Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-01-10 @ 3:45 PM
Study NCT ID:
NCT01989468
Status:
COMPLETED
Last Update Posted:
2019-04-16
First Post:
2013-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
24 Week Efficacy and 3-year Safety and Efficacy of Secukinumab in Active Psoriatic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Norway', 'Sweden']}, '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': 'C555450', 'term': 'secukinumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@novartis.com', 'phone': '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': 'All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.', 'eventGroups': [{'id': 'EG000', 'title': 'Any AIN457 150 mg', 'description': '1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.', 'otherNumAtRisk': 202, 'deathsNumAtRisk': 202, 'otherNumAffected': 153, 'seriousNumAtRisk': 202, 'deathsNumAffected': 4, 'seriousNumAffected': 42}, {'id': 'EG001', 'title': 'Any AIN457 300 mg', 'description': '2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.', 'otherNumAtRisk': 284, 'deathsNumAtRisk': 284, 'otherNumAffected': 201, 'seriousNumAtRisk': 284, 'deathsNumAffected': 0, 'seriousNumAffected': 35}, {'id': 'EG002', 'title': 'Any AIN457', 'description': 'Any patients exposed to AIN457', 'otherNumAtRisk': 406, 'deathsNumAtRisk': 406, 'otherNumAffected': 320, 'seriousNumAtRisk': 406, 'deathsNumAffected': 4, 'seriousNumAffected': 76}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.', 'otherNumAtRisk': 137, 'deathsNumAtRisk': 137, 'otherNumAffected': 65, 'seriousNumAtRisk': 137, 'deathsNumAffected': 0, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 39}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 10}, 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'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 12}, 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'MedDRA (21.0)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 61}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 31}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Vitamin D deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 40}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 41}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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137, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Phyllodes tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Salivary gland neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Small cell lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Facial paresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Hemiplegia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Lacunar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Quadriparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Device loosening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Sopor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Urethral stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cystocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Ovarian cyst torsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Rectocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Uterovaginal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Nasal turbinate hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Dermal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Patients Achieving American College of Rheumatology 20 (ACR20) Response Criteria on Secukinumab Versus Placebo at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 150 mg', 'description': '1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}, {'id': 'OG001', 'title': 'AIN457 300 mg', 'description': '2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'A patient will be considered as improved according the ACR20 criteria if she/he has at least 20% decrease in the swollen and tender joint count, and at least 20% improvements in 3 of the following 5 criteria: physical disability on the Health Assessment Questionnaire; pain score on a visual analog scale; patient global assessment; physician global assessment; and acute phase reactant \\[either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)\\]', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value, was considered.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Achieving American College of Rheumatology 50 (ACR50) Response Criteria on Secukinumab Versus Placebo at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 150 mg', 'description': '1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}, {'id': 'OG001', 'title': 'AIN457 300 mg', 'description': '2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'A patient will be considered as improved according the ACR50 criteria if she/he has at least 50% decreases in the swollen and tender joint count, and at least 50% improvements in 3 of the following 5 criteria: physical disability on the Health Assessment Questionnaire; pain score on a visual analog scale; patient global assessment; physician global assessment; and acute phase reactant \\[either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)\\]', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value, was considered.