Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-03-06 @ 2:40 AM
Study NCT ID:
NCT02984020
Status:
COMPLETED
Last Update Posted:
2024-08-27
First Post:
2016-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Korean Post-marketing Surveillance for Xeljanz
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D015535', 'term': 'Arthritis, Psoriatic'}], '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'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclosure previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).', 'eventGroups': [{'id': 'EG000', 'title': 'Post-Marketing Surveillance: Xeljanz', 'description': 'Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.', 'otherNumAtRisk': 1009, 'deathsNumAtRisk': 1009, 'otherNumAffected': 261, 'seriousNumAtRisk': 1009, 'deathsNumAffected': 2, 'seriousNumAffected': 40}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Type IIa hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Gastrointestinal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hyperchlorhydria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Generalised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Swelling face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Gallbladder polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 31}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Tinea cruris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Tinea versicolour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Vaginal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Muscle rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Alanine aminotransferase abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Aspartate aminotransferase abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'High density lipoprotein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Liver function test increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Joint effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Musculoskeletal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Rheumatoid nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Tenosynovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cerebral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cerebral artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cognitive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Post herpetic neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Tension headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Renal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Breast mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Breast pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Heavy menstrual bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Scrotal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Vocal cord thickening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hyperkeratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Skin disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'seriousEvents': [{'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Peritonsillar abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Sinusitis fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cartilage injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Synovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Mononeuritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1009, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-Marketing Surveillance: Xeljanz', 'description': 'Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.'}], 'classes': [{'title': 'Adverse Events(AEs)', 'categories': [{'measurements': [{'value': '261', 'groupId': 'OG000'}]}]}, {'title': 'Adverse Drug Reactions(ADRs)', 'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000'}]}]}, {'title': 'Serious Adverse Events(SAEs)', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Serious Adverse Drug Reactions(SADRs)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Adverse Events of Special Interest', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Adverse Drug Reactions of Special Interest', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)', 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. SAE was any untoward medical occurrence that at any dose resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. SADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to Xeljanz was assessed by the physician.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-Marketing Surveillance: Xeljanz', 'description': 'Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.'}], 'classes': [{'title': 'Unexpected Adverse Events', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}]}]}, {'title': 'Unexpected Adverse Drug Reactions', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Unexpected Serious Adverse Events', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Unexpected Serious Adverse Drug Reactions', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)', 'description': "An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. SAE was any untoward medical occurrence that at any dose resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. SADR was any SAE that is attributed to Xeljanz. Relatedness to Xeljanz was assessed by the physician. An unexpected AE was an AE with a difference in nature, severity, specificity, or outcome, compared to the product licensure/safety notification of the drug. Unexpected ADRs were unexpected AEs that were, in the investigator's opinion, of causal relationship to the study treatment.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.'}, {'type': 'PRIMARY', 'title': 'Duration of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-Marketing Surveillance: Xeljanz', 'description': 'Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '320'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)', 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Only participants with available data are reported.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events by Their Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-Marketing Surveillance: Xeljanz', 'description': 'Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.'}], 'classes': [{'title': 'Mild', 'categories': [{'measurements': [{'value': '201', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)', 'description': 'The evaluation of AE severity was done according to the following categories: mild: not causing any significant problem to the participant. Administration of medicinal product continues without dose adjustment. Moderate: causes a problem that dose not interfere significantly with usual activities or the clinical status. Dose of the medical product is adjusted or other therapy is added due to the AE. Severe: causes a problem that interferes significantly with usual activities or the clinical status. The medicinal product is stopped due to the AE. Only participants with available severity assessment data are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events by Their Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-Marketing Surveillance: Xeljanz', 'description': 'Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.'