Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
Study NCT ID:
NCT03441633
Status:
COMPLETED
Last Update Posted:
2023-06-09
First Post:
2018-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Apixaban Drug Utilization Study In Stroke Prevention In Atrial Fibrillation (Spaf)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D020521', 'term': 'Stroke'}], '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'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522181', 'term': 'apixaban'}, {'id': 'D000069604', 'term': 'Dabigatran'}, {'id': 'D000069552', 'term': 'Rivaroxaban'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}]}}, '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': 'Not applicable as safety data was not planned to be collected during the study', 'description': 'Safety data was not planned to be collected during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Apixaban: Naive', 'description': 'Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Apixaban: Non Naive', 'description': 'Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Acenocoumarol: Naive', 'description': 'Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Acenocoumarol: Non-Naive', 'description': 'Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Warfarin: Naive', 'description': 'Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Warfarin: Non Naive', 'description': 'Participants who were treated with warfarin with prior prescription of different VKA, apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Dabigatran: Naive', 'description': 'Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Dabigatran: Non-Naive', 'description': 'Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Rivaroxaban: Naive', 'description': 'Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Rivaroxaban: Non-Naive', 'description': 'Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants by Their Sociodemographic Characteristics: Smoking Habit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4712', 'groupId': 'OG000'}, {'value': '1423', 'groupId': 'OG001'}, {'value': '32212', 'groupId': 'OG002'}, {'value': '192', 'groupId': 'OG003'}, {'value': '2286', 'groupId': 'OG004'}, {'value': '363', 'groupId': 'OG005'}, {'value': '2855', 'groupId': 'OG006'}, {'value': '953', 'groupId': 'OG007'}, {'value': '5132', 'groupId': 'OG008'}, {'value': '1562', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban: Naive', 'description': 'Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.'}, {'id': 'OG001', 'title': 'Apixaban: Non Naive', 'description': 'Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG002', 'title': 'Acenocoumarol: Naive', 'description': 'Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG003', 'title': 'Acenocoumarol: Non-Naive', 'description': 'Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG004', 'title': 'Warfarin: Naive', 'description': 'Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG005', 'title': 'Warfarin: Non-Naive', 'description': 'Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG006', 'title': 'Dabigatran: Naive', 'description': 'Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG007', 'title': 'Dabigatran: Non-Naive', 'description': 'Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG008', 'title': 'Rivaroxaban: Naive', 'description': 'Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG009', 'title': 'Rivaroxaban: Non-Naive', 'description': 'Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}], 'classes': [{'categories': [{'title': 'Missing', 'measurements': [{'value': '207', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '1844', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '112', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '225', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '354', 'groupId': 'OG008'}, {'value': '38', 'groupId': 'OG009'}]}, {'title': 'Non-smoker', 'measurements': [{'value': '3104', 'groupId': 'OG000'}, {'value': '946', 'groupId': 'OG001'}, {'value': '19440', 'groupId': 'OG002'}, {'value': '119', 'groupId': 'OG003'}, {'value': '1166', 'groupId': 'OG004'}, {'value': '234', 'groupId': 'OG005'}, {'value': '1684', 'groupId': 'OG006'}, {'value': '623', 'groupId': 'OG007'}, {'value': '3079', 'groupId': 'OG008'}, {'value': '1030', 'groupId': 'OG009'}]}, {'title': 'Ex-smoker', 'measurements': [{'value': '459', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '3676', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '320', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}, {'value': '355', 'groupId': 'OG006'}, {'value': '72', 'groupId': 'OG007'}, {'value': '608', 'groupId': 'OG008'}, {'value': '102', 'groupId': 'OG009'}]}, {'title': 'Smoker', 'measurements': [{'value': '942', 'groupId': 'OG000'}, {'value': '371', 'groupId': 'OG001'}, {'value': '7252', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '688', 'groupId': 'OG004'}, {'value': '89', 'groupId': 'OG005'}, {'value': '591', 'groupId': 'OG006'}, {'value': '235', 'groupId': 'OG007'}, {'value': '1091', 'groupId': 'OG008'}, {'value': '392', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.000', 'groupIds': ['OG000', 'OG006'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.68', 'ciUpperLimit': '0.82', 'groupDescription': 'Dabigatran vs. Apixaban in naive participants (Non-smoker)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG006'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.32', 'ciLowerLimit': '1.14', 'ciUpperLimit': '1.52', 'groupDescription': 'Dabigatran vs. Apixaban in naive participants (Ex-smoker)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG006'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.17', 'groupDescription': 'Dabigatran vs. Apixaban in naive participants (Smoker)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.755', 'groupIds': ['OG001', 'OG007'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.13', 'groupDescription': 'Dabigatran vs. Apixaban in non-naive participants (Non-smoker)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.426', 'groupIds': ['OG001', 'OG007'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.32', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.83', 'groupDescription': 'Dabigatran vs. Apixaban in non-naive participants (Ex-smoker)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.930', 'groupIds': ['OG001', 'OG007'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.12', 'groupDescription': 'Dabigatran vs. Apixaban in non-naive participants (Smoker)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.72', 'ciUpperLimit': '0.84', 'groupDescription': 'Rivaroxaban vs. Apixaban in naive participants (Non-smoker)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.25', 'ciLowerLimit': '1.10', 'ciUpperLimit': '1.42', 'groupDescription': 'Rivaroxaban vs. Apixaban in naive participants (Ex-smoker)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.98', 'ciUpperLimit': '1.19', 'groupDescription': 'Rivaroxaban vs. Apixaban in naive participants (Smoker)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.755', 'groupIds': ['OG001', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.14', 'groupDescription': 'Rivaroxaban vs. Apixaban in non-naive participants (Non-smoker)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.426', 'groupIds': ['OG001', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.52', 'groupDescription': 'Rivaroxaban vs. Apixaban in non-naive participants (Ex-smoker)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.930', 'groupIds': ['OG001', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.12', 'groupDescription': 'Rivaroxaban vs. Apixaban in non-naive participants (Smoker)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.74', 'ciUpperLimit': '0.84', 'groupDescription': 'Acenocoumarol vs. Apixaban in naive participants (Non-smoker)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '1.08', 'ciUpperLimit': '1.32', 'groupDescription': 'Acenocoumarol vs. Apixaban in naive participants (Ex-smoker)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '1.08', 'ciUpperLimit': '1.26', 'groupDescription': 'Acenocoumarol vs. Apixaban in naive participants (Smoker)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.755', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.60', 'ciUpperLimit': '1.13', 'groupDescription': 'Acenocoumarol vs. Apixaban in non-naive participants (Non-smoker)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.426', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.48', 'ciLowerLimit': '0.82', 'ciUpperLimit': '2.52', 'groupDescription': 'Acenocoumarol vs. Apixaban in non-naive participants (Ex-smoker)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.930', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.40', 'groupDescription': 'Acenocoumarol vs. Apixaban in non-naive participants (Smoker)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.54', 'ciLowerLimit': '0.49', 'ciUpperLimit': '0.60', 'groupDescription': 'Warfarin vs. Apixaban in naive participants (Non-smoker)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.51', 'ciLowerLimit': '1.29', 'ciUpperLimit': '1.76', 'groupDescription': 'Warfarin vs. Apixaban in naive participants (Ex-smoker)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.72', 'ciLowerLimit': '1.54', 'ciUpperLimit': '1.93', 'groupDescription': 'Warfarin vs. Apixaban in naive participants (Smoker)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.755', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.17', 'groupDescription': 'Warfarin vs. Apixaban in non-naive participants (Non-smoker)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.426', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.25', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.95', 'groupDescription': 'Warfarin vs. Apixaban in non-naive participants (Ex-smoker)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.930', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.20', 'groupDescription': 'Warfarin vs. Apixaban in naive participants (Smoker)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included smoking habit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.'}, {'type': 'PRIMARY', 'title': 'Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4712', 'groupId': 'OG000'}, {'value': '1423', 'groupId': 'OG001'}, {'value': '32212', 'groupId': 'OG002'}, {'value': '192', 'groupId': 'OG003'}, {'value': '2286', 'groupId': 'OG004'}, {'value': '363', 'groupId': 'OG005'}, {'value': '2855', 'groupId': 'OG006'}, {'value': '953', 'groupId': 'OG007'}, {'value': '5132', 'groupId': 'OG008'}, {'value': '1562', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban: Naive', 'description': 'Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.'}, {'id': 'OG001', 'title': 'Apixaban: Non Naive', 'description': 'Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG002', 'title': 'Acenocoumarol: Naive', 'description': 'Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG003', 'title': 'Acenocoumarol: Non-Naive', 'description': 'Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG004', 'title': 'Warfarin: Naive', 'description': 'Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG005', 'title': 'Warfarin: Non-Naive', 'description': 'Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG006', 'title': 'Dabigatran: Naive', 'description': 'Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG007', 'title': 'Dabigatran: Non-Naive', 'description': 'Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG008', 'title': 'Rivaroxaban: Naive', 'description': 'Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG009', 'title': 'Rivaroxaban: Non-Naive', 'description': 'Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}], 'classes': [{'categories': [{'title': 'Missing', 'measurements': [{'value': '2162', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}, {'value': '11299', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '839', 'groupId': 'OG004'}, {'value': '91', 'groupId': 'OG005'}, {'value': '1263', 'groupId': 'OG006'}, {'value': '211', 'groupId': 'OG007'}, {'value': '2475', 'groupId': 'OG008'}, {'value': '366', 'groupId': 'OG009'}]}, {'title': 'No intake', 'measurements': [{'value': '1749', 'groupId': 'OG000'}, {'value': '810', 'groupId': 'OG001'}, {'value': '14337', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}, {'value': '984', 'groupId': 'OG004'}, {'value': '212', 'groupId': 'OG005'}, {'value': '1054', 'groupId': 'OG006'}, {'value': '550', 'groupId': 'OG007'}, {'value': '1696', 'groupId': 'OG008'}, {'value': '923', 'groupId': 'OG009'}]}, {'title': 'Moderate intake', 