Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
Study NCT ID:
NCT04218266
Status:
COMPLETED
Last Update Posted:
2022-10-27
First Post:
2020-01-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Gather Information About the Proper Dosing of the Oral FXIa Inhibitor BAY 2433334 and to Compare the Safety of the Study Drug to Apixaban, a Non-vitamin K Oral Anticoagulant (NOAC) in Patients With Irregular Heartbeat (Atrial Fibrillation) That Can Lead to Heart-related Complications.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}}}}, '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': 'C522181', 'term': 'apixaban'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayer.com', 'phone': '(+) 1-888-8422937', 'title': 'Therapeutic Area Head', 'organization': 'Bayer AG'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Asundexian 50 mg', 'description': 'Participants received Asundexian (BAY2433334) 50 mg and Apixaban placebo for 12 weeks', 'otherNumAtRisk': 254, 'deathsNumAtRisk': 254, 'otherNumAffected': 116, 'seriousNumAtRisk': 254, 'deathsNumAffected': 4, 'seriousNumAffected': 20}, {'id': 'EG001', 'title': 'Asundexian 20 mg', 'description': 'Participants received Asundexian (BAY2433334) 20 mg and Apixaban placebo for 12 weeks', 'otherNumAtRisk': 249, 'deathsNumAtRisk': 249, 'otherNumAffected': 110, 'seriousNumAtRisk': 249, 'deathsNumAffected': 2, 'seriousNumAffected': 22}, {'id': 'EG002', 'title': 'Apixaban', 'description': 'Participants received Asundexian (BAY2433334) placebo and Apixaban for 12 weeks', 'otherNumAtRisk': 250, 'deathsNumAtRisk': 250, 'otherNumAffected': 113, 'seriousNumAtRisk': 250, 'deathsNumAffected': 5, 'seriousNumAffected': 20}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Polycythaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Spontaneous haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Arrhythmia supraventricular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cardiomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Accessory spleen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vertigo labyrinthine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Autoimmune thyroiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Myopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Swelling of eyelid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Change of bowel habit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oral discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Saliva altered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Large intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Feeling abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hernia pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vessel puncture site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Medical device site inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cholestasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hepatic fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hepatomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Amyloidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pulpitis dental', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tinea cruris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gingival abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Infective exacerbation of chronic obstructive airways disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oral fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haematuria traumatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sunburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Inflammation of wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lip injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tooth fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Post-traumatic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Craniocerebral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Skin wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood potassium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood thyroid stimulating hormone decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood thyroid stimulating hormone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Heart rate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Neutrophil count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Reticulocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urinary occult blood positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Angiocardiogram', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SARS-CoV-2 test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Folate deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Musculoskeletal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Limb discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ageusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Essential tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Head discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypertonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Neuritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Parkinsonism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Orthostatic intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nightmare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nocturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Renal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sputum discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hydrothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pharyngeal paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pharyngeal swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Intertrigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Papule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Skin disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Skin fissures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Skin reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Skin haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cardiac pacemaker insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cardioversion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tooth extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cataract operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Peripheral coldness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Phlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Subclavian artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypertensive urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sinus arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Atrial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tachyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Congestive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sudden cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Campylobacter gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ejection fraction decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Bladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Colon neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Peripheral sensorimotor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Bronchial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cardiac ablation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Percutaneous coronary intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Number of Participants With All Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}, {'value': '503', 'groupId': 'OG002'}, {'value': '250', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Asundexian 20 mg', 'description': 'Participants received Asundexian (BAY2433334) 20 mg and Apixaban placebo for 12 weeks'}, {'id': 'OG001', 'title': 'Asundexian 50 mg', 'description': 'Participants received Asundexian (BAY2433334) 50 mg and Apixaban placebo for 12 weeks'}, {'id': 'OG002', 'title': 'Asundexian Pooled', 'description': 'Asundexian 20 mg group and Asundexian 50 mg group'}, {'id': 'OG003', 'title': 'Apixaban', 'description': 'Participants received Asundexian (BAY2433334) placebo and Apixaban for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG002', 'OG003'], 'paramType': 'Crude incidence ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.42', 'ciLowerLimit': '0.26', 'ciUpperLimit': '0.67', 'groupDescription': 'Comparison of the Asundexian pooled group (Asundexian 20 mg group and Asundexian 50 mg group) versus Apixaban group in all bleeding', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration)', 'description': 'Adjudication of all bleeding events was performed by members of the Clinical events committee (CEC) who reviewed events in a blinded fashion and adjudicated and classified the following events in a consistent and unbiased manner according to the following classifications: ISTH (major, clinically relevant non-major and minor); Thrombolysis in myocardial infarction (TIMI major, minor, requiring medical attention, minimal); Bleeding Academic Research Consortium (BARC type 1, 2, 3, 5).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (SAF)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With ISTH Major Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}, {'value': '250', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Asundexian 20 mg', 'description': 'Participants received Asundexian (BAY2433334) 20 mg and Apixaban placebo for 12 weeks'}, {'id': 'OG001', 'title': 'Asundexian 50 mg', 'description': 'Participants received Asundexian (BAY2433334) 50 mg and Apixaban placebo for 12 weeks'}, {'id': 'OG002', 'title': 'Apixaban', 'description': 'Participants received Asundexian (BAY2433334) placebo and Apixaban for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration)', 'description': 'ISTH Major Bleeding criteria: 1. Fatal bleeding, and/or 2. Symptomatic bleeding in a critical area or organ (intracranial, intraocular, intraspinal, pericardial, retroperitoneal, intraarticular, or intramuscular with compartment syndrome), and/or 3. Clinically overt bleeding associated with a recent decrease in the hemoglobin level of ≥ 2 g/dL (20 g/L; 1.24 mmol/L) compared to the most recent hemoglobin value available before the event, and/or 4. Clinically overt bleeding leading to transfusion of 2 or more units of packed red blood cells or whole blood.