Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2026-03-05 @ 6:58 PM
Study NCT ID:
NCT04108468
Status:
COMPLETED
Last Update Posted:
2025-12-02
First Post:
2019-09-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
GOLimumab and Methotrexate Versus Methotrexate in Very Early PsA
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': 'D008727', 'term': 'Methotrexate'}, {'id': 'C529000', 'term': 'golimumab'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'H.Marzo-Ortega@leeds.ac.uk', 'phone': '+44 (0) 113 392 4848', 'title': 'Professor Helena Marzo-Ortega', 'organization': 'Leeds Teaching Hospital Trust'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '52 Weeks', 'description': 'Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit.\n\nAEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.', 'eventGroups': [{'id': 'EG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 38, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 41, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Flashing lights', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vitreous hemorrage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Lower gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 24, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Other: Broken tooth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Other: Fatty infiltration of pancreas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Other: Loose stools', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Other: Mouth ulcers', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Stomach pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Flu like symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Other: Fatty liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Other: Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Other: Liver fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Other: Steatohepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Abdominal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Bladder infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Herpes simplex reactivation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Mucosal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nail infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Other: Genital thrush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Papulopustular rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Shingles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Soft tissue infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 26, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vaginal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Other: Skin injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Other: Spider bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Other: Twisted right knee', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Other: Vaccine complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 23, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 35, 'numAffected': 21}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Aspartate Aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Other: HBA1C elevated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Other: Macrocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Other: Vitamin D insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Glucose intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Muscle cramp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Other: Mass right forearm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Other: Muscle spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': "Other: Raynaud's phenomenon", 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Other: Trigger finger', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Other: Restless legs syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Libido decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Other: Mood swings', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Urinary frequency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dyspareunia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Erectile Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Irregular menstruation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Other: Erythematous lesion at the tip of penis, balanitis (dermatologist confirmed)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Other: High secretion from the breast', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Uterine haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pharyngeal mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Postnasal drip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dyshidrotic eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Other: Contact dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Skin hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Other: Varicose veins', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Psoriatic Arthritis Disease Activity Score (PASDAS) at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '3.09', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '2.70', 'spread': '1.38', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.064', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.55', 'ciLowerLimit': '-1.12', 'ciUpperLimit': '0.03', 'estimateComment': 'The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline PASDAS and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Psoriatic Arthritis Disease Activity Score (PASDAS) at 12 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '3.70', 'spread': '1.62', 'groupId': 'OG000'}, {'value': '3.01', 'spread': '1.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.86', 'ciLowerLimit': '-1.48', 'ciUpperLimit': '-0.24', 'estimateComment': 'The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline BASDAS and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Psoriatic Arthritis Disease Activity Score (PASDAS) at 36 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '3.30', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '2.93', 'spread': '3.42', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.096', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.58', 'ciLowerLimit': '-1.26', 'ciUpperLimit': '0.11', 'estimateComment': 'The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline PASDAS and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '36 weeks', 'description': 'The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Psoriatic Arthritis Disease Activity Score (PASDAS) at 52 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '3.36', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '3.42', 'spread': '1.55', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.844', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.72', 'ciUpperLimit': '0.59', 'estimateComment': 'The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline PASDAS and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', 'description': 'The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Composite Psoriatic Disease Activity Index (CPDAI) at 12 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '4.10', 'spread': '2.76', 'groupId': 'OG000'}, {'value': '3.49', 'spread': '2.41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.041', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.96', 'ciLowerLimit': '-1.88', 'ciUpperLimit': '-0.04', 'estimateComment': 'The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline CPDAI and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'The Composite Psoriatic Disease Activity Index ranges from 0-15; higher scores represent a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Composite Psoriatic Disease Activity Index (CPDAI) at 24 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '3.24', 'spread': '2.58', 'groupId': 'OG000'}, {'value': '3.12', 'spread': '2.45', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.375', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.44', 'ciLowerLimit': '-1.41', 'ciUpperLimit': '0.54', 'estimateComment': 'The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline CPDAI and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'The Composite Psoriatic Disease Activity Index ranges from 0-15; higher scores represent a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Composite Psoriatic Disease Activity Index (CPDAI) at 36 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '2.97', 'spread': '2.69', 'groupId': 'OG000'}, {'value': '3.17', 'spread': '2.80', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.392', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.44', 'ciLowerLimit': '-1.46', 'ciUpperLimit': '0.58', 'estimateComment': 'The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline CPDAI and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '36 weeks', 'description': 'The Composite Psoriatic Disease Activity Index ranges from 0-15; higher scores represent a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Composite Psoriatic Disease Activity Index (CPDAI) at 52 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '3.03', 'spread': '2.71', 'groupId': 'OG000'}, {'value': '3.49', 'spread': '2.75', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.541', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.32', 'ciLowerLimit': '-1.34', 'ciUpperLimit': '0.71', 'estimateComment': 'The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline CPDAI and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', 'description': 'The Composite Psoriatic Disease Activity Index ranges from 0-15; higher scores represent a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Participant Disease Activity Visual Analogue Score at 24 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '27.56', 'spread': '23.54', 'groupId': 'OG000'}, {'value': '27.72', 'spread': '23.42', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.633', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.35', 'ciLowerLimit': '-12.14', 'ciUpperLimit': '7.43', 'estimateComment': 'The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'The Participant Disease Activity Visual Analogue Score ranges from 0-100; higher scores represent a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Participant Disease Activity Visual Analogue Score at 52 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '32.73', 'spread': '25.62', 'groupId': 'OG000'}, {'value': '36.57', 'spread': '26.