Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-02-28 @ 10:03 PM
Study NCT ID:
NCT02239120
Status:
COMPLETED
Last Update Posted:
2019-09-06
First Post:
2014-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069604', 'term': 'Dabigatran'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Centre', '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': 'Adverse Events (AE) and serious AE starting between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months. All-cause mortality reported from randomisation until full follow up period, approximately 43 months.', 'description': 'All-cause mortality numbers are based on randomized set whereas Serious Adverse Events (SAE) and non-SAE are based on treated set.', 'eventGroups': [{'id': 'EG000', 'title': 'Dabigatran Etexilate 110 or 150 Milligram (mg)', 'description': 'Participants were orally administered one 110 mg (for participants aged ≥75 years or with a creatinine clearance (CrCl) of 30 to \\<50 millilitre/ minute (mL/min)) or one 150 mg (for participants aged \\<75 years and with a CrCl of ≥50 mL/minute) Dabigatran etexilate (DE) capsule twice daily.', 'otherNumAtRisk': 2676, 'deathsNumAtRisk': 2695, 'otherNumAffected': 306, 'seriousNumAtRisk': 2676, 'deathsNumAffected': 56, 'seriousNumAffected': 724}, {'id': 'EG001', 'title': 'Acetylsalicylic Acid, Aspirin (ASA) 100 mg', 'description': 'Participants were orally administered one 100 mg Aspirin non-enteric coated tablet once daily.', 'otherNumAtRisk': 2674, 'deathsNumAtRisk': 2695, 'otherNumAffected': 295, 'seriousNumAtRisk': 2674, 'deathsNumAffected': 58, 'seriousNumAffected': 740}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 173}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 170}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 136}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 128}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 20}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Atrial fibrillation or atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 29}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Congestive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Prinzmetal angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Heart disease congenital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Deafness neurosensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Sudden hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Inappropriate antidiuretic hormone secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Eye haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Macular degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Macular fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pterygium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Retinal drusen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Duodenal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Intra-abdominal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Ischaemic enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Rectal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hepatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Bronchitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Escherichia sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Infectious pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, 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'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Urethral stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Renal and urinary 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'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cervical polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Spermatocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Uterine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Uterine prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vaginal polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Alveolitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Bronchopneumopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Laryngeal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Nasal polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pulmonary alveolar haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pulmonary congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Tachypnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypersensitivity vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Tanning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cardiac pacemaker insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hysterectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Myomectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Tooth extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Aortic occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Arteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Blue toe syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Extremity necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Iliac artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Peripheral artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vasospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2676, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2674, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adjudicated Recurrent Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2695', 'groupId': 'OG000'}, {'value': '2695', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran Etexilate 110 or 150 Milligram (mg)', 'description': 'Participants were orally administered one 110 mg (for participants aged ≥75 years or with a creatinine clearance (CrCl) of 30 to \\<50 millilitre/ minute (mL/min)) or one 150 mg (for participants aged \\<75 years and with a CrCl of ≥50 mL/minute) Dabigatran etexilate (DE) capsule twice daily.'