Viewing Study NCT01492361

Home

Certify Doc

Genes

Clinical Trials

CompTox

DrugMatrix

Open Targets

Products

Support

Bugs

Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 12:07 PM

Ignite Modification Date: 2025-12-31 @ 8:28 PM

Study NCT ID: NCT01492361

Status: COMPLETED

Last Update Posted: 2022-04-14

First Post: 2011-12-13

Is Gene Therapy: True

Has Adverse Events: True

Brief Title: A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D015228', 'term': 'Hypertriglyceridemia'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C035276', 'term': 'eicosapentaenoic acid ethyl ester'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alex.giaquinto@amarincorp.com', 'phone': '908-326-1324', 'title': 'Dr. Alexander Giaquinto, Executive Director, Regulatory Affairs', 'organization': 'Amarin Pharma, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.', 'description': 'Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'AMR101', 'description': 'AMR101: Parallel Assignment', 'otherNumAtRisk': 4089, 'deathsNumAtRisk': 4089, 'otherNumAffected': 3268, 'seriousNumAtRisk': 4089, 'deathsNumAffected': 274, 'seriousNumAffected': 1252}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo: Parallel Assignment', 'otherNumAtRisk': 4090, 'deathsNumAtRisk': 4090, 'otherNumAffected': 3248, 'seriousNumAtRisk': 4090, 'deathsNumAffected': 310, 'seriousNumAffected': 1254}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 178}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 224}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 230}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 205}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 363}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 450}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 216}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 142}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 264}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 201}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 227}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 195}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 226}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 240}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 314}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 300}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 311}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 315}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 295}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 292}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 261}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 267}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 240}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 246}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 322}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 303}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 309}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 306}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 232}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 239}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 227}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 238}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 243}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 233}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 241}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 241}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 312}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 333}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 105}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 118}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 31}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Arthritis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Intervertebral discitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Infective exacerbation of chronic obstructive airways disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Liver abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Meningitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Necrotising fasciitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Parainfluenzae virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Perirectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pneumococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pneumonia streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Abscess intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Implant site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pneumonia staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Bronchitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gastroenteritis rotavirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pneumonia influenzal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pneumonia pseudomonal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Postoperative abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Streptococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Tracheobronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Acquired immunodeficiency syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Bronchitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Campylobacter gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Catheter site cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cellulitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cystitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cystitis escherichia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cytomegalovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Dengue fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Device related sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Diabetic foot infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Diarrhoea infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Epiglottitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gastrointestinal bacterial overgrowth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Genital infection fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Graft infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Groin abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hepatitis C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Incision site abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Infected skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Infectious colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Infective exacerbation of bronchiectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Joint abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Keratitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Latent tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Lower respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Mastitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Mycobacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Parotitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Peritonitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pharyngolaryngeal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pilonidal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Post procedural infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Rectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Shunt infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Subacute endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Systemic candida', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Tick-borne fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Viral sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Vulval cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Wound sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Orchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Rotavirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Abdominal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Abdominal wall abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Bacterial sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Biliary abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Breast abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Bursitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cholecystitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Diverticulitis intestinal haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Enterococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Epididymitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gas gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'H1N1 influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Helicobacter gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hepatitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Klebsiella infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Listeriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Neutropenic sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Osteomyelitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Parasitic gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pelvic abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pharyngeal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pneumonia respiratory syncytial viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Post procedural cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pseudomembranous colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pseudomonas infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pyelocystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Rhinovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Sepsis syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Sialoadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Streptococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Streptococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Wound abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Wound infection staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 26}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 8}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 14}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 9}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 9}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Prostate cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Bladder transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pancreatic carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Squamous cell carcinoma of lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Metastases to liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Bladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cancer pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hepatic cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Metastases to lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Non-small cell lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Colon cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Endometrial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': "Non-Hodgkin's lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Prostate cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Rectal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Breast cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cervix carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Metastases to bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Parathyroid tumour benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Renal cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Bladder cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Breast cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Chronic lymphocytic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Malignant melanoma in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Metastatic renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Renal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Colon adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Acute myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Colon neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Bone cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Colon cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Colorectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Endometrial adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gastrointestinal stromal tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Lipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Metastases to peritoneum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Metastatic carcinoma of the bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Mucinous adenocarcinoma of appendix', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Oesophageal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pancreatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Plasma cell myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Prostatic adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Thyroid cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Uterine cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Adenocarcinoma gastric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Anal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Benign neoplasm of thyroid gland', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Breast cancer male', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cervix neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cholangiocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cholesteatoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Colorectal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Diffuse large B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Endometrial cancer stage I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Extranodal marginal zone B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gastrointestinal stromal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Iris melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Large cell lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Large intestine benign neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Leiomyosarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Lung adenocarcinoma stage IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Lung carcinoma cell type unspecified recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Malignant glioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Metastases to abdominal cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Metastases to chest wall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Metastases to kidney', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Metastasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Metastatic gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Metastatic squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Nasal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Oesophageal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Oropharyngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Ovarian epithelial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Ovarian granulosa-theca cell tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pituitary tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pleural mesothelioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Salivary gland adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Small cell lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Small intestine carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Testis cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Transitional cell cancer of the renal pelvis and ureter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Tumour ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Breast cancer stage I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Clear cell renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Laryngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Lymphocytic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Acute lymphocytic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Adenoid cystic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Adrenal adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Adrenal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Anal squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Bladder cancer stage III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Central nervous system neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Colorectal cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Duodenal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Endometrial cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gastric adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gastric cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gastric neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gastrointestinal tract adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hepatic cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Intraductal proliferative breast lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Lip and/or oral cavity cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Lung adenocarcinoma stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Malignant mesenteric neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Metastases to lymph nodes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Metastatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Mucoepidermoid carcinoma of salivary gland', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Neuroendocrine carcinoma of the skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Neuroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Nodular melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Non-small cell lung cancer stage III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Non-small cell lung cancer stage IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Oesophageal cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Ovarian adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Ovarian cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Ovarian epithelial cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Ovarian neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Penile cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Prostate cancer stage IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Rectal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Refractory anaemia with ringed sideroblasts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Refractory cytopenia with unilineage dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Retroperitoneal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Schwannoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Skin cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Squamous cell carcinoma of pharynx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Throat cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Tongue cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Tonsil cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Transitional cell carcinoma recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Urethral cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 48}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 53}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 17}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 16}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Ischaemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Ventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Supraventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cardiac valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cor pulmonale chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hypertensive heart disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pleuropericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Ventricular parasystole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Arteriospasm coronary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Silent myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Aortic valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Aortic valve disease mixed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cardiac ventricular thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Congestive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Coronary artery dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Microvascular coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pericardial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Stress cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Tachycardia paroxysmal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Diverticulum intestinal haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Diverticulum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Obstructive pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Intestinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Anal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Peptic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Duodenal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pancreatitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Retroperitoneal fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gastric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Diverticular perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Diverticulum intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Faeces discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gastric polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Large intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Peritoneal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Appendix disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Chronic gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Duodenogastric reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gastric antral vascular ectasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gastrointestinal angiodysplasia haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gastrointestinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Intra-abdominal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Mallory-Weiss syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pancreatic cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pancreatitis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Peptic ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Peritoneal adhesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pharyngo-oesophageal diverticulum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Proctitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Rectal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Retroperitoneal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Subileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Thrombosis mesenteric vessel', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Volvulus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gastrointestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Impaired gastric emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Abdominal adhesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Abdominal hernia obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Duodenal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Duodenitis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Enterovesical fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Epigastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gastric perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gastric ulcer perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gastroduodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gastrointestinal angiodysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gastrointestinal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Mesenteric arterial occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Mouth haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Oesophageal food impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Oesophageal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Oesophageal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pancreatic mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Portal hypertensive gastropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Rectal polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Retroperitoneal haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Strangulated umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 73}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Spondylolisthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Foot deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Intervertebral disc degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cervical spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Vertebral foraminal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Polymyalgia rheumatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pseudarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gouty arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Intervertebral disc compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Knee deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Mandibular mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Mobility decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Osteochondrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pathological fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Periarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Rheumatic fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Soft tissue mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Sympathetic posterior cervical syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Synovial cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Costochondritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Exostosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Back disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Coccydynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gouty tophus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Haemarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Joint range of motion decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pain in jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Systemic lupus erythematosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Temporomandibular joint syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 34}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 22}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Bronchial hyperreactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Nasal polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Respiratory acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Bronchitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pharyngeal mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pneumomediastinum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Status asthmaticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Bronchiectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Bronchial fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hypercapnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Nasal septum deviation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Nasal turbinate hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Tracheal mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 15}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Incisional hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Multiple injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Ligament injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Postoperative ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Subdural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Thoracic vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Traumatic haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Clavicle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Muscle rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Postoperative fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Postoperative hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Craniocerebral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Fractured sacrum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Post procedural discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Post procedural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Post procedural swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Avulsion fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Bone fragmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cartilage injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Chest injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Dislocation of sternum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Foreign body in gastrointestinal tract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Incarcerated incisional hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Multiple fractures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Muscle injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Periprosthetic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Post laminectomy syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Post procedural pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Postoperative adhesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Postoperative renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Postoperative thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Radiation oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Spinal cord injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Traumatic liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Alcohol poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Brain contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Jaw fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Stomal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Anaemia postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Axillary nerve injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Back injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Carbon monoxide poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cervical vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Forearm fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gastrointestinal stoma complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Heat stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Oesophageal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Poisoning deliberate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Post procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Post procedural haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Procedural hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pubis fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Radiation injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Sciatic nerve injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Skull fractured base', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Spinal column injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Stress fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Traumatic intracranial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Traumatic renal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Ureteric anastomosis complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Urethral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Vascular pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 66}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 52}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Systemic inflammatory response syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Complication associated with device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Drowning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Generalised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Vascular stent restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Exercise tolerance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Incarcerated hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Catheter site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pelvic mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Suprapubic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 34}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 12}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Renal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Urethral stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'End stage renal disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cystitis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Bladder outlet obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Stress urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Bladder neck obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Urinary bladder haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Bladder stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Renal artery fibromuscular dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Renal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Renal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Tubulointerstitial nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Ureteric dilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Ureteric stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Urethral meatus stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Calculus bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Acute prerenal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Bladder dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Bladder prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Diabetic nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hypertonic bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Nephropathy toxic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Renal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Stag horn calculus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Urinary bladder polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 31}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Metabolic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cervical radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Intracranial aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Lumbar radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': "Dementia Alzheimer's type", 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Facial paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hypertensive encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Transient global amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Unresponsive to stimuli', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Brain injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Carotid artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cerebrospinal fluid leakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cognitive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Dural arteriovenous fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Haemorrhagic transformation stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'IIIrd nerve paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Intracranial mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Nerve compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Neurodegenerative disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Neurological symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pseudoradicular syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Quadriplegia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Radicular syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Sensory ganglionitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Speech disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Toxic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Trigeminal nerve disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Vasogenic cerebral oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Vocal cord paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hypoxic-ischaemic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Acute disseminated encephalomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Altered state of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Amyotrophic lateral sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Autonomic nervous system imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Carotid artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Demyelinating polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Diabetic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hypoglycaemic coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hypoglycaemic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hypoglycaemic unconsciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Multiple sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Multiple sclerosis relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Myelopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Reversible ischaemic neurological deficit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Spinal cord herniation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Trigeminal neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Vascular dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Obesity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Lactic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hyperglycaemic hyperosmolar nonketotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Shock hypoglycaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Tumour lysis syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Diabetic metabolic decompensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Electrolyte imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hypernatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hyperosmolar state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Iron deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 16}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Accelerated hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Aortic aneurysm rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Intermittent claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Angiodysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Arteriovenous fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Embolism arterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Extravasation blood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Iliac artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Malignant hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Peripheral embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Renovascular hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Vena cava thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Blood pressure fluctuation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Extremity necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Leriche syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Temporal arteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 18}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 7}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 7}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Jaundice cholestatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Ischaemic hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Alcoholic liver disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cryptogenic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gallbladder polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gallbladder disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gallbladder enlargement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Biliary dilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cholestasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Non-alcoholic steatohepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 20}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Haemorrhagic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Lymphoid tissue hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Normocytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Thrombotic microangiopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Autoimmune haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Splenic infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Immune thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Microcytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pernicious anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 11}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Prostatomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Adnexa uteri mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Genital haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pelvic prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': "Peyronie's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Prostatism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Vaginal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Uterine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Endometrial hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Endometrial hypoplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Female genital tract fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Ovarian cyst ruptured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Seminal vesicular cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Testicular cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Uterine prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Alcohol abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Alcohol withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Agitated depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Delirium tremens', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Schizoaffective disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Acute psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Alcoholism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Diabetic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Dermal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Granuloma annulare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Photosensitivity reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Rash erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Panniculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Knee arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Implantable defibrillator insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Lung lobectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Aortic valve replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Artificial urinary sphincter implant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Polypectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Rotator cuff repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Shoulder operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Stem cell transplant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Transurethral prostatectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cardiac ablation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Spinal operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Endotracheal intubation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Gastric bypass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Large intestinal polypectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Transurethral bladder resection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Troponin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Arteriogram coronary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Ejection fraction decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Biopsy pleura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Prostatic specific antigen increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Influenza A virus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Anticoagulation drug level above therapeutic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Blood pressure difference of extremities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cardiac murmur', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Ejection fraction abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Electrocardiogram T wave abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Influenza virus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Eyelid ptosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Retinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Eye swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Retinal vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Retinal artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Chalazion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 8}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 5}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Vestibular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Inner ear disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Sudden hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Device malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Device breakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Device failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Device occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Thyroid mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 4}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': "Addison's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Inappropriate antidiuretic hormone secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Toxic nodular goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Anaphylactic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Allergy to arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Sarcoidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Hypertrophic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}, {'term': 'Pancreas divisum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4089, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4090, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Composite of CV Death, Nonfatal MI (Including Silent MI), Nonfatal Stroke, Coronary Revascularization, or Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4089', 'groupId': 'OG000'}, {'value': '4090', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AMR101', 'description': 'AMR101: Parallel Assignment'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Parallel Assignment'}], 'classes': [{'categories': [{'measurements': [{'value': '705', 'groupId': 'OG000'}, {'value': '901', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.00000001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.68', 'ciUpperLimit': '0.83', 'pValueComment': "The 2-sided alpha level for the primary analysis was adjusted to 0.0437 from 0.05 to account for the two interim analyses based on a group sequential design with O'Brien-Fleming boundaries generated using the Lan-DeMets alpha-spending function.", 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by CV risk category, use of ezetimibe, and geographical region'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Total follow-up time of up to approximately 6 years.', 'description': 'The primary outcome measure was the number of patients with a first occurrence of any component of the composite of CV death, nonfatal MI (including silent MI), nonfatal stroke, coronary revascularization, or unstable angina determined to be caused by myocardial ischemia by invasive / non-invasive testing and requiring emergent hospitalization during the follow-up period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Composite of CV Death, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4089', 'groupId': 'OG000'}, {'value': '4090', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AMR101', 'description': 'AMR101: Parallel Assignment'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Parallel Assignment'}], 'classes': [{'categories': [{'measurements': [{'value': '459', 'groupId': 'OG000'}, {'value': '606', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0000006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.65', 'ciUpperLimit': '0.83', 'pValueComment': 'Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by CV risk category, use of ezetimibe, and geographical region.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Total follow-up time of up to approximately 6 years.', 'description': 'The key secondary outcome measure was the number of patients with a first occurrence of any component of the composite of CV death, nonfatal MI (including silent MI), or nonfatal stroke during the follow-up period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Composite of CV Death or Nonfatal MI (Including Silent MI).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4089', 'groupId': 'OG000'}, {'value': '4090', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AMR101', 'description': 'AMR101: Parallel Assignment'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Parallel Assignment'}], 'classes': [{'categories': [{'measurements': [{'value': '392', 'groupId': 'OG000'}, {'value': '507', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.66', 'ciUpperLimit': '0.86', 'pValueComment': 'Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by CV risk category, use of ezetimibe, and geographical region.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Total follow-up time of up to approximately 6 years.', 'description': 'Number of patients with a first occurrence of any component of the composite of CV death or nonfatal MI (including silent MI) during the follow-up period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fatal or Nonfatal MI (Including Silent MI).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4089', 'groupId': 'OG000'}, {'value': '4090', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AMR101', 'description': 'AMR101: Parallel Assignment'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Parallel Assignment'}], 'classes': [{'categories': [{'measurements': [{'value': '250', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.58', 'ciUpperLimit': '0.81', 'pValueComment': 'Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by CV risk category, use of ezetimibe, and geographical region.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Total follow-up time of up to approximately 6 years.', 'description': 'Number of patients with a first occurrence of fatal or nonfatal MI (including silent MI) during the follow-up period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Non-elective Coronary Revascularization Represented as the Composite of Emergent or Urgent Classifications.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4089', 'groupId': 'OG000'}, {'value': '4090', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AMR101', 'description': 'AMR101: Parallel Assignment'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Parallel Assignment'}], 'classes': [{'categories': [{'measurements': [{'value': '216', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.65', 'ciLowerLimit': '0.55', 'ciUpperLimit': '0.78', 'pValueComment': 'Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by CV risk category, use of ezetimibe, and geographical region.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Total follow-up time of up to approximately 6 years.', 'description': 'Number of patients with a first occurrence of non-elective coronary revascularization represented as the composite of emergent or urgent classifications during the follow-up period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'CV Death.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4089', 'groupId': 'OG000'}, {'value': '4090', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AMR101', 'description': 'AMR101: Parallel Assignment'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Parallel Assignment'}], 'classes': [{'categories': [{'measurements': [{'value': '174', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0315', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.66', 'ciUpperLimit': '0.98', 'pValueComment': 'Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by CV risk category, use of ezetimibe, and geographical region.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Total follow-up time of up to approximately 6 years.', 'description': 'Number of patients with an occurrence of CV death during the follow-up period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4089', 'groupId': 'OG000'}, {'value': '4090', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AMR101', 'description': 'AMR101: Parallel Assignment'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Parallel Assignment'}], 'classes': [{'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0018', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.53', 'ciUpperLimit': '0.87', 'pValueComment': 'Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by CV risk category, use of ezetimibe, and geographical region.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Total follow-up time of up to approximately 6 years.', 'description': 'Number of patients with a first occurrence of unstable angina determined to be caused by myocardial ischemia by invasive / non-invasive testing and requiring emergent hospitalization during the follow-up period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fatal or Nonfatal Stroke.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4089', 'groupId': 'OG000'}, {'value': '4090', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AMR101', 'description': 'AMR101: Parallel Assignment'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Parallel Assignment'}], 'classes': [{'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0129', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.55', 'ciUpperLimit': '0.93', 'pValueComment': 'Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by CV risk category, use of ezetimibe, and geographical region.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Total follow-up time of up to approximately 6 years.', 'description': 'Number of patients with a first occurrence of fatal or nonfatal stroke during the follow-up period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Mortality, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4089', 'groupId': 'OG000'}, {'value': '4090', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AMR101', 'description': 'AMR101: Parallel Assignment'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Parallel Assignment'}], 'classes': [{'categories': [{'measurements': [{'value': '549', 'groupId': 'OG000'}, {'value': '690', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.69', 'ciUpperLimit': '0.86', 'pValueComment': 'Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by CV risk category, use of ezetimibe, and geographical region.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Total follow-up time of up to approximately 6 years.', 'description': 'Number of patients with a first occurrence of any component of the composite of total mortality, nonfatal MI (including silent MI), or nonfatal stroke during the follow-up period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Mortality.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4089', 'groupId': 'OG000'}, {'value': '4090', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AMR101', 'description': 'AMR101: Parallel Assignment'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Parallel Assignment'}], 'classes': [{'categories': [{'measurements': [{'value': '274', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0915', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.02', 'pValueComment': 'Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by CV risk category, use of ezetimibe, and geographical region.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Total follow-up time of up to approximately 6 years.', 'description': 'Number of patients with an occurrence of death from any cause during the follow-up period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AMR101', 'description': 'AMR101: Parallel Assignment'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo: Parallel Assignment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4089'}, {'groupId': 'FG001', 'numSubjects': '4090'}]}, {'type': 'Completed Final Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3419'}, {'groupId': 'FG001', 'numSubjects': '3335'}]}, {'type': 'Death Before Final Visit', 'comment': 'Participants who died on trial were considered completed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '265'}, {'groupId': 'FG001', 'numSubjects': '295'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3684'}, {'groupId': 'FG001', 'numSubjects': '3630'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '405'}, {'groupId': 'FG001', 'numSubjects': '460'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '281'}, {'groupId': 'FG001', 'numSubjects': '297'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Other than specified above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '138'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4089', 'groupId': 'BG000'}, {'value': '4090', 'groupId': 'BG001'}, {'value': '8179', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AMR101', 'description': 'AMR101: Parallel Assignment'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo: Parallel Assignment'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.0', 'groupId': 'BG000', 'lowerLimit': '57.0', 'upperLimit': '69.0'}, {'value': '64.0', 'groupId': 'BG001', 'lowerLimit': '57.0', 'upperLimit': '69.0'}, {'value': '64.0', 'groupId': 'BG002', 'lowerLimit': '57.0', 'upperLimit': '69.