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.826', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.24', 'ciLowerLimit': '-9.95', 'ciUpperLimit': '12.43', 'estimateComment': 'The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', 'description': 'The Participant Disease Activity Visual Analogue Score ranges from 0-100; higher scores represent a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': '36-item Short Form Health Survey (SF-36) Physical Component Score at 24 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '45.62', 'spread': '9.45', 'groupId': 'OG000'}, {'value': '46.10', 'spread': '9.32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.268', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.24', 'ciLowerLimit': '-1.76', 'ciUpperLimit': '6.25', 'estimateComment': 'The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'The 36-item Short Form Health Survey (SF-36) Physical Component Score ranges from 0-100; higher scores represent a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': '36-item Short Form Health Survey (SF-36) Physical Component Score at 52 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '44.44', 'spread': '10.25', 'groupId': 'OG000'}, {'value': '42.80', 'spread': '10.38', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.605', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.21', 'ciLowerLimit': '-3.42', 'ciUpperLimit': '5.83', 'estimateComment': 'The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', 'description': 'The 36-item Short Form Health Survey (SF-36) Physical Component Score ranges from 0-100; higher scores represent a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': '36-item Short Form Health Survey (SF-36) Mental Component Score at 24 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '52.11', 'spread': '9.34', 'groupId': 'OG000'}, {'value': '51.27', 'spread': '8.84', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.620', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.85', 'ciLowerLimit': '-4.23', 'ciUpperLimit': '2.54', 'estimateComment': 'The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'The 36-item Short Form Health Survey (SF-36) Mental Component Score ranges from 0-100; higher scores represent a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': '36-item Short Form Health Survey (SF-36) Mental Component Score at 52 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '52.44', 'spread': '10.03', 'groupId': 'OG000'}, {'value': '51.65', 'spread': '9.75', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.449', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.39', 'ciLowerLimit': '-5.02', 'ciUpperLimit': '2.24', 'estimateComment': 'The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', 'description': 'The 36-item Short Form Health Survey (SF-36) Mental Component Score ranges from 0-100; higher scores represent a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 12 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '18.74', 'spread': '10.12', 'groupId': 'OG000'}, {'value': '23.07', 'spread': '11.74', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.364', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.72', 'ciLowerLimit': '-2.04', 'ciUpperLimit': '5.48', 'estimateComment': 'The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'In the joint set scanned in the Full Analysis Set, the Ultrasound Global OMERACT-EULAR System Score ranged from 0-72; higher scores represent a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 24 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '20.63', 'spread': '10.06', 'groupId': 'OG000'}, {'value': '22.44', 'spread': '10.26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.806', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.51', 'ciLowerLimit': '-3.60', 'ciUpperLimit': '4.61', 'estimateComment': 'The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'In the joint set scanned in the Full Analysis Set, the Ultrasound Global OMERACT-EULAR System Score ranged from 0-72; higher scores represent a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 36 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '22.46', 'spread': '9.83', 'groupId': 'OG000'}, {'value': '24.20', 'spread': '7.96', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.588', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '-2.79', 'ciUpperLimit': '4.89', 'estimateComment': 'The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '36 weeks', 'description': 'In the joint set scanned in the Full Analysis Set, the Ultrasound Global OMERACT-EULAR System Score ranged from 0-72; higher scores represent a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Ultrasound Entheseal Inflammatory Score at 12 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '4.86', 'spread': '4.80', 'groupId': 'OG000'}, {'value': '4.68', 'spread': '4.28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.372', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.76', 'ciLowerLimit': '-2.45', 'ciUpperLimit': '0.93', 'estimateComment': 'The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'The Ultrasound Entheseal Inflammatory Score ranged from 0-70; a higher score represents a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Ultrasound Entheseal Inflammatory Score at 24 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '4.89', 'spread': '4.49', 'groupId': 'OG000'}, {'value': '4.90', 'spread': '3.92', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.781', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-2.05', 'ciUpperLimit': '1.55', 'estimateComment': 'The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'The Ultrasound Entheseal Inflammatory Score ranged from 0-70; a higher score represents a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Ultrasound Entheseal Inflammatory Score at 36 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '6.17', 'spread': '6.49', 'groupId': 'OG000'}, {'value': '4.14', 'spread': '3.45', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.037', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.26', 'ciLowerLimit': '-4.39', 'ciUpperLimit': '-0.14', 'estimateComment': 'The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '36 weeks', 'description': 'The Ultrasound Entheseal Inflammatory Score ranged from 0-70; a higher score represents a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Ultrasound Entheseal Chronicity Score at 12 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '3.17', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '2.50', 'spread': '2.79', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.058', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.95', 'ciLowerLimit': '-1.93', 'ciUpperLimit': '0.03', 'estimateComment': 'The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'The Ultrasound Entheseal Chronicity Score ranged from 0-50; a higher score represents a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Ultrasound Entheseal Chronicity Score at 24 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '2.85', 'spread': '2.31', 'groupId': 'OG000'}, {'value': '2.63', 'spread': '2.21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.213', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.60', 'ciLowerLimit': '-1.54', 'ciUpperLimit': '0.35', 'estimateComment': 'The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'The Ultrasound Entheseal Chronicity Score ranged from 0-50; a higher score represents a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Ultrasound Entheseal Chronicity Score at 36 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '2.79', 'spread': '2.64', 'groupId': 'OG000'}, {'value': '2.97', 'spread': '2.66', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.606', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.31', 'ciLowerLimit': '-0.88', 'ciUpperLimit': '1.50', 'estimateComment': 'The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '36 weeks', 'description': 'The Ultrasound Entheseal Chronicity Score ranged from 0-50; a higher score represents a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Leeds Enthesitis Index at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '0.95', 'spread': '1.76', 'groupId': 'OG000'}, {'value': '0.74', 'spread': '1.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.971', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence-rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.48', 'ciUpperLimit': '2.14', 'estimateComment': 'The placebo/methotrexate arm was the reference category.', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '12 Weeks', 'description': 'The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Leeds Enthesitis Index at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '0.61', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '0.53', 'spread': '0.98', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.817', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence-rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.49', 'ciUpperLimit': '2.46', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '24 Weeks', 'description': 'The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Leeds Enthesitis Index at 36 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '0.65', 'spread': '1.37', 'groupId': 'OG000'}, {'value': '0.74', 'spread': '1.43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.441', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence-rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.35', 'ciLowerLimit': '0.63', 'ciUpperLimit': '2.93', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '36 Weeks', 'description': 'The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Leeds Enthesitis Index at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '0.43', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '0.97', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.563', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence-rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.29', 'ciLowerLimit': '0.55', 'ciUpperLimit': '3.03', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '52 Weeks', 'description': 'The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Leeds Dactylitis Index at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '11.46', 'spread': '19.88', 'groupId': 'OG000'}, {'value': '2.22', 'spread': '7.92', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.083', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence-rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '0.02', 'ciUpperLimit': '1.26', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '12 Weeks', 'description': 'The Leeds Dactylitis Index ranges from 0-\\~40; a higher score represents a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Leeds Dactylitis Index at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '5.04', 'spread': '17.10', 'groupId': 'OG000'}, {'value': '0.48', 'spread': '2.52', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.432', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence-rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.26', 'ciLowerLimit': '0.01', 'ciUpperLimit': '7.64', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '24 Weeks', 'description': 'The Leeds Dactylitis Index ranges from 0-\\~40; a higher score represents a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Leeds Dactylitis Index at 36 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '4.38', 'spread': '11.31', 'groupId': 'OG000'}, {'value': '3.36', 'spread': '15.15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.071', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence-rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '0.01', 'ciUpperLimit': '1.21', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '36 Weeks', 'description': 'The Leeds Dactylitis Index ranges from 0-\\~40; a higher score represents a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Leeds Dactylitis Index at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '6.58', 'spread': '14.89', 'groupId': 'OG000'}, {'value': '3.45', 'spread': '14.76', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.037', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence-rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '0.00', 'ciUpperLimit': '0.84', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '52 Weeks', 'description': 'The Leeds Dactylitis Index ranges from 0-\\~40; a higher score represents a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'The Modified Nail Psoriasis Severity Index (mNAPSI) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '4.78', 'spread': '8.73', 'groupId': 'OG000'}, {'value': '6.37', 'spread': '10.66', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.296', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence-rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.32', 'ciUpperLimit': '1.41', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '12 Weeks', 'description': 'The Modified Nail Psoriasis Severity Index ranges from 0-140; a higher score represents a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'The Modified Nail Psoriasis Severity Index (mNAPSI) at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '4.02', 'spread': '6.41', 'groupId': 'OG000'}, {'value': '3.12', 'spread': '6.88', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.081', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence-rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.51', 'ciLowerLimit': '0.23', 'ciUpperLimit': '1.09', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '24 Weeks', 'description': 'The Modified Nail Psoriasis Severity Index ranges from 0-140; a higher score represents a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'The Modified Nail Psoriasis Severity Index (mNAPSI) at 36 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '4.47', 'spread': '7.73', 'groupId': 'OG000'}, {'value': '5.50', 'spread': '11.