Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-04-26 @ 3:21 AM
Study NCT ID:
NCT02409667
Status:
COMPLETED
Last Update Posted:
2019-05-13
First Post:
2015-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Plaque Psoriasis Efficacy and Safety With Secukinumab
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Ireland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D058225', 'term': 'Plaque, Amyloid'}, {'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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 (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Week 52', 'description': 'The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Period 1: All Participants', 'description': 'Participants received secukinumab 300 mg subcutaneous (s.c.) every 4 weeks for 24 weeks.', 'otherNumAtRisk': 1647, 'deathsNumAtRisk': 1647, 'otherNumAffected': 884, 'seriousNumAtRisk': 1647, 'deathsNumAffected': 1, 'seriousNumAffected': 73}, {'id': 'EG001', 'title': 'Treatment Period 2: Group 1', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.', 'otherNumAtRisk': 644, 'deathsNumAtRisk': 644, 'otherNumAffected': 272, 'seriousNumAtRisk': 644, 'deathsNumAffected': 0, 'seriousNumAffected': 25}, {'id': 'EG002', 'title': 'Treatment Period 2: Group 2', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.', 'otherNumAtRisk': 662, 'deathsNumAtRisk': 662, 'otherNumAffected': 288, 'seriousNumAtRisk': 662, 'deathsNumAffected': 0, 'seriousNumAffected': 25}, {'id': 'EG003', 'title': 'Treatment Period 2: Group 3', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 75 to \\<90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks will be treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.', 'otherNumAtRisk': 114, 'deathsNumAtRisk': 114, 'otherNumAffected': 64, 'seriousNumAtRisk': 114, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'Treatment Period 2: Group 4', 'description': 'Participants with moderate to severe plaque psoriasis, who had reached PASI 75 to \\<90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks, were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 2 weeks.', 'otherNumAtRisk': 93, 'deathsNumAtRisk': 93, 'otherNumAffected': 60, 'seriousNumAtRisk': 93, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Injection site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pulpitis dental', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 368}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 94}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 95}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 23}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 141}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Erythrodermic psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 3}, 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'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Haemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Monoplegia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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'numAtRisk': 1647, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Ectopic pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Alcohol abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Anxiety disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 0}, {'groupId': 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'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Calculus urethral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Ureteric stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Breast enlargement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': "Peyronie's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nasal polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Actinic keratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dermatitis exfoliative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lichenoid keratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Skin exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Alcohol use', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Iliac artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1647, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 644, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 662, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maintenance of PASI 90 Response at Week 52 in Participants With a PASI 90 Response at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '644', 'groupId': 'OG000'}, {'value': '662', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Period 2: Group 1', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.'}, {'id': 'OG001', 'title': 'Treatment Period 2: Group 2', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '552', 'groupId': 'OG000'}, {'value': '496', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1499', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.91', 'ciLowerLimit': '1.44', 'ciUpperLimit': '2.55', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The statistical null-hypothesis to be rejected in the primary analysis was that the odds ratio of maintaining a PASI 90 response for patients with secukinumab 4-weekly dosing versus patients on secukinumab 6-weekly dosing exceeds the non-inferiority margin of 1+δ.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 52', 'description': 'PASI 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, arms, trunk, legs; 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 section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set for Treatment Period 2 of PASI 90 responders (FAS-P90R): The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.'}, {'type': 'SECONDARY', 'title': 'Key Secondary: PASI 90 Response Rate at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Period 2: Group 3', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 75 to \\<90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks will be treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.'}, {'id': 'OG001', 'title': 'Treatment Period 2: Group 4', 'description': 'Participants with moderate to severe plaque psoriasis, who had reached PASI 75 to \\<90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks, were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1013', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '0.35', 'ciUpperLimit': '1.10', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 52', 'description': 'PASI 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, arms, trunk, legs; 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 section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS for Treatment Period 2 of PASI 75 responders who did not achieve a PASI 90 response (FAS-P75R): All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at the Week 24 visit, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after visit Week 24.'}, {'type': 'SECONDARY', 'title': 'PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI 90 Response at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '644', 'groupId': 'OG000'}, {'value': '662', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Period 2: Group 1', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.'