Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-03-14 @ 4:04 AM
Study NCT ID:
NCT03151551
Status:
COMPLETED
Last Update Posted:
2020-11-03
First Post:
2017-05-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015535', 'term': 'Arthritis, Psoriatic'}], 'ancestors': [{'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C549079', 'term': 'ixekizumab'}, {'id': 'D000068879', 'term': 'Adalimumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up To Week 52', 'description': 'All participants who received at least one dose of study drug. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly', 'eventGroups': [{'id': 'EG000', 'title': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.', 'otherNumAtRisk': 283, 'deathsNumAtRisk': 283, 'otherNumAffected': 65, 'seriousNumAtRisk': 283, 'deathsNumAffected': 0, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Adalimumab', 'description': '80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.', 'otherNumAtRisk': 283, 'deathsNumAtRisk': 283, 'otherNumAffected': 44, 'seriousNumAtRisk': 283, 'deathsNumAffected': 0, 'seriousNumAffected': 35}, {'id': 'EG002', 'title': 'Ixekizumab Follow-up', 'description': 'Follow-up: Participants did not receive drug during the Post-Treatment Follow-Up Period.', 'otherNumAtRisk': 265, 'deathsNumAtRisk': 265, 'otherNumAffected': 8, 'seriousNumAtRisk': 265, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': 'Adalimumab Follow-up', 'description': 'Follow-up: Participants did not receive drug during the Post-Treatment Follow-Up Period.', 'otherNumAtRisk': 260, 'deathsNumAtRisk': 260, 'otherNumAffected': 5, 'seriousNumAtRisk': 260, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 30, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 9, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 46, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 26, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 21, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 23, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Acute abdomen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Injection site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Large intestine infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Lymph node tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Meningitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumonia legionella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pyoderma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Maternal exposure during pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gastrointestinal stromal tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pituitary tumour benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rectal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Haemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Radiologically isolated syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Menometrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vocal cord thickening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Erythrodermic psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Necrosis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Simultaneously Achieving American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI100)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': '80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000', 'lowerLimit': '30.4', 'upperLimit': '41.6'}, {'value': '27.9', 'groupId': 'OG001', 'lowerLimit': '22.7', 'upperLimit': '33.1'}]}]}], 'analyses': [{'pValue': '0.036', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.1', 'ciLowerLimit': '0.5', 'ciUpperLimit': '15.8', 'groupDescription': 'After data lock and initial analysis run, a medical inconsistency in baseline PASI data was identified (PASI=0 but BSA≥3%). The scenario was not anticipated or described in protocol or SAP. The inconsistency was resolved using medical judgment. The impacted participants had met baseline criteria for active psoriasis. Therefore, in the primary analysis, participants with baseline PASI=0 \\& BSA≥3% were considered PASI100 responders if, and only if, PASI=0 \\& BSA=0 achieved at week 24.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "ACR50 response is a ≥50% improvement from baseline for tender joint count(TJC)\\& swollen joint count (SJC)\\& in at least 3 of the following 5 criteria: Participant's(pts) assessment of joint pain Visual Analog Scale (VAS),Pts Global Assessment of Disease Activity (PatGA)VAS, Physician's Global Assessment of Disease Activity (PGA)VAS, Pts assessment of physical function using the Health Assessment Questionnaire-Disability Index(HAQ-DI), or High Sensitivity(assay)C-Reactive Protein (hs-CRP). PASI is an index combining assessments of the extent of body-surface involvement in head, trunk, arms, legs, and severity of desquamation, erythema and plaque thickness in each region, yielding overall score of 0-no involvement, to 72-most severe involvement. Pts achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Pts with active plaque PsO with a BSA≥3% \\& PASI=0 at baseline were considered PASI100 responders if they had achieved PASI=0 \\& BSA=0 at week 24.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving ACR50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': '80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.5', 'groupId': 'OG000', 'lowerLimit': '44.7', 'upperLimit': '56.4'}, {'value': '46.6', 'groupId': 'OG001', 'lowerLimit': '40.8', 'upperLimit': '52.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.9', 'ciLowerLimit': '-4.3', 'ciUpperLimit': '12.1', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'If the lower bound of the 2-sided 95% confidence Interval (CI) for the difference in proportions of responders on IXE minus ADA is greater than the pre-specified margin -12%, IXE will be deemed non-inferior to ADA.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "ACR50 response is defined as a ≥50% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of joint pain Visual Analog Scale (VAS), Participant's Global Assessment of Disease Activity (PatGA) VAS, Physician's Global Assessment of Disease Activity (PGA) VAS, participant's assessment of physical function using the Health Assessment Questionnaire-Disability Index (HAQ-DI), or High Sensitivity (assay) C-Reactive Protein (hs-CRP).", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving PASI100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': '80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.1', 'groupId': 'OG000', 'lowerLimit': '54.4', 'upperLimit': '65.8'}, {'value': '46.6', 'groupId': 'OG001', 'lowerLimit': '40.8', 'upperLimit': '52.5'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.4', 'ciLowerLimit': '5.3', 'ciUpperLimit': '21.6', 'groupDescription': 'After data lock and initial analysis run, a medical inconsistency in baseline PASI data was identified (PASI=0 but BSA≥3%). The scenario was not anticipated or described in protocol or SAP. The inconsistency was resolved using medical judgment. The impacted participants had met baseline criteria for active psoriasis. Therefore, in the primary analysis, participants with baseline PASI=0 \\& BSA≥3% were considered PASI100 responders if, and only if, PASI=0 \\& BSA=0 achieved at week 24.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'PASI is an index combining assessments of the extent of body-surface involvement in head, trunk, arms, legs, and severity of desquamation, erythema and plaque thickness in each region, yielding overall score of 0-no involvement, to 72-most severe involvement. Participants achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Any participants with active plaque psoriasis (PsO) with a BSA ≥3% and PASI = 0 at baseline were considered PASI100 responders if \\& only if they had achieved PASI=0 \\& BSA=0 at week 24.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Tender Joint Count (TJC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': '80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.91', 'spread': '0.566', 'groupId': 'OG000'}, {'value': '-14.88', 'spread': '0.569', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.155', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.03', 'ciLowerLimit': '-2.46', 'ciUpperLimit': '0.39', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.725', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model that included treatment group, concomitant conventional synthetic disease-modifying anti-rheumatic drugs (csDMARD) use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had a baseline and at least one post-baseline TJC value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Swollen Joint Count (SJC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': '80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.58', 'spread': '0.196', 'groupId': 'OG000'}, {'value': '-9.53', 'spread': '0.198', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.823', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '0.