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (SAF)'}, {'type': 'SECONDARY', 'title': 'Number of Participants of ISTH Clinically Relevant Non-major (CRNM) Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}, {'value': '503', 'groupId': 'OG002'}, {'value': '250', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Asundexian 20 mg', 'description': 'Participants received Asundexian (BAY2433334) 20 mg and Apixaban placebo for 12 weeks'}, {'id': 'OG001', 'title': 'Asundexian 50 mg', 'description': 'Participants received Asundexian (BAY2433334) 50 mg and Apixaban placebo for 12 weeks'}, {'id': 'OG002', 'title': 'Asundexian Pooled', 'description': 'Asundexian 20 mg group and Asundexian 50 mg group'}, {'id': 'OG003', 'title': 'Apixaban', 'description': 'Participants received Asundexian (BAY2433334) placebo and Apixaban for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG002', 'OG003'], 'paramType': 'Crude incidence ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.33', 'ciLowerLimit': '0.09', 'ciUpperLimit': '0.97', 'groupDescription': 'Comparison of the Asundexian pooled group (Asundexian 20 mg group and Asundexian 50 mg group) versus Apixaban group in ISTH CRNM bleeding', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration)', 'description': 'ISTH Clinically Relevant Non-Major Bleeding is considered any sign or symptom of hemorrhage that does not fit the criteria for the ISTH definition of major bleeding, but does meet at least one of the following criteria 1. requiring medical intervention by a healthcare professional. 2. leading to hospitalization or increased level of care. 3. prompting a face to face (i.e. not just a telephone or electronic communication) evaluation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (SAF)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With ISTH Minor Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}, {'value': '503', 'groupId': 'OG002'}, {'value': '250', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Asundexian 20 mg', 'description': 'Participants received Asundexian (BAY2433334) 20 mg and Apixaban placebo for 12 weeks'}, {'id': 'OG001', 'title': 'Asundexian 50 mg', 'description': 'Participants received Asundexian (BAY2433334) 50 mg and Apixaban placebo for 12 weeks'}, {'id': 'OG002', 'title': 'Asundexian Pooled', 'description': 'Asundexian 20 mg group and Asundexian 50 mg group'}, {'id': 'OG003', 'title': 'Apixaban', 'description': 'Participants received Asundexian (BAY2433334) placebo and Apixaban for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG002', 'OG003'], 'paramType': 'Crude incidence ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.47', 'ciLowerLimit': '0.28', 'ciUpperLimit': '0.83', 'groupDescription': 'Comparison of the Asundexian pooled group (Asundexian 20 mg group and Asundexian 50 mg group) versus Apixaban group in ISTH minor bleeding', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration)', 'description': 'All other overt bleeding episodes not meeting ISTH Major Bleeding criteria or clinically relevant non major bleeding were classified as minor bleeding.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (SAF)'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Composite of International Society on Thrombosis and Hemostasis (ISTH) Major Bleeding or Clinically Relevant Non-major (CRNM) Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}, {'value': '503', 'groupId': 'OG002'}, {'value': '250', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Asundexian 20 mg', 'description': 'Participants received Asundexian (BAY2433334) 20 mg and Apixaban placebo for 12 weeks'}, {'id': 'OG001', 'title': 'Asundexian 50 mg', 'description': 'Participants received Asundexian (BAY2433334) 50 mg and Apixaban placebo for 12 weeks'}, {'id': 'OG002', 'title': 'Asundexian Pooled', 'description': 'Asundexian 20 mg group and Asundexian 50 mg group'}, {'id': 'OG003', 'title': 'Apixaban', 'description': 'Participants received Asundexian (BAY2433334) placebo and Apixaban for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG002', 'OG003'], 'paramType': 'Crude incidence ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.33', 'ciLowerLimit': '0.09', 'ciUpperLimit': '0.97', 'groupDescription': 'Comparison of the Asundexian pooled group (Asundexian 20 mg group and Asundexian 50 mg group) versus Apixaban group in ISTH major bleeding or CRNM bleeding', 'statisticalMethod': 'Other', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration)', 'description': 'ISTH Major Bleeding criteria: 1. Fatal bleeding, and/or 2. Symptomatic bleeding in a critical area or organ (intracranial, intraocular, intraspinal, pericardial, retroperitoneal, intraarticular, or intramuscular with compartment syndrome), and/or 3. Clinically overt bleeding associated with a recent decrease in the hemoglobin level of ≥ 2 g/dL (20 g/L; 1.24 mmol/L) compared to the most recent hemoglobin value available before the event, and/or 4. Clinically overt bleeding leading to transfusion of 2 or more units of packed red blood cells or whole blood.\n\nISTH Clinically Relevant Non-Major Bleeding is considered any sign or symptom of hemorrhage that does not fit the criteria for the ISTH definition of major bleeding, but does meet at least one of the following criteria 1. requiring medical intervention by a healthcare professional. 