Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT01076205
Status:
COMPLETED
Last Update Posted:
2019-02-07
First Post:
2010-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Effect on Quality of Life/Work Productivity of Humira in Patients With Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie (prior sponsor Abbott)'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '60 months', 'eventGroups': [{'id': 'EG000', 'title': 'Adalimumab', 'description': 'Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.', 'otherNumAtRisk': 7229, 'deathsNumAtRisk': 7229, 'otherNumAffected': 831, 'seriousNumAtRisk': 7229, 'deathsNumAffected': 23, 'seriousNumAffected': 932}], 'otherEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 177}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 137}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 130}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 106}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 88}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 79}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 213}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Therapy cessation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 78}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}], 'seriousEvents': [{'term': 'Hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 110}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Knee arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 30}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Elective surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 27}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Arthrodesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 25}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 24}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Synovectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 19}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Foot operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 18}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Joint arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 18}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Bunion operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 14}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cholecystectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 12}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Therapy cessation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 12}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 10}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Therapy change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 10}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Rehabilitation therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 9}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Laparoscopic surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 8}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Spinal operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 8}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Coronary arterial stent insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 7}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Intervertebral disc operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 7}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Osteosynthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 7}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Osteotomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 7}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Antibiotic therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 6}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Arthroscopic surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 6}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Coronary artery bypass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 6}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Knee operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 6}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Rheumatoid nodule removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 6}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Antibiotic prophylaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 5}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Aortic valve replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 5}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Bursa removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 5}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cardiac pacemaker insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 5}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Inguinal hernia repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 5}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Ankle arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': "Baker's cyst excision", 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cataract operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Fracture treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Renal stone removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Rotator cuff repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Shoulder operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Spinal fusion surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Thyroidectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Abdominal operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Abscess drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Ankle operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Breast conserving surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cancer surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cardiac operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Coronary angioplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Emergency care', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Gallbladder operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Haematoma evacuation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Hysterectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Joint surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Meniscus operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pain management', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Shoulder arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Sigmoidectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Skin graft', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Skin neoplasm excision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Spinal decompression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Stent placement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Tendon operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Toe operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Tooth extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Arterial stent insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Breast reconstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cardiac ablation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Carpal tunnel decompression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cartilage operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Chemotherapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Gastrectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Hernia repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Hip surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Infiltration anaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Joint dislocation reduction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Massage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Mastectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Medical device removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Nasal operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Nasal polypectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Open reduction of fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Ovarian cystectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Postoperative care', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Prostatic operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pulmonary resection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Radiotherapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Removal of internal fixation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Sinus operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Tendon sheath incision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Tenoplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Thyroid operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Transurethral prostatectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Ureteral stent insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Wound treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Abdominal hernia repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Adhesiolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Adrenocortical steroid therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Aneurysm repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Angioplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Antiallergic therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Anticoagulant therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Aortic aneurysm repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Appendicectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Arterial aneurysm repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Arterial bypass operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Arterial catheterisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Arthrotomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Bone operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Bronchial lesion excision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Bursal operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cardiac pacemaker replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cerebrovascular operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Chest wall operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Coronary revascularisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cryotherapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cyst removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Debridement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Diabetes mellitus management', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Eye operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Femoral hernia repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Fistula repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Fluid replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Fracture debridement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Frontal sinus operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Gastric operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Gingival operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Haemostasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Implantable defibrillator insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Infusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Injection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Intestinal operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Jaw operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Joint debridement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Joint injection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Joint stabilisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Laparotomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Leg amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Ligament operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Limb operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Lip repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Lithotripsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Lung transplant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Lymphoma operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Meniscus removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Nasal septal operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Nephrectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Nephroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Nephrostomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Neurectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Oophorectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Ossiculoplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Ostectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pancreatic operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Parotidectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Percutaneous coronary intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Peritoneal lavage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pharyngeal operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Polypectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pyeloplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Radical prostatectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Radioactive iodine therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Rectal polypectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Renal artery stent placement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Resuscitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Skin lesion removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Spinal cord operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Sternotomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Therapeutic embolisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Thrombolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Toe amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Tongue operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Tonsillectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Transfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Tumour excision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Umbilical hernia repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Unevaluable therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Ureterectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Ureteric operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Urinary incontinence surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Varicose vein operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Venous operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Vertebral body replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Wound closure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Wound drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Wrist surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 59}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Post procedural infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Gastroenteritis norovirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Intervertebral discitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Breast abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Chronic sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Escherichia sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Genital herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Infectious colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Infectious pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Lymph node tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Nasal herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pertussis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Soft tissue infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Vestibular neuronitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Abscess neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Abscess soft tissue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Acne pustular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Atypical pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Bronchitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Bursitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Candida infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Candida pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Carbuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cholangitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Chronic hepatitis C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Clostridial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Diabetic gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Disseminated tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Emphysematous cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Encephalitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Endocarditis staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Epstein-Barr virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Furuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Gallbladder empyema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Genital candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Groin abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Herpes ophthalmic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Herpes simplex encephalitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Herpes virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Infected seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Infection susceptibility increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Keratouveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Liver abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Lung abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Lymphangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Meningoencephalitis herpetic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Mycobacterium marinum infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Necrotising fasciitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Parotitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Peritoneal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pneumococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pneumonia escherichia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pneumonia fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pneumonia legionella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pneumonia necrotising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Poliomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pulmonary sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pulpitis dental', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Purulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pyonephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Rash pustular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Salmonellosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Septic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Superinfection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Testicular abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Tracheitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Tuberculosis gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Tuberculosis of genitourinary system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Tuberculosis of intrathoracic lymph nodes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Tuberculous pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Vulvovaginal mycotic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Wound infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 35}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Foot deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Synovial cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Synovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Acquired claw toe', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Osteoporotic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Lupus-like syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Musculoskeletal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Spondylolisthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Facet joint syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Metatarsalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Osteochondrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pseudarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Rheumatoid nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Scoliosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Spinal instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Ankle impingement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Arthritis reactive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Bursal haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Chondromalacia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Compartment syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Exostosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': "Felty's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Fibromyalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Groin pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Haemarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Hip deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Joint destruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Ligament pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Meniscal degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Polyarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'SAPHO syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': "Sjogren's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Spondyloarthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Synovial disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Tenosynovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Tenosynovitis stenosans', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Vertebral foraminal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Wrist deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 19}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Multiple fractures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Accident at work', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Fracture displacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Thoracic vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Accident at home', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Post procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Post procedural fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Acetabulum fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Burns second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Clavicle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Craniocerebral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Forearm fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Fractured ischium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Ilium fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Kidney rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Limb crushing injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Limb traumatic amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Multiple injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Nerve injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pancreatic duct rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Skin wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Soft tissue injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Stab wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Suture related complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Unevaluable event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Complication associated with device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Drug ineffective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Perforated ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'No adverse event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Condition aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Drug interaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Exercise tolerance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Granuloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Injection site warmth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Precancerous mucosal lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Breast cancer female', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 15}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Metastases to bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Bronchial carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cervix carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Neuroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Plasma cell myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Skin cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Acute myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Anogenital warts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Atypical fibroxanthoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Benign cardiac neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Bladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': "Bowen's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Brain neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Breast neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Bronchial neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cholangiocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Chronic lymphocytic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Colon neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Ear neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Epiglottic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Gastric cancer stage I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Gastric cancer stage III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': "Hodgkin's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': "Hodgkin's disease mixed cellularity stage unspecified", 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Intraductal papilloma of breast', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Intraductal proliferative breast lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Invasive breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Lipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Lung squamous cell carcinoma stage III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Malignant melanoma in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Metastases to liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Metastases to lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Metastases to lymph nodes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Neoplasm skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Neuroendocrine carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': "Non-Hodgkin's lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Plasmacytoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Renal cell carcinoma recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Thyroid adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Uterine cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 14}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Adams-Stokes syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Bradyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Hypertensive heart disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Stress cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Tachyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Tachycardia induced cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Wolff-Parkinson-White syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cerebellar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Movement disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Dizziness postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Monoparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Brain stem infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cognitive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Complex regional pain syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Diabetic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Dysaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Facial paresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Generalised tonic-clonic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Gliosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Intercostal neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Intracranial aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Intracranial venous sinus thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Lacunar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Nerve root compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Orthostatic intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Paraplegia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Post herpetic neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Post polio syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Spinal cord ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Thalamic infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Toxic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Vertebral artery dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Colitis microscopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Diverticular perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Aphthous ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Chronic gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Diverticulum intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Erosive duodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Faecaloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Femoral hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Gastrointestinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Gingival recession', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Hypoaesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Intestinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Leukoplakia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pancreatic duct stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pancreatic mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pancreatitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Rectal polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Salivary gland pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Subileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Ulcerative gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Alveolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Rheumatoid lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Hyperventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Lung infiltration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Nasal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Bronchiectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Laryngeal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Nasal septum deviation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Nasal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Organising pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Paranasal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pleural fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pulmonary hilum mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Sputum discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Arthroscopy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Liver function test increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Bronchoscopy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Biopsy bone marrow', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Biopsy liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Computerised tomogram thorax abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Double stranded DNA antibody positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Angiogram peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Antinuclear antibody positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Arteriogram coronary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Autoantibody test', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Biopsy lymph gland', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Blood bactericidal activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Blood calcium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Catheterisation cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Colonoscopy normal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'DNA antibody positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Ejection fraction decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Emergency care examination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Endoscopic retrograde cholangiopancreatography', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Endoscopy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Epstein-Barr virus antibody positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Fibrin D dimer increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Haematocrit decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Heart rate irregular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Laboratory test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Laparoscopy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Mediastinoscopy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Mycobacterium tuberculosis complex test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Neurological examination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Proteus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Red blood cell sedimentation rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Staphylococcus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Transaminases abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Ultrasound abdomen abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Wound healing normal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pustular psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Dermatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Erythema multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Hand dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Hidradenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Lichenoid keratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Lividity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Mucocutaneous ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Neurodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Petechiae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Photosensitivity reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Rash generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Rash vesicular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Rosacea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Skin hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Skin necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Subcutaneous emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Swelling face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Systemic lupus erythematosus rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Urticarial vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Aortic dilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Lymphatic fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Microembolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pelvic venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Peripheral artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Azotaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Bladder diverticulum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Bladder stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Renal artery arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Stress urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Ureteric stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Urinary hesitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Urinary tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 10}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 5}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cholestasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Biliary cirrhosis primary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Gallbladder perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Hepatitis cholestatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Agranulocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Bicytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Erythropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Hypochromic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Stress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Acute stress disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Middle insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Panic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Tobacco abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Obesity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Shock hypoglycaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 5}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Menstrual disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Ovarian adhesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Prostatic dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Prostatic haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 5}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Thyroid mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Adrenocortical insufficiency acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': "Basedow's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Sudden hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Otosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Eye disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Eye haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Iritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Ophthalmic vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Immunosuppression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Sarcoidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Device breakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 2}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Delivery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Ectopic pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Alcohol use', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Foreign travel', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Postmenopause', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Developmental hip dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Hereditary neuropathic amyloidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7229, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Number of Missed Working Days Due to Sick Leave in the Past 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3156', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.'