Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-01 @ 8:17 AM
Study NCT ID:
NCT01077258
Status:
COMPLETED
Last Update Posted:
2014-04-25
First Post:
2010-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Adalimumab in Patients With Rheumatoid Arthritis in Routine Clinical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'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': 'Adverse events (AEs) were collected throughout the 24-month period.', 'description': 'During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).', 'eventGroups': [{'id': 'EG000', 'title': 'Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.', 'otherNumAtRisk': 4208, 'otherNumAffected': 0, 'seriousNumAtRisk': 4208, 'seriousNumAffected': 245}], 'seriousEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Rash pustular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Localized infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Acute tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Chronic sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Device-related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Encephalitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Furuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Genital herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Herpes virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Infection susceptibility increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Mastoiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Pneumocystis jiroveci pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Pneumonia staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Pyothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Sinobronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Vulvovaginal mycotic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Infection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Unevaluable event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Injection site urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Condition aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Disease recurrence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Injection site scab', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Local swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Mucosal dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Peripheral edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Pruritus generalized', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Nail discoloration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Pustular psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Skin reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Cutaneous vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Lichenoid keratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Rash generalized', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Skin discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Skin nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Swelling face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Alveolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Alveolitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Dry throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Hypercapnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Upper airway obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Acute abdomen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Glossodynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Hematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Hypoesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Mouth edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Swollen tongue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Tongue blistering', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Tongue disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 6}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Joint arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 4}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Synovectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Injection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Antibiotic therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Arthrodesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Esophageal operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Mastoid operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Mastoidectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Rehabilitation therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Sinus operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Spinal operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Stent placement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Therapy cessation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Vertebroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Anosmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Hypogeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Neurological symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Transient ischemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Congestive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Thoracic vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Bloody airway discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Wound secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Joint effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Fasciitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Lupus-like syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Skin cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Skin papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Bronchial carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Large intestine cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Laryngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Metastases to liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Papillary tumor of renal