Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT02826603
Status:
COMPLETED
Last Update Posted:
2019-07-09
First Post:
2015-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C555450', 'term': 'secukinumab'}, {'id': 'D000069549', 'term': 'Ustekinumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'novartis.email@novartis.com', 'phone': '+1 (862) 778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks', 'description': 'All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'AIN457 300 mg', 'description': 'Secukinumab 300mg s.c. injection in 2 150mg pre-fiilled syringes', 'otherNumAtRisk': 550, 'deathsNumAtRisk': 550, 'otherNumAffected': 216, 'seriousNumAtRisk': 550, 'deathsNumAffected': 2, 'seriousNumAffected': 29}, {'id': 'EG001', 'title': 'UST 45/90 mg', 'description': 'Ustekinumab s.c. 45mg or 90 mg (depending on body weight) (using 45mg pre-filled syringes)', 'otherNumAtRisk': 552, 'deathsNumAtRisk': 552, 'otherNumAffected': 229, 'seriousNumAtRisk': 552, 'deathsNumAffected': 0, 'seriousNumAffected': 21}, {'id': 'EG002', 'title': 'All Patients', 'description': 'All Patients from both arms', 'otherNumAtRisk': 1102, 'deathsNumAtRisk': 1102, 'otherNumAffected': 445, 'seriousNumAtRisk': 1102, 'deathsNumAffected': 2, 'seriousNumAffected': 50}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 50}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 54}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 109}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 43}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 61}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 110}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 23}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 34}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 51}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 33}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 31}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 20}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 30}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 39}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'seriousEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Colitis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Sudden cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Dengue fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pneumonia streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Skin candida', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Comminuted fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Gun shot wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Incisional hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Postoperative ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Laryngeal squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Squamous cell carcinoma of lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Squamous cell carcinoma of the oral cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'T-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Device inappropriate shock delivery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Renal infarct', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pulmonary thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Toxic skin eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 550, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 552, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1102, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '550', 'groupId': 'OG000'}, {'value': '552', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Secukinumab 300mg (2 x 150 mg)', 'description': 'Secukinumab 300mg s.c. injection (2 150mg pre-fiilled syringes)'}, {'id': 'OG001', 'title': 'Ustekinumab 2 x 45mg or 90mg', 'description': 'Ustekinumab s.c. 45 mg or 90 mg (depending on body weight) using 45mg pre-filled syringes (1 or 2 syringes)'}], 'classes': [{'categories': [{'measurements': [{'value': '366', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.21', 'ciLowerLimit': '1.72', 'ciUpperLimit': '2.84', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'Number of participants who achieved ≥ 90% reduction in PASI compared to baseline.\n\nLogistic regression analysis of PASI 90 response at Week 12\n\nPASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, upper limbs, trunk, lower limbs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\\* area score weight of body region(head: 0.1, upper limbs: 0.2, trunk: 0.3, lower limbs: 0.4).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full analysis set (FAS) is all patients from the randomized set assigned to study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned at randomization. If the actual randomization stratum was different to the assigned stratum in IRT, the actual stratum was used in the analyses.'}, {'type': 'PRIMARY', 'title': 'Participants With IGA Mod 2011 0 or 1 at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '550', 'groupId': 'OG000'}, {'value': '552', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Secukinumab 300mg (2 x 150 mg)', 'description': 'Secukinumab 300mg s.c. injection (2 150mg pre-fiilled syringes)'}, {'id': 'OG001', 'title': 'Ustekinumab 2 x 45mg or 90mg', 'description': 'Ustekinumab s.c. 45 mg or 90 mg (depending on body weight) using 45mg pre-filled syringes (1 or 2 syringes)'}], 'classes': [{'categories': [{'measurements': [{'value': '397', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.10', 'ciLowerLimit': '1.63', 'ciUpperLimit': '2.72', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': "Investigator's Global Assessment uses a scale (IGA mod 2011) that rates disease from a score of 0 (clear skin) to 4 (severe disease)", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had values at a given week, were included in the analysis for that week.'