2. leading to hospitalization or increased level of care. 3. prompting a face to face (i.e. not just a telephone or electronic communication) evaluation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (SAF)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Asundexian 20 mg', 'description': 'Participants received Asundexian (BAY2433334) 20 mg and Apixaban placebo for 12 weeks'}, {'id': 'FG001', 'title': 'Asundexian 50 mg', 'description': 'Participants received Asundexian (BAY2433334) 50 mg and Apixaban placebo for 12 weeks'}, {'id': 'FG002', 'title': 'Apixaban', 'description': 'Participants received Asundexian (BAY2433334) placebo and Apixaban for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '251'}, {'groupId': 'FG001', 'numSubjects': '254'}, {'groupId': 'FG002', 'numSubjects': '250'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '249'}, {'groupId': 'FG001', 'numSubjects': '254'}, {'groupId': 'FG002', 'numSubjects': '250'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Treatment completed', 'groupId': 'FG000', 'numSubjects': '226'}, {'comment': 'Treatment completed', 'groupId': 'FG001', 'numSubjects': '227'}, {'comment': 'Treatment completed', 'groupId': 'FG002', 'numSubjects': '218'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Study drug never administered', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study was conducted at 94 centers in 14 countries or regions, between 30-Jan-2020 (first participant first visit) and 08-Oct-2021 (last participant last visit)', 'preAssignmentDetails': '862 participants were screened. 107 participants were screening failures. 755 participants were randomized in a 1:1:1 ratio to 3 treatment groups: 251 participants to the asundexian 20 mg group, 254 participants to the asundexian 50 mg group and 250 participants to the apixaban group. 2 participants of asundexian 20 mg group never administered drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'BG000'}, {'value': '254', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}, {'value': '753', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Asundexian 20 mg', 'description': 'Participants received Asundexian (BAY2433334) 20 mg and Apixaban placebo for 12 weeks'}, {'id': 'BG001', 'title': 'Asundexian 50 mg', 'description': 'Participants received Asundexian (BAY2433334) 50 mg and Apixaban placebo for 12 weeks'}, {'id': 'BG002', 'title': 'Apixaban', 'description': 'Participants received Asundexian (BAY2433334) placebo and Apixaban for 12 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '110', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '216', 'groupId': 'BG000'}, {'value': '211', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}, {'value': '643', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '308', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}, {'value': '445', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Asian', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '119', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '209', 'groupId': 'BG000'}, {'value': '212', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '630', 'groupId': 'BG003'}]}, {'title': 'Not reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'SAF (safety analysis set)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-09-25', 'size': 849480, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-10-25T23:37', 'hasProtocol': True}, {'date': '2021-10-14', 'size': 399314, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-10-25T23:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 755}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-26', 'studyFirstSubmitDate': '2020-01-02', 'resultsFirstSubmitDate': '2022-09-19', 'studyFirstSubmitQcDate': '2020-01-02', 'lastUpdatePostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-26', 'studyFirstPostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Composite of International Society on Thrombosis and Hemostasis (ISTH) Major Bleeding or Clinically Relevant Non-major (CRNM) Bleeding', 'timeFrame': 'After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration)', 'description': 'ISTH Major Bleeding criteria: 1. Fatal bleeding, and/or 2. Symptomatic bleeding in a critical area or organ (intracranial, intraocular, intraspinal, pericardial, retroperitoneal, intraarticular, or intramuscular with compartment syndrome), and/or 3. Clinically overt bleeding associated with a recent decrease in the hemoglobin level of ≥ 2 g/dL (20 g/L; 1.24 mmol/L) compared to the most recent hemoglobin value available before the event, and/or 4. Clinically overt bleeding leading to transfusion of 2 or more units of packed red blood cells or whole blood.\n\nISTH Clinically Relevant Non-Major Bleeding is considered any sign or symptom of hemorrhage that does not fit the criteria for the ISTH definition of major bleeding, but does meet at least one of the following criteria 1. requiring medical intervention by a healthcare professional. 2. leading to hospitalization or increased level of care. 3. prompting a face to face (i.e. not just a telephone or electronic communication) evaluation.