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Disease Activity Score for 28 Joints (DAS28-CRP) (Utilizing hsCRP) in Subjects Treated With Secukinumab Versus Placebo at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 150 mg', 'description': '1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}, {'id': 'OG001', 'title': 'AIN457 300 mg', 'description': '2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.24', 'spread': '0.095', 'groupId': 'OG000'}, {'value': '-1.56', 'spread': '0.093', 'groupId': 'OG001'}, {'value': '-0.64', 'spread': '0.127', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 24', 'description': "DAS28-CRP is a measure of disease activity based on 28-Swollen and Tender Joint Count \\[proximal interphalangeal joints (10 joints) metacarpophalangeal joints (10) wrists (2) elbows (2) shoulders (2) knees (2)\\], CRP, and the Patient's Global Assessment of disease activity. Values range from 2.0 to 10.0 where higher values mean a higher disease activity. DAS28-CRP \\< 2.6 is interpreted as remission.", 'unitOfMeasure': 'Unit on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value, was considered.'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects Achieving a Psoriatic Area and Severity Index 75 (PASI75) Response in Subjects on Secukinumab Versus Placebo at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 150 mg', 'description': '1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}, {'id': 'OG001', 'title': 'AIN457 300 mg', 'description': '2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI75 represents an improvement in the PASI score of at least 75% as compared with baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value, was considered.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Physical Function Component of the Short-form Health Survey (SF-36-PCS) in Subjects Treated With Secukinumab Versus Placebo at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 150 mg', 'description': '1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}, {'id': 'OG001', 'title': 'AIN457 300 mg', 'description': '2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}], 'classes': [{'title': 'Mental Component Summary (MCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.68', 'spread': '0.837', 'groupId': 'OG000'}, {'value': '4.41', 'spread': '0.822', 'groupId': 'OG001'}, {'value': '-0.10', 'spread': '1.142', 'groupId': 'OG002'}]}]}, {'title': 'Physical Component Summary (PCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.42', 'spread': '0.600', 'groupId': 'OG000'}, {'value': '6.46', 'spread': '0.590', 'groupId': 'OG001'}, {'value': '2.94', 'spread': '0.830', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 24', 'description': 'SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both physically and emotionally based. Two overall summary scores, the Physical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS is used to assess improvement from baseline of at least one dose of secukinumab versus placebo. The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.', 'unitOfMeasure': 'Unit on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value, was considered.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving a Psoriatic Area and Severity Index 90 (PASI90) Response in Subjects Treated With Secukinumab Versus Placebo at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 150 mg', 'description': '1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}, {'id': 'OG001', 'title': 'AIN457 300 mg', 'description': '2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI90 represents an improvement in the PASI score of at least 90% as compared with baseline.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value, was considered.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI Score) in Subjects Treated With Secukinumab Versus Placebo at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 150 mg', 'description': '1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}, {'id': 'OG001', 'title': 'AIN457 300 mg', 'description': '2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.043', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '0.042', 'groupId': 'OG001'}, {'value': '-0.17', 'spread': '0.055', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 24', 'description': 'The HAQ measures physical disability and functional status. It has 4 dimensions: disability, pain, drug side effects and dollar costs. In this trial, only the disability dimension was used. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from four response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) and 3 (unable to do). Within each of the 8 categories, only the item indicating the most severe impairment contributes to the category score. The HAQ score is calculated by summing the computed scores for each category and dividing by the number of categories answered. It ranges from 0 (without any difficulty) to 3 (unable to do). A negative change from baseline indicates improvement.', 'unitOfMeasure': 'Unit on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value, was considered.