}], 'classes': [{'title': 'Recovered', 'categories': [{'measurements': [{'value': '200', 'groupId': 'OG000'}]}]}, {'title': 'Recovered with sequelae', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Recovering', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}, {'title': 'Not recovered', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)', 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. The outcomes of AE included recovered, recovered with sequelae, recovering, not recovered and unknown. One participant may experience more than one event hence one participant may be included in more than one category specified below. Only participants with available outcome assessment are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events by Their Seriousness Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-Marketing Surveillance: Xeljanz', 'description': 'Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.'}], 'classes': [{'title': 'Results in death', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Is life-threatening', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Requires inpatient hospitalization or prolongation of hospitalization', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Results in persistent or significant disability/incapacity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Results in congenital anomaly/birth defect', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Is an important medical event', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Non-SAE', 'categories': [{'measurements': [{'value': '238', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)', 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. The seriousness criteria for AEs included results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in congenital anomaly/birth defect, other important medical event. Only participants with available seriousness assessment data are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events by Their Action Taken With Regard to Xeljanz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-Marketing Surveillance: Xeljanz', 'description': 'Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.'}], 'classes': [{'title': 'Permanently discontinued', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'Temporarily discontinued or delayed', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Dose reduced', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '188', 'groupId': 'OG000'}]}]}, {'title': 'Not applicable', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)', 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship. The action taken with regard to the medicinal product included: permanently discontinued, temporarily discontinued or delayed, dose reduced, dose increased, no change, not applicable. Only participants with available action taken assessment data are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events by Their Causality to Xeljanz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-Marketing Surveillance: Xeljanz', 'description': 'Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.'}], 'classes': [{'title': 'Certain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Probable/likely', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Possible', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}]}]}, {'title': 'Unlikely', 'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000'}]}]}, {'title': 'Conditional/unclassified', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Unaccessible/unclassifiable', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)', 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship. The causality of AEs to Xeljanz were assessed by physician according to the following criteria: certain, probable/likely, possible, unlikely, conditional/unclassified and unassessible/unclassifiable. One participant may experience more than one event hence, one participant may be included in more than one category specified below. Only participants with available causality assessment data are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events According to Demographic Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-Marketing Surveillance: Xeljanz', 'description': 'Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.'}], 'classes': [{'title': 'Sex: Male', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'Sex: Female', 'categories': [{'measurements': [{'value': '225', 'groupId': 'OG000'}]}]}, {'title': 'Age: < 40 years', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Age: >= 40 years and < 50 years', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}, {'title': 'Age: >= 50 years and < 60 years', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}]}]}, {'title': 'Age: >= 60 years and < 70 years', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}]}]}, {'title': 'Age: >= 70 years', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'Geriatric (>= 65 years)', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)', 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Number of participants with AEs classified according to the following demographic characteristics: sex: male and female; age: less than (\\<) 40 years, greater than or equal to (\\>=) 40 and \\< 50 years and \\>= 50 years and \\<60 years; \\>= 60 and \\<70 years; geriatric (\\>=65 years). Only participants with available demographic and AE assessment data are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events According to Other Baseline Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-Marketing Surveillance: Xeljanz', 'description': 'Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.'}], 'classes': [{'title': 'Indication: RA', 'categories': [{'measurements': [{'value': '261', 'groupId': 'OG000'}]}]}, {'title': 'Indication: PsA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Duration of the disease: < 3 years', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}]}]}, {'title': 'Duration of the disease: >= 3 years and < 6 years', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}, {'title': 'Duration of the disease: >= 6 years and < 9 years', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Duration of the disease: >= 9 years and < 12 years', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Duration of the disease: >= 12 years', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}, {'title': 'Duration of the disease: Unknown', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Severity of disease activity: High (DAS28 > 5.1)', 'categories': [{'measurements': [{'value': '226', 'groupId': 'OG000'}]}]}, {'title': 'Severity of disease activity: Moderate (DAS28 > 3.2 and <= 5.1)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Severity of disease activity: Low (DAS28 <= 3.2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Severity of disease activity: Not