}, {'id': 'OG001', 'title': 'Treatment Period 2: Group 2', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.'}], 'classes': [{'title': 'PASI 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '610', 'groupId': 'OG000'}, {'value': '629', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '608', 'groupId': 'OG000'}, {'value': '624', 'groupId': 'OG001'}]}]}, {'title': 'PASI 75', 'denoms': [{'units': 'Participants', 'counts': [{'value': '610', 'groupId': 'OG000'}, {'value': '629', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '597', 'groupId': 'OG000'}, {'value': '588', 'groupId': 'OG001'}]}]}, {'title': 'PASI 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '610', 'groupId': 'OG000'}, {'value': '629', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '553', 'groupId': 'OG000'}, {'value': '496', 'groupId': 'OG001'}]}]}, {'title': 'PASI 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '610', 'groupId': 'OG000'}, {'value': '629', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '378', 'groupId': 'OG000'}, {'value': '305', 'groupId': 'OG001'}]}]}, {'title': 'IGA mod 2011', 'denoms': [{'units': 'Participants', 'counts': [{'value': '609', 'groupId': 'OG000'}, {'value': '628', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '564', 'groupId': 'OG000'}, {'value': '529', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 52', 'description': "PASI 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, arms, trunk, legs; 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 section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants from the FAS-P90R with evaluable data were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.'}, {'type': 'SECONDARY', 'title': 'PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Period 2: Group 3', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 75 to \\<90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks will be treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.'}, {'id': 'OG001', 'title': 'Treatment Period 2: Group 4', 'description': 'Participants with moderate to severe plaque psoriasis, who had reached PASI 75 to \\<90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks, were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 2 weeks.'}], 'classes': [{'title': 'PASI 50', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}, {'title': 'PASI 75', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}, {'title': 'PASI 90', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'PASI 100', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'IGA mod 2011 0 or 1', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 52', 'description': "PASI 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, arms, trunk, legs; 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 section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants from the FAS-P75R with evaluable data were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at the Week 24 visit, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after visit Week 24.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PASI in Participants With a PASI 90 Response at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '644', 'groupId': 'OG000'}, {'value': '662', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Period 2: Group 1', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.'}, {'id': 'OG001', 'title': 'Treatment Period 2: Group 2', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.'}], 'classes': [{'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '642', 'groupId': 'OG000'}, {'value': '656', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-20.7', 'spread': '8.471', 'groupId': 'OG000'}, {'value': '-19.9', 'spread': '8.511', 'groupId': 'OG001'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '638', 'groupId': 'OG000'}, {'value': '655', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-20.7', 'spread': '8.581', 'groupId': 'OG000'}, {'value': '-19.8', 'spread': '8.474', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '638', 'groupId': 'OG000'}, {'value': '650', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-20.6', 'spread': '8.439', 'groupId': 'OG000'}, {'value': '-19.7', 'spread': '8.563', 'groupId': 'OG001'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '632', 'groupId': 'OG000'}, {'value': '649', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-20.5', 'spread': '8.392', 'groupId': 'OG000'}, {'value': '-19.6', 'spread': '8.393', 'groupId': 'OG001'}]}]}, {'title': 'Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '623', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-20.5', 'spread': '8.384', 'groupId': 'OG000'}, {'value': '-19.6', 'spread': '8.484', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'OG000'}, {'value': '638', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-20.5', 'spread': '8.472', 'groupId': 'OG000'}, {'value': '-19.2', 'spread': '8.509', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '610', 'groupId': 'OG000'}, {'value': '629', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-20.4', 'spread': '8.301', 'groupId': 'OG000'}, {'value': '-19.2', 'spread': '8.513', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0489', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean (LSM) estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '-0.00', 'groupDescription': 'Week 28', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1073', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.02', 'groupDescription': 'Week 32', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.24', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '-0.12', 'groupDescription': 'Week 36', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '-0.11', 'groupDescription': 'Week 40', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.30', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '-0.15', 'groupDescription': 'Week 44', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.49', 'ciLowerLimit': '-0.70', 'ciUpperLimit': '-0.27', 'groupDescription': 'Week 48', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.59', 'ciLowerLimit': '-0.81', 'ciUpperLimit': '-0.36', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 28, 32, 36, 40, 44, 48 and 52', 'description': 'PASI 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, arms, trunk, legs; 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 section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants from the FAS-P90R, who had evaluable data at both baseline and the post-baseline time point, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PASI in Participants With a PASI Response of ≥75 to <90 at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Period 2: Group 3', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 75 to \\<90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks will be treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.'}, {'id': 'OG001', 'title': 'Treatment Period 2: Group 4', 'description': 'Participants with moderate to severe plaque psoriasis, who had reached PASI 75 to \\<90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks, were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 2 weeks.'