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.458', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence-rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.36', 'ciUpperLimit': '1.59', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '36 Weeks', 'description': 'The Modified Nail Psoriasis Severity Index ranges from 0-140; a higher score represents a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'The Modified Nail Psoriasis Severity Index (mNAPSI) at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '3.91', 'spread': '7.32', 'groupId': 'OG000'}, {'value': '7.72', 'spread': '12.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.798', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence-rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.46', 'ciUpperLimit': '2.72', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEAN', 'timeFrame': '52 Weeks', 'description': 'The Modified Nail Psoriasis Severity Index ranges from 0-140; a higher score represents a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Psoriasis Area and Severity Index (PASI) Score at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '2.10'}, {'value': '0.20', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '1.20'}]}]}], 'analyses': [{'pValue': '0.512', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.38', 'ciLowerLimit': '-1.53', 'ciUpperLimit': '0.77', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Quantile (median) regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEDIAN', 'timeFrame': '12 Weeks', 'description': 'The Psoriasis Area and Severity Index ranges from 0-72; a higher score represents a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Psoriasis Area and Severity Index (PASI) Score at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '0.60', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '1.60'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.70'}]}]}], 'analyses': [{'pValue': '0.320', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.44', 'ciLowerLimit': '-1.33', 'ciUpperLimit': '0.44', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Quantile (median) regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEDIAN', 'timeFrame': '24 Weeks', 'description': 'The Psoriasis Area and Severity Index ranges from 0-72; a higher score represents a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Psoriasis Area and Severity Index (PASI) Score at 36 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '0.70', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '1.75'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.60'}]}]}], 'analyses': [{'pValue': '0.220', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciLowerLimit': '-1.22', 'ciUpperLimit': '0.28', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Quantile (median) regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEDIAN', 'timeFrame': '36 Weeks', 'description': 'The Psoriasis Area and Severity Index ranges from 0-72; a higher score represents a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Psoriasis Area and Severity Index (PASI) Score at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '0.40', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '1.60'}, {'value': '0.55', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '1.80'}]}]}], 'analyses': [{'pValue': '0.912', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.85', 'ciUpperLimit': '0.95', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Quantile (median) regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'description': 'The Psoriasis Area and Severity Index ranges from 0-72; a higher score represents a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Dermatology Life Quality Index (DLQI) Score at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '2.00'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '1.00'}]}]}], 'analyses': [{'pValue': '0.281', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.50', 'ciLowerLimit': '-1.42', 'ciUpperLimit': '0.42', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Quantile (median) regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEDIAN', 'timeFrame': '24 Weeks', 'description': 'The Dermatology Life Quality Index ranges from 0-30; a higher score represents a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Dermatology Life Quality Index (DLQI) Score at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '2.00'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '4.00'}]}]}], 'analyses': [{'pValue': '0.985', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-1.44', 'ciUpperLimit': '1.47', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Quantile (median) regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).\n\nMultiple imputation addressed missing data.'}], 'paramType': 'MEDIAN', 'timeFrame': '52 Weeks', 'description': 'The Dermatology Life Quality Index ranges from 0-30; a higher score represents a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Minimal Disease Activity (MDA) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.869', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.45', 'ciUpperLimit': '2.60', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Weeks', 'description': 'Minimal Disease Activity (coded 0=No, 1=Yes) is achieved when at least 5 of the 7 following criteria are met: Tender joint count (/68) ≤1 Swollen joint count (/66) ≤1 PASI ≤1 or BSA≤3 Patient pain VAS ≤15 Patient global disease activity VAS ≤20 HAQ ≤0.5 Enthesitis count ≤1.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Minimal Disease Activity (MDA) at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.802', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.38', 'ciUpperLimit': '2.13', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 Weeks', 'description': 'Minimal Disease Activity (coded 0=No, 1=Yes) is achieved when at least 5 of the 7 following criteria are met: Tender joint count (/68) ≤1 Swollen joint count (/66) ≤1 PASI ≤1 or BSA≤3 Patient pain VAS ≤15 Patient global disease activity VAS ≤20 HAQ ≤0.5 Enthesitis count ≤1.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Minimal Disease Activity (MDA) at 36 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.767', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.14', 'ciLowerLimit': '0.48', 'ciUpperLimit': '2.72', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 Weeks', 'description': 'Minimal Disease Activity (coded 0=No, 1=Yes) is achieved when at least 5 of the 7 following criteria are met: Tender joint count (/68) ≤1 Swollen joint count (/66) ≤1 PASI ≤1 or BSA≤3 Patient pain VAS ≤15 Patient global disease activity VAS ≤20 HAQ ≤0.5 Enthesitis count ≤1.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Minimal Disease Activity (MDA) at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.315', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.63', 'ciLowerLimit': '0.26', 'ciUpperLimit': '1.55', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '52 Weeks', 'description': 'Minimal Disease Activity (coded 0=No, 1=Yes) is achieved when at least 5 of the 7 following criteria are met: Tender joint count (/68) ≤1 Swollen joint count (/66) ≤1 PASI ≤1 or BSA≤3 Patient pain VAS ≤15 Patient global disease activity VAS ≤20 HAQ ≤0.5 Enthesitis count ≤1.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'American College of Rheumatology 20 (ACR20) Response at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.516', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.34', 'ciLowerLimit': '0.55', 'ciUpperLimit': '3.27', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Weeks', 'description': "American College of Rheumatology 20 Response (coded 0=No, 1=Yes) is achieved when there is:\n\n* 20% improvement in both TJC (68 joints count) and SJC (66 joints count) and\n* 20% improvement in at least 3 of the following 5 ACR Core set criteria:\n\n 1. Patient's Assessment of Pain Visual Analogue Scale (VAS)\n 2. Patient's Global Assessment of Disease Activity VAS\n 3. Physician's Global Assessment of Disease Activity VAS\n 4. Patient's Assessment of Physical Function as measured by the HAQ-DI\n 5. Acute phase reactant as measured by CRP", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'American College of Rheumatology 20 (ACR20) Response at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.939', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.39', 'ciUpperLimit': '2.38', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 Weeks', 'description': "American College of Rheumatology 20 Response (coded 0=No, 1=Yes) is achieved when there is:\n\n* 20% improvement in both TJC (68 joints count) and SJC (66 joints count) and\n* 20% improvement in at least 3 of the following 5 ACR Core set criteria:\n\n 1. Patient's Assessment of Pain Visual Analogue Scale (VAS)\n 2. Patient's Global Assessment of Disease Activity VAS\n 3. Physician's Global Assessment of Disease Activity VAS\n 4. Patient's Assessment of Physical Function as measured by the HAQ-DI\n 5. Acute phase reactant as measured by CRP", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'American College of Rheumatology 20 (ACR20) Response at 36 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.701', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '0.48', 'ciUpperLimit': '2.94', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 Weeks', 'description': "American College of Rheumatology 20 Response (coded 0=No, 1=Yes) is achieved when there is:\n\n* 20% improvement in both TJC (68 joints count) and SJC (66 joints count) and\n* 20% improvement in at least 3 of the following 5 ACR Core set criteria:\n\n 1. Patient's Assessment of Pain Visual Analogue Scale (VAS)\n 2. Patient's Global Assessment of Disease Activity VAS\n 3. Physician's Global Assessment of Disease Activity VAS\n 4. Patient's Assessment of Physical Function as measured by the HAQ-DI\n 5. Acute phase reactant as measured by CRP", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'American College of Rheumatology 20 (ACR20) Response at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.124', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.48', 'ciLowerLimit': '0.19', 'ciUpperLimit': '1.22', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '52 Weeks', 'description': "American College of Rheumatology 20 Response (coded 0=No, 1=Yes) is achieved when there is:\n\n* 20% improvement in both TJC (68 joints count) and SJC (66 joints count) and\n* 20% improvement in at least 3 of the following 5 ACR Core set criteria:\n\n 1. Patient's Assessment of Pain Visual Analogue Scale (VAS)\n 2. Patient's Global Assessment of Disease Activity VAS\n 3. Physician's Global Assessment of Disease Activity VAS\n 4. Patient's Assessment of Physical Function as measured by the HAQ-DI\n 5. Acute phase reactant as measured by CRP", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'American College of Rheumatology 50 (ACR50) Response at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.161', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.89', 'ciLowerLimit': '0.78', 'ciUpperLimit': '4.63', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Weeks', 'description': "American College of Rheumatology 50 Response (coded 0=No, 1=Yes) is achieved when there is:\n\n* 50% improvement in both TJC (68 joints count) and SJC (66 joints count) and\n* 50% improvement in at least 3 of the following 5 ACR Core set criteria:\n\n 1. Patient's Assessment of Pain Visual Analogue Scale (VAS)\n 2. Patient's Global Assessment of Disease Activity VAS\n 3. Physician's Global Assessment of Disease Activity VAS\n 4. Patient's Assessment of Physical Function as measured by the HAQ-DI\n 5. Acute phase reactant as measured by CRP", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'American College of Rheumatology 50 (ACR50) Response at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.251', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.67', 'ciLowerLimit': '0.70', 'ciUpperLimit': '4.02', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 Weeks', 'description': "American College of Rheumatology 50 Response (coded 0=No, 1=Yes) is achieved when there is:\n\n* 50% improvement in both TJC (68 joints count) and SJC (66 joints count) and\n* 50% improvement in at least 3 of the following 5 ACR Core set criteria:\n\n 1. Patient's Assessment of Pain Visual Analogue Scale (VAS)\n 2. Patient's Global Assessment of Disease Activity VAS\n 3. Physician's Global Assessment of Disease Activity VAS\n 4. Patient's Assessment of Physical Function as measured by the HAQ-DI\n 5. Acute phase reactant as measured by CRP", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'American College of Rheumatology 50 (ACR50) Response at 36 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.363', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.50', 'ciLowerLimit': '0.63', 'ciUpperLimit': '3.60', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 Weeks', 'description': "American College of Rheumatology 50 Response (coded 0=No, 1=Yes) is achieved when there is:\n\n* 50% improvement in both TJC (68 joints count) and SJC (66 joints count) and\n* 50% improvement in at least 3 of the following 5 ACR Core set criteria:\n\n 1. Patient's Assessment of Pain Visual Analogue Scale (VAS)\n 2. Patient's Global Assessment of Disease Activity VAS\n 3. Physician's Global Assessment of Disease Activity VAS\n 4. Patient's Assessment of Physical Function as measured by the HAQ-DI\n 5. Acute phase reactant as measured by CRP", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'American College of Rheumatology 50 (ACR50) Response at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.991', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.40', 'ciUpperLimit': '2.46', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '52 Weeks', 'description': "American College of Rheumatology 50 Response (coded 0=No, 1=Yes) is achieved when there is:\n\n* 50% improvement in both TJC (68 joints count) and SJC (66 joints count) and\n* 50% improvement in at least 3 of the following 5 ACR Core set criteria:\n\n 1. Patient's Assessment of Pain Visual Analogue Scale (VAS)\n 2. Patient's Global Assessment of Disease Activity VAS\n 3. Physician's Global Assessment of Disease Activity VAS\n 4. Patient's Assessment of Physical Function as measured by the HAQ-DI\n 5. Acute phase reactant as measured by CRP", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'American College of Rheumatology 70 (ACR70) Response at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.037', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.12', 'ciLowerLimit': '1.07', 'ciUpperLimit': '9.10', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Weeks', 'description': "American College of Rheumatology 70 Response (coded 0=No, 1=Yes) is achieved when there is:\n\n* 70% improvement in both TJC (68 joints count) and SJC (66 joints count) and\n* 70% improvement in at least 3 of the following 5 ACR Core set criteria:\n\n 1. Patient's Assessment of Pain Visual Analogue Scale (VAS)\n 2. Patient's Global Assessment of Disease Activity VAS\n 3. Physician's Global Assessment of Disease Activity VAS\n 4. Patient's Assessment of Physical Function as measured by the HAQ-DI\n 5. Acute phase reactant as measured by CRP", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'American College of Rheumatology 70 (ACR70) Response at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.056', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.50', 'ciLowerLimit': '0.98', 'ciUpperLimit': '6.40', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 Weeks', 'description': "American College of Rheumatology 70 Response (coded 0=No, 1=Yes) is achieved when there is:\n\n* 70% improvement in both TJC (68 joints count) and SJC (66 joints count) and\n* 70% improvement in at least 3 of the following 5 ACR Core set criteria:\n\n 1. Patient's Assessment of Pain Visual Analogue Scale (VAS)\n 2. Patient's Global Assessment of Disease Activity VAS\n 3. Physician's Global Assessment of Disease Activity VAS\n 4. Patient's Assessment of Physical Function as measured by the HAQ-DI\n 5. Acute phase reactant as measured by CRP", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'American College of Rheumatology 70 (ACR70) Response at 36 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.277', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.72', 'ciLowerLimit': '0.65', 'ciUpperLimit': '4.57', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 Weeks', 'description': "American College of Rheumatology 70 Response (coded 0=No, 1=Yes) is achieved when there is:\n\n* 70% improvement in both TJC (68 joints count) and SJC (66 joints count) and\n* 70% improvement in at least 3 of the following 5 ACR Core set criteria:\n\n 1. Patient's Assessment of Pain Visual Analogue Scale (VAS)\n 2. Patient's Global Assessment of Disease Activity VAS\n 3. Physician's Global Assessment of Disease Activity VAS\n 4. Patient's Assessment of Physical Function as measured by the HAQ-DI\n 5. Acute phase reactant as measured by CRP", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'American College of Rheumatology 70 (ACR70) Response at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.548', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.38', 'ciLowerLimit': '0.48', 'ciUpperLimit': '3.92', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '52 Weeks', 'description': "American College of Rheumatology 70 Response (coded 0=No, 1=Yes) is achieved when there is:\n\n* 70% improvement in both TJC (68 joints count) and SJC (66 joints count) and\n* 70% improvement in at least 3 of the following 5 ACR Core set criteria:\n\n 1. Patient's Assessment of Pain Visual Analogue Scale (VAS)\n 2. Patient's Global Assessment of Disease Activity VAS\n 3. Physician's Global Assessment of Disease Activity VAS\n 4. Patient's Assessment of Physical Function as measured by the HAQ-DI\n 5. Acute phase reactant as measured by CRP", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Psoriatic Arthritis Response Criteria (PsARC) Response at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.018', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.70', 'ciLowerLimit': '1.25', 'ciUpperLimit': '10.97', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Weeks', 'description': "Psoriatic Arthritis Response Criteria Response (coded 0=No, 1=Yes) 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:\n\n1. At least 30% reduction in tender joint grade (total of 68 joints graded 0-3)\n2. At least 30% reduction in swollen joint grade (total of 66 joints graded 0-3)\n3. At least a 1 point reduction in physician's assessment of articular disease (1-5 Likert scale)\n4. At least a 1 point reduction in patient's assessment of articular disease (1-5 Likert scale)", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Psoriatic Arthritis Response Criteria (PsARC) Response at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.926', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.28', 'ciUpperLimit': '4.02', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 Weeks', 'description': "Psoriatic Arthritis Response Criteria Response (coded 0=No, 1=Yes) 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:\n\n1. At least 30% reduction in tender joint grade (total of 68 joints graded 0-3)\n2. At least 30% reduction in swollen joint grade (total of 66 joints graded 0-3)\n3. At least a 1 point reduction in physician's assessment of articular disease (1-5 Likert scale)\n4. At least a 1 point reduction in patient's assessment of articular disease (1-5 Likert scale)", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Psoriatic Arthritis Response Criteria (PsARC) Response at 36 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.385', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.73', 'ciLowerLimit': '0.50', 'ciUpperLimit': '5.94', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 Weeks', 'description': "Psoriatic Arthritis Response Criteria Response (coded 0=No, 1=Yes) 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:\n\n1. At least 30% reduction in tender joint grade (total of 68 joints graded 0-3)\n2. At least 30% reduction in swollen joint grade (total of 66 joints graded 0-3)\n3. At least a 1 point reduction in physician's assessment of articular disease (1-5 Likert scale)\n4. At least a 1 point reduction in patient's assessment of articular disease (1-5 Likert scale)", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Psoriatic Arthritis Response Criteria (PsARC) Response at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.684', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.32', 'ciUpperLimit': '2.12', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '52 Weeks', 'description': "Psoriatic Arthritis Response Criteria Response (coded 0=No, 1=Yes) 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:\n\n1. At least 30% reduction in tender joint grade (total of 68 joints graded 0-3)\n2. At least 30% reduction in swollen joint grade (total of 66 joints graded 0-3)\n3. At least a 1 point reduction in physician's assessment of articular disease (1-5 Likert scale)\n4. At least a 1 point reduction in patient's assessment of articular disease (1-5 Likert scale)", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Psoriatic Arthritis Skin Index (PASI) Response at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.063', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.72', 'ciLowerLimit': '0.86', 'ciUpperLimit': '326.19', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Weeks', 'description': 'Psoriatic Arthritis Skin Index (PASI) Response (coded 0=No, 1=Yes) is defined as an improvement of at least 75% in the PASI compared to baseline.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (restricted to those with \\>=3% body surface area affected by psoriasis at baseline)'}, {'type': 'SECONDARY', 'title': 'Psoriatic Arthritis Skin Index (PASI) Response at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.041', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.90', 'ciLowerLimit': '1.09', 'ciUpperLimit': '72.42', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 Weeks', 'description': 'Psoriatic Arthritis Skin Index (PASI) Response (coded 0=No, 1=Yes) is defined as an improvement of at least 75% in the PASI compared to baseline.