}, {'type': 'SECONDARY', 'title': 'Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '550', 'groupId': 'OG000'}, {'value': '552', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Secukinumab 300mg (2 x 150 mg)', 'description': 'Secukinumab 300mg s.c. injection (2 150mg pre-fiilled syringes)'}, {'id': 'OG001', 'title': 'Ustekinumab 2 x 45mg or 90mg', 'description': 'Ustekinumab s.c. 45 mg or 90 mg (depending on body weight) using 45mg pre-filled syringes (1 or 2 syringes)'}], 'classes': [{'categories': [{'measurements': [{'value': '484', 'groupId': 'OG000'}, {'value': '409', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.62', 'ciLowerLimit': '1.89', 'ciUpperLimit': '3.62', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'Number of participants who achieved ≥ 75% reduction in PASI at Week 12 compared to baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '550', 'groupId': 'OG000'}, {'value': '552', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Secukinumab 300mg (2 x 150 mg)', 'description': 'Secukinumab 300mg s.c. injection (2 150mg pre-fiilled syringes)'}, {'id': 'OG001', 'title': 'Ustekinumab 2 x 45mg or 90mg', 'description': 'Ustekinumab s.c. 45 mg or 90 mg (depending on body weight) using 45mg pre-filled syringes (1 or 2 syringes)'}], 'classes': [{'categories': [{'measurements': [{'value': '221', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.53', 'ciLowerLimit': '2.65', 'ciUpperLimit': '4.71', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 4', 'description': 'Number of participants who achieved ≥ 75% reduction in PASI at Week 4 compared to baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '550', 'groupId': 'OG000'}, {'value': '552', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Secukinumab 300mg (2 x 150 mg)', 'description': 'Secukinumab 300mg s.c. injection (2 150mg pre-fiilled syringes)'}, {'id': 'OG001', 'title': 'Ustekinumab 2 x 45mg or 90mg', 'description': 'Ustekinumab s.c. 45 mg or 90 mg (depending on body weight) using 45mg pre-filled syringes (1 or 2 syringes)'}], 'classes': [{'categories': [{'measurements': [{'value': '250', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.33', 'ciLowerLimit': '1.80', 'ciUpperLimit': '3.01', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': 'Number of participants who achieved 100% reduction in PASI at Week 16 compared to baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Participants With IGA Mod 2011 0 or 1 at 16 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '550', 'groupId': 'OG000'}, {'value': '552', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Secukinumab 300mg (2 x 150 mg)', 'description': 'Secukinumab 300mg s.c. injection (2 150mg pre-fiilled syringes)'}, {'id': 'OG001', 'title': 'Ustekinumab 2 x 45mg or 90mg', 'description': 'Ustekinumab s.c. 45 mg or 90 mg (depending on body weight) using 45mg pre-filled syringes (1 or 2 syringes)'}], 'classes': [{'categories': [{'measurements': [{'value': '432', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.57', 'ciLowerLimit': '1.96', 'ciUpperLimit': '3.37', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': "Investigator's Global Assessment uses a scale (IGA mod 2011) that rates disease from a score of 0 (clear skin) to 4 (severe disease)", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had values at a given week, were included in the analysis for that week.'}, {'type': 'SECONDARY', 'title': 'Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '550', 'groupId': 'OG000'}, {'value': '552', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Secukinumab 300mg (2 x 150 mg)', 'description': 'Secukinumab 300mg s.c. injection (2 150mg pre-fiilled syringes)'}, {'id': 'OG001', 'title': 'Ustekinumab 2 x 45mg or 90mg', 'description': 'Ustekinumab s.c. 45 mg or 90 mg (depending on body weight) using 45mg pre-filled syringes (1 or 2 syringes)'}], 'classes': [{'categories': [{'measurements': [{'value': '210', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.50', 'ciLowerLimit': '1.89', 'ciUpperLimit': '3.31', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'Number of participants who achieved 100% reduction in PASI at Week 12 compared to baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '550', 'groupId': 'OG000'}, {'value': '552', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Secukinumab 300mg (2 x 150 mg)', 'description': 'Secukinumab 300mg s.c. injection (2 150mg pre-fiilled syringes)'}, {'id': 'OG001', 'title': 'Ustekinumab 2 x 45mg or 90mg', 'description': 'Ustekinumab s.c. 45 mg or 90 mg (depending on body weight) using 45mg pre-filled syringes (1 or 2 syringes)'}], 'classes': [{'categories': [{'measurements': [{'value': '506', 'groupId': 'OG000'}, {'value': '441', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.86', 'ciLowerLimit': '1.96', 'ciUpperLimit': '4.17', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': 'Number of participants who achieved ≥ 75% reduction in PASI at Week 16 compared to baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '550', 'groupId': 'OG000'}, {'value': '552', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Secukinumab 