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With All Bleeding', 'timeFrame': 'After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration)', 'description': 'Adjudication of all bleeding events was performed by members of the Clinical events committee (CEC) who reviewed events in a blinded fashion and adjudicated and classified the following events in a consistent and unbiased manner according to the following classifications: ISTH (major, clinically relevant non-major and minor); Thrombolysis in myocardial infarction (TIMI major, minor, requiring medical attention, minimal); Bleeding Academic Research Consortium (BARC type 1, 2, 3, 5).'}, {'measure': 'Number of Participants With ISTH Major Bleeding', 'timeFrame': 'After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration)', 'description': 'ISTH Major Bleeding criteria: 1. Fatal bleeding, and/or 2. Symptomatic bleeding in a critical area or organ (intracranial, intraocular, intraspinal, pericardial, retroperitoneal, intraarticular, or intramuscular with compartment syndrome), and/or 3. Clinically overt bleeding associated with a recent decrease in the hemoglobin level of ≥ 2 g/dL (20 g/L; 1.24 mmol/L) compared to the most recent hemoglobin value available before the event, and/or 4. Clinically overt bleeding leading to transfusion of 2 or more units of packed red blood cells or whole blood.'}, {'measure': 'Number of Participants of ISTH Clinically Relevant Non-major (CRNM) Bleeding', 'timeFrame': 'After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration)', 'description': 'ISTH Clinically Relevant Non-Major Bleeding is considered any sign or symptom of hemorrhage that does not fit the criteria for the ISTH definition of major bleeding, but does meet at least one of the following criteria 1. requiring medical intervention by a healthcare professional. 2. leading to hospitalization or increased level of care. 3. prompting a face to face (i.e. not just a telephone or electronic communication) evaluation.'}, {'measure': 'Number of Participants With ISTH Minor Bleeding', 'timeFrame': 'After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration)', 'description': 'All other overt bleeding episodes not meeting ISTH Major Bleeding criteria or clinically relevant non major bleeding were classified as minor bleeding.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation (AF)']}, 'referencesModule': {'references': [{'pmid': '35385695', 'type': 'DERIVED', 'citation': 'Piccini JP, Caso V, Connolly SJ, Fox KAA, Oldgren J, Jones WS, Gorog DA, Durdil V, Viethen T, Neumann C, Mundl H, Patel MR; PACIFIC-AF Investigators. Safety of the oral factor XIa inhibitor asundexian compared with apixaban in patients with atrial fibrillation (PACIFIC-AF): a multicentre, randomised, double-blind, double-dummy, dose-finding phase 2 study. Lancet. 2022 Apr 9;399(10333):1383-1390. doi: 10.1016/S0140-6736(22)00456-1. Epub 2022 Apr 3.'}], 'seeAlsoLinks': [{'url': 'http://www.clinicaltrialsregister.eu/', 'label': 'Click here to find information about studies related to Bayer Healthcare products conducted in Europe'}, {'url': 'http://clinicaltrials.bayer.com/', 'label': 'Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give to participants and to look at how well BAY 2433334 works in patients with irregular heartbeat (atrial fibrillation) that can lead to blood clots, stroke and other heart-related complications. In addition researchers want to compare the safety of the study drug to apixaban, a non-vitamin K oral anticoagulant (NOAC) in patients with atrial fibrillation. This study is also done to learn how the drug in this study moves into, through and out of the body. BAY 2433334, works by blocking a step of the blood clotting process in our body and thins the blood and is a so called oral FXIa inhibitor.\n\nApixaban, works by reducing the production of blood clotting factors in our body and thins the blood and is a so called non-vitamin K oral anticoagulant (NOAC). Thinning the blood can prevent you from blood clots which can cause a stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant must be 45 years of age or older at the time of signing the informed consent.\n* Participant with AF documented by ECG evidence with\n\n * CHA2DS2-VASc score ≥ 2 if male or CHA2DS2-VASc score ≥ 3 if female\n * Indication for treatment with an oral anticoagulant in\n\n * any participant currently not treated with an oral anticoagulant (e.g. treatment naïve) or alternatively,\n * participant on a NOAC in case of at least one bleeding risk feature (history of a prior bleed within the last 12 months requiring medical attention and / or moderate renal dysfunction with eGFR 30-50 ml/min and / or current clinically indicated antiplatelet therapy with Acetylsalicylic acid(ASA) ≤ 100 mg)\n* Written informed consent\n\nExclusion Criteria:\n\n* Mechanical heart valve prosthesis\n* Any degree of rheumatic mitral stenosis or moderate-to-severe, non-rheumatic mitral stenosis\n* Atrial fibrillation due to a reversible cause, participants in sinus rhythm after successful ablation, or plan for cardioversion or ablation during study conduct\n* Requirement for chronic anticoagulation (for a different indication than AF) or antiplatelet therapy (up to 100 mg ASA is allowed). Anticipated need for chronic therapy with Nonsteroidal anti-inflammatory drugs (NSAIDs)\n* Treated with a Vitamin K antagonist in the 30 days prior to screening'}, 'identificationModule': {'nctId': 'NCT04218266', 'acronym': 'PACIFIC-AF', 'briefTitle': 'Study to Gather Information About the Proper Dosing of the Oral FXIa Inhibitor BAY 2433334 and to Compare the Safety of the Study Drug to Apixaban, a Non-vitamin K Oral Anticoagulant (NOAC) in Patients With Irregular Heartbeat (Atrial Fibrillation) That Can Lead to Heart-related Complications.