assessed', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Radiologic progression: Yes', 'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000'}]}]}, {'title': 'Radiologic progression: No', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}]}]}, {'title': 'Radiologic progression: Not assessed', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'Status of latent tuberculosis: Yes', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}, {'title': 'Status of latent tuberculosis: No', 'categories': [{'measurements': [{'value': '206', 'groupId': 'OG000'}]}]}, {'title': 'Status of latent tuberculosis: Unknown', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Herpes zoster Vaccination: Yes', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Herpes zoster Vaccination: No', 'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}]}]}, {'title': 'Herpes zoster Vaccination: Unknown', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}]}]}, {'title': 'Smoking: Ex-smoking', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Smoking: Current smoking', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Smoking: Non-smoking', 'categories': [{'measurements': [{'value': '188', 'groupId': 'OG000'}]}]}, {'title': 'Smoking: Unknown', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'Prior rheumatoid arthritis therapy: Yes', 'categories': [{'measurements': [{'value': '238', 'groupId': 'OG000'}]}]}, {'title': 'Prior rheumatoid arthritis therapy: No', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Medical history: Yes', 'categories': [{'measurements': [{'value': '209', 'groupId': 'OG000'}]}]}, {'title': 'Medical history: No', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}, {'title': 'Renal disorder: Yes', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Renal disorder: No', 'categories': [{'measurements': [{'value': '255', 'groupId': 'OG000'}]}]}, {'title': 'Hepatic disorder: Yes', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Hepatic disorder: No', 'categories': [{'measurements': [{'value': '248', 'groupId': 'OG000'}]}]}, {'title': 'Allergic history: Yes', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Allergic history: No', 'categories': [{'measurements': [{'value': '250', 'groupId': 'OG000'}]}]}, {'title': 'Concomitant medication: Yes', 'categories': [{'measurements': [{'value': '259', 'groupId': 'OG000'}]}]}, {'title': 'Concomitant medication: No', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Duration of administration: < 6 months', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}, {'title': 'Duration of administration: >= 6 months and < 7 months', 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}]}]}, {'title': 'Duration of administration: >= 7 months', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'Duration of administration: Unknown', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)', 'description': 'Other baseline characteristics included: indication; duration of the disease; severity of disease; radiologic progression; status of latent tuberculosis; herpes zoster vaccination; smoking; prior rheumatoid arthritis therapy; medical history; renal disorder; hepatic disorder; allergic history; concomitant medication; duration of administration. Only participants with available other baseline characteristics and AE assessment data are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events - Multivariate Logistic Regression Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-Marketing Surveillance: Xeljanz', 'description': 'Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '261', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.69', 'ciUpperLimit': '0.86', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Multiple logistic regression including total treatment duration of Xeljanz as factor'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '2.43', 'ciLowerLimit': '1.64', 'ciUpperLimit': '3.59', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Multiple logistic regression including other past/present disease as factor'}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)', 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Logistic regression analysis of multivariate analysis was performed and presented an odds ratio with 95% confidence interval to identify the factors that affect occurrence of AEs in demography and baseline characteristics, or concomitant treatment status, etc.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.'}, {'type': 'PRIMARY', 'title': 'Number of Geriatric Participants With Adverse Events and Adverse Drug Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-Marketing Surveillance: Xeljanz', 'description': 'Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.'}], 'classes': [{'title': 'Adverse Events', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'Adverse Drug Reactions', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)', 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population included geriatric participants (aged \\>=65 years) in the safety population.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events and Adverse Drug Reactions - Renal Disorder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-Marketing Surveillance: Xeljanz', 'description': 'Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.'}], 'classes': [{'title': 'Adverse Events', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Adverse Drug Reactions', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)', 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. Renal disorder was judged by the investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population included participants with renal disorder in the safety population.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events and Adverse Drug Reactions - Hepatic Disorder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-Marketing Surveillance: Xeljanz', 'description': 'Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.'}], 'classes': [{'title': 'Adverse Events', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Adverse Drug Reactions', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)', 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. Hepatic disorder was judged by the investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population included participants with hepatic disorder in the safety population.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events and Adverse Drug Reactions - Other Than Safety Analysis Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-Marketing Surveillance: Xeljanz', 'description': 'Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.'}], 'classes': [{'title': 'Adverse Events', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Adverse Drug Reactions', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)', 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. AEs and ADRs for participants excluded from the safety analysis population were reported. The reason for exclusion included: not met the inclusion criteria/met exclusion criteria; off-label use; other significant protocol violation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population included participants excluded from the safety population.