}, {'id': 'OG001', 'title': 'Acetylsalicylic Acid, Aspirin (ASA) 100 mg', 'description': 'Participants were orally administered one 100 mg Aspirin non-enteric coated tablet once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.09', 'groupId': 'OG000'}, {'value': '4.80', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1028', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.03', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariates in model are age(\\<or\\>= 75years), creatinine clearance \\< or \\>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomisation until full follow up period, approximately 43 months.', 'description': 'Adjudicated recurrent stroke (ischemic, hemorrhagic, or unspecified) is presented. The annualised event rate represents the average number of events per patient during a 1-year period.', 'unitOfMeasure': 'Annualised event rate (%/ year)', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised set (RS): RS consisted of all participants who were randomised, regardless of whether they took trial medication. The start date of the observation period for this population was the date of randomisation.'}, {'type': 'PRIMARY', 'title': 'First Major Bleed (Adjudicated)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2676', 'groupId': 'OG000'}, {'value': '2674', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran Etexilate 110 or 150 Milligram (mg)', 'description': 'Participants were orally administered one 110 mg (for participants aged ≥75 years or with a creatinine clearance (CrCl) of 30 to \\<50 millilitre/ minute (mL/min)) or one 150 mg (for participants aged \\<75 years and with a CrCl of ≥50 mL/minute) Dabigatran etexilate (DE) capsule twice daily.'}, {'id': 'OG001', 'title': 'Acetylsalicylic Acid, Aspirin (ASA) 100 mg', 'description': 'Participants were orally administered one 100 mg Aspirin non-enteric coated tablet once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.84', 'groupId': 'OG000'}, {'value': '1.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1076', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.36', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.97', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariates in model are age(\\<or\\>= 75years), creatinine clearance \\< or \\>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.'}], 'paramType': 'NUMBER', 'timeFrame': 'Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.', 'description': 'First major bleed is primary safety endpoint. Major bleeds were defined according to the International Society of Thrombosis and Haemostasis (ISTH) definition as follows:\n\n* Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome and/or,\n* Bleeding (which should be overt) associated with a reduction in haemoglobin of at least 2 grams/ decilitre (g/dL) (1.24 millimoles Per Litre (mmol/L)), or leading to transfusion of ≥2 units of blood or packed cells (equivalent to ≥4.5 units in Japan); the haemoglobin drop should be considered to be due to and temporally related to the bleeding event and/or,\n* Fatal bleed. The annualised event rate represents the average number of events per patient during a 1-year period.', 'unitOfMeasure': 'Annualised event rate (%/ year)', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (TS): TS consisted of all patients who were treated with at least 1 dose of trial medication. The start date of the observation period for this population was the date of first intake of trial medication.'}, {'type': 'SECONDARY', 'title': 'Adjudicated Ischaemic Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2695', 'groupId': 'OG000'}, {'value': '2695', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran Etexilate 110 or 150 Milligram (mg)', 'description': 'Participants were orally administered one 110 mg (for participants aged ≥75 years or with a creatinine clearance (CrCl) of 30 to \\<50 millilitre/ minute (mL/min)) or one 150 mg (for participants aged \\<75 years and with a CrCl of ≥50 mL/minute) Dabigatran etexilate (DE) capsule twice daily.'