Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-26 @ 11:01 AM
Study NCT ID:
NCT01163292
Status:
COMPLETED
Last Update Posted:
2018-07-06
First Post:
2010-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Special Investigation (Follow-up Survey of the Study of Adalimumab (D2E7) for Prevention of Joint Destruction in Patients With Rheumatoid Arthritis in Japan (M06-859 (NCT00870467))
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': 'Week 0 to Week 52', 'eventGroups': [{'id': 'EG000', 'title': 'Adalimumab', 'description': 'Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)', 'otherNumAtRisk': 106, 'otherNumAffected': 46, 'seriousNumAtRisk': 106, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Non-Adalimumab', 'description': 'Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)', 'otherNumAtRisk': 114, 'otherNumAffected': 36, 'seriousNumAtRisk': 114, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Ver. 15.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Liver disorder (enzyme elevation)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Punctate keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Xerophthalmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Chelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pancreatic enlargement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Driug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Genital candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bronchitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Ver. 15.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Periarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Trigger finger', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Breast discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pleural fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pharyngeal erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Rash generalized', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Seborrheic dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'seriousEvents': [{'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Ver. 15.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Large intestine carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Scar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Disease Activity Score (DAS28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)'}, {'id': 'OG001', 'title': 'Non-Adalimumab', 'description': 'Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '2.93', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '2.73', 'spread': '1.04', 'groupId': 'OG001'}]}]}, {'title': 'Week 26', 'categories': [{'measurements': [{'value': '2.72', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '3.17', 'spread': '1.11', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '2.70', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '3.20', 'spread': '1.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.144', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Week 0', 'statisticalMethod': 'Wilcoxon Rank Sum', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Week 26', 'statisticalMethod': 'Wilcoxon Rank Sum', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Week 52', 'statisticalMethod': 'Wilcoxon Rank Sum', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 26, and 52', 'description': "The Disease Activity Score (DAS28) is a combined index used to measure disease activity in participants with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate (ESR). DAS 28 (ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with post-baseline DAS28 data, using last-observation-carried forward (LOCF) imputation method.'}, {'type': 'SECONDARY', 'title': 'Matrix Metalloprotease-3 (MMP-3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)'}, {'id': 'OG001', 'title': 'Non-Adalimumab', 'description': 'Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)'}], 'classes': [{'title': 'Week 0 Positive', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Week 0 Negative', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 Positive', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 Negative', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 Positive', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 Negative', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.290', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Week 0', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Week 26', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Week 52', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0, 26, and 52', 'description': 'MMP-3 level in serum. Positive = \\>/= 121.0 ng/mL (male) and 59.7 ng/mL (female)', 'unitOfMeasure': 'units on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with post-baseline MMP-3 data, using LOCF imputation method'}, {'type': 'SECONDARY', 'title': 'Modified Total Sharp Score (mTSS) Change From Week 0 to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)'}, {'id': 'OG001', 'title': 'Non-Adalimumab', 'description': 'Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.335', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon Rank Sum', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Week 52', 'description': 'Modified Total Sharp Score (mTSS) is a method of assessing radiographs used in evaluation of inhibition of joint destruction of disease. Digitized X-rays of hands and feet were obtained, then scored in a blinded manner: for erosion (0 \\[no damage\\] to 5 \\[complete collapse or total destruction of joint\\]) and for joint space narrowing (0 \\[no damage\\] to 4 \\[complete luxation of joint\\]). Sum of scores was given as total mTSS (0 \\[normal\\] to 380 \\[maximal disease\\]). Large positive change in mTSS indicates disease progression; small positive/no change indicates slowing/halting of disease progression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with post-baseline mTSS data, using LOCF imputation method'}, {'type': 'SECONDARY', 'title': 'Health Assessment Questionnaire Disability Index (HAQ-DI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)'}, {'id': 'OG001', 'title': 'Non-Adalimumab', 