300mg (2 x 150 mg)', 'description': 'Secukinumab 300mg s.c. injection (2 150mg pre-fiilled syringes)'}, {'id': 'OG001', 'title': 'Ustekinumab 2 x 45mg or 90mg', 'description': 'Ustekinumab s.c. 45 mg or 90 mg (depending on body weight) using 45mg pre-filled syringes (1 or 2 syringes)'}], 'classes': [{'categories': [{'measurements': [{'value': '423', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.85', 'ciLowerLimit': '2.19', 'ciUpperLimit': '3.71', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': 'Number of participants who achieved ≥ 90% reduction in PASI at Week 16 compared to baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '550', 'groupId': 'OG000'}, {'value': '552', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Secukinumab 300mg (2 x 150 mg)', 'description': 'Secukinumab 300mg s.c. injection (2 150mg pre-fiilled syringes)'}, {'id': 'OG001', 'title': 'Ustekinumab 2 x 45mg or 90mg', 'description': 'Ustekinumab s.c. 45 mg or 90 mg (depending on body weight) using 45mg pre-filled syringes (1 or 2 syringes)'}], 'classes': [{'categories': [{'measurements': [{'value': '402', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.84', 'ciLowerLimit': '1.41', 'ciUpperLimit': '2.41', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 52', 'description': 'Number of participants who achieved ≥ 90% reduction in PASI at Week 52 compared to baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Secukinumab 300mg (2 x 150 mg)', 'description': 'Secukinumab 300mg s.c. injection (2 150mg pre-fiilled syringes)'}, {'id': 'FG001', 'title': 'Ustekinumab 2 x 45mg or 90mg', 'description': 'Ustekinumab s.c. 45 mg or 90 mg (depending on body weight) using 45mg pre-filled syringes (1 or 2 syringes)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '550'}, {'groupId': 'FG001', 'numSubjects': '552'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '489'}, {'groupId': 'FG001', 'numSubjects': '488'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '64'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Noncompliance with treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'New therapy for study indication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Overall, 1353 patients were screened of which 1102 patients completed the Screening phase; 251 patients were screen failures', 'preAssignmentDetails': 'The randomized set was defined as all patients who were randomized at the baseline visit. Unless otherwise specified, mis-randomized patients were excluded from the randomized set.\n\nMis-randomized patients were those who were screen failures, but had been randomized by the Investigator before eligibility was assessed, but had not been treated'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '550', 'groupId': 'BG000'}, {'value': '552', 'groupId': 'BG001'}, {'value': '1102', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Secukinumab 300mg (2 x 150 mg)', 'description': 'Secukinumab 300mg s.c. injection (2 150mg pre-fiilled syringes)'}, {'id': 'BG001', 'title': 'Ustekinumab 2 x 45mg or 90mg', 'description': 'Ustekinumab s.c. 45 mg or 90 mg (depending on body weight) using 45mg pre-filled syringes (1 or 2 syringes)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.4', 'spread': '14.09', 'groupId': 'BG000'}, {'value': '45.3', 'spread': '14.16', 'groupId': 'BG001'}, {'value': '45.4', 'spread': '14.12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'average age of participants', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '488', 'groupId': 'BG000'}, {'value': '494', 'groupId': 'BG001'}, {'value': '982', 'groupId': 'BG002'}]}]}, {'title': '>=65 years and <75 years', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}]}, {'title': '>=75 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '194', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '370', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '356', 'groupId': 'BG000'}, {'value': '376', 'groupId': 'BG001'}, {'value': '732', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '416', 'groupId': 'BG000'}, {'value': '410', 'groupId': 'BG001'}, {'value': '826', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}]}, {'title': 'Native American', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}, {'title': 'Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-04-22', 'size': 1383466, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-06-17T15:05', 'hasProtocol': True}, {'date': '2018-07-18', 'size': 452304, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-06-17T15:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-07-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-18', 'studyFirstSubmitDate': '2015-11-30', 'resultsFirstSubmitDate': '2019-06-17', 'studyFirstSubmitQcDate': '2016-07-05', 'lastUpdatePostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-18', 'studyFirstPostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12', 'timeFrame': 'Week 12', 'description': 'Number of participants who achieved ≥ 90% reduction in PASI compared to baseline.\n\nLogistic regression analysis of PASI 90 response at Week 12\n\nPASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, upper limbs, trunk, lower limbs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\\* area score weight of body region(head: 0.1, upper limbs: 0.2, trunk: 0.3, lower limbs: 0.4).'