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in DAS28 (ESR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '841', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-Marketing Surveillance: Xeljanz', 'description': 'Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.35', 'spread': '1.11', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)', 'description': 'DAS28 is a modified version of the original Disease Activity Score (DAS). It is a quantitative measure of disease activity used to monitor the treatment or RA. DAS28 (erythrocyte sedimentation rate \\[ESR\\]) was calculated from: DAS28 (ESR) = 0.56\\*√(tender joint counter \\[TJC\\] 28) + 0.28\\*√(swollen joint count \\[SJC\\] 28) + 0.014\\*VAS+ 0.70\\*ln(ESR), where VAS = visual analogue scale. Total score range: 0-9.4, higher score=more disease activity.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set included all participants who received at least 1 dose of Xeljanz and were available for an effectiveness assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in DAS28 (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-Marketing Surveillance: Xeljanz', 'description': 'Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.42', 'spread': '1.10', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)', 'description': 'DAS28 is a modified version of the original Disease Activity Score (DAS). It is a quantitative measure of disease activity used to monitor the treatment or RA. DAS28-3 ( C-reactive protein \\[CRP\\]) was calculated from the swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set included all participants who received at least 1 dose of Xeljanz and were available for an effectiveness assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With EULAR Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '903', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-Marketing Surveillance: Xeljanz', 'description': 'Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.'}], 'classes': [{'title': 'Good', 'categories': [{'measurements': [{'value': '404', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '446', 'groupId': 'OG000'}]}]}, {'title': 'None', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)', 'description': 'European League Against Rheumatism (EULAR) response is a DAS-based response criteria that classifies individual participants as none, moderate, or good responders, depending on the extent of change and the level of disease activity reached. Participants with improvement in DAS28 from baseline \\>1.2 and DAS28 based EULAR \\<=3.2 were good responders; participants with improvement in DAS28 from baseline \\>0.6 and \\<=1.2 and DAS28 based EULAR \\>3.2 and \\<=5.1 were moderate responders; participants with improvement in DAS28 from baseline \\<=0.6 and DAS28-based EULAR \\>5.1 were none responders.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set included all participants who received at least 1 dose of Xeljanz and were available for an effectiveness assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '903', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-Marketing Surveillance: Xeljanz', 'description': 'Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '209', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)', 'description': 'ACR20 response: ≥20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and CRP.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set included all participants who received at least 1 dose of Xeljanz and were available for an effectiveness assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Effectiveness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '903', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-Marketing Surveillance: Xeljanz', 'description': 'Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.'}], 'classes': [{'title': 'Effective: Improved', 'categories': [{'measurements': [{'value': '853', 'groupId': 'OG000'}]}]}, {'title': 'Ineffective: No change', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'Ineffective: Aggravated', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)', 'description': 'The variables included DAS28, EULAR response, and ACR20 response. The investigator made the assessment of the overall effectiveness as improved, no change, or aggravated, based on each test results and clinical judgment. No change and aggravated were classified as ineffective.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set included all participants who received at least 1 dose of Xeljanz and were available for an effectiveness assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Effectiveness by Demographic Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '853', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-Marketing Surveillance: Xeljanz', 'description': 'Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.'}], 'classes': [{'title': 'Sex: Male', 'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}]}]}, {'title': 'Sex: Female', 'categories': [{'measurements': [{'value': '725', 'groupId': 'OG000'}]}]}, {'title': 'Age: < 40 years', 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}]}]}, {'title': 'Age: >= 40 years and < 50 years', 'categories': [{'measurements': [{'value': '162', 'groupId': 'OG000'}]}]}, {'title': 'Age: >= 50 years and < 60 years', 'categories': [{'measurements': [{'value': '256', 'groupId': 'OG000'}]}]}, {'title': 'Age: >= 60 years and < 70 years', 'categories': [{'measurements': [{'value': '219', 'groupId': 'OG000'}]}]}, {'title': 'Age: >= 70 years', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}]}]}, {'title': 'Geriatric (>= 65 years)', 'categories': [{'measurements': [{'value': '200', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)', 'description': 'The variables included DAS28, EULAR response, and ACR20 response. The investigator made the assessment of the overall effectiveness as improved, no change, or aggravated, based on each test results and clinical judgment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set included all participants who received at least 1 dose of Xeljanz and were available for an effectiveness assessment and with improved effectiveness.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Improved Effectiveness - Multivariate Logistic Regression Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '903', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-Marketing Surveillance: Xeljanz', 'description': 'Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '853', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0053', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.42', 'ciLowerLimit': '1.11', 'ciUpperLimit': '1.82', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Multiple logistic regression including total duration of treatment with Xeljanz as factor'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)', 'description': 'The variables included DAS28, EULAR response, and ACR20 response. The investigator made the assessment of the overall effectiveness as improved, no change, or aggravated, based on each test results and clinical judgment. Logistic regression analysis of multivariate analysis was performed and presented as odds ratios with 95% confidence interval to identify the factors that affected classified overall assessment (effective/ineffective) in demography and baseline characteristics of the participants.