}], 'classes': [{'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.1', 'spread': '6.160', 'groupId': 'OG000'}, {'value': '-16.3', 'spread': '8.029', 'groupId': 'OG001'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15.9', 'spread': '6.002', 'groupId': 'OG000'}, {'value': '-16.6', 'spread': '7.941', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.1', 'spread': '6.356', 'groupId': 'OG000'}, {'value': '-16.6', 'spread': '7.996', 'groupId': 'OG001'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.1', 'spread': '6.908', 'groupId': 'OG000'}, {'value': '-16.8', 'spread': '8.170', 'groupId': 'OG001'}]}]}, {'title': 'Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.1', 'spread': '6.553', 'groupId': 'OG000'}, {'value': '-16.6', 'spread': '8.259', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15.6', 'spread': '6.246', 'groupId': 'OG000'}, {'value': '-16.8', 'spread': '8.307', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15.5', 'spread': '6.371', 'groupId': 'OG000'}, {'value': '-16.6', 'spread': '8.011', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1740', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.40', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.99', 'groupDescription': 'Week 28', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0287', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.08', 'ciUpperLimit': '1.50', 'groupDescription': 'Week 32', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1202', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '1.41', 'groupDescription': 'Week 36', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1157', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '1.68', 'groupDescription': 'Week 40', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3189', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.54', 'ciLowerLimit': '-0.52', 'ciUpperLimit': '1.59', 'groupDescription': 'Week 44', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0240', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '0.16', 'ciUpperLimit': '2.18', 'groupDescription': 'Week 48', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0090', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.47', 'ciLowerLimit': '0.37', 'ciUpperLimit': '2.57', 'groupDescription': 'Week 52', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 28, 32, 36, 40, 44, 48 and 52', 'description': 'PASI 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, arms, trunk, legs; 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 section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the FAS-P75R, who had evaluable data at both baseline and the post-baseline time point, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in DLQI in Participants With a PASI 90 Response at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '605', 'groupId': 'OG000'}, {'value': '624', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Period 2: Group 1', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.'}, {'id': 'OG001', 'title': 'Treatment Period 2: Group 2', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.7', 'spread': '7.325', 'groupId': 'OG000'}, {'value': '-11.4', 'spread': '7.480', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.62', 'ciLowerLimit': '-0.93', 'ciUpperLimit': '-0.31', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants from the FAS-P90R, who had evaluable data at both baseline and week 52, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in DLQI in Participants With a PASI Response of ≥75 to <90 at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Period 2: Group 3', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 75 to \\<90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks will be treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.'}, {'id': 'OG001', 'title': 'Treatment Period 2: Group 4', 'description': 'Participants with moderate to severe plaque psoriasis, who had reached PASI 75 to \\<90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks, were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.0', 'spread': '6.605', 'groupId': 'OG000'}, {'value': '-9.72', 'spread': '6.880', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0675', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '2.42', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the FAS-P75R, who had evaluable data at both baseline and week 52, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Work Productivity and Activity Impairment Questionnaire - Psoriasis (WPAI-PSO) Score in Participants With a PASI 90 Response at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '644', 'groupId': 'OG000'}, {'value': '662', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Period 2: Group 1', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.'}, {'id': 'OG001', 'title': 'Treatment Period 2: Group 2', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.'}], 'classes': [{'title': 'Absenteeism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '356', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.70', 'spread': '19.590', 'groupId': 'OG000'}, {'value': '-1.99', 'spread': '19.759', 'groupId': 'OG001'}]}]}, {'title': 'Presenteeism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '348', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-23.1', 'spread': '25.968', 'groupId': 'OG000'}, {'value': '-23.0', 'spread': '26.522', 'groupId': 'OG001'}]}]}, {'title': 'Total activity impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-24.3', 'spread': '27.850', 'groupId': 'OG000'}, {'value': '-23.2', 'spread': '29.861', 'groupId': 'OG001'}]}]}, {'title': 'Work productivity loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '546', 'groupId': 'OG000'}, {'value': '550', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-31.9', 'spread': '29.392', 'groupId': 'OG000'}, {'value': '-28.6', 'spread': '27.996', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2101', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.97', 'ciLowerLimit': '-2.48', 'ciUpperLimit': '0.55', 'groupDescription': 'Absenteeism', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2971', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.67', 'ciLowerLimit': '-1.93', 'ciUpperLimit': '0.59', 'groupDescription': 'Presenteeism', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5499', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.61', 'ciLowerLimit': '-2.59', 'ciUpperLimit': '1.38', 'groupDescription': 'Total activity impairment', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0758', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.08', 'ciLowerLimit': '-2.28', 'ciUpperLimit': '0.11', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': "The WPAI-PSO is a self-administered questionnaire comprised of 6 questions about effects of psoriasis on the patient's ability to work and perform regular activities based on the previous 7 days. The questionnaire quantifies the number of hours the respondent was unable to work and evaluates how much the respondent's psoriasis affected productivity while working. For respondents who were not in paid employment, the questionnaire evaluated how much the respondent's psoriasis affects their ability to perform regular daily activities. Four outcomes were generated from the WPAI-PSO: % Absenteeism: percent work time missed due to health; % Presenteism: percent impairment while working due to health; % Total work productivity impairment: percent overall work impairment due to health; % Total activity impairment: percent activity impairment due to health for all respondents. First 3 outcomes applied to employed participants only. A negative change from baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants from the FAS-P90R, who had evaluable data at both baseline and week 52, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in WPAI-PSO Score in Participants With a PASI Response of ≥75 to <90 at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Period 2: Group 3', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 75 to \\<90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks will be treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.'