Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2026-01-01 @ 12:33 AM
Study NCT ID:
NCT01544595
Status:
COMPLETED
Last Update Posted:
2018-12-20
First Post:
2012-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Extension Study of Secukinumab Prefilled Syringes in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Egypt', 'India', 'Mexico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D003872', 'term': 'Dermatitis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C555450', 'term': 'secukinumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.', 'description': 'Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.', 'eventGroups': [{'id': 'EG000', 'title': 'Any AIN457 150 mg', 'description': 'safety data from patients while on AIN457 150 mg', 'otherNumAtRisk': 545, 'deathsNumAtRisk': 545, 'otherNumAffected': 