OG000'}, {'value': '414.3', 'spread': '525.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': 'Costs of outpatient visits were calculated for the first 6 months of treatment as the number of visits multiplied by the cost of the visit (450.0 Czech koruna \\[CZK\\] per visit). Costs were calculated based on the number of outpatient visits during the treatment.', 'unitOfMeasure': 'Czech koruna', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Categorized According to Number of International Normalized Ratios (INR) Measurements During First 6 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban', 'description': 'Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}], 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '97.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': '1 to 9', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '4.8', 'groupId': 'OG001'}]}]}, {'title': '10 to 19', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '46.0', 'groupId': 'OG001'}]}]}, {'title': '>=20', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '49.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': "INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. In this outcome measure, percentage of participants were categorized according to number of INR measurements included zero (0), 1 to 9, 10 to 19 and greater than or equal to (\\>=) 20.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.'}, {'type': 'PRIMARY', 'title': 'Cost of INR Measurements During First 6 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban', 'description': 'Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'spread': '33.7', 'groupId': 'OG000'}, {'value': '4003.0', 'spread': '1230.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': "INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. Costs related to INR measurements, were calculated for the period of 6 months as the number of INR measurements multiplied by the cost of the INR measurement (213.0 CZK per measurement). Costs were based on the expenditure of total number of INR measurements during first 6-month treatment.", 'unitOfMeasure': 'Czech koruna', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.'}, {'type': 'PRIMARY', 'title': 'Dosage of Warfarin and Apixaban at the Initiation of the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban', 'description': 'Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '3.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (from retrospective data retrieved in the study)', 'description': 'In this outcome measure, dosage of apixaban and warfarin used at the initiation of treatment was reported.', 'unitOfMeasure': 'Milligrams per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.'}, {'type': 'PRIMARY', 'title': 'Dosage of Warfarin and Apixaban During First 6 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban', 'description': 'Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': 'In this outcome measure, dosage of apixaban and warfarin used during first 6 months of treatment was reported.', 'unitOfMeasure': 'Milligrams per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.'}, {'type': 'PRIMARY', 'title': 'Cost of Medication During First 6 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban', 'description': 'Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '8551.0', 'spread': '2932.5', 'groupId': 'OG000'}, {'value': '1263.5', 'spread': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': 'In this outcome measure, cost of medication, i.e., costs of apixaban and warfarin were based on the dosage of active substance and were calculated for the first 6 months of treatment (daily cost times 182.4 days), regardless of how long the individual participant treated was reported.', 'unitOfMeasure': 'Czech koruna', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Categorized According to Number of Hospital Admissions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban', 'description': 'Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}], 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000'}, {'value': '81.0', 'groupId': 'OG001'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '4.8', 'groupId': 'OG001'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': 'In this outcome measure, percentage of participants were categorized according to number of hospital admissions from 0 to 3 were reported.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.'}, {'type': 'PRIMARY', 'title': 'Cost of Hospital Admissions During First 6 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban', 'description': 'Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2777.5', 'spread': '13820.1', 'groupId': 'OG000'}, {'value': '12326.8', 'spread': '43596.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': 'In this outcome measure, costs of hospital admissions were based on the number of hospital admissions during the treatment period by considering the reason for hospitalization. If the reason for admission was not related to the recorded event (ischemic, hemorrhagic, or other adverse event), or the participant experienced none of these events, the cost of hospitalization was calculated as the number of days multiplied by the cost per a day of hospitalization (1898.2 CZK per day).', 'unitOfMeasure': 'Czech koruna', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Categorized According to Number of Diagnostic Procedures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban', 'description': 'Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}], 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': 'In this outcome measure, percentage of participants were categorized according to number of diagnostic procedures.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data collected by trial sites for diagnostic procedures were incorrect, hence data was not evaluated and analyzed for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Categorized According to Type of Ischemic Events During First 6 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban', 'description': 'Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}], 'classes': [{'title': 'Cardiac ischemia', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Stroke/TIA', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '9.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': 'In this outcome measure, percentage of participants were categorized according to type of ischemic events which included cardiac ischemia and stroke/TIA.