'measurements': [{'value': '765', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}, {'value': '6241', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '447', 'groupId': 'OG004'}, {'value': '58', 'groupId': 'OG005'}, {'value': '505', 'groupId': 'OG006'}, {'value': '187', 'groupId': 'OG007'}, {'value': '915', 'groupId': 'OG008'}, {'value': '255', 'groupId': 'OG009'}]}, {'title': 'Risk consumption', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '335', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '33', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '46', 'groupId': 'OG008'}, {'value': '18', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.000', 'groupIds': ['OG000', 'OG006'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.09', 'groupDescription': 'Dabigatran vs. Apixaban in naive participants (No intake)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG006'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.98', 'ciUpperLimit': '1.25', 'groupDescription': 'Dabigatran vs. Apixaban in naive participants (Moderate intake)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.164', 'groupIds': ['OG000', 'OG006'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.52', 'ciLowerLimit': '0.94', 'ciUpperLimit': '2.45', 'groupDescription': 'Dabigatran vs. Apixaban in naive participants (Risk consumption)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.826', 'groupIds': ['OG001', 'OG007'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.22', 'groupDescription': 'Dabigatran vs. Apixaban in non-naive participants (No intake)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.190', 'groupIds': ['OG001', 'OG007'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.43', 'groupDescription': 'Dabigatran vs. Apixaban in non-naive participants (Moderate intake)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.526', 'groupIds': ['OG001', 'OG007'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.58', 'ciLowerLimit': '0.18', 'ciUpperLimit': '1.57', 'groupDescription': 'Dabigatran vs. Apixaban in non-naive participants (Risk consumption)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.77', 'ciUpperLimit': '0.91', 'groupDescription': 'Rivaroxaban vs. Apixaban in naive participants (No intake)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '1.01', 'ciUpperLimit': '1.24', 'groupDescription': 'Rivaroxaban vs. Apixaban in naive participants (Moderate intake)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.164', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.83', 'groupDescription': 'Rivaroxaban vs. Apixaban in naive participants (Risk consumption)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.826', 'groupIds': ['OG001', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.26', 'groupDescription': 'Rivaroxaban vs. Apixaban in non-naive participants (No intake)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.190', 'groupIds': ['OG001', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.13', 'groupDescription': 'Rivaroxaban vs. Apixaban in non-naive participants (Moderate intake)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.526', 'groupIds': ['OG001', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.26', 'ciLowerLimit': '0.62', 'ciUpperLimit': '2.65', 'groupDescription': 'Rivaroxaban vs. Apixaban in non-naive participants (Risk consumption)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.36', 'ciLowerLimit': '1.28', 'ciUpperLimit': '1.45', 'groupDescription': 'Acenocoumarol vs. Apixaban in naive participants (No intake)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.24', 'ciLowerLimit': '1.14', 'ciUpperLimit': '1.35', 'groupDescription': 'Acenocoumarol vs. Apixaban in naive participants (Moderate intake)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.164', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.36', 'ciLowerLimit': '0.98', 'ciUpperLimit': '1.95', 'groupDescription': 'Acenocoumarol vs. Apixaban in naive participants (Risk consumption)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.826', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.41', 'groupDescription': 'Acenocoumarol vs. Apixaban in non-naive participants (No intake)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.190', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.22', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.76', 'groupDescription': 'Acenocoumarol vs. Apixaban in non-naive participants (Moderate intake)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.526', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.21', 'ciLowerLimit': '0.17', 'ciUpperLimit': '4.50', 'groupDescription': 'Acenocoumarol vs. Apixaban in non-naive participants (Risk consumption)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.28', 'ciLowerLimit': '1.16', 'ciUpperLimit': '1.42', 'groupDescription': 'Warfarin vs. Apixaban in naive participants (No intake)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.25', 'ciLowerLimit': '1.10', 'ciUpperLimit': '1.43', 'groupDescription': 'Warfarin vs. Apixaban in naive participants (Moderate intake)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.164', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.49', 'ciUpperLimit': '1.64', 'groupDescription': 'Warfarin vs. Apixaban in naive participants (Risk consumption)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.826', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.34', 'groupDescription': 'Warfarin vs. Apixaban in non-naive participants (No intake)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.190', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.23', 'groupDescription': 'Warfarin vs. Apixaban in non-naive participants (Moderate intake)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.526', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '0.09', 'ciUpperLimit': '2.36', 'groupDescription': 'Warfarin vs. Apixaban in non-naive participants (Risk consumption)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included alcoholic habit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.'}, {'type': 'PRIMARY', 'title': 'Number of Participants by Their Sociodemographic Characteristics: MEDEA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4027', 'groupId': 'OG000'}, {'value': '1210', 'groupId': 'OG001'}, {'value': '25477', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}, {'value': '2163', 'groupId': 'OG004'}, {'value': '322', 'groupId': 'OG005'}, {'value': '2393', 'groupId': 'OG006'}, {'value': '789', 'groupId': 'OG007'}, {'value': '4430', 'groupId': 'OG008'}, {'value': '1389', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban: Naive', 'description': 'Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.'}, {'id': 'OG001', 'title': 'Apixaban: Non Naive', 'description': 'Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG002', 'title': 'Acenocoumarol: Naive', 'description': 'Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG003', 'title': 'Acenocoumarol: Non-Naive', 'description': 'Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG004', 'title': 'Warfarin: Naive', 'description': 'Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG005', 'title': 'Warfarin: Non-Naive', 'description': 'Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG006', 'title': 'Dabigatran: Naive', 'description': 'Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG007', 'title': 'Dabigatran: Non-Naive', 'description': 'Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG008', 'title': 'Rivaroxaban: Naive', 'description': 'Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG009', 'title': 'Rivaroxaban: Non-Naive', 'description': 'Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}], 'classes': [{'categories': [{'title': 'Missing - Urban area', 'measurements': [{'value': '190', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '1754', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '120', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}, {'value': '110', 'groupId': 'OG006'}, {'value': '57', 'groupId': 'OG007'}, {'value': '230', 'groupId': 'OG008'}, {'value': '145', 'groupId': 'OG009'}]}, {'title': 'Quintile 1 - Urban area', 'measurements': [{'value': '716', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '4735', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '149', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}, {'value': '558', 'groupId': 'OG006'}, {'value': '156', 'groupId': 'OG007'}, {'value': '973', 'groupId': 'OG008'}, {'value': '230', 'groupId': 'OG009'}]}, {'title': 'Quintile 2 - Urban area', 'measurements': [{'value': '754', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}, {'value': '4753', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '315', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}, {'value': '461', 'groupId': 'OG006'}, {'value': '148', 'groupId': 'OG007'}, {'value': '803', 'groupId': 'OG008'}, {'value': '234', 'groupId': 'OG009'}]}, {'title': 'Quintile 3 - Urban area', 'measurements': [{'value': '825', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}, {'value': '4801', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '606', 'groupId': 'OG004'}, {'value': '52', 'groupId': 'OG005'}, {'value': '447', 'groupId': 'OG006'}, {'value': '137', 'groupId': 'OG007'}, {'value': '904', 'groupId': 'OG008'}, {'value': '230', 'groupId': 'OG009'}]}, {'title': 'Quintile 4 - Urban area', 'measurements': [{'value': '807', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '4744', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '635', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}, {'value': '429', 'groupId': 'OG006'}, {'value': '152', 'groupId': 'OG007'}, {'value': '837', 'groupId': 'OG008'}, {'value': '300', 'groupId': 'OG009'}]}, {'title': 'Quintile 5 - Urban area', 'measurements': [{'value': '735', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}, {'value': '4690', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '338', 'groupId': 'OG004'}, {'value': '41', 'groupId': 'OG005'}, {'value': '388', 'groupId': 'OG006'}, {'value': '139', 'groupId': 'OG007'}, {'value': '683', 'groupId': 'OG008'}, {'value': '250', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.000', 'groupIds': ['OG000', 'OG006'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.36', 'ciLowerLimit': '1.20', 'ciUpperLimit': '1.53', 'groupDescription': 'Dabigatran vs. Apixaban in naive participants (Quintile 1 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.014', 'groupIds': ['OG000', 'OG006'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.15', 'groupDescription': 'Dabigatran vs. Apixaban in naive participants (Quintile 2 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG006'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.77', 'ciUpperLimit': '0.99', 'groupDescription': 'Dabigatran vs. Apixaban in naive participants (Quintile 3 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG006'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.75', 'ciUpperLimit': '0.97', 'groupDescription': 'Dabigatran vs. Apixaban in naive participants (Quintile 4 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.013', 'groupIds': ['OG000', 'OG006'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.74', 'ciUpperLimit': '0.97', 'groupDescription': 'Dabigatran vs. Apixaban in naive participants (Quintile 5 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.157', 'groupIds': ['OG001', 'OG007'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.31', 'groupDescription': 'Dabigatran vs. Apixaban in non-naive participants (Quintile 1 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.124', 'groupIds': ['OG001', 'OG007'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.29', 'groupDescription': 'Dabigatran vs. Apixaban in non-naive participants (Quintile 2 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.062', 'groupIds': ['OG001', 'OG007'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.61', 'ciUpperLimit': '0.96', 'groupDescription': 'Dabigatran vs. Apixaban in non-naive participants (Quintile 3 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.079', 'groupIds': ['OG001', 'OG007'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.22', 'groupDescription': 'Dabigatran vs. Apixaban in non-naive participants (Quintile 4 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.140', 'groupIds': ['OG001', 'OG007'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.38', 'groupDescription': 'Dabigatran vs. Apixaban in non-naive participants (Quintile 5 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.31', 'ciLowerLimit': '1.17', 'ciUpperLimit': '1.45', 'groupDescription': 'Rivaroxaban vs. Apixaban in naive participants (Quintile 1 