Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-03-04 @ 9:57 PM
Study NCT ID:
NCT02597920
Status:
COMPLETED
Last Update Posted:
2019-02-21
First Post:
2015-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Patient Convenience Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This study was conducted in an unblinded manner so site and patient selection bias could have occurred. Therefore, current practice patterns at these sites may not necessarily reflect patterns of care elsewhere.'}}, 'adverseEventsModule': {'timeFrame': 'From signing the informed consent till end of the study; up to 290 days', 'description': 'In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort A Pradaxa®', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF), who were using Vitamin K antagonist (VKA) therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) twice daily dose of Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).', 'otherNumAtRisk': 585, 'deathsNumAtRisk': 585, 'otherNumAffected': 0, 'seriousNumAtRisk': 585, 'deathsNumAffected': 1, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Cohort B Pradaxa®', 'description': 'Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on twice daily dose of 110 or 150 mg Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).', 'otherNumAtRisk': 1159, 'deathsNumAtRisk': 1159, 'otherNumAffected': 0, 'seriousNumAtRisk': 1159, 'deathsNumAffected': 5, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'Cohort B VKA', 'description': 'Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 0, 'seriousNumAtRisk': 78, 'deathsNumAffected': 1, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1159, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1159, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1159, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1159, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1159, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1159, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1159, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1159, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Lung adenocarcinoma stage III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1159, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1159, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1159, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1159, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pulmonary infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1159, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 585, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1159, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A Pradaxa®', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF), who were using Vitamin K antagonist (VKA) therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) twice daily dose of Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).'}], 'classes': [{'title': 'CDS-Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '583', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '63.4', 'spread': '25.2', 'groupId': 'OG000'}]}]}, {'title': 'CDS-Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '567', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.3', 'spread': '19.4', 'groupId': 'OG000'}]}]}, {'title': 'CDS-Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '543', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.2', 'spread': '17.9', 'groupId': 'OG000'}]}]}, {'title': 'SDS-Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '583', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '53.8', 'spread': '16.8', 'groupId': 'OG000'}]}]}, {'title': 'SDS-Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '567', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67.7', 'spread': '13.9', 'groupId': 'OG000'}]}]}, {'title': 'SDS-Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '543', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70.0', 'spread': '13.0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Within group comparison of Baseline CDS with that of Visit 2.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Within group comparison of Baseline CDS with that of Visit 3.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Within group comparison of Baseline SDS with that of Visit 2.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Within group comparison of Baseline SDS with that of Visit 3.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Visit 2 (7-124 days after initiation on Pradaxa® or VKA), Visit 3 (125-365 days after initiation on Pradaxa® or VKA).', 'description': 'The PACT-Q is a self-administered questionnaire which was developed as a means to investigate patients´ satisfaction with anticoagulant treatment and treatment convenience in patients with deep venous thrombosis (DVT), pulmonary embolism (PE) or atrial fibrillation (AF). The PACT-Q2 is composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score (CDS). Items for anticoagulant treatment satisfaction are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score (SDS). High scores are more favorable. The two dimension scores are presented for Baseline, Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD).', 'unitOfMeasure': 'Units on Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible. PACT-Q2 score obtained after discontinuation of treatment or using incorrect procedure was excluded from the summary for that particular visit.'