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.'}, {'type': 'PRIMARY', 'title': 'Cost of Ischemic Events During First 6 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban', 'description': 'Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '684.8', 'spread': '4331.2', 'groupId': 'OG000'}, {'value': '5386.6', 'spread': '16735.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': 'Costs of ischemic events (cardiac ischemia and stroke/TIA) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of ischemic events during the first 6 months of treatment.', 'unitOfMeasure': 'Czech koruna', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Categorized With Major Hemorrhagic Events During First 6 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban', 'description': 'Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': 'In this outcome measure, percentage of participants with major hemorrhagic events which included intracranial bleeding was reported.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Categorized According to Type of Minor Hemorrhagic Events During First 6 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban', 'description': 'Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}], 'classes': [{'title': 'Epistaxis', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'GI bleeding', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Muscle hematomas', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Other- Intraparenchymal hematoma of the lower lobe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': 'In this outcome measure, percentage of participants were categorized according to type of minor hemorrhagic events which included epistaxis, gastrointestinal (GI) bleeding, muscle hematomas and intraparenchymal hematoma of the lower lobe.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.'}, {'type': 'PRIMARY', 'title': 'Cost of Major Hemorrhagic Events During First 6 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban', 'description': 'Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2092.7', 'spread': '13235.4', 'groupId': 'OG000'}, {'value': '2657.4', 'spread': '14793.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': 'Costs of major hemorrhagic events (intracranial bleeding) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of major hemorrhagic events during the first 6 months of treatment.', 'unitOfMeasure': 'Czech koruna', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.'}, {'type': 'PRIMARY', 'title': 'Cost of Minor Hemorrhagic Events During First 6 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban', 'description': 'Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1285.1', 'spread': '5697.5', 'groupId': 'OG000'}, {'value': '1666.7', 'spread': '10157.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': 'Costs of minor hemorrhagic events (epistaxis, GI bleeding, muscle hematomas and intraparenchymal hematoma of the lower lobe) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of minor hemorrhagic events during the first 6 months of treatment.', 'unitOfMeasure': 'Czech koruna', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Other Adverse Events During First 6 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban', 'description': 'Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': 'An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Other adverse events included all events other than ischemic, major and minor hemorrhagic events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.'}, {'type': 'PRIMARY', 'title': 'Cost of Other Adverse Events During First 6 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban', 'description': 'Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2063.9', 'spread': '9628.8', 'groupId': 'OG000'}, {'value': '1328.7', 'spread': '10546.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': 'Costs of other adverse events included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the number of other adverse events during the treatment.', 'unitOfMeasure': 'Czech koruna', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Died (Treatment-Related) During First 6 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban', 'description': 'Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': 'In this outcome measure, percentage of participants who died due to the given treatment were reported.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Apixaban', 'description': 'Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}, {'id': 'FG001', 'title': 'Warfarin', 'description': 'Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '67'}]}, {'type': 'Full Analysis Set (FAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '67'}]}, {'type': 'Per Protocol (PP) Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '67'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Data from eligible participants with non-valvular atrial fibrillation (NVAF) who started treatment with warfarin or apixaban for the prevention of a secondary stroke or transient ischemic attack (TIA) between 2009 to 2019 were observed in this study. Participants' records were retrieved and observed only for first 6 months of the warfarin/apixaban treatment. Collected data from all the participants were observed approximately for 10 months in this observational study."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Apixaban', 'description': 'Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}, {'id': 'BG001', 'title': 'Warfarin', 'description': 'Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '78.1', 'spread': '12.1', 'groupId': 'BG000'}, {'value': '79.5', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '79.0', 'spread': '10.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Body-Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26.9', 'spread': '4.8', 'groupId': 'BG000'}, {'value': '28.7', 'spread': '5.4', 'groupId': 'BG001'}, {'value': '28.0', 'spread': '5.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilogram per meter square (kg/m^2)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration from index event to the initiation of non-vitamin K antagonist anticoagulant therapy (NOAC)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11.8', 'spread': '12.7', 'groupId': 'BG000'}, {'value': '10.0', 'spread': '6.2', 'groupId': 'BG001'}, {'value': '10.7', 'spread': '9.