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.014', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.09', 'groupDescription': 'Rivaroxaban vs. Apixaban in naive participants (Quintile 2 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.12', 'groupDescription': 'Rivaroxaban vs. Apixaban in naive participants (Quintile 3 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.05', 'groupDescription': 'Rivaroxaban vs. Apixaban in naive participants (Quintile 4 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.013', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.74', 'ciUpperLimit': '0.93', 'groupDescription': 'Rivaroxaban vs. Apixaban in naive participants (Quintile 5 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.157', 'groupIds': ['OG001', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.13', 'groupDescription': 'Rivaroxaban vs. Apixaban in non-naive participants (Quintile 1 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.124', 'groupIds': ['OG001', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.20', 'groupDescription': 'Rivaroxaban vs. Apixaban in non-naive participants (Quintile 2 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.062', 'groupIds': ['OG001', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.65', 'ciUpperLimit': '0.96', 'groupDescription': 'Rivaroxaban vs. Apixaban in non-naive participants (Quintile 3 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.079', 'groupIds': ['OG001', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.23', 'ciLowerLimit': '1.02', 'ciUpperLimit': '1.48', 'groupDescription': 'Rivaroxaban vs. Apixaban in non-naive participants (Quintile 4 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.140', 'groupIds': ['OG001', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.21', 'ciLowerLimit': '0.99', 'ciUpperLimit': '1.49', 'groupDescription': 'Rivaroxaban vs. Apixaban in non-naive participants (Quintile 5 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.05', 'groupDescription': 'Acenocoumarol vs. Apixaban in naive participants (Quintile 1 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.014', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.84', 'ciUpperLimit': '0.99', 'groupDescription': 'Acenocoumarol vs. Apixaban in naive participants (Quintile 2 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.76', 'ciUpperLimit': '0.90', 'groupDescription': 'Acenocoumarol vs. Apixaban in naive participants (Quintile 3 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.77', 'ciUpperLimit': '0.91', 'groupDescription': 'Acenocoumarol vs. Apixaban in naive participants (Quintile 4 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.013', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.00', 'groupDescription': 'Acenocoumarol vs. Apixaban in naive participants (Quintile 5 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.157', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.68', 'ciUpperLimit': '1.54', 'groupDescription': 'Acenocoumarol vs. Apixaban in non-naive participants (Quintile 1 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.124', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.53', 'ciUpperLimit': '1.29', 'groupDescription': 'Acenocoumarol vs. Apixaban in non-naive participants (Quintile 2 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.062', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.48', 'ciUpperLimit': '1.13', 'groupDescription': 'Acenocoumarol vs. Apixaban in non-naive participants (Quintile 3 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.079', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.57', 'ciUpperLimit': '1.33', 'groupDescription': 'Acenocoumarol vs. Apixaban in non-naive participants (Quintile 4 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.140', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.67', 'ciUpperLimit': '1.59', 'groupDescription': 'Acenocoumarol vs. Apixaban in non-naive participants (Quintile 5 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.39', 'ciLowerLimit': '0.32', 'ciUpperLimit': '0.47', 'groupDescription': 'Warfarin vs. Apixaban in naive participants (Quintile 1 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.014', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.73', 'ciUpperLimit': '0.97', 'groupDescription': 'Warfarin vs. Apixaban in naive participants (Quintile 2 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.70', 'ciLowerLimit': '1.51', 'ciUpperLimit': '1.91', 'groupDescription': 'Warfarin vs. Apixaban in naive participants (Quintile 3 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.86', 'ciLowerLimit': '1.65', 'ciUpperLimit': '2.10', 'groupDescription': 'Warfarin vs. Apixaban in naive participants (Quintile 4 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.013', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.08', 'groupDescription': 'Warfarin vs. Apixaban in naive participants (Quintile 5 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.157', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.35', 'ciLowerLimit': '1.00', 'ciUpperLimit': '1.80', 'groupDescription': 'Warfarin vs. Apixaban in non-naive participants (Quintile 1 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.124', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.41', 'ciLowerLimit': '1.04', 'ciUpperLimit': '1.88', 'groupDescription': 'Warfarin vs. Apixaban in non-naive participants (Quintile 2 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.062', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.55', 'ciUpperLimit': '1.05', 'groupDescription': 'Warfarin vs. Apixaban in non-naive participants (Quintile 3 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.079', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.67', 'ciUpperLimit': '1.26', 'groupDescription': 'Warfarin vs. Apixaban in non-naive participants (Quintile 4 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.140', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.81', 'ciLowerLimit': '0.56', 'ciUpperLimit': '1.15', 'groupDescription': 'Warfarin vs. Apixaban in non-naive participants (Quintile 5 - Urban area)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included MEDEA. MEDEA was a deprivation index that was associated with overall mortality in urban areas. It included factors like job, education, housing conditions and single parent homes. The MEDEA index was categorized in quintiles for urban areas, with quintile 1 corresponding to the least deprived population and quintile 5, the most deprived.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF. Here, "Overall Number of Participants Analyzed (N)" signifies participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4712', 'groupId': 'OG000'}, {'value': '1423', 'groupId': 'OG001'}, {'value': '32212', 'groupId': 'OG002'}, {'value': '192', 'groupId': 'OG003'}, {'value': '2286', 'groupId': 'OG004'}, {'value': '363', 'groupId': 'OG005'}, {'value': '2855', 'groupId': 'OG006'}, {'value': '953', 'groupId': 'OG007'}, {'value': '5132', 'groupId': 'OG008'}, {'value': '1562', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban: Naive', 'description': 'Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.'}, {'id': 'OG001', 'title': 'Apixaban: Non Naive', 'description': 'Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG002', 'title': 'Acenocoumarol: Naive', 'description': 'Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG003', 'title': 'Acenocoumarol: Non-Naive', 'description': 'Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG004', 'title': 'Warfarin: Naive', 'description': 'Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG005', 'title': 'Warfarin: Non-Naive', 'description': 'Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG006', 'title': 'Dabigatran: Naive', 'description': 'Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG007', 'title': 'Dabigatran: Non-Naive', 'description': 'Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG008', 'title': 'Rivaroxaban: Naive', 'description': 'Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG009', 'title': 'Rivaroxaban: Non-Naive', 'description': 'Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}], 'classes': [{'title': 'Missing', 'categories': [{'measurements': [{'value': '1424', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}, {'value': '6898', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '509', 'groupId': 'OG004'}, {'value': '87', 'groupId': 'OG005'}, {'value': '960', 'groupId': 'OG006'}, {'value': '178', 'groupId': 'OG007'}, {'value': '1746', 'groupId': 'OG008'}, {'value': '311', 'groupId': 'OG009'}]}]}, {'title': '18.5 - 25 kg per m^2 (Normal)', 'categories': [{'measurements': [{'value': '423', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}, {'value': '4471', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '295', 'groupId': 'OG004'}, {'value': '78', 'groupId': 'OG005'}, {'value': '272', 'groupId': 'OG006'}, {'value': '144', 'groupId': 'OG007'}, {'value': '464', 'groupId': 'OG008'}, {'value': '271', 'groupId': 'OG009'}]}]}, {'title': 'Less than (<) 18.5 kg per m^2 (Underweight)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': '25 - 30 kg per m^2 (Overweight)', 'categories': [{'measurements': [{'value': '1229', 'groupId': 'OG000'}, {'value': '493', 'groupId': 'OG001'}, {'value': '10074', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}, {'value': '712', 'groupId': 'OG004'}, {'value': '119', 'groupId': 'OG005'}, {'value': '735', 'groupId': 'OG006'}, {'value': '306', 'groupId': 'OG007'}, {'value': '1289', 'groupId': 'OG008'}, {'value': '482', 'groupId': 'OG009'}]}]}, {'title': 'Greater than (>) 30 kg per m^2 (Obese)', 'categories': [{'measurements': [{'value': '1624', 'groupId': 'OG000'}, {'value': '410', 'groupId': 'OG001'}, {'value': '10628', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '764', 'groupId': 'OG004'}, {'value': '77', 'groupId': 'OG005'}, {'value': '878', 'groupId': 'OG006'}, {'value': '317', 'groupId': 'OG007'}, {'value': '1617', 'groupId': 'OG008'}, {'value': '498', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.000', 'groupIds': ['OG000', 'OG006'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.25', 'groupDescription': 'Dabigatran vs. Apixaban in naive participants (18.5 - 25 kg per m\\^2 Normal)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.202', 'groupIds': ['OG000', 'OG006'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.38', 'ciLowerLimit': '0.58', 'ciUpperLimit': '3.23', 'groupDescription': 'Dabigatran vs. Apixaban in naive participants (\\<18.5 kg per m\\^2 Underweight)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG006'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.09', 'groupDescription': 'Dabigatran vs. Apixaban in naive participants (25 - 30 kg per m\\^2 Overweight)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG006'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.76', 'ciUpperLimit': '0.93', 'groupDescription': 'Dabigatran vs. Apixaban in naive participants (\\>30 kg per m\\^2 Obese)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.083', 'groupIds': ['OG001', 'OG007'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.03', 'groupDescription': 'Dabigatran vs. Apixaban in non-naive participants (18.5 - 25 kg per m\\^2 Normal)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.011', 'groupIds': ['OG001', 'OG007'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.99', 'ciLowerLimit': '0.68', 'ciUpperLimit': '6.18', 'groupDescription': 'Dabigatran vs. Apixaban in non-naive participants (\\<18.5 kg per m\\^2 Underweight)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.227', 'groupIds': ['OG001', 'OG007'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.06', 'groupDescription': 'Dabigatran vs. Apixaban in non-naive participants (25 - 30 kg per m\\^2 Overweight)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG007'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.23', 'ciLowerLimit': '1.03', 'ciUpperLimit': '1.47', 'groupDescription': 'Dabigatran vs. Apixaban in non-naive participants (\\>30 kg per m\\^2 Obese)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.16', 'groupDescription': 'Rivaroxaban vs. Apixaban in naive participants (18.5 - 25 kg per m\\^2 Normal)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.202', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.22', 'ciLowerLimit': '0.58', 'ciUpperLimit': '2.66', 'groupDescription': 'Rivaroxaban vs. Apixaban in naive participants (\\<18.5 kg per m\\^2 Underweight)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.04', 'groupDescription': 'Rivaroxaban vs. Apixaban in naive participants (25 - 30 kg per m\\^2 