pelvis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Urteric cancer local', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Eyelid edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Eyelid exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Eyelids pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Xerophthalmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Arthroscopy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Antinuclar antibody positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Arteriogram coronary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'DNA antibody positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Electrophoresis protein abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Transaminase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Panic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Bladder tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Chromaturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Cystitis hemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Micturition urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Anemia hemolytic autoimmune', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Uterine prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Hepatotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}, {'term': 'Electrolyte imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4208, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v12.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Disease Activity Score (DAS) 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2950', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.'}], 'classes': [{'title': 'Month 3 (n=2620)', 'categories': [{'measurements': [{'value': '-1.5', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=2243', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 9 (n=1877)', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=1776)', 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 18 (n=1519)', 'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 24 (n=1248)', 'categories': [{'measurements': [{'value': '-2.2', 'spread': '1.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 18, and 24', 'description': "The Disease Activity Score 28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (on a visual analog scale \\[VAS\\] from 0 to 10 cm) are included in the DAS28 score. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. 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': 'Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. "n" indicates the number of participants with available data at each time point.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants in DAS28 Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2950', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.'}], 'classes': [{'title': 'Month 3 (n=2620)', 'categories': [{'measurements': [{'value': '18.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=2243)', 'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 9 (n=1877)', 'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=1776)', 'categories': [{'measurements': [{'value': '27.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 18 (n=1519)', 'categories': [{'measurements': [{'value': '29.8', 'groupId': 'OG000'}]}]}, {'title': 'Month 24 (n=1248)', 'categories': [{'measurements': [{'value': '34.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 3, 6, 9, 12, 18, and 24', 'description': "Clinical remission is defined as a disease activity score (DAS) 28 score of \\< 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale \\[VAS\\] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data at each time point (indicated by n)'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Significant Therapeutic Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2950', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.'}], 'classes': [{'title': 'Month 3 (n=2620)', 'categories': [{'measurements': [{'value': '38.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=2243)', 'categories': [{'measurements': [{'value': '49.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 9 (n=1877)', 'categories': [{'measurements': [{'value': '54.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=1776)', 'categories': [{'measurements': [{'value': '56.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 18 (n=1519)', 'categories': [{'measurements': [{'value': '60.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 24 (n=1248)', 'categories': [{'measurements': [{'value': '61.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 18, and 24', 'description': "Significant therapeutic response was determined by DAS28 critical difference (Dcrit). A Dcrit response is a statistically determined value that exceeds the threshold of random fluctuation and signifies a positive individual response during treatment. A DAS28-Dcrit individual therapeutic response is defined as a decrease (improvement) in DAS28 from Baseline of ≥ 1.8.\n\nThe DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale \\[VAS\\] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data at each time point (indicated by n)'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Low, Moderate and High Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2950', 'groupId': 'OG000'}, {'value': '2620', 'groupId': 'OG001'}, {'value': '2243', 'groupId': 'OG002'}, {'value': '1877', 'groupId': 'OG003'}, {'value': '1776', 'groupId': 'OG004'}, {'value': '1519', 'groupId': 'OG005'}, {'value': '1248', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Month 0', 'description': 'Baseline'}, {'id': 'OG001', 'title': 'Month 3', 'description': '3 months after inclusion'}, {'id': 'OG002', 'title': 'Month 6', 'description': '6 months after inclusion'}, {'id': 'OG003', 'title': 'Month 9', 'description': '9 months after inclusion'}, {'id': 'OG004', 'title': 'Month 12', 'description': '12 months after inclusion'}, {'id': 'OG005', 'title': 'Month 18', 'description': '18 months after inclusion'}, {'id': 'OG006', 'title': 'Month 