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The index event was the first stroke/TIA event based on which the NOAC treatment was initiated.', 'unitOfMeasure': 'Days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Participants With Anticoagulant Treatment Before the Initiation of NOAC Therapy', 'classes': [{'title': 'Aspirin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}, {'title': 'Clopidogrel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Thrombolytics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'Clexane', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': 'Fraxiparine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': 'Low molecular weight heparin (LMWH) - preventive dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-05', 'size': 2515211, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-05-05T12:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-05', 'studyFirstSubmitDate': '2020-06-15', 'resultsFirstSubmitDate': '2022-05-05', 'studyFirstSubmitQcDate': '2020-06-15', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-05-05', 'studyFirstPostDateStruct': {'date': '2020-06-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CHA2-DS2-VASc Score at Baseline', 'timeFrame': 'Baseline (from retrospective data retrieved in the study)', 'description': 'CHA2DS2-VASc scoring scale was used to estimate the risk of stroke and systemic emboli in participants with NVAF. CHA2DS2-VASc score was calculated based on 8 risk factors (age 65-74 years, age \\>=75 years, sex category, i.e. female sex, congestive heart failure history, hypertension history, stroke/TIA/thromboembolism history, vascular disease history and diabetes mellitus history). Total CHA2DS2-VASc score ranged from 0-9 where 0= low risk and 9= high risk of stroke.'}, {'measure': 'HAS-BLED Score at Baseline', 'timeFrame': 'Baseline (from retrospective data retrieved in the study)', 'description': 'HAS-BLED scoring scale was used to estimate the risk of bleeding. HAS-BLED score was calculated based on 9 risk factors (hypertension, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age \\>65 years, medication usage predisposing to bleeding and alcohol use). Total HAS-BLED score ranged from 0 to 9 where 0 = low risk and \\>=3 = high risk of bleed.'}, {'measure': 'CHA2-DS2-VASc Score at Month 6', 'timeFrame': 'Month 6 (from retrospective data retrieved in the study)', 'description': 'CHA2DS2-VASc scoring scale was used to estimate the risk of stroke and systemic emboli in participants with NVAF. CHA2DS2-VASc score was calculated based on 8 risk factors (age 65-74 years, age \\>=75 years, sex category i.e. female sex, congestive heart failure history, hypertension history, stroke/TIA/thromboembolism history, vascular disease history and diabetes mellitus history). Total CHA2DS2-VASc score ranged from 0-9 where 0= low risk and 9= high risk of stroke.'}, {'measure': 'HAS-BLED Score at Month 6', 'timeFrame': 'Month 6 (from retrospective data retrieved in the study)', 'description': 'HAS-BLED scoring scale was used to estimate the risk of bleeding. HAS-BLED score was calculated based on 9 risk factors (hypertension, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age \\>65 years, medication usage predisposing to bleeding and alcohol use). Total HAS-BLED score ranged from 0 to 9 where 0 = low risk and \\>=3 = high risk of bleed.'}, {'measure': 'Percentage of Participants Categorized According to Number of Outpatient Visits During First 6 Months of Treatment', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': 'In this outcome measure, percentage of participants were categorized according to number of outpatient visits from 0 to 5.'}, {'measure': 'Cost of Outpatient Visits During First 6 Months of Treatment', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': 'Costs of outpatient visits were calculated for the first 6 months of treatment as the number of visits multiplied by the cost of the visit (450.0 Czech koruna \\[CZK\\] per visit). Costs were calculated based on the number of outpatient visits during the treatment.'}, {'measure': 'Percentage of Participants Categorized According to Number of International Normalized Ratios (INR) Measurements During First 6 Months of Treatment', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': "INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. In this outcome measure, percentage of participants were categorized according to number of INR measurements included zero (0), 1 to 9, 10 to 19 and greater than or equal to (\\>=) 20."}, {'measure': 'Cost of INR Measurements During First 6 Months of Treatment', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': "INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. Costs related to INR measurements, were calculated for the period of 6 months as the number of INR measurements multiplied by the cost of the INR measurement (213.0 CZK per measurement). Costs were based on the expenditure of total number of INR measurements during first 6-month treatment."}, {'measure': 'Dosage of Warfarin and Apixaban at the Initiation of the Treatment', 'timeFrame': 'Baseline (from retrospective data retrieved in the study)', 'description': 'In this outcome measure, dosage of apixaban and warfarin used at the initiation of treatment was reported.'}, {'measure': 'Dosage of Warfarin and Apixaban During First 6 Months of Treatment', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': 'In this outcome measure, dosage of apixaban and warfarin used during first 6 months of treatment was reported.'}, {'measure': 'Cost of Medication During First 6 Months of Treatment', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': 'In this outcome measure, cost of medication, i.e., costs of apixaban and warfarin were based on the dosage of active substance and were calculated for the first 6 months of treatment (daily cost times 182.4 days), regardless of how long the individual participant treated was reported.'}, {'measure': 'Percentage of Participants Categorized According to Number of Hospital Admissions', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': 'In this outcome measure, percentage of participants were categorized according to number of hospital admissions from 0 to 3 were reported.'