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1162', 'groupId': 'BG000'}, {'value': '1195', 'groupId': 'BG001'}, {'value': '2357', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2927', 'groupId': 'BG000'}, {'value': '2895', 'groupId': 'BG001'}, {'value': '5822', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '3691', 'groupId': 'BG000'}, {'value': '3688', 'groupId': 'BG001'}, {'value': '7379', 'groupId': 'BG002'}]}, {'title': 'Other than white', 'measurements': [{'value': '398', 'groupId': 'BG000'}, {'value': '401', 'groupId': 'BG001'}, {'value': '799', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'New Zealand', 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '847', 'groupId': 'BG000'}, {'value': '831', 'groupId': 'BG001'}, {'value': '1678', 'groupId': 'BG002'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '1548', 'groupId': 'BG000'}, {'value': '1598', 'groupId': 'BG001'}, {'value': '3146', 'groupId': 'BG002'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '397', 'groupId': 'BG000'}, {'value': '439', 'groupId': 'BG001'}, {'value': '836', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '195', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '359', 'groupId': 'BG002'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '213', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '414', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '262', 'groupId': 'BG002'}]}]}, {'title': 'Russia', 'categories': [{'measurements': [{'value': '352', 'groupId': 'BG000'}, {'value': '357', 'groupId': 'BG001'}, {'value': '709', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Cardiovascular Risk Stratum', 'classes': [{'categories': [{'title': 'Secondary-prevention cohort', 'measurements': [{'value': '2892', 'groupId': 'BG000'}, {'value': '2893', 'groupId': 'BG001'}, {'value': '5785', 'groupId': 'BG002'}]}, {'title': 'Primary-prevention cohort', 'measurements': [{'value': '1197', 'groupId': 'BG000'}, {'value': '1197', 'groupId': 'BG001'}, {'value': '2394', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-07-08', 'size': 4851566, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-03-15T16:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8179}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'dispFirstSubmitDate': '2019-06-04', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-21', 'studyFirstSubmitDate': '2011-12-13', 'dispFirstSubmitQcDate': '2019-06-04', 'resultsFirstSubmitDate': '2022-02-08', 'studyFirstSubmitQcDate': '2011-12-13', 'dispFirstPostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-21', 'studyFirstPostDateStruct': {'date': '2011-12-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of CV Death, Nonfatal MI (Including Silent MI), Nonfatal Stroke, Coronary Revascularization, or Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization.', 'timeFrame': 'Total follow-up time of up to approximately 6 years.', 'description': 'The primary outcome measure was the number of patients with a first occurrence of any component of the composite of CV death, nonfatal MI (including silent MI), nonfatal stroke, coronary revascularization, or unstable angina determined to be caused by myocardial ischemia by invasive / non-invasive testing and requiring emergent hospitalization during the follow-up period.'}], 'secondaryOutcomes': [{'measure': 'Composite of CV Death, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.', 'timeFrame': 'Total follow-up time of up to approximately 6 years.', 'description': 'The key secondary outcome measure was the number of patients with a first occurrence of any component of the composite of CV death, nonfatal MI (including silent MI), or nonfatal stroke during the follow-up period.'}, {'measure': 'Composite of CV Death or Nonfatal MI (Including Silent MI).', 'timeFrame': 'Total follow-up time of up to approximately 6 years.', 'description': 'Number of patients with a first occurrence of any component of the composite of CV death or nonfatal MI (including silent MI) during the follow-up period.'}, {'measure': 'Fatal or Nonfatal MI (Including Silent MI).', 'timeFrame': 'Total follow-up time of up to approximately 6 years.', 'description': 'Number of patients with a first occurrence of fatal or nonfatal MI (including silent MI) during the follow-up period.'}, {'measure': 'Non-elective Coronary Revascularization Represented as the Composite of Emergent or Urgent Classifications.', 'timeFrame': 'Total follow-up time of up to approximately 6 years.', 'description': 'Number of patients with a first occurrence of non-elective coronary revascularization represented as the composite of emergent or urgent classifications during the follow-up period.'}, {'measure': 'CV Death.', 'timeFrame': 'Total follow-up time of up to approximately 6 years.', 'description': 'Number of patients with an occurrence of CV death during the follow-up period.'}, {'measure': 'Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization.', 'timeFrame': 'Total follow-up time of up to approximately 6 years.', 'description': 'Number of patients with a first occurrence of unstable angina determined to be caused by myocardial ischemia by invasive / non-invasive testing and requiring emergent hospitalization during the follow-up period.'}, {'measure': 'Fatal or Nonfatal Stroke.', 'timeFrame': 'Total follow-up time of up to approximately 6 years.', 'description': 'Number of patients with a first occurrence of fatal or nonfatal stroke during the follow-up period.'}, {'measure': 'Total Mortality, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.', 'timeFrame': 'Total follow-up time of up to approximately 6 years.', 'description': 'Number of patients with a first occurrence of any component of the composite of total mortality, nonfatal MI (including silent MI), or nonfatal stroke during the follow-up period.'}, {'measure': 'Total Mortality.', 'timeFrame': 'Total follow-up time of up to approximately 6 years.', 'description': 'Number of patients with an occurrence of death from any cause during the follow-up period.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Coronary Artery Disease', 'Myocardial Ischemia', 'Coronary Disease', 'Heart Diseases', 'Acute Coronary Syndrome', 'Cardiovascular Diseases', 'Arteriosclerosis', 'Arterial Occlusive Diseases', 'Vascular Diseases', 'Angina Pectoris', 'Chest Pain', 'Anticholesteremic Agents', 'Hypolipidemic Agents', 'Lipid Regulating Agents', 'Hypertriglyceridemia', 'Omega-3 Fatty Acids', 'Statin', 'Triglycerides', 'EPA', 'Docosahexaenoic Acid', 'Fish', 'Fatty acids', 'Fibrates', 'Niacin', 'Lipids', 'Lipoprotein', 'Atorvastatin', 'Lovaza', 'Simvastatin', 'Lovastatin', 'Pravastatin', 'Fluvastatin', 'Rosuvastatin', 'Trilipix', 'Vytorin', 'Simcor', 'Ezetimibe', 'Zetia', 'Ethyl-EPA', 'Ethyl Icosapentate', 'Crestor', 'Zocor', 'Lipitor', 'LDL', 'HDL', 'Cholesterol', 'Dyslipidemia', 'AMR101', 'Cardiovascular Disease, Unspecified', 'VASCEPA', 'Icosapent Ethyl'], 'conditions': ['Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '28294373', 'type': 'BACKGROUND', 'citation': 'Bhatt DL, Steg PG, Brinton EA, Jacobson TA, Miller M, Tardif JC, Ketchum SB, Doyle RT Jr, Murphy SA, Soni PN, Braeckman RA, Juliano RA, Ballantyne CM; REDUCE-IT Investigators. Rationale and design of REDUCE-IT: Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial. Clin Cardiol. 2017 Mar;40(3):138-148. doi: 10.1002/clc.22692. Epub 2017 Mar 15.'}, {'pmid': '30415628', 'type': 'RESULT', 'citation': 'Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Doyle RT Jr, Juliano RA, Jiao L, Granowitz C, Tardif JC, Ballantyne CM; REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019 Jan 3;380(1):11-22. doi: 10.1056/NEJMoa1812792. Epub 2018 Nov 10.'}, {'pmid': '30898607', 'type': 'RESULT', 'citation': 'Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Doyle RT Jr, Juliano RA, Jiao L, Granowitz C, Tardif JC, Gregson J, Pocock SJ, Ballantyne CM; REDUCE-IT Investigators. Effects of Icosapent Ethyl on Total Ischemic Events: From REDUCE-IT. J Am Coll Cardiol. 2019 Jun 11;73(22):2791-2802. doi: 10.1016/j.jacc.2019.02.032. Epub 2019 Mar 18.'}, {'pmid': '31707829', 'type': 'RESULT', 'citation': 'Bhatt DL, Miller M, Brinton EA, Jacobson TA, Steg PG, Ketchum SB, Doyle RT Jr, Juliano RA, Jiao L, Granowitz C, Tardif JC, Olshansky B, Chung MK, Gibson CM, Giugliano RP, Budoff MJ, Ballantyne CM; REDUCE-IT Investigators. REDUCE-IT USA: Results From the 3146 Patients Randomized in the United States. Circulation. 2020 Feb 4;141(5):367-375. doi: 10.1161/CIRCULATIONAHA.119.044440. Epub 2019 Nov 11.'}, {'pmid': '33010162', 'type': 'RESULT', 'citation': 'Olshansky B, Bhatt DL, Miller M, Steg PG, Brinton EA, Jacobson TA, Ketchum SB, Doyle RT Jr, Juliano RA, Jiao L, Granowitz C, Tardif JC, Mehta C, Mukherjee R, Ballantyne CM, Chung MK; REDUCE-IT Investigators. REDUCE-IT INTERIM: accumulation of data across prespecified interim analyses to final results. Eur Heart J Cardiovasc Pharmacother. 2021 May 23;7(3):e61-e63. doi: 10.1093/ehjcvp/pvaa118. No abstract available.'}, {'pmid': '33148016', 'type': 'RESULT', 'citation': 'Peterson BE, Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Juliano RA, Jiao L, Doyle RT Jr, Granowitz C, Gibson CM, Pinto D, Giugliano RP, Budoff MJ, Tardif JC, Verma S, Ballantyne CM; REDUCE-IT Investigators. Reduction in Revascularization With Icosapent Ethyl: Insights From REDUCE-IT Revascularization Analyses. Circulation. 2021 Jan 5;143(1):33-44. doi: 10.1161/CIRCULATIONAHA.120.050276. Epub 2020 Nov 5.'}, {'pmid': '31439224', 'type': 'RESULT', 'citation': 'Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Jiao L, Tardif JC, Gregson J, Pocock SJ, Ballantyne CM; REDUCE-IT Investigators. Reduction in First and Total Ischemic Events With Icosapent Ethyl Across Baseline Triglyceride Tertiles. J Am Coll Cardiol. 2019 Aug 27;74(8):1159-1161. doi: 10.1016/j.jacc.2019.06.043. No abstract available.'}, {'pmid': '34620410', 'type': 'RESULT', 'citation': 'Gaba P, Bhatt DL, Giugliano RP, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Juliano RA, Jiao L, Doyle RT Jr, Granowitz C, Tardif JC, Ballantyne CM, Pinto DS, Budoff MJ, Gibson CM. Comparative Reductions in Investigator-Reported and Adjudicated Ischemic Events in REDUCE-IT. J Am Coll Cardiol. 2021 Oct 12;78(15):1525-1537. doi: 10.1016/j.jacc.2021.08.009.'}, {'pmid': '34706555', 'type': 'RESULT', 'citation': 'Majithia A, Bhatt DL, Friedman AN, Miller M, Steg PG, Brinton EA, Jacobson TA, Ketchum SB, Juliano RA, Jiao L, Doyle RT Jr, Granowitz C, Budoff M, Preston Mason R, Tardif JC, Boden WE, Ballantyne CM. Benefits of Icosapent Ethyl Across the Range of Kidney Function in Patients With Established Cardiovascular Disease or Diabetes: REDUCE-IT RENAL. Circulation. 2021 Nov 30;144(22):1750-1759. doi: 10.1161/CIRCULATIONAHA.121.055560. Epub 2021 Oct 28.'}, {'pmid': '34710343', 'type': 'RESULT', 'citation': 'Verma S, Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Dhingra NK, Ketchum SB, Juliano RA, Jiao L, Doyle RT Jr, Granowitz C, Gibson CM, Pinto D, Giugliano RP, Budoff MJ, Mason RP, Tardif JC, Ballantyne CM; REDUCE-IT Investigators. Icosapent Ethyl Reduces Ischemic Events in Patients With a History of Previous Coronary Artery Bypass Grafting: REDUCE-IT CABG. Circulation. 2021 Dec 7;144(23):1845-1855. doi: 10.1161/CIRCULATIONAHA.121.056290. Epub 2021 Oct 28.'}, {'pmid': '35027114', 'type': 'RESULT', 'citation': 'Singh N, Bhatt DL, Miller M, Steg PG, Brinton EA, Jacobson TA, Jiao L, Tardif JC, Mason RP, Ballantyne CM; REDUCE-IT Investigators. Consistency of Benefit of Icosapent Ethyl by Background Statin Type in REDUCE-IT. J Am Coll Cardiol. 2022 Jan 18;79(2):220-222. doi: 10.1016/j.jacc.2021.11.005. No abstract available.'}, {'pmid': '40982548', 'type': 'DERIVED', 'citation': 'Gurevitz C, Bhatt DL, Giugliano RP, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Lira Pineda A, Doyle RT Jr, Giugliano G, Mason RP, Tardif JC, Martens FMAC, Ballantyne CM, Budoff MJ, Gibson CM. Benefit of Icosapent Ethyl Across Types and Sizes of Myocardial Infarction in REDUCE-IT. Eur J Prev Cardiol. 2025 Sep 22:zwaf602. doi: 10.1093/eurjpc/zwaf602. Online ahead of print.'}, {'pmid': '39968782', 'type': 'DERIVED', 'citation': 'Aggarwal R, Bhatt DL, Steg PG, Miller M, Brinton EA, Dunbar RL, Ketchum SB, Tardif JC, Martens FMAC, Ballantyne CM, Szarek M, Mason RP; REDUCE-IT Investigators. Cardiovascular Outcomes With Icosapent Ethyl by Baseline Low-Density Lipoprotein Cholesterol: A Secondary Analysis of the REDUCE-IT Randomized Trial. J Am Heart Assoc. 2025 Mar 4;14(5):e038656. doi: 10.1161/JAHA.124.038656. Epub 2025 Feb 19.'}, {'pmid': '38156550', 'type': 'DERIVED', 'citation': 'Weintraub WS, Bhatt DL, Zhang Z, Dolman S, Boden WE, Bress AP, Bellows BK, Derington CG, Philip S, Steg G, Miller M, Brinton EA, Jacobson TA, Tardif JC, Ballantyne CM, Kolm P. Cost-Effectiveness of Icosapent Ethyl in REDUCE-IT USA: Results From Patients Randomized in the United States. J Am Heart Assoc. 2024 Jan 2;13(1):e032413. doi: 10.1161/JAHA.123.032413. Epub 2023 Dec 29.'}, {'pmid': '38035037', 'type': 'DERIVED', 'citation': 'Miller M, Bhatt DL, Brinton EA, Jacobson TA, Steg PG, Pineda AL, Ketchum SB, Doyle RT Jr, Tardif JC, Ballantyne CM. Effectiveness of icosapent ethyl on first and total cardiovascular events in patients with metabolic syndrome, but without diabetes: REDUCE-IT MetSyn. Eur Heart J Open. 2023 Nov 12;3(6):oead114. doi: 10.1093/ehjopen/oead114. eCollection 2023 Nov.'