24', 'description': '24 months after inclusion'}], 'classes': [{'title': 'Low disease activity', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '30.2', 'groupId': 'OG001'}, {'value': '36.5', 'groupId': 'OG002'}, {'value': '41.8', 'groupId': 'OG003'}, {'value': '43.7', 'groupId': 'OG004'}, {'value': '46.7', 'groupId': 'OG005'}, {'value': '51.4', 'groupId': 'OG006'}]}]}, {'title': 'Moderate disease ctivity', 'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000'}, {'value': '45.9', 'groupId': 'OG001'}, {'value': '45.6', 'groupId': 'OG002'}, {'value': '43.9', 'groupId': 'OG003'}, {'value': '43.1', 'groupId': 'OG004'}, {'value': '41.7', 'groupId': 'OG005'}, {'value': '37.7', 'groupId': 'OG006'}]}]}, {'title': 'High disease activity', 'categories': [{'measurements': [{'value': '64.3', 'groupId': 'OG000'}, {'value': '23.9', 'groupId': 'OG001'}, {'value': '17.9', 'groupId': 'OG002'}, {'value': '14.3', 'groupId': 'OG003'}, {'value': '13.2', 'groupId': 'OG004'}, {'value': '11.6', 'groupId': 'OG005'}, {'value': '10.9', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 18, and 24', 'description': "The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale \\[VAS\\] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.\n\nLow disease activity is defined as a DAS28 score ≤ 3.2; Moderate disease activity as a DAS28 \\>3.2 to ≤5.1; High disease activity as a DAS28 \\>5.1.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data at each time point'}, {'type': 'SECONDARY', 'title': 'Erythrocyte Sedimentation Rate (ESR) Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2950', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.'}], 'classes': [{'title': 'Month 0 (n=2900)', 'categories': [{'measurements': [{'value': '32.1', 'spread': '22.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=2684)', 'categories': [{'measurements': [{'value': '23.2', 'spread': '20.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=2259)', 'categories': [{'measurements': [{'value': '22.1', 'spread': '19.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 9 (n=1910)', 'categories': [{'measurements': [{'value': '21.6', 'spread': '18.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=1805)', 'categories': [{'measurements': [{'value': '21.4', 'spread': '17.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 18 (n=1515)', 'categories': [{'measurements': [{'value': '21.0', 'spread': '17.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 24 (n=1263)', 'categories': [{'measurements': [{'value': '21.2', 'spread': '18.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 18, and 24', 'description': 'Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.', 'unitOfMeasure': 'mm/hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data at each time point (indicated by n)'}, {'type': 'SECONDARY', 'title': 'C-Reactive Protein (CRP) Levels Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2950', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.'}], 'classes': [{'title': 'Month 0 (n=2899)', 'categories': [{'measurements': [{'value': '20.0', 'spread': '36.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=2677)', 'categories': [{'measurements': [{'value': '11.9', 'spread': '31.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=2289)', 'categories': [{'measurements': [{'value': '9.2', 'spread': '19.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 9 (n=1936)', 'categories': [{'measurements': [{'value': '8.1', 'spread': '15.8', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=1813)', 'categories': [{'measurements': [{'value': '8.0', 'spread': '17.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 18 (n=1537)', 'categories': [{'measurements': [{'value': '6.6', 'spread': '11.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 24 (n=1297)', 'categories': [{'measurements': [{'value': '5.7', 'spread': '10.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 18, and 24', 'description': 'C-Reactive Protein (CRP) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 10 mg/L, slightly increasing with age.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data at each time point (indicated by n)'}, {'type': 'SECONDARY', 'title': 'Tender Joint Count (TJC) Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2950', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.'}], 'classes': [{'title': 'Month 0 (n=2950)', 'categories': [{'measurements': [{'value': '10.6', 'spread': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=2778)', 'categories': [{'measurements': [{'value': '5.4', 'spread': '6.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=2393)', 'categories': [{'measurements': [{'value': '4.3', 'spread': '5.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 9 (n=2010)', 'categories': [{'measurements': [{'value': '3.9', 'spread': '5.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=1886)', 'categories': [{'measurements': [{'value': '3.6', 'spread': '5.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 18 (n=1621)', 'categories': [{'measurements': [{'value': '3.4', 'spread': '4.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 24 (n=1339)', 'categories': [{'measurements': [{'value': '3.1', 'spread': '4.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 18, and 24', 'description': 'Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.', 'unitOfMeasure': 'tender joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data at each time point (indicated by n)'}, {'type': 'SECONDARY', 'title': 'Swollen Joint Count (SJC) Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2950', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.'}], 'classes': [{'title': 'Month 0 (n=2950)', 'categories': [{'measurements': [{'value': '7.7', 'spread': '5.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=2768)', 'categories': [{'measurements': [{'value': '3.7', 'spread': '4.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=2375)', 'categories': [{'measurements': [{'value': '3.0', 'spread': '4.