}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2267', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.3', 'spread': '32.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1855', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.4', 'spread': '37.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1290', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.6', 'spread': '30.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '868', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.7', 'spread': '32.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '596', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.4', 'spread': '27.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.1', 'spread': '32.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6, 12, 24, 36, 48, and 60 months', 'description': 'Primary effectiveness outcomes related to employment were performed in patients who were employed part- or full-time at baseline. Sick leave days were based on patient recall.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set), with available data at baseline and each time point.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With > 5 Missed Working Days Due to Sick Leave in the Past 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3156', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3156', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2326', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1906', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1321', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '890', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '613', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '426', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 6, 12, 24, 36, 48, and 60 months', 'description': 'Primary effectiveness outcomes related to employment were performed in patients who were employed part- or full-time at baseline. Sick leave days were based on patient recall.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set), with available data at each time point.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Work Productivity and Activity Impairment: Absenteeism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2253', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.'}], 'classes': [{'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1482', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.9', 'spread': '34.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1220', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.0', 'spread': '37.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '969', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.3', 'spread': '38.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '660', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.5', 'spread': '36.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.0', 'spread': '34.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.2', 'spread': '34.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.2', 'spread': '40.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3, 6, 12, 24, 36, 48, and 60 months', 'description': 'The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health.\n\nWPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes.', 'unitOfMeasure': 'percent impairment', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set) and at each time point, and with available WPAI data.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Work Productivity and Activity Impairment: Presenteeism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2758', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.'}], 'classes': [{'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2157', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.3', 'spread': '25.8', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1852', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.8', 'spread': '26.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1513', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.7', 'spread': '28.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1084', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.9', 'spread': '28.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '717', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-15.3', 'spread': '28.8', 'groupId': 'OG000'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '490', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.4', 'spread': '29.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-15.2', 'spread': '27.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3, 6, 12, 24, 36, 48, and 60 months', 'description': 'The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health.\n\nWPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes.', 'unitOfMeasure': 'percent impairment', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set) and at each time point, and with available WPAI data.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Work Productivity and Activity Impairment: Total Work Productivity Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2026', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.'}], 'classes': [{'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1313', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-13.0', 'spread': '27.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1073', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-14.4', 'spread': '28.8', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '851', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.4', 'spread': '30.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '596', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-15.3', 'spread': '30.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-18.8', 'spread': '29.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.7', 'spread': '31.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.5', 'spread': '33.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3, 6, 12, 24, 36, 48, and 60 months', 'description': 'The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health.\n\nWPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes.', 'unitOfMeasure': 'percent impairment', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set) and at each time point, and with available WPAI data.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Work Productivity and Activity Impairment: Total Activity Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3248', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.'}], 'classes': [{'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2758', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.9', 'spread': '26.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2420', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.8', 'spread': '27.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2007', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-13.8', 'spread': '28.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1424', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-14.3', 'spread': '28.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '970', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-15.4', 'spread': '29.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '687', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-14.8', 'spread': '29.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '509', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-14.8', 'spread': '28.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3, 6, 12, 24, 36, 48, and 60 months', 'description': 'The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health.\n\nWPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes.', 'unitOfMeasure': 'percent impairment', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set) and with available WPAI data.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Work Activity Index (WAI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2110', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.'}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1908', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '5.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1442', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '986', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '6.8', 'groupId': 'OG000'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '666', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '7.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '452', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '6.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '7.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6, 12, 24, 36, 48, and 60 months', 'description': 'The WAI is a tool designed to record the work ability of employees and consists of 7 questions. The modified WAI used in this study included Questions 1, 2, 4, 6, and 7 of the WAI. Question 3, which involves the number of current diseases diagnosed by a physician, was omitted because this parameter was unlikely to reflect change due to treatment. Question 5 (sick leave during the past year) was replaced with the previous question concerning sick leave days.WAI scores range from 7 (worst) to 49 (best).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set) and at each time point, and with available WAI data.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Disease Activity Score - 28 Joints (DAS28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4466', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.'}], 'classes': [{'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3749', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.34', 'spread': '1.39', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3229', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.56', 'spread': '1.46', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2621', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.71', 'spread': '1.55', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1818', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.84', 'spread': '1.57', 'groupId': 'OG000'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1250', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.94', 'spread': '1.61', 'groupId': 'OG000'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '912', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.01', 'spread': '1.59', 'groupId': 'OG000'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '650', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.15', 'spread': '1.63', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3, 6, 12, 24, 36, 48, and 60 months', 'description': "The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \\> 5.1 indicates high disease activity, a DAS28 score \\< 3.2 indicates low disease activity, and a DAS28 score \\< 2.6 indicates clinical remission.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Tender Joint Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4466', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.'}], 'classes': [{'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4280', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.3', 'spread': '6.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3657', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.9', 'spread': '6.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2969', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.3', 'spread': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2095', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.6', 'spread': '6.