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (restricted to those with \\>=3% body surface area affected by psoriasis at baseline)'}, {'type': 'SECONDARY', 'title': 'Psoriatic Arthritis Skin Index (PASI) Response at 36 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.069', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.71', 'ciLowerLimit': '0.86', 'ciUpperLimit': '52.14', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 Weeks', 'description': 'Psoriatic Arthritis Skin Index (PASI) Response (coded 0=No, 1=Yes) is defined as an improvement of at least 75% in the PASI compared to baseline.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (restricted to those with \\>=3% body surface area affected by psoriasis at baseline)'}, {'type': 'SECONDARY', 'title': 'Psoriatic Arthritis Skin Index (PASI) Response at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.397', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.34', 'ciLowerLimit': '0.33', 'ciUpperLimit': '16.66', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '52 Weeks', 'description': 'Psoriatic Arthritis Skin Index (PASI) Response (coded 0=No, 1=Yes) is defined as an improvement of at least 75% in the PASI compared to baseline.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (restricted to those with \\>=3% body surface area affected by psoriasis at baseline)'}, {'type': 'SECONDARY', 'title': 'Ultrasound Imaging Remission at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.309', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.33', 'ciLowerLimit': '0.04', 'ciUpperLimit': '2.83', 'estimateComment': 'The placebo/methotrexate arm was the reference category.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Weeks', 'description': 'Ultrasound Imaging Remission (coded 0=No, 1=Yes) is achieved when all joints and entheses score grey scale\\<=1 \\& power Doppler=0.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Ultrasound Imaging Remission at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.871', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.17', 'ciUpperLimit': '4.60', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 Weeks', 'description': 'Ultrasound Imaging Remission (coded 0=No, 1=Yes) is achieved when all joints and entheses score grey scale\\<=1 \\& power Doppler=0.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Ultrasound Imaging Remission at 36 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.555', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.48', 'ciLowerLimit': '0.04', 'ciUpperLimit': '5.52', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 Weeks', 'description': 'Ultrasound Imaging Remission (coded 0=No, 1=Yes) is achieved when all joints and entheses score grey scale\\<=1 \\& power Doppler=0.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Additional Steroid Received Before 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'OG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '0.11', 'ciUpperLimit': '0.72', 'estimateComment': 'The placebo/methotrexate group was the reference category.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Weeks', 'description': 'Participants were eligible for additional steroid at weeks 8 and 12 if they had not achieved a PsARC response; this variable was coded 0=No, 1=Yes.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'FG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Unable to attend final visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Missed study medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Methotrexate', 'description': 'Methotrexate: Methotrexate'}, {'id': 'BG001', 'title': 'Golimumab & Methotrexate', 'description': 'Methotrexate: Methotrexate\n\nGolimumab: Simponi'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.9', 'spread': '12.5', 'groupId': 'BG000'}, {'value': '42.1', 'spread': '12.5', 'groupId': 'BG001'}, {'value': '42.5', 'spread': '12.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Not stated', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'PASDAS', 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '5.9', 'spread': '1.3', 'groupId': 'BG001'}, {'value': '5.7', 'spread': '1.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Psoriatic Arthritis Disease Activity Score (PASDAS) is a composite outcome based on the physician global VAS, participant global VAS, SF-36 physical component score, 66 swollen joint count, 68 tender joint count, Leeds enthesitis index, tender dactylitis count and C-reactive protein. The PASDAS ranges from 0-10, with higher values indicating higher disease activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Leeds Enthesitis Index', 'classes': [{'categories': [{'measurements': [{'value': '1.51', 'spread': '1.76', 'groupId': 'BG000'}, {'value': '1.37', 'spread': '1.47', 'groupId': 'BG001'}, {'value': '1.44', 'spread': '1.62', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Leeds Enthesitis Index is a count of the number of tender entheses out of a possible 6 (lateral epicondyle, left and right, medial femoral condyle, left and right, Achilles tendon insertion, left and right). A higher score indicates a wider extent of enthesitis.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Leeds Dactylitis Index', 'classes': [{'categories': [{'measurements': [{'value': '26.60', 'spread': '30.56', 'groupId': 'BG000'}, {'value': '38.04', 'spread': '50.85', 'groupId': 'BG001'}, {'value': '32.45', 'spread': '42.32', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Leeds Dactylitis Index measures dactylitis severity. The ratio of the circumference of the affected digit to the circumference of the digit on the opposite side is measured. Each dactylitic digit is defined by a minimum increase of 10% in circumference over the contra-lateral digit. The calculated ratio is then multiplied by a tenderness score of 0 (non-tender), 1 (tender), 2 (tender and wince) or 3 (tender and withdraw). Tenderness is assessed in the area between the joints. The results of each digit are then added to produce a total score. Range 0-\\~40, higher score means worse dactylitis', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Psoriatic Arthritis Skin Index Score', 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'BG000', 'lowerLimit': '0.9', 'upperLimit': '5.1'}, {'value': '3.4', 'groupId': 'BG001', 'lowerLimit': '0.5', 'upperLimit': '6.9'}, {'value': '2.7', 'groupId': 'BG002', 'lowerLimit': '0.6', 'upperLimit': '6.0'}]}]}], 'paramType': 'MEDIAN', 'description': 'The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Pso to 72 for the most severe disease.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Modified Nail Psoriasis Severity Index (mNAPSI)', 'classes': [{'categories': [{'measurements': [{'value': '7.25', 'spread': '11.26', 'groupId': 'BG000'}, {'value': '11.36', 'spread': '18.15', 'groupId': 'BG001'}, {'value': '9.35', 'spread': '15.23', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Each fingernail is scored for the presence and the severity of pitting, onycholysis, oil-drop dyschromia and nail plate crumbling (score 0-3) and the presence or absence of splinter haemorrhages, leuconychia, red spots in the lunula and nail bed hyperkeratosis (score 1 for each if present). The scale ranges from 0 to 140, higher scores indicate worse nail psoriasis.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Composite Psoriatic Disease Activity Index (CPDAI)', 'classes': [{'categories': [{'measurements': [{'value': '6.4', 'spread': '2.7', 'groupId': 'BG000'}, {'value': '7.0', 'spread': '2.6', 'groupId': 'BG001'}, {'value': '6.7', 'spread': '2.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Domains include peripheral arthritis (assessed by 68 tender joints count, 66 swollen joints count, and the Health Assessment Questionnaire), skin as assessed by the PASI and the DLQI, enthesitis as assessed by the number of sites with enthesitis and the HAQ, dactylitis as assessed by the number of digits affected, and spinal disease as assessed by the BASDAI and ASQoL. Scores range from 0 to 15. Higher scores indicate higher disease activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ultrasound Global OMERACT-EULAR System Score (GLOESS)', 'classes': [{'categories': [{'measurements': [{'value': '21.6', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '24.8', 'spread': '13.0', 'groupId': 'BG001'}, {'value': '23.2', 'spread': '12.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Joints are scored 0-3 for grey scale and power Doppler; a combined score takes a value of 0 if grey scale=0, if grey scale is \\>0 then the combined score is the maximum of the grey scale and power Doppler scores. Scores for individual joints are then summated to give a total global score. For the set of joints scanned in all participants, this ranges from 0-72; for the subset in whom a wider set of joints were scanned, this ranges from 0 to 144. Higher scores indicate worse synovial hypertrophy and vascularisation.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ultrasound Entheseal Inflammatory Score', 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'spread': '3.7', 'groupId': 'BG000'}, {'value': '5.4', 'spread': '3.9', 'groupId': 'BG001'}, {'value': '4.8', 'spread': '3.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Grey scale changes in the entheses related to inflammation (entheseal hypoechogenicity and thickening) are added to power Doppler scores. The score ranges from 0-70, higher scores indicate worse entheseal inflammation.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ultrasound Entheseal Chronicity Score', 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '3.1', 'groupId': 'BG000'}, {'value': '3.5', 'spread': '3.0', 'groupId': 'BG001'}, {'value': '3.2', 'spread': '3.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Grey scale changes related to chronic findings (calcifications, erosion and enthesophytes) are summated. The score ranges from 0-50; higher scores indicate a greater extent of chronic entheseal pathology.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Participant Disease Activity Visual Analogue Scale', 'classes': [{'categories': [{'measurements': [{'value': '52.1', 'spread': '25.2', 'groupId': 'BG000'}, {'value': '59.1', 'spread': '21.4', 'groupId': 'BG001'}, {'value': '55.7', 'spread': '23.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Participants are asked to assess their current level of joint pain by marking a vertical line on a 100 mm horizontal VAS where 0 represents no joint pain ("excellent") and 100 represents worst imaginable joint pain ("poor").', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Dermatology Life Quality Index (DLQI)', 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'BG000', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '5.0', 'groupId': 'BG001', 'lowerLimit': '1.0', 'upperLimit': '9.0'}, {'value': '3.5', 'groupId': 'BG002', 'lowerLimit': '1.0', 'upperLimit': '8.5'}]}]}], 'paramType': 'MEDIAN', 'description': 'The DLQI is a simple, patient administered, 10 question, validated, quality of life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. 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". Totals range from 0 to 30 (less to more impairment) and a 5-point change from baseline is considered clinically relevant.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': '36-Item Short Form Health Survey (SF-36) Physical Component Summary', 'classes': [{'categories': [{'measurements': [{'value': '37.5', 'spread': '9.9', 'groupId': 'BG000'}, {'value': '32.5', 'spread': '10.0', 'groupId': 'BG001'}, {'value': '34.9', 'spread': '10.