}, {'type': 'PRIMARY', 'title': 'Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1159', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B Pradaxa®', 'description': 'Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on twice daily dose of 110 or 150 mg Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).'}, {'id': 'OG001', 'title': 'Cohort B VKA', 'description': 'Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.'}], 'classes': [{'title': 'CDS-Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.3', 'spread': '13.4', 'groupId': 'OG000'}, {'value': '69.1', 'spread': '22.6', 'groupId': 'OG001'}]}]}, {'title': 'CDS-Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.3', 'spread': '10.5', 'groupId': 'OG000'}, {'value': '69.5', 'spread': '22.3', 'groupId': 'OG001'}]}]}, {'title': 'SDS-Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.9', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '58.0', 'spread': '13.3', 'groupId': 'OG001'}]}]}, {'title': 'SDS-Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.4', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '58.8', 'spread': '15.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Between group comparison of Visit 2 CDS', 'statisticalMethod': 'Propensity score matching method', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Between group comparison of Visit 3 CDS', 'statisticalMethod': 'Propensity score matching method', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Between group comparison of Visit 2 SDS', 'statisticalMethod': 'Propensity score matching method', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Between group comparison of Visit 3 SDS', 'statisticalMethod': 'Propensity score matching method', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Visit 2 (7-124 days after initiation on Pradaxa® or VKA) and Visit 3 (125-365 days after initiation on Pradaxa® or VKA).', 'description': 'The PACT-Q2 is composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The PACT-Q2 was to be administered to patients once treatment was ongoing. Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores are more favorable. The two dimension scores are presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD). Propensity score matching method is used to identify matched Pradaxa® and VKA patients. Only the matched patients in each treatment group are summarized and used for comparison.', 'unitOfMeasure': 'Units on Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible. PACT-Q2 score obtained after discontinuation of treatment or using incorrect procedure was excluded from the summary for that particular visit.'}, {'type': 'PRIMARY', 'title': 'Patient Characterization at Baseline - Categorical Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A Pradaxa®', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF), who were using Vitamin K antagonist (VKA) therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) twice daily dose of Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).'}, {'id': 'OG001', 'title': 'Cohort B Pradaxa®', 'description': 'Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on twice daily dose of 110 or 150 mg Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).'}, {'id': 'OG002', 'title': 'Cohort B VKA', 'description': 'Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.'}], 'classes': [{'title': 'Age: < 65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.2', 'groupId': 'OG000'}, {'value': '17.9', 'groupId': 'OG001'}, {'value': '12.8', 'groupId': 'OG002'}]}]}, {'title': 'Age: ≥ 65 and < 75 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000'}, {'value': '36.6', 'groupId': 'OG001'}, {'value': '28.2', 'groupId': 'OG002'}]}]}, {'title': 'Age: ≥ 75 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '49.4', 'groupId': 'OG000'}, {'value': '45.6', 'groupId': 'OG001'}, {'value': '59.0', 'groupId': 'OG002'}]}]}, {'title': 'Gender: Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '55.9', 'groupId': 'OG000'}, {'value': '55.1', 'groupId': 'OG001'}, {'value': '44.9', 'groupId': 'OG002'}]}]}, {'title': 'Gender: Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '44.1', 'groupId': 'OG000'}, {'value': '44.9', 'groupId': 'OG001'}, {'value': '55.1', 'groupId': 'OG002'}]}]}, {'title': 'MH: Thromboembolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000'}, {'value': '9.1', 'groupId': 'OG001'}, {'value': '12.8', 'groupId': 'OG002'}]}]}, {'title': 'MH: Cardiovascular Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22.4', 'groupId': 'OG000'}, {'value': '18.5', 'groupId': 'OG001'}, {'value': '21.8', 'groupId': 'OG002'}]}]}, {'title': 'MH: Bleedings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}, {'value': '7.7', 'groupId': 'OG002'}]}]}, {'title': 'MH: Other Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}, {'value': '6.4', 'groupId': 'OG001'}, {'value': '9.0', 'groupId': 'OG002'}]}]}, {'title': 'CoMo: Thromboembolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000'}, {'value': '4.0', 'groupId': 'OG001'}, {'value': '9.0', 'groupId': 'OG002'}]}]}, {'title': 'CoMo: Cardiovascular Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '79.7', 'groupId': 'OG000'}, {'value': '79.4', 'groupId': 'OG001'}, {'value': '82.1', 'groupId': 'OG002'}]}]}, {'title': 'CoMo: Bleedings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '2.6', 'groupId': 'OG001'}, {'value': '7.7', 'groupId': 'OG002'}]}]}, {'title': 'CoMo: Other Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21.9', 'groupId': 'OG000'}, {'value': '18.4', 'groupId': 