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.249', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS mean was calculated using MMRM model that included treatment group, concomitant conventional synthetic disease-modifying anti-rheumatic drugs (csDMARD) use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had a baseline and at least one post-baseline SJC value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Change From Baseline in Participant's Assessment of Pain Visual Analogue Score (VAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': '80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.'}], 'classes': [{'categories': [{'measurements': [{'value': '-37.21', 'spread': '1.623', 'groupId': 'OG000'}, {'value': '-36.54', 'spread': '1.621', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.752', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.67', 'ciLowerLimit': '-4.80', 'ciUpperLimit': '3.47', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.104', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': "The pain VAS is a participant-administered single-item scale designed to measure current joint pain from Psoriatic arthritis (PsA) using a 100-millimeter(mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by marking a vertical tick on the horizontal 100-mm scale, where the left end from 0 mm (no pain) to right end 100 mm (worst possible joint pain). LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.", 'unitOfMeasure': 'millimeters (mm)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had a baseline and at least one post-baseline VAS value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Change From Baseline in Participant's Global Assessment of Disease Activity", 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': '80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.'}], 'classes': [{'categories': [{'measurements': [{'value': '-40.61', 'spread': '1.594', 'groupId': 'OG000'}, {'value': '-37.82', 'spread': '1.596', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.177', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.79', 'ciLowerLimit': '-6.83', 'ciUpperLimit': '1.26', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.060', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': "The patient's overall assessment of his or her PsA activity was recorded using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.", 'unitOfMeasure': 'Millimeter (mm)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had a baseline and at least one post-baseline VAS value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Change From Baseline in Physician's Global Assessment of Disease Activity", 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': '80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.'}], 'classes': [{'categories': [{'measurements': [{'value': '-48.15', 'spread': '1.113', 'groupId': 'OG000'}, {'value': '-46.79', 'spread': '1.097', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.332', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.35', 'ciLowerLimit': '-4.08', 'ciUpperLimit': '1.38', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.391', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': "The investigator was asked to give an overall assessment of the severity of the participant's current PsA activity using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.", 'unitOfMeasure': 'Millimeter (mm)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had a baseline and at least one post-baseline VAS value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in C-Reactive Protein (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': '80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.68', 'spread': '0.462', 'groupId': 'OG000'}, {'value': '-6.01', 'spread': '0.461', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.592', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.32', 'ciLowerLimit': '-0.86', 'ciUpperLimit': '1.50', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.599', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': "CRP is the ACR Core Set laboratory measure of acute-phase reactant. It was measured with a high sensitivity assay at the central laboratory to help assess the effect of ixekizumab on the participant's PsA. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.", 'unitOfMeasure': 'Milligram per Liter (mg/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had a baseline and at least one post-baseline CRP value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in HAQ-DI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': '80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.68', 'spread': '0.035', 'groupId': 'OG000'}, {'value': '-0.62', 'spread': '0.035', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.176', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.045', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': "HAQ-DI is a participant reported questionnaire that measures disease-associated disability (physical function). It consists of 24 questions with 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities. The disability section scores the participant's self-perception on the degree of difficulty (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do), covering the 8 domains. The reported use of special aids or devices and/or the need for assistance of another person to perform these activities is assessed. The HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had a baseline and at least one post-baseline HAQ-DI value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Simultaneously Achieving ACR50 and PASI100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': '80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.2', 'groupId': 'OG000', 'lowerLimit': '33.5', 'upperLimit': '44.9'}, {'value': '26.1', 'groupId': 'OG001', 'lowerLimit': '21.0', 'upperLimit': '31.3'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.1', 'ciLowerLimit': '5.4', 'ciUpperLimit': '20.7', 'groupDescription': 'After data lock and initial analysis run, a medical inconsistency in baseline PASI data was identified (PASI=0 but BSA≥3%). The scenario was not anticipated or described in protocol or SAP. The inconsistency was resolved using medical judgment. The impacted participants had met baseline criteria for active psoriasis. Therefore, in the primary analysis, participants with baseline PASI=0 \\& BSA≥3% were considered PASI100 responders if, and only if, PASI=0 \\& BSA=0 achieved at week 52.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': "ACR50 response is a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of VAS, Pts Global Assessment of Disease Activity (PatGA) VAS, Physician's Global Assessment of Disease Activity (PGA)VAS, participant assessment of physical function using the HAQ-DI, or High Sensitivity(assay) C-Reactive Protein (hs-CRP). PASI is an index combining assessments of the extent of body-surface involvement in head, trunk, arms, legs, and severity of desquamation, erythema and plaque thickness in each region, yielding overall score of 0-no involvement, to 72-most severe involvement. Participant achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Pts achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Pts with active plaque PsO with a BSA≥3% \\& PASI=0 at baseline were considered PASI100 responders if they had achieved PASI=0 \\& BSA=0 at week 52.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had a baseline and at least one post-baseline ACR50 and PASI100 value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Disease Activity Score-CRP (DAS28-CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': '80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.45', 'spread': '0.071', 'groupId': 'OG000'}, {'value': '-2.36', 'spread': '0.071', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.368', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.091', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': "The DAS28-CRP is a measure of disease activity in 28 joints that consists of a composite numerical score with the following variables: TJC28, SJC28, hs-CRP (measured in milligrams per liter), and Participant's Global Assessment of Disease Activity recorded by participants on a 0 to 100 VAS. For DAS28-CRP, the Tender Joint Count 28 (TJC28) and Swollen Joint Count (SJC28) are a subset of TJC and SJC, and include 14 joints on each side of the body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. DAS28 values range from 0 to 9.4. Higher values indicate more severe symptoms and greater functional impairment. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had a baseline and at least one post-baseline DAS28-CRP value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Achieving Minimal Disease Activity (MDA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': '80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.'}], 'classes': [{'title': 'MDA-6 Entheseal Points', 'categories': [{'measurements': [{'value': '48.1', 'groupId': 'OG000', 'lowerLimit': '42.2', 'upperLimit': '53.9'}, {'value': '42.8', 'groupId': 'OG001', 'lowerLimit': '37.0', 'upperLimit': '48.5'}]}]}, {'title': 'MDA-18 Entheseal Points', 'categories': [{'measurements': [{'value': '47.3', 'groupId': 'OG000', 'lowerLimit': '41.5', 'upperLimit': '53.2'}, {'value': '41.0', 'groupId': 'OG001', 'lowerLimit': '35.3', 'upperLimit': '46.7'}]}]}], 'analyses': [{'pValue': '0.108', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.4', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '14.5', 'groupDescription': 'MDA-18 Entheseal Points', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.179', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.3', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '13.5', 'groupDescription': 'MDA-6 Entheseal Points', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'MDA is a composite of 7 key outcome measures: TJC ≤1; SJC ≤1; psoriasis activity and severity index (PASI total score) ≤1 or BSA ≤3; participant pain VAS score of ≤15; participant global disease activity VAS score of ≤20; HAQ-DI score ≤0.5; and tender entheseal points ≤1. Participants are classified as achieving MDA if they fulfill 5 of 7 outcome measures.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had a baseline and at least one post-baseline MDA value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': '80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.8', 'groupId': 'OG000', 'lowerLimit': '61.3', 'upperLimit': '72.3'}, {'value': '65.7', 'groupId': 'OG001', 'lowerLimit': '60.2', 'upperLimit': '71.3'}]}]}], 'analyses': [{'pValue': '0.846', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-8.9', 'ciUpperLimit': '6.7', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'The PsARC is a composite criteria reported in terms of the percentage of participants achieving response according to the following criterion: TJC, SJC, PGA, and PatGA. Overall response is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria: at least 30% reduction in TJC, at least 30% reduction in SJC, at least a 20 millimeter (mm) reduction in PGA and at least a 20 mm reduction in PatGA.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had a baseline and at least one post-baseline PsARC value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': '80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.35', 'spread': '0.136', 'groupId': 'OG000'}, {'value': '-3.85', 'spread': '0.136', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.49', 'ciLowerLimit': '-0.83', 'ciUpperLimit': '-0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.170', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The CPDAI is a validated instrument intended to assess composite psoriatic disease activity and response to therapy. Domains include peripheral arthritis as assessed by the number of tender and swollen joints and the HAQ-DI, skin as assessed by the PASI and the Dermatology Life Quality Index (DLQI), enthesitis as assessed by the number of sites with enthesitis and the HAQ-DI, and dactylitis as assessed by the number of digits affected. Each domain with the exception of spinal disease is scored from 0-3. Individual domain scores are summed to give an overall composite score (range 0-12) with a higher score indicating higher disease activity. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had a baseline and at least one post-baseline CPDAI value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index in Participants With Enthesitis at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': '80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.93', 'spread': '0.234', 'groupId': 'OG000'}, {'value': '-4.06', 'spread': '0.241', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.687', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '0.72', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.305', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The SPARCC enthesitis index evaluates tenderness in a total of 16 entheseal sites: the greater trochanter (right/left \\[R/L\\]), quadriceps tendon insertion into the patella (R/L), patellar ligament insertion into the patella and tibial tuberosity (R/L), Achilles tendon insertion (R/L), plantar fascia insertion (R/L), medial epicondyles of humerus (R/L),Lateral epicondyle humerus (R/L) and the supraspinatus insertion (R/L). Tenderness at each site is quantified on a dichotomous basis: 0 = nontender and 1 = tender. The results from each site are then added to produce a total score (range 0 to 16) with the Higher scores indicating more severe enthesitis. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had a baseline SPARCC score \\> 0. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in the Leeds Enthesitis Index (LEI) in Participants With Enthesitis at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': '80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.93', 'spread': '0.113', 'groupId': 'OG000'}, {'value': '-2.02', 'spread': '0.116', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.507', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.38', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.144', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle of humerus, right/left (R/L); medial femoral condyle,(R/L); Achilles tendon insertion, (R/L)). Each site is assigned a score of 0 (absent) or 1 (present); the results from each site are then added to produce a total score (range 0 to 6) with the higher scores indicating more severe enthesitis. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had a baseline enthesitis (LEI \\>0). Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in the Leeds Dactylitis Index-Basic (LDI-B) in Participants With Dactylitis at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': '80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.'}], 'classes': [{'categories': [{'measurements': [{'value': '-52.28', 'spread': '11.495', 'groupId': 'OG000'}, {'value': '-48.89', 'spread': '9.855', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.820', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.40', 'ciLowerLimit': '-32.78', 'ciUpperLimit': '25.99', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.951', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The LDI-B measures the severity of dactylitis.In each digit,the ratio of the circumference(cf) of the affected digit to the cf of the digit on the opposite hand or foot measured in mm. Each dactylitic digit is defined by a minimum increase of 10% in cf over the contra-lateral digit.If the same digits on each hand or foot were thought to be involved,the clinician referred to a table of normative values for a value which was used to provide the comparison.If the ratio is \\>1.1,then subtract 1 from the calculated ratio and multiply it by 100 and the tenderness score of 0(not tender) or 1(tender).Otherwise,if the ratio of the cf of the digit is ≤1.1,then the LDI-B score is set to 0.LDI-B score can be \\>=0 with higher numbers indicating worse dactylitis.LS mean was calculated using MMRM model: treatment group,concomitant csDMARD use at baseline,moderate-to-severe Ps involvement,visit as fixed factors,baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had a baseline dactylitis (LDI-B \\>0). Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Psoriasis Body Surface Area (BSA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': '80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.33', 'spread': '0.623', 'groupId': 'OG000'}, {'value': '-10.79', 'spread': '0.613', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.052', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.54', 'ciLowerLimit': '-3.09', 'ciUpperLimit': '0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.790', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': "The investigator evaluates the percentage involvement of psoriasis on each participant's BSA on a continuous scale from 0% = no involvement to 100% = full involvement, where 1% corresponded to the size of the participant's handprint including the palm, fingers, and thumb. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had a baseline and at least one post-baseline BSA value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Fingernails Score in the Subgroup of Participants With Fingernail Involvement at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': '80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.78', 'spread': '0.731', 'groupId': 'OG000'}, {'value': '-15.08', 'spread': '0.742', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.70', 'ciLowerLimit': '-4.57', 'ciUpperLimit': '-0.84', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.949', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis). LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had baseline fingernail involvement (NAPSI \\>0). Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in the Itch NRS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': '80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.83', 'spread': '0.159', 'groupId': 'OG000'}, {'value': '-3.54', 'spread': '0.159', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.158', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.29', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '0.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.202', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant\'s itching from psoriasis is indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had a baseline and at least one post-baseline NRS value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Fatigue Severity NRS (Fatigue NRS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': '80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.03', 'spread': '0.161', 'groupId': 'OG000'}, {'value': '-2.95', 'spread': '0.161', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.711', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.49', 'ciUpperLimit': '0.33', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.21', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The Fatigue Severity NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no fatigue" and 10 representing "as bad as you can imagine." Participants rate their fatigue (weariness, tiredness) by circling the 1 number that described their worst level of fatigue during the past 24 hours. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had a baseline and at least one post-baseline Fatigue NRS value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': '80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.07', 'spread': '0.526', 'groupId': 'OG000'}, {'value': '9.55', 'spread': '0.524', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.439', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.52', 'ciLowerLimit': '-0.80', 'ciUpperLimit': '1.85', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.674', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': "The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had a baseline and at least one post-baseline PCS value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in SF-36: Mental Component Summary (MCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': '80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.23', 'spread': '0.660', 'groupId': 'OG000'}, {'value': '4.77', 'spread': '0.656', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.594', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.46', 'ciLowerLimit': '-1.23', 'ciUpperLimit': '2.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.860', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': "The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had a baseline and at least one post-baseline MCS value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Measures of Health Utility (EuroQol-5 Dimensions 5 Level [EQ-5D 5L]) United Kingdom(UK) Population-Based Index Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': '80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.21', 'spread': '0.013', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '0.013', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.979', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.00', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.017', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': "The EQ-5D-5L consists of 2 components: a descriptive system of the respondent's health and a rating of his/her current health state. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The descriptive part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.The EQ-5D-5L health states were converted into a single summary index by applying a crosswalk using a UK Population value set to each of the levels in each dimension.This produced participant-level index scores between -0.594 and 1.0 (worse to better health). LS mean was calculated using MMRM model that included treatment group,concomitant csDMARD use at baseline,moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had a baseline and at least one post-baseline EQ-5D 5L value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Measures of Health Utility (EuroQol-5 Dimensions 5 Level [EQ-5D 5L]) VAS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': '80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.26', 'spread': '1.37', 'groupId': 'OG000'}, {'value': '17.48', 'spread': '1.36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.78', 'ciLowerLimit': '1.28', 'ciUpperLimit': '8.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.782', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': "EQ-5D-5L is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of 2 components: a descriptive system of the respondent's health and a rating of his/her current health state using a 0 (worst health you can imagine) to 100mm VAS (best health you can imagine). LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.", 'unitOfMeasure': 'millimeters (mm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had a baseline and at least one post-baseline EQ-5D 5L value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': '80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.03', 'spread': '0.273', 'groupId': 'OG000'}, {'value': '-6.91', 'spread': '0.272', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.12', 'ciLowerLimit': '-1.78', 'ciUpperLimit': '-0.46', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.335', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period of this scale is over the last "week." Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Scores range from 0 to 30 (less to more impairment), and a 4-point change from baseline is considered as the minimal clinically important difference threshold. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had a baseline and at least one post-baseline DLQI value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Answering "Mostly Satisfied" to Each Question in Treatment Satisfaction Questionnaire (TSQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': '80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.'}], 'classes': [{'title': 'Effectiveness of Medication', 'categories': [{'measurements': [{'value': '64.3', 'groupId': 'OG000', 'lowerLimit': '58.7', 'upperLimit': '69.9'}, {'value': '58.7', 'groupId': 'OG001', 'lowerLimit': '52.9', 'upperLimit': '64.4'}]}]}, {'title': 'Effectiveness over Time of Medication', 'categories': [{'measurements': [{'value': '62.9', 'groupId': 'OG000', 'lowerLimit': '57.3', 'upperLimit': '68.5'}, {'value': '56.2', 'groupId': 'OG001', 'lowerLimit': '50.4', 'upperLimit': '62.0'}]}]}, {'title': 'Long Term Safety of Medication', 'categories': [{'measurements': [{'value': '63.3', 'groupId': 'OG000', 'lowerLimit': '57.6', 'upperLimit': '68.9'}, {'value': '58.7', 'groupId': 'OG001', 'lowerLimit': '52.9', 'upperLimit': '64.4'}]}]}, {'title': 'Overall Satisfaction with Medication', 'categories': [{'measurements': [{'value': '64.0', 'groupId': 'OG000', 'lowerLimit': '58.4', 'upperLimit': '69.6'}, {'value': '59.0', 'groupId': 'OG001', 'lowerLimit': '53.3', 'upperLimit': '64.7'}]}]}, {'title': 'Mostly Satisfied to any Questions', 'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000', 'lowerLimit': '64.6', 'upperLimit': '75.3'}, {'value': '67.8', 'groupId': 'OG001', 'lowerLimit': '62.4', 'upperLimit': '73.3'}]}]}], 'analyses': [{'pValue': '0.165', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.7', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '13.7', 'groupDescription': 'Effectiveness of Medication', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.098', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.7', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '14.8', 