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set included all participants who received at least 1 dose of Xeljanz and were available for an effectiveness assessment and with improved effectiveness.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Post-Marketing Surveillance: Xeljanz', 'description': 'Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1041'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1009'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Experienced off-label use against Xeljanz local product document', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'Not met the inclusion/exclusion criterion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Other significant protocol violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'This was a study conducted in Korea. The investigator enrolled participants to whom Xeljanz was prescribed for the first time according to the local product document and who agreed to participate in this study. Xeljanz was administered according to the "Dosage and Administration" of the approved labeling.\n\nXeljanz was medicated by the investigator\'s prescription under usual clinical practice.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Post-Marketing Surveillance: Xeljanz', 'description': 'Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Mean', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '55.04', 'spread': '12.64', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 40 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '126', 'groupId': 'BG000'}]}]}, {'title': '>= 40 years and < 50 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '195', 'groupId': 'BG000'}]}]}, {'title': '>= 50 years and < 60 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '305', 'groupId': 'BG000'}]}]}, {'title': '>= 60 years and < 70 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '258', 'groupId': 'BG000'}]}]}, {'title': '>= 70 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '125', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '852', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '157', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Indication, RA/PsA', 'classes': [{'title': 'RA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1009', 'groupId': 'BG000'}]}]}, {'title': 'PsA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'RA = rheumatoid arthritis, PsA = psoriatic arthritis.', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of the disease, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '98.36', 'spread': '80.77', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The duration of disease since the date that the participant was initially diagnosed with RA or PsA was recorded.', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of the disease, Customized', 'classes': [{'title': '< 3 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '219', 'groupId': 'BG000'}]}]}, {'title': '>= 3 years and < 6 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '193', 'groupId': 'BG000'}]}]}, {'title': '>= 6 years and < 9 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '146', 'groupId': 'BG000'}]}]}, {'title': '>= 9 years and < 12 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '121', 'groupId': 'BG000'}]}]}, {'title': '>= 12 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '214', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '116', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The duration of disease since the date that the participant was initially diagnosed with RA or PsA was recorded.', 'unitOfMeasure': 'Participants'}, {'title': 'Severity of disease activity, High/Moderate/Low/Not assessed', 'classes': [{'title': 'High (DAS28 > 5.1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '874', 'groupId': 'BG000'}]}]}, {'title': 'Moderate (DAS28 > 3.2 and <= 5.1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '135', 'groupId': 'BG000'}]}]}, {'title': 'Low (DAS28 <= 3.2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Not assessed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Disease Activity Score 18 (DAS28) \\>5.1 is considered to be indicative of high disease activity; DAS28 \\>3.2 and ≤5.1 indicates moderate disease activity; DAS28 ≤3.2 indicates low disease activity.', 'unitOfMeasure': 'Participants'}, {'title': 'Radiologic progression, Yes/No/Not assessed', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '506', 'groupId': 'BG000'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '290', 'groupId': 'BG000'}]}]}, {'title': 'Not assessed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '213', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Radiologic progression based on clinically relevant evaluation methods, such as X-ray, ultrasonography, or magnetic resonance imaging was recorded.', 'unitOfMeasure': 'Participants'}, {'title': 'Status of latent tuberculosis, Yes/No/Unknown', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '226', 'groupId': 'BG000'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '770', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Herpes zoster Vaccination, Yes/No/Unknown', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '115', 'groupId': 'BG000'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '407', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '487', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking, Ex-smoking/Current smoking/Non-smoking/Unknown', 'classes': [{'title': 'Ex-smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}]}]}, {'title': 'Current smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}]}]}, {'title': 'Non-smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '706', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '182', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Renal disorder, Yes/No', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '990', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hepatic disorder, Yes/No', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '969', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Allergic history, Yes/No', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '984', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior rheumatoid arthritis therapy, Yes/No', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '890', 'groupId': 'BG000'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '119', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Concomitant medication, Yes/No', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '997', 'groupId': 'BG000'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1009', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants who received concomitant medication were recorded.