}, {'id': 'OG001', 'title': 'Acetylsalicylic Acid, Aspirin (ASA) 100 mg', 'description': 'Participants were orally administered one 100 mg Aspirin non-enteric coated tablet once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.97', 'groupId': 'OG000'}, {'value': '4.71', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0892', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.68', 'ciUpperLimit': '1.03', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariates in model are age(\\<or\\>= 75years), creatinine clearance \\< or \\>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomisation until full follow up period, up to 43 months', 'description': 'Adjudicated ischaemic stroke is a key secondary endpoint. The annualised event rate represents the average number of events per patient during a 1-year period.', 'unitOfMeasure': 'Annualised event rate (%/ year)', 'reportingStatus': 'POSTED', 'populationDescription': 'RS'}, {'type': 'SECONDARY', 'title': 'Adjudicated Composite of Non-fatal Stroke, Non-fatal Myocardial Infarction, or Cardiovascular Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2695', 'groupId': 'OG000'}, {'value': '2695', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran Etexilate 110 or 150 Milligram (mg)', 'description': 'Participants were orally administered one 110 mg (for participants aged ≥75 years or with a creatinine clearance (CrCl) of 30 to \\<50 millilitre/ minute (mL/min)) or one 150 mg (for participants aged \\<75 years and with a CrCl of ≥50 mL/minute) Dabigatran etexilate (DE) capsule twice daily.'}, {'id': 'OG001', 'title': 'Acetylsalicylic Acid, Aspirin (ASA) 100 mg', 'description': 'Participants were orally administered one 100 mg Aspirin non-enteric coated tablet once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.80', 'groupId': 'OG000'}, {'value': '5.40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1911', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.06', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariates in model are age(\\<or\\>= 75years), creatinine clearance \\< or \\>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomisation until full follow up period, up to 43 months', 'description': 'Adjudicated composite of non-fatal stroke, non-fatal myocardial infarction (MI), or cardiovascular death is a key secondary endpoint. The annualised event rate represents the average number of events per patient during a 1-year period.', 'unitOfMeasure': 'Annualised event rate (%/ year)', 'reportingStatus': 'POSTED', 'populationDescription': 'RS'}, {'type': 'SECONDARY', 'title': 'Disabling Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2695', 'groupId': 'OG000'}, {'value': '2695', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran Etexilate 110 or 150 Milligram (mg)', 'description': 'Participants were orally administered one 110 mg (for participants aged ≥75 years or with a creatinine clearance (CrCl) of 30 to \\<50 millilitre/ minute (mL/min)) or one 150 mg (for participants aged \\<75 years and with a CrCl of ≥50 mL/minute) Dabigatran etexilate (DE) capsule twice daily.'}, {'id': 'OG001', 'title': 'Acetylsalicylic Acid, Aspirin (ASA) 100 mg', 'description': 'Participants were orally administered one 100 mg Aspirin non-enteric coated tablet once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.55', 'groupId': 'OG000'}, {'value': '0.93', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0354', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.59', 'ciLowerLimit': '0.36', 'ciUpperLimit': '0.96', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariates in model are age(\\<or\\>= 75years), creatinine clearance \\< or \\>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomisation until full follow up period, up to 43 months', 'description': 'Disabling stroke (modified Rankin Scale greater than or equal to 4, as determined 3 months after recurrent stroke) is presented. The annualised event rate represents the average number of events per patient during a 1-year period.', 'unitOfMeasure': 'Annualised event rate (%/ year)', 'reportingStatus': 'POSTED', 'populationDescription': 'RS'}, {'type': 'SECONDARY', 'title': 'All-cause Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2695', 'groupId': 'OG000'}, {'value': '2695', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran Etexilate 110 or 150 Milligram (mg)', 'description': 'Participants were orally administered one 110 mg (for participants aged ≥75 years or with a creatinine clearance (CrCl) of 30 to \\<50 millilitre/ minute (mL/min)) or one 150 mg (for participants aged \\<75 years and with a CrCl of ≥50 mL/minute) Dabigatran etexilate (DE) capsule twice daily.'}, {'id': 'OG001', 'title': 'Acetylsalicylic Acid, Aspirin (ASA) 100 mg', 'description': 'Participants were orally administered one 100 mg Aspirin non-enteric coated tablet once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.24', 'groupId': 'OG000'}, {'value': '1.28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8074', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.38', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariates in model are age(\\<or\\>= 75years), creatinine clearance \\< or \\>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomisation until full follow up period, up to 43 months', 'description': 'All-cause death is presented. The annualised event rate represents the average number of events per patient during a 1-year period.', 'unitOfMeasure': 'Annualised event rate (%/ year)', 'reportingStatus': 'POSTED', 'populationDescription': 'RS'}, {'type': 'SECONDARY', 'title': 'Adjudicated Intracranial Hemorrhage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2676', 'groupId': 'OG000'}, {'value': '2674', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran Etexilate 110 or 150 Milligram (mg)', 'description': 'Participants were orally administered one 110 mg (for participants aged ≥75 years or with a creatinine clearance (CrCl) of 30 to \\<50 millilitre/ minute (mL/min)) or one 150 mg (for participants aged \\<75 years and with a CrCl of ≥50 mL/minute) Dabigatran etexilate (DE) capsule twice daily.'