}, {'id': 'OG001', 'title': 'Treatment Period 2: Group 4', 'description': 'Participants with moderate to severe plaque psoriasis, who had reached PASI 75 to \\<90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks, were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 2 weeks.'}], 'classes': [{'title': 'Absenteeism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.36', 'spread': '12.990', 'groupId': 'OG000'}, {'value': '-3.45', 'spread': '18.698', 'groupId': 'OG001'}]}]}, {'title': 'Presenteeism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-22.9', 'spread': '28.377', 'groupId': 'OG000'}, {'value': '-22.1', 'spread': '26.333', 'groupId': 'OG001'}]}]}, {'title': 'Total activity impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-23.1', 'spread': '28.657', 'groupId': 'OG000'}, {'value': '-21.7', 'spread': '29.905', 'groupId': 'OG001'}]}]}, {'title': 'Work productivity loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-18.2', 'spread': '28.824', 'groupId': 'OG000'}, {'value': '-22.5', 'spread': '25.192', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4156', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.20', 'ciLowerLimit': '-1.71', 'ciUpperLimit': '4.11', 'groupDescription': 'Absenteeism', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8619', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.63', 'ciLowerLimit': '-6.59', 'ciUpperLimit': '7.85', 'groupDescription': 'Presenteeism', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6139', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.61', 'ciLowerLimit': '-6.31', 'ciUpperLimit': '10.61', 'groupDescription': 'Total activity impairment', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5674', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.70', 'ciLowerLimit': '-4.16', 'ciUpperLimit': '7.56', 'groupDescription': 'Work productivity loss', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': "The WPAI-PSO is a self-administered questionnaire comprised of 6 questions about effects of psoriasis on the patient's ability to work and perform regular activities based on the previous 7 days. The questionnaire quantifies the number of hours the respondent was unable to work and evaluates how much the respondent's psoriasis affected productivity while working. For respondents who were not in paid employment, the questionnaire evaluated how much the respondent's psoriasis affects their ability to perform regular daily activities. Four outcomes were generated from the WPAI-PSO: % Absenteeism: percent work time missed due to health; % Presenteism: percent impairment while working due to health; % Total work productivity impairment: percent overall work impairment due to health; % Total activity impairment: percent activity impairment due to health for all respondents. First 3 outcomes applied to employed participants only. A negative change from baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the FAS-P75R, who had evaluable data at both baseline and week 52, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pain, Itching and Scaling Score in Participants With a PASI 90 Response at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '644', 'groupId': 'OG000'}, {'value': '662', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Period 2: Group 1', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.'}, {'id': 'OG001', 'title': 'Treatment Period 2: Group 2', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.'}], 'classes': [{'title': 'Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}, {'value': '478', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.56', 'spread': '2.771', 'groupId': 'OG000'}, {'value': '-4.17', 'spread': '2.2727', 'groupId': 'OG001'}]}]}, {'title': 'Itching', 'denoms': [{'units': 'Participants', 'counts': [{'value': '590', 'groupId': 'OG000'}, {'value': '608', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.59', 'spread': '2.885', 'groupId': 'OG000'}, {'value': '-5.20', 'spread': '2.985', 'groupId': 'OG001'}]}]}, {'title': 'Scaling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '598', 'groupId': 'OG000'}, {'value': '610', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.05', 'spread': '2.659', 'groupId': 'OG000'}, {'value': '-5.73', 'spread': '2.757', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1219', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '0.04', 'groupDescription': 'Pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.38', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '-0.18', 'groupDescription': 'Itching', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.31', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '-0.14', 'groupDescription': 'Scaling', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': "Self-administered, 11-point numeric rating scales (NRS, 0-10) were used to evaluate the patients' assessment of their current pain, itching and scaling. Respondents answered the following questions for the assessment: Pain: Overall, how severe was your psoriasis-related pain over the past 24 hours?; Itching: Overall, how severe was your psoriasis-related itch over the past 24 hours?; and Scaling: Overall, how severe was your psoriasis-related scaling over the past 24 hours? Patients had to rate their pain, itching, and scaling from 0 to 10 (11-point scale), with the understanding that the 0 represents the absence or null end of the pain, itching, or scale intensity (i.e. no pain, itching or scaling) and the 10 represents the other extreme of pain, itching, or scaling intensity (i.e. pain, itching or scaling as bad as it could be). The number that the patient selected represents his or her intensity score in the respective category. A negative change from baseline indicates improvement", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants from the FAS-P90R, who had evaluable data at both baseline and week 52, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pain, Itching and Scaling Score in Participants With a PASI Response of ≥75 to <90 at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Period 2: Group 3', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 75 to \\<90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks will be treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.'