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Multicenter, Randomized, Active Comparator-controlled, Double-blind, Double-dummy, Parallel Group, Dose-finding Phase 2 Study to Compare the Safety of the Oral FXIa Inhibitor BAY2433334 to Apixaban in Patients With Atrial Fibrillation', 'orgStudyIdInfo': {'id': '19765'}, 'secondaryIdInfos': [{'id': '2019-002365-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BAY2433334 50mg+Apixaban matching placebo', 'interventionNames': ['Drug: BAY2433334', 'Other: Apixaban matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BAY2433334 20mg+Apixaban matching placebo', 'interventionNames': ['Drug: BAY2433334', 'Other: Apixaban matching placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BAY2433334 matching placebo+Apixaban', 'description': 'Apixaban usual dose is 5 mg, reduced to 2.5 mg for participants with any 2 of the following criteria: age 80 years or older, body weight less than 60 kg, or serum creatinine level of 1.5 mg per dL or more.', 'interventionNames': ['Drug: Apixaban', 'Other: BAY2433334 matching placebo']}], 'interventions': [{'name': 'BAY2433334', 'type': 'DRUG', 'description': 'Tablet, taken orally once a day.', 'armGroupLabels': ['BAY2433334 20mg+Apixaban matching placebo', 'BAY2433334 50mg+Apixaban matching placebo']}, {'name': 'Apixaban', 'type': 'DRUG', 'description': 'Capsule, taken orally twice a day.', 'armGroupLabels': ['BAY2433334 matching placebo+Apixaban']}, {'name': 'BAY2433334 matching placebo', 'type': 'OTHER', 'description': 'Tablet, taken orally once a day.', 'armGroupLabels': ['BAY2433334 matching placebo+Apixaban']}, {'name': 'Apixaban matching placebo', 'type': 'OTHER', 'description': 'Capsule, taken orally twice a day.', 'armGroupLabels': ['BAY2433334 20mg+Apixaban matching placebo', 'BAY2433334 50mg+Apixaban matching placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'state': 'Styria', 'country': 'Austria', 'facility': 'Medizinische Universität Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '6020', 'city': 'Innsbruck', 'state': 'Tyrol', 'country': 'Austria', 'facility': 'Medizinische Universität Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '5280', 'city': 'Braunau am Inn', 'state': 'Upper Austria', 'country': 'Austria', 'facility': 'Krankenhaus St. Josef Braunau', 'geoPoint': {'lat': 48.25628, 'lon': 13.04343}}, {'zip': '4020', 'city': 'Linz', 'state': 'Upper Austria', 'country': 'Austria', 'facility': 'Ordensklinikum Linz GmbH Elisabethinen', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '6807', 'city': 'Feldkirch', 'state': 'Vorarlberg', 'country': 'Austria', 'facility': 'Landeskrankenhaus Feldkirch', 'geoPoint': {'lat': 47.23306, 'lon': 9.6}}, {'zip': '5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'Uniklinikum Salzburg - Landeskrankenhaus', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Universitätsklinikum AKH Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1210', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Klinik Floridsdorf - Krankenhaus Nord', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams Brabant', 'country': 'Belgium', 'facility': 'UZ Leuven Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '2820', 'city': 'Bonheiden', 'country': 'Belgium', 'facility': 'Imeldaziekenhuis - St-Elisabethkliniek', 'geoPoint': {'lat': 51.02261, 'lon': 4.54714}}, {'zip': '8000', 'city': 'Bruges', 'country': 'Belgium', 'facility': 'AZ St-Jan Brugge Oostende AV', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'UZ Antwerpen', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '3500', 'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Jessa Ziekenhuis', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'zip': '2800', 'city': 'Mechelen', 'country': 'Belgium', 'facility': 'VZW Emmaus', 'geoPoint': {'lat': 51.02574, 'lon': 4.47762}}, {'zip': '8800', 'city': 'Roeselare', 'country': 'Belgium', 'facility': 'AZ Delta', 'geoPoint': {'lat': 50.94653, 'lon': 3.12269}}, {'zip': 'B3H 3A7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Queen Elizabeth II Health Sciences Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Heart Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H1T 3Y7', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Clinique Sante Cardio MC', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1V 4G5', 'city': 'Ste-Foy', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institut universitaire de cardiologie et de pneumologie'}, {'zip': '304 60', 'city': 'Pilsen', 'country': 'Czechia', 'facility': 'Fakultni nemocnice Plzen - Lochotin', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}, {'zip': '100 34', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Fakultni nemocnice Kralovske Vinohrady', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '140 21', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Institut Klinicke a Experimentalni Mediciny', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '150 06', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Fakultni nemocnice v