}, {'id': 'OG001', 'title': 'Acetylsalicylic Acid, Aspirin (ASA) 100 mg', 'description': 'Participants were orally administered one 100 mg Aspirin non-enteric coated tablet once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.67', 'groupId': 'OG000'}, {'value': '0.63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9064', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.58', 'ciUpperLimit': '1.83', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariates in model are age(\\<or\\>= 75years), creatinine clearance \\< or \\>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.'}], 'paramType': 'NUMBER', 'timeFrame': 'Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.', 'description': 'Adjudicated intracranial haemorrhage comprised the subtypes of intracerebral bleeds, intraventricular bleeds, subdural bleeds, epidural bleeds, and subarachnoid bleeds. Microbleeds did not qualify as intracranial haemorrhage, except when they were symptomatic.\n\nThe annualised event rate represents the average number of events per patient during a 1-year period.', 'unitOfMeasure': 'Annualised event rate (%/ year)', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Adjudicated Fatal Bleed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2676', 'groupId': 'OG000'}, {'value': '2674', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran Etexilate 110 or 150 Milligram (mg)', 'description': 'Participants were orally administered one 110 mg (for participants aged ≥75 years or with a creatinine clearance (CrCl) of 30 to \\<50 millilitre/ minute (mL/min)) or one 150 mg (for participants aged \\<75 years and with a CrCl of ≥50 mL/minute) Dabigatran etexilate (DE) capsule twice daily.'}, {'id': 'OG001', 'title': 'Acetylsalicylic Acid, Aspirin (ASA) 100 mg', 'description': 'Participants were orally administered one 100 mg Aspirin non-enteric coated tablet once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}, {'value': '0.05', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.', 'description': 'Adjudicated fatal bleeding was defined as a bleeding event which the Independent Event Adjudication Committee (IAC) determined as the primary cause of death or contributed directly to death. The annualised event rate represents the average number of events per patient during a 1-year period. Because there were 0 events in one treatment group, the hazard ratio is unable to be calculated.', 'unitOfMeasure': 'Annualised event rate (%/ year)', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Adjudicated Life-threatening Bleed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2676', 'groupId': 'OG000'}, {'value': '2674', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran Etexilate 110 or 150 Milligram (mg)', 'description': 'Participants were orally administered one 110 mg (for participants aged ≥75 years or with a creatinine clearance (CrCl) of 30 to \\<50 millilitre/ minute (mL/min)) or one 150 mg (for participants aged \\<75 years and with a CrCl of ≥50 mL/minute) Dabigatran etexilate (DE) capsule twice daily.'}, {'id': 'OG001', 'title': 'Acetylsalicylic Acid, Aspirin (ASA) 100 mg', 'description': 'Participants were orally administered one 100 mg Aspirin non-enteric coated tablet once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.76', 'groupId': 'OG000'}, {'value': '0.91', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4352', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.49', 'ciUpperLimit': '1.36', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariates in model are age(\\<or\\>= 75years), creatinine clearance \\< or \\>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.'}], 'paramType': 'NUMBER', 'timeFrame': 'Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.', 'description': 'Major bleeds were to be classified as life-threatening if they met one or more of the following criteria: fatal bleed, symptomatic intracranial bleed, reduction in haemoglobin of at least 5 grams/ deciliter (g/dL), transfusion of at least 4 units of packed red blood cells (equivalent to 9 units in Japan), associated with hypotension requiring the use of intravenous inotropic agents, or necessitated surgical intervention.\n\nThe annualised event rate represents the average number of events per patient during a 1-year period.', 'unitOfMeasure': 'Annualised event rate (%/ year)', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Any Bleed (Investigator-reported)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2676', 'groupId': 'OG000'}, {'value': '2674', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran Etexilate 110 or 150 Milligram (mg)', 'description': 'Participants were orally administered one 110 mg (for participants aged ≥75 years or with a creatinine clearance (CrCl) of 30 to \\<50 millilitre/ minute (mL/min)) or one 150 mg (for participants aged \\<75 years and with a CrCl of ≥50 mL/minute) Dabigatran etexilate (DE) capsule twice daily.'