}, {'id': 'OG001', 'title': 'Treatment Period 2: Group 4', 'description': 'Participants with moderate to severe plaque psoriasis, who had reached PASI 75 to \\<90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks, were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 2 weeks.'}], 'classes': [{'title': 'Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.59', 'spread': '2.754', 'groupId': 'OG000'}, {'value': '-3.68', 'spread': '3.049', 'groupId': 'OG001'}]}]}, {'title': 'Itching', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.13', 'spread': '2.883', 'groupId': 'OG000'}, {'value': '-4.49', 'spread': '3.129', 'groupId': 'OG001'}]}]}, {'title': 'Scaling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.66', 'spread': '2.960', 'groupId': 'OG000'}, {'value': '-5.40', 'spread': '2.899', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6457', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '0.92', 'groupDescription': 'Pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6136', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.19', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '0.94', 'groupDescription': 'Itching', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0203', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.12', 'ciUpperLimit': '1.39', 'groupDescription': 'Scaling', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': "Self-administered, 11-point numeric rating scales (NRS, 0-10) were used to evaluate the patients' assessment of their current pain, itching and scaling. Respondents answered the following questions for the assessment: Pain: Overall, how severe was your psoriasis-related pain over the past 24 hours?; Itching: Overall, how severe was your psoriasis-related itch over the past 24 hours?; and Scaling: Overall, how severe was your psoriasis-related scaling over the past 24 hours? Patients had to rate their pain, itching, and scaling from 0 to 10 (11-point scale), with the understanding that the 0 represents the absence or null end of the pain, itching, or scale intensity (i.e. no pain, itching or scaling) and the 10 represents the other extreme of pain, itching, or scaling intensity (i.e. pain, itching or scaling as bad as it could be). The number that the patient selected represents his or her intensity score in the respective category. A negative change from baseline indicates improvement", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the FAS-P75R, who had evaluable data at both baseline and week 52, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the European Quality of Life - 5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) in Participants With a PASI 90 Response at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '603', 'groupId': 'OG000'}, {'value': '620', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Period 2: Group 1', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.'}, {'id': 'OG001', 'title': 'Treatment Period 2: Group 2', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.34', 'spread': '23.296', 'groupId': 'OG000'}, {'value': '21.24', 'spread': '22.074', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0027', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.22', 'ciLowerLimit': '0.77', 'ciUpperLimit': '3.68', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'A visual analogue scale (VAS) was used within the EQ-5D. This scale recorded the respondent\'s self-rated health on a vertical 20-cm VAS where the endpoints were labeled "best imaginable health state" and "worst imaginable health state." This resulted in a numeric value set ranging from 0 (="worst imaginable health state") up to 100 (="best imaginable health state"). A positive change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants from the FAS-P90R, who had evaluable data at both baseline and week 52, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the EQ-5D VAS in Participants With a PASI Response of ≥75 to <90 at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Period 2: Group 3', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 75 to \\<90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks will be treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.'}, {'id': 'OG001', 'title': 'Treatment Period 2: Group 4', 'description': 'Participants with moderate to severe plaque psoriasis, who had reached PASI 75 to \\<90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks, were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.86', 'spread': '20.099', 'groupId': 'OG000'}, {'value': '18.92', 'spread': '19.855', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2823', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.31', 'ciLowerLimit': '-6.55', 'ciUpperLimit': '1.92', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'A visual analogue scale (VAS) was used within the EQ-5D. This scale recorded the respondent\'s self-rated health on a vertical 20-cm VAS where the endpoints were labeled "best imaginable health state" and "worst imaginable health state." This resulted in a numeric value set ranging from 0 (="worst imaginable health state") up to 100 (="best imaginable health state").', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the FAS-P75R, who had evaluable data at both baseline and week 52, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the EQ-5D Utility Index (Germany, United Kingdom (UK)) in Participants With a PASI 90 Response at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '605', 'groupId': 'OG000'}, {'value': '623', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Period 2: Group 1', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.'}, {'id': 'OG001', 'title': 'Treatment Period 2: Group 2', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.'}], 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.200', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.182', 'groupId': 'OG001'}]}]}, {'title': 'UK', 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.250', 'groupId': 'OG000'}, {'value': '0.22', 'spread': '0.230', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0861', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.00', 'ciUpperLimit': '0.02', 'groupDescription': 'Germany', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0117', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '0.00', 'ciUpperLimit': '0.04', 'groupDescription': 'UK', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The EQ-5D quantifies the health state of a patient for the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort \\& anxiety/depression. In this study the EQ-5D-5L version has been used which evaluates each of these dimensions using the following 5 labels: no problems, slight problems, moderate problems, severe problems \\& unable to/extreme problems. Based on the 5 dimensions, a summary score (utility index) was derived using country specific value sets evaluating the patient condition described by the outcome in the single dimensions. The EQ-5D-5L (in this trail) utility index based on the crosswalk value sets available from the EuroQol for Germany \\& UK (https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/) was calculated. A positive change from baseline indicates improvement.\n\nA visual analogue scale was used within the EQ-5D measuring the health state of the patients, ranging from 0 (worst imaginable health state) up to 100 (best imaginable health state).