Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-02-18 @ 1:30 PM
Study NCT ID:
NCT02240667
Status:
COMPLETED
Last Update Posted:
2019-04-19
First Post:
2014-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Drug Persistence/Adherence in Patients Treated With Dabigatran or VKA for Stroke Prevention in Non Valvular Atrial Fibrillation (SPAF)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069604', 'term': 'Dabigatran'}, {'id': 'C008208', 'term': 'acarboxyprothrombin'}, {'id': 'D010644', 'term': 'Phenprocoumon'}], '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': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}]}}, '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}}, 'adverseEventsModule': {'timeFrame': 'From start of treatment until six days after permanent treatment discontinuation or end of study, up to 12 months.', 'description': 'The Treated set (TS) includes all patients with main diagnosis of nonvalvular AF with at least one evaluable efficacy endpoint (being on treatment is an efficacy endpoint). Treatment emergent Adverse events were reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Dabigatran (Dabigatran vs VKA)', 'description': 'Patients with non-valvular AF treated with Dabigatran as the first Oral Anticoagulants (OACs) for stroke prevention.', 'otherNumAtRisk': 771, 'deathsNumAtRisk': 771, 'otherNumAffected': 0, 'seriousNumAtRisk': 771, 'deathsNumAffected': 10, 'seriousNumAffected': 45}, {'id': 'EG001', 'title': 'Vitamin K Antagonists (VKA)', 'description': 'Patients with non-valvular AF treated with VKA as the first Oral Anticoagulants (OACs) for stroke prevention.', 'otherNumAtRisk': 650, 'deathsNumAtRisk': 650, 'otherNumAffected': 0, 'seriousNumAtRisk': 650, 'deathsNumAffected': 5, 'seriousNumAffected': 39}], 'seriousEvents': [{'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Mitral valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Optic ischaemic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Oesophageal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Large intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastrointestinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Intestinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Duodenal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Anal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Papilla of Vater stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Generalised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cholestasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Biliary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Wound complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Electrocardiogram change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Troponin I increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastrointestinal stromal tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Adenocarcinoma gastric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Adenocarcinoma pancreas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cerebral microangiopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Chorea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Mediastinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 771, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients Treated With Anticoagulation Initially Started at the 12 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '476', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran (Dabigatran vs VKA)', 'description': 'Patients with non-valvular AF treated with dabigatran as the first Oral Anticoagulants (OACs) were matched 1:1 based on Propensity Score (PS).'}, {'id': 'OG001', 'title': 'VKA (Dabigatran vs VKA)', 'description': 'Patients with non-valvular AF treated with VKA as the first Oral Anticoagulants (OACs) were matched 1:1 based on Propensity Score (PS).'}], 'classes': [{'categories': [{'measurements': [{'value': '89.5', 'groupId': 'OG000', 'lowerLimit': '86.3', 'upperLimit': '91.9'}, {'value': '89.5', 'groupId': 'OG001', 'lowerLimit': '86.3', 'upperLimit': '92.0'}]}]}], 'analyses': [{'pValue': '0.8496', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Persistence in both treatment groups was compared by means of the stratified Log-rank test', 'statisticalMethod': 'stratified log-rank test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 month (Visit 5)', 'description': 'Percentage of patients treated with the initially allocated anticoagulant at the 12-month visit, defined as Kaplan Meier estimate at 12 months for persistence, stratified for dabigatran etexilate and VKA.Persistence is defined as the time between initiation and permanent discontinuation of therapy. The initiation date is the documented start of treatment (at visit 1), and the date of permanent discontinuation is the documented permanent discontinuation of dabigatran etexilate or VKA therapy.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in the TS who were matched 1:1 based on propensity score matching in order to ensure comparability of outcome variables between both treatment groups (dabigatran etexilate and VKA).'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '476', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran (Dabigatran vs VKA)', 'description': 'Patients with non-valvular AF treated with dabigatran as the first Oral Anticoagulants (OACs) were matched 1:1 based on Propensity Score (PS).'}, {'id': 'OG001', 'title': 'VKA (Dabigatran vs VKA)', 'description': 'Patients with non-valvular AF treated with VKA as the first Oral Anticoagulants (OACs) were matched 1:1 based on Propensity Score (PS).'