'description': 'Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '0.27', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '0.24', 'spread': '0.33', 'groupId': 'OG001'}]}]}, {'title': 'Week 26', 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '0.24', 'spread': '0.36', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '0.26', 'spread': '0.39', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.266', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Week 0', 'statisticalMethod': 'Wilcoxon Rank Sum', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.440', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Week 26', 'statisticalMethod': 'Wilcoxon Rank Sum', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.609', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Week 52', 'statisticalMethod': 'Wilcoxon Rank Sum', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 26, and 52', 'description': 'Participants assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Participants assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ-DI indicated improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with post-baseline HAQ-DI data, using LOCF imputation method'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)'}, {'id': 'OG001', 'title': 'Non-Adalimumab', 'description': 'Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Week 52', 'description': 'Adverse events (AEs) were collected from week 0 till the end of the study. Please see Adverse Event section below for more details.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants registered'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Adalimumab', 'description': 'Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)'}, {'id': 'FG001', 'title': 'Non-Adalimumab', 'description': 'Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '114'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '92'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Initiation of biological therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Sufficient response to adalimumab', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Refusal to receive adalimumab', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Economic reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'No further visits', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Adalimumab', 'description': 'Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)'}, {'id': 'BG001', 'title': 'Non-Adalimumab', 'description': 'Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.0', 'spread': '13.0', 'groupId': 'BG000'}, {'value': '54.7', 'spread': '12.3', 'groupId': 'BG001'}, {'value': '55.3', 'spread': '12.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body weight', 'classes': [{'categories': [{'measurements': [{'value': '55.46', 'spread': '8.99', 'groupId': 'BG000'}, {'value': '57.53', 'spread': '11.08', 'groupId': 'BG001'}, {'value': '56.53', 'spread': '10.16', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Rheumatoid arthritis duration', 'classes': [{'categories': [{'measurements': [{'value': '1.290', 'spread': '0.428', 'groupId': 'BG000'}, {'value': '1.316', 'spread': '0.438', 'groupId': 'BG001'}, {'value': '1.303', 'spread': '0.433', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Prior Disease Modifying Anti-Rheumatic Drug (except methotrexate)', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Concomitant Glucocorticoid Use', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Rheumatoid Factor', 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Health Assessment Questionnaire Disability Index (HAQ-DI)', 'classes': [{'categories': [{'measurements': [{'value': '0.29', 'spread': '0.34', 'groupId': 'BG000'}, {'value': '0.25', 'spread': '0.33', 'groupId': 'BG001'}, {'value': '0.27', 'spread': '0.34', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Participants assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Participants assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Disease Activity Score', 'classes': [{'categories': [{'measurements': [{'value': '2.89', 'spread': '1.10', 'groupId': 'BG000'}, {'value': '2.74', 'spread': '1.11', 'groupId': 'BG001'}, {'value': '2.81', 'spread': '1.11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate (ESR). DAS 28 (ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Modified Total Sharp Score (mTSS)', 'classes': [{'categories': [{'measurements': [{'value': '15.61', 'spread': '22.19', 'groupId': 'BG000'}, {'value': '16.47', 'spread': '22.30', 'groupId': 'BG001'}, {'value': '16.05', 'spread': '22.20', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Modified Total Sharp Score (mTSS) is a method of assessing radiographs, used in evaluation of inhibition of joint destruction of disease. Digitized X-rays of hands and feet were obtained, then scored in a blinded manner: for erosion (0 \\[no damage\\] to 5 \\[complete collapse or total destruction of joint\\]) and for joint space narrowing (0 \\[no damage\\] to 4 \\[complete luxation of joint\\]). Sum of scores was given as total mTSS (0 \\[normal\\] to 380 \\[maximal disease\\]).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Matrix Metalloprotease (MMP-3)', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '149.95', 'spread': '114.81', 'groupId': 'BG000'}, {'value': '113.70', 'spread': '135.15', 'groupId': 'BG001'}, {'value': '130.50', 'spread': '125.92', 'groupId': 'BG002'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '86.94', 'spread': '113.09', 'groupId': 'BG000'}, {'value': '88.88', 'spread': '182.09', 'groupId': 'BG001'}, {'value': '87.94', 'spread': '152.09', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Matrix metalloprotease level in serum', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All participants registered'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-08', 'studyFirstSubmitDate': '2010-07-14', 'resultsFirstSubmitDate': '2013-10-18', 'studyFirstSubmitQcDate': '2010-07-14', 'lastUpdatePostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-10-18', 'studyFirstPostDateStruct': {'date': '2010-07-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease Activity Score (DAS28)', 'timeFrame': 'Weeks 0, 26, and 52', 'description': "The Disease Activity Score (DAS28) is a combined index used to measure disease activity in participants with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate (ESR). DAS 28 (ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity."}], 'secondaryOutcomes': [{'measure': 'Matrix Metalloprotease-3 (MMP-3)', 'timeFrame': 'Weeks 0, 26, and 52', 'description': 'MMP-3 level in serum. Positive = \\>/= 121.0 ng/mL (male) and 59.7 ng/mL (female)'}, {'measure': 'Modified Total Sharp Score (mTSS) Change From Week 0 to Week 52', 'timeFrame': 'Week 0 to Week 52', 'description': 'Modified Total Sharp Score (mTSS) is a method of assessing radiographs used in evaluation of inhibition of joint destruction of disease. Digitized X-rays of hands and feet were obtained, then scored in a blinded manner: for erosion (0 \\[no damage\\] to 5 \\[complete collapse or total destruction of joint\\]) and for joint space narrowing (0 \\[no damage\\] to 4 \\[complete luxation of joint\\]). Sum of scores was given as total mTSS (0 \\[normal\\] to 380 \\[maximal disease\\]). Large positive change in mTSS indicates disease progression; small positive/no change indicates slowing/halting of disease progression.'}, {'measure': 'Health Assessment Questionnaire Disability Index (HAQ-DI)', 'timeFrame': 'Weeks 0, 26, and 52', 'description': 'Participants assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Participants assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ-DI indicated improvement.'}, {'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Week 0 to Week 52', 'description': 'Adverse events (AEs) were collected from week 0 till the end of the study. Please see Adverse Event section below for more details.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '26925252', 'type': 'DERIVED', 'citation': 'Tanaka Y, Yamanaka H, Ishiguro N, Miyasaka N, Kawana K, Hiramatsu K, Takeuchi T. Adalimumab discontinuation in patients with early rheumatoid arthritis who were initially treated with methotrexate alone or in combination with adalimumab: 1 year outcomes of the HOPEFUL-2 study. RMD Open. 2016 Feb 18;2(1):e000189. doi: 10.1136/rmdopen-2015-000189. eCollection 2016.'}], 'seeAlsoLinks': [{'url': 'http://rxabbvie.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The present survey was conducted to evaluate the effectiveness and safety of treatment with adalimumab during the 52-week period following completion of the treatment period in Study NCT00870467 (M06-859) in participants who continued treatment with adalimumab for 52 weeks.', 'detailedDescription': 'This survey was conducted to assess the risk and benefit of continuing or discontinuing biological therapy with adalimumab (Humira) during the 52-week period following completion of the treatment period in Study NCT00870467 (M06-859).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The participants were patients who continued treatment with adalimumab until the end of the treatment period in the NCT00870467(M06-859) study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The participants were patients who continued treatment with adalimumab until the end of the treatment period in the NCT00870467(M06-859) study and provided informed consent to participate in the present follow-up survey.\n\nExclusion Criteria:\n\n* Participants who used biological agents other than adalimumab after the period of treatment in the NCT00870467(M06-859) study were excluded from the present follow-up study.'}, 'identificationModule': {'nctId': 'NCT01163292', 'briefTitle': 'Special Investigation (Follow-up Survey of the Study of Adalimumab (D2E7) for Prevention of Joint Destruction in Patients With Rheumatoid Arthritis in Japan (M06-859 (NCT00870467))', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Humira 40 mg/0.8 mL Syringe for Subcutaneous Injection - Special Investigation (Follow-up Survey of the Study of Adalimumab (D2E7) for Prevention of Joint Destruction in Patients With Rheumatoid Arthritis in Japan (M06-859)]', 'orgStudyIdInfo': {'id': 'P12-069'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adalimumab', 'description': 'Participants who continued adalimumab treatment after completion of Study NCT00870467 (M06-859)'}, {'label': 'Non-Adalimumab', 'description': 'Participants who discontinued adalimumab treatment after completion of Study NCT00870467(M06-859)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anjo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54680', 'geoPoint': {'lat': 34.95828, 'lon': 137.08054}}, {'city': 'Aomori', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54677', 'geoPoint': {'lat': 40.81667, 'lon': 140.73333}}, {'city': 'Chiba', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54516', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Chiba', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54660', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Chiba', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54683', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54521', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Gifu', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 39854', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'city': 'Hamamatsu', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54666', 'geoPoint': {'lat': 34.7, 'lon': 137.73333}}, {'city': 'Hiroshima', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54682', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Hyōgo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54669', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'city': 'Hyōgo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54674', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'city': 'Ibaraki', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54653', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}, {'city': 'Kagoshima', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54670', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Kagoshima', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54692', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Kawagoe', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54679', 'geoPoint': {'lat': 35.90861, 'lon': 139.48528}}, {'city': 