Overweight)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.80', 'ciUpperLimit': '0.95', 'groupDescription': 'Rivaroxaban vs. Apixaban in naive participants (\\>30 kg per m\\^2 Obese)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.083', 'groupIds': ['OG001', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.17', 'groupDescription': 'Rivaroxaban vs. Apixaban in non-naive participants (18.5 - 25 kg per m\\^2 Normal)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.011', 'groupIds': ['OG001', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '0.02', 'ciUpperLimit': '1.05', 'groupDescription': 'Rivaroxaban vs. Apixaban in non-naive participants (\\<18.5 kg per m\\^2 Underweight)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.227', 'groupIds': ['OG001', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.72', 'ciUpperLimit': '0.98', 'groupDescription': 'Rivaroxaban vs. Apixaban in non-naive participants (25 - 30 kg per m\\^2 Overweight)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '0.99', 'ciUpperLimit': '1.35', 'groupDescription': 'Rivaroxaban vs. Apixaban in non-naive participants (\\>30 kg per m\\^2 Obese)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.63', 'ciLowerLimit': '1.47', 'ciUpperLimit': '1.82', 'groupDescription': 'Acenocoumarol vs. Apixaban in naive participants (18.5 - 25 kg per m\\^2 Normal)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.202', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.70', 'ciLowerLimit': '0.98', 'ciUpperLimit': '3.25', 'groupDescription': 'Acenocoumarol vs. Apixaban in naive participants (\\<18.5 kg per m\\^2 Underweight)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.29', 'ciLowerLimit': '1.20', 'ciUpperLimit': '1.38', 'groupDescription': 'Acenocoumarol vs. Apixaban in naive participants (25 - 30 kg per m\\^2 Overweight)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.00', 'groupDescription': 'Acenocoumarol vs. Apixaban in naive participants (\\>30 kg per m\\^2 Obese)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.083', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.56', 'ciUpperLimit': '1.28', 'groupDescription': 'Acenocoumarol vs. Apixaban in non-naive participants (18.5 - 25 kg per m\\^2 Normal)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.011', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.49', 'ciLowerLimit': '0.13', 'ciUpperLimit': '8.58', 'groupDescription': 'Acenocoumarol vs. Apixaban in non-naive participants (\\<18.5 kg per m\\^2 Underweight)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.227', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.42', 'groupDescription': 'Acenocoumarol vs. Apixaban in non-naive participants (25 - 30 kg per m\\^2 Overweight)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.55', 'groupDescription': 'Acenocoumarol vs. Apixaban in non-naive participants (\\>30 kg per m\\^2 Obese)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.50', 'ciLowerLimit': '1.28', 'ciUpperLimit': '1.76', 'groupDescription': 'Warfarin vs. Apixaban in naive participants (18.5 - 25 kg per m\\^2 Normal)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.202', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.36', 'ciUpperLimit': '2.73', 'groupDescription': 'Warfarin vs. Apixaban in naive participants (\\<18.5 kg per m\\^2 Underweight)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.28', 'ciLowerLimit': '1.15', 'ciUpperLimit': '1.43', 'groupDescription': 'Warfarin vs. Apixaban in naive participants (25 - 30 kg per m\\^2 Overweight)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.06', 'groupDescription': 'Warfarin vs. Apixaban in naive participants (\\>30 kg per m\\^2 Obese)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.083', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.27', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.68', 'groupDescription': 'Warfarin vs. Apixaban in non-naive participants (18.5 - 25 kg per m\\^2 Normal)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.011', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.37', 'ciLowerLimit': '0.18', 'ciUpperLimit': '6.21', 'groupDescription': 'Warfarin vs. Apixaban in non-naive participants (\\<18.5 kg per m\\^2 Underweight)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.227', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.17', 'groupDescription': 'Warfarin vs. Apixaban in non-naive participants (25 - 30 kg per m\\^2 Overweight)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.67', 'ciLowerLimit': '0.50', 'ciUpperLimit': '0.87', 'groupDescription': 'Warfarin vs. Apixaban in non-naive participants (\\>30 kg per m\\^2 Obese)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included BMI. BMI was defined as an index for assessing overweight and underweight and was obtained by dividing body weight in kilograms (kg) by height in meters squared (m\\^2).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.'}, {'type': 'PRIMARY', 'title': 'Number of Participants by Comorbidity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4712', 'groupId': 'OG000'}, {'value': '1423', 'groupId': 'OG001'}, {'value': '32212', 'groupId': 'OG002'}, {'value': '192', 'groupId': 'OG003'}, {'value': '2286', 'groupId': 'OG004'}, {'value': '363', 'groupId': 'OG005'}, {'value': '2855', 'groupId': 'OG006'}, {'value': '953', 'groupId': 'OG007'}, {'value': '5132', 'groupId': 'OG008'}, {'value': '1562', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban: Naive', 'description': 'Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.'}, {'id': 'OG001', 'title': 'Apixaban: Non Naive', 'description': 'Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG002', 'title': 'Acenocoumarol: Naive', 'description': 'Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG003', 'title': 'Acenocoumarol: Non-Naive', 'description': 'Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG004', 'title': 'Warfarin: Naive', 'description': 'Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG005', 'title': 'Warfarin: Non-Naive', 'description': 'Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG006', 'title': 'Dabigatran: Naive', 'description': 'Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG007', 'title': 'Dabigatran: Non-Naive', 'description': 'Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG008', 'title': 'Rivaroxaban: Naive', 'description': 'Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG009', 'title': 'Rivaroxaban: Non-Naive', 'description': 'Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}], 'classes': [{'categories': [{'measurements': [{'value': '3695', 'groupId': 'OG000'}, {'value': '1316', 'groupId': 'OG001'}, {'value': '26450', 'groupId': 'OG002'}, {'value': '173', 'groupId': 'OG003'}, {'value': '1819', 'groupId': 'OG004'}, {'value': '318', 'groupId': 'OG005'}, {'value': '2030', 'groupId': 'OG006'}, {'value': '870', 'groupId': 'OG007'}, {'value': '3731', 'groupId': 'OG008'}, {'value': '1417', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.000', 'groupIds': ['OG000', 'OG006'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.61', 'ciUpperLimit': '0.75', 'groupDescription': 'Dabigatran vs. Apixaban in naive participants', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.052', 'groupIds': ['OG001', 'OG007'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.63', 'ciUpperLimit': '1.15', 'groupDescription': 'Dabigatran vs. Apixaban in non-naive participants', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '0.67', 'ciUpperLimit': '0.80', 'groupDescription': 'Rivaroxaban vs. Apixaban in naive participants', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.052', 'groupIds': ['OG001', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.61', 'ciUpperLimit': '1.03', 'groupDescription': 'Rivaroxaban vs. Apixaban in non-naive participants', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.26', 'ciLowerLimit': '1.17', 'ciUpperLimit': '1.36', 'groupDescription': 'Acenocumarol vs. Apixaban in naive participants', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.052', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.45', 'ciUpperLimit': '1.27', 'groupDescription': 'Acenocumarol vs. Apixaban in non-naive participants', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.21', 'groupDescription': 'Warfarin vs. Apixaban in naive participants', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.052', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.57', 'ciLowerLimit': '0.40', 'ciUpperLimit': '0.84', 'groupDescription': 'Warfarin vs. Apixaban in non-naive participants', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months after date of first prescription', 'description': 'Comorbidity was defined as the presence of one or more additional diseases or disorders co-occurring with (that is, concomitant or concurrent with) a primary disease or disorder.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.'}, {'type': 'PRIMARY', 'title': 'Risk of Bleeding Events: HAS-BLED Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4712', 'groupId': 'OG000'}, {'value': '1423', 'groupId': 'OG001'}, {'value': '32212', 'groupId': 'OG002'}, {'value': '192', 'groupId': 'OG003'}, {'value': '2286', 'groupId': 'OG004'}, {'value': '363', 'groupId': 'OG005'}, {'value': '2855', 'groupId': 'OG006'}, {'value': '953', 'groupId': 'OG007'}, {'value': '5132', 'groupId': 'OG008'}, {'value': '1562', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban: Naive', 'description': 'Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.'}, {'id': 'OG001', 'title': 'Apixaban: Non Naive', 'description': 'Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG002', 'title': 'Acenocoumarol: Naive', 'description': 'Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG003', 'title': 'Acenocoumarol: Non-Naive', 'description': 'Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG004', 'title': 'Warfarin: Naive', 'description': 'Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG005', 'title': 'Warfarin: Non-Naive', 'description': 'Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG006', 'title': 'Dabigatran: Naive', 'description': 'Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG007', 'title': 'Dabigatran: Non-Naive', 'description': 'Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG008', 'title': 'Rivaroxaban: Naive', 'description': 'Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG009', 'title': 'Rivaroxaban: Non-Naive', 'description': 'Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '2.5', 'spread': '1.0', 'groupId': 'OG003'}, {'value': '1.9', 'spread': '1.1', 'groupId': 'OG004'}, {'value': '2.4', 'spread': '1.2', 'groupId': 'OG005'}, {'value': '1.5', 'spread': '1.0', 'groupId': 'OG006'}, {'value': '2.6', 'spread': '1.0', 'groupId': 'OG007'}, {'value': '1.6', 'spread': '1.0', 'groupId': 'OG008'}, {'value': '2.6', 'spread': '1.1', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.000', 'groupIds': ['OG000', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '-0.17', 'groupDescription': 'Dabigatran vs. Apixaban in naive participants (HAS - BLED)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.001', 'groupIds': ['OG001', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '-0.01', 'groupDescription': 'Dabigatran vs. Apixaban in non-naive participants (HAS - BLED)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '-0.15', 'groupDescription': 'Rivaroxaban vs. Apixaban in naive participants (HAS - BLED)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.001', 'groupIds': ['OG001', 'OG009'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '-0.04', 'groupDescription': 'Rivaroxaban vs. Apixaban in non-naive participants (HAS - BLED)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.50', 'ciLowerLimit': '0.47', 'ciUpperLimit': '0.53', 'groupDescription': 'Acenocumarol vs. Apixaban in naive participants (HAS - BLED)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '-0.02', 'groupDescription': 'Acenocumarol vs. Apixaban in non-naive participants (HAS - BLED)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '0.12', 'ciUpperLimit': '0.23', 'groupDescription': 'Warfarin vs. Apixaban in naive participants (HAS - BLED)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.001', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.24', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '-0.10', 'groupDescription': 'Warfarin vs. Apixaban in non-naive participants (HAS - BLED)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 12 months prior to enrollment', 'description': 'Risk of bleeding events was assessed by using HAS-BLED score. HAS-BLED was a scoring system that was developed to assess 1 year risk of occurrence of major hemorrhage. HAS-BLED score was assessed by combining score of 9 risk factors: hypertension history, 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 or drug usage history. The total score ranged from 0 to 9 where 0 = low risk of bleed per 100 participants-year and \\>3 = high risk of bleed per 100 participants-year.', 'unitOfMeasure': 'bleed per 100 participants-year', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.'