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 9 (n=2003)', 'categories': [{'measurements': [{'value': '2.6', 'spread': '3.8', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=1868)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '3.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 18 (n=1609)', 'categories': [{'measurements': [{'value': '2.1', 'spread': '3.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 24 (n=1326)', 'categories': [{'measurements': [{'value': '2.0', 'spread': '3.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 18, and 24', 'description': 'Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.', 'unitOfMeasure': 'swollen joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data at each time point (indicated by n)'}, {'type': 'SECONDARY', 'title': 'Hannover Functional Questionnaire (FFbH) Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2950', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.'}], 'classes': [{'title': 'Month 0 (n=2938)', 'categories': [{'measurements': [{'value': '61.9', 'spread': '22.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=2755)', 'categories': [{'measurements': [{'value': '68.4', 'spread': '22.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=2369)', 'categories': [{'measurements': [{'value': '70.4', 'spread': '22.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 9 (n=1997)', 'categories': [{'measurements': [{'value': '71.3', 'spread': '22.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=1882)', 'categories': [{'measurements': [{'value': '71.9', 'spread': '22.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 18 (n=1623)', 'categories': [{'measurements': [{'value': '72.4', 'spread': '22.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 24 (n=1341)', 'categories': [{'measurements': [{'value': '72.7', 'spread': '22.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 18, and 24', 'description': 'A self-administered patient questionnaire used to assess patient function based on 18 questions. The numerically coded responses to the questions are added to provide a total patient score. The FFbH was calculated from this patient score by the following formula:\n\nFFbH = (patient score x 100) ÷ 2 (number of valid responses). The resulting FFbH score reflects the degree of remaining functional capacity where 0 indicates maximal impairment and 100 indicates maximal functional capacity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data at each time point (indicated by n)'}, {'type': 'SECONDARY', 'title': 'Patients Global Assessment of Disease Activity Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2950', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.'}], 'classes': [{'title': 'Month 0 (n=2950)', 'categories': [{'measurements': [{'value': '6.3', 'spread': '1.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=2731)', 'categories': [{'measurements': [{'value': '4.7', 'spread': '2.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=2353)', 'categories': [{'measurements': [{'value': '4.4', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 9 (n=1975)', 'categories': [{'measurements': [{'value': '4.2', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=1869)', 'categories': [{'measurements': [{'value': '4.1', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 18 (n=1609)', 'categories': [{'measurements': [{'value': '4.0', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 24 (n=1339)', 'categories': [{'measurements': [{'value': '3.8', 'spread': '2.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 18 and 24', 'description': 'Participants indicated their global assessment of disease activity over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data at each time point (indicated by n)'}, {'type': 'SECONDARY', 'title': 'Participants Assessment of Fatigue Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2950', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.'}], 'classes': [{'title': 'Month 0 (n=2940)', 'categories': [{'measurements': [{'value': '5.8', 'spread': '2.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=2727)', 'categories': [{'measurements': [{'value': '4.5', 'spread': '2.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=2351)', 'categories': [{'measurements': [{'value': '4.2', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 9 (n=1976)', 'categories': [{'measurements': [{'value': '4.0', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=1864)', 'categories': [{'measurements': [{'value': '4.0', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 18 (n=1608)', 'categories': [{'measurements': [{'value': '3.9', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 24 (n=1335)', 'categories': [{'measurements': [{'value': '3.7', 'spread': '2.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 3, 6, 9, 12, 18, and 24', 'description': 'Participants indicated their level of fatigue over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data at each time point (indicated by n)'}, {'type': 'SECONDARY', 'title': 'Participants Assessment of Pain Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2950', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.'}], 'classes': [{'title': 'Month 0 (n=2942)', 'categories': [{'measurements': [{'value': '6.4', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=2732)', 'categories': [{'measurements': [{'value': '4.5', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=2356)', 'categories': [{'measurements': [{'value': '4.2', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 9 (n=1973)', 'categories': [{'measurements': [{'value': '4.1', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=1866)', 'categories': [{'measurements': [{'value': '3.9', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 18 (n=1609)', 'categories': [{'measurements': [{'value': '3.9', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 24 (n=1339)', 'categories': [{'measurements': [{'value': '3.7', 'spread': '2.