}, {'id': 'OG001', 'title': 'Acetylsalicylic Acid, Aspirin (ASA) 100 mg', 'description': 'Participants were orally administered one 100 mg Aspirin non-enteric coated tablet once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.21', 'groupId': 'OG000'}, {'value': '11.64', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.28', 'ciLowerLimit': '1.12', 'ciUpperLimit': '1.47', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariates in model are age(\\<or\\>= 75years), creatinine clearance \\< or \\>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.'}], 'paramType': 'NUMBER', 'timeFrame': 'Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.', 'description': 'This was the sum of all major and minor bleeds (Minor bleeds were clinical bleeds that did not fulfil the criteria for major bleeds), regardless of severity.\n\nThe annualised event rate represents the average number of events per patient during a 1-year period.', 'unitOfMeasure': 'Annualised event rate (%/ year)', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dabigatran Etexilate 110 or 150 Milligram (mg)', 'description': 'Participants were orally administered one 110 mg (for participants aged ≥75 years or with a creatinine clearance (CrCl) of 30 to \\<50 millilitre/ minute (mL/min)) or one 150 mg (for participants aged \\<75 years and with a CrCl of ≥50 mL/minute) Dabigatran etexilate (DE) capsule twice daily.'}, {'id': 'FG001', 'title': 'Acetylsalicylic Acid, Aspirin (ASA) 100 mg', 'description': 'Participants were orally administered one 100 mg Aspirin non-enteric coated tablet once daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomised', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2695'}, {'groupId': 'FG001', 'numSubjects': '2695'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2620'}, {'groupId': 'FG001', 'numSubjects': '2623'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '72'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '14'}]}]}], 'recruitmentDetails': 'This was randomised, active comparator, double-blind, 2 arms (1:1 ratio) event-driven Phase III trial in participants with embolic stroke of undetermined source (ESUS). Study was conducted at multiple centers in 42 countries between 3 Dec 2014 (first participant enrollment) and 14 August 2018 (last participant visit).', 'preAssignmentDetails': 'All participants were screened for eligibility to participate in the trial. Participants attended specialist sites which would then ensured that all participants met all inclusion/exclusion criteria. Participants were not to be randomized to trial treatment if any one of the specific entry criteria were not met.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2695', 'groupId': 'BG000'}, {'value': '2695', 'groupId': 'BG001'}, {'value': '5390', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dabigatran Etexilate 110 or 150 Milligram (mg)', 'description': 'Participants were orally administered one 110 mg (for participants aged ≥75 years or with a creatinine clearance (CrCl) of 30 to \\<50 millilitre/ minute (mL/min)) or one 150 mg (for participants aged \\<75 years and with a CrCl of ≥50 mL/minute) Dabigatran etexilate (DE) capsule twice daily.'}, {'id': 'BG001', 'title': 'Acetylsalicylic Acid, Aspirin (ASA) 100 mg', 'description': 'Participants were orally administered one 100 mg Aspirin non-enteric coated tablet once daily.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.5', 'spread': '11.44', 'groupId': 'BG000'}, {'value': '63.9', 'spread': '11.39', 'groupId': 'BG001'}, {'value': '64.2', 'spread': '11.42', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1001', 'groupId': 'BG000'}, {'value': '986', 'groupId': 'BG001'}, {'value': '1987', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1694', 'groupId': 'BG000'}, {'value': '1709', 'groupId': 'BG001'}, {'value': '3403', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '281', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '549', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2354', 'groupId': 'BG000'}, {'value': '2371', 'groupId': 'BG001'}, {'value': '4725', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Information on race and ethnicity was not collected for all patients in France.', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '631', 'groupId': 'BG000'}, {'value': '597', 'groupId': 'BG001'}, {'value': '1228', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1926', 'groupId': 'BG000'}, {'value': '1966', 'groupId': 'BG001'}, {'value': '3892', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Randomised set (RS): The RS consisted of all patients who were randomised, regardless of whether they took trial medication. The start date of the observation period for this population was the date of randomisation.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-10', 'size': 220692, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-08-12T06:25', 'hasProtocol': False}, {'date': '2016-04-21', 'size': 1097285, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-08-12T06:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5390}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-13', 'studyFirstSubmitDate': '2014-09-10', 'resultsFirstSubmitDate': '2019-08-13', 'studyFirstSubmitQcDate': '2014-09-10', 'lastUpdatePostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-13', 'studyFirstPostDateStruct': {'date': '2014-09-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adjudicated Recurrent Stroke', 'timeFrame': 'From randomisation until full follow up period, approximately 43 months.', 'description': 'Adjudicated recurrent stroke (ischemic, hemorrhagic, or unspecified) is presented. The annualised event rate represents the average number of events per patient during a 1-year period.'