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1456', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.9', 'spread': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1040', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.1', 'spread': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.4', 'spread': '6.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3, 6, 12, 24, 36, 48, and 60 months', 'description': 'Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.', 'unitOfMeasure': 'joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Swollen Joint Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4466', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.'}], 'classes': [{'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4280', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.2', 'spread': '4.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3657', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.8', 'spread': '5.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2969', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.1', 'spread': '5.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2095', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.4', 'spread': '5.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1456', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.8', 'spread': '5.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1040', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.0', 'spread': '5.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.5', 'spread': '6.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3, 6, 12, 24, 36, 48, and 60 months', 'description': 'Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.', 'unitOfMeasure': 'joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Erythrocyte Sedimentation Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4466', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.'}], 'classes': [{'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3893', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.1', 'spread': '20.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3321', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.9', 'spread': '20.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2705', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.5', 'spread': '21.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1891', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-9.0', 'spread': '22.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1299', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.9', 'spread': '22.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '953', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-9.3', 'spread': '22.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '673', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-9.9', 'spread': '22.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3, 6, 12, 24, 36, 48, and 60 months', 'unitOfMeasure': 'mm/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in C-reactive Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4353', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.'}], 'classes': [{'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3858', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.1', 'spread': '45.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3296', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.3', 'spread': '49.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2693', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.5', 'spread': '59.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1918', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.0', 'spread': '64.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1319', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.6', 'spread': '65.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '950', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.8', 'spread': '47.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '678', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.8', 'spread': '39.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3, 6, 12, 24, 36, 48, and 60 months', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Health-Assessment Questionnaire-Disability Index (HAQ-DI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4449', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.'}], 'classes': [{'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.22', 'spread': '0.51', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3537', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.24', 'spread': '0.54', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2873', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.58', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2014', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.60', 'groupId': 'OG000'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1400', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.30', 'spread': '0.62', 'groupId': 'OG000'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '992', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.32', 'spread': '0.61', 'groupId': 'OG000'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '727', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.63', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3, 6, 12, 24, 36, 48, and 60 months', 'description': 'The HAQ-DI is a patient-reported assessment of physical function that includes 20 items in eight categories representing a comprehensive set of functional activities, including dressing, eating, walking, and hygiene. Patients are asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst), with a higher score representing a high-dependency disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.'}, {'type': 'PRIMARY', 'title': 'EuroQol-5 Dimensions (EQ-5D) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4400', 'groupId': 'OG000'}, {'value': '4118', 'groupId': 'OG001'}, {'value': '3524', 'groupId': 'OG002'}, {'value': '2856', 'groupId': 'OG003'}, {'value': '2020', 'groupId': 'OG004'}, {'value': '1401', 'groupId': 'OG005'}, {'value': '992', 'groupId': 'OG006'}, {'value': '732', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Month 0 - at enrollment'}, {'id': 'OG001', 'title': 'Month 3', 'description': '3 months after enrollment'}, {'id': 'OG002', 'title': 'Month 6', 'description': '6 months after enrollment'}, {'id': 'OG003', 'title': 'Month 12', 'description': '12 months after enrollment'}, {'id': 'OG004', 'title': 'Month 24', 'description': '24 months after enrollment'}, {'id': 'OG005', 'title': 'Month 36', 'description': '36 months after enrollment'}, {'id': 'OG006', 'title': 'Month 48', 'description': '48 months after enrollment'}, {'id': 'OG007', 'title': 'Month 60', 'description': '60 months after enrollment'}], 'classes': [{'title': 'Mobility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4398', 'groupId': 'OG000'}, {'value': '4118', 'groupId': 'OG001'}, {'value': '3524', 'groupId': 'OG002'}, {'value': '2856', 'groupId': 'OG003'}, {'value': '2020', 'groupId': 'OG004'}, {'value': '1401', 'groupId': 'OG005'}, {'value': '992', 'groupId': 'OG006'}, {'value': '732', 'groupId': 'OG007'}]}], 'categories': [{'title': 'No problems', 'measurements': [{'value': '1662', 'groupId': 'OG000'}, {'value': '2072', 'groupId': 'OG001'}, {'value': '1937', 'groupId': 'OG002'}, {'value': '1644', 'groupId': 'OG003'}, {'value': '1190', 'groupId': 'OG004'}, {'value': '843', 'groupId': 'OG005'}, {'value': '614', 'groupId': 'OG006'}, {'value': '447', 'groupId': 'OG007'}]}, {'title': 'Some problems', 'measurements': [{'value': '2728', 'groupId': 'OG000'}, {'value': '2034', 'groupId': 'OG001'}, {'value': '1575', 'groupId': 'OG002'}, {'value': '1200', 'groupId': 'OG003'}, {'value': '824', 'groupId': 'OG004'}, {'value': '554', 'groupId': 'OG005'}, {'value': '376', 'groupId': 'OG006'}, {'value': '282', 'groupId': 'OG007'}]}, {'title': 'Extreme problems', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}]}, {'title': 'Self-care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4394', 'groupId': 'OG000'}, {'value': '4116', 'groupId': 'OG001'}, {'value': '3523', 'groupId': 'OG002'}, {'value': '2856', 'groupId': 'OG003'}, {'value': '2020', 'groupId': 'OG004'}, {'value': '1401', 'groupId': 'OG005'}, {'value': '992', 'groupId': 'OG006'}, {'value': '732', 'groupId': 'OG007'}]}], 'categories': [{'title': 'No problems', 'measurements': [{'value': '2599', 'groupId': 'OG000'}, {'value': '2792', 'groupId': 'OG001'}, {'value': '2476', 'groupId': 'OG002'}, {'value': '2088', 'groupId': 'OG003'}, {'value': '1484', 'groupId': 'OG004'}, {'value': '1038', 'groupId': 'OG005'}, {'value': '729', 'groupId': 'OG006'}, {'value': '506', 'groupId': 'OG007'}]}, {'title': 'Some problems', 'measurements': [{'value': '1680', 'groupId': 'OG000'}, {'value': '1226', 'groupId': 'OG001'}, {'value': '972', 'groupId': 'OG002'}, {'value': '706', 'groupId': 'OG003'}, {'value': '503', 'groupId': 'OG004'}, {'value': '338', 'groupId': 'OG005'}, {'value': '243', 'groupId': 'OG006'}, {'value': '208', 'groupId': 'OG007'}]}, {'title': 'Extreme problems', 'measurements': [{'value': '115', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}]}]}, {'title': 'Usual activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4395', 'groupId': 'OG000'}, {'value': '4116', 'groupId': 'OG001'}, {'value': '3523', 'groupId': 'OG002'}, {'value': '2856', 'groupId': 'OG003'}, {'value': '2020', 'groupId': 'OG004'}, {'value': '1401', 'groupId': 'OG005'}, {'value': '992', 'groupId': 'OG006'}, {'value': '732', 'groupId': 'OG007'}]}], 'categories': [{'title': 'No problems', 'measurements': [{'value': '953', 'groupId': 'OG000'}, {'value': '1463', 'groupId': 'OG001'}, {'value': '1431', 'groupId': 'OG002'}, {'value': '1303', 'groupId': 'OG003'}, {'value': '958', 'groupId': 'OG004'}, {'value': '677', 'groupId': 'OG005'}, {'value': '503', 'groupId': 'OG006'}, {'value': '353', 'groupId': 'OG007'}]}, {'title': 'Some problems', 'measurements': [{'value': '3236', 'groupId': 'OG000'}, {'value': '2511', 'groupId': 'OG001'}, {'value': '1989', 'groupId': 'OG002'}, {'value': '1455', 'groupId': 'OG003'}, {'value': '1015', 'groupId': 'OG004'}, {'value': '696', 'groupId': 'OG005'}, {'value': '464', 'groupId': 'OG006'}, {'value': '362', 'groupId': 'OG007'}]}, {'title': 'Extreme problems', 'measurements': [{'value': '206', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}, {'value': '25', 'groupId': 'OG006'}, {'value': '17', 'groupId': 'OG007'}]}]}, {'title': 'Pain/discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4400', 'groupId': 'OG000'}, {'value': '4118', 'groupId': 'OG001'}, {'value': '3524', 'groupId': 'OG002'}, {'value': '2856', 'groupId': 'OG003'}, {'value': '2020', 'groupId': 'OG004'}, {'value': '1401', 'groupId': 'OG005'}, {'value': '992', 'groupId': 'OG006'}, {'value': '732', 'groupId': 'OG007'}]}], 'categories': [{'title': 'No problems', 'measurements': [{'value': '147', 'groupId': 'OG000'}, {'value': '585', 'groupId': 'OG001'}, {'value': '587', 'groupId': 'OG002'}, {'value': '582', 'groupId': 'OG003'}, {'value': '478', 'groupId': 'OG004'}, {'value': '383', 'groupId': 'OG005'}, {'value': '298', 'groupId': 'OG006'}, {'value': '225', 'groupId': 'OG007'}]}, {'title': 'Some problems', 'measurements': [{'value': '2965', 'groupId': 'OG000'}, {'value': '2932', 'groupId': 'OG001'}, {'value': '2508', 'groupId': 'OG002'}, {'value': '1989', 'groupId': 'OG003'}, {'value': '1381', 'groupId': 'OG004'}, {'value': '917', 'groupId': 'OG005'}, {'value': '631', 'groupId': 'OG006'}, {'value': '461', 'groupId': 'OG007'}]}, {'title': 'Extreme problems', 'measurements': [{'value': '1288', 'groupId': 'OG000'}, {'value': '601', 'groupId': 'OG001'}, {'value': '429', 'groupId': 'OG002'}, {'value': '285', 'groupId': 'OG003'}, {'value': '161', 'groupId': 'OG004'}, {'value': '101', 'groupId': 'OG005'}, {'value': '63', 'groupId': 'OG006'}, {'value': '46', 'groupId': 'OG007'}]}]}, {'title': 'Anxiety/depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4395', 'groupId': 'OG000'}, {'value': '4116', 'groupId': 'OG001'}, {'value': '3523', 'groupId': 'OG002'}, {'value': '2854', 'groupId': 'OG003'}, {'value': '2020', 'groupId': 'OG004'}, {'value': '1400', 'groupId': 'OG005'}, {'value': '992', 'groupId': 'OG006'}, {'value': '732', 'groupId': 'OG007'}]}], 'categories': [{'title': 'No problems', 'measurements': [{'value': '2159', 'groupId': 'OG000'}, {'value': '2328', 'groupId': 'OG001'}, {'value': '2141', 'groupId': 'OG002'}, {'value': '1791', 'groupId': 'OG003'}, {'value': '1349', 'groupId': 'OG004'}, {'value': '977', 'groupId': 'OG005'}, {'value': '705', 'groupId': 'OG006'}, {'value': '526', 'groupId': 'OG007'}]}, {'title': 'Some problems', 'measurements': [{'value': '1961', 'groupId': 'OG000'}, {'value': '1601', 'groupId': 'OG001'}, {'value': '1238', 'groupId': 'OG002'}, {'value': '956', 'groupId': 'OG003'}, {'value': '607', 'groupId': 'OG004'}, {'value': '395', 'groupId': 'OG005'}, {'value': '265', 'groupId': 'OG006'}, {'value': '190', 'groupId': 'OG007'}]}, {'title': 'Extreme problems', 'measurements': [{'value': '275', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '107', 'groupId': 'OG003'}, {'value': '64', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}, {'value': '22', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and 3, 6, 12, 24, 36, 48, and 60 months', 'description': 'The EuroQol-5 Dimensions (EQ-5D) is a generic instrument for measuring health-related quality of life. The patient questionnaire consists of two parts. The first part includes statements for the following five areas (dimensions):\n\n* agility/mobility\n* self-care\n* usual activities\n* pain, bodily discomfort\n* anxiety, depression\n\nFor each dimension the patient is asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Euroqol Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4405', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.'