}, {'type': 'PRIMARY', 'title': 'Risk of Thromboembolic Events: CHADS2 Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4712', 'groupId': 'OG000'}, {'value': '1423', 'groupId': 'OG001'}, {'value': '32212', 'groupId': 'OG002'}, {'value': '192', 'groupId': 'OG003'}, {'value': '2286', 'groupId': 'OG004'}, {'value': '363', 'groupId': 'OG005'}, {'value': '2855', 'groupId': 'OG006'}, {'value': '953', 'groupId': 'OG007'}, {'value': '5132', 'groupId': 'OG008'}, {'value': '1562', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban: Naive', 'description': 'Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.'}, {'id': 'OG001', 'title': 'Apixaban: Non Naive', 'description': 'Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG002', 'title': 'Acenocoumarol: Naive', 'description': 'Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG003', 'title': 'Acenocoumarol: Non-Naive', 'description': 'Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG004', 'title': 'Warfarin: Naive', 'description': 'Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG005', 'title': 'Warfarin: Non-Naive', 'description': 'Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG006', 'title': 'Dabigatran: Naive', 'description': 'Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG007', 'title': 'Dabigatran: Non-Naive', 'description': 'Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG008', 'title': 'Rivaroxaban: Naive', 'description': 'Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG009', 'title': 'Rivaroxaban: Non-Naive', 'description': 'Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '2.3', 'spread': '1.3', 'groupId': 'OG003'}, {'value': '1.8', 'spread': '1.3', 'groupId': 'OG004'}, {'value': '2.5', 'spread': '1.5', 'groupId': 'OG005'}, {'value': '1.5', 'spread': '1.3', 'groupId': 'OG006'}, {'value': '2.6', 'spread': '1.4', 'groupId': 'OG007'}, {'value': '1.5', 'spread': '1.2', 'groupId': 'OG008'}, {'value': '2.6', 'spread': '1.4', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.000', 'groupIds': ['OG000', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '-0.12', 'groupDescription': 'Dabigatran vs. Apixaban in naive participants (CHADS2)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '-0.12', 'groupDescription': 'Dabigatran vs. Apixaban in non-naive participants (CHADS2)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '-0.18', 'groupDescription': 'Rivaroxaban vs. Apixaban in naive participants (CHADS2)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG009'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '-0.11', 'groupDescription': 'Rivaroxaban vs. Apixaban in non-naive participants (CHADS2)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '0.17', 'ciUpperLimit': '0.25', 'groupDescription': 'Acenocumarol vs. Apixaban in naive participants (CHADS2)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.50', 'ciLowerLimit': '-0.70', 'ciUpperLimit': '-0.30', 'groupDescription': 'Acenocumarol vs. Apixaban in non-naive participants (CHADS2)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.14', 'groupDescription': 'Warfarin vs. Apixaban in naive participants (CHADS2)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.37', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '-0.20', 'groupDescription': 'Warfarin vs. Apixaban in non-naive participants (CHADS2)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 12 months prior to enrollment', 'description': 'Thromboembolic events were defined as an embolic stroke that occurred when a blood clot that formed elsewhere in the body breaks loose and travels to the brain via bloodstream. Risk of thromboembolic events was calculated using CHADS2 score. CHADS2 score was assessed by combining score of 5 risk factors (congestive heart failure history, hypertension history, age \\>=75 years, diabetes mellitus history and stroke/transient ischemic attack symptoms previously). Total CHADS2 score ranged from 0-6 where 0 =low risk and 6 =high risk of stroke.', 'unitOfMeasure': 'stroke risk per year', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.'}, {'type': 'PRIMARY', 'title': 'Risk of Thromboembolic Events: CHA2DS2Vasc Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4712', 'groupId': 'OG000'}, {'value': '1423', 'groupId': 'OG001'}, {'value': '32212', 'groupId': 'OG002'}, {'value': '192', 'groupId': 'OG003'}, {'value': '2286', 'groupId': 'OG004'}, {'value': '363', 'groupId': 'OG005'}, {'value': '2855', 'groupId': 'OG006'}, {'value': '953', 'groupId': 'OG007'}, {'value': '5132', 'groupId': 'OG008'}, {'value': '1562', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban: Naive', 'description': 'Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.'}, {'id': 'OG001', 'title': 'Apixaban: Non Naive', 'description': 'Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG002', 'title': 'Acenocoumarol: Naive', 'description': 'Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG003', 'title': 'Acenocoumarol: Non-Naive', 'description': 'Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG004', 'title': 'Warfarin: Naive', 'description': 'Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG005', 'title': 'Warfarin: Non-Naive', 'description': 'Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG006', 'title': 'Dabigatran: Naive', 'description': 'Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG007', 'title': 'Dabigatran: Non-Naive', 'description': 'Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG008', 'title': 'Rivaroxaban: Naive', 'description': 'Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG009', 'title': 'Rivaroxaban: Non-Naive', 'description': 'Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '1.7', 'groupId': 'OG002'}, {'value': '3.7', 'spread': '1.6', 'groupId': 'OG003'}, {'value': '2.9', 'spread': '1.8', 'groupId': 'OG004'}, {'value': '3.9', 'spread': '1.9', 'groupId': 'OG005'}, {'value': '2.7', 'spread': '1.8', 'groupId': 'OG006'}, {'value': '4.0', 'spread': '1.7', 'groupId': 'OG007'}, {'value': '2.7', 'spread': '1.7', 'groupId': 'OG008'}, {'value': '4.1', 'spread': '1.7', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.000', 'groupIds': ['OG000', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '-0.26', 'groupDescription': 'Dabigatran vs. Apixaban in naive participants (CHA2DS2Vasc)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-0.46', 'ciUpperLimit': '-0.19', 'groupDescription': 'Dabigatran vs. Apixaban in non-naive participants (CHA2DS2Vasc)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.38', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '-0.32', 'groupDescription': 'Rivaroxaban vs. Apixaban in naive participants (CHA2DS2Vasc)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG009'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.27', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '-0.15', 'groupDescription': 'Rivaroxaban vs. Apixaban in non-naive participants (CHA2DS2Vasc)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.19', 'ciLowerLimit': '0.14', 'ciUpperLimit': '0.24', 'groupDescription': 'Acenocumarol vs. Apixaban in naive participants (CHA2DS2Vasc)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.62', 'ciLowerLimit': '-0.86', 'ciUpperLimit': '-0.37', 'groupDescription': 'Acenocumarol vs. Apixaban in non-naive participants (CHA2DS2Vasc)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '-0.01', 'groupDescription': 'Warfarin vs. Apixaban in naive participants (CHA2DS2Vasc)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.43', 'ciLowerLimit': '-0.64', 'ciUpperLimit': '-0.21', 'groupDescription': 'Warfarin vs. Apixaban in non-naive participants (CHA2DS2Vasc)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 12 months prior to enrollment', 'description': 'Thromboembolic events were defined as an embolic stroke that occurred when a blood clot that formed elsewhere in the body breaks loose and travels to the brain via bloodstream. Risk of thromboembolic events was calculated using CHA2DS2Vasc score. CHA2DS2Vasc score was assessed by combining score of 8 risk factors (female, \\>=65 and \\<75 years, congestive heart failure history, hypertension history, diabetes mellitus history, vascular disease history, age \\>=75 years and stroke/TIA symptoms previously). Total CHA2DS2Vasc score ranged from 0-9 where 0=low risk and 9=high risk of stroke.', 'unitOfMeasure': 'stroke risk per year', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.'}, {'type': 'PRIMARY', 'title': 'Number of Participants by Comedications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4712', 'groupId': 'OG000'}, {'value': '1423', 'groupId': 'OG001'}, {'value': '32212', 'groupId': 'OG002'}, {'value': '192', 'groupId': 'OG003'}, {'value': '2286', 'groupId': 'OG004'}, {'value': '363', 'groupId': 'OG005'}, {'value': '2855', 'groupId': 'OG006'}, {'value': '953', 'groupId': 'OG007'}, {'value': '5132', 'groupId': 'OG008'}, {'value': '1562', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban: Naive', 'description': 'Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.'}, {'id': 'OG001', 'title': 'Apixaban: Non Naive', 'description': 'Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG002', 'title': 'Acenocoumarol: Naive', 'description': 'Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG003', 'title': 'Acenocoumarol: Non-Naive', 'description': 'Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG004', 'title': 'Warfarin: Naive', 'description': 'Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG005', 'title': 'Warfarin: Non-Naive', 'description': 'Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG006', 'title': 'Dabigatran: Naive', 'description': 'Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG007', 'title': 'Dabigatran: Non-Naive', 'description': 'Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG008', 'title': 'Rivaroxaban: Naive', 'description': 'Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG009', 'title': 'Rivaroxaban: Non-Naive', 'description': 'Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}], 'classes': [{'categories': [{'measurements': [{'value': '4712', 'groupId': 'OG000'}, {'value': '1406', 'groupId': 'OG001'}, {'value': '32212', 'groupId': 'OG002'}, {'value': '188', 'groupId': 'OG003'}, {'value': '2286', 'groupId': 'OG004'}, {'value': '352', 'groupId': 'OG005'}, {'value': '2855', 'groupId': 'OG006'}, {'value': '947', 'groupId': 'OG007'}, {'value': '5132', 'groupId': 'OG008'}, {'value': '1532', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG001', 'OG007'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.88', 'ciLowerLimit': '0.77', 'ciUpperLimit': '5.30', 'groupDescription': 'Dabigatran vs. Apixaban in non-naive participants', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.008', 'groupIds': ['OG001', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '0.33', 'ciUpperLimit': '1.12', 'groupDescription': 'Rivaroxaban vs. Apixaban in non-naive participants', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.008', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '0.20', 'ciUpperLimit': '1.99', 'groupDescription': 'Acenocumarol vs. Apixaban in non-naive participants', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.008', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.39', 'ciLowerLimit': '0.18', 'ciUpperLimit': '0.86', 'groupDescription': 'Warfarin vs. Apixaban in non-naive participants', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 30 days after date of first prescription', 'description': 'Comedication was defined as the second or alternative medication used to relieve the side-effects of another medicine.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}, {'value': '6108', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '344', 'groupId': 'OG004'}, {'value': '79', 'groupId': 'OG005'}, {'value': '447', 'groupId': 'OG006'}, {'value': '311', 'groupId': 'OG007'}, {'value': '527', 'groupId': 'OG008'}, {'value': '495', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban: Naive', 'description': 'Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.'