}, {'measure': 'First Major Bleed (Adjudicated)', 'timeFrame': 'Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.', 'description': 'First major bleed is primary safety endpoint. Major bleeds were defined according to the International Society of Thrombosis and Haemostasis (ISTH) definition as follows:\n\n* Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome and/or,\n* Bleeding (which should be overt) associated with a reduction in haemoglobin of at least 2 grams/ decilitre (g/dL) (1.24 millimoles Per Litre (mmol/L)), or leading to transfusion of ≥2 units of blood or packed cells (equivalent to ≥4.5 units in Japan); the haemoglobin drop should be considered to be due to and temporally related to the bleeding event and/or,\n* Fatal bleed. The annualised event rate represents the average number of events per patient during a 1-year period.'}], 'secondaryOutcomes': [{'measure': 'Adjudicated Ischaemic Stroke', 'timeFrame': 'From randomisation until full follow up period, up to 43 months', 'description': 'Adjudicated ischaemic stroke is a key secondary endpoint. The annualised event rate represents the average number of events per patient during a 1-year period.'}, {'measure': 'Adjudicated Composite of Non-fatal Stroke, Non-fatal Myocardial Infarction, or Cardiovascular Death', 'timeFrame': 'From randomisation until full follow up period, up to 43 months', 'description': 'Adjudicated composite of non-fatal stroke, non-fatal myocardial infarction (MI), or cardiovascular death is a key secondary endpoint. The annualised event rate represents the average number of events per patient during a 1-year period.'}, {'measure': 'Disabling Stroke', 'timeFrame': 'From randomisation until full follow up period, up to 43 months', 'description': 'Disabling stroke (modified Rankin Scale greater than or equal to 4, as determined 3 months after recurrent stroke) is presented. The annualised event rate represents the average number of events per patient during a 1-year period.'}, {'measure': 'All-cause Death', 'timeFrame': 'From randomisation until full follow up period, up to 43 months', 'description': 'All-cause death is presented. The annualised event rate represents the average number of events per patient during a 1-year period.'}, {'measure': 'Adjudicated Intracranial Hemorrhage', 'timeFrame': 'Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.', 'description': 'Adjudicated intracranial haemorrhage comprised the subtypes of intracerebral bleeds, intraventricular bleeds, subdural bleeds, epidural bleeds, and subarachnoid bleeds. Microbleeds did not qualify as intracranial haemorrhage, except when they were symptomatic.\n\nThe annualised event rate represents the average number of events per patient during a 1-year period.'}, {'measure': 'Adjudicated Fatal Bleed', 'timeFrame': 'Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.', 'description': 'Adjudicated fatal bleeding was defined as a bleeding event which the Independent Event Adjudication Committee (IAC) determined as the primary cause of death or contributed directly to death. The annualised event rate represents the average number of events per patient during a 1-year period. Because there were 0 events in one treatment group, the hazard ratio is unable to be calculated.'}, {'measure': 'Adjudicated Life-threatening Bleed', 'timeFrame': 'Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.', 'description': 'Major bleeds were to be classified as life-threatening if they met one or more of the following criteria: fatal bleed, symptomatic intracranial bleed, reduction in haemoglobin of at least 5 grams/ deciliter (g/dL), transfusion of at least 4 units of packed red blood cells (equivalent to 9 units in Japan), associated with hypotension requiring the use of intravenous inotropic agents, or necessitated surgical intervention.\n\nThe annualised event rate represents the average number of events per patient during a 1-year period.'}, {'measure': 'Any Bleed (Investigator-reported)', 'timeFrame': 'Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.', 'description': 'This was the sum of all major and minor bleeds (Minor bleeds were clinical bleeds that did not fulfil the criteria for major bleeds), regardless of severity.\n\nThe annualised event rate represents the average number of events per patient during a 1-year period.'}]}, 'conditionsModule': {'conditions': ['Stroke', 'Secondary Prevention']}, 'referencesModule': {'references': [{'pmid': '35656979', 'type': 'DERIVED', 'citation': 'Del Brutto VJ, Diener HC, Easton JD, Granger CB, Cronin L, Kleine E, Grauer C, Brueckmann M, Toyoda K, Schellinger PD, Lyrer P, Molina CA, Chutinet A, Bladin CF, Estol CJ, Sacco RL. Predictors of Recurrent Stroke After Embolic Stroke of Undetermined Source in the RE-SPECT ESUS Trial. J Am Heart Assoc. 2022 Jun 7;11(11):e023545. doi: 10.1161/JAHA.121.023545. Epub 2022 Jun 3.'