'OG001'}, {'value': '25.6', 'groupId': 'OG002'}]}]}, {'title': 'CM: Antihypertensives', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '84.8', 'groupId': 'OG000'}, {'value': '81.1', 'groupId': 'OG001'}, {'value': '84.6', 'groupId': 'OG002'}]}]}, {'title': 'CM: Lipid modifying agents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '45.3', 'groupId': 'OG000'}, {'value': '42.6', 'groupId': 'OG001'}, {'value': '51.3', 'groupId': 'OG002'}]}]}, {'title': 'CM: Antiarrhythmic agents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29.4', 'groupId': 'OG000'}, {'value': '25.4', 'groupId': 'OG001'}, {'value': '19.2', 'groupId': 'OG002'}]}]}, {'title': 'CM: Proton pump inhibitors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000'}, {'value': '15.9', 'groupId': 'OG001'}, {'value': '26.9', 'groupId': 'OG002'}]}]}, {'title': 'CM: Antithrombotic agents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000'}, {'value': '10.1', 'groupId': 'OG001'}, {'value': '21.8', 'groupId': 'OG002'}]}]}, {'title': 'CM: Amiodarone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}, {'value': '2.6', 'groupId': 'OG002'}]}]}, {'title': 'CM: Antidepressants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}, {'value': '4.3', 'groupId': 'OG001'}, {'value': '6.4', 'groupId': 'OG002'}]}]}, {'title': 'CM: Verapamil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '2.8', 'groupId': 'OG001'}, {'value': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'CM: H2-receptor antagonists', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'CM: NSAIDS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}, {'value': '2.6', 'groupId': 'OG002'}]}]}, {'title': 'DoP: 110 mg twice daily', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '55.9', 'groupId': 'OG000'}, {'value': '57.3', 'groupId': 'OG001'}]}]}, {'title': 'DoP: 150 mg twice daily', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '44.1', 'groupId': 'OG000'}, {'value': '42.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Categorical parameters of the patient characteristics at baseline included age, gender, Stroke- and/or bleeding related risk factors in medical history and at baseline (MH), co-morbidities (CoMo), concomitant therapies (CM) and dosing of Pradaxa® (DoP).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible.'}, {'type': 'PRIMARY', 'title': 'Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A Pradaxa®', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF), who were using Vitamin K antagonist (VKA) therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) twice daily dose of Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).'}, {'id': 'OG001', 'title': 'Cohort B Pradaxa®', 'description': 'Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on twice daily dose of 110 or 150 mg Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).'}, {'id': 'OG002', 'title': 'Cohort B VKA', 'description': 'Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.'}], 'classes': [{'title': 'CHA2DS2-VASc', 'categories': [{'measurements': [{'value': '3.4', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '3.8', 'spread': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'HAS-BLED', 'categories': [{'measurements': [{'value': '2.1', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '1.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ Transient Ischaemic Attack (TIA), Vascular disease, Age 65-74, Sex category. HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\\>65 years), Drugs and Alcohol. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. CHA2DS2-VASc stroke risk score and HAS-BLED bleeding risk score at baseline are patient characteristics.', 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible.'}, {'type': 'PRIMARY', 'title': 'Patient Characterization at Baseline - Creatinine Clearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A Pradaxa®', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF), who were using Vitamin K antagonist (VKA) therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) twice daily dose of Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).'}, {'id': 'OG001', 'title': 'Cohort B Pradaxa®', 'description': 'Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on twice daily dose of 110 or 150 mg Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).'}, {'id': 'OG002', 'title': 'Cohort B VKA', 'description': 'Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.40', 'spread': '27.08', 'groupId': 'OG000'}, {'value': '75.89', 'spread': '26.60', 'groupId': 'OG001'}, {'value': '63.83', 'spread': '37.55', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "Creatinine clearance at baseline is a measure of the patient's kidney function and is one of the baseline patient characteristics.", 'unitOfMeasure': 'millilitre/ minute [mL/min]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible.'}, {'type': 'PRIMARY', 'title': 'Patient Characteristics at Baseline - Vitamin K Antagonist Treatment Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A Pradaxa®', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF), who were using Vitamin K antagonist (VKA) therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) twice daily dose of Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).'}, {'id': 'OG001', 'title': 'Cohort B Pradaxa®', 'description': 'Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on twice daily dose of 110 or 150 mg Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).'