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of Xeljanz according to local product document and was assessed for safety information.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-26', 'size': 11433242, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-05-19T17:33', 'hasProtocol': True}, {'date': '2021-02-24', 'size': 33522089, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-05-19T17:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1041}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-22', 'studyFirstSubmitDate': '2016-11-03', 'resultsFirstSubmitDate': '2023-05-19', 'studyFirstSubmitQcDate': '2016-12-02', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-22', 'studyFirstPostDateStruct': {'date': '2016-12-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs)', 'timeFrame': 'From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)', 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. SAE was any untoward medical occurrence that at any dose resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. SADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to Xeljanz was assessed by the physician.'}, {'measure': 'Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs', 'timeFrame': 'From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)', 'description': "An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. SAE was any untoward medical occurrence that at any dose resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. SADR was any SAE that is attributed to Xeljanz. Relatedness to Xeljanz was assessed by the physician. An unexpected AE was an AE with a difference in nature, severity, specificity, or outcome, compared to the product licensure/safety notification of the drug. Unexpected ADRs were unexpected AEs that were, in the investigator's opinion, of causal relationship to the study treatment."}, {'measure': 'Duration of Adverse Events', 'timeFrame': 'From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)', 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Only participants with available data are reported.'}, {'measure': 'Number of Participants With Adverse Events by Their Severity', 'timeFrame': 'From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)', 'description': 'The evaluation of AE severity was done according to the following categories: mild: not causing any significant problem to the participant. Administration of medicinal product continues without dose adjustment. Moderate: causes a problem that dose not interfere significantly with usual activities or the clinical status. Dose of the medical product is adjusted or other therapy is added due to the AE. Severe: causes a problem that interferes significantly with usual activities or the clinical status. The medicinal product is stopped due to the AE. Only participants with available severity assessment data are reported.'}, {'measure': 'Number of Participants With Adverse Events by Their Outcome', 'timeFrame': 'From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)', 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. The outcomes of AE included recovered, recovered with sequelae, recovering, not recovered and unknown. One participant may experience more than one event hence one participant may be included in more than one category specified below. Only participants with available outcome assessment are reported.'}, {'measure': 'Number of Participants With Adverse Events by Their Seriousness Criteria', 'timeFrame': 'From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)', 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. The seriousness criteria for AEs included results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in congenital anomaly/birth defect, other important medical event. Only participants with available seriousness assessment data are reported.'}, {'measure': 'Number of Participants With Adverse Events by Their Action Taken With Regard to Xeljanz', 'timeFrame': 'From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)', 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship. The action taken with regard to the medicinal product included: permanently discontinued, temporarily discontinued or delayed, dose reduced, dose increased, no change, not applicable. Only participants with available action taken assessment data are reported.'}, {'measure': 'Number of Participants With Adverse Events by Their Causality to Xeljanz', 'timeFrame': 'From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)', 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship. The causality of AEs to Xeljanz were assessed by physician according to the following criteria: certain, probable/likely, possible, unlikely, conditional/unclassified and unassessible/unclassifiable. One participant may experience more than one event hence, one participant may be included in more than one category specified below. Only participants with available causality assessment data are reported.'}, {'measure': 'Number of Participants With Adverse Events According to Demographic Characteristics', 'timeFrame': 'From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)', 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Number of participants with AEs classified according to the following demographic characteristics: sex: male and female; age: less than (\\<) 40 years, greater than or equal to (\\>=) 40 and \\< 50 years and \\>= 50 years and \\<60 years; \\>= 60 and \\<70 years; geriatric (\\>=65 years). Only participants with available demographic and AE assessment data are reported.'}, {'measure': 'Number of Participants With Adverse Events According to Other Baseline Characteristics', 'timeFrame': 'From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)', 'description': 'Other baseline characteristics included: indication; duration of the disease; severity of disease; radiologic progression; status of latent tuberculosis; herpes zoster vaccination; smoking; prior rheumatoid arthritis therapy; medical history; renal disorder; hepatic disorder; allergic history; concomitant medication; duration of administration. Only participants with available other baseline characteristics and AE assessment data are reported.'}, {'measure': 'Number of Participants With Adverse Events - Multivariate Logistic Regression Analysis', 'timeFrame': 'From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)', 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Logistic regression analysis of multivariate analysis was performed and presented an odds ratio with 95% confidence interval to identify the factors that affect occurrence of AEs in demography and baseline characteristics, or concomitant treatment status, etc.'}, {'measure': 'Number of Geriatric Participants With Adverse Events and Adverse Drug Reactions', 'timeFrame': 'From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)', 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz.'