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With Dactylitis at Week 24 in the Subset of Patients Who Had Dactylitis at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 150 mg', 'description': '1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}, {'id': 'OG001', 'title': 'AIN457 300 mg', 'description': '2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'The presence of dactylitis was assessed by dactylitis count (number of fingers and toes with dactylitis, with a range of 0-20). If dactylitis is present with any finger or toe, the patient is counted as a patient with dactylitis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Dactylitis subset of the Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value at Baseline and post-basline, was considered.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With Enthesitis at Week 24 in the Subset of Patients Who Had Enthesitis at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 150 mg', 'description': '1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}, {'id': 'OG001', 'title': 'AIN457 300 mg', 'description': '2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'The presence of Enthesitis was assessed using a validated enthesitis index that uses 6 sites for evaluation of enthesitis: lateral epicondyle humerus L + R, proximal achilles L + R and medial condyle femur. If enthesitis is present at any of the 6 sites, the subject is counted as a subject with enthesitis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Enthesitis subset of the Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value at Baseline and post-basline, was considered.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by Primary System Organ Class (SOC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '406', 'groupId': 'OG002'}, {'value': '137', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Any AIN457 150 mg', 'description': 'Any patients exposed to AIN457 150 mg'}, {'id': 'OG001', 'title': 'Any AIN457 300 mg', 'description': 'Any patients exposed to AIN457 300 mg'}, {'id': 'OG002', 'title': 'Any AIN457', 'description': 'Any patients exposed to AIN457'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}], 'classes': [{'title': 'AEs by Primary System Organ Class (SOC)', 'categories': [{'measurements': [{'value': '176', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '363', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}]}, {'title': 'SAEs by Primary System Organ Class (SOC)', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Deaths by Primary System Organ Class (SOC)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study treatment to last study visit, up to 3 years', 'description': 'Analysis of frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC).', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set, based on Final Analysis. All subjects who took at least one dose of study treatment during the treatment period. A subject with multiple adverse events within a primary system organ class was counted only once in the total row. Deaths up to 28 days after the last dose are included. Only descriptive analysis done.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AIN457 150 mg', 'description': '1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}, {'id': 'FG001', 'title': 'AIN457 300 mg', 'description': '2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}, {'id': 'FG002', 'title': 'Placebo_AIN457 150 mg', 'description': 'Placebo switch to Secukinumab/AIN457 150 mg'}, {'id': 'FG003', 'title': 'Placebo_AIN457 300 mg', 'description': 'Placebo switch to Secukinumab/AIN457 300 mg'}, {'id': 'FG004', 'title': 'Placebo Not Rerandomized', 'description': 'Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'All randomized patients were included in the Full Analysis Set (FAS) and Safety Set (SAF).', 'achievements': [{'groupId': 'FG000', 'numSubjects': '138'}, {'groupId': 'FG001', 'numSubjects': '139'}, {'groupId': 'FG002', 'numSubjects': '64'}, {'groupId': 'FG003', 'numSubjects': '65'}, {'groupId': 'FG004', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'comment': 'Completed Week 156', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '102'}, {'groupId': 'FG002', 'numSubjects': '45'}, {'groupId': 'FG003', 'numSubjects': '49'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '16'}, {'groupId': 'FG004', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Technical Problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Subject Guardian Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were randomized to 1 of 3 treatment arms (1:1:1) and planned to be treated for 156 weeks. Placebo non-responders had the option to be re-randomized at Week 16 and placebo responders had the option to be re-randomized at Week 24. Thus, of the 137 original placebo patients 64 were re-randomized to AIN457 150 mg and 65 to AIN457 300 mg.', 'preAssignmentDetails': 'A screening period (SCR) running up to 10 weeks before randomization was used to assess eligibility.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}, {'value': '414', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'AIN457 150 mg', 'description': '1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}, {'id': 'BG001', 'title': 'AIN457 300 mg', 'description': '2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.'