}, {'id': 'OG002', 'title': 'Cohort B VKA', 'description': 'Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.44', 'spread': '3.65', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Vitamin K Antagonist (VKA) treatment duration at baseline is only applicable for Cohort A patients and is one of the baseline patient characteristics.', 'unitOfMeasure': 'Years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible.'}, {'type': 'SECONDARY', 'title': 'Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A Pradaxa®', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF), who were using Vitamin K antagonist (VKA) therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) twice daily dose of Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).'}], 'classes': [{'title': 'CDS-Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '567', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.3', 'spread': '19.4', 'groupId': 'OG000'}]}]}, {'title': 'CDS-Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '543', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.2', 'spread': '17.9', 'groupId': 'OG000'}]}]}, {'title': 'SDS-Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '567', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67.7', 'spread': '13.9', 'groupId': 'OG000'}]}]}, {'title': 'SDS-Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '543', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70.0', 'spread': '13.0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Within group comparison of Visit 2 CDS with that of Visit 3.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Within group comparison of Visit 2 SDS with that of Visit 3.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Visit 2 (7-124 days after initiation on Pradaxa® or VKA) and Visit 3 (125-365 days after initiation on Pradaxa® or VKA).', 'description': 'The PACT-Q2 is composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The PACT-Q2 was to be administered to patients once treatment was ongoing. Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores are more favorable. The two dimension scores are presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD).', 'unitOfMeasure': 'Units on Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible. PACT-Q2 score obtained after discontinuation of treatment or using incorrect procedure was excluded from the summary for that particular visit.'}, {'type': 'SECONDARY', 'title': 'Description of PACT-Q1 Items for Patients in Cohort B at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1148', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B Pradaxa®', 'description': 'Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on twice daily dose of 110 or 150 mg Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).'}, {'id': 'OG001', 'title': 'Cohort B VKA', 'description': 'Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.'}], 'classes': [{'title': 'A1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1147', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'A2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1146', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'A3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1147', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'A4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1147', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'A5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1147', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'A6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1147', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.1', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'A7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1147', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The PACT-Q1 is composed of a single dimension (7 items), covering the expectations of patients regarding their anticoagulant treatment, and was to be administered before treatment initiation. The 7 items are: A1: How confident are you that your anticoagulant treatment will prevent blood clots? A2: Do you expect that your anticoagulant treatment will relieve some of the symptoms you experience? A3: Do you expect that your anticoagulant treatment will cause side effects such as minor bruises or bleeding? A4: How important is it for you to have an anticoagulant treatment that is easy to take? A5: How concerned are you about making mistakes when taking your anticoagulant treatment? A6: How important is it for you to take care of your anticoagulant treatment by yourself? A7: How concerned are you about how much you pay for your anticoagulant treatment? Responses ranged from 1 (Not at all) to 5 (Extremely/ Completely/ Very much).', 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible. PACT-Q1 score at Visit 1 obtained after discontinuation of treatment or using incorrect procedure was excluded from the summary.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort A Pradaxa®', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF), who were using Vitamin K antagonist (VKA) therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) twice daily dose of Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).'}, {'id': 'FG001', 'title': 'Cohort B Pradaxa®', 'description': 'Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on twice daily dose of 110 or 150 mg Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).'