}, {'pmid': '35538232', 'type': 'DERIVED', 'citation': 'Diener HC, Easton JD, Hart RG, Kasner S, Kamel H, Ntaios G. Review and update of the concept of embolic stroke of undetermined source. Nat Rev Neurol. 2022 Aug;18(8):455-465. doi: 10.1038/s41582-022-00663-4. Epub 2022 May 10.'}, {'pmid': '34649459', 'type': 'DERIVED', 'citation': 'Bahit MC, Sacco RL, Easton JD, Meyerhoff J, Cronin L, Kleine E, Grauer C, Brueckmann M, Diener HC, Lopes RD, Brainin M, Lyrer P, Wachter R, Segura T, Granger CB; RE-SPECT ESUS Steering Committee and Investigators. Predictors of Atrial Fibrillation Development in Patients With Embolic Stroke of Undetermined Source: An Analysis of the RE-SPECT ESUS Trial. Circulation. 2021 Nov 30;144(22):1738-1746. doi: 10.1161/CIRCULATIONAHA.121.055176. Epub 2021 Oct 15.'}, {'pmid': '33588594', 'type': 'DERIVED', 'citation': 'Uchiyama S, Toyoda K, Lee BC, Liou CW, Wong LKS, Grauer C, Brueckmann M, Taniguchi A, Urano Y, Easton JD; RE-SPECT ESUS Investigators. Dabigatran or Aspirin in East Asian Patients With Embolic Stroke of Undetermined Source: RE-SPECT ESUS Subgroup Analysis. Stroke. 2021 Mar;52(3):1069-1073. doi: 10.1161/STROKEAHA.120.031891. Epub 2021 Feb 16.'}, {'pmid': '33504190', 'type': 'DERIVED', 'citation': 'Diener HC, Chutinet A, Easton JD, Granger CB, Kleine E, Marquardt L, Meyerhoff J, Zini A, Sacco RL. Dabigatran or Aspirin After Embolic Stroke of Undetermined Source in Patients With Patent Foramen Ovale: Results From RE-SPECT ESUS. Stroke. 2021 Mar;52(3):1065-1068. doi: 10.1161/STROKEAHA.120.031237. Epub 2021 Jan 28.'}, {'pmid': '32404035', 'type': 'DERIVED', 'citation': 'Diener HC, Sacco RL, Easton JD, Granger CB, Bar M, Bernstein RA, Brainin M, Brueckmann M, Cronin L, Donnan G, Gdovinova Z, Grauer C, Kleine E, Kleinig TJ, Lyrer P, Martins S, Meyerhoff J, Milling T, Pfeilschifter W, Poli S, Reif M, Rose DZ, Sanak D, Schabitz WR. Antithrombotic Treatment of Embolic Stroke of Undetermined Source: RE-SPECT ESUS Elderly and Renally Impaired Subgroups. Stroke. 2020 Jun;51(6):1758-1765. doi: 10.1161/STROKEAHA.119.028643. Epub 2020 May 14.'}, {'pmid': '31091372', 'type': 'DERIVED', 'citation': 'Diener HC, Sacco RL, Easton JD, Granger CB, Bernstein RA, Uchiyama S, Kreuzer J, Cronin L, Cotton D, Grauer C, Brueckmann M, Chernyatina M, Donnan G, Ferro JM, Grond M, Kallmunzer B, Krupinski J, Lee BC, Lemmens R, Masjuan J, Odinak M, Saver JL, Schellinger PD, Toni D, Toyoda K; RE-SPECT ESUS Steering Committee and Investigators. Dabigatran for Prevention of Stroke after Embolic Stroke of Undetermined Source. N Engl J Med. 2019 May 16;380(20):1906-1917. doi: 10.1056/NEJMoa1813959.'}]}, 'descriptionModule': {'briefSummary': 'This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1 ratio) and have visits every three months. The study doctor may prescribe blinded concomitant ASA for pts with coronary artery disease but this is not mandatory. All Adverse Events (AEs), Serious Adverse Events (SAEs), outcome events will be recorded. The trial will conclude when the required number of stroke events are positively adjudicated which is estimated to take 3 years (including 2.5 years of enrollment).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '150 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Ischemic stroke with a brain lesion visualized by neuroimaging (either brain Computed Tomography (CT) or Magnetic Resonance Image (MRI)). The visualized stroke is a non-lacunar infarct , e.g. involving the cortex or \\>1.5 cm (\\>2.0 cm if measured on MRI diffusion-weighted images) in largest diameter if exclusively subcortical.Visualization by CT usually requires delayed imaging \\>24-48 hours after stroke onset.\n* The index stroke must have occurred either up to 3 months before randomization (Modified Rankin Scale(mRS) \\<=3 at randomization) or up to 6 months before randomization (mRS \\<=3 at randomization) in selected patients that are \\>= 60 years plus at least one additional risk factor for recurrent stroke.\n* Arterial imaging or cervical plus Transcranial Doppler (TCD) ultrasonography does not show extra-cranial or intracranial atherosclerosis with \\>= 50% luminal stenosis in artery supplying the area of acute ischemia.\n* As evidenced by cardiac monitoring for \\>= 20 hours with automated rhythm detection, there is absence of AF \\> 6 minutes in duration (within a 20 hour period, either as single episode or cumulative time of multiple episodes).\n\nFurther inclusion criteria apply.\n\nExclusion criteria:\n\n* Modified Rankin Scale of \\>=4 at time of randomization or inability to swallow medications.\n* Major risk cardioembolic source of embolism such as: a) intracardiac thrombus as evidenced by transthoracic or transesophageal echocardiography, b) paroxysmal, persistent or permanent Atrial fibrillation (AF), c) atrial flutter, d) prosthetic cardiac valve (mitral or aortic, bioprosthetic or mechanical), e) atrial myxoma, f) other cardiac tumors, g) moderate or severe mitral stenosis, h) recent (\\< 4weeks) myocardial infarction, i) valvular vegetations, or j) infective endocarditis.\n* Any indication that requires treatment with an anticoagulant as per Investigator's judgment.\n* History of atrial fibrillation (unless it was due to reversible causes such as hyperthyroidism or binge drinking, and has been permanently resolved).