}, {'id': 'BG003', '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '367', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '227', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '187', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '392', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, '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': 414}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-15', 'studyFirstSubmitDate': '2013-11-07', 'resultsFirstSubmitDate': '2019-02-25', 'studyFirstSubmitQcDate': '2013-11-14', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-15', 'studyFirstPostDateStruct': {'date': '2013-11-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Patients Achieving American College of Rheumatology 20 (ACR20) Response Criteria on Secukinumab Versus Placebo at Week 24', 'timeFrame': 'Week 24', 'description': 'A patient will be considered as improved according the ACR20 criteria if she/he has at least 20% decrease in the swollen and tender joint count, and at least 20% improvements in 3 of the following 5 criteria: physical disability on the Health Assessment Questionnaire; pain score on a visual analog scale; patient global assessment; physician global assessment; and acute phase reactant \\[either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)\\]'}], 'secondaryOutcomes': [{'measure': 'Proportion of Patients Achieving American College of Rheumatology 50 (ACR50) Response Criteria on Secukinumab Versus Placebo at Week 24', 'timeFrame': 'Week 24', 'description': 'A patient will be considered as improved according the ACR50 criteria if she/he has at least 50% decreases in the swollen and tender joint count, and at least 50% improvements in 3 of the following 5 criteria: physical disability on the Health Assessment Questionnaire; pain score on a visual analog scale; patient global assessment; physician global assessment; and acute phase reactant \\[either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)\\]'}, {'measure': 'Change From Baseline in Disease Activity Score for 28 Joints (DAS28-CRP) (Utilizing hsCRP) in Subjects Treated With Secukinumab Versus Placebo at Week 24', 'timeFrame': 'Week 24', 'description': "DAS28-CRP is a measure of disease activity based on 28-Swollen and Tender Joint Count \\[proximal interphalangeal joints (10 joints) metacarpophalangeal joints (10) wrists (2) elbows (2) shoulders (2) knees (2)\\], CRP, and the Patient's Global Assessment of disease activity. Values range from 2.0 to 10.0 where higher values mean a higher disease activity. DAS28-CRP \\< 2.6 is interpreted as remission."}, {'measure': 'Proportion of Subjects Achieving a Psoriatic Area and Severity Index 75 (PASI75) Response in Subjects on Secukinumab Versus Placebo at Week 24', 'timeFrame': 'Week 24', 'description': 'PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI75 represents an improvement in the PASI score of at least 75% as compared with baseline.'}, {'measure': 'Change From Baseline in Physical Function Component of the Short-form Health Survey (SF-36-PCS) in Subjects Treated With Secukinumab Versus Placebo at Week 24', 'timeFrame': 'Week 24', 'description': 'SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both physically and emotionally based. Two overall summary scores, the Physical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS is used to assess improvement from baseline of at least one dose of secukinumab versus placebo. The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.'}, {'measure': 'Percentage of Subjects Achieving a Psoriatic Area and Severity Index 90 (PASI90) Response in Subjects Treated With Secukinumab Versus Placebo at Week 24', 'timeFrame': 'Week 24', 'description': 'PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI90 represents an improvement in the PASI score of at least 90% as compared with baseline.'}, {'measure': 'Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI Score) in Subjects Treated With Secukinumab Versus Placebo at Week 24', 'timeFrame': 'Week 24', 'description': 'The HAQ measures physical disability and functional status. It has 4 dimensions: disability, pain, drug side effects and dollar costs. In this trial, only the disability dimension was used. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from four response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) and 3 (unable to do). Within each of the 8 categories, only the item indicating the most severe impairment contributes to the category score. The HAQ score is calculated by summing the computed scores for each category and dividing by the number of categories answered. It ranges from 0 (without any difficulty) to 3 (unable to do). A negative change from baseline indicates improvement.'}, {'measure': 'Proportion of Patients With Dactylitis at Week 24 in the Subset of Patients Who Had Dactylitis at Baseline', 'timeFrame': 'Week 24', 'description': 'The presence of dactylitis was assessed by dactylitis count (number of fingers and toes with dactylitis, with a range of 0-20). If dactylitis is present with any finger or toe, the patient is counted as a patient with dactylitis.'