}, {'id': 'OG001', 'title': 'Apixaban: Non Naive', 'description': 'Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG002', 'title': 'Acenocoumarol: Naive', 'description': 'Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG003', 'title': 'Acenocoumarol: Non-Naive', 'description': 'Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG004', 'title': 'Warfarin: Naive', 'description': 'Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG005', 'title': 'Warfarin: Non-Naive', 'description': 'Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG006', 'title': 'Dabigatran: Naive', 'description': 'Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG007', 'title': 'Dabigatran: Non-Naive', 'description': 'Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG008', 'title': 'Rivaroxaban: Naive', 'description': 'Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG009', 'title': 'Rivaroxaban: Non-Naive', 'description': 'Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}], 'classes': [{'categories': [{'title': 'MPR: Poor adherence', 'measurements': [{'value': '162', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '5634', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '103', 'groupId': 'OG004'}, {'value': '57', 'groupId': 'OG005'}, {'value': '241', 'groupId': 'OG006'}, {'value': '177', 'groupId': 'OG007'}, {'value': '147', 'groupId': 'OG008'}, {'value': '131', 'groupId': 'OG009'}]}, {'title': 'MPR: Good adherence', 'measurements': [{'value': '259', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}, {'value': '460', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '151', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '206', 'groupId': 'OG006'}, {'value': '133', 'groupId': 'OG007'}, {'value': '378', 'groupId': 'OG008'}, {'value': '360', 'groupId': 'OG009'}]}, {'title': 'MPR: Over adherence', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '90', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.000', 'groupIds': ['OG000', 'OG006'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.41', 'ciLowerLimit': '1.14', 'ciUpperLimit': '1.75', 'groupDescription': 'Dabigatran vs. Apixaban in naive participants (Poor adherence)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG006'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.67', 'ciLowerLimit': '0.55', 'ciUpperLimit': '0.82', 'groupDescription': 'Dabigatran vs. Apixaban in naive participants (Good adherence)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG006'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '0.03', 'ciUpperLimit': '2.01', 'groupDescription': 'Dabigatran vs. Apixaban in naive participants (Over adherence)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG007'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.58', 'ciLowerLimit': '1.23', 'ciUpperLimit': '2.04', 'groupDescription': 'Dabigatran vs. Apixaban in non-naive participants (Poor adherence)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG007'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.44', 'ciLowerLimit': '0.34', 'ciUpperLimit': '0.57', 'groupDescription': 'Dabigatran vs. Apixaban in non-naive participants (Good adherence)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG007'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.43', 'ciLowerLimit': '0.02', 'ciUpperLimit': '3.73', 'groupDescription': 'Dabigatran vs. Apixaban in non-naive participants (Over adherence)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '0.52', 'ciUpperLimit': '0.84', 'groupDescription': 'Rivaroxaban vs. Apixaban in naive participants (Poor adherence)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.14', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.36', 'groupDescription': 'Rivaroxaban vs. Apixaban in naive participants (Good adherence)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.52', 'ciLowerLimit': '0.06', 'ciUpperLimit': '3.41', 'groupDescription': 'Rivaroxaban vs. Apixaban in naive participants (Over adherence)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.65', 'ciLowerLimit': '0.50', 'ciUpperLimit': '0.85', 'groupDescription': 'Rivaroxaban vs. Apixaban in non-naive participants (Poor adherence)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.37', 'groupDescription': 'Rivaroxaban vs. Apixaban in non-naive participants (Good adherence)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.22', 'ciUpperLimit': '5.85', 'groupDescription': 'Rivaroxaban vs. Apixaban in non-naive participants (Over adherence)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.37', 'ciLowerLimit': '2.86', 'ciUpperLimit': '3.99', 'groupDescription': 'Acenocumarol vs. Apixaban in naive participants (Poor adherence)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '0.09', 'ciUpperLimit': '0.13', 'groupDescription': 'Acenocumarol vs. Apixaban in naive participants (Good adherence)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.34', 'ciLowerLimit': '0.11', 'ciUpperLimit': '1.52', 'groupDescription': 'Acenocumarol vs. Apixaban in naive participants (Over adherence)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.23', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.91', 'groupDescription': 'Acenocumarol vs. Apixaban in non-naive participants (Poor adherence)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '0.00', 'ciUpperLimit': '0.09', 'groupDescription': 'Acenocumarol vs. Apixaban in non-naive participants (Good adherence)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.07', 'ciLowerLimit': '0.07', 'ciUpperLimit': '18.00', 'groupDescription': 'Acenocumarol vs. Apixaban in non-naive participants (Over adherence)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.58', 'ciLowerLimit': '0.45', 'ciUpperLimit': '0.75', 'groupDescription': 'Warfarin vs. Apixaban in naive participants (Poor adherence)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.51', 'ciLowerLimit': '0.41', 'ciUpperLimit': '0.63', 'groupDescription': 'Warfarin vs. Apixaban in naive participants (Good adherence)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.40', 'ciLowerLimit': '11.01', 'ciUpperLimit': '123.80', 'groupDescription': 'Warfarin vs. Apixaban in naive participants (Over adherence)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.31', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.86', 'groupDescription': 'Warfarin vs. Apixaban in non-naive participants (Poor adherence)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '0.05', 'ciUpperLimit': '0.17', 'groupDescription': 'Warfarin vs. Apixaban in non-naive participants (Good adherence)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.73', 'ciLowerLimit': '2.81', 'ciUpperLimit': '46.50', 'groupDescription': 'Warfarin vs. Apixaban in non-naive participants (Over adherence)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months after date of first prescription', 'description': 'MPR was one of the methods of measuring adherence and was defined as the ratio of all days supply to elapsed days, during the 12-month observation period. All days supply defined as sum of number of days supply between the start date and last prescription dispensed. Elapsed days defined as number of days between the start date and the last prescription dispensed. There were three categories of adherence: poor defined as \\<80% of MPR, good defined as between 80% and 120% of MPR and over adherence defined as \\>120% of MPR.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF. Here "N" signifies number of participants evaluable for the specified outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1305', 'groupId': 'OG000'}, {'value': '666', 'groupId': 'OG001'}, {'value': '17434', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}, {'value': '1353', 'groupId': 'OG004'}, {'value': '206', 'groupId': 'OG005'}, {'value': '1449', 'groupId': 'OG006'}, {'value': '559', 'groupId': 'OG007'}, {'value': '1718', 'groupId': 'OG008'}, {'value': '817', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban: Naive', 'description': 'Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.'}, {'id': 'OG001', 'title': 'Apixaban: Non Naive', 'description': 'Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG002', 'title': 'Acenocoumarol: Naive', 'description': 'Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG003', 'title': 'Acenocoumarol: Non-Naive', 'description': 'Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG004', 'title': 'Warfarin: Naive', 'description': 'Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG005', 'title': 'Warfarin: Non-Naive', 'description': 'Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG006', 'title': 'Dabigatran: Naive', 'description': 'Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG007', 'title': 'Dabigatran: Non-Naive', 'description': 'Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG008', 'title': 'Rivaroxaban: Naive', 'description': 'Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG009', 'title': 'Rivaroxaban: Non-Naive', 'description': 'Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}], 'classes': [{'categories': [{'measurements': [{'value': '881', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '11326', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '1009', 'groupId': 'OG004'}, {'value': '127', 'groupId': 'OG005'}, {'value': '1002', 'groupId': 'OG006'}, {'value': '248', 'groupId': 'OG007'}, {'value': '1191', 'groupId': 'OG008'}, {'value': '322', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.000', 'groupIds': ['OG000', 'OG006'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.27', 'groupDescription': 'Dabigatran vs. Apixaban in naive participants (Discontinuation first year)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG007'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.45', 'ciLowerLimit': '1.15', 'ciUpperLimit': '1.83', 'groupDescription': 'Dabigatran vs. Apixaban in non-naive participants (Discontinuation first year)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.27', 'groupDescription': 'Rivaroxaban vs. Apixaban in naive participants (Discontinuation first year)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG009'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.18', 'ciLowerLimit': '0.96', 'ciUpperLimit': '1.47', 'groupDescription': 'Rivaroxaban vs. Apixaban in non-naive participants (Discontinuation first year)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.01', 'groupDescription': 'Acenocumarol vs. Apixaban in naive participants (Discontinuation first year)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.82', 'ciLowerLimit': '3.14', 'ciUpperLimit': '7.55', 'groupDescription': 'Acenocumarol vs. Apixaban in non-naive participants (Discontinuation first year)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.41', 'ciLowerLimit': '1.19', 'ciUpperLimit': '1.67', 'groupDescription': 'Warfarin vs. Apixaban in naive participants (Discontinuation first year)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.92', 'ciLowerLimit': '2.12', 'ciUpperLimit': '4.05', 'groupDescription': 'Warfarin vs. Apixaban in non-naive participants (Discontinuation first year)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months after date of first prescription', 'description': 'Discontinuation rate was defined as the lack of subsequent prescription of the index drugs within 2 months after last supply day of the last prescription. It was analyzed by calculating the treatment withdrawal or switch rate.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF. Here "N" signifies number of participants evaluable for the specified outcome measure.'}, {'type': 'PRIMARY', 'title': 'Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1305', 'groupId': 'OG000'}, {'value': '666', 'groupId': 'OG001'}, {'value': '17434', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}, {'value': '1353', 'groupId': 'OG004'}, {'value': '206', 'groupId': 'OG005'}, {'value': '1449', 'groupId': 'OG006'}, {'value': '559', 'groupId': 'OG007'}, {'value': '1718', 'groupId': 'OG008'}, {'value': '817', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban: Naive', 'description': 'Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.'