}, {'id': 'FG002', 'title': 'Cohort B VKA', 'description': 'Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Information about study termination is not available for 1 subject.', 'groupId': 'FG000', 'numSubjects': '585'}, {'groupId': 'FG001', 'numSubjects': '1159'}, {'groupId': 'FG002', 'numSubjects': '78'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '544'}, {'groupId': 'FG001', 'numSubjects': '1075'}, {'groupId': 'FG002', 'numSubjects': '72'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '84'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Worsening of other pre-existing disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Refuse to continue in the study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other than specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Non-interventional study (NIS) on patients diagnosed with non-valvular atrial fibrillation (NVAF).', 'preAssignmentDetails': 'A total of 1852 patients were enrolled, out of which 1822 were found eligible.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '585', 'groupId': 'BG000'}, {'value': '1159', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '1822', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort A Pradaxa®', 'description': 'Patients with a diagnosis of non-valvular atrial fibrillation (NVAF), who were using Vitamin K antagonist (VKA) therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) twice daily dose of Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).'}, {'id': 'BG001', 'title': 'Cohort B Pradaxa®', 'description': 'Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on twice daily dose of 110 or 150 mg Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).'}, {'id': 'BG002', 'title': 'Cohort B VKA', 'description': 'Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.3', 'spread': '8.9', 'groupId': 'BG000'}, {'value': '72.7', 'spread': '9.1', 'groupId': 'BG001'}, {'value': '74.9', 'spread': '10.1', 'groupId': 'BG002'}, {'value': '73.0', 'spread': '9.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Age (mean and standard deviation (SD)) at the time of signing informed consent form is presented.', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 65 years', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '207', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '300', 'groupId': 'BG003'}]}]}, {'title': '≥ 65 and < 75 years', 'categories': [{'measurements': [{'value': '213', 'groupId': 'BG000'}, {'value': '424', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '659', 'groupId': 'BG003'}]}]}, {'title': '≥ 75 years', 'categories': [{'measurements': [{'value': '289', 'groupId': 'BG000'}, {'value': '528', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '863', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of participants are presented by age categories.', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '258', 'groupId': 'BG000'}, {'value': '520', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '821', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '327', 'groupId': 'BG000'}, {'value': '639', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '1001', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of subjects are categorized as Male or Female by each cohort.', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Race and ethnicity was not collected under study protocol.', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'Race and ethnicity was not collected under study protocol.', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Race and ethnicity was not collected under study protocol.', 'groupId': 'BG002'}, {'value': 'NA', 'comment': 'Race and ethnicity was not collected under study protocol.', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Race and ethnicity was not collected under study protocol.', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Northern Europe', 'categories': [{'measurements': [{'value': '252', 'groupId': 'BG000'}, {'value': '447', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '738', 'groupId': 'BG003'}]}]}, {'title': 'Southern Europe', 'categories': [{'measurements': [{'value': '333', 'groupId': 'BG000'}, {'value': '712', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '1084', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of subjects are presented by region. Northern European countries included Belgium, Denmark, Norway, Sweden and The Netherlands while the Southern European countries included Greece and Portugal.', 'unitOfMeasure': 'Participants'}, {'title': 'Creatinine clearance at baseline', 'classes': [{'title': '<30 milliliter per minute (mL/min)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': '30 to < 50 mL/min', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '258', 'groupId': 'BG003'}]}]}, {'title': '50 to < 80 mL/min', 'categories': [{'measurements': [{'value': '277', 'groupId': 'BG000'}, {'value': '510', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '812', 'groupId': 'BG003'}]}]}, {'title': '≥ 80 mL/min', 'categories': [{'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '371', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '556', 'groupId': 'BG003'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '189', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of subjects are presented for different categories of creatinine.', 'unitOfMeasure': 'Participants'}, {'title': 'CHA2DS2-VASc stroke risk score at baseline', 'classes': [{'title': 'Intermediate risk (score = 1)', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '177', 'groupId': 'BG003'}]}]}, {'title': 