}], 'classes': [{'title': 'Low', 'categories': [{'measurements': [{'value': '19.12', 'groupId': 'OG000'}, {'value': '23.74', 'groupId': 'OG001'}]}]}, {'title': 'Medium', 'categories': [{'measurements': [{'value': '45.8', 'groupId': 'OG000'}, {'value': '46.85', 'groupId': 'OG001'}]}]}, {'title': 'High', 'categories': [{'measurements': [{'value': '5.88', 'groupId': 'OG000'}, {'value': '3.99', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '29.2', 'groupId': 'OG000'}, {'value': '25.42', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 month (visit 3)', 'description': 'Percentage of patients with low, medium or high adherence at the 6-month visit, stratified for dabigatran etexilate and VKA; categorisation is done on the basis of the Morisky questionnaire (high, medium and low adherence with a Morisky score of 0, 1 to 2, and \\> 2, respectively).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in the TS who were matched 1:1 based on propensity score matching in order to ensure comparability of outcome variables between both treatment groups (dabigatran etexilate and VKA).'}, {'type': 'SECONDARY', 'title': 'Number of Patients With the Reason for Definitive Treatment Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '476', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran (Dabigatran vs VKA)', 'description': 'Patients with non-valvular AF treated with dabigatran as the first Oral Anticoagulants (OACs) were matched 1:1 based on Propensity Score (PS).'}, {'id': 'OG001', 'title': 'VKA (Dabigatran vs VKA)', 'description': 'Patients with non-valvular AF treated with VKA as the first Oral Anticoagulants (OACs) were matched 1:1 based on Propensity Score (PS).'}], 'classes': [{'title': 'Visit 2 (Month 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Serious adverse event', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': "Patient's wish", 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Decision of physician', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3 (Month 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Serious adverse event', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': "Patient's wish", 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Decision of physician', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4 (Month 9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Serious adverse event', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': "Patient's wish", 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Decision of physician', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5 (Month 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Serious adverse event', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': "Patient's wish", 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Decision of physician', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 2, 3, 4 and 5 (after approx. 3, 6, 9 and 12 months of treatment)', 'description': 'Number of patients with the reason for definitive treatment discontinuation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in the TS who were matched 1:1 based on propensity score matching in order to ensure comparability of outcome variables between both treatment groups (dabigatran etexilate and VKA).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dabigatran (Dabigatran vs VKA)', 'description': 'Patients with non-valvular AF treated with Dabigatran as the first Oral Anticoagulants (OACs) for stroke prevention.'}, {'id': 'FG001', 'title': 'Vitamin K Antagonists (VKA)', 'description': 'Patients with non-valvular AF treated with VKA as the first Oral Anticoagulants (OACs) for stroke prevention.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '771'}, {'groupId': 'FG001', 'numSubjects': '650'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '771'}, {'groupId': 'FG001', 'numSubjects': '650'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'In this study 1506 patients were entered, 1421 patients had at least one documented prescription of dabigatran etexilate (DE) or vitamin K antagonists (VKA)and were analyzed in the Treated set. 952 patients were matched 1:1 based on Propensity Score (PS).', 'preAssignmentDetails': 'The patients were enrolled from 1000 sites from Germany. Approximately 2/3 (about 670) will be community-based primary care internists/general practitioners and approximately 1/3 (about 330) community-based cardiologists across Germany.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '771', 'groupId': 'BG000'}, {'value': '650', 'groupId': 'BG001'}, {'value': '1421', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dabigatran (Dabigatran vs VKA)', 'description': 'Patients with non-valvular AF treated with Dabigatran as the first Oral Anticoagulants (OACs) for stroke prevention.'}, {'id': 'BG001', 'title': 'Vitamin K Antagonists (VKA)', 'description': 'Patients with non-valvular AF treated with VKA as the first Oral Anticoagulants (OACs) for stroke prevention.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '771', 'groupId': 'BG000'}, {'value': '650', 'groupId': 'BG001'}, {'value': '1421', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '96'}, {'value': '75', 'groupId': 'BG001', 'lowerLimit': '38', 'upperLimit': '96'}, {'value': '75', 'groupId': 'BG002', 'lowerLimit': '23', 'upperLimit': '96'}]}]}, {'title': 'Dabigatran vs VKA(matched pop)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'BG000'}, {'value': '476', 'groupId': 'BG001'}, {'value': '952', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000', 'lowerLimit': '40', 'upperLimit': '96'}, {'value': '75', 'groupId': 'BG001', 'lowerLimit': '38', 'upperLimit': '96'}, {'value': '75', 'groupId': 'BG002', 'lowerLimit': '38', 'upperLimit': '96'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'TS'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '771', 'groupId': 'BG000'}, {'value': '650', 'groupId': 'BG001'}, {'value': '1421', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '339', 'groupId': 'BG000'}, {'value': '284', 'groupId': 'BG001'}, {'value': '623', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '432', 'groupId': 'BG000'}, {'value': '366', 'groupId': 'BG001'}, {'value': '798', 'groupId': 'BG002'}]}]}, {'title': 'Dabigatran vs VKA(matched pop)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'BG000'}, {'value': '476', 'groupId': 'BG001'}, {'value': '952', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '214', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '419', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '262', 'groupId': 'BG000'}, {'value': '271', 'groupId': 'BG001'}, {'value': '533', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'TS'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Race and Ethnicity was not reported in this trial', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'The Treated set (TS) includes all patients with main diagnosis of nonvalvular AF (=IC 2) with at least one evaluable efficacy endpoint (being on treatment is an efficacy endpoint).