}, {'id': 'OG001', 'title': 'Apixaban: Non Naive', 'description': 'Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG002', 'title': 'Acenocoumarol: Naive', 'description': 'Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG003', 'title': 'Acenocoumarol: Non-Naive', 'description': 'Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG004', 'title': 'Warfarin: Naive', 'description': 'Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG005', 'title': 'Warfarin: Non-Naive', 'description': 'Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG006', 'title': 'Dabigatran: Naive', 'description': 'Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG007', 'title': 'Dabigatran: Non-Naive', 'description': 'Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG008', 'title': 'Rivaroxaban: Naive', 'description': 'Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG009', 'title': 'Rivaroxaban: Non-Naive', 'description': 'Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '15.0', 'upperLimit': '30.0'}, {'value': '30.0', 'groupId': 'OG001', 'lowerLimit': '15.0', 'upperLimit': '30.0'}, {'value': '16.0', 'groupId': 'OG002', 'lowerLimit': '16.0', 'upperLimit': '32.0'}, {'value': '16.0', 'groupId': 'OG003', 'lowerLimit': '16.0', 'upperLimit': '32.0'}, {'value': '53.0', 'groupId': 'OG004', 'lowerLimit': '53.0', 'upperLimit': '53.0'}, {'value': '16.0', 'groupId': 'OG005', 'lowerLimit': '5.0', 'upperLimit': '53.0'}, {'value': '22.0', 'groupId': 'OG006', 'lowerLimit': '22.0', 'upperLimit': '29.0'}, {'value': '22.0', 'groupId': 'OG007', 'lowerLimit': '22.0', 'upperLimit': '29.0'}, {'value': '21.0', 'groupId': 'OG008', 'lowerLimit': '15.0', 'upperLimit': '28.0'}, {'value': '28.0', 'groupId': 'OG009', 'lowerLimit': '21.0', 'upperLimit': '28.0'}]}]}], 'analyses': [{'pValue': '0.000', 'groupIds': ['OG000', 'OG006'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.63', 'ciLowerLimit': '3.02', 'ciUpperLimit': '4.24', 'groupDescription': 'Dabigatran vs. Apixaban in naive participants (NDDDs)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '-0.77', 'ciUpperLimit': '0.98', 'groupDescription': 'Dabigatran vs. Apixaban in non-naive participants (NDDDs)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.51', 'ciLowerLimit': '0.84', 'ciUpperLimit': '2.17', 'groupDescription': 'Rivaroxaban vs. Apixaban in naive participants (NDDDs)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG009'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.98', 'ciLowerLimit': '1.16', 'ciUpperLimit': '2.80', 'groupDescription': 'Rivaroxaban vs. Apixaban in non-naive participants (NDDDs)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.41', 'ciUpperLimit': '1.39', 'groupDescription': 'Acenocumarol vs. Apixaban in naive participants (NDDDs)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.25', 'ciLowerLimit': '-4.32', 'ciUpperLimit': '-0.18', 'groupDescription': 'Acenocumarol vs. Apixaban in non-naive participants (NDDDs)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.52', 'ciLowerLimit': '27.56', 'ciUpperLimit': '29.48', 'groupDescription': 'Warfarin vs. Apixaban in naive participants (NDDDs)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.93', 'ciLowerLimit': '-1.05', 'ciUpperLimit': '4.90', 'groupDescription': 'Warfarin vs. Apixaban in non-naive participants (NDDDs)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 12 months after date of first prescription', 'description': 'NDDD was a measure that represented the average daily maintenance dose for the main indication of a drug.', 'unitOfMeasure': 'milligrams per day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF. Here "N" signifies number of participants evaluable for the specified outcome measure.'}, {'type': 'PRIMARY', 'title': 'International Normalized Ratio (INR) Values During the Last 12 Months Values in Participants Previously Treated With VKA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19192', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '872', 'groupId': 'OG002'}, {'value': '158', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Acenocoumarol: Naive', 'description': 'Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG001', 'title': 'Acenocoumarol: Non-Naive', 'description': 'Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG002', 'title': 'Warfarin: Naive', 'description': 'Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG003', 'title': 'Warfarin: Non-Naive', 'description': 'Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '0.3', 'groupId': 'OG002'}, {'value': '2.6', 'spread': '0.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 12 months after date of first prescription', '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. INR was categorized according to the risk level: risk for coagulation (INR\\<2); optimal range (2\\<INR\\<3); and risk of hemorrhages (INR\\>3).", 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Study population included all participants with a first-recorded prescription of VKA for SPAF registered in SIDIAP database during the study and diagnosed with NVAF. Here "N" signifies number of participants evaluable for the specified outcome measure.'}, {'type': 'PRIMARY', 'title': 'Time in Therapeutic Range (TTR) Values During the Last 12 Months Values in Participants Previously Treated With VKA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19192', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '872', 'groupId': 'OG002'}, {'value': '158', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Acenocoumarol: Naive', 'description': 'Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG001', 'title': 'Acenocoumarol: Non-Naive', 'description': 'Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG002', 'title': 'Warfarin: Naive', 'description': 'Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'OG003', 'title': 'Warfarin: Non-Naive', 'description': 'Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.2', 'groupId': 'OG000', 'lowerLimit': '47.2', 'upperLimit': '71.8'}, {'value': '59.6', 'groupId': 'OG001', 'lowerLimit': '47.7', 'upperLimit': '68.4'}, {'value': '66.2', 'groupId': 'OG002', 'lowerLimit': '52.2', 'upperLimit': '77.4'}, {'value': '58.9', 'groupId': 'OG003', 'lowerLimit': '43.2', 'upperLimit': '68.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 12 months after date of first prescription', 'description': "TTR was defined as the duration of time in which the participant's INR values were within a desired range (2 to 3). 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. INR was categorized according to the risk level: risk for coagulation (INR\\<2); optimal range (2\\<INR\\<3); and risk of hemorrhages (INR\\>3).", 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Study population included all participants with a first-recorded prescription of VKA for SPAF registered in SIDIAP database during the study and diagnosed with NVAF. Here "N" signifies number of participants evaluable for the specified outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Apixaban: Naive', 'description': 'Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.'}, {'id': 'FG001', 'title': 'Apixaban: Non Naive', 'description': 'Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'FG002', 'title': 'Acenocoumarol: Naive', 'description': 'Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'FG003', 'title': 'Acenocoumarol: Non-Naive', 'description': 'Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'FG004', 'title': 'Warfarin: Naive', 'description': 'Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'FG005', 'title': 'Warfarin: Non-Naive', 'description': 'Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'FG006', 'title': 'Dabigatran: Naive', 'description': 'Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'FG007', 'title': 'Dabigatran: Non-Naive', 'description': 'Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'FG008', 'title': 'Rivaroxaban: Naive', 'description': 'Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'FG009', 'title': 'Rivaroxaban: Non-Naive', 'description': 'Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4712'}, {'groupId': 'FG001', 'numSubjects': '1423'}, {'groupId': 'FG002', 'numSubjects': '32212'}, {'groupId': 'FG003', 'numSubjects': '192'}, {'groupId': 'FG004', 'numSubjects': '2286'}, {'groupId': 'FG005', 'numSubjects': '363'}, {'groupId': 'FG006', 'numSubjects': '2855'}, {'groupId': 'FG007', 'numSubjects': '953'}, {'groupId': 'FG008', 'numSubjects': '5132'}, {'groupId': 'FG009', 'numSubjects': '1562'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4712'}, {'groupId': 'FG001', 'numSubjects': '1423'}, {'groupId': 'FG002', 'numSubjects': '32212'}, {'groupId': 'FG003', 'numSubjects': '192'}, {'groupId': 'FG004', 'numSubjects': '2286'}, {'groupId': 'FG005', 'numSubjects': '363'}, {'groupId': 'FG006', 'numSubjects': '2855'}, {'groupId': 'FG007', 'numSubjects': '953'}, {'groupId': 'FG008', 'numSubjects': '5132'}, {'groupId': 'FG009', 'numSubjects': '1562'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4712', 'groupId': 'BG000'}, {'value': '1423', 'groupId': 'BG001'}, {'value': '32212', 'groupId': 'BG002'}, {'value': '192', 'groupId': 'BG003'}, {'value': '2286', 'groupId': 'BG004'}, {'value': '363', 'groupId': 'BG005'}, {'value': '2855', 'groupId': 'BG006'}, {'value': '953', 'groupId': 'BG007'}, {'value': '5132', 'groupId': 'BG008'}, {'value': '1562', 'groupId': 'BG009'}, {'value': '51690', 'groupId': 'BG010'}]}], 'groups': [{'id': 'BG000', 'title': 'Apixaban: Naive', 'description': 'Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.'}, {'id': 'BG001', 'title': 'Apixaban: Non Naive', 'description': 'Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'BG002', 'title': 'Acenocoumarol: Naive', 'description': 'Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'BG003', 'title': 'Acenocoumarol: Non-Naive', 'description': 'Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'BG004', 'title': 'Warfarin: Naive', 'description': 'Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'BG005', 'title': 'Warfarin: Non Naive', 'description': 'Participants who were treated with warfarin with prior prescription of different VKA, apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'BG006', 'title': 'Dabigatran: Naive', 'description': 'Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'BG007', 'title': 'Dabigatran: Non-Naive', 'description': 'Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'BG008', 'title': 'Rivaroxaban: Naive', 'description': 'Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'BG009', 'title': 'Rivaroxaban: Non-Naive', 'description': 'Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.'}, {'id': 'BG010', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4712', 'groupId': 'BG000'}, {'value': '1423', 'groupId': 'BG001'}, {'value': '32212', 'groupId': 'BG002'}, {'value': '192', 'groupId': 'BG003'}, {'value': '2286', 'groupId': 'BG004'}, {'value': '363', 'groupId': 'BG005'}, {'value': '2855', 'groupId': 'BG006'}, {'value': '953', 'groupId': 'BG007'}, {'value': '5132', 'groupId': 'BG008'}, {'value': '1562', 'groupId': 'BG009'}, {'value': '51690', 'groupId': 'BG010'}]}], 'categories': [{'measurements': [{'value': '71.8', 'spread': '11.1', 'groupId': 'BG000'}, {'value': '78.1', 'spread': '8.7', 'groupId': 'BG001'}, {'value': '73.5', 'spread': '12.3', 'groupId': 'BG002'}, {'value': '74.6', 'spread': '10.7', 'groupId': 'BG003'}, {'value': '69.7', 'spread': '13.4', 'groupId': 'BG004'}, {'value': '74.9', 'spread': '12.9', 'groupId': 'BG005'}, {'value': '69.9', 'spread': '12.3', 'groupId': 'BG006'}, {'value': '76.5', 'spread': '9.5', 'groupId': 'BG007'}, {'value': '69.3', 'spread': '13.2', 'groupId': 'BG008'}, {'value': '76.4', 'spread': '10.5', 'groupId': 'BG009'}, {'value': '72.8', 'spread': '12.3', 'groupId': 'BG010'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4712', 'groupId': 'BG000'}, {'value': '1423', 'groupId': 'BG001'}, {'value': '32212', 'groupId': 'BG002'}, {'value': '192', 'groupId': 'BG003'}, {'value': '2286', 'groupId': 'BG004'}, {'value': '363', 'groupId': 'BG005'}, {'value': '2855', 'groupId': 'BG006'}, {'value': '953', 'groupId': 'BG007'}, {'value': '5132', 'groupId': 'BG008'}, {'value': '1562', 'groupId': 'BG009'}, {'value': '51690', 'groupId': 'BG010'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2661', 'groupId': 'BG000'}, {'value': '751', 'groupId': 'BG001'}, {'value': '15531', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}, {'value': '979', 'groupId': 'BG004'}, {'value': '205', 'groupId': 'BG005'}, {'value': '1399', 'groupId': 'BG006'}, {'value': '479', 'groupId': 'BG007'}, {'value': '2649', 'groupId': 'BG008'}, {'value': '811', 'groupId': 'BG009'}, {'value': '25559', 'groupId': 'BG010'}]}, {'title': 'Male', 'measurements': [{'value': '2051', 'groupId': 'BG000'}, {'value': '672', 'groupId': 'BG001'}, {'value': '16681', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}, {'value': '1307', 'groupId': 'BG004'}, {'value': '158', 'groupId': 'BG005'}, {'value': '1456', 'groupId': 'BG006'}, {'value': '474', 'groupId': 'BG007'}, {'value': '2483', 'groupId': 'BG008'}, {'value': '751', 'groupId': 'BG009'}, {'value': '26131', 'groupId': 'BG010'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for stroke prevention in atrial fibrillation(SPAF) registered in information system for the improvement of research in primary care(SIDIAP) database during the study and diagnosed with non-valvular atrial fibrillation(NVAF).