}, {'pmid': '36802845', 'type': 'DERIVED', 'citation': 'Olshansky B, Bhatt DL, Miller M, Steg PG, Brinton EA, Jacobson TA, Ketchum SB, Doyle RT Jr, Juliano RA, Jiao L, Kowey PR, Reiffel JA, Tardif JC, Ballantyne CM, Chung MK; REDUCE-IT Investigators. Cardiovascular Benefits of Icosapent Ethyl in Patients With and Without Atrial Fibrillation in REDUCE-IT. J Am Heart Assoc. 2023 Mar 7;12(5):e026756. doi: 10.1161/JAHA.121.026756. Epub 2023 Feb 21.'}, {'pmid': '35762321', 'type': 'DERIVED', 'citation': 'Ridker PM, Rifai N, MacFadyen J, Glynn RJ, Jiao L, Steg PG, Miller M, Brinton EA, Jacobson TA, Tardif JC, Ballantyne CM, Mason RP, Bhatt DL. Effects of Randomized Treatment With Icosapent Ethyl and a Mineral Oil Comparator on Interleukin-1beta, Interleukin-6, C-Reactive Protein, Oxidized Low-Density Lipoprotein Cholesterol, Homocysteine, Lipoprotein(a), and Lipoprotein-Associated Phospholipase A2: A REDUCE-IT Biomarker Substudy. Circulation. 2022 Aug 2;146(5):372-379. doi: 10.1161/CIRCULATIONAHA.122.059410. Epub 2022 Jun 28.'}, {'pmid': '35483753', 'type': 'DERIVED', 'citation': 'Gaba P, Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Juliano RA, Jiao L, Doyle RT Jr, Granowitz C, Tardif JC, Giugliano RP, Martens FMAC, Gibson CM, Ballantyne CM; REDUCE-IT Investigators. Prevention of Cardiovascular Events and Mortality With Icosapent Ethyl in Patients With Prior Myocardial Infarction. J Am Coll Cardiol. 2022 May 3;79(17):1660-1671. doi: 10.1016/j.jacc.2022.02.035.'}, {'pmid': '35377160', 'type': 'DERIVED', 'citation': 'Selvaraj S, Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Juliano RA, Jiao L, Tardif JC, Ballantyne CM; REDUCE-IT Investigators. Impact of Icosapent Ethyl on Cardiovascular Risk Reduction in Patients With Heart Failure in REDUCE-IT. J Am Heart Assoc. 2022 Apr 5;11(7):e024999. doi: 10.1161/JAHA.121.024999. Epub 2022 Apr 4.'}, {'pmid': '35261279', 'type': 'DERIVED', 'citation': 'Peterson BE, Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Juliano RA, Jiao L, Doyle RT Jr, Granowitz C, Gibson CM, Pinto D, Giugliano RP, Budoff MJ, Tardif JC, Verma S, Ballantyne CM; REDUCE-IT Investigators. Treatment With Icosapent Ethyl to Reduce Ischemic Events in Patients With Prior Percutaneous Coronary Intervention: Insights From REDUCE-IT PCI. J Am Heart Assoc. 2022 Mar 15;11(6):e022937. doi: 10.1161/JAHA.121.022937. Epub 2022 Mar 9.'}]}, 'descriptionModule': {'briefSummary': 'AMR101 (icosapent ethyl \\[ethyl-EPA\\]) is a highly purified ethyl ester of eicosapentaenoic acid (EPA) developed by Amarin Pharma Inc. for the treatment of cardiovascular disease in statin-treated patients with hypertriglyceridemia. The purpose of this study was to evaluate whether this drug, combined with a statin therapy, will be superior to the statin therapy alone, when used as a prevention in reducing long-term cardiovascular events in high-risk patients with mixed dyslipidemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and non-pregnant or sterile women ages 45 and older\n* Hypertriglyceridemia\n* On statin therapy for at least four weeks\n* Either having established cardiovascular disease or at high risk for cardiovascular disease\n\nExclusion Criteria:\n\n* Severe heart failure\n* Any life-threatening disease other than cardiovascular disease\n* Active severe liver disease\n* Hemoglobin A1c \\>10.0%\n* Poorly controlled hypertension\n* Planned coronary intervention (such as stent placement or heart bypass) or any non-cardiac major surgical procedure\n* Known familial lipoprotein lipase deficiency (Fredrickson Type I), apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia (Fredrickson Type III)\n* Known hypersensitivity to the study product, fish and/or shellfish, or placebo\n* History of acute or chronic pancreatitis\n* Patients are excluded if using the following medications:\n\n * PCSK9 inhibitors\n * niacin \\>200 mg/day or fibrates;\n * any omega-3 fatty acid medications ;\n * dietary supplements containing omega-3 fatty acids (e.g., flaxseed oil, fish oil, krill oil, or algal oil);\n * bile acid sequestrants'}, 'identificationModule': {'nctId': 'NCT01492361', 'acronym': 'REDUCE-IT', 'briefTitle': 'A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amarin Pharma Inc.'}, 'officialTitle': 'Evaluation of the Effect of AMR101 on Cardiovascular Health and Mortality in Hypertriglyceridemic Patients With Cardiovascular Disease or at High Risk for Cardiovascular Disease: REDUCE-IT (Reduction of Cardiovascular Events With EPA - Intervention Trial)', 'orgStudyIdInfo': {'id': 'AMR-01-01-0019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AMR101', 'description': 'AMR101 (icosapent ethyl) + statin therapy, daily', 'interventionNames': ['Drug: AMR101', 'Drug: Statin therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo + statin therapy, daily', 'interventionNames': ['Drug: Placebo', 'Drug: Statin therapy']}], 'interventions': [{'name': 'AMR101', 'type': 'DRUG', 'otherNames': ['VASCEPA® (icosapent ethyl)'], 'description': 'Parallel Assignment', 'armGroupLabels': ['AMR101']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['matching placebo'], 'description': 'Parallel Assignment', 'armGroupLabels': ['Placebo']}, {'name': 'Statin therapy', 'type': 'DRUG', 'description': 'Stable statin therapy (± ezetimibe) for at least 28 days before lipid qualification measurement (LDL-C \\>40 mg/dL and ≤100 mg/dL)', 'armGroupLabels': ['AMR101', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35235', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '35662', 'city': 'Muscle Shoals', 'state': 'Alabama', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 34.74481, 'lon': -87.66753}}, {'zip': '85206', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85251', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85745', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72204', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '91710', 'city': 'Chino', 'state': 'California', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 34.01223, 'lon': -117.68894}}, {'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '92020', 'city': 'El Cajon', 'state': 'California', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 32.79477, 'lon': -116.96253}}, {'zip': '91436', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '95628', 'city': 'Fair Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 38.64463, 'lon': -121.27217}}, {'zip': '90716', 'city': 'Hawaiian Gardens', 'state': 'California', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 33.8314, 'lon': -118.07284}}, {'zip': '93534', 'city': 'Lancaster', 'state': 'California', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 34.69804, 'lon': -118.13674}}, {'zip': '95648', 'city': 'Lincoln', 'state': 'California', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 38.89156, 'lon': -121.29301}}, {'zip': '90015', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90017', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91950', 'city': 'National City', 'state': 'California', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 32.67811, 'lon': -117.0992}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '90723', 'city': 'Paramount', 'state': 'California', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 33.88946, 'lon': -118.15979}}, {'zip': '95661', 'city': 'Roseville', 'state': 'California', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '93003', 'city': 'Ventura', 'state': 'California', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80909', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80401', 'city': 'Golden', 'state': 'Colorado', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 39.75554, 'lon': -105.2211}}, {'zip': '06437', 'city': 'Guilford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 41.28899, 'lon': -72.68176}}, {'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '19718', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '19803', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33437', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '34209', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32132', 'city': 'Edgewater', 'state': 'Florida', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 28.98888, 'lon': -80.90228}}, {'zip': '32003', 'city': 'Fleming Island', 'state': 'Florida', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 30.0933, 'lon': -81.71898}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33312', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '34429', 'city': 'Inverness', 'state': 'Florida', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 28.83582, 'lon': -82.33037}}, {'zip': '32204', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32205', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33144', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33175', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '33014', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '34471', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33026', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '33324', 'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'zip': '34695', 'city': 'Safety Harbor', 'state': 'Florida', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 27.99085, 'lon': -82.69316}}, {'zip': '34233', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33713', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '32960', 'city': 'Vero Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 27.63864, 'lon': -80.39727}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30094', 'city': 'Conyers', 'state': 'Georgia', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 33.66761, 'lon': -84.01769}}, {'zip': '30014', 'city': 'Covington', 'state': 'Georgia', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 33.59678, 'lon': -83.86018}}, {'zip': '30041', 'city': 'Cumming', 'state': 'Georgia', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 34.20732, 'lon': -84.14019}}, {'zip': '30076', 'city': 'Roswell', 'state': 'Georgia', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 34.02316, 'lon': -84.36159}}, {'zip': '96818', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '60101', 'city': 'Addison', 'state': 'Illinois', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 41.9317, 'lon': -87.98896}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '61761', 'city': 'Norman', 'state': 'Illinois', 'country': 'United States', 'facility': 'Amarin Investigational Site'}, {'zip': '60064', 'city': 'North Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 42.32558, 'lon': -87.84118}}, {'zip': '61636', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '60190', 'city': 'Winfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 41.8617, 'lon': -88.1609}}, {'zip': '47713', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '67203', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67207', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '40213', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '71301', 'city': 'Alexandria', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 31.31129, 'lon': -92.44514}}, {'zip': '70535', 'city': 'Eunice', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 30.49437, 'lon': -92.41763}}, {'zip': '70072', 'city': 'Marrero', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 29.89937, 'lon': -90.10035}}, {'zip': '04210', 'city': 'Auburn', 'state': 'Maine', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 44.09785, 'lon': -70.23117}}, {'zip': '21236', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21093', 'city': 'Lutherville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 39.42122, 'lon': -76.62608}}, {'zip': '20912', 'city': 'Takoma Park', 'state': 'Maryland', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 38.97789, 'lon': -77.00748}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02721', 'city': 'Fall River', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 41.70149, 'lon': -71.15505}}, {'zip': '48910', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '49855', 'city': 'Marquette', 'state': 'Michigan', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 46.54354, 'lon': -87.39542}}, {'zip': '48098', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '56303', 'city': 'Saint Cloud', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 45.5608, 'lon': -94.16249}}, {'zip': '39531', 'city': 'Biloxi', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 30.39603, 'lon': -88.88531}}, {'zip': '38801', 'city': 'Tupelo', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 34.25807, 'lon': -88.70464}}, {'zip': '63141', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '63303', 'city': 'City of Saint Peters', 'state': 'Missouri', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 38.80033, 'lon': -90.62651}}, {'zip': '63031', 'city': 'Florissant', 'state': 'Missouri', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 38.78922, 'lon': -90.32261}}, {'zip': '65109', 'city': 'Jefferson City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 38.5767, 'lon': -92.17352}}, {'zip': '64114', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68901', 'city': 'Hastings', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 40.58612, 'lon': -98.38839}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '68154', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89052', 'city': 'Henderson', 'state': 'Nevada', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'zip': '89101', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '07712', 'city': 'Ocean City', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 39.27762, 'lon': -74.5746}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '12206', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '11206', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '11023', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'zip': '13088', 'city': 'Liverpool', 'state': 'New York', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 43.10646, 'lon': -76.2177}}, {'zip': '10001', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11758', 'city': 'North Massapequa', 'state': 'New York', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 40.70093, 'lon': -73.46207}}, {'zip': '11787', 'city': 'Smithtown', 'state': 'New York', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 40.85593, 'lon': -73.20067}}, {'zip': '13850', 'city': 'Vestal', 'state': 'New York', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 42.08507, 'lon': -76.05381}}, {'zip': '14224', 'city': 'West Seneca', 'state': 'New York', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 