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 18, and 24', 'description': 'Participants indicated their level of pain over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data at each time point (indicated by n)'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Impairment in Daily Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2864', 'groupId': 'OG000'}, {'value': '2648', 'groupId': 'OG001'}, {'value': '2288', 'groupId': 'OG002'}, {'value': '1914', 'groupId': 'OG003'}, {'value': '1513', 'groupId': 'OG004'}, {'value': '1302', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Month 0', 'description': 'Baseline'}, {'id': 'OG001', 'title': 'Month 3', 'description': '3 months after inclusion'}, {'id': 'OG002', 'title': 'Month 6', 'description': '6 months after inclusion'}, {'id': 'OG003', 'title': 'Month 9', 'description': '9 months after inclusion'}, {'id': 'OG004', 'title': 'Month 18', 'description': '18 months after inclusion'}, {'id': 'OG005', 'title': 'Month 24', 'description': '24 months after inclusion'}], 'classes': [{'title': 'No days of impairment', 'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000'}, {'value': '35.8', 'groupId': 'OG001'}, {'value': '40.3', 'groupId': 'OG002'}, {'value': '45.7', 'groupId': 'OG003'}, {'value': '51.4', 'groupId': 'OG004'}, {'value': '52.1', 'groupId': 'OG005'}]}]}, {'title': 'Less than 7 days of impairment', 'categories': [{'measurements': [{'value': '28.5', 'groupId': 'OG000'}, {'value': '36.3', 'groupId': 'OG001'}, {'value': '35.5', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '30.0', 'groupId': 'OG004'}, {'value': '30.4', 'groupId': 'OG005'}]}]}, {'title': '7 to 14 days of impairment', 'categories': [{'measurements': [{'value': '28.8', 'groupId': 'OG000'}, {'value': '16.1', 'groupId': 'OG001'}, {'value': '14.9', 'groupId': 'OG002'}, {'value': '13.2', 'groupId': 'OG003'}, {'value': '12.0', 'groupId': 'OG004'}, {'value': '10.8', 'groupId': 'OG005'}]}]}, {'title': 'More than 14 days of impairment', 'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000'}, {'value': '11.7', 'groupId': 'OG001'}, {'value': '9.4', 'groupId': 'OG002'}, {'value': '7.8', 'groupId': 'OG003'}, {'value': '6.7', 'groupId': 'OG004'}, {'value': '6.7', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Months 3, 6, 9, 18, and 24', 'description': 'Participants were asked to report how many days of impairment in daily activities they had experienced in the last 4 weeks.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data at each time point'}, {'type': 'SECONDARY', 'title': 'Number of Days Missed From Work Due to Rheumatoid Arthritis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2950', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.'}], 'classes': [{'title': 'Month 0 (n=1168)', 'categories': [{'measurements': [{'value': '20.6', 'spread': '52.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=938)', 'categories': [{'measurements': [{'value': '9.9', 'spread': '33.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=728)', 'categories': [{'measurements': [{'value': '4.4', 'spread': '21.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 18 (n=604)', 'categories': [{'measurements': [{'value': '5.2', 'spread': '27.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 24 (n=507)', 'categories': [{'measurements': [{'value': '3.8', 'spread': '17.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Months 6, 12, 18, and 24', 'description': 'Participants reported the number of days they had missed from work in the prior 6 months. The Baseline measurement includes data for the prior 12 months.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set participants who were employed and with available data at each time point (indicated by n)'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With In-patient Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2950', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.'}], 'classes': [{'title': 'Baseline (n=2893)', 'categories': [{'measurements': [{'value': '21.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=2293)', 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=1844)', 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000'}]}]}, {'title': 'Month 18 (n=1584)', 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 24 (n=1320)', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6, 12, 18, and 24', 'description': 'The percentage of participants with in-patient hospitalization in the prior 6 months. Baseline data includes in-patient hospitalizations that occurred within the prior 12 months.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data at each time point (indicated by n)'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2950', 'groupId': 'OG000'}, {'value': '2820', 'groupId': 'OG001'}, {'value': '2415', 'groupId': 'OG002'}, {'value': '2041', 'groupId': 'OG003'}, {'value': '1917', 'groupId': 'OG004'}, {'value': '1651', 'groupId': 'OG005'}, {'value': '1372', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Month 0', 'description': 'Baseline'}, {'id': 'OG001', 'title': 'Month 3', 'description': '3 months after inclusion'}, {'id': 'OG002', 'title': 'Month 6', 'description': '6 months after inclusion'}, {'id': 'OG003', 'title': 'Month 9', 'description': '9 months after inclusion'}, {'id': 'OG004', 'title': 'Month 12', 'description': '12 months after inclusion'}, {'id': 'OG005', 'title': 'Month 18', 'description': '18 months after inclusion'}, {'id': 'OG006', 'title': 'Month 24', 'description': '24 months after inclusion'}], 'classes': [{'title': 'Methotrexate', 'categories': [{'measurements': [{'value': '54.0', 'groupId': 'OG000'}, {'value': '52.3', 'groupId': 'OG001'}, {'value': '53.2', 'groupId': 'OG002'}, {'value': '53.1', 'groupId': 'OG003'}, {'value': '53.2', 'groupId': 'OG004'}, {'value': '52.9', 'groupId': 'OG005'}, {'value': '51.0', 'groupId': 'OG006'}]}]}, {'title': 'Sulfasalazine', 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000'}, {'value': '3.7', 'groupId': 'OG001'}, {'value': '3.6', 'groupId': 'OG002'}, {'value': '3.2', 'groupId': 'OG003'}, {'value': '3.5', 'groupId': 'OG004'}, {'value': '3.3', 'groupId': 'OG005'}, {'value': '2.8', 'groupId': 