}, {'measure': 'Number of Participants With Adverse Events and Adverse Drug Reactions - Renal Disorder', 'timeFrame': 'From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)', 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. Renal disorder was judged by the investigator.'}, {'measure': 'Number of Participants With Adverse Events and Adverse Drug Reactions - Hepatic Disorder', 'timeFrame': 'From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)', 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. Hepatic disorder was judged by the investigator.'}, {'measure': 'Number of Participants With Adverse Events and Adverse Drug Reactions - Other Than Safety Analysis Population', 'timeFrame': 'From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)', 'description': 'An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. AEs and ADRs for participants excluded from the safety analysis population were reported. The reason for exclusion included: not met the inclusion criteria/met exclusion criteria; off-label use; other significant protocol violation.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in DAS28 (ESR)', 'timeFrame': 'From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)', 'description': 'DAS28 is a modified version of the original Disease Activity Score (DAS). It is a quantitative measure of disease activity used to monitor the treatment or RA. DAS28 (erythrocyte sedimentation rate \\[ESR\\]) was calculated from: DAS28 (ESR) = 0.56\\*√(tender joint counter \\[TJC\\] 28) + 0.28\\*√(swollen joint count \\[SJC\\] 28) + 0.014\\*VAS+ 0.70\\*ln(ESR), where VAS = visual analogue scale. Total score range: 0-9.4, higher score=more disease activity.'}, {'measure': 'Change From Baseline in DAS28 (CRP)', 'timeFrame': 'From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)', 'description': 'DAS28 is a modified version of the original Disease Activity Score (DAS). It is a quantitative measure of disease activity used to monitor the treatment or RA. DAS28-3 ( C-reactive protein \\[CRP\\]) was calculated from the swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity.'}, {'measure': 'Number of Participants With EULAR Response', 'timeFrame': 'From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)', 'description': 'European League Against Rheumatism (EULAR) response is a DAS-based response criteria that classifies individual participants as none, moderate, or good responders, depending on the extent of change and the level of disease activity reached. Participants with improvement in DAS28 from baseline \\>1.2 and DAS28 based EULAR \\<=3.2 were good responders; participants with improvement in DAS28 from baseline \\>0.6 and \\<=1.2 and DAS28 based EULAR \\>3.2 and \\<=5.1 were moderate responders; participants with improvement in DAS28 from baseline \\<=0.6 and DAS28-based EULAR \\>5.1 were none responders.'}, {'measure': 'Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Month 6', 'timeFrame': 'From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)', 'description': 'ACR20 response: ≥20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and CRP.'}, {'measure': 'Number of Participants With Effectiveness', 'timeFrame': 'From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)', 'description': 'The variables included DAS28, EULAR response, and ACR20 response. The investigator made the assessment of the overall effectiveness as improved, no change, or aggravated, based on each test results and clinical judgment. No change and aggravated were classified as ineffective.'}, {'measure': 'Number of Participants With Effectiveness by Demographic Characteristics', 'timeFrame': 'From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)', 'description': 'The variables included DAS28, EULAR response, and ACR20 response. The investigator made the assessment of the overall effectiveness as improved, no change, or aggravated, based on each test results and clinical judgment.'}, {'measure': 'Number of Participants With Improved Effectiveness - Multivariate Logistic Regression Analysis', 'timeFrame': 'From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)', 'description': 'The variables included DAS28, EULAR response, and ACR20 response. The investigator made the assessment of the overall effectiveness as improved, no change, or aggravated, based on each test results and clinical judgment. Logistic regression analysis of multivariate analysis was performed and presented as odds ratios with 95% confidence interval to identify the factors that affected classified overall assessment (effective/ineffective) in demography and baseline characteristics of the participants.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis', 'Psoriatic Arthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=A3921249', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to identify any problems and questions with respect to the safety and efficacy of Xeljanz during the post-marketing period as required by the regulation of MFDS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult rheumatoid arthritis or psoriatic arthritis taking tofacitinib within label as Ministry of Food and Drung Safety in Korea has approved', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nTo be included in the study all patients will have received at least 1 dose of Xeljanz for the treatment of the following indication as per local labelling. Moderately to severely active RA in adult patients who have had an inadequate response or intolerance to previous therapy with at least 1 biological DMARD. Or Active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to previous antirheumatic drugs (DMARDs)\n\nExclusion Criteria:\n\n1. Patients with a history of hypersensitivity to any ingredients of the product.\n2. Patients with serious infection (eg, sepsis) or active infection including localized infection.\n3. Patients with active tuberculosis.\n4. Patients with severe hepatic function disorder.\n5. Patients with an absolute neutrophil count (ANC) \\<500 cells/mm3.\n6. Patients with a lymphocyte count \\<500 cells/mm3.\n7. Patients with a hemoglobin concentration \\<8 g/dL.\n8. Pregnant or possibly pregnant women.\n9. Because of lactose contained in this drug, it should not be administered to patients with hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.