}], 'classes': [{'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4073', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.0', 'spread': '24.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3480', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.7', 'spread': '24.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2815', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.9', 'spread': '25.8', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1990', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.9', 'spread': '25.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1393', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.2', 'spread': '25.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '986', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.8', 'spread': '25.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '725', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.9', 'spread': '25.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3, 6, 12, 24, 36, 48, and 60 months', 'description': 'EuroQol-5 Dimensions (EQ-5D): The EQ-5D is a generic instrument for measuring health-related quality of life. The patient questionnaire consists of two parts. The second part is a vertical, thermometer-like, VAS ranging from 0 to 100 that provides a patient-reported assessment of overall health. Patients are asked to mark how good or bad their health is on that day, with 100 meaning "the best health you can imagine" and 0 meaning "the worst health you can imagine."', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Number of Physician Visits in Past 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4344', 'groupId': 'OG000'}, {'value': '3408', 'groupId': 'OG001'}, {'value': '2774', 'groupId': 'OG002'}, {'value': '1946', 'groupId': 'OG003'}, {'value': '1357', 'groupId': 'OG004'}, {'value': '960', 'groupId': 'OG005'}, {'value': '703', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Month 0 - at enrollment'}, {'id': 'OG001', 'title': 'Month 6', 'description': '6 months after enrollment'}, {'id': 'OG002', 'title': 'Month 12', 'description': '12 months after enrollment'}, {'id': 'OG003', 'title': 'Month 24', 'description': '24 months after enrollment'}, {'id': 'OG004', 'title': 'Month 36', 'description': '36 months after enrollment'}, {'id': 'OG005', 'title': 'Month 48', 'description': '48 months after enrollment'}, {'id': 'OG006', 'title': 'Month 60', 'description': '60 months after enrollment'}], 'classes': [{'title': 'Rheumatologist', 'categories': [{'measurements': [{'value': '3.3', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '2.7', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '2.0', 'groupId': 'OG002'}, {'value': '1.9', 'spread': '1.5', 'groupId': 'OG003'}, {'value': '1.8', 'spread': '1.4', 'groupId': 'OG004'}, {'value': '1.9', 'spread': '1.4', 'groupId': 'OG005'}, {'value': '1.8', 'spread': '1.6', 'groupId': 'OG006'}]}]}, {'title': 'General practitioner', 'categories': [{'measurements': [{'value': '4.0', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '4.4', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '3.2', 'groupId': 'OG002'}, {'value': '2.1', 'spread': '2.5', 'groupId': 'OG003'}, {'value': '2.1', 'spread': '3.0', 'groupId': 'OG004'}, {'value': '1.9', 'spread': '2.4', 'groupId': 'OG005'}, {'value': '1.8', 'spread': '2.5', 'groupId': 'OG006'}]}]}, {'title': 'Orthopedic specialist', 'categories': [{'measurements': [{'value': '0.9', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '1.6', 'groupId': 'OG002'}, {'value': '0.5', 'spread': '1.3', 'groupId': 'OG003'}, {'value': '0.5', 'spread': '1.3', 'groupId': 'OG004'}, {'value': '0.5', 'spread': '1.0', 'groupId': 'OG005'}, {'value': '0.5', 'spread': '1.9', 'groupId': 'OG006'}]}]}, {'title': 'Other specialists', 'categories': [{'measurements': [{'value': '1.2', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '1.8', 'groupId': 'OG002'}, {'value': '0.8', 'spread': '1.4', 'groupId': 'OG003'}, {'value': '0.8', 'spread': '1.5', 'groupId': 'OG004'}, {'value': '0.8', 'spread': '1.5', 'groupId': 'OG005'}, {'value': '0.8', 'spread': '1.5', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6, 12, 24, 36, 48, and 60 months', 'description': 'Participants self-reported the number of physician visits they had in the past 6 months.', 'unitOfMeasure': 'visits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Number of Inpatient Hospitalizations in Past 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4344', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4344', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3408', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2774', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1946', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1357', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '960', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6, 12, 24, 36, 48, and 60 months', 'description': 'Participants self-reported the number of hospitalizations they had in the past 6 months.', 'unitOfMeasure': 'hospitalizations', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Duration of Inpatient Hospitalizations in Past 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4344', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4344', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '7.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3408', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '4.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2774', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '4.8', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1946', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '3.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1357', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '3.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '960', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '3.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '2.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6, 12, 24, 36, 48, and 60 months', 'description': 'Participants who had been hospitalized were asked how many days they were hospitalized in the past 6 months.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Number of Days With Impairment of Non-Occupational Activities in Past 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3368', 'groupId': 'OG000'}, {'value': '2666', 'groupId': 'OG001'}, {'value': '2199', 'groupId': 'OG002'}, {'value': '1572', 'groupId': 'OG003'}, {'value': '1093', 'groupId': 'OG004'}, {'value': '784', 'groupId': 'OG005'}, {'value': '574', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Month 0 - at enrollment'}, {'id': 'OG001', 'title': 'Month 6', 'description': '6 months after enrollment'}, {'id': 'OG002', 'title': 'Month 12', 'description': '12 months after enrollment'}, {'id': 'OG003', 'title': 'Month 24', 'description': '24 months after enrollment'}, {'id': 'OG004', 'title': 'Month 36', 'description': '36 months after enrollment'}, {'id': 'OG005', 'title': 'Month 48', 'description': '48 months after enrollment'}, {'id': 'OG006', 'title': 'Month 60', 'description': '60 months after enrollment'}], 'classes': [{'title': 'Household', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3368', 'groupId': 'OG000'}, {'value': '2666', 'groupId': 'OG001'}, {'value': '2199', 'groupId': 'OG002'}, {'value': '1572', 'groupId': 'OG003'}, {'value': '1093', 'groupId': 'OG004'}, {'value': '784', 'groupId': 'OG005'}, {'value': '574', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '56.9', 'spread': '64.3', 'groupId': 'OG000'}, {'value': '27.7', 'spread': '50.6', 'groupId': 'OG001'}, {'value': '22.4', 'spread': '46.1', 'groupId': 'OG002'}, {'value': '20.6', 'spread': '46.3', 'groupId': 'OG003'}, {'value': '18.2', 'spread': '43.7', 'groupId': 'OG004'}, {'value': '19.2', 'spread': '46.1', 'groupId': 'OG005'}, {'value': '16.1', 'spread': '39.8', 'groupId': 'OG006'}]}]}, {'title': 'Child-rearing/parenting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1220', 'groupId': 'OG000'}, {'value': '1068', 'groupId': 'OG001'}, {'value': '896', 'groupId': 'OG002'}, {'value': '654', 'groupId': 'OG003'}, {'value': '435', 'groupId': 'OG004'}, {'value': '300', 'groupId': 'OG005'}, {'value': '195', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '15.1', 'spread': '41.6', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '23.1', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '18.1', 'groupId': 'OG002'}, {'value': '2.8', 'spread': '18.4', 'groupId': 'OG003'}, {'value': '1.9', 'spread': '13.6', 'groupId': 'OG004'}, {'value': '3.0', 'spread': '19.7', 'groupId': 'OG005'}, {'value': '1.6', 'spread': '8.2', 'groupId': 'OG006'}]}]}, {'title': 'Educational', 'denoms': [{'units': 'Participants', 'counts': [{'value': '975', 'groupId': 'OG000'}, {'value': '887', 'groupId': 'OG001'}, {'value': '750', 'groupId': 'OG002'}, {'value': '558', 'groupId': 'OG003'}, {'value': '379', 'groupId': 'OG004'}, {'value': '257', 'groupId': 'OG005'}, {'value': '168', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '8.3', 'spread': '31.6', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '17.1', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '13.3', 'groupId': 'OG002'}, {'value': '1.1', 'spread': '10.1', 'groupId': 'OG003'}, {'value': '1.0', 'spread': '10.1', 'groupId': 'OG004'}, {'value': '0.9', 'spread': '11.5', 'groupId': 'OG005'}, {'value': '1.4', 'spread': '12.6', 'groupId': 'OG006'}]}]}, {'title': 'Recreational', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3101', 'groupId': 'OG000'}, {'value': '2467', 'groupId': 'OG001'}, {'value': '2000', 'groupId': 'OG002'}, {'value': '1426', 'groupId': 'OG003'}, {'value': '1016', 'groupId': 'OG004'}, {'value': '728', 'groupId': 'OG005'}, {'value': '532', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '59.1', 'spread': '65.6', 'groupId': 'OG000'}, {'value': '28.3', 'spread': '50.9', 'groupId': 'OG001'}, {'value': '23.0', 'spread': '47.4', 'groupId': 'OG002'}, {'value': '19.5', 'spread': '45.0', 'groupId': 'OG003'}, {'value': '18.5', 'spread': '44.9', 'groupId': 'OG004'}, {'value': '19.1', 'spread': '46.0', 'groupId': 'OG005'}, {'value': '16.3', 'spread': '41.7', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6, 12, 24, 36, 48, and 60 months', 'description': 'Patients reported the number of days that sickness affected non-occupational activities in four categories: household, child-rearing/parenting, education, and recreational (free-time). Participants with no impairment were considered to have 0 days.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Duration of Morning Stiffness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4370', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4370', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '65.3', 'spread': '72.8', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4222', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '34.6', 'spread': '55.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3617', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27.4', 'spread': '44.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2931', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24.2', 'spread': '43.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2070', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.9', 'spread': '39.8', 'groupId': 'OG000'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.0', 'spread': '41.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1034', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.0', 'spread': '29.8', 'groupId': 'OG000'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '743', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.2', 'spread': '32.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3, 6, 12, 24, 36, 48, and 60 months', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.'