}, {'measure': 'Cost of Hospital Admissions During First 6 Months of Treatment', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': 'In this outcome measure, costs of hospital admissions were based on the number of hospital admissions during the treatment period by considering the reason for hospitalization. If the reason for admission was not related to the recorded event (ischemic, hemorrhagic, or other adverse event), or the participant experienced none of these events, the cost of hospitalization was calculated as the number of days multiplied by the cost per a day of hospitalization (1898.2 CZK per day).'}, {'measure': 'Percentage of Participants Categorized According to Number of Diagnostic Procedures', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': 'In this outcome measure, percentage of participants were categorized according to number of diagnostic procedures.'}, {'measure': 'Percentage of Participants Categorized According to Type of Ischemic Events During First 6 Months of Treatment', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': 'In this outcome measure, percentage of participants were categorized according to type of ischemic events which included cardiac ischemia and stroke/TIA.'}, {'measure': 'Cost of Ischemic Events During First 6 Months of Treatment', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': 'Costs of ischemic events (cardiac ischemia and stroke/TIA) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of ischemic events during the first 6 months of treatment.'}, {'measure': 'Percentage of Participants Categorized With Major Hemorrhagic Events During First 6 Months of Treatment', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': 'In this outcome measure, percentage of participants with major hemorrhagic events which included intracranial bleeding was reported.'}, {'measure': 'Percentage of Participants Categorized According to Type of Minor Hemorrhagic Events During First 6 Months of Treatment', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': 'In this outcome measure, percentage of participants were categorized according to type of minor hemorrhagic events which included epistaxis, gastrointestinal (GI) bleeding, muscle hematomas and intraparenchymal hematoma of the lower lobe.'}, {'measure': 'Cost of Major Hemorrhagic Events During First 6 Months of Treatment', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': 'Costs of major hemorrhagic events (intracranial bleeding) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of major hemorrhagic events during the first 6 months of treatment.'}, {'measure': 'Cost of Minor Hemorrhagic Events During First 6 Months of Treatment', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': 'Costs of minor hemorrhagic events (epistaxis, GI bleeding, muscle hematomas and intraparenchymal hematoma of the lower lobe) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of minor hemorrhagic events during the first 6 months of treatment.'}, {'measure': 'Number of Participants With Other Adverse Events During First 6 Months of Treatment', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': 'An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Other adverse events included all events other than ischemic, major and minor hemorrhagic events.'}, {'measure': 'Cost of Other Adverse Events During First 6 Months of Treatment', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': 'Costs of other adverse events included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the number of other adverse events during the treatment.'}, {'measure': 'Percentage of Participants Who Died (Treatment-Related) During First 6 Months of Treatment', 'timeFrame': 'Up to first 6 months of treatment (from retrospective data retrieved in the study)', 'description': 'In this outcome measure, percentage of participants who died due to the given treatment were reported.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=B0661121', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To describe the direct costs related to warfarin/apixaban treatment', 'detailedDescription': 'To describe the direct costs related to warfarin/apixaban treatment during the first 6 months of the secondary stroke prevention in NVAF patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'NVAF patients, who used either warfarin or apixaban as a secondary stroke/TIA prevention.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of non-valvular atrial fibrillation (NVAF);\n* New initiation of anticoagulation therapy (apixaban or warfarin) due to the ischemic event (stroke/TIA) meaning patients previously not anticoagulated due to diagnosis of NVAF;\n* Indication to anticoagulation therapy as a secondary stroke prevention within 7 to 30 days after the stroke/TIA event;\n* Apixaban arm: genetically determined higher sensitivity to warfarin;\n* Patients whose status allowed oral treatment with apixaban/warfarin;\n* Age ≥ 18;\n* Access to patient´s records of the first 6 months of the warfarin/apixaban treatment.\n\nExclusion Criteria:\n\n* Diagnosis of valvular disease;\n* Treatment with other anticoagulants in previous 6 months due to other the NVAF indication;\n* Treatment or prophylaxis of deep vein thrombosis or pulmonary embolism;\n* Contraindications according SmPC of Eliquis'}, 'identificationModule': {'nctId': 'NCT04435769', 'briefTitle': 'Non-Interventional Study Describing Direct Costs Related to Anti-coagulation Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Non-interventional Study Describing Direct Costs Related to Anticoagulation Treatment in Patients With Nonvalvular Atrial Fibrillation (NVAF) in Secondary Stroke Prevention Prescribed Apixaban or Warfarin Treatment', 'orgStudyIdInfo': {'id': 'B0661121'}, 'secondaryIdInfos': [{'id': 'APIXABAN SECOND LINE', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-valvular Atrial Fibrillation (NVAF) on warfarin', 'description': 'The study follows two cohorts of Non-valvular Atrial Fibrillation (NVAF) patients, who used warfarin as a secondary stroke/TIA prevention.'}, {'label': 'Non-valvular Atrial Fibrillation (NVAF) on apixaban', 'description': 'The study follows two cohorts of Non-valvular Atrial Fibrillation (NVAF) patients, who used apixaban as a secondary stroke/TIA prevention.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '150 06', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Fakultní nemocnice Motol', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}