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants from the FAS-P90R, who had evaluable data at both baseline and week 52, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the EQ-5D Utility Index (Germany, UK) in Participants With a PASI Response of ≥75 to <90 at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Period 2: Group 3', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 75 to \\<90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks will be treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.'}, {'id': 'OG001', 'title': 'Treatment Period 2: Group 4', 'description': 'Participants with moderate to severe plaque psoriasis, who had reached PASI 75 to \\<90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks, were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 2 weeks.'}], 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.164', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.164', 'groupId': 'OG001'}]}]}, {'title': 'UK', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.206', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '0.204', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1852', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.01', 'groupDescription': 'Germany', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2203', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.02', 'groupDescription': 'UK', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The EQ-5D quantifies the health state of a patient for the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. In the current study the EQ-5D-5L version has been used which evaluates each of these dimensions using the following five labels: "no problems", "slight problems", "moderate problems", "severe problems" and "unable to/extreme problems".\n\nBased on the five dimensions, a summary score (utility index) was derived using country specific value sets evaluating the patient condition described by the outcome in the single dimensions. For this trial, the EQ-5D-5L utility index based on the crosswalk value sets available from the EuroQol for Germany and for UK (https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/) was calculated.\n\nA visual analogue scale (VAS) was used within the EQ-5D measuring the health state of the patients, ranging from 0 (="worst imaginable health state") up to 100 (="best imaginable health state").', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the FAS-P75R, who had evaluable data at both baseline and week 52, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Period 1: All Participants', 'description': 'Participants received secukinumab 300 mg subcutaneous (s.c.) every 4 weeks for 24 weeks.'}, {'id': 'FG001', 'title': 'Treatment Period 2: Group 1', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.'}, {'id': 'FG002', 'title': 'Treatment Period 2: Group 2', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.'}, {'id': 'FG003', 'title': 'Treatment Period 2: Group 3', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 75 to \\<90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks will be treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.'}, {'id': 'FG004', 'title': 'Treatment Period 2: Group 4', 'description': 'Participants with moderate to severe plaque psoriasis, who had reached PASI 75 to \\<90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks, were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 2 weeks.'}], 'periods': [{'title': 'Treatment Period 1, Baseline to Week 24', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1647'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1526'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal of informed consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Non-compliance with study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 2, Week 24 to Week 52)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '644'}, {'groupId': 'FG002', 'numSubjects': '662'}, {'groupId': 'FG003', 'numSubjects': '114'}, {'groupId': 'FG004', 'numSubjects': '93'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '621'}, {'groupId': 'FG002', 'numSubjects': '641'}, {'groupId': 'FG003', 'numSubjects': '106'}, {'groupId': 'FG004', 'numSubjects': '90'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Withdrawal of informed consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'The screening period was up to 4 weeks and rescreening was allowed for an unlimited number of times. At the Screening Visit, every patient was registered in an Interactive Response Technology and the Investigator ensured that the patient fulfilled all the inclusion/exclusion criteria'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1647', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Period 1: All Participants', 'description': 'Participants received secukinumab 300 mg subcutaneous (s.c.) every 4 weeks for 24 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.1', 'spread': '13.38', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '476', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1171', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '1597', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The safety set for Treatment Period 1 includes all subjects who took at least one dose of study treatment during this treatment period.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-22', 'size': 3858277, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-05-04T10:29', 'hasProtocol': False}, {'date': '2015-06-16', 'size': 839633, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-05-04T10:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16487}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-12', 'studyFirstSubmitDate': '2015-03-31', 'resultsFirstSubmitDate': '2018-05-04', 'studyFirstSubmitQcDate': '2015-04-01', 'lastUpdatePostDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-12', 'studyFirstPostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maintenance of PASI 90 Response at Week 52 in Participants With a PASI 90 Response at Week 24', 'timeFrame': 'Week 52', 'description': 'PASI 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, arms, trunk, legs; 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 section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).'}], 'secondaryOutcomes': [{'measure': 'Key Secondary: PASI 90 Response Rate at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24', 'timeFrame': 'Week 52', 'description': 'PASI 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, arms, trunk, legs; 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 section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).'}, {'measure': 'PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI 90 Response at Week 24', 'timeFrame': 'week 52', 'description': "PASI 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, arms, trunk, legs; 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 section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe."}, {'measure': 'PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24', 'timeFrame': 'Week 52', 'description': "PASI 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, arms, trunk, legs; 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 section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe."}, {'measure': 'Change From Baseline in PASI in Participants With a PASI 90 Response at Week 24', 'timeFrame': 'Baseline, Weeks 28, 32, 36, 40, 44, 48 and 52', 'description': 'PASI 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, arms, trunk, legs; 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 section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in PASI in Participants With a PASI Response of ≥75 to <90 at Week 24', 'timeFrame': 'Baseline, Weeks 28, 32, 36, 40, 44, 48 and 52', 'description': 'PASI 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, arms, trunk, legs; 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 section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in DLQI in Participants With a PASI 90 Response at Week 24', 'timeFrame': 'Baseline, Week 52', 'description': 'The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in DLQI in Participants With a PASI Response of ≥75 to <90 at Week 24', 'timeFrame': 'Baseline, Week 52', 'description': 'The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in Work Productivity and Activity Impairment Questionnaire - Psoriasis (WPAI-PSO) Score in Participants With a PASI 90 Response at Week 24', 'timeFrame': 'Baseline, Week 52', 'description': "The WPAI-PSO is a self-administered questionnaire comprised of 6 questions about effects of psoriasis on the patient's ability to work and perform regular activities based on the previous 7 days. The questionnaire quantifies the number of hours the respondent was unable to work and evaluates how much the respondent's psoriasis affected productivity while working. For respondents who were not in paid employment, the questionnaire evaluated how much the respondent's psoriasis affects their ability to perform regular daily activities. Four outcomes were generated from the WPAI-PSO: % Absenteeism: percent work time missed due to health; % Presenteism: percent impairment while working due to health; % Total work productivity impairment: percent overall work impairment due to health; % Total activity impairment: percent activity impairment due to health for all respondents. First 3 outcomes applied to employed participants only. A negative change from baseline indicates improvement."}, {'measure': 'Change From Baseline in WPAI-PSO Score in Participants With a PASI Response of ≥75 to <90 at Week 24', 'timeFrame': 'Baseline, Week 52', 'description': "The WPAI-PSO is a self-administered questionnaire comprised of 6 questions about effects of psoriasis on the patient's ability to work and perform regular activities based on the previous 7 days. The questionnaire quantifies the number of hours the respondent was unable to work and evaluates how much the respondent's psoriasis affected productivity while working. For respondents who were not in paid employment, the questionnaire evaluated how much the respondent's psoriasis affects their ability to perform regular daily activities. Four outcomes were generated from the WPAI-PSO: % Absenteeism: percent work time missed due to health; % Presenteism: percent impairment while working due to health; % Total work productivity impairment: percent overall work impairment due to health; % Total activity impairment: percent activity impairment due to health for all respondents. First 3 outcomes applied to employed participants only. A negative change from baseline indicates improvement."}, {'measure': 'Change From Baseline in Pain, Itching and Scaling Score in Participants With a PASI 90 Response at Week 24', 'timeFrame': 'Baseline, Week 52', 'description': "Self-administered, 11-point numeric rating scales (NRS, 0-10) were used to evaluate the patients' assessment of their current pain, itching and scaling. Respondents answered the following questions for the assessment: Pain: Overall, how severe was your psoriasis-related pain over the past 24 hours?; Itching: Overall, how severe was your psoriasis-related itch over the past 24 hours?; and Scaling: Overall, how severe was your psoriasis-related scaling over the past 24 hours? Patients had to rate their pain, itching, and scaling from 0 to 10 (11-point scale), with the understanding that the 0 represents the absence or null end of the pain, itching, or scale intensity (i.e. no pain, itching or scaling) and the 10 represents the other extreme of pain, itching, or scaling intensity (i.e. pain, itching or scaling as bad as it could be). The number that the patient selected represents his or her intensity score in the respective category. A negative change from baseline indicates improvement"}, {'measure': 'Change From Baseline in Pain, Itching and Scaling Score in Participants With a PASI Response of ≥75 to <90 at Week 24', 'timeFrame': 'Baseline, Week 52', 'description': "Self-administered, 11-point numeric rating scales (NRS, 0-10) were used to evaluate the patients' assessment of their current pain, itching and scaling. Respondents answered the following questions for the assessment: Pain: Overall, how severe was your psoriasis-related pain over the past 24 hours?; Itching: Overall, how severe was your psoriasis-related itch over the past 24 hours?; and Scaling: Overall, how severe was your psoriasis-related scaling over the past 24 hours? Patients had to rate their pain, itching, and scaling from 0 to 10 (11-point scale), with the understanding that the 0 represents the absence or null end of the pain, itching, or scale intensity (i.e. no pain, itching or scaling) and the 10 represents the other extreme of pain, itching, or scaling intensity (i.e. pain, itching or scaling as bad as it could be). The number that the patient selected represents his or her intensity score in the respective category. A negative change from baseline indicates improvement"}, {'measure': 'Change From Baseline in the European Quality of Life - 5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) in Participants With a PASI 90 Response at Week 24', 'timeFrame': 'Baseline, Week 52', 'description': 'A visual analogue scale (VAS) was used within the EQ-5D. This scale recorded the respondent\'s self-rated health on a vertical 20-cm VAS where the endpoints were labeled "best imaginable health state" and "worst imaginable health state." This resulted in a numeric value set ranging from 0 (="worst imaginable health state") up to 100 (="best imaginable health state"). A positive change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in the EQ-5D VAS in Participants With a PASI Response of ≥75 to <90 at Week 24', 'timeFrame': 'Baseline, Week 52', 'description': 'A visual analogue scale (VAS) was used within the EQ-5D. This scale recorded the respondent\'s self-rated health on a vertical 20-cm VAS where the endpoints were labeled "best imaginable health state" and "worst imaginable health state." This resulted in a numeric value set ranging from 0 (="worst imaginable health state") up to 100 (="best imaginable health state").'