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The SF-36 physical component summary scale ranges from 0-100, with scores above 50 indicating better than average physical health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '36-Item Short Form Health Survey (SF-36) Mental Component Summary', 'classes': [{'categories': [{'measurements': [{'value': '46.6', 'spread': '12.5', 'groupId': 'BG000'}, {'value': '46.7', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '46.7', 'spread': '11.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The SF-36 mental component summary scale ranges from 0-100, with scores above 50 indicating better than average mental health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-09', 'size': 2824354, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-06-10T09:01', 'hasProtocol': True}, {'date': '2023-11-17', 'size': 1352603, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-06-10T09:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2023-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2019-09-26', 'resultsFirstSubmitDate': '2024-07-15', 'studyFirstSubmitQcDate': '2019-09-27', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-14', 'studyFirstPostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psoriatic Arthritis Disease Activity Score (PASDAS) at 24 Weeks', 'timeFrame': '24 weeks', 'description': 'The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Psoriatic Arthritis Disease Activity Score (PASDAS) at 12 Weeks.', 'timeFrame': '12 weeks', 'description': 'The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome.'}, {'measure': 'Psoriatic Arthritis Disease Activity Score (PASDAS) at 36 Weeks.', 'timeFrame': '36 weeks', 'description': 'The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome.'}, {'measure': 'Psoriatic Arthritis Disease Activity Score (PASDAS) at 52 Weeks.', 'timeFrame': '52 weeks', 'description': 'The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome.'}, {'measure': 'Composite Psoriatic Disease Activity Index (CPDAI) at 12 Weeks.', 'timeFrame': '12 weeks', 'description': 'The Composite Psoriatic Disease Activity Index ranges from 0-15; higher scores represent a worse outcome.'}, {'measure': 'Composite Psoriatic Disease Activity Index (CPDAI) at 24 Weeks.', 'timeFrame': '24 weeks', 'description': 'The Composite Psoriatic Disease Activity Index ranges from 0-15; higher scores represent a worse outcome.'}, {'measure': 'Composite Psoriatic Disease Activity Index (CPDAI) at 36 Weeks.', 'timeFrame': '36 weeks', 'description': 'The Composite Psoriatic Disease Activity Index ranges from 0-15; higher scores represent a worse outcome.'}, {'measure': 'Composite Psoriatic Disease Activity Index (CPDAI) at 52 Weeks.', 'timeFrame': '52 weeks', 'description': 'The Composite Psoriatic Disease Activity Index ranges from 0-15; higher scores represent a worse outcome.'}, {'measure': 'Participant Disease Activity Visual Analogue Score at 24 Weeks.', 'timeFrame': '24 weeks', 'description': 'The Participant Disease Activity Visual Analogue Score ranges from 0-100; higher scores represent a worse outcome.'}, {'measure': 'Participant Disease Activity Visual Analogue Score at 52 Weeks.', 'timeFrame': '52 weeks', 'description': 'The Participant Disease Activity Visual Analogue Score ranges from 0-100; higher scores represent a worse outcome.'}, {'measure': '36-item Short Form Health Survey (SF-36) Physical Component Score at 24 Weeks.', 'timeFrame': '24 weeks', 'description': 'The 36-item Short Form Health Survey (SF-36) Physical Component Score ranges from 0-100; higher scores represent a better outcome.'}, {'measure': '36-item Short Form Health Survey (SF-36) Physical Component Score at 52 Weeks.', 'timeFrame': '52 weeks', 'description': 'The 36-item Short Form Health Survey (SF-36) Physical Component Score ranges from 0-100; higher scores represent a better outcome.'}, {'measure': '36-item Short Form Health Survey (SF-36) Mental Component Score at 24 Weeks.', 'timeFrame': '24 weeks', 'description': 'The 36-item Short Form Health Survey (SF-36) Mental Component Score ranges from 0-100; higher scores represent a better outcome.'}, {'measure': '36-item Short Form Health Survey (SF-36) Mental Component Score at 52 Weeks.', 'timeFrame': '52 weeks', 'description': 'The 36-item Short Form Health Survey (SF-36) Mental Component Score ranges from 0-100; higher scores represent a better outcome.'}, {'measure': 'Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 12 Weeks.', 'timeFrame': '12 weeks', 'description': 'In the joint set scanned in the Full Analysis Set, the Ultrasound Global OMERACT-EULAR System Score ranged from 0-72; higher scores represent a worse outcome.'}, {'measure': 'Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 24 Weeks.', 'timeFrame': '24 weeks', 'description': 'In the joint set scanned in the Full Analysis Set, the Ultrasound Global OMERACT-EULAR System Score ranged from 0-72; higher scores represent a worse outcome.'}, {'measure': 'Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 36 Weeks.', 'timeFrame': '36 weeks', 'description': 'In the joint set scanned in the Full Analysis Set, the Ultrasound Global OMERACT-EULAR System Score ranged from 0-72; higher scores represent a worse outcome.'}, {'measure': 'Ultrasound Entheseal Inflammatory Score at 12 Weeks.', 'timeFrame': '12 weeks', 'description': 'The Ultrasound Entheseal Inflammatory Score ranged from 0-70; a higher score represents a worse outcome.'}, {'measure': 'Ultrasound Entheseal Inflammatory Score at 24 Weeks.', 'timeFrame': '24 weeks', 'description': 'The Ultrasound Entheseal Inflammatory Score ranged from 0-70; a higher score represents a worse outcome.'}, {'measure': 'Ultrasound Entheseal Inflammatory Score at 36 Weeks.', 'timeFrame': '36 weeks', 'description': 'The Ultrasound Entheseal Inflammatory Score ranged from 0-70; a higher score represents a worse outcome.'}, {'measure': 'Ultrasound Entheseal Chronicity Score at 12 Weeks.', 'timeFrame': '12 weeks', 'description': 'The Ultrasound Entheseal Chronicity Score ranged from 0-50; a higher score represents a worse outcome.'}, {'measure': 'Ultrasound Entheseal Chronicity Score at 24 Weeks.', 'timeFrame': '24 weeks', 'description': 'The Ultrasound Entheseal Chronicity Score ranged from 0-50; a higher score represents a worse outcome.'}, {'measure': 'Ultrasound Entheseal Chronicity Score at 36 Weeks.', 'timeFrame': '36 weeks', 'description': 'The Ultrasound Entheseal Chronicity Score ranged from 0-50; a higher score represents a worse outcome.'}, {'measure': 'Leeds Enthesitis Index at 12 Weeks', 'timeFrame': '12 Weeks', 'description': 'The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome.'}, {'measure': 'Leeds Enthesitis Index at 24 Weeks', 'timeFrame': '24 Weeks', 'description': 'The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome.'}, {'measure': 'Leeds Enthesitis Index at 36 Weeks', 'timeFrame': '36 Weeks', 'description': 'The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome.'}, {'measure': 'Leeds Enthesitis Index at 52 Weeks', 'timeFrame': '52 Weeks', 'description': 'The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome.'}, {'measure': 'Leeds Dactylitis Index at 12 Weeks', 'timeFrame': '12 Weeks', 'description': 'The Leeds Dactylitis Index ranges from 0-\\~40; a higher score represents a worse outcome.'}, {'measure': 'Leeds Dactylitis Index at 24 Weeks', 'timeFrame': '24 Weeks', 'description': 'The Leeds Dactylitis Index ranges from 0-\\~40; a higher score represents a worse outcome.'}, {'measure': 'Leeds Dactylitis Index at 36 Weeks', 'timeFrame': '36 Weeks', 'description': 'The Leeds Dactylitis Index ranges from 0-\\~40; a higher score represents a worse outcome.'}, {'measure': 'Leeds Dactylitis Index at 52 Weeks', 'timeFrame': '52 Weeks', 'description': 'The Leeds Dactylitis Index ranges from 0-\\~40; a higher score represents a worse outcome.'}, {'measure': 'The Modified Nail Psoriasis Severity Index (mNAPSI) at 12 Weeks', 'timeFrame': '12 Weeks', 'description': 'The Modified Nail Psoriasis Severity Index ranges from 0-140; a higher score represents a worse outcome.'}, {'measure': 'The Modified Nail Psoriasis Severity Index (mNAPSI) at 24 Weeks', 'timeFrame': '24 Weeks', 'description': 'The Modified Nail Psoriasis Severity Index ranges from 0-140; a higher score represents a worse outcome.'}, {'measure': 'The Modified Nail Psoriasis Severity Index (mNAPSI) at 36 Weeks', 'timeFrame': '36 Weeks', 'description': 'The Modified Nail Psoriasis Severity Index ranges from 0-140; a higher score represents a worse outcome.'}, {'measure': 'The Modified Nail Psoriasis Severity Index (mNAPSI) at 52 Weeks', 'timeFrame': '52 Weeks', 'description': 'The Modified Nail Psoriasis Severity Index ranges from 0-140; a higher score represents a worse outcome.'}, {'measure': 'Psoriasis Area and Severity Index (PASI) Score at 12 Weeks', 'timeFrame': '12 Weeks', 'description': 'The Psoriasis Area and Severity Index ranges from 0-72; a higher score represents a worse outcome.'}, {'measure': 'Psoriasis Area and Severity Index (PASI) Score at 24 Weeks', 'timeFrame': '24 Weeks', 'description': 'The Psoriasis Area and Severity Index ranges from 0-72; a higher score represents a worse outcome.'}, {'measure': 'Psoriasis Area and Severity Index (PASI) Score at 36 Weeks', 'timeFrame': '36 Weeks', 'description': 'The Psoriasis Area and Severity Index ranges from 0-72; a higher score represents a worse outcome.'}, {'measure': 'Psoriasis Area and Severity Index (PASI) Score at 52 Weeks', 'timeFrame': '52 Weeks', 'description': 'The Psoriasis Area and Severity Index ranges from 0-72; a higher score represents a worse outcome.'}, {'measure': 'Dermatology Life Quality Index (DLQI) Score at 24 Weeks', 'timeFrame': '24 Weeks', 'description': 'The Dermatology Life Quality Index ranges from 0-30; a higher score represents a worse outcome.'}, {'measure': 'Dermatology Life Quality Index (DLQI) Score at 52 Weeks', 'timeFrame': '52 Weeks', 'description': 'The Dermatology Life Quality Index ranges from 0-30; a higher score represents a worse outcome.'}, {'measure': 'Minimal Disease Activity (MDA) at 12 Weeks', 'timeFrame': '12 Weeks', 'description': 'Minimal Disease Activity (coded 0=No, 1=Yes) is achieved when at least 5 of the 7 following criteria are met: Tender joint count (/68) ≤1 Swollen joint count (/66) ≤1 PASI ≤1 or BSA≤3 Patient pain VAS ≤15 Patient global disease activity VAS ≤20 HAQ ≤0.5 Enthesitis count ≤1.'}, {'measure': 'Minimal Disease Activity (MDA) at 24 Weeks', 'timeFrame': '24 Weeks', 'description': 'Minimal Disease Activity (coded 0=No, 1=Yes) is achieved when at least 5 of the 7 following criteria are met: Tender joint count (/68) ≤1 Swollen joint count (/66) ≤1 PASI ≤1 or BSA≤3 Patient pain VAS ≤15 Patient global disease activity VAS ≤20 HAQ ≤0.5 Enthesitis count ≤1.'}, {'measure': 'Minimal Disease Activity (MDA) at 36 Weeks', 'timeFrame': '36 Weeks', 'description': 'Minimal Disease Activity (coded 0=No, 1=Yes) is achieved when at least 5 of the 7 following criteria are met: Tender joint count (/68) ≤1 Swollen joint count (/66) ≤1 PASI ≤1 or BSA≤3 Patient pain VAS ≤15 Patient global disease activity VAS ≤20 HAQ ≤0.5 Enthesitis count ≤1.'}, {'measure': 'Minimal Disease Activity (MDA) at 52 Weeks', 'timeFrame': '52 Weeks', 'description': 'Minimal Disease Activity (coded 0=No, 1=Yes) is achieved when at least 5 of the 7 following criteria are met: Tender joint count (/68) ≤1 Swollen joint count (/66) ≤1 PASI ≤1 or BSA≤3 Patient pain VAS ≤15 Patient global disease activity VAS ≤20 HAQ ≤0.5 Enthesitis count ≤1.'