'OG006'}]}]}, {'title': 'Hydroxychloroquine/Chloroquine', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}, {'value': '1.6', 'groupId': 'OG002'}, {'value': '1.2', 'groupId': 'OG003'}, {'value': '1.2', 'groupId': 'OG004'}, {'value': '1.3', 'groupId': 'OG005'}, {'value': '1.4', 'groupId': 'OG006'}]}]}, {'title': 'Leflunomide', 'categories': [{'measurements': [{'value': '22.1', 'groupId': 'OG000'}, {'value': '18.0', 'groupId': 'OG001'}, {'value': '15.9', 'groupId': 'OG002'}, {'value': '15.3', 'groupId': 'OG003'}, {'value': '15.0', 'groupId': 'OG004'}, {'value': '14.1', 'groupId': 'OG005'}, {'value': '12.7', 'groupId': 'OG006'}]}]}, {'title': 'Other disease-modifying antirheumatic drug', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '2.8', 'groupId': 'OG001'}, {'value': '2.5', 'groupId': 'OG002'}, {'value': '2.3', 'groupId': 'OG003'}, {'value': '2.0', 'groupId': 'OG004'}, {'value': '2.2', 'groupId': 'OG005'}, {'value': '2.1', 'groupId': 'OG006'}]}]}, {'title': 'Analgesics', 'categories': [{'measurements': [{'value': '21.8', 'groupId': 'OG000'}, {'value': '15.4', 'groupId': 'OG001'}, {'value': '14.9', 'groupId': 'OG002'}, {'value': '14.0', 'groupId': 'OG003'}, {'value': '12.9', 'groupId': 'OG004'}, {'value': '11.7', 'groupId': 'OG005'}, {'value': '12.0', 'groupId': 'OG006'}]}]}, {'title': 'Non-steroidal anti-inflammatory drug', 'categories': [{'measurements': [{'value': '46.1', 'groupId': 'OG000'}, {'value': '36.9', 'groupId': 'OG001'}, {'value': '34.2', 'groupId': 'OG002'}, {'value': '33.9', 'groupId': 'OG003'}, {'value': '32.7', 'groupId': 'OG004'}, {'value': '31.7', 'groupId': 'OG005'}, {'value': '30.5', 'groupId': 'OG006'}]}]}, {'title': 'Cyclo-oxygenase 2 (COX-2) Inhibitors', 'categories': [{'measurements': [{'value': '12.4', 'groupId': 'OG000'}, {'value': '10.4', 'groupId': 'OG001'}, {'value': '10.2', 'groupId': 'OG002'}, {'value': '9.6', 'groupId': 'OG003'}, {'value': '9.2', 'groupId': 'OG004'}, {'value': '9.6', 'groupId': 'OG005'}, {'value': '9.7', 'groupId': 'OG006'}]}]}, {'title': 'Systemic glucocorticoids', 'categories': [{'measurements': [{'value': '80.9', 'groupId': 'OG000'}, {'value': '73.4', 'groupId': 'OG001'}, {'value': '69.1', 'groupId': 'OG002'}, {'value': '65.7', 'groupId': 'OG003'}, {'value': '62.1', 'groupId': 'OG004'}, {'value': '58.8', 'groupId': 'OG005'}, {'value': '57.4', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 18, and 24', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data at each time point (indicated by n)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4208'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1640'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2568'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1390'}]}, {'type': 'Adverse drug reaction', 'reasons': [{'groupId': 'FG000', 'numSubjects': '218'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '663'}]}, {'type': 'Clinical remission', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}]}, {'type': 'Other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '260'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4208', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.6', 'spread': '13.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Age data was available for 4147 participants', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '3199', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '958', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Gender data available for 4157 participants', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '4208', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4208}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-09', 'studyFirstSubmitDate': '2010-02-25', 'resultsFirstSubmitDate': '2014-02-28', 'studyFirstSubmitQcDate': '2010-02-25', 'lastUpdatePostDateStruct': {'date': '2014-04-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-02-28', 'studyFirstPostDateStruct': {'date': '2010-03-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Disease Activity Score (DAS) 28', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 18, and 24', 'description': "The Disease Activity Score 28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (on a visual analog scale \\[VAS\\] from 0 to 10 cm) are included in the DAS28 score. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. 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': 'Percentage of Participants in DAS28 Remission', 'timeFrame': 'Months 3, 6, 9, 12, 18, and 24', 'description': "Clinical remission is defined as a disease activity score (DAS) 28 score of \\< 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale \\[VAS\\] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With a Significant Therapeutic Response', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 18, and 24', 'description': "Significant therapeutic response was determined by DAS28 critical difference (Dcrit). A Dcrit response is a statistically determined value that exceeds the threshold of random fluctuation and signifies a positive individual response during treatment. A DAS28-Dcrit individual therapeutic response is defined as a decrease (improvement) in DAS28 from Baseline of ≥ 1.8.\n\nThe DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale \\[VAS\\] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity."}, {'measure': 'Percentage of Participants With Low, Moderate and High Disease Activity', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 18, and 24', 'description': "The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale \\[VAS\\] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.\n\nLow disease activity is defined as a DAS28 score ≤ 3.2; Moderate disease activity as a DAS28 \\>3.2 to ≤5.1; High disease activity as a DAS28 \\>5.1."}, {'measure': 'Erythrocyte Sedimentation Rate (ESR) Over Time', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 18, and 24', 'description': 'Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.'