'groupDescription': 'Effectiveness over Time of Medication', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.241', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.6', 'ciLowerLimit': '-3.4', 'ciUpperLimit': '12.6', 'groupDescription': 'Long Term Safety of Medication', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.215', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.9', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '13.0', 'groupDescription': 'Overall Satisfaction with Medication', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.561', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.1', 'ciLowerLimit': '-5.5', 'ciUpperLimit': '9.7', 'groupDescription': 'Mostly Satisfied to any Questions', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'The TSQ is a clinician-administered questionnaire that provides an assessment of the patient\'s opinion of the effectiveness, safety, and overall satisfaction of the study medication. Participants were asked to respond to questionnaire items using a 4-point Likert scale (from "mostly satisfied" to "mostly dissatisfied").', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had a baseline and at least one post-baseline TSQ value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Who Answered "Yes" to Any 10 Questions in Columbia Suicide Severity Rating Scale (C-SSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': '80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 52', 'description': 'The C-SSRS is a scale that captures the occurrence, severity, and frequency of suicide-related ideations and behaviors during the assessment period.\n\n1. Wish to be dead\n2. Non-specific active suicidal thoughts\n3. Active suicidal ideation with any methods (not plan) without intent to act\n4. Active suicidal ideation with some intent to act, without specific plan\n5. Active suicidal ideation with specific plan and intent\n6. Preparatory acts or behavior\n7. Aborted attempt\n8. Interrupted attempt\n9. Non-fatal suicide attempt\n10. Completed suicide', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.\n\nFollow-up: Participants did not receive drug during the Post-Treatment Follow-Up Period.'}, {'id': 'FG001', 'title': 'Adalimumab', 'description': '80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.\n\nFollow-up: Participants did not receive drug during the Post-Treatment Follow-Up Period.'}], 'periods': [{'title': 'Open-Label Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '283'}, {'groupId': 'FG001', 'numSubjects': '283'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '283'}, {'groupId': 'FG001', 'numSubjects': '283'}]}, {'type': 'IXE 160 mg at Baseline, 80 mg Q2W/Q4W', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'comment': 'Row represents Ixekizumab data only.', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'IXE 160 mg at Baseline, 80 mg Q4W', 'achievements': [{'groupId': 'FG000', 'numSubjects': '218'}, {'comment': 'Row represents Ixekizumab data only.', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'ADA 80 mg at Baseline, 40 mg Q2W', 'achievements': [{'comment': 'Row represents adalimumab data only.', 'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'ADA 40 mg at Baseline, 40 mg Q2W', 'achievements': [{'comment': 'Row represents adalimumab data only.', 'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '219'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '265'}, {'groupId': 'FG001', 'numSubjects': '259'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Post-Treatment Follow-Up Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'All participants who received at least one dose of study drug could enter the follow-up period.', 'groupId': 'FG000', 'numSubjects': '265'}, {'comment': 'All participants who received at least one dose of study drug could enter the follow-up period.', 'groupId': 'FG001', 'numSubjects': '258'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '240'}, {'groupId': 'FG001', 'numSubjects': '230'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Per protocol and statistical analysis plan (SAP), the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.', 'preAssignmentDetails': 'Open-Label Treatment Period from Week 0 to Week 52 inclusive followed by Post-Treatment Follow-Up Period of up to a minimum of 12 weeks.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'BG000'}, {'value': '283', 'groupId': 'BG001'}, {'value': '566', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.'}, {'id': 'BG001', 'title': 'Adalimumab', 'description': '80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.5', 'spread': '12.02', 'groupId': 'BG000'}, {'value': '48.3', 'spread': '12.30', 'groupId': 'BG001'}, {'value': '47.9', 'spread': '12.15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '312', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '198', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '392', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '222', 'groupId': 'BG000'}, {'value': '211', 'groupId': 'BG001'}, {'value': '433', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Argentina', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Finland', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-26', 'size': 993674, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-02-22T17:14', 'hasProtocol': True}, {'date': '2018-12-03', 'size': 1132941, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-02-22T17:14', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 566}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-09', 'studyFirstSubmitDate': '2017-05-04', 'resultsFirstSubmitDate': '2019-02-22', 'studyFirstSubmitQcDate': '2017-05-11', 'lastUpdatePostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-08', 'studyFirstPostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline in Tender Joint Count (TJC)', 'timeFrame': 'Baseline, Week 52', 'description': 'TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model that included treatment group, concomitant conventional synthetic disease-modifying anti-rheumatic drugs (csDMARD) use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.'}, {'measure': 'Change From Baseline in Swollen Joint Count (SJC)', 'timeFrame': 'Baseline, Week 52', 'description': 'SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS mean was calculated using MMRM model that included treatment group, concomitant conventional synthetic disease-modifying anti-rheumatic drugs (csDMARD) use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.'}, {'measure': "Change From Baseline in Participant's Assessment of Pain Visual Analogue Score (VAS)", 'timeFrame': 'Baseline, Week 52', 'description': "The pain VAS is a participant-administered single-item scale designed to measure current joint pain from Psoriatic arthritis (PsA) using a 100-millimeter(mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by marking a vertical tick on the horizontal 100-mm scale, where the left end from 0 mm (no pain) to right end 100 mm (worst possible joint pain). LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms."}, {'measure': "Change From Baseline in Participant's Global Assessment of Disease Activity", 'timeFrame': 'Baseline, Week 52', 'description': "The patient's overall assessment of his or her PsA activity was recorded using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms."}, {'measure': "Change From Baseline in Physician's Global Assessment of Disease Activity", 'timeFrame': 'Baseline, Week 52', 'description': "The investigator was asked to give an overall assessment of the severity of the participant's current PsA activity using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms."}, {'measure': 'Change From Baseline in C-Reactive Protein (CRP)', 'timeFrame': 'Baseline, Week 52', 'description': "CRP is the ACR Core Set laboratory measure of acute-phase reactant. It was measured with a high sensitivity assay at the central laboratory to help assess the effect of ixekizumab on the participant's PsA. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms."}, {'measure': 'Change From Baseline in HAQ-DI', 'timeFrame': 'Baseline, Week 52', 'description': "HAQ-DI is a participant reported questionnaire that measures disease-associated disability (physical function). It consists of 24 questions with 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities. The disability section scores the participant's self-perception on the degree of difficulty (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do), covering the 8 domains. The reported use of special aids or devices and/or the need for assistance of another person to perform these activities is assessed. The HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms."}, {'measure': 'Percentage of Participants Simultaneously Achieving ACR50 and PASI100', 'timeFrame': 'Week 52', 'description': "ACR50 response is a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of VAS, Pts Global Assessment of Disease Activity (PatGA) VAS, Physician's Global Assessment of Disease Activity (PGA)VAS, participant assessment of physical function using the HAQ-DI, or High Sensitivity(assay) C-Reactive Protein (hs-CRP). PASI is an index combining assessments of the extent of body-surface involvement in head, trunk, arms, legs, and severity of desquamation, erythema and plaque thickness in each region, yielding overall score of 0-no involvement, to 72-most severe involvement. Participant achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Pts achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Pts with active plaque PsO with a BSA≥3% \\& PASI=0 at baseline were considered PASI100 responders if they had achieved PASI=0 \\& BSA=0 at week 52."}, {'measure': 'Change From Baseline in Disease Activity Score-CRP (DAS28-CRP)', 'timeFrame': 'Baseline, Week 52', 'description': "The DAS28-CRP is a measure of disease activity in 28 joints that consists of a composite numerical score with the following variables: TJC28, SJC28, hs-CRP (measured in milligrams per liter), and Participant's Global Assessment of Disease Activity recorded by participants on a 0 to 100 VAS. For DAS28-CRP, the Tender Joint Count 28 (TJC28) and Swollen Joint Count (SJC28) are a subset of TJC and SJC, and include 14 joints on each side of the body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. DAS28 values range from 0 to 9.4. Higher values indicate more severe symptoms and greater functional impairment. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms."}, {'measure': 'Percentage of Participants Achieving Minimal Disease Activity (MDA)', 'timeFrame': 'Week 52', 'description': 'MDA is a composite of 7 key outcome measures: TJC ≤1; SJC ≤1; psoriasis activity and severity index (PASI total score) ≤1 or BSA ≤3; participant pain VAS score of ≤15; participant global disease activity VAS score of ≤20; HAQ-DI score ≤0.5; and tender entheseal points ≤1. Participants are classified as achieving MDA if they fulfill 5 of 7 outcome measures.'}, {'measure': 'Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)', 'timeFrame': 'Week 52', 'description': 'The PsARC is a composite criteria reported in terms of the percentage of participants achieving response according to the following criterion: TJC, SJC, PGA, and PatGA. Overall response is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria: at least 30% reduction in TJC, at least 30% reduction in SJC, at least a 20 millimeter (mm) reduction in PGA and at least a 20 mm reduction in PatGA.'}, {'measure': 'Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score', 'timeFrame': 'Baseline, Week 52', 'description': 'The CPDAI is a validated instrument intended to assess composite psoriatic disease activity and response to therapy. Domains include peripheral arthritis as assessed by the number of tender and swollen joints and the HAQ-DI, skin as assessed by the PASI and the Dermatology Life Quality Index (DLQI), enthesitis as assessed by the number of sites with enthesitis and the HAQ-DI, and dactylitis as assessed by the number of digits affected. Each domain with the exception of spinal disease is scored from 0-3. Individual domain scores are summed to give an overall composite score (range 0-12) with a higher score indicating higher disease activity. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.'}, {'measure': 'Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index in Participants With Enthesitis at Baseline', 'timeFrame': 'Baseline, Week 52', 'description': 'The SPARCC enthesitis index evaluates tenderness in a total of 16 entheseal sites: the greater trochanter (right/left \\[R/L\\]), quadriceps tendon insertion into the patella (R/L), patellar ligament insertion into the patella and tibial tuberosity (R/L), Achilles tendon insertion (R/L), plantar fascia insertion (R/L), medial epicondyles of humerus (R/L),Lateral epicondyle humerus (R/L) and the supraspinatus insertion (R/L). Tenderness at each site is quantified on a dichotomous basis: 0 = nontender and 1 = tender. The results from each site are then added to produce a total score (range 0 to 16) with the Higher scores indicating more severe enthesitis. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.'}, {'measure': 'Change From Baseline in the Leeds Enthesitis Index (LEI) in Participants With Enthesitis at Baseline', 'timeFrame': 'Baseline, Week 52', 'description': 'The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle of humerus, right/left (R/L); medial femoral condyle,(R/L); Achilles tendon insertion, (R/L)). Each site is assigned a score of 0 (absent) or 1 (present); the results from each site are then added to produce a total score (range 0 to 6) with the higher scores indicating more severe enthesitis. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.'}, {'measure': 'Change From Baseline in the Leeds Dactylitis Index-Basic (LDI-B) in Participants With Dactylitis at Baseline', 'timeFrame': 'Baseline, Week 52', 'description': 'The LDI-B measures the severity of dactylitis.In each digit,the ratio of the circumference(cf) of the affected digit to the cf of the digit on the opposite hand or foot measured in mm. Each dactylitic digit is defined by a minimum increase of 10% in cf over the contra-lateral digit.If the same digits on each hand or foot were thought to be involved,the clinician referred to a table of normative values for a value which was used to provide the comparison.If the ratio is \\>1.1,then subtract 1 from the calculated ratio and multiply it by 100 and the tenderness score of 0(not tender) or 1(tender).Otherwise,if the ratio of the cf of the digit is ≤1.1,then the LDI-B score is set to 0.LDI-B score can be \\>=0 with higher numbers indicating worse dactylitis.LS mean was calculated using MMRM model: treatment group,concomitant csDMARD use at baseline,moderate-to-severe Ps involvement,visit as fixed factors,baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.'}, {'measure': 'Change From Baseline in Psoriasis Body Surface Area (BSA)', 'timeFrame': 'Baseline, Week 52', 'description': "The investigator evaluates the percentage involvement of psoriasis on each participant's BSA on a continuous scale from 0% = no involvement to 100% = full involvement, where 1% corresponded to the size of the participant's handprint including the palm, fingers, and thumb. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms."}, {'measure': 'Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Fingernails Score in the Subgroup of Participants With Fingernail Involvement at Baseline', 'timeFrame': 'Baseline, Week 52', 'description': 'The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis). LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.'}, {'measure': 'Change From Baseline in the Itch NRS', 'timeFrame': 'Baseline, Week 52', 'description': 'The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant\'s itching from psoriasis is indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.'}, {'measure': 'Change From Baseline in Fatigue Severity NRS (Fatigue NRS) Score', 'timeFrame': 'Baseline, Week 52', 'description': 'The Fatigue Severity NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no fatigue" and 10 representing "as bad as you can imagine." Participants rate their fatigue (weariness, tiredness) by circling the 1 number that described their worst level of fatigue during the past 24 hours. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.'}, {'measure': 'Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS)', 'timeFrame': 'Baseline, Week 52', 'description': "The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms."}, {'measure': 'Change From Baseline in SF-36: Mental Component Summary (MCS)', 'timeFrame': 'Baseline, Week 52', 'description': "The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms."}, {'measure': 'Change From Baseline in Measures of Health Utility (EuroQol-5 Dimensions 5 Level [EQ-5D 5L]) United Kingdom(UK) Population-Based Index Score', 'timeFrame': 'Baseline, Week 52', 'description': "The EQ-5D-5L consists of 2 components: a descriptive system of the respondent's health and a rating of his/her current health state. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The descriptive part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.The EQ-5D-5L health states were converted into a single summary index by applying a crosswalk using a UK Population value set to each of the levels in each dimension.This produced participant-level index scores between -0.594 and 1.0 (worse to better health). LS mean was calculated using MMRM model that included treatment group,concomitant csDMARD use at baseline,moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms."}, {'measure': 'Change From Baseline in Measures of Health Utility (EuroQol-5 Dimensions 5 Level [EQ-5D 5L]) VAS Score', 'timeFrame': 'Baseline, Week 52', 'description': "EQ-5D-5L is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of 2 components: a descriptive system of the respondent's health and a rating of his/her current health state using a 0 (worst health you can imagine) to 100mm VAS (best health you can imagine). LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms."}, {'measure': 'Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score', 'timeFrame': 'Baseline, Week 52', 'description': 'The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period of this scale is over the last "week." Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Scores range from 0 to 30 (less to more impairment), and a 4-point change from baseline is considered as the minimal clinically important difference threshold. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.'}, {'measure': 'Percentage of Participants Answering "Mostly Satisfied" to Each Question in Treatment Satisfaction Questionnaire (TSQ)', 'timeFrame': 'Week 52', 'description': 'The TSQ is a clinician-administered questionnaire that provides an assessment of the patient\'s opinion of the effectiveness, safety, and overall satisfaction of the study medication. Participants were asked to respond to questionnaire items using a 4-point Likert scale (from "mostly satisfied" to "mostly dissatisfied").'}, {'measure': 'Number of Participants Who Answered "Yes" to Any 10 Questions in Columbia Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'Week 52', 'description': 'The C-SSRS is a scale that captures the occurrence, severity, and frequency of suicide-related ideations and behaviors during the assessment period.\n\n1. Wish to be dead\n2. Non-specific active suicidal thoughts\n3. Active suicidal ideation with any methods (not plan) without intent to act\n4. Active suicidal ideation with some intent to act, without specific plan\n5. Active suicidal ideation with specific plan and intent\n6. Preparatory acts or behavior\n7. Aborted attempt\n8. Interrupted attempt\n9. Non-fatal suicide attempt\n10. Completed suicide'}], 'primaryOutcomes': [{'measure': 'Percentage of Participants Simultaneously Achieving American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI100)', 'timeFrame': 'Week 24', 'description': "ACR50 response is a ≥50% improvement from baseline for tender joint count(TJC)\\& swollen joint count (SJC)\\& in at least 3 of the following 5 criteria: Participant's(pts) assessment of joint pain Visual Analog Scale (VAS),Pts Global Assessment of Disease Activity (PatGA)VAS, Physician's Global Assessment of Disease Activity (PGA)VAS, Pts assessment of physical function using the Health Assessment Questionnaire-Disability Index(HAQ-DI), or High Sensitivity(assay)C-Reactive Protein (hs-CRP). PASI is an index combining assessments of the extent of body-surface involvement in head, trunk, arms, legs, and severity of desquamation, erythema and plaque thickness in each region, yielding overall score of 0-no involvement, to 72-most severe involvement. Pts achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Pts with active plaque PsO with a BSA≥3% \\& PASI=0 at baseline were considered PASI100 responders if they had achieved PASI=0 \\& BSA=0 at week 24."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving ACR50', 'timeFrame': 'Week 24', 'description': "ACR50 response is defined as a ≥50% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of joint pain Visual Analog Scale (VAS), Participant's Global Assessment of Disease Activity (PatGA) VAS, Physician's Global Assessment of Disease Activity (PGA) VAS, participant's assessment of physical function using the Health Assessment Questionnaire-Disability Index (HAQ-DI), or High Sensitivity (assay) C-Reactive Protein (hs-CRP)."}, {'measure': 'Percentage of Participants Achieving PASI100', 'timeFrame': 'Week 24', 'description': 'PASI is an index combining assessments of the extent of body-surface involvement in head, trunk, arms, legs, and severity of desquamation, erythema and plaque thickness in each region, yielding overall score of 0-no involvement, to 72-most severe involvement. Participants achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Any participants with active plaque psoriasis (PsO) with a BSA ≥3% and PASI = 0 at baseline were considered PASI100 responders if \\& only if they had achieved PASI=0 \\& BSA=0 at week 24.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psoriatic Arthritis']}, 'referencesModule': {'references': [{'pmid': '40014255', 'type': 'DERIVED', 'citation': 'Kristensen LE, McGonagle D, Rudwaleit M, Kameda H, Wurtzen PA, Ngantcha M, Holzkamper T, Smolen J. Synergistic Improvements in Synovitis, Enthesitis, and Patient-Reported Outcomes for Patients with Psoriatic Arthritis Treated with Ixekizumab in SPIRIT Trials. Rheumatol Ther. 2025 Apr;12(2):381-395. doi: 10.1007/s40744-025-00748-8. Epub 2025 Feb 27.'}, {'pmid': '37400681', 'type': 'DERIVED', 'citation': 'Kirkham BW, Egeberg A, Behrens F, Pinter A, Merola JF, Holzkamper T, Gallo G, Ng KJ, Bolce R, Schuster C, Nash P, Puig L. A Comprehensive Review of Ixekizumab Efficacy in Nail Psoriasis from Clinical Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Rheumatol Ther. 2023 Oct;10(5):1127-1146. doi: 10.1007/s40744-023-00553-1. Epub 2023 Jul 3.'}, {'pmid': '35393269', 'type': 'DERIVED', 'citation': 'Deodhar AA, Combe B, Accioly AP, Bolce R, Zhu D, Gellett AM, Sprabery AT, Burmester GR. Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure. Ann Rheum Dis. 2022 Jul;81(7):944-950. doi: 10.1136/annrheumdis-2021-222027. Epub 2022 Apr 7.'}, {'pmid': '35279805', 'type': 'DERIVED', 'citation': 'Elewski BE, Blauvelt A, Gallo G, Wolf E, McKean-Matthews M, Burge R, Merola JF, Gottlieb AB, Guenther LC. Simultaneous Nail and Skin Clearance in Ixekizumab Head-to-Head Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Dermatol Ther (Heidelb). 2022 Apr;12(4):911-920. doi: 10.1007/s13555-022-00704-2. Epub 2022 Mar 13.'}, {'pmid': '33200394', 'type': 'DERIVED', 'citation': 'Smolen JS, Sebba A, Ruderman EM, Schulze-Koops H, Sapin C, Gellett AM, Sprabery AT, Li L, de la Torre I, Gallo G, Liu-Leage S, Pillai S, Reis P, Nash P. Efficacy and Safety of Ixekizumab with or Without Methotrexate in Biologic-Naive Patients with Psoriatic Arthritis: 52-Week Results from SPIRIT-H2H Study. Rheumatol Ther. 2020 Dec;7(4):1021-1035. doi: 10.1007/s40744-020-00250-3. Epub 2020 Nov 16.'}, {'pmid': '32660977', 'type': 'DERIVED', 'citation': 'Smolen JS, Mease P, Tahir H, Schulze-Koops H, de la Torre I, Li L, Hojnik M, Sapin C, Okada M, Caporali R, Gratacos J, Goupille P, Liu Leage S, Pillai S, Nash P. Multicentre, randomised, open-label, parallel-group study evaluating the efficacy and safety of ixekizumab versus adalimumab in patients with psoriatic arthritis naive to biological disease-modifying antirheumatic drug: final results by week 52. Ann Rheum Dis. 2020 Oct;79(10):1310-1319. doi: 10.1136/annrheumdis-2020-217372. Epub 2020 Jul 13.'}], 'seeAlsoLinks': [{'url': 'https://www.lillytrialguide.com/en-US/studies/psoriatic-arthritis/RHCF#?postal=', 'label': 'A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis (Spirit-H2H)'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the effectiveness and safety of ixekizumab versus adalimumab in participants with psoriatic arthritis (PsA) who are biologic disease-modifying anti-rheumatic drugs (DMARD) naive.