'High risk (score >=2)', 'categories': [{'measurements': [{'value': '537', 'groupId': 'BG000'}, {'value': '1033', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '1645', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'CHA2DS2-VASc score: Congestive heart failure, Hypertension, Age (≥ 75), Diabetes mellitus, Stroke/Transient Ischaemic Attack (TIA), Vascular disease, Age 65-74, Sex category.', 'unitOfMeasure': 'Participants'}, {'title': 'HAS-BLED bleeding risk score at baseline', 'classes': [{'title': 'Low risk (score < 3)', 'categories': [{'measurements': [{'value': '388', 'groupId': 'BG000'}, {'value': '1031', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '1478', 'groupId': 'BG003'}]}]}, {'title': 'High risk (score >=3)', 'categories': [{'measurements': [{'value': '197', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '344', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'HAS-BLED score: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile International Normalized Ratio (INR), Elderly (\\>65 years), Drugs and Alcohol.', 'unitOfMeasure': 'Participants'}, {'title': 'Speciality of treating physician', 'classes': [{'title': 'Cardiologist', 'categories': [{'measurements': [{'value': '548', 'groupId': 'BG000'}, {'value': '1087', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '1702', 'groupId': 'BG003'}]}]}, {'title': 'General practitioner', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}]}, {'title': 'Other specialist', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of subjects treated by different physicians are presented', 'unitOfMeasure': 'Participants'}, {'title': 'Type of hospital or practise', 'classes': [{'title': 'Public', 'categories': [{'measurements': [{'value': '207', 'groupId': 'BG000'}, {'value': '387', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '627', 'groupId': 'BG003'}]}]}, {'title': 'Private', 'categories': [{'measurements': [{'value': '373', 'groupId': 'BG000'}, {'value': '753', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '1170', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of subjects treated at different type of facilities', 'unitOfMeasure': 'Participants'}, {'title': 'Owner of medical practice', 'classes': [{'title': 'Physician or physician group', 'categories': [{'measurements': [{'value': '390', 'groupId': 'BG000'}, {'value': '783', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '1212', 'groupId': 'BG003'}]}]}, {'title': 'Health Maintenance Organisation', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': 'Community health center', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}]}]}, {'title': 'Medical / academic health center', 'categories': [{'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '242', 'groupId': 'BG003'}]}]}, {'title': 'Other hospital', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '201', 'groupId': 'BG003'}]}]}, {'title': 'Other health care corporation', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of subjects are presented by owner of medical practice', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-07-17', 'size': 1124214, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-01-25T08:03', 'hasProtocol': True}, {'date': '2017-03-01', 'size': 378158, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-01-25T08:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1852}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-08', 'studyFirstSubmitDate': '2015-11-04', 'resultsFirstSubmitDate': '2018-01-25', 'studyFirstSubmitQcDate': '2015-11-04', 'lastUpdatePostDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-08', 'studyFirstPostDateStruct': {'date': '2015-11-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment', 'timeFrame': 'Baseline, Visit 2 (7-124 days after initiation on Pradaxa® or VKA), Visit 3 (125-365 days after initiation on Pradaxa® or VKA).', 'description': 'The PACT-Q is a self-administered questionnaire which was developed as a means to investigate patients´ satisfaction with anticoagulant treatment and treatment convenience in patients with deep venous thrombosis (DVT), pulmonary embolism (PE) or atrial fibrillation (AF). The PACT-Q2 is composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score (CDS). Items for anticoagulant treatment satisfaction are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score (SDS). High scores are more favorable. The two dimension scores are presented for Baseline, Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD).'}, {'measure': 'Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups', 'timeFrame': 'Visit 2 (7-124 days after initiation on Pradaxa® or VKA) and Visit 3 (125-365 days after initiation on Pradaxa® or VKA).', 'description': 'The PACT-Q2 is composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The PACT-Q2 was to be administered to patients once treatment was ongoing. Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores are more favorable. The two dimension scores are presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD). Propensity score matching method is used to identify matched Pradaxa® and VKA patients. Only the matched patients in each treatment group are summarized and used for comparison.'}, {'measure': 'Patient Characterization at Baseline - Categorical Parameters', 'timeFrame': 'Baseline', 'description': 'Categorical parameters of the patient characteristics at baseline included age, gender, Stroke- and/or bleeding related risk factors in medical history and at baseline (MH), co-morbidities (CoMo), concomitant therapies (CM) and dosing of Pradaxa® (DoP).'