Motole', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '274 01', 'city': 'Slaný', 'country': 'Czechia', 'facility': 'Nemocnice Slany', 'geoPoint': {'lat': 50.23046, 'lon': 14.08693}}, {'zip': '762 75', 'city': 'Zlín', 'country': 'Czechia', 'facility': 'Krajska nemocnice T. Bati, a.s.', 'geoPoint': {'lat': 49.22645, 'lon': 17.67065}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Hôpital Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '85025', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'Centre Hospitalier Départemental Vendée', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '28630', 'city': 'Le Coudray', 'country': 'France', 'facility': 'Centre Hospitalier Louis Pasteur', 'geoPoint': {'lat': 48.42115, 'lon': 1.50057}}, {'zip': '75018', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Bichat - Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '22000', 'city': 'Saint-Brieuc', 'country': 'France', 'facility': 'Centre Hospitalier Régional - Saint Brieuc', 'geoPoint': {'lat': 48.51513, 'lon': -2.76838}}, {'zip': '31403', 'city': 'Toulouse', 'country': 'France', 'facility': 'Hôpital de Rangueil - Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '59322', 'city': 'Valenciennes', 'country': 'France', 'facility': 'Centre Hospitalier - Valenciennes Cedex', 'geoPoint': {'lat': 50.35909, 'lon': 3.52506}}, {'zip': '8230', 'city': 'Balatonfüred', 'country': 'Hungary', 'facility': 'Tagore Medical Center', 'geoPoint': {'lat': 46.96188, 'lon': 17.87187}}, {'zip': '1122', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'University of Semmelweis/ Semmelweis Egyetem', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Magyar Honvedseg Egeszsegugyi Kozpont', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '8800', 'city': 'Nagykanizsa', 'country': 'Hungary', 'facility': 'Kanizsai Dorottya Hospital', 'geoPoint': {'lat': 46.45347, 'lon': 16.99104}}, {'zip': '4400', 'city': 'Nyíregyháza', 'country': 'Hungary', 'facility': 'Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft.', 'geoPoint': {'lat': 47.95539, 'lon': 21.71671}}, {'zip': '7624', 'city': 'Pécs', 'country': 'Hungary', 'facility': 'Pecsi Tudomanyegyetem Klinikai Kozpont', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'zip': '7100', 'city': 'Szekszárd', 'country': 'Hungary', 'facility': 'Tolna Megyei Balassa Janos Korhaz', 'geoPoint': {'lat': 46.34723, 'lon': 18.71189}}, {'zip': '6600', 'city': 'Szentes', 'country': 'Hungary', 'facility': 'Csongrad-Csanad Megyei Dr. Bugyi Istvan Korhaz', 'geoPoint': {'lat': 46.65834, 'lon': 20.2608}}, {'zip': '00161', 'city': 'Rome', 'state': 'Lazio', 'country': 'Italy', 'facility': 'A.O.U. Policlinico Umberto I', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '16132', 'city': 'Genoa', 'state': 'Liguria', 'country': 'Italy', 'facility': 'IRCCS Ospedale Policlinico San Martino', 'geoPoint': {'lat': 44.40478, 'lon': 8.94439}}, {'zip': '25123', 'city': 'Brescia', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'ASST Spedali Civili di Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '63074', 'city': 'Ascoli Piceno', 'state': 'The Marches', 'country': 'Italy', 'facility': 'ASUR Marche - Area Vasta 5', 'geoPoint': {'lat': 42.85351, 'lon': 13.57395}}, {'zip': '52044', 'city': 'Arezzo', 'state': 'Tuscany', 'country': 'Italy', 'facility': 'AUSL Toscana Sud-Est', 'geoPoint': {'lat': 43.46276, 'lon': 11.88068}}, {'zip': '52100', 'city': 'Arezzo', 'state': 'Tuscany', 'country': 'Italy', 'facility': 'AUSL Toscana Sud-Est', 'geoPoint': {'lat': 43.46276, 'lon': 11.88068}}, {'zip': '06129', 'city': 'Perugia', 'state': 'Umbria', 'country': 'Italy', 'facility': 'A.O. di Perugia', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'zip': '819-1104', 'city': 'Itoshima', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Nakamura Cardiovascular Clinic', 'geoPoint': {'lat': 33.54225, 'lon': 130.18421}}, {'zip': '670-8560', 'city': 'Himeji', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Hyogo Prefectural Harima-Himeji General Medical Center', 'geoPoint': {'lat': 34.81667, 'lon': 134.7}}, {'zip': '240-0116', 'city': 'Miura-gun', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Hayama Heart Center'}, {'zip': '596-0042', 'city': 'Kishiwada', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Kishiwada Tokushukai Hospital', 'geoPoint': {'lat': 34.46667, 'lon': 135.36667}}, {'zip': '581-0011', 'city': 'Yao', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Yao Tokushukai General Hospital', 'geoPoint': {'lat': 34.61667, 'lon': 135.6}}, {'zip': '123-0845', 'city': 'Adachi-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Nishiarai Heart Central Clinic'}, {'zip': '192-0918', 'city': 'Hachiōji', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Minamino Cardiovascular Hospital', 'geoPoint': {'lat': 35.65583, 'lon': 139.32389}}, {'zip': '193-0811', 'city': 'Hachiōji', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo Angel Hospital', 'geoPoint': {'lat': 35.65583, 'lon': 139.32389}}, {'zip': '136-0072', 'city': 'Koto-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Koto Hospital'}, {'zip': 'LV-5401', 'city': 'Daugavpils', 'country': 'Latvia', 'facility': "Doctor's Practice in Cardiology", 'geoPoint': {'lat': 55.88333, 'lon': 26.53333}}, {'zip': 'LV-5417', 'city': 'Daugavpils', 'country': 