\n\nAccording to Contraindication on label, the investigator should discontinue the patient's treatment if the laboratory test results are as below Patients with an absolute neutrophil count (ANC) \\<500 cells/mm3 Patients with a hemoglobin level \\<8 g/dL"}, 'identificationModule': {'nctId': 'NCT02984020', 'briefTitle': 'Korean Post-marketing Surveillance for Xeljanz', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Korean Post-marketing Surveillance for Xeljanz(Registered) in Rheumatoid Arthritis and Psoriatic Arthritis Patients', 'orgStudyIdInfo': {'id': 'A3921249'}}, 'contactsLocationsModule': {'locations': [{'zip': '330-721', 'city': 'Chunan-si', 'state': 'Chungcheongnam-do', 'country': 'South Korea', 'facility': 'Soonchunhyang University Cheonan Hospital, Department of Rheumatology'}, {'zip': '700-712', 'city': 'Jung-Gu', 'state': 'Daegu', 'country': 'South Korea', 'facility': 'Keimyung University Dongsan Medical Center'}, {'zip': '35365', 'city': 'Seogu', 'state': 'Daejon', 'country': 'South Korea', 'facility': 'Kongyang University Hospital / Rheumatology', 'geoPoint': {'lat': 36.74484, 'lon': 127.13739}}, {'zip': '10475', 'city': 'Goyang-si', 'state': 'Deogyang-gu', 'country': 'South Korea', 'facility': 'Myongji Hospital / Rheumatology', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'zip': '05278', 'city': 'Seoul', 'state': 'Gangdong-gu', 'country': 'South Korea', 'facility': 'Kyung Hee University Hospital at Gangdong / Rheumatology', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05367', 'city': 'Seoul', 'state': 'Gangdong-gu', 'country': 'South Korea', 'facility': 'VHS Medical Center / Rheumatologist', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '24253', 'city': 'Chuncheon', 'state': 'Gangwon-do', 'country': 'South Korea', 'facility': 'Hallym University Chuncheon Sacred Heart Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'zip': '61453', 'city': 'Donggu', 'state': 'Gwang JU', 'country': 'South Korea', 'facility': 'Chosun University Hospital, Rheumatism Department', 'geoPoint': {'lat': 37.866, 'lon': 127.34942}}, {'city': 'Seongnam-si', 'state': 'Gyeongg-do', 'country': 'South Korea', 'facility': 'Division of Rheumatology', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '13496', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'CHA Bundang Medical Center', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '50612', 'city': 'Yangsan', 'state': 'Gyeongsangnam-do', 'country': 'South Korea', 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}, {'zip': '50612', 'city': 'Yangsan', 'state': 'Gyeongsangnam-do', 'country': 'South Korea', 'facility': 'Yangsan Hospital-Pusan National University', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}, {'zip': '561-712', 'city': 'Jeonju', 'state': 'Jeollabuk-do', 'country': 'South Korea', 'facility': 'Chonbuk National University Hospital, Department of Rheumatology', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'zip': '570711', 'city': 'Iksan', 'state': 'Jeonlabuk-do', 'country': 'South Korea', 'facility': 'Wonkwang University Hospital / Division of Rheumatology', 'geoPoint': {'lat': 35.94389, 'lon': 126.95444}}, {'zip': '442-712', 'city': 'Suwon', 'state': 'Kyeongki-do', 'country': 'South Korea', 'facility': 'Ajou University Hospital, Department of Rheumatology', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'city': 'Ansan, Gyeonggi-do', 'country': 'South Korea', 'facility': 'Korea University Ansan Hospital'}, {'zip': '47392', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Inje University Busan Paik hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '607-702', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Kosin University Gospel Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '612-896', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Inje University Haeundae Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '28644', 'city': 'Chungcheongbuk-do', 'country': 'South Korea', 'facility': 'Chungbuk National University Hospital'}, {'zip': '705-718', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Daegu Catholic University Medical Center, Department of Rheumatology', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '302-799', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Eulji University Hospital, Internal Medicine, Rheumatology', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Giheung-gu, Yongin-si, Gyeonggi-do', 'country': 'South Korea', 'facility': 'Yongin Severance Hospital'}, {'city': 'Goyang-si, Gyeonggi-do', 'country': 'South Korea', 'facility': 'Inje University IlsanPaik Hospital'}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Dongguk University Ilsan Medical Center', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '405-760', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Gachon University Gil Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Incheon', 'country': 'South Korea', 'facility': 'Division of Rheumatology', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Jeju Special Self-Goverming Province', 'country': 'South Korea', 'facility': 'Jeju National University Hospital'}, {'city': 'Metropolitan City, Daejeon', 'country': 'South Korea', 'facility': 'Division of Rheumatology', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '602-739', 'city': 'Pusan', 'country': 'South Korea', 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Pusan', 'country': 'South Korea', 'facility': 'Dong-A University Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'zip': '04782', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hanyang Rheuma Uhm Wan-Sik Clinic', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07061', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Division of Rheumatology, SMG-SNU Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital, Department of Internal Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital, Rheumatology, Internal Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '130-872', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyung Hee University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '133-792', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hanyang University Hospital, Department of Rheumatology', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '134-890', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyunghee University East-West Neo Medical Center, 149 Sangil-dong, Gangdong-gu', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center, Division of Rheumatology, Department of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '137-701', 'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Kangnam St. Mary's Hospital/ Rheumatology, Internal Medicine", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '137-701', 'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Seoul St. Mary's Hospital/ Rheumatology, Internal Medicine", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '139-711', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Eulji Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '140-887', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Soonchunhyang University Hospital Seoul/Department of Rheumatology', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '143-729', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Konkuk University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Division of Rheumatology', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Ewha Womans University Mokdong Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hallym University Kangnam Sacred Heart Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyung Hee University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}