}, {'measure': 'Change From Baseline in the EQ-5D Utility Index (Germany, United Kingdom (UK)) in Participants With a PASI 90 Response at Week 24', 'timeFrame': 'Baseline, Week 52', 'description': 'The EQ-5D quantifies the health state of a patient for the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort \\& anxiety/depression. In this study the EQ-5D-5L version has been used which evaluates each of these dimensions using the following 5 labels: no problems, slight problems, moderate problems, severe problems \\& unable to/extreme problems. Based on the 5 dimensions, a summary score (utility index) was derived using country specific value sets evaluating the patient condition described by the outcome in the single dimensions. The EQ-5D-5L (in this trail) utility index based on the crosswalk value sets available from the EuroQol for Germany \\& UK (https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/) was calculated. A positive change from baseline indicates improvement.\n\nA visual analogue scale was used within the EQ-5D measuring the health state of the patients, ranging from 0 (worst imaginable health state) up to 100 (best imaginable health state).'}, {'measure': 'Change From Baseline in the EQ-5D Utility Index (Germany, UK) in Participants With a PASI Response of ≥75 to <90 at Week 24', 'timeFrame': 'Baseline, Week 52', 'description': 'The EQ-5D quantifies the health state of a patient for the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. In the current study the EQ-5D-5L version has been used which evaluates each of these dimensions using the following five labels: "no problems", "slight problems", "moderate problems", "severe problems" and "unable to/extreme problems".\n\nBased on the five dimensions, a summary score (utility index) was derived using country specific value sets evaluating the patient condition described by the outcome in the single dimensions. For this trial, the EQ-5D-5L utility index based on the crosswalk value sets available from the EuroQol for Germany and for UK (https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/) was calculated.\n\nA visual analogue scale (VAS) was used within the EQ-5D measuring the health state of the patients, ranging from 0 (="worst imaginable health state") up to 100 (="best imaginable health state").'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['plaque, psoriasis'], 'conditions': ['Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': 'To demonstrate in the patient pool of PASI 90 responders at Week 24 that secukinumab 300 mg s.c. when administered at a longer dosing interval is non-inferior to secukinumab 300 mg s.c. every 4 weeks treatment with respect to maintaining a PASI 90 response rate at Week 52.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n1. Chronic plaque-type psoriasis diagnosed for at least 6 months prior to Screening and candidate for systemic therapy.\n2. Moderate to severe psoriasis at Baseline as evidenced by:\n\n * PASI ≥ 10 and\n * IGA mod 2011 score of 3 or higher (based on a scale of 0 to 4) and\n * BSA affected by plaque-type psoriasis of ≥ 10%.\n\nMain Exclusion Criteria:\n\n1. History of exposure to any biologic drug taken for the treatment of chronic plaque psoriasis or any other indication including but not limited to anti-tumor necrosis factor (TNF) alpha, anti interleukin (IL)12/23, or any anti-IL 17A or IL 17A receptor (IL 17AR) antibody.\n2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.\n3. Forms of psoriasis other than chronic plaque-type (eg, pustular, erythrodermic and guttate psoriasis).\n4. Drug-induced psoriasis (ie, new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium).\n5. Ongoing use of prohibited psoriasis treatments (eg, topical or systemic corticosteroids, ultraviolet (UV) therapy).\n6. Ongoing use of other non-psoriasis prohibited treatments. Washout periods detailed in the protocol have to be adhered to. All other prior non-psoriasis concomitant treatments must be at a stable dose as detailed in the protocol before initiation of study drug.\n7. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (\\> 5 mIU/mL).\n8. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study drug and for 16 weeks after stopping study drug.\n9. Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy.\n10. Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions) which, in the opinion of the Investigator, significantly immunocompromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy.'}, 'identificationModule': {'nctId': 'NCT02409667', 'acronym': 'OPTIMISE', 'briefTitle': 'Plaque Psoriasis Efficacy and Safety With Secukinumab', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Long Term Clear Skin Maintenance Treatment Optimization in Patients With Moderate to Severe Chronic Plaque Psoriasis: A Randomized, Multicenter, Open-label With Blinded-assessment, Comparative, 52 Week Study to Evaluate the Efficacy, Safety and Tolerability of Secukinumab 300 mg s.c.', 'orgStudyIdInfo': {'id': 'CAIN457A3302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Secukinumab 300mg in PASI 90 responders (every 4 weeks)', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg subcutanous (s.c.) every 4 weeks were treated with Secukinumab 300 mg subcutanous (s.c.) from week 24 until Week 52 every 4 weeks.', 'interventionNames': ['Biological: Secukinumab']}, {'type': 'EXPERIMENTAL', 'label': 'Secukinumab 300mg in PASI 90 responders (longer intervals)', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg subcutanous (s.c.) every 4 weeks were treated with Secukinumab 300 mg subcutanous (s.c.) from week 24 until Week 52 every 6 weeks.', 'interventionNames': ['Biological: Secukinumab']}, {'type': 'EXPERIMENTAL', 'label': 'Secukinumab 300mg in PASI 75-90 responders (every 4 weeks)', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 75 to \\<90 response after 24 weeks of treatment with secukinumab 300 mg subcutanous (s.c.) every 4 weeks will be treated with Secukinumab 300 mg subcutanous (s.c.) from week 24 until Week 52 every 4 weeks.', 'interventionNames': ['Biological: Secukinumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Secukinumab 300mg in PASI 75-90 responders (shorter intervals)', 'description': 'Participants with moderate to severe plaque psoriasis who had reached PASI 75 to \\<90 response after 24 weeks of treatment with secukinumab 300 mg subcutanous (s.c.) every 4 weeks were treated with Secukinumab 300 mg subcutanous (s.c.) from week 24 until Week 52 every 2 weeks.', 'interventionNames': ['Biological: Secukinumab']}], 'interventions': [{'name': 'Secukinumab', 'type': 'BIOLOGICAL', 'description': 'Secukinumab for s.c. injection was supplied in single boxes each containing 2 pre-filled syringes (PFS) of 150 mg secukinumab in a 1 mL liquid formulation. Each 300 mg dose was administered as 2 PFS injections of 150 mg secukinumab.', 'armGroupLabels': ['Secukinumab 300mg in PASI 75-90 responders (every 4 weeks)', 'Secukinumab 300mg in PASI 75-90 responders (shorter intervals)', 'Secukinumab 300mg in PASI 90 responders (every 4 weeks)', 'Secukinumab 300mg in PASI 90 responders (longer intervals)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': 'A-4020', 'city': 'Linz', 'country': 'Austria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'A 1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 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