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-01-04', 'size': 921804, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-12-20T02:04', 'hasProtocol': True}, {'date': '2015-08-13', 'size': 6683947, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-12-20T02:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1506}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-18', 'studyFirstSubmitDate': '2014-09-15', 'resultsFirstSubmitDate': '2018-12-20', 'studyFirstSubmitQcDate': '2014-09-15', 'lastUpdatePostDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-18', 'studyFirstPostDateStruct': {'date': '2014-09-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients Treated With Anticoagulation Initially Started at the 12 Month', 'timeFrame': '12 month (Visit 5)', 'description': 'Percentage of patients treated with the initially allocated anticoagulant at the 12-month visit, defined as Kaplan Meier estimate at 12 months for persistence, stratified for dabigatran etexilate and VKA.Persistence is defined as the time between initiation and permanent discontinuation of therapy. The initiation date is the documented start of treatment (at visit 1), and the date of permanent discontinuation is the documented permanent discontinuation of dabigatran etexilate or VKA therapy.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit.', 'timeFrame': '6 month (visit 3)', 'description': 'Percentage of patients with low, medium or high adherence at the 6-month visit, stratified for dabigatran etexilate and VKA; categorisation is done on the basis of the Morisky questionnaire (high, medium and low adherence with a Morisky score of 0, 1 to 2, and \\> 2, respectively).'}, {'measure': 'Number of Patients With the Reason for Definitive Treatment Discontinuation', 'timeFrame': 'Visit 2, 3, 4 and 5 (after approx. 3, 6, 9 and 12 months of treatment)', 'description': 'Number of patients with the reason for definitive treatment discontinuation'}]}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': '1600 AF patients receiving Pradaxa or VKA for stroke prevention will be followed up for 12 months in quarterly visits. Prescriptions, adverse events and (if applicable) reasons for definitive treatment discontinuation will be collected. At 6 months, patient adherence will be assessed, using the Morisky Score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'AF patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Newly prescribed treatment with Pradaxa® (dabigatran etexilate)/VKA in the indication "Stroke prevention in non-valvular atrial fibrillation" (AF) respecting the indication and contraindications as described in the respective Summary of Product Characteristics for Pradaxa® 110 mg or 150 mg hard capsules or the appropriate VKA (patients are eligible for both Pradaxa® and VKA therapy).\n* Treatment with dabigatran etexilate or VKA is given in accordance with the respective Summaries of Product Characteristics. The routine diagnostic procedures and treatment that would be undertaken irrespective of the study are unaffected.\n* Only patients who are eligible both for therapy with Pradaxa® and for therapy with VKA in accordance with the respective Summaries of Product Characteristics will be documented (patients eligible for VKA and Pradaxa®)\n* Patients must have signed the patient consent form prior to inclusion in the Non-Interventional Study (NIS).\n\nExclusion criteria:\n\n* Patients with the general and special contraindications mentioned in the packaging leaflet or Summary of Product Characteristics must not be included.\n* Patients participating at the same time or within the last 30 days in another Non-Interventional Study (NIS) or an interventional clinical trial must not be included.\n* Patients treated with anticoagulants for a condition other than non-valvular atrial fibrillation must not be included.\n* Pradaxa® and VKA should not be used during pregnancy and lactation. Pregnant or breastfeeding women must therefore not be included in the NIS.'}, 'identificationModule': {'nctId': 'NCT02240667', 'briefTitle': 'Drug Persistence/Adherence in Patients Treated With Dabigatran or VKA for Stroke Prevention in Non Valvular Atrial Fibrillation (SPAF)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Drug Persistence/Adherence in Patients Being Treated With Dabigatran Etexilate or VKA for Stroke Prevention in Non-valvular Atrial Fibrillation (SPAF)', 'orgStudyIdInfo': {'id': '1160.218'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects with atrial fibrillation', 'interventionNames': ['Drug: Dabigatran etexilate', 'Drug: Vitamin K antagonists']}], 'interventions': [{'name': 'Dabigatran etexilate', 'type': 'DRUG', 'description': '150 mg or 110 mg capsules twice daily', 'armGroupLabels': ['Subjects with atrial fibrillation']}, {'name': 'Vitamin K antagonists', 'type': 'DRUG', 'otherNames': ['Phenprocoumon'], 'description': 'International Normalized Ratio (INR) 2-3', 'armGroupLabels': ['Subjects with atrial fibrillation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'Germany'}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}