}, {'type': 'SECONDARY', 'title': "Participant's Assessment of Pain", 'denoms': [{'units': 'Participants', 'counts': [{'value': '4455', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4455', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.1', 'spread': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4178', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '2.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3582', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '2.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2901', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '2.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2045', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1415', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1004', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '730', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '2.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3, 6, 12, 24, 36, 48, and 60 months', 'description': 'Participants were asked to evaluate their level of pain in the past 7 days on a scale from 0 (no pain) to 10 (unbearable pain).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.'}, {'type': 'SECONDARY', 'title': "Participant's Assessment of Fatigue", 'denoms': [{'units': 'Participants', 'counts': [{'value': '4449', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4449', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.8', 'spread': '2.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4180', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '2.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3580', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '2.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2901', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': '2.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2046', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '2.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1418', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1005', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '732', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '2.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3, 6, 12, 24, 36, 48, and 60 months', 'description': 'Participants were asked to indicate how much they had suffered from abnormal exhaustion and fatigue during the past 7 days on a scale from 0 (none) to 10 (strongly).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Taking Concomitant RA Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4466', 'groupId': 'OG000'}, {'value': '4466', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Month 0 - at enrollment'}, {'id': 'OG001', 'title': 'Any Visit', 'description': 'From baseline to month 60'}], 'classes': [{'title': 'Methotrexate', 'categories': [{'measurements': [{'value': '53.4', 'groupId': 'OG000'}, {'value': '58.6', 'groupId': 'OG001'}]}]}, {'title': 'Leflunomide', 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000'}, {'value': '13.0', 'groupId': 'OG001'}]}]}, {'title': 'Sulfasalazine', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '4.1', 'groupId': 'OG001'}]}]}, {'title': 'Analgesics', 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}]}]}, {'title': 'NSAIDs or coxibs', 'categories': [{'measurements': [{'value': '22.1', 'groupId': 'OG000'}, {'value': '24.2', 'groupId': 'OG001'}]}]}, {'title': 'Systemic glucocorticoids', 'categories': [{'measurements': [{'value': '68.1', 'groupId': 'OG000'}, {'value': '73.4', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '9.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to month 60', 'description': 'Assessment of concomitant medications included disease-modifying antirheumatic drugs (DMARDs) (methotrexate, Leflunomid, sulfasalazine), systemic glucocorticoids, non-steroidal anti-inflammatory drugs (NSAIDs), Cox-2 inhibitors (coxibs), analgesics and others.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set).'}, {'type': 'SECONDARY', 'title': 'Patient Assessment of Adalimumab Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4007', 'groupId': 'OG000'}, {'value': '3452', 'groupId': 'OG001'}, {'value': '2814', 'groupId': 'OG002'}, {'value': '1983', 'groupId': 'OG003'}, {'value': '1366', 'groupId': 'OG004'}, {'value': '971', 'groupId': 'OG005'}, {'value': '716', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Month 3', 'description': '3 months after enrollment'}, {'id': 'OG001', 'title': 'Month 6', 'description': '6 months after enrollment'}, {'id': 'OG002', 'title': 'Month 12', 'description': '12 months after enrollment'}, {'id': 'OG003', 'title': 'Month 24', 'description': '24 months after enrollment'}, {'id': 'OG004', 'title': 'Month 36', 'description': '36 months after enrollment'}, {'id': 'OG005', 'title': 'Month 48', 'description': '48 months after enrollment'}, {'id': 'OG006', 'title': 'Month 60', 'description': '60 months after enrollment'}], 'classes': [{'title': 'Considerably better', 'categories': [{'measurements': [{'value': '35.6', 'groupId': 'OG000'}, {'value': '39.6', 'groupId': 'OG001'}, {'value': '46.3', 'groupId': 'OG002'}, {'value': '51.6', 'groupId': 'OG003'}, {'value': '51.5', 'groupId': 'OG004'}, {'value': '55.5', 'groupId': 'OG005'}, {'value': '53.6', 'groupId': 'OG006'}]}]}, {'title': 'Better', 'categories': [{'measurements': [{'value': '36.6', 'groupId': 'OG000'}, {'value': '39.7', 'groupId': 'OG001'}, {'value': '37.3', 'groupId': 'OG002'}, {'value': '37.1', 'groupId': 'OG003'}, {'value': '40.4', 'groupId': 'OG004'}, {'value': '38.1', 'groupId': 'OG005'}, {'value': '38.8', 'groupId': 'OG006'}]}]}, {'title': 'About the same', 'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000'}, {'value': '14.9', 'groupId': 'OG001'}, {'value': '12.2', 'groupId': 'OG002'}, {'value': '9.1', 'groupId': 'OG003'}, {'value': '6.7', 'groupId': 'OG004'}, {'value': '5.6', 'groupId': 'OG005'}, {'value': '5.6', 'groupId': 'OG006'}]}]}, {'title': 'Worse', 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}, {'value': '3.8', 'groupId': 'OG002'}, {'value': '1.9', 'groupId': 'OG003'}, {'value': '1.3', 'groupId': 'OG004'}, {'value': '0.5', 'groupId': 'OG005'}, {'value': '1.1', 'groupId': 'OG006'}]}]}, {'title': 'Noticeably worse', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '0.4', 'groupId': 'OG002'}, {'value': '0.3', 'groupId': 'OG003'}, {'value': '0.1', 'groupId': 'OG004'}, {'value': '0.3', 'groupId': 'OG005'}, {'value': '0.8', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 3, 6, 12, 24, 36, 48, and 60', 'description': 'Participants were asked to rate therapy with adalimumab in comparison with other previous therapies according to the following response options:\n\n* Considerably better\n* Better\n* About the same\n* Worse\n* Noticeably worse', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), with available data at each time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Adalimumab', 'description': 'Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7229'}]}, {'type': 'COMPLETED', 'comment': 'Participants who were ongoing at the 60 month visit.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1210'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6019'}]}], 'dropWithdraws': [{'type': 'Adverse Drug Reaction', 'reasons': [{'groupId': 'FG000', 'numSubjects': '299'}]}, {'type': 'Lack of Effectiveness', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1423'}]}, {'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1075'}]}, {'type': 'Unknown Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '71'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3151'}]}]}], 'recruitmentDetails': 'Adults with rheumatoid arthritis (RA) were enrolled at 326 clinical centers in Germany and seen during regular visits for routine clinical care.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7229', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Adalimumab', 'description': 'Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7165', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '54.9', 'spread': '13.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants with available data'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7176', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5267', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1909', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants with available data'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Duration of Disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7039', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '9.6', 'spread': '8.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants with available data'}, {'title': 'Number of Missed Work Days in Last 6 Months', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3887', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '19.9', 'spread': '41.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants who were employed part-time or full-time'}, {'title': 'Work Productivity and Activity Impairment', 'classes': [{'title': 'Absenteeism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2362', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '21.4', 'spread': '36.9', 'groupId': 'BG000'}]}]}, {'title': 'Presenteeism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3046', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '47.2', 'spread': '27.3', 'groupId': 'BG000'}]}]}, {'title': 'Total work productivity impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2124', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '50.9', 'spread': '29.2', 'groupId': 'BG000'}]}]}, {'title': 'Total activity impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6862', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '54.9', 'spread': '25.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes.', 'unitOfMeasure': 'percent impairment', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants with available WPAI data; The first 3 scores were assessed in participants who were employed.'}, {'title': 'Work Activity Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2183', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '32.1', 'spread': '7.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The WAI is a tool designed to record the work ability of employees and consists of 7 questions. The modified WAI used in this study included Questions 1, 2, 4, 6, and 7 of the WAI. Question 3, which involves the number of current diseases diagnosed by a physician, was omitted because this parameter was unlikely to reflect change due to treatment. Question 5 (sick leave during the past year) was replaced with the previous question concerning sick leave days. WAI scores range from 7 (worst) to 49 (best).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants who were employed part-time or full-time'}, {'title': 'Disease Activity Score - 28 Joints (DAS28)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6132', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4.63', 'spread': '1.51', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \\> 5.1 indicates high disease activity, a DAS28 score \\< 3.2 indicates low disease activity, and a DAS28 score \\< 2.6 indicates clinical remission.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants with available data'}, {'title': 'Tender Joint Count', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7111', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7.4', 'spread': '6.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.', 'unitOfMeasure': 'joints', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants with available data'}, {'title': 'Swollen Joint Count', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7111', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5.0', 'spread': '5.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.', 'unitOfMeasure': 'joints', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants with available data'}, {'title': 'Erythrocyte Sedimentation Rate', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6348', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '26.5', 'spread': '21.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm/hr', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants with available data'}, {'title': 'C-reactive Protein', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6764', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '17.3', 'spread': '48.