}, {'measure': 'C-Reactive Protein (CRP) Levels Over Time', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 18, and 24', 'description': 'C-Reactive Protein (CRP) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 10 mg/L, slightly increasing with age.'}, {'measure': 'Tender Joint Count (TJC) Over Time', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 18, and 24', 'description': 'Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.'}, {'measure': 'Swollen Joint Count (SJC) Over Time', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 18, and 24', 'description': 'Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.'}, {'measure': 'Hannover Functional Questionnaire (FFbH) Over Time', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 18, and 24', 'description': 'A self-administered patient questionnaire used to assess patient function based on 18 questions. The numerically coded responses to the questions are added to provide a total patient score. The FFbH was calculated from this patient score by the following formula:\n\nFFbH = (patient score x 100) ÷ 2 (number of valid responses). The resulting FFbH score reflects the degree of remaining functional capacity where 0 indicates maximal impairment and 100 indicates maximal functional capacity.'}, {'measure': 'Patients Global Assessment of Disease Activity Over Time', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 18 and 24', 'description': 'Participants indicated their global assessment of disease activity over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.'}, {'measure': 'Participants Assessment of Fatigue Over Time', 'timeFrame': 'Baseline and Month 3, 6, 9, 12, 18, and 24', 'description': 'Participants indicated their level of fatigue over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.'}, {'measure': 'Participants Assessment of Pain Over Time', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 18, and 24', 'description': 'Participants indicated their level of pain over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.'}, {'measure': 'Percentage of Participants With Impairment in Daily Activities', 'timeFrame': 'Baseline and Months 3, 6, 9, 18, and 24', 'description': 'Participants were asked to report how many days of impairment in daily activities they had experienced in the last 4 weeks.'}, {'measure': 'Number of Days Missed From Work Due to Rheumatoid Arthritis', 'timeFrame': 'Baseline and Months 6, 12, 18, and 24', 'description': 'Participants reported the number of days they had missed from work in the prior 6 months. The Baseline measurement includes data for the prior 12 months.'}, {'measure': 'Percentage of Participants With In-patient Hospitalization', 'timeFrame': 'Month 6, 12, 18, and 24', 'description': 'The percentage of participants with in-patient hospitalization in the prior 6 months. Baseline data includes in-patient hospitalizations that occurred within the prior 12 months.'}, {'measure': 'Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 18, and 24'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Safety', 'Long-term observation', 'Routine Clinical Setting', 'Rheumatoid Arthritis', 'Effectiveness'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '31311386', 'type': 'DERIVED', 'citation': 'Behrens F, Koehm M, Schwaneck EC, Schmalzing M, Wittig BM, Gnann H, Greger G, Tony HP, Burkhardt H. Addition or removal of concomitant methotrexate alters adalimumab effectiveness in rheumatoid arthritis but not psoriatic arthritis. Scand J Rheumatol. 2019 Sep;48(5):375-382. doi: 10.1080/03009742.2019.1600717. Epub 2019 Jul 16.'}, {'pmid': '26990995', 'type': 'DERIVED', 'citation': 'Scharbatke EC, Behrens F, Schmalzing M, Koehm M, Greger G, Gnann H, Burkhardt H, Tony HP. Association of Improvement in Pain With Therapeutic Response as Determined by Individual Improvement Criteria in Patients With Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2016 Nov;68(11):1607-1615. doi: 10.1002/acr.22884. Epub 2016 Oct 1.'}], 'seeAlsoLinks': [{'url': 'http://rxabbvie.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Observation of safety, tolerability and effectiveness of adalimumab (Humira) therapy in a large patient collective under everyday clinical conditions over 2 years.', 'detailedDescription': 'Patients with rheumatoid arthritis who started treatment with adalimumab in a normal clinical setting according to the product label were documented. The follow-up observation period was for 2 years and focused on safety information and maintenance of efficacy during a normal clinical setting. Follow-up with participants was via regular office visits at intervals as determined by routine clinical practice or as recommended by national guidelines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community sample: patients with rheumatoid arthritis who resided in Germany. German regulations state that all patients are eligible for non-interventional studies; there are no exclusions. Adult patients (≥ 18 years of age) with RA who were preparing to initiate adalimumab therapy according to the product label were eligible for study enrollment. The eligibility criteria below reflect the approved label as stated in the German Summary of Product Characteristics (SPC) for Humira.