}, {'measure': 'American College of Rheumatology 20 (ACR20) Response at 12 Weeks', 'timeFrame': '12 Weeks', 'description': "American College of Rheumatology 20 Response (coded 0=No, 1=Yes) is achieved when there is:\n\n* 20% improvement in both TJC (68 joints count) and SJC (66 joints count) and\n* 20% improvement in at least 3 of the following 5 ACR Core set criteria:\n\n 1. Patient's Assessment of Pain Visual Analogue Scale (VAS)\n 2. Patient's Global Assessment of Disease Activity VAS\n 3. Physician's Global Assessment of Disease Activity VAS\n 4. Patient's Assessment of Physical Function as measured by the HAQ-DI\n 5. Acute phase reactant as measured by CRP"}, {'measure': 'American College of Rheumatology 20 (ACR20) Response at 24 Weeks', 'timeFrame': '24 Weeks', 'description': "American College of Rheumatology 20 Response (coded 0=No, 1=Yes) is achieved when there is:\n\n* 20% improvement in both TJC (68 joints count) and SJC (66 joints count) and\n* 20% improvement in at least 3 of the following 5 ACR Core set criteria:\n\n 1. Patient's Assessment of Pain Visual Analogue Scale (VAS)\n 2. Patient's Global Assessment of Disease Activity VAS\n 3. Physician's Global Assessment of Disease Activity VAS\n 4. Patient's Assessment of Physical Function as measured by the HAQ-DI\n 5. Acute phase reactant as measured by CRP"}, {'measure': 'American College of Rheumatology 20 (ACR20) Response at 36 Weeks', 'timeFrame': '36 Weeks', 'description': "American College of Rheumatology 20 Response (coded 0=No, 1=Yes) is achieved when there is:\n\n* 20% improvement in both TJC (68 joints count) and SJC (66 joints count) and\n* 20% improvement in at least 3 of the following 5 ACR Core set criteria:\n\n 1. Patient's Assessment of Pain Visual Analogue Scale (VAS)\n 2. Patient's Global Assessment of Disease Activity VAS\n 3. Physician's Global Assessment of Disease Activity VAS\n 4. Patient's Assessment of Physical Function as measured by the HAQ-DI\n 5. Acute phase reactant as measured by CRP"}, {'measure': 'American College of Rheumatology 20 (ACR20) Response at 52 Weeks', 'timeFrame': '52 Weeks', 'description': "American College of Rheumatology 20 Response (coded 0=No, 1=Yes) is achieved when there is:\n\n* 20% improvement in both TJC (68 joints count) and SJC (66 joints count) and\n* 20% improvement in at least 3 of the following 5 ACR Core set criteria:\n\n 1. Patient's Assessment of Pain Visual Analogue Scale (VAS)\n 2. Patient's Global Assessment of Disease Activity VAS\n 3. Physician's Global Assessment of Disease Activity VAS\n 4. Patient's Assessment of Physical Function as measured by the HAQ-DI\n 5. Acute phase reactant as measured by CRP"}, {'measure': 'American College of Rheumatology 50 (ACR50) Response at 12 Weeks', 'timeFrame': '12 Weeks', 'description': "American College of Rheumatology 50 Response (coded 0=No, 1=Yes) is achieved when there is:\n\n* 50% improvement in both TJC (68 joints count) and SJC (66 joints count) and\n* 50% improvement in at least 3 of the following 5 ACR Core set criteria:\n\n 1. Patient's Assessment of Pain Visual Analogue Scale (VAS)\n 2. Patient's Global Assessment of Disease Activity VAS\n 3. Physician's Global Assessment of Disease Activity VAS\n 4. Patient's Assessment of Physical Function as measured by the HAQ-DI\n 5. Acute phase reactant as measured by CRP"}, {'measure': 'American College of Rheumatology 50 (ACR50) Response at 24 Weeks', 'timeFrame': '24 Weeks', 'description': "American College of Rheumatology 50 Response (coded 0=No, 1=Yes) is achieved when there is:\n\n* 50% improvement in both TJC (68 joints count) and SJC (66 joints count) and\n* 50% improvement in at least 3 of the following 5 ACR Core set criteria:\n\n 1. Patient's Assessment of Pain Visual Analogue Scale (VAS)\n 2. Patient's Global Assessment of Disease Activity VAS\n 3. Physician's Global Assessment of Disease Activity VAS\n 4. Patient's Assessment of Physical Function as measured by the HAQ-DI\n 5. Acute phase reactant as measured by CRP"}, {'measure': 'American College of Rheumatology 50 (ACR50) Response at 36 Weeks', 'timeFrame': '36 Weeks', 'description': "American College of Rheumatology 50 Response (coded 0=No, 1=Yes) is achieved when there is:\n\n* 50% improvement in both TJC (68 joints count) and SJC (66 joints count) and\n* 50% improvement in at least 3 of the following 5 ACR Core set criteria:\n\n 1. Patient's Assessment of Pain Visual Analogue Scale (VAS)\n 2. Patient's Global Assessment of Disease Activity VAS\n 3. Physician's Global Assessment of Disease Activity VAS\n 4. Patient's Assessment of Physical Function as measured by the HAQ-DI\n 5. Acute phase reactant as measured by CRP"}, {'measure': 'American College of Rheumatology 50 (ACR50) Response at 52 Weeks', 'timeFrame': '52 Weeks', 'description': "American College of Rheumatology 50 Response (coded 0=No, 1=Yes) is achieved when there is:\n\n* 50% improvement in both TJC (68 joints count) and SJC (66 joints count) and\n* 50% improvement in at least 3 of the following 5 ACR Core set criteria:\n\n 1. Patient's Assessment of Pain Visual Analogue Scale (VAS)\n 2. Patient's Global Assessment of Disease Activity VAS\n 3. Physician's Global Assessment of Disease Activity VAS\n 4. Patient's Assessment of Physical Function as measured by the HAQ-DI\n 5. Acute phase reactant as measured by CRP"}, {'measure': 'American College of Rheumatology 70 (ACR70) Response at 12 Weeks', 'timeFrame': '12 Weeks', 'description': "American College of Rheumatology 70 Response (coded 0=No, 1=Yes) is achieved when there is:\n\n* 70% improvement in both TJC (68 joints count) and SJC (66 joints count) and\n* 70% improvement in at least 3 of the following 5 ACR Core set criteria:\n\n 1. Patient's Assessment of Pain Visual Analogue Scale (VAS)\n 2. Patient's Global Assessment of Disease Activity VAS\n 3. Physician's Global Assessment of Disease Activity VAS\n 4. Patient's Assessment of Physical Function as measured by the HAQ-DI\n 5. Acute phase reactant as measured by CRP"}, {'measure': 'American College of Rheumatology 70 (ACR70) Response at 24 Weeks', 'timeFrame': '24 Weeks', 'description': "American College of Rheumatology 70 Response (coded 0=No, 1=Yes) is achieved when there is:\n\n* 70% improvement in both TJC (68 joints count) and SJC (66 joints count) and\n* 70% improvement in at least 3 of the following 5 ACR Core set criteria:\n\n 1. Patient's Assessment of Pain Visual Analogue Scale (VAS)\n 2. Patient's Global Assessment of Disease Activity VAS\n 3. Physician's Global Assessment of Disease Activity VAS\n 4. Patient's Assessment of Physical Function as measured by the HAQ-DI\n 5. Acute phase reactant as measured by CRP"}, {'measure': 'American College of Rheumatology 70 (ACR70) Response at 36 Weeks', 'timeFrame': '36 Weeks', 'description': "American College of Rheumatology 70 Response (coded 0=No, 1=Yes) is achieved when there is:\n\n* 70% improvement in both TJC (68 joints count) and SJC (66 joints count) and\n* 70% improvement in at least 3 of the following 5 ACR Core set criteria:\n\n 1. Patient's Assessment of Pain Visual Analogue Scale (VAS)\n 2. Patient's Global Assessment of Disease Activity VAS\n 3. Physician's Global Assessment of Disease Activity VAS\n 4. Patient's Assessment of Physical Function as measured by the HAQ-DI\n 5. Acute phase reactant as measured by CRP"}, {'measure': 'American College of Rheumatology 70 (ACR70) Response at 52 Weeks', 'timeFrame': '52 Weeks', 'description': "American College of Rheumatology 70 Response (coded 0=No, 1=Yes) is achieved when there is:\n\n* 70% improvement in both TJC (68 joints count) and SJC (66 joints count) and\n* 70% improvement in at least 3 of the following 5 ACR Core set criteria:\n\n 1. Patient's Assessment of Pain Visual Analogue Scale (VAS)\n 2. Patient's Global Assessment of Disease Activity VAS\n 3. Physician's Global Assessment of Disease Activity VAS\n 4. Patient's Assessment of Physical Function as measured by the HAQ-DI\n 5. Acute phase reactant as measured by CRP"}, {'measure': 'Psoriatic Arthritis Response Criteria (PsARC) Response at 12 Weeks', 'timeFrame': '12 Weeks', 'description': "Psoriatic Arthritis Response Criteria Response (coded 0=No, 1=Yes) 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:\n\n1. At least 30% reduction in tender joint grade (total of 68 joints graded 0-3)\n2. At least 30% reduction in swollen joint grade (total of 66 joints graded 0-3)\n3. At least a 1 point reduction in physician's assessment of articular disease (1-5 Likert scale)\n4. At least a 1 point reduction in patient's assessment of articular disease (1-5 Likert scale)"}, {'measure': 'Psoriatic Arthritis Response Criteria (PsARC) Response at 24 Weeks', 'timeFrame': '24 Weeks', 'description': "Psoriatic Arthritis Response Criteria Response (coded 0=No, 1=Yes) 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:\n\n1. At least 30% reduction in tender joint grade (total of 68 joints graded 0-3)\n2. At least 30% reduction in swollen joint grade (total of 66 joints graded 0-3)\n3. At least a 1 point reduction in physician's assessment of articular disease (1-5 Likert scale)\n4. At least a 1 point reduction in patient's assessment of articular disease (1-5 Likert scale)"}, {'measure': 'Psoriatic Arthritis Response Criteria (PsARC) Response at 36 Weeks', 'timeFrame': '36 Weeks', 'description': "Psoriatic Arthritis Response Criteria Response (coded 0=No, 1=Yes) 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:\n\n1. At least 30% reduction in tender joint grade (total of 68 joints graded 0-3)\n2. At least 30% reduction in swollen joint grade (total of 66 joints graded 0-3)\n3. At least a 1 point reduction in physician's assessment of articular disease (1-5 Likert scale)\n4. At least a 1 point reduction in patient's assessment of articular disease (1-5 Likert scale)"}, {'measure': 'Psoriatic Arthritis Response Criteria (PsARC) Response at 52 Weeks', 'timeFrame': '52 Weeks', 'description': "Psoriatic Arthritis Response Criteria Response (coded 0=No, 1=Yes) 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:\n\n1. At least 30% reduction in tender joint grade (total of 68 joints graded 0-3)\n2. At least 30% reduction in swollen joint grade (total of 66 joints graded 0-3)\n3. At least a 1 point reduction in physician's assessment of articular disease (1-5 Likert scale)\n4. At least a 1 point reduction in patient's assessment of articular disease (1-5 Likert scale)"}, {'measure': 'Psoriatic Arthritis Skin Index (PASI) Response at 12 Weeks', 'timeFrame': '12 Weeks', 'description': 'Psoriatic Arthritis Skin Index (PASI) Response (coded 0=No, 1=Yes) is defined as an improvement of at least 75% in the PASI compared to baseline.'}, {'measure': 'Psoriatic Arthritis Skin Index (PASI) Response at 24 Weeks', 'timeFrame': '24 Weeks', 'description': 'Psoriatic Arthritis Skin Index (PASI) Response (coded 0=No, 1=Yes) is defined as an improvement of at least 75% in the PASI compared to baseline.'}, {'measure': 'Psoriatic Arthritis Skin Index (PASI) Response at 36 Weeks', 'timeFrame': '36 Weeks', 'description': 'Psoriatic Arthritis Skin Index (PASI) Response (coded 0=No, 1=Yes) is defined as an improvement of at least 75% in the PASI compared to baseline.'}, {'measure': 'Psoriatic Arthritis Skin Index (PASI) Response at 52 Weeks', 'timeFrame': '52 Weeks', 'description': 'Psoriatic Arthritis Skin Index (PASI) Response (coded 0=No, 1=Yes) is defined as an improvement of at least 75% in the PASI compared to baseline.'