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-11-07', 'size': 698839, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-02-23T20:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51690}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-07', 'studyFirstSubmitDate': '2018-02-02', 'resultsFirstSubmitDate': '2018-02-23', 'studyFirstSubmitQcDate': '2018-02-15', 'lastUpdatePostDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-15', 'studyFirstPostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants by Their Sociodemographic Characteristics: Smoking Habit', 'timeFrame': 'Day 1', 'description': 'Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included smoking habit.'}, {'measure': 'Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit', 'timeFrame': 'Day 1', 'description': 'Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included alcoholic habit.'}, {'measure': 'Number of Participants by Their Sociodemographic Characteristics: MEDEA', 'timeFrame': 'Day 1', 'description': 'Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included MEDEA. MEDEA was a deprivation index that was associated with overall mortality in urban areas. It included factors like job, education, housing conditions and single parent homes. The MEDEA index was categorized in quintiles for urban areas, with quintile 1 corresponding to the least deprived population and quintile 5, the most deprived.'}, {'measure': 'Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI)', 'timeFrame': 'Day 1', 'description': 'Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included BMI. BMI was defined as an index for assessing overweight and underweight and was obtained by dividing body weight in kilograms (kg) by height in meters squared (m\\^2).'}, {'measure': 'Number of Participants by Comorbidity', 'timeFrame': 'Up to 12 months after date of first prescription', 'description': 'Comorbidity was defined as the presence of one or more additional diseases or disorders co-occurring with (that is, concomitant or concurrent with) a primary disease or disorder.'}, {'measure': 'Risk of Bleeding Events: HAS-BLED Score', 'timeFrame': 'Up to 12 months prior to enrollment', 'description': 'Risk of bleeding events was assessed by using HAS-BLED score. HAS-BLED was a scoring system that was developed to assess 1 year risk of occurrence of major hemorrhage. HAS-BLED score was assessed by combining score of 9 risk factors: hypertension history, 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 or drug usage history. The total score ranged from 0 to 9 where 0 = low risk of bleed per 100 participants-year and \\>3 = high risk of bleed per 100 participants-year.'}, {'measure': 'Risk of Thromboembolic Events: CHADS2 Score', 'timeFrame': 'Up to 12 months prior to enrollment', 'description': 'Thromboembolic events were defined as an embolic stroke that occurred when a blood clot that formed elsewhere in the body breaks loose and travels to the brain via bloodstream. Risk of thromboembolic events was calculated using CHADS2 score. CHADS2 score was assessed by combining score of 5 risk factors (congestive heart failure history, hypertension history, age \\>=75 years, diabetes mellitus history and stroke/transient ischemic attack symptoms previously). Total CHADS2 score ranged from 0-6 where 0 =low risk and 6 =high risk of stroke.'}, {'measure': 'Risk of Thromboembolic Events: CHA2DS2Vasc Score', 'timeFrame': 'Up to 12 months prior to enrollment', 'description': 'Thromboembolic events were defined as an embolic stroke that occurred when a blood clot that formed elsewhere in the body breaks loose and travels to the brain via bloodstream. Risk of thromboembolic events was calculated using CHA2DS2Vasc score. CHA2DS2Vasc score was assessed by combining score of 8 risk factors (female, \\>=65 and \\<75 years, congestive heart failure history, hypertension history, diabetes mellitus history, vascular disease history, age \\>=75 years and stroke/TIA symptoms previously). Total CHA2DS2Vasc score ranged from 0-9 where 0=low risk and 9=high risk of stroke.'}, {'measure': 'Number of Participants by Comedications', 'timeFrame': 'Up to 30 days after date of first prescription', 'description': 'Comedication was defined as the second or alternative medication used to relieve the side-effects of another medicine.'}, {'measure': 'Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR)', 'timeFrame': 'Up to 12 months after date of first prescription', 'description': 'MPR was one of the methods of measuring adherence and was defined as the ratio of all days supply to elapsed days, during the 12-month observation period. All days supply defined as sum of number of days supply between the start date and last prescription dispensed. Elapsed days defined as number of days between the start date and the last prescription dispensed. There were three categories of adherence: poor defined as \\<80% of MPR, good defined as between 80% and 120% of MPR and over adherence defined as \\>120% of MPR.'}, {'measure': 'Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year', 'timeFrame': 'Up to 12 months after date of first prescription', 'description': 'Discontinuation rate was defined as the lack of subsequent prescription of the index drugs within 2 months after last supply day of the last prescription. It was analyzed by calculating the treatment withdrawal or switch rate.'}, {'measure': 'Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD)', 'timeFrame': 'Up to 12 months after date of first prescription', 'description': 'NDDD was a measure that represented the average daily maintenance dose for the main indication of a drug.'}, {'measure': 'International Normalized Ratio (INR) Values During the Last 12 Months Values in Participants Previously Treated With VKA', 'timeFrame': 'Up to 12 months after date of first prescription', '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. INR was categorized according to the risk level: risk for coagulation (INR\\<2); optimal range (2\\<INR\\<3); and risk of hemorrhages (INR\\>3)."}, {'measure': 'Time in Therapeutic Range (TTR) Values During the Last 12 Months Values in Participants Previously Treated With VKA', 'timeFrame': 'Up to 12 months after date of first prescription', 'description': "TTR was defined as the duration of time in which the participant's INR values were within a desired range (2 to 3). 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. INR was categorized according to the risk level: risk for coagulation (INR\\<2); optimal range (2\\<INR\\<3); and risk of hemorrhages (INR\\>3)."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'apixaban', 'stroke'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0661076&StudyName=APIXABAN+DRUG+UTILIZATION+STUDY+IN+STROKE+PREVENTION+IN+ATRIAL+FIBRILLATION+%28SPAF%29', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Apixaban is a direct anticoagulant, which inhibits the factor Xa. Its clinical efficiency in prevention of stroke and systemic embolism in adult patients with NVAF (non/valvular atrial fibrillation) was demonstrated as well as has shown better safety profile compared with warfarin. A Drug Utilization study will evaluate whether this drug has been used in accordance with the approved indication and recommendations described in the summary of product characteristics (SmPC) and estimate possible misuse or overuse apixaban.', 'detailedDescription': 'The primary research question is to evaluate the apixaban utilization according to the approved SPAF indication and recommendations by EMA.\n\nIn addition a comparison with a cohort of NVAF patients treated with VKA, dabigatran and rivaroxaban for the SPAF indication will also be performed.\n\nObjective 1: To characterize patients using apixaban according to demographics, comorbidity, risk of thromboembolic events (CHADS2 and CHA2DS2-Vasc scores), risk of bleeding events (HAS-BLED score), comedications and compare it with the profile of patients treated with VKA, dabigatran and rivaroxaban.\n\nObjective 2: Describe the level of appropriate usage according to the posology recommended in the apixaban SmPC.\n\nObjective 3: Describe the potential interactions with other drugs prescribed concomintatly according with the SmPC recommendations.\n\nObjective 4: Estimate the level of apixaban adherence by the medication possession ratio (MPR) and discontinuation rates and compare it with VKA, dabigatran and rivaroxaban cohort.\n\nObjective 5: To analyze INR (International Normalized Ratio) values during the last 12 months and to obtain TTR (Time in Therapeutic Range) values in patients previously treated with VKA, and during the whole study period for those in the cohort treated with VKA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'SIDIAP currently collects information from 274 primary health care centers, including more than 5.8 million patients, about 80 % of the Catalonia population, or more than 10 % of the Spanish population covered by the Catalan Institute of Health.\n\nThe study population for these cohorts includes all eligible subjects from the source population with a first -recorded prescription of apixaban VKA, dabigatran or rivaroxaban for the SPAF indication, registered in SIDIAP database and diagnosis of NVAF for study period.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients more than 18 years-old.\n2. Patients diagnosed with NVAF registered in primary care according to ICD-10.\n3. Patients initiating apixaban (naïve or VKA experienced), VKA (naïve or VKA experienced), dabigatran or rivaroxaban for the SPAF indication.\n4. Continuous enrolment in the 12 months pre-index.\n\nExclusion Criteria:\n\n1. Patients with valvular heart disease (ICD 10: I05.0-I05.09, I08.0-I08.9) including patients with mitral prosthetic valves.\n2. Lost to follow-up (e.g. transfer to primary care center non-ICS).'}, 'identificationModule': {'nctId': 'NCT03441633', 'acronym': 'SPAF', 'briefTitle': 'Apixaban Drug Utilization Study In Stroke Prevention In Atrial Fibrillation (Spaf)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'APIXABAN DRUG UTILIZATION STUDY IN STROKE PREVENTION IN ATRIAL FIBRILLATION (SPAF)', 'orgStudyIdInfo': {'id': 'B0661076'}, 'secondaryIdInfos': [{'id': 'SPAF', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1. Apixaban', 'description': 'Patients who are on treatment with apixaban.\n\n1a. patients who have initiated with apixaban as treatment naïve (no prior prescription of VKA previous to the 12 months before index date).\n\n1b. patients who previously have been treated with VKA in the 12 months before index date.', 'interventionNames': ['Drug: apixaban']}, {'label': 'Group 2. VKA', 'description': 'Patients who are on treatment with VKA.\n\n2a. patients who have initiated with VKA as treatment naïve (no prior prescription of VKA previous to the 12 months before index date).\n\n2b. patients who previously have been treated with VKA in the 12 months before index date.', 'interventionNames': ['Drug: VKA']}, {'label': 'Group 3. Dabigatran', 'description': 'Patients who are on treatment with dabigatran.\n\n3a. patients who have initiated with dabigatran as treatment naïve (no prior prescription of VKA previous to the 12 months before index date).\n\n3b. patients who previously have been treated with VKA in the 12 months before index date.', 'interventionNames': ['Drug: dabigatran']}, {'label': 'Group 4. Rivaroxaban', 'description': 'Patients who are on treatment with rivaroxaban.\n\n4a. patients who have initiated with rivaroxaban as treatment naïve (no prior prescription of VKA previous to the 12 months before index date).\n\n4b. patients who previously have been treated with VKA in the 12 months before index date.', 'interventionNames': ['Drug: rivaroxaban']}], 'interventions': [{'name': 'apixaban', 'type': 'DRUG', 'description': 'current or new medication', 'armGroupLabels': ['Group 1. Apixaban']}, {'name': 'dabigatran', 'type': 'DRUG', 'description': 'current or new medication', 'armGroupLabels': ['Group 3. Dabigatran']}, {'name': 'VKA', 'type': 'DRUG', 'description': 'current or new medication', 'armGroupLabels': ['Group 2. VKA']}, {'name': 'rivaroxaban', 'type': 'DRUG', 'description': 'current or new medication', 'armGroupLabels': ['Group 4. Rivaroxaban']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8007', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'IDIAP Jordi Gol', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], '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'}}}}