'Kawagoe', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 59580', 'geoPoint': {'lat': 35.90861, 'lon': 139.48528}}, {'city': 'Kawasaki', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54662', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'city': 'Kirishima', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54693', 'geoPoint': {'lat': 31.74087, 'lon': 130.76288}}, {'city': 'Kitakyushu', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54671', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'city': 'Kumamoto', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54643', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'city': 'Kyoto', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 59583', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Maebashi', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 59582', 'geoPoint': {'lat': 36.4, 'lon': 139.08333}}, {'city': 'Matsumoto', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 39849', 'geoPoint': {'lat': 36.23333, 'lon': 137.96667}}, {'city': 'Matsuyama', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54520', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'city': 'Miyazaki', 'country': 'Japan', 'facility': 'Site 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ID/Investigator# 54649', 'geoPoint': {'lat': 34.68505, 'lon': 135.80485}}, {'city': 'Niigata', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 39844', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'city': 'Okayama', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 39847', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Okayama', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54681', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 39846', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54518', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Ōita', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54675', 'geoPoint': {'lat': 33.23333, 'lon': 131.6}}, {'city': 'Rifu', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54646', 'geoPoint': {'lat': 38.33092, 'lon': 140.97691}}, {'city': 'Sagamihara, Kanagawa', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54661'}, {'city': 'Saitama', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54514', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'city': 'Saitama', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54689', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'city': 'Sapporo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 25922', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Sapporo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 39850', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Sapporo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54651', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Sapporo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54652', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Sasebo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54522', 'geoPoint': {'lat': 33.16834, 'lon': 129.72502}}, {'city': 'Setouchi', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54650', 'geoPoint': {'lat': 34.65919, 'lon': 134.14238}}, {'city': 'Shimotsuke', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 39851', 'geoPoint': {'lat': 36.41323, 'lon': 139.86622}}, {'city': 'Shizuoka', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 39845', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Shizuoka', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54517', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Takamatsu', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 59579', 'geoPoint': {'lat': 34.33333, 'lon': 134.05}}, {'city': 'Takasaki', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54655', 'geoPoint': {'lat': 36.33333, 'lon': 139.01667}}, {'city': 'Tenri', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54519', 'geoPoint': {'lat': 34.58333, 'lon': 135.83333}}, {'city': 'Tokorozawa', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54515', 'geoPoint': {'lat': 35.79916, 'lon': 139.46903}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 39842', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 39852', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 39853', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54647', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54657', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54658', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54678', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54688', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 59581', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tomigusuku', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54672', 'geoPoint': {'lat': 26.18583, 'lon': 127.68192}}, {'city': 'Toyama', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54648', 'geoPoint': {'lat': 36.7, 'lon': 137.21667}}, {'city': 'Toyama', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54691', 'geoPoint': {'lat': 36.7, 'lon': 137.21667}}, {'city': 'Toyoake', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54690', 'geoPoint': {'lat': 35.038, 'lon': 136.99931}}, {'city': 'Toyohashi', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54676', 'geoPoint': {'lat': 34.76667, 'lon': 137.38333}}, {'city': 'Tsu', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54668', 'geoPoint': {'lat': 34.73333, 'lon': 136.51667}}, {'city': 'Yokohama', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 39843', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Yokohama', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54663', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Yokohama', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54664', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Yokohama', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54665', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Yotsukaidō', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54659', 'geoPoint': {'lat': 35.65, 'lon': 140.16667}}], 'overallOfficials': [{'name': 'Aki Kuroki', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie (prior sponsor, Abbott)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}