}, {'measure': 'Ultrasound Imaging Remission at 12 Weeks', 'timeFrame': '12 Weeks', 'description': 'Ultrasound Imaging Remission (coded 0=No, 1=Yes) is achieved when all joints and entheses score grey scale\\<=1 \\& power Doppler=0.'}, {'measure': 'Ultrasound Imaging Remission at 24 Weeks', 'timeFrame': '24 Weeks', 'description': 'Ultrasound Imaging Remission (coded 0=No, 1=Yes) is achieved when all joints and entheses score grey scale\\<=1 \\& power Doppler=0.'}, {'measure': 'Ultrasound Imaging Remission at 36 Weeks', 'timeFrame': '36 Weeks', 'description': 'Ultrasound Imaging Remission (coded 0=No, 1=Yes) is achieved when all joints and entheses score grey scale\\<=1 \\& power Doppler=0.'}, {'measure': 'Additional Steroid Received Before 24 Weeks', 'timeFrame': '12 Weeks', 'description': 'Participants were eligible for additional steroid at weeks 8 and 12 if they had not achieved a PsARC response; this variable was coded 0=No, 1=Yes.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psoriatic Arthritis']}, 'descriptionModule': {'briefSummary': 'An investigator-initiated double-blind, parallel-group randomised controlled trial of Methotrexate versus GOLimumab and Methotrexate in very early PsA using clinical and whole body MRI outcomes.', 'detailedDescription': 'Phase IIIb. Early Psoriatic Arthritis. Investigator initiated, double-blind, randomized, placebo-controlled, two-armed, parallel-group, single centre trial.\n\nThe Primary Objective is to assess whether the combination of golimumab with methotrexate and steroids is superior to standard care (MTX monotherapy plus steroids) in reducing clinical disease activity in patients with early, treatment naïve PsA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMale and female patients aged ≥18 years at the time of signing the Informed Consent Form.\n\nSubjects with a diagnosis of psoriatic arthritis as per the Classification for Psoriatic Arthritis (CASPAR) criteria (Appendix 4) confirmed less than 24 months prior to screening.\n\nSubjects with active PsA defined as the presence of at least 3/68 tender and at least 3/66 swollen joints or 2 swollen and 2 tender joints plus one affected entheseal site (Achilles tendon and/or plantar fascia) at baseline.\n\nAre treatment naïve to DMARDs. Are capable of understanding and signing an informed consent form. Women of childbearing potential or men capable of fathering children must be using adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, surgical sterilization) during the study and for 6 months after receiving the last administration of study agent. Female subjects of childbearing potential must test negative for pregnancy. Female subjects must agree to not donate eggs (ova, oocytes) during the study and for 6 months after last dose of study agent. Male subjects must agree to not donate sperm while in the study and for 6 months after last dose of study agent.\n\nPatients fulfilling the following TB criteria:\n\n7.1. Have no history of latent or active TB prior to screening. An exception is made for subjects with a history of latent TB and documentation of having completed appropriate treatment for latent TB 3 years prior to the first administration of study agent. It is the responsibility of the investigator to verify the adequacy of previous antituberculous treatment and provide appropriate documentation.\n\n7.2. Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.\n\n7.3. Have had no close contact with a person with active TB or, if there has been such a contact, will be referred to a physician specializing in TB to undergo additional evaluation, and if warranted, receive appropriate treatment as if having latent TB prior to or simultaneously with the first administration of study agent.\n\n7.4. Within 6 weeks prior to the administration of study agent, either have a negative QuantiFERON-TB Gold test result or have a newly identified positive QuantiFERON-TB Gold test result in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study agent.\n\n7.5. In the event of 2 indeterminate QuantiFERON-TB Gold in-tube tests results, the subjects will be treated as if having latent TB prior or simultaneously with the first administration of study agent.\n\n7.6. Have a chest radiograph (posterior-anterior view), read by a qualified radiologist, whose diagnostic assessment is consistent with no evidence of current active TB or old inactive TB, and taken within 12 months of the study.\n\n7.7. Have a screening laboratory test result as follows: 7.7.1. Hb≥8.5 g/dL or ≥5.3 mmol/L 7.7.2. White blood cell (WBC) count ≥3.5x103 cells/uL 7.7.3. Neutrophils ≥1.5 x103 cells/uL 7.7.4. Platelets ≥100x103 cells/uL 7.7.5. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels not exceeding 1.5 times the upper limit of normal (UKN) for the central laboratory conducting the test.\n\n7.7.6. Serum creatinine not exceeding 1.5 mg/dL\n\nExclusion Criteria:\n\n1. Received previous treatment with any DMARDs.\n2. Received previous treatment with golimumab or other tumour necrosis factor inhibitor (TNFi) or other biologic drugs.\n3. Any chronic inflammatory arthritis diagnosed before 16 years old. Exclusions for general safety\n\nPatients with significant concurrent medical diseases including uncompensated congestive heart failure, myocardial infarction within 52 weeks from screening, unstable angina pectoris, uncontrolled hypertension (BP\\>160/95), severe pulmonary disease, or history of human immunodeficiency virus (HIV) infection, immunodeficiency syndromes, central nervous system (CNS) demyelinating events suggestive of multiple sclerosis, renal or gastrointestinal conditions, which in the opinion of the investigator places the patient at an unacceptable risk for participation in the study or would make implementation of the protocol difficult.\n\nPatients with cancer or a history of cancer (other than resected cutaneous basal cell carcinoma, and in situ cervical cancer) within 5 years of screening.\n\nPatients with current crystal or infective arthritis. Patients with chronic infection of the upper respiratory tract (eg. Sinusitis), chest (eg. Bronchiectatic lung disease), urinary tract or skin (eg. Paronychia, chronic ulcers, open wounds) within 4 weeks of screening.\n\nPatients who have a chest radiograph within 3 months prior to the first administration of study agent that shows an abnormality suggestive of a malignancy or current active infection, including TB, histoplasmosis or coccidioidomycosis.\n\nPatients with any ongoing or active infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics within the preceding 30 days of screening and/or orally administered antibiotics in the preceding 15 days of screening.\n\nPatients with abnormal liver function including known liver cirrhosis, fibrosis, or known alcoholic steatohepatitis (NASH) at the time of screening or abnormal blood tests as shown by:\n\nAminotransferase (AST) / alanine aminotransferase (ALT) \\> 3x ULN, OR Bilirubin \\>51umol/L\n\nPatients with known severe hypoproteinaemia at the time of screening, e.g. in nephrotic syndrome or impaired renal function, as shown by:\n\n• Serum Creatinine \\> 133 mol/L\n\nPatients with known significantly impaired bone marrow function as for example significant anaemia, leukopaenia, neutropaenia or thrombocytopaenia as shown by the following laboratory values at the time of screening:\n\nWhite blood cells \\< 3000 x 106/L Platelets \\< 125 x 109/L Haemoglobin \\< 9.0 g/dL for males and \\< 8.5 g/dL for females Patients with a history of latent or active TB prior to screening will not be eligible. For exceptions refer to inclusion criteria.\n\nSubjects must undergo screening for hepatitis B virus (HBV). At a minimum, this includes testing for HBsAg (surface antigen), anti-HBs (surface antibody), and anti-HBc total (core antibody total).\n\n11.1. Subjects who test positive for surface antigen (HBsAg+) are not eligible for this study, regardless of the results of other hepatitis B tests.\n\n11.2. Subjects who test negative for surface antibody (HBsAg-) and test positive for core antibody (anti-HBc+) and surface antibody (anti-HBs+) are eligible for this study.\n\n11.3. Subjects who test positive only for surface antibody (anti-HBs+) are eligible for this study.\n\n11.4. Subjects who test positive only for core antibody (anti-HBc+) must undergo further testing for hepatitis B deoxyribonucleic acid (HBV DNA test). If the HBV DNA test is positive, the subject is not eligible for this study. If the HBV DNA test is negative, the subject is eligible for this study. In the event the DNA test cannot be performed, the subject is not eligible for the study.\n\nPrimary or secondary immunodeficiency (history of or currently active) unless related to primary disease under investigation.\n\nPregnancy, lactation (nursing) or women of child-bearing potential (WCBP) unwilling to use an effective birth control measure (Appendix 1) whilst receiving treatment and after the last dose of protocol treatment as indicated in the relevant SmPC/IB.\n\nMen whose partners are of child-bearing potential but who are unwilling to use an effective birth control measure whilst receiving treatment and after the last dose of protocol treatment as indicated in the relevant SmPC/IB.\n\nPatients who have received any corticosteroids within 4 weeks prior to screening.\n\nPatients with a history of confirmed blood dyscrasia. Patients with a history of mental illness that would interfere with their ability to comply with the study protocol.\n\nPatients with a history of drug and/or alcohol abuse that would interfere with their ability to comply with the study protocol.\n\nPatients with a history of any viral hepatitis within 1 year of screening Patients who have received or are expected to receive any live virus or bacterial vaccinations or treatments that include live organisms (eg. a therapeutic infectious agent such as BCG that is instilled into the bladder for the treatment of cancer) within 3 months prior to the first administration of study agent, during the trial, or within 6 months after the last administration of the study agent.\n\nPatients who demonstrate Hypersensitivity to the active substance, or any of the excipients detailed in the SmPC.'}, 'identificationModule': {'nctId': 'NCT04108468', 'acronym': 'GOLMePsA', 'briefTitle': 'GOLimumab and Methotrexate Versus Methotrexate in Very Early PsA', 'organization': {'class': 'OTHER', 'fullName': 'The Leeds Teaching Hospitals NHS Trust'}, 'officialTitle': 'An Investigator-initiated Double-blind, Parallel-group Randomised Controlled Trial of GOLimumab and Methotrexate Versus Methotrexate in Very Early PsA Using Clinical and Whole Body MRI Outcomes: the GOLMePsA Study.', 'orgStudyIdInfo': {'id': 'RR13/10782'}, 'secondaryIdInfos': [{'id': '14/EM/0124', 'type': 'OTHER', 'domain': 'Research Ethics Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Methotrexate', 'interventionNames': ['Drug: Methotrexate']}, {'type': 'EXPERIMENTAL', 'label': 'Golimumab & Methotrexate', 'interventionNames': ['Drug: Methotrexate', 'Drug: Golimumab']}], 'interventions': [{'name': 'Methotrexate', 'type': 'DRUG', 'description': 'Methotrexate', 'armGroupLabels': ['Golimumab & Methotrexate', 'Methotrexate']}, {'name': 'Golimumab', 'type': 'DRUG', 'description': 'Simponi', 'armGroupLabels': ['Golimumab & Methotrexate']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS7 4SA', 'city': 'Leeds', 'state': 'West Yorkshire', 'country': 'United Kingdom', 'facility': 'The Leeds Teaching Hospitals NHS Trust', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Leeds Teaching Hospitals NHS Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Janssen Pharmaceutica N.V., Belgium', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}