}, {'measure': 'Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score', 'timeFrame': 'Baseline', 'description': 'CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ Transient Ischaemic Attack (TIA), Vascular disease, Age 65-74, Sex category. HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\\>65 years), Drugs and Alcohol. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. CHA2DS2-VASc stroke risk score and HAS-BLED bleeding risk score at baseline are patient characteristics.'}, {'measure': 'Patient Characterization at Baseline - Creatinine Clearance', 'timeFrame': 'Baseline', 'description': "Creatinine clearance at baseline is a measure of the patient's kidney function and is one of the baseline patient characteristics."}, {'measure': 'Patient Characteristics at Baseline - Vitamin K Antagonist Treatment Duration', 'timeFrame': 'Baseline', 'description': 'Vitamin K Antagonist (VKA) treatment duration at baseline is only applicable for Cohort A patients and is one of the baseline patient characteristics.'}], 'secondaryOutcomes': [{'measure': 'Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment', 'timeFrame': 'Visit 2 (7-124 days after initiation on Pradaxa® or VKA) and Visit 3 (125-365 days after initiation on Pradaxa® or VKA).', 'description': 'The PACT-Q2 is composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The PACT-Q2 was to be administered to patients once treatment was ongoing. Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores are more favorable. The two dimension scores are presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD).'}, {'measure': 'Description of PACT-Q1 Items for Patients in Cohort B at Baseline', 'timeFrame': 'Baseline', 'description': 'The PACT-Q1 is composed of a single dimension (7 items), covering the expectations of patients regarding their anticoagulant treatment, and was to be administered before treatment initiation. The 7 items are: A1: How confident are you that your anticoagulant treatment will prevent blood clots? A2: Do you expect that your anticoagulant treatment will relieve some of the symptoms you experience? A3: Do you expect that your anticoagulant treatment will cause side effects such as minor bruises or bleeding? A4: How important is it for you to have an anticoagulant treatment that is easy to take? A5: How concerned are you about making mistakes when taking your anticoagulant treatment? A6: How important is it for you to take care of your anticoagulant treatment by yourself? A7: How concerned are you about how much you pay for your anticoagulant treatment? Responses ranged from 1 (Not at all) to 5 (Extremely/ Completely/ Very much).'}]}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': "The aim of this non-interventional study is to describe patient's perception of anticoagulant treatment when using Pradaxa® to prevent stroke and systemic embolism while suffering from atrial fibrillation (according to its approved indication in the approved dosages of 110 mg or 150 mg twice daily) in comparison to standard care using Vitamin K Antagonist (VKA)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'European patients with non valvular atrial fibrillation', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\nCohort A:\n\n1. A. Written informed consent prior to participation\n2. A. Female and male patients \\>= 18 years of age with a diagnosis of non-valvular atrial fibrillation.\n3. A. At least 3 months of continuous VKA treatment for stroke prevention prior to baseline assessment.\n4. A. Patients switched to Pradaxa® according Summary of Product Characteristics and physician's discretion.\n\nOR\n\nCohort B:\n\n1. B. Written informed consent prior to participation.\n2. B. Female and male patients \\>= 18 years of age newly diagnosed with non-valvular atrial fibrillation and no previous treatment for stroke prevention (no use of any oral anticoagulant (OAC) within one year prior to enrolment).\n3. B. Stroke prevention treatment initiated with Pradaxa® or VKA according to Summary of Product Characteristics and physician's discretion.\n\nExclusion criteria:\n\n1. Contraindication to the use of Pradaxa® or VKA as described in the Summary of Product Characteristics (SmPC).\n2. Patients receiving Pradaxa® or VKA for any other condition than stroke prevention in atrial fibrillation.\n3. Current participation in any clinical trial of a drug or device.\n4. Current participation in an European registry on the use of oral anticoagulation in AF."}, 'identificationModule': {'nctId': 'NCT02597920', 'briefTitle': 'Patient Convenience Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': "Non-interventional Study Describing Patients' Perception on Anticoagulant Treatment and Treatment Convenience When Treated With Pradaxa or Vitamin K Antagonist for Stroke Prophylaxis in Atrial Fibrillation", 'orgStudyIdInfo': {'id': '1160.247'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Switch patients / A', 'description': 'Patients with non-valvular atrial fibrillation (NVAF), currently on Vitamin K Antagonist (VKA) therapy, who are switched to Pradaxa.'}, {'label': 'New AF patients / B', 'description': 'Newly diagnosed NVAF patients who are treated with VKA or Pradaxa (VKA : Pradaxa = 1:1).'}]}, 'contactsLocationsModule': {'locations': [{'city': "Braine-l'Alleud", 'country': 'Belgium', 'facility': 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