42.85006, 'lon': -78.79975}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '28054', 'city': 'Gastonia', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 35.26208, 'lon': -81.1873}}, {'zip': '27284', 'city': 'Kernersville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 36.11986, 'lon': -80.07365}}, {'zip': '27609', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '58103', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45419', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '44053', 'city': 'Lorain', 'state': 'Ohio', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 41.45282, 'lon': -82.18237}}, {'zip': '44870', 'city': 'Sandusky', 'state': 'Ohio', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 41.44894, 'lon': -82.70796}}, {'zip': '74104', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '97702', 'city': 'Bend', 'state': 'Oregon', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 44.05817, 'lon': -121.31531}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15009', 'city': 'Beaver', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 40.69534, 'lon': -80.30478}}, {'zip': '18901', 'city': 'Doylestown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 40.31011, 'lon': -75.12989}}, {'zip': '17740', 'city': 'Jersey Shore', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 41.20202, 'lon': -77.26442}}, {'zip': '17074', 'city': 'Newport', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 40.47786, 'lon': -77.13054}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19460', 'city': 'Phoenixville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 40.13038, 'lon': -75.51491}}, {'zip': '18960', 'city': 'Sellersville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 40.35399, 'lon': -75.3049}}, {'zip': '16684', 'city': 'Tipton', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 40.6359, 'lon': -78.29585}}, {'zip': '19610', 'city': 'Wyomissing', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 40.32954, 'lon': -75.96521}}, {'zip': '19067', 'city': 'Yardley', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 40.24566, 'lon': -74.846}}, {'zip': '29720', 'city': 'Lancaster', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 34.72043, 'lon': -80.7709}}, {'zip': '29681', 'city': 'Simpsonville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 34.73706, 'lon': -82.25428}}, {'zip': '57701', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '37620', 'city': 'Bristol', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 36.59511, 'lon': -82.18874}}, {'zip': '38401', 'city': 'Columbia', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 35.61507, 'lon': -87.03528}}, {'zip': '38138', 'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'zip': '38301', 'city': 'Jackson', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}, {'zip': '37917', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '37167', 'city': 'Smyrna', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 35.98284, 'lon': -86.5186}}, {'zip': '78756', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77702', 'city': 'Beaumont', 'state': 'Texas', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 30.08605, 'lon': -94.10185}}, {'zip': '75007', 'city': 'Carrollton', 'state': 'Texas', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 32.95373, 'lon': -96.89028}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77024', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77025', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77053', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77070', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77077', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77079', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '76054', 'city': 'Hurst', 'state': 'Texas', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 32.82346, 'lon': -97.17057}}, {'zip': '78130', 'city': 'New Braunfels', 'state': 'Texas', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 29.703, 'lon': -98.12445}}, {'zip': '75075', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '78228', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78238', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77372', 'city': 'Splendora', 'state': 'Texas', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 30.23299, 'lon': -95.16104}}, {'zip': '77375', 'city': 'Tomball', 'state': 'Texas', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 30.09716, 'lon': -95.61605}}, {'zip': '84088', 'city': 'West Jordan', 'state': 'Utah', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 40.60967, 'lon': -111.9391}}, {'zip': '22044', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}, {'zip': '20109', 'city': 'Manassas', 'state': 'Virginia', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 38.75095, 'lon': -77.47527}}, {'zip': '23114', 'city': 'Midlothian', 'state': 'Virginia', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 37.50598, 'lon': -77.64916}}, {'zip': '23606', 'city': 'Newport News', 'state': 'Virginia', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 36.98038, 'lon': -76.42975}}, {'zip': '98166', 'city': 'Burien', 'state': 'Washington', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 47.47038, 'lon': -122.34679}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '25701', 'city': 'Huntington', 'state': 'West Virginia', 'country': 'United States', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 38.41925, 'lon': -82.44515}}, {'zip': '2015', 'city': 'Camperdown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '2480', 'city': 'Lismore', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -28.81354, 'lon': 153.2773}}, {'zip': '4064', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '4032', 'city': 'Chermside', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -27.38472, 'lon': 153.03062}}, {'zip': '5042', 'city': 'Bedford Park', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -35.02204, 'lon': 138.56815}}, {'zip': '7250', 'city': 'Launceston', 'state': 'Tasmania', 'country': 'Australia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -41.43876, 'lon': 147.13467}}, {'zip': '3065', 'city': 'Fitzroy', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -37.79839, 'lon': 144.97833}}, {'zip': '3220', 'city': 'Geelong', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -38.14711, 'lon': 144.36069}}, {'zip': '3081', 'city': 'Heidelberg Heights', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -37.74313, 'lon': 145.05695}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '6160', 'city': 'Fremantle', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -32.05632, 'lon': 115.74557}}, {'zip': '6027', 'city': 'Joondalup', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -31.74445, 'lon': 115.76835}}, {'zip': '6150', 'city': 'Murdoch', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -32.06987, 'lon': 115.83757}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': '6000', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': 'T5A 4L8', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V3K 3V9', 'city': 'Coquitlam', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 49.2846, 'lon': -122.78217}}, {'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V6Z1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'L6Z 4N5', 'city': 'Brampton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}, {'zip': 'L9Y 1W3', 'city': 'Collingwood', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 44.4834, 'lon': -80.21638}}, {'zip': 'N0N 1G0', 'city': 'Corunna', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 42.88338, 'lon': -82.43313}}, {'zip': 'L3Y 5G8', 'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'N7T 4X3', 'city': 'Sarnia', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 42.97866, 'lon': -82.40407}}, {'zip': 'N7G 1Y7', 'city': 'Strathroy', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 42.9551, 'lon': -81.62232}}, {'zip': 'H7T 2P5', 'city': 'Laval', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}, {'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3H 1A1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'J6E 6J2', 'city': 'Saint-Charles-Borromée', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 46.05007, 'lon': -73.46586}}, {'zip': 'J1J 2E3', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': 'G1V 4G5', 'city': 'Québec', 'country': 'Canada', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'G1V 4M6', 'city': 'Québec', 'country': 'Canada', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '500001', 'city': 'Hyderabad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Amarin Investigational Site'}, {'zip': '500004', 'city': 'Hyderabad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Amarin Investigational Site'}, {'zip': '500003', 'city': 'Secunderabad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Amarin Investigational Site'}, {'zip': '530013', 'city': 'Visakhapatnam', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 17.68009, 'lon': 83.20161}}, {'zip': '560034', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '560038', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '560052', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '570015', 'city': 'Mysore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 12.29791, 'lon': 76.63925}}, {'zip': '570020', 'city': 'Mysore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 12.29791, 'lon': 76.63925}}, {'zip': '686016', 'city': 'Kottayam', 'state': 'Kerala', 'country': 'India', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 9.58692, 'lon': 76.52132}}, {'zip': '422055', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '422005', 'city': 'Nashik', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 19.99727, 'lon': 73.79096}}, {'zip': '411004', 'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '110025', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '110060', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '600086', 'city': 'Chennai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '641037', 'city': 'Coimbatore', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 11.00555, 'lon': 76.96612}}, {'zip': '7600 SZ', 'city': 'Almelo', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 52.35667, 'lon': 6.6625}}, {'zip': '3813 TZ', 'city': 'Amersfoort', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 52.155, 'lon': 5.3875}}, {'zip': '1261 AN', 'city': 'Blaricum', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 52.2725, 'lon': 5.24167}}, {'zip': '2906 ZC', 'city': 'Capelle aan den IJssel', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 51.92917, 'lon': 4.57778}}, {'zip': '1782 GZ', 'city': 'Den Helder', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 52.95988, 'lon': 4.75933}}, {'zip': '7416 SE', 'city': 'Deventer', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 52.255, 'lon': 6.16389}}, {'zip': '6716 RP', 'city': 'Ede', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 52.03333, 'lon': 5.65833}}, {'zip': '5611 NV', 'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'zip': '7513 ER', 'city': 'Enschede', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}, {'zip': '4462 RA', 'city': 'Goes', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 51.50417, 'lon': 3.88889}}, {'zip': '4204 AA', 'city': 'Gorinchem', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 51.83652, 'lon': 4.97243}}, {'zip': '2803 HH', 'city': 'Gouda', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 52.01667, 'lon': 4.70833}}, {'zip': '9728 NT', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '2035 RC', 'city': 'Haarlem', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 52.38084, 'lon': 4.63683}}, {'zip': '3844 DG', 'city': 'Harderwijk', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 52.34167, 'lon': 5.62083}}, {'zip': '8441 PW', 'city': 'Heerenveen', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 52.95929, 'lon': 5.91854}}, {'zip': '6419 PC', 'city': 'Heerlen', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 50.88365, 'lon': 5.98154}}, {'zip': '2134 TM', 'city': 'Hoofddorp', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 52.3025, 'lon': 4.68889}}, {'zip': '8934 AD', 'city': 'Leeuwarden', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 53.20271, 'lon': 5.80973}}, {'zip': '2353 GA', 'city': 'Leiderdorp', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 52.15833, 'lon': 4.52917}}, {'zip': '6532 SZ', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '4708 AE', 'city': 'Roosendaal', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 51.53083, 'lon': 4.46528}}, {'zip': '3021 HC', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '3045 PM', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '3083 AN', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '5223 GV', 'city': "s'Hertogenbosch", 'country': 'Netherlands', 'facility': 'Amarin Investigational Site'}, {'zip': '3118 JH', 'city': 'Schiedam', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 51.91917, 'lon': 4.38889}}, {'zip': '8601 ZK', 'city': 'Sneek', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 53.03297, 'lon': 5.6589}}, {'zip': '2597 AX', 'city': 'The Hague', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'zip': '5022 GC', 'city': 'Tilburg', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 51.55551, 'lon': 5.0913}}, {'zip': '5042 AD', 'city': 'Tilburg', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 51.55551, 'lon': 5.0913}}, {'zip': '5406 PT', 'city': 'Uden', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 51.66083, 'lon': 5.61944}}, {'zip': '5504 DB', 'city': 'Veldhoven', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 51.41833, 'lon': 5.40278}}, {'zip': '2725 NA', 'city': 'Zoetermeer', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 52.0575, 'lon': 4.49306}}, {'zip': '7207 AE', 'city': 'Zutphen', 'country': 'Netherlands', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 52.13833, 'lon': 6.20139}}, {'zip': '0622', 'city': 'Takapuna', 'state': 'Auckland', 'country': 'New Zealand', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -36.79167, 'lon': 174.77583}}, {'zip': '8011', 'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'zip': '9016', 'city': 'Dunedin', 'country': 'New Zealand', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -45.87416, 'lon': 170.50361}}, {'zip': '3240', 'city': 'Hamilton', 'country': 'New