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate to severe active rheumatoid arthritis in adults with insufficient response to disease-modifying antirheumatic drugs, including 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': 'NCT01077258', 'briefTitle': 'Efficacy and Safety of Adalimumab in Patients With Rheumatoid Arthritis in Routine Clinical Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Effectiveness and Safety of Adalimumab in Patients With Rheumatoid Arthritis in Routine Clinical Practice', 'orgStudyIdInfo': {'id': 'P10-448'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rheumatoid arthritis', 'description': 'Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '52062', 'city': 'Aachen', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 35036', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '59227', 'city': 'Ahlen', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 35510', 'geoPoint': {'lat': 51.76338, 'lon': 7.8887}}, {'zip': '22926', 'city': 'Ahrensburg', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 35040', 'geoPoint': {'lat': 53.67661, 'lon': 10.23705}}, {'zip': '04600', 'city': 'Altenburg', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 35043', 'geoPoint': {'lat': 50.98763, 'lon': 12.43684}}, {'zip': '24161', 'city': 'Altenholz', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 35046', 'geoPoint': {'lat': 54.39793, 'lon': 10.1279}}, {'zip': '92224', 'city': 'Amberg', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 35049', 'geoPoint': {'lat': 49.44287, 'lon': 11.86267}}, {'zip': '99310', 'city': 'Arnstadt', 'country': 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'Site Reference ID/Investigator# 35570', 'geoPoint': {'lat': 50.21667, 'lon': 12.31667}}, {'zip': '24576', 'city': 'Bad Bramstedt', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 35573', 'geoPoint': {'lat': 53.91827, 'lon': 9.88243}}, {'zip': '35080', 'city': 'Bad Endbach', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 33372', 'geoPoint': {'lat': 50.75, 'lon': 8.5}}, {'zip': '49186', 'city': 'Bad Iburg', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 33378', 'geoPoint': {'lat': 52.1549, 'lon': 8.04216}}, {'zip': '49186', 'city': 'Bad Iburg', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 33382', 'geoPoint': {'lat': 52.1549, 'lon': 8.04216}}, {'zip': '55543', 'city': 'Bad Kreuznach', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 33387', 'geoPoint': {'lat': 49.8414, 'lon': 7.86713}}, {'zip': '55543', 'city': 'Bad Kreuznach', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 35575', 'geoPoint': {'lat': 49.8414, 'lon': 7.86713}}, {'zip': '04924', 'city': 'Bad Liebenwerda', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 33391', 'geoPoint': {'lat': 51.51826, 'lon': 13.39459}}, {'zip': '31848', 'city': 'Bad Münder am Deister', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 33396', 'geoPoint': {'lat': 52.19551, 'lon': 9.46421}}, {'zip': '61231', 'city': 'Bad Nauheim', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 102216', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}, {'zip': '53474', 'city': 'Bad Neuenahr', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 35578', 'geoPoint': {'lat': 50.54484, 'lon': 7.13386}}, {'zip': '74906', 'city': 'Bad Rappenau', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 33404', 'geoPoint': {'lat': 49.23848, 'lon': 9.1018}}, {'zip': '36433', 'city': 'Bad Salzungen', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 51883', 'geoPoint': {'lat': 50.81342, 'lon': 10.2361}}, {'zip': '63628', 'city': 'Bad Soden-Salmünster', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 33412', 'geoPoint': {'lat': 50.27574, 'lon': 9.36705}}, {'zip': '76530', 'city': 'Baden-Baden', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 33425', 'geoPoint': {'lat': 48.7606, 'lon': 8.23975}}, {'zip': '96047', 'city': 'Bamberg', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 33429', 'geoPoint': {'lat': 49.89873, 'lon': 10.90067}}, {'zip': '02625', 'city': 'Bautzen', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 33438', 'geoPoint': {'lat': 51.18035, 'lon': 14.43494}}, {'zip': '95445', 'city': 'Bayreuth', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 33442', 'geoPoint': {'lat': 49.94782, 'lon': 11.57893}}, {'zip': '95445', 'city': 'Bayreuth', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 33446', 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13.41053}}, {'zip': '10711', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 33697', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10719', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 34246', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10777', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 33683', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10961', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 34269', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12161', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 35527', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12161', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 35597', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12207', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 33620', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12435', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 33690', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12435', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 33704', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13055', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 33687', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13437', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 33661', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13595', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 35550', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14109', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Site 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{'zip': '89143', 'city': 'Blaubeuren Abbey', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 34288', 'geoPoint': {'lat': 48.41215, 'lon': 9.78427}}, {'zip': '46399', 'city': 'Bocholt', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 34291', 'geoPoint': {'lat': 51.83879, 'lon': 6.61531}}, {'zip': '46399', 'city': 'Bocholt', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 35566', 'geoPoint': {'lat': 51.83879, 'lon': 6.61531}}, {'zip': '44789', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 35641', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '94327', 'city': 'Bogen', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 35644', 'geoPoint': {'lat': 48.91122, 'lon': 12.68955}}, {'zip': '53111', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 34302', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '53129', 'city': 'Bonn', 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