'Latvia', 'facility': 'Daugavpils Regional Hospital', 'geoPoint': {'lat': 55.88333, 'lon': 26.53333}}, {'zip': 'LV-3414', 'city': 'Liepāja', 'country': 'Latvia', 'facility': 'Liepaja Regional Hospital', 'geoPoint': {'lat': 56.50474, 'lon': 21.01085}}, {'zip': 'LV-1001', 'city': 'Riga', 'country': 'Latvia', 'facility': '1st Riga Clinical Hospital', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': 'LV-1002', 'city': 'Riga', 'country': 'Latvia', 'facility': 'P. Stradins Clinical University Hospital', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': 'LV-1038', 'city': 'Riga', 'country': 'Latvia', 'facility': 'Riga East Clinical University Hospital "Gailezers"', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academisch Medisch Centrum (AMC)', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '6815 AD', 'city': 'Arnhem', 'country': 'Netherlands', 'facility': 'Ziekenhuis Rijnstate', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}, {'zip': '4818 CK', 'city': 'Breda', 'country': 'Netherlands', 'facility': 'Amphia Ziekenhuis, locatie Molengracht', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'zip': '3318 AT', 'city': 'Dordrecht', 'country': 'Netherlands', 'facility': 'Albert Schweitzer Ziekenhuis, Dordwijk', 'geoPoint': {'lat': 51.81, 'lon': 4.67361}}, {'zip': '7511 JX', 'city': 'Enschede', 'country': 'Netherlands', 'facility': 'Medisch Spectrum Twente', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}, {'zip': '9728 NT', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Martini Ziekenhuis, Locatie van Swieten', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '2035 RC', 'city': 'Haarlem', 'country': 'Netherlands', 'facility': 'Spaarne Gasthuis - locatie Zuid', 'geoPoint': {'lat': 52.38084, 'lon': 4.63683}}, {'zip': '6229 HX', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht UMC', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Ciutat Sanitària i Universitària de Bellvitge', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Ciutat Sanitària i Universitaria de la Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08041', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i de Sant Pau | Cardiología', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '791 82', 'city': 'Falun', 'country': 'Sweden', 'facility': 'Falu Lasarett', 'geoPoint': {'lat': 60.60357, 'lon': 15.62597}}, {'zip': '222 21', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Clemenstorget Hjärtmottagning', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'zip': '703 62', 'city': 'Örebro', 'country': 'Sweden', 'facility': 'Avdelningen för kliniska prövningar AKP', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}, {'zip': '831 83', 'city': 'Östersund', 'country': 'Sweden', 'facility': 'Östersunds Sjukhus', 'geoPoint': {'lat': 63.1792, 'lon': 14.63566}}, {'zip': '931 86', 'city': 'Skellefteå', 'country': 'Sweden', 'facility': 'Skellefteå Lasarett', 'geoPoint': {'lat': 64.75067, 'lon': 20.95279}}, {'zip': '118 83', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Södersjukhuset AB', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '182 88', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Danderyds sjukhus', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '5001', 'city': 'Aarau', 'state': 'Canton of Aargau', 'country': 'Switzerland', 'facility': 'Kantonsspital Aarau', 'geoPoint': {'lat': 47.39254, 'lon': 8.04422}}, {'zip': '4031', 'city': 'Basel', 'state': 'Canton of Basel-City', 'country': 'Switzerland', 'facility': 'Universitätsspital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '9007', 'city': 'Sankt Gallen', 'state': 'Canton of St. Gallen', 'country': 'Switzerland', 'facility': 'Kantonsspital St. Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselspital Universitätsspital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': '1211', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Hôpital Cantonal Universitaire de Genève', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'zip': '6900', 'city': 'Lugano', 'country': 'Switzerland', 'facility': 'Ospedale regionale di Lugano', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}, {'zip': 'CB7 5SQ', 'city': 'Ely', 'state': 'Cambridgeshire', 'country': 'United Kingdom', 'facility': 'Staploe Medical Centre', 'geoPoint': {'lat': 52.39964, 'lon': 0.26196}}, {'zip': 'AL7 4HQ', 'city': 'Welwyn Garden City', 'state': 'Hertfordshire', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth II Hospital', 'geoPoint': {'lat': 51.80174, 'lon': -0.20691}}, {'zip': 'HA1 3UJ', 'city': 'Harrow', 'state': 'London', 'country': 'United Kingdom', 'facility': 'Northwick Park Hospital', 'geoPoint': {'lat': 51.57835, 'lon': -0.33208}}, {'zip': 'PO19 6SE', 'city': 'Chichester', 'state': 'West Sussex', 'country': 'United Kingdom', 'facility': "St Richard's Hospital", 'geoPoint': {'lat': 50.83673, 'lon': -0.78003}}, {'zip': 'L14 3PE', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Heart and Chest Hospital', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Availability of this study\'s data will later be determined according to Bayer\'s commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.\n\nAs such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.\n\nInterested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}