Zealand', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -37.78333, 'lon': 175.28333}}, {'zip': '4120', 'city': 'Hastings', 'country': 'New Zealand', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -39.6381, 'lon': 176.84918}}, {'zip': '7010', 'city': 'Nelson', 'country': 'New Zealand', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -41.27078, 'lon': 173.28404}}, {'zip': '4342', 'city': 'New Plymouth', 'country': 'New Zealand', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -39.06667, 'lon': 174.08333}}, {'zip': '0622', 'city': 'Takapuna Auckland', 'country': 'New Zealand', 'facility': 'Amarin Investigational Site'}, {'zip': '3112', 'city': 'Tauranga', 'country': 'New Zealand', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -37.68611, 'lon': 176.16667}}, {'zip': '0110', 'city': 'Whangarei', 'country': 'New Zealand', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -35.73167, 'lon': 174.32391}}, {'zip': '15-351', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '15-875', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '40-748', 'city': 'Katowice', 'country': 'Poland', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '40-772', 'city': 'Katowice', 'country': 'Poland', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '31-011', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '43-190', 'city': 'Mikolów', 'country': 'Poland', 'facility': 'Amarin Investigational Site'}, {'zip': '96-100', 'city': 'Skierniewice', 'country': 'Poland', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 51.95485, 'lon': 20.15837}}, {'zip': '33-100', 'city': 'Tarnów', 'country': 'Poland', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 50.01381, 'lon': 20.98698}}, {'zip': '01-231', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '04-628', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '01-192', 'city': 'Warszawska', 'country': 'Poland', 'facility': 'Amarin Investigational Site'}, {'zip': '50-088', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '50-315', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '95-100', 'city': 'Zgierz', 'country': 'Poland', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 51.85561, 'lon': 19.40623}}, {'zip': '110084', 'city': 'Argeş', 'country': 'Romania', 'facility': 'Amarin Investigational Site'}, {'zip': '810249', 'city': 'Brăila', 'country': 'Romania', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 45.27152, 'lon': 27.97429}}, {'zip': '010628', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '011234', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '0200054', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '050098', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '050524', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '061098', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '400006', 'city': 'Cluj-Napoca', 'country': 'Romania', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'zip': '900203', 'city': 'Constanța', 'country': 'Romania', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 44.18073, 'lon': 28.63432}}, {'zip': '200030', 'city': 'Craiova, Dolj', 'country': 'Romania', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'zip': '700661', 'city': 'Iași', 'country': 'Romania', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'zip': '430123', 'city': 'Maramureş', 'country': 'Romania', 'facility': 'Amarin Investigational Site'}, {'zip': '540098', 'city': 'Mureş', 'country': 'Romania', 'facility': 'Amarin Investigational Site'}, {'zip': '550245', 'city': 'Sibiu', 'country': 'Romania', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 45.8, 'lon': 24.15}}, {'zip': '540136', 'city': 'Târgu Mureş', 'country': 'Romania', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 46.54245, 'lon': 24.55747}}, {'zip': '300359', 'city': 'Timișoara', 'country': 'Romania', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}, {'zip': '163000', 'city': 'Arkhangelsk', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}, {'zip': '163001', 'city': 'Arkhangelsk', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}, {'zip': '163045', 'city': 'Arkhangelsk', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}, {'zip': '420012', 'city': "Kazan'", 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'zip': '420097', 'city': "Kazan'", 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'zip': '650000', 'city': 'Kemerovo', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 55.35417, 'lon': 86.10435}}, {'zip': '650002', 'city': 'Kemerovo', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 55.35417, 'lon': 86.10435}}, {'zip': '187342', 'city': 'Kirovsk, Leningradskaya Region', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 67.61475, 'lon': 33.67274}}, {'zip': '350086', 'city': 'Krasnodar', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 45.04534, 'lon': 38.98178}}, {'zip': '109240', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '111020', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '111539', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '115093', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '117292', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '117593', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '117630', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '117997', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '121374', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '121552', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '124489', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '603126', 'city': 'Nizhny Novgorod', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'zip': '630008', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'zip': '630047', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'zip': '630089', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'zip': '185000', 'city': 'Petrozavodsk', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 61.78491, 'lon': 34.34691}}, {'zip': '190000', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '190107', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '192283', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '194044', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '194156', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '194291', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '194354', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '196601', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197022', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197110', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197227', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197341', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197729', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '198205', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '199106', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '410002', 'city': 'Saratov', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 51.54048, 'lon': 45.9901}}, {'zip': '410028', 'city': 'Saratov', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 51.54048, 'lon': 45.9901}}, {'zip': '197706', 'city': 'Sestroretsk, Saint-Petersburg', 'country': 'Russia', 'facility': 'Amarin Investigational Site'}, {'zip': '634050', 'city': 'Tomsk', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}, {'zip': '643012', 'city': 'Tomsk', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}, {'zip': '400001', 'city': 'Volgograd', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 48.71378, 'lon': 44.4976}}, {'zip': '394018', 'city': 'Voronezh', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 51.66833, 'lon': 39.19204}}, {'zip': '394065', 'city': 'Voronezh', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 51.66833, 'lon': 39.19204}}, {'zip': '150030', 'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}, {'zip': '150062', 'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}, {'zip': '620102', 'city': 'Yekaterinburg', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}, {'zip': '620109', 'city': 'Yekaterinburg', 'country': 'Russia', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}, {'zip': '9301', 'city': 'Bloemfontein', 'state': 'Freestate', 'country': 'South Africa', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -29.12107, 'lon': 26.214}}, {'zip': '1500', 'city': 'Benoni', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -26.18848, 'lon': 28.32078}}, {'zip': '0157', 'city': 'Pretoria', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '2013', 'city': 'Soweto', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -26.26781, 'lon': 27.85849}}, {'zip': '1035', 'city': 'Witbank', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Amarin Investigational Site'}, {'zip': '4001', 'city': 'Durban', 'state': 'KwaZulu-Natal', 'country': 'South Africa', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'zip': '4037', 'city': 'Newlands', 'state': 'KwaZulu-Natal', 'country': 'South Africa', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -29.77785, 'lon': 30.96112}}, {'zip': '7530', 'city': 'Bellville', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -33.90022, 'lon': 18.62847}}, {'zip': '7925', 'city': 'Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '7550', 'city': 'Durbanville', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -33.83079, 'lon': 18.6486}}, {'zip': '7460', 'city': 'Goodwood', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -33.90492, 'lon': 18.54881}}, {'zip': '7570', 'city': 'Kraaifontein', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -33.84808, 'lon': 18.71723}}, {'zip': '7646', 'city': 'Paarl', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -33.73378, 'lon': 18.97523}}, {'zip': '7500', 'city': 'Panorama', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Amarin Investigational Site'}, {'zip': '7500', 'city': 'Parow', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -33.89723, 'lon': 18.59992}}, {'zip': '7405', 'city': 'Pinelands', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -33.94222, 'lon': 18.50681}}, {'zip': '7130', 'city': 'Somerset West', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -34.08401, 'lon': 18.82113}}, {'zip': '6850', 'city': 'Worcester', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': -33.64651, 'lon': 19.44852}}, {'zip': '43000', 'city': 'Lutsk', 'state': 'Volyn Oblast', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 50.75784, 'lon': 25.35024}}, {'zip': '18009', 'city': 'Cherkasy', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 49.44452, 'lon': 32.05738}}, {'zip': '58002', 'city': 'Chernivtsi', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 48.29045, 'lon': 25.93241}}, {'zip': '49006', 'city': 'Dnipropetrovsk', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'zip': '49023', 'city': 'Dnipropetrovsk', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'zip': '49027', 'city': 'Dnipropetrovsk', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'zip': '83001', 'city': 'Donetsk', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 48.023, 'lon': 37.80224}}, {'zip': '83045', 'city': 'Donetsk', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 48.023, 'lon': 37.80224}}, {'zip': '76005', 'city': 'Ivano-Frankivsk', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 48.92312, 'lon': 24.71248}}, {'zip': '76018', 'city': 'Ivano-Frankivsk', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 48.92312, 'lon': 24.71248}}, {'zip': '61002', 'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'zip': '61018', 'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'zip': '61039', 'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'zip': '61176', 'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'zip': '01032', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '01103', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '01151', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '01601', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '02091', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '02660', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '03151', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '04050', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '04114', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '91016', 'city': 'Luhansk', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 48.56814, 'lon': 39.30553}}, {'zip': '43024', 'city': 'Lutsk', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 50.75784, 'lon': 25.35024}}, {'zip': '79034', 'city': 'Lviv', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 49.83826, 'lon': 24.02324}}, {'zip': '65009', 'city': 'Odesa', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 46.48572, 'lon': 30.74383}}, {'zip': '65025', 'city': 'Odesa', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 46.48572, 'lon': 30.74383}}, {'zip': '65082', 'city': 'Odesa', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 46.48572, 'lon': 30.74383}}, {'zip': '36011', 'city': 'Poltava', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 49.58925, 'lon': 34.55367}}, {'zip': '46003', 'city': 'Ternopil', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 49.55404, 'lon': 25.59067}}, {'zip': '88000', 'city': 'Uzhhorod', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 48.6242, 'lon': 22.2947}}, {'zip': '88014', 'city': 'Uzhhorod', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 48.6242, 'lon': 22.2947}}, {'zip': '21018', 'city': 'Vinnytsia', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 49.2322, 'lon': 28.46871}}, {'zip': '21029', 'city': 'Vinnytsia', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 49.2322, 'lon': 28.46871}}, {'zip': '69035', 'city': 'Zaporizhzhia', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 47.15214, 'lon': 35.74246}}, {'zip': '69065', 'city': 'Zaporizhzhia', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 47.15214, 'lon': 35.74246}}, {'zip': '69106', 'city': 'Zaporizhzhia', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 47.15214, 'lon': 35.74246}}, {'zip': '69600', 'city': 'Zaporizhzhia', 'country': 'Ukraine', 'facility': 'Amarin Investigational Site', 'geoPoint': {'lat': 47.15214, 'lon': 35.74246}}], 'overallOfficials': [{'name': 'Deepak L. Bhatt, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital, 75 Francis Street, Boston"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amarin Pharma Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}