}, {'measure': 'Proportion of Patients With Enthesitis at Week 24 in the Subset of Patients Who Had Enthesitis at Baseline', 'timeFrame': 'Week 24', 'description': 'The presence of Enthesitis was assessed using a validated enthesitis index that uses 6 sites for evaluation of enthesitis: lateral epicondyle humerus L + R, proximal achilles L + R and medial condyle femur. If enthesitis is present at any of the 6 sites, the subject is counted as a subject with enthesitis.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by Primary System Organ Class (SOC)', 'timeFrame': 'From first dose of study treatment to last study visit, up to 3 years', 'description': 'Analysis of frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Psoriatic arthritis', 'AIN457', 'PsA', 'ACR', 'CASPAR', 'PASDAS', 'secukinumab', 'autoinjector'], 'conditions': ['Psoriatic Arthritis']}, 'referencesModule': {'references': [{'pmid': '38446397', 'type': 'DERIVED', 'citation': 'Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, Willems D, Taieb V, Eells J, McInnes IB. Comparative Effectiveness of Bimekizumab and Secukinumab in Patients with Psoriatic Arthritis at 52 Weeks Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Jun;11(3):817-828. doi: 10.1007/s40744-024-00652-7. Epub 2024 Mar 6.'}, {'pmid': '34795065', 'type': 'DERIVED', 'citation': 'Pournara E, Kormaksson M, Nash P, Ritchlin CT, Kirkham BW, Ligozio G, Pricop L, Ogdie A, Coates LC, Schett G, McInnes IB. Clinically relevant patient clusters identified by machine learning from the clinical development programme of secukinumab in psoriatic arthritis. RMD Open. 2021 Nov;7(3):e001845. doi: 10.1136/rmdopen-2021-001845.'}, {'pmid': '31801620', 'type': 'DERIVED', 'citation': 'Coates LC, Wallman JK, McGonagle D, Schett GA, McInnes IB, Mease PJ, Rasouliyan L, Quebe-Fehling E, Asquith DL, Fasth AER, Pricop L, Gaillez C. Secukinumab efficacy on resolution of enthesitis in psoriatic arthritis: pooled analysis of two phase 3 studies. Arthritis Res Ther. 2019 Dec 4;21(1):266. doi: 10.1186/s13075-019-2055-z.'}, {'pmid': '31203228', 'type': 'DERIVED', 'citation': 'Deodhar A, Gladman DD, McInnes IB, Spindeldreher S, Martin R, Pricop L, Porter B, Safi J Jr, Shete A, Bruin G. Secukinumab Immunogenicity over 52 Weeks in Patients with Psoriatic Arthritis and Ankylosing Spondylitis. J Rheumatol. 2020 Apr;47(4):539-547. doi: 10.3899/jrheum.190116. Epub 2019 Jun 15.'}, {'pmid': '29544534', 'type': 'DERIVED', 'citation': 'Nash P, Mease PJ, McInnes IB, Rahman P, Ritchlin CT, Blanco R, Dokoupilova E, Andersson M, Kajekar R, Mpofu S, Pricop L; FUTURE 3 study group. Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3). Arthritis Res Ther. 2018 Mar 15;20(1):47. doi: 10.1186/s13075-018-1551-x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to provide 24 - 52 week efficacy, safety and tolerability data, and up to 3-year efficacy, safety and tolerability data in subjects with active Psoriatic Arthritis despite current or previous nonsteroidal anti-inflammatory drug (NSAID), disease-modifying antirheumatic drug (DMARD) therapy and/or previous anti-tumor necrosis factor alpha (TNFα) therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Psoriatic Arthritis (PsA) classified by ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria.\n* Rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative.\n* Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis.\n* Inadequate control of symptoms with NSAID.\n\nExclusion Criteria:\n\n* Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process.\n* Subjects taking high potency opioid analgesics.\n* Previous exposure to secukinumab or other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor.\n* Ongoing use of prohibited psoriasis treatments / medications.\n* Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα.\n* Previous treatment with any cell-depleting therapies.'}, 'identificationModule': {'nctId': 'NCT01989468', 'briefTitle': '24 Week Efficacy and 3-year Safety and Efficacy of Secukinumab in Active Psoriatic Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase III, Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Autoinjectors, to Demonstrate Efficacy at 24 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 3 Years in Subjects With Active Psoriatic Arthritis', 'orgStudyIdInfo': {'id': 'CAIN457F2318'}, 'secondaryIdInfos': [{'id': '2013-004002-25', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Secukinumab (AIN457) 150 mg s.c.', 'description': '1 s.c. 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Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.', 'interventionNames': ['Biological: Secukinumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching Placebo at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'Secukinumab', 'type': 'BIOLOGICAL', 'otherNames': ['Secukinumab 150 mg', 'Secukinumab 300 mg'], 'description': 'Secukinumab 150 mg provided in a 1 mL autoinjector (1 autoinjector for 150 mg dose, 2 autoinjectors for 300 mg dose)', 'armGroupLabels': ['Secukinumab (AIN457) 150 mg s.c.', 'Secukinumab (AIN457) 300 mg s.c.']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Secukinumab placebo provided in 1 mL autoinjector', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 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