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Presence of established diagnosis of active psoriatic arthritis for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria\n* Active PsA defined as the presence of at least 3 (out of 68) tender and at least 3 (out of 66) swollen joints\n* Presence of active plaque psoriasis with a BSA ≥3%\n* Men must agree to use a reliable method of birth control or remain abstinent during the study\n* Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment\n* Have had an inadequate response when treated with 1 or more conventional synthetic disease-modifying antirheumatic drugs (csDMARDs)\n\nExclusion Criteria:\n\n* Current or prior use of biologic agents for treatment of Ps or PsA\n* Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA\n* Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab\n* Serious disorder or illness other than psoriatic arthritis\n* Serious infection within the last 3 months\n* Active Crohn's disease or active ulcerative colitis\n* Active vasculitis or uveitis\n* Diagnosis of or history of malignant disease \\<5 years prior to randomization\n* Women who are breastfeeding"}, 'identificationModule': {'nctId': 'NCT03151551', 'acronym': 'SPIRIT-H2H', 'briefTitle': 'A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A 52-Week Multicenter, Randomized, Open-Label, Parallel- Group Study Evaluating the Efficacy and Safety of Ixekizumab Versus Adalimumab in Patients With Psoriatic Arthritis Who Are Biologic Disease-Modifying Anti-Rheumatic Drug Naive', 'orgStudyIdInfo': {'id': '16687'}, 'secondaryIdInfos': [{'id': 'I1F-MC-RHCF', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2016-004585-25', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ixekizumab', 'description': '160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline for all participants.\n\n80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.\n\n80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.', 'interventionNames': ['Drug: Ixekizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Adalimumab', 'description': '80 mg adalimumab given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.\n\n40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.', 'interventionNames': ['Drug: Adalimumab']}], 'interventions': [{'name': 'Ixekizumab', 'type': 'DRUG', 'otherNames': ['LY2439821'], 'description': 'Administered SC', 'armGroupLabels': ['Ixekizumab']}, {'name': 'Adalimumab', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Adalimumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'C1426AAL', 'city': 'Ciudad Autonoma de Buenos Aire', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Atencion Integral en Reumatología'}, {'zip': 'C1430EGF', 'city': 'Ciudad de Buenos Aires', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Clinica Adventista de Belgrano'}, {'zip': 'B1878DVC', 'city': 'Quilmes', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'CER Instituto Medico', 'geoPoint': {'lat': -34.72065, 'lon': -58.25454}}, {'zip': 'B1646DBM', 'city': 'San Fernando', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Instituto de Asist Reumatologica Integral', 'geoPoint': {'lat': -34.44104, 'lon': -58.56279}}, {'zip': 'T4000AXL', 'city': 'San Miguel de Tucumán', 'state': 'Tucumán Province', 'country': 'Argentina', 'facility': 'Centro Medico Privado de Reumatologia', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'zip': 'C1015ABO', 'city': 'Ciudad Autonoma de Buenos Aire', 'country': 'Argentina', 'facility': 'Organizacion Medica de Investigacion - OMI'}, {'zip': 'C1204AAD', 'city': 'Ciudad Autonoma de Buenos Aire', 'country': 'Argentina', 'facility': 'Instituto Centenario'}, {'zip': 'C1221ADC', 'city': 'Ciudad Autonoma de Buenos Aire', 'country': 'Argentina', 'facility': 'Hospital Ramos Mejia'}, {'zip': 'C1417EYG', 'city': 'Ciudad Autonoma de Buenos Aire', 'country': 'Argentina', 'facility': 'Centro de Medicina Familiar Mindout Research'}, {'zip': 'C1440AAD', 'city': 'Ciudad Autonoma de Buenos Aire', 'country': 'Argentina', 'facility': 'CENUDIAB'}, {'zip': '5004', 'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Consultora Integral de Salud S.R.L.', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': 'J5402DIL', 'city': 'San Juan', 'country': 'Argentina', 'facility': 'Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan', 'geoPoint': {'lat': -31.53726, 'lon': -68.52568}}, {'zip': '2217', 'city': 'Kogarah', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Combined Rheumatology Practice (CRP)', 'geoPoint': {'lat': -33.9681, 'lon': 151.13564}}, {'zip': '5011', 'city': 'Woodville South', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Rheumatology, The Queen Elizabeth Hospital', 'geoPoint': {'lat': -34.88186, 'lon': 138.53477}}, {'zip': '7000', 'city': 'Hobart', 'state': 'Tasmania', 'country': 'Australia', 'facility': 'Southern Clinical Research Pty Ltd', 'geoPoint': {'lat': -42.87936, 'lon': 147.32941}}, {'zip': '3124', 'city': 'Camberwell', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Emeritus Research', 'geoPoint': {'lat': -37.84205, 'lon': 145.0694}}, {'zip': '3065', 'city': 'Fitzroy', 'state': 'Victoria', 'country': 'Australia', 'facility': 'St Vincents Hospital Melbourne', 'geoPoint': {'lat': -37.79839, 'lon': 144.97833}}, {'zip': '1060', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Zentrum für klinische Studien Dr. Ursula Hanusch GmbH', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'AKH', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1100', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Rheuma-Zentrum Wien Oberlaa', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '3600', 'city': 'Genk', 'country': 'Belgium', 'facility': 'Reumaclinic', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '6060', 'city': 'Gilly', 'country': 'Belgium', 'facility': 'Saint Joseph Hospital', 'geoPoint': {'lat': 50.42449, 'lon': 4.4789}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '7000', 'city': 'Mons', 'country': 'Belgium', 'facility': 'Hopital Ambroise Pare', 'geoPoint': {'lat': 50.45413, 'lon': 3.95229}}, {'zip': 'L4M 6L2', 'city': 'Barrie', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Waterside Clinic', 'geoPoint': {'lat': 44.40011, 'lon': -79.66634}}, {'zip': 'K9J 5K2', 'city': 'Peterborough', 'state': 'Ontario', 'country': 'Canada', 'facility': 'SKiN Center for Dermatology', 'geoPoint': {'lat': 44.30012, 'lon': -78.31623}}, {'zip': 'G8Z 1Y2', 'city': 'Trois-Rivières', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre de Recherche Musculo-Squelettique', 'geoPoint': {'lat': 46.34515, 'lon': -72.5477}}, {'zip': 'S7K 0H6', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Polmed Research Inc.', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}, {'zip': 'G1V 3M7', 'city': 'Québec', 'country': 'Canada', 'facility': 'Group de recherche en maladies osseuses', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '2000', 'city': 'Frederiksberg', 'state': 'Capital Region', 'country': 'Denmark', 'facility': 'Frederiksberg Hospital', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}, {'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Aalborg Universitetshospital - Psykiatrien', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '00029', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsinki University Hospital, HYKS', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '05800', 'city': 'Hyvinkää', 'country': 'Finland', 'facility': 'Kiljava Medical Research', 'geoPoint': {'lat': 60.63195, 'lon': 24.8606}}, {'zip': '45100', 'city': 'Kouvola', 'country': 'Finland', 'facility': 'Terveystalo Kouvola', 'geoPoint': {'lat': 60.86667, 'lon': 26.7}}, {'zip': '20521', 'city': 'Turku', 'country': 'Finland', 'facility': 'Turun Yliopistollinen Keskussairaala', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '37170', 'city': 'Chambray-lès-Tours', 'country': 'France', 'facility': 'Hôpital Trousseau, CHRU de Tours', 'geoPoint': {'lat': 47.33537, 'lon': 0.70286}}, {'zip': '85025', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'Centre Hospitalier de Vendee Les Oudairies', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '69003', 'city': 'Lyon', 'country': 'France', 'facility': 'Hopital Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Centre hospitalier universitaire Lapeyronie', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '45067', 'city': 'Orléans', 'country': 'France', 'facility': 'Nouvel Hôpital Orléans La Source', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Hôpital Pierre-Paul Riquet', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '80336', 'city': 'München', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Klinikum der Universität München', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Klinikum der Johann Wolfgang Goethe-Universität Frankfurt', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '40878', 'city': 'Ratingen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Rheumazentrum Ratingen', 'geoPoint': {'lat': 51.29724, 'lon': 6.84929}}, {'zip': '20095', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'HRF Hamburger Rheuma Forschungszentrum', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '5000', 'city': 'Szolnok', 'state': 'Jász-Nagykun-Szolnok', 'country': 'Hungary', 'facility': 'Allergo-Derm Bakos Kft', 'geoPoint': {'lat': 47.18066, 'lon': 20.19835}}, {'zip': '1036', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Obudai Egeszsegugyi Centrum Kft', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1135', 'city': 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