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/L', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants with available data'}, {'title': 'Health-Assessment Questionnaire-Disability Index (HAQ-DI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6977', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.19', 'spread': '0.74', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The HAQ-DI is a patient-reported assessment of physical function that includes 20 items in eight categories representing a comprehensive set of functional activities, including dressing, eating, walking, and hygiene. Patients are asked about their ability to complete these tasks in the past week on the following scale: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst), with a higher score representing a high-dependency disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants with available data'}, {'title': 'Euroqol Visual Analog Scale (VAS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6912', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '52.2', 'spread': '22.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'EuroQol-5 Dimensions (EQ-5D) is a generic instrument for measuring health-related quality of life. The VAS is a vertical scale ranging from 0 to 100 that provides a patient-reported assessment of overall health. Patients are asked to mark how good or bad their health is on that day, with 100 meaning "the best health you can imagine" and 0 meaning "the worst health you can imagine."', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants with available data'}], 'populationDescription': 'The safety set included all enrolled participants who received at least one dose of adalimumab.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2008-10-28', 'size': 555290, 'label': 'Study Protocol and Statistical Analysis Plan: original', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-09-07T10:50', 'hasProtocol': True}, {'date': '2012-03-06', 'size': 1033340, 'label': 'Study Protocol: amendment', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-09-07T10:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7229}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-10', 'studyFirstSubmitDate': '2010-02-24', 'resultsFirstSubmitDate': '2018-09-10', 'studyFirstSubmitQcDate': '2010-02-24', 'lastUpdatePostDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-10', 'studyFirstPostDateStruct': {'date': '2010-02-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Number of Missed Working Days Due to Sick Leave in the Past 6 Months', 'timeFrame': 'Baseline and 6, 12, 24, 36, 48, and 60 months', 'description': 'Primary effectiveness outcomes related to employment were performed in patients who were employed part- or full-time at baseline. Sick leave days were based on patient recall.'}, {'measure': 'Percentage of Participants With > 5 Missed Working Days Due to Sick Leave in the Past 6 Months', 'timeFrame': 'Baseline, 6, 12, 24, 36, 48, and 60 months', 'description': 'Primary effectiveness outcomes related to employment were performed in patients who were employed part- or full-time at baseline. Sick leave days were based on patient recall.'}, {'measure': 'Change From Baseline in Work Productivity and Activity Impairment: Absenteeism', 'timeFrame': 'Baseline and 3, 6, 12, 24, 36, 48, and 60 months', 'description': 'The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health.\n\nWPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes.'}, {'measure': 'Change From Baseline in Work Productivity and Activity Impairment: Presenteeism', 'timeFrame': 'Baseline and 3, 6, 12, 24, 36, 48, and 60 months', 'description': 'The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health.\n\nWPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes.'}, {'measure': 'Change From Baseline in Work Productivity and Activity Impairment: Total Work Productivity Impairment', 'timeFrame': 'Baseline and 3, 6, 12, 24, 36, 48, and 60 months', 'description': 'The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health.\n\nWPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes.'}, {'measure': 'Change From Baseline in Work Productivity and Activity Impairment: Total Activity Impairment', 'timeFrame': 'Baseline and 3, 6, 12, 24, 36, 48, and 60 months', 'description': 'The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health.\n\nWPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes.'}, {'measure': 'Change From Baseline in Work Activity Index (WAI)', 'timeFrame': 'Baseline and 6, 12, 24, 36, 48, and 60 months', 'description': 'The WAI is a tool designed to record the work ability of employees and consists of 7 questions. The modified WAI used in this study included Questions 1, 2, 4, 6, and 7 of the WAI. Question 3, which involves the number of current diseases diagnosed by a physician, was omitted because this parameter was unlikely to reflect change due to treatment. Question 5 (sick leave during the past year) was replaced with the previous question concerning sick leave days.WAI scores range from 7 (worst) to 49 (best).'}, {'measure': 'Change From Baseline in Disease Activity Score - 28 Joints (DAS28)', 'timeFrame': 'Baseline and 3, 6, 12, 24, 36, 48, and 60 months', 'description': "The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \\> 5.1 indicates high disease activity, a DAS28 score \\< 3.2 indicates low disease activity, and a DAS28 score \\< 2.6 indicates clinical remission."}, {'measure': 'Change From Baseline in Tender Joint Count', 'timeFrame': 'Baseline and 3, 6, 12, 24, 36, 48, and 60 months', 'description': 'Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.'}, {'measure': 'Change From Baseline in Swollen Joint Count', 'timeFrame': 'Baseline and 3, 6, 12, 24, 36, 48, and 60 months', 'description': 'Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.'}, {'measure': 'Change From Baseline in Erythrocyte Sedimentation Rate', 'timeFrame': 'Baseline and 3, 6, 12, 24, 36, 48, and 60 months'}, {'measure': 'Change From Baseline in C-reactive Protein', 'timeFrame': 'Baseline and 3, 6, 12, 24, 36, 48, and 60 months'}, {'measure': 'Change From Baseline in Health-Assessment Questionnaire-Disability Index (HAQ-DI)', 'timeFrame': 'Baseline and 3, 6, 12, 24, 36, 48, and 60 months', 'description': 'The HAQ-DI is a patient-reported assessment of physical function that includes 20 items in eight categories representing a comprehensive set of functional activities, including dressing, eating, walking, and hygiene. Patients are asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst), with a higher score representing a high-dependency disability.'}, {'measure': 'EuroQol-5 Dimensions (EQ-5D) Scores', 'timeFrame': 'Baseline and 3, 6, 12, 24, 36, 48, and 60 months', 'description': 'The EuroQol-5 Dimensions (EQ-5D) is a generic instrument for measuring health-related quality of life. The patient questionnaire consists of two parts. The first part includes statements for the following five areas (dimensions):\n\n* agility/mobility\n* self-care\n* usual activities\n* pain, bodily discomfort\n* anxiety, depression\n\nFor each dimension the patient is asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3).'}, {'measure': 'Change From Baseline in Euroqol Visual Analog Scale (VAS)', 'timeFrame': 'Baseline and 3, 6, 12, 24, 36, 48, and 60 months', 'description': 'EuroQol-5 Dimensions (EQ-5D): The EQ-5D is a generic instrument for measuring health-related quality of life. The patient questionnaire consists of two parts. The second part is a vertical, thermometer-like, VAS ranging from 0 to 100 that provides a patient-reported assessment of overall health. Patients are asked to mark how good or bad their health is on that day, with 100 meaning "the best health you can imagine" and 0 meaning "the worst health you can imagine."'}], 'secondaryOutcomes': [{'measure': 'Number of Physician Visits in Past 6 Months', 'timeFrame': 'Baseline, 6, 12, 24, 36, 48, and 60 months', 'description': 'Participants self-reported the number of physician visits they had in the past 6 months.'}, {'measure': 'Number of Inpatient Hospitalizations in Past 6 Months', 'timeFrame': 'Baseline, 6, 12, 24, 36, 48, and 60 months', 'description': 'Participants self-reported the number of hospitalizations they had in the past 6 months.'}, {'measure': 'Duration of Inpatient Hospitalizations in Past 6 Months', 'timeFrame': 'Baseline, 6, 12, 24, 36, 48, and 60 months', 'description': 'Participants who had been hospitalized were asked how many days they were hospitalized in the past 6 months.'}, {'measure': 'Number of Days With Impairment of Non-Occupational Activities in Past 6 Months', 'timeFrame': 'Baseline, 6, 12, 24, 36, 48, and 60 months', 'description': 'Patients reported the number of days that sickness affected non-occupational activities in four categories: household, child-rearing/parenting, education, and recreational (free-time). Participants with no impairment were considered to have 0 days.'}, {'measure': 'Duration of Morning Stiffness', 'timeFrame': 'Baseline and 3, 6, 12, 24, 36, 48, and 60 months'}, {'measure': "Participant's Assessment of Pain", 'timeFrame': 'Baseline and 3, 6, 12, 24, 36, 48, and 60 months', 'description': 'Participants were asked to evaluate their level of pain in the past 7 days on a scale from 0 (no pain) to 10 (unbearable pain).'}, {'measure': "Participant's Assessment of Fatigue", 'timeFrame': 'Baseline and 3, 6, 12, 24, 36, 48, and 60 months', 'description': 'Participants were asked to indicate how much they had suffered from abnormal exhaustion and fatigue during the past 7 days on a scale from 0 (none) to 10 (strongly).'}, {'measure': 'Percentage of Participants Taking Concomitant RA Medications', 'timeFrame': 'Baseline to month 60', 'description': 'Assessment of concomitant medications included disease-modifying antirheumatic drugs (DMARDs) (methotrexate, Leflunomid, sulfasalazine), systemic glucocorticoids, non-steroidal anti-inflammatory drugs (NSAIDs), Cox-2 inhibitors (coxibs), analgesics and others.'}, {'measure': 'Patient Assessment of Adalimumab Therapy', 'timeFrame': 'Months 3, 6, 12, 24, 36, 48, and 60', 'description': 'Participants were asked to rate therapy with adalimumab in comparison with other previous therapies according to the following response options:\n\n* Considerably better\n* Better\n* About the same\n* Worse\n* Noticeably worse'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Work Productivity', 'Long-term Observation', 'Humira', 'Quality of Life', 'Rheumatoid Arthritis'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '32206973', 'type': 'DERIVED', 'citation': 'Behrens F, Tony HP, Koehm M, Schwaneck EC, Gnann H, Greger G, Burkhardt H, Schmalzing M. Sustained improvement in work outcomes in employed patients with rheumatoid arthritis during 2 years of adalimumab therapy: an observational cohort study. Clin Rheumatol. 2020 Sep;39(9):2583-2592. doi: 10.1007/s10067-020-05038-y. Epub 2020 Mar 23.'}, {'pmid': '31867564', 'type': 'DERIVED', 'citation': 'Behrens F, Koehm M, Schwaneck EC, Schmalzing M, Gnann H, Greger G, Tony HP, Burkhardt H. Use of a "critical difference" statistical criterion improves the predictive utility of the Health Assessment Questionnaire-Disability Index score in patients with rheumatoid arthritis. BMC Rheumatol. 2019 Dec 10;3:51. doi: 10.1186/s41927-019-0095-2. eCollection 2019.'}], 'seeAlsoLinks': [{'url': 'http://rxabbvie.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The AGIL study was designed to evaluate the effectiveness and safety of adalimumab over 5 years in routine daily clinical practice in Germany, with a focus on the impact of therapy on employment-related outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community sample: Patients with rheumatoid arthritis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate to severe active rheumatoid arthritis in adults with insufficient response to disease-modifying antirheumatic drugs\n* Inclusive methotrexate\n* Moderate to severe active rheumatoid arthritis in adults who have not been treated with methotrexate before; In case of incompatibility with methotrexate, Humira can be used as monotherapy.\n\nExclusion Criteria:\n\n* Hypersensitivity against the drug or one of the other ingredients\n* Active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections)\n* Moderate to severe cardiac insufficiency'}, 'identificationModule': {'nctId': 'NCT01076205', 'acronym': 'AGIL', 'briefTitle': 'Safety and Effect on Quality of Life/Work Productivity of Humira in Patients With Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Long Term Documentation of the Safety and Efficacy as Well as the Effects on Quality of Life and Work Productivity in Patients With Rheumatoid Arthritis Under HUMIRA® (Adalimumab) in Routine Clinical Practice (AGIL)', 'orgStudyIdInfo': {'id': 'P11-973'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adalimumab', 'description': 'Adults with moderate to severe active rheumatoid arthritis (RA) who initiated adalimumab therapy during routine clinical care.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Henning Kleine, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie Deutschland GmbH & Co. KG, Medical Department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie (prior sponsor, Abbott)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}