\n* Other specific stroke etiology (i.e. cerebral arteritis or arterial dissection, migraine with aura/vasospasm, drug abuse).\n* Renal impairment with estimated creatinine clearance (as calculated by Cockcroft-Gault equation) \\<30mL/min at screening, or where Investigator expects creatinine clearance is likely to drop below 30mL/min during the course of the study.\n\nFurther exclusion criteria apply."}, 'identificationModule': {'nctId': 'NCT02239120', 'briefTitle': 'Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Randomized, Double-blind, Evaluation in Secondary Stroke Prevention Comparing the EfficaCy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate (110 mg or 150 mg, Oral b.i.d.) Versus Acetylsalicylic Acid (100 mg Oral q.d.) in Patients With Embolic Stroke of Undetermined Source (RESPECT ESUS)', 'orgStudyIdInfo': {'id': '1160.189'}, 'secondaryIdInfos': [{'id': '2013-003444-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dabigatran etexilate 110 or 150 mg', 'description': 'Patients will be assigned Dabigatran 150 mg b.i.d. (unless they are 75 years or older, or have a Creatinine Clearance (CrCl) of greater than or equal to 30 to less than 50ml/min (or experience GI bleed during trial), in which case they will receive Dabigatran 110 mg b.i.d.). All patients in this arm will also receive ASA placebo (q.d.)', 'interventionNames': ['Drug: optional ASA as comedication', 'Drug: placebo to ASA', 'Drug: dabigatran etexilate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ASA 100 mg', 'description': 'All patients will receive blinded ASA 100 mg q.d. and dabigatran placebo 150 mg b.i.d. (unless they are 75 years or older, or have a CrCl of greater than or equal to 30 to less than 50ml/min (or experience GI bleed during trial), in which case they will receive placebo Dabigatran 110 mg b.i.d', 'interventionNames': ['Drug: placebo to optional ASA as comedication', 'Drug: placebo to dabigatran etexilate', 'Drug: ASA 100 mg']}], 'interventions': [{'name': 'optional ASA as comedication', 'type': 'DRUG', 'description': 'optional concomitant treatment which can be used for patients with coronary artery disease. It is not required for these pts.', 'armGroupLabels': ['dabigatran etexilate 110 or 150 mg']}, {'name': 'placebo to ASA', 'type': 'DRUG', 'description': 'placebo to comparator drug', 'armGroupLabels': ['dabigatran etexilate 110 or 150 mg']}, {'name': 'placebo to optional ASA as comedication', 'type': 'DRUG', 'description': 'optional concomitant treatment which can be used for patients with coronary artery disease. It is not required for these pts.', 'armGroupLabels': ['ASA 100 mg']}, {'name': 'placebo to dabigatran etexilate', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['ASA 100 mg']}, {'name': 'ASA 100 mg', 'type': 'DRUG', 'description': 'active comparator drug', 'armGroupLabels': ['ASA 100 mg']}, {'name': 'dabigatran etexilate', 'type': 'DRUG', 'description': 'active drug', 'armGroupLabels': ['dabigatran etexilate 110 or 150 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Bronislava Shafran, MD PC', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Westside Medical Associates of Los Angeles', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92020', 'city': 'El Cajon', 'state': 'California', 'country': 'United States', 'facility': 'TriWest Research Associates, LLC', 'geoPoint': {'lat': 32.79477, 'lon': -116.96253}}, {'zip': '93721', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'University of California', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Glendale Adventist Medical Center', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Collaborative Neuroscience Network, LLC (CNS)', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Los Angeles Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Huntington Hospital', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Neurological Institute', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '80528', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '81501', 'city': 'Grand Junction', 'state': 'Colorado', 'country': 'United States', 'facility': "St. Mary's Hospital and Regional Medical Center", 'geoPoint': {'lat': 39.06387, 'lon': -108.55065}}, {'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '33462', 'city': 'Atlantis', 'state': 'Florida', 'country': 'United States', 'facility': 'JEM Research Institute', 'geoPoint': {'lat': 26.5909, 'lon': -80.10088}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Boca Raton Regional Hospital', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33472', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Tenet Florida Physician Services', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '34209', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Nova Clinical Research, LLC', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '33064', 'city': 'Deerfield Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Broward Health North', 'geoPoint': {'lat': 26.31841, 'lon': -80.09977}}, {'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Center for Advanced Research Excellence', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Bruce W. 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