}, {'measure': 'Participants With IGA Mod 2011 0 or 1 at Week 12', 'timeFrame': 'Week 12', 'description': "Investigator's Global Assessment uses a scale (IGA mod 2011) that rates disease from a score of 0 (clear skin) to 4 (severe disease)"}], 'secondaryOutcomes': [{'measure': 'Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 12', 'timeFrame': 'Week 12', 'description': 'Number of participants who achieved ≥ 75% reduction in PASI at Week 12 compared to baseline.'}, {'measure': 'Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 4', 'timeFrame': 'Week 4', 'description': 'Number of participants who achieved ≥ 75% reduction in PASI at Week 4 compared to baseline.'}, {'measure': 'Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 16', 'timeFrame': 'Week 16', 'description': 'Number of participants who achieved 100% reduction in PASI at Week 16 compared to baseline.'}, {'measure': 'Participants With IGA Mod 2011 0 or 1 at 16 Weeks', 'timeFrame': 'Week 16', 'description': "Investigator's Global Assessment uses a scale (IGA mod 2011) that rates disease from a score of 0 (clear skin) to 4 (severe disease)"}, {'measure': 'Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 12', 'timeFrame': 'Week 12', 'description': 'Number of participants who achieved 100% reduction in PASI at Week 12 compared to baseline.'}, {'measure': 'Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16', 'timeFrame': 'Week 16', 'description': 'Number of participants who achieved ≥ 75% reduction in PASI at Week 16 compared to baseline.'}, {'measure': 'Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 16', 'timeFrame': 'Week 16', 'description': 'Number of participants who achieved ≥ 90% reduction in PASI at Week 16 compared to baseline.'}, {'measure': 'Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 52', 'timeFrame': 'Week 52', 'description': 'Number of participants who achieved ≥ 90% reduction in PASI at Week 52 compared to baseline.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Plaque psoriasis', 'secukinumab', 'ustekinumab', 'ain457', 'ain457a'], 'conditions': ['Plaque Psoriasis']}, 'referencesModule': {'references': [{'pmid': '36334236', 'type': 'DERIVED', 'citation': 'Alpalhao M, Duarte J, Diogo R, Vandemeulebroecke M, Ortmann CE, Kasparek T, Filipe P. Lower Limbs are the Most Difficult-to-Treat Body Region of Patients with Psoriasis: Pooled Analysis of CLEAR and CLARITY Studies of Secukinumab Versus Ustekinumab by Body Region. BioDrugs. 2022 Nov;36(6):781-789. doi: 10.1007/s40259-022-00558-2. Epub 2022 Nov 5.'}, {'pmid': '34870789', 'type': 'DERIVED', 'citation': 'Conrad C, Ortmann CE, Vandemeulebroecke M, Kasparek T, Reich K. Nail Involvement as a Predictor of Differential Treatment Effects of Secukinumab Versus Ustekinumab in Patients with Moderate to Severe Psoriasis. Dermatol Ther (Heidelb). 2022 Jan;12(1):233-241. doi: 10.1007/s13555-021-00654-1. Epub 2021 Dec 6.'}, {'pmid': '32365251', 'type': 'DERIVED', 'citation': 'Bagel J, Blauvelt A, Nia J, Hashim P, Patekar M, de Vera A, Ahmad K, Paguet B, Xia S, Muscianisi E, Lebwohl M. Secukinumab maintains superiority over ustekinumab in clearing skin and improving quality of life in patients with moderate to severe plaque psoriasis: 52-week results from a double-blind phase 3b trial (CLARITY). J Eur Acad Dermatol Venereol. 2021 Jan;35(1):135-142. doi: 10.1111/jdv.16558. Epub 2020 Jun 8.'}, {'pmid': '30334147', 'type': 'DERIVED', 'citation': 'Bagel J, Nia J, Hashim PW, Patekar M, de Vera A, Hugot S, Sheng K, Xia S, Gilloteau I, Muscianisi E, Blauvelt A, Lebwohl M. Secukinumab is Superior to Ustekinumab in Clearing Skin in Patients with Moderate to Severe Plaque Psoriasis (16-Week CLARITY Results). Dermatol Ther (Heidelb). 2018 Dec;8(4):571-579. doi: 10.1007/s13555-018-0265-y. Epub 2018 Oct 17.'}]}, 'descriptionModule': {'briefSummary': 'Demonstrate superiority of secukinumab over ustekinumab in treatment of moderate to severe plaque psoriasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must give a written, signed and dated informed consent\n* Chronic plaque-type psoriasis present for at least 6 months before randomization\n* Moderate to severe plaque psoriasis as defined at randomization by:\n\n * PASI score of ≥12 and\n * Body Surface Area (BSA) affected by plaque-type psoriasis ≥10% and\n * IGA mod 2011 ≥3 (based on a scale of 0-4)\n* Candidate for systemic therapy, defined as having psoriasis inadequately controlled by:\n\n * Topical treatment (including topical corticosteroids) and/or\n * Phototherapy and/or\n * Previous systemic therapy\n\nExclusion Criteria:\n\n* Forms of psoriasis other than plaque psoriasis\n* Drug-induced psoriasis\n* Ongoing use of prohibited treatments\n* Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA, or ustekinumab, or any therapies targeting IL-12 or IL-23\n* Use of any other investigational drugs within 5 half-lives of the investigational treatment before study drug initiation\n* Pregnant or nursing (lactating) women\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT02826603', 'acronym': 'CLARITY', 'briefTitle': 'Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 52-week, Randomized, Double-blind Study of Secukinumab (300 mg) Compared to Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'CAIN457A2326'}, 'secondaryIdInfos': [{'id': '2015-002898-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Secukinumab', 'description': 'Secukinumab', 'interventionNames': ['Drug: Secukinumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ustekinumab', 'description': 'Ustekinumab', 'interventionNames': ['Drug: Ustekinumab']}], 'interventions': [{'name': 'Secukinumab', 'type': 'DRUG', 'description': '300mg, s.c. at randomization, Weeks 1, 2 and 3 and thereafter 4-weekly till Week 48', 'armGroupLabels': ['Secukinumab']}, {'name': 'Ustekinumab', 'type': 'DRUG', 'description': 'Per approved label, 45 mg or 90 mg s.c. based on subject weight (at randomization visit) to be administered at randomization, Week 4, 16, 28 and 40. At other timepoints subjects will receive placebo injections.', 'armGroupLabels': ['Ustekinumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85308', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72916', 'city': 'Fort Smith', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.38592, 'lon': -94.39855}}, {'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '72758', 'city': 'Rogers', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.33202, 'lon': -94.11854}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '93405', 'city': 'California City', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.1258, 'lon': -117.9859}}, {'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '93710', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '92697', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '95819', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92117', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '95405', 'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06611', 'city': 'Trumbull', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.24287, 'lon': -73.20067}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33990', 'city': 'Cape Coral', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 26.56285, 'lon': -81.94953}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33916', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32073', 'city': 'Orange Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 30.16607, 'lon': -81.70648}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '33609', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33624', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33409', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30022', 'city': 'Alpharetta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.07538, 'lon': -84.29409}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '31217', 'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '30263', 'city': 'Newnan', 'state': 'Georgia', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.38067, 'lon': -84.79966}}, {'zip': '60077', 'city': 'Skokie', 'state': 'Illinois', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.03336, 'lon': -87.73339}}, {'zip': '62703', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '46256', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '47150', 'city': 'New Albany', 'state': 'Indiana', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.28562, 'lon': -85.82413}}, {'zip': '40241', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '42301', 'city': 'Owensboro', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.77422, 'lon': -87.11333}}, {'zip': '42303', 'city': 'Owensboro', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.77422, 'lon': -87.11333}}, {'zip': '70809', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '70601', 'city': 'Lake Charles', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 30.21309, 'lon': -93.2044}}, {'zip': '70605', 'city': 'Lake Charles', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 30.21309, 'lon': -93.2044}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '20852', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '01915', 'city': 'Beverly', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.55843, 'lon': -70.88005}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02135', 'city': 'Brighton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.3501, 'lon': -71.15644}}, {'zip': '02169', 'city': 'Quincy', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.25288, 'lon': -71.00227}}, {'zip': '55432', 'city': 'Fridley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.08608, 'lon': -93.26328}}, {'zip': '39216-4505', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '64506', 'city': 'Saint Joseph', 'state': 'Missouri', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.76861, 'lon': -94.84663}}, {'zip': '63104', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63117', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89128', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08520', 'city': 'East Windsor', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.268, 'lon': -74.54043}}, {'zip': '07044', 'city': 'Verona', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.82982, 'lon': -74.24015}}, {'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '11375', 'city': 'Forest Hills', 'state': 'New York', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.71621, 'lon': -73.85014}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10025 1737', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10075', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14623', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27516', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '28209', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27401', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '27262', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '27804', 'city': 'Rocky Mount', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.93821, 'lon': -77.79053}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106-5028', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43016', 'city': 'Dublin', 'state': 'Ohio', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.09923, 'lon': -83.11408}}, {'zip': '45324', 'city': 'Fairborn', 'state': 'Ohio', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.82089, 'lon': -84.01938}}, {'zip': '73103', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97045', 'city': 'Oregon City', 'state': 'Oregon', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.35734, 'lon': -122.60676}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97223', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19341', 'city': 'Exton', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.029, 'lon': -75.62077}}, {'zip': '19046', 'city': 'Jenkintown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.09594, 'lon': -75.12517}}, {'zip': '15213-3403', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '19462', 'city': 'Plymouth Meeting', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.10233, 'lon': -75.27435}}, {'zip': '29621', 'city': 'Anderson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.50344, 'lon': -82.65013}}, {'zip': '29407', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29651', 'city': 'Greer', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.93873, 'lon': -82.22706}}, {'zip': '37072-2301', 'city': 'Goodlettsville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.32311, 'lon': -86.71333}}, {'zip': '37922', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '37130', 'city': 'Murfreesboro', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.84562, 'lon': -86.39027}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '76011', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77056', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78660', 'city': 'Pflugerville', 'state': 'Texas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 30.43937, 'lon': -97.62}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84107', 'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '98201', 'city': 'Everett', 'state': 'Washington', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.97898, 'lon': -122.20208}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '99362', 'city': 'Walla Walla', 'state': 'Washington', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.06458, 'lon': -118.34302}}, {'zip': '98801', 'city': 'Wenatchee', 'state': 'Washington', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.42346, 'lon': -120.31035}}, {'zip': '53717', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': 'A1A 5E8', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'M8X 1Y9', 'city': 'Etobicoke', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.64415, 'lon': -79.56985}}, {'zip': 'L8N 1V6', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'J2S 66', 'city': 'Sainte-Hyacinthe', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Novartis Investigative Site'}, {'zip': '500 05', 'city': 'Hradec Králové', 'state': 'CZE', 'country': 'Czechia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '100 34', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '01010', 'city': 'Guatemala City', 'country': 'Guatemala', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 14.64072, 'lon': -90.51327}}, {'zip': '01015', 'city': 'Guatemala City', 'country': 'Guatemala', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 14.64072, 'lon': -90.51327}}, {'zip': '4032', 'city': 'Debrecen', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '7632', 'city': 'Pécs', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'zip': '6725', 'city': 'Szeged', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'zip': '201', 'city': 'Kopavogur', 'country': 'Iceland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 64.11234, 'lon': -21.91298}}, {'zip': '50586', 'city': 'Kuala Lumpur', 'state': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'zip': '80100', 'city': 'Johor Bahru', 'country': 'Malaysia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 1.4655, 'lon': 103.7578}}, {'zip': '02 495', 'city': 'Warsaw', 'state': 'Mazowian', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '80-803', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '90-265', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '90-436', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '10-045', 'city': 'Olsztyn', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.78376, 'lon': 20.49272}}, {'zip': '02-097', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '02-507', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '040 15', 'city': 'Košice', 'state': 'Slovak Republic', 'country': 'Slovakia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.71441, 'lon': 21.25802}}, {'zip': '972 01', 'city': 'Bojnice', 'country': 'Slovakia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.78511, 'lon': 18.5864}}, {'zip': '13620', 'city': 'Bundang Gu', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Novartis Investigative Site'}, {'zip': '06351', 'city': 'Seoul', 'state': 'Korea', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06591', 'city': 'Seoul', 'state': 'Seocho Gu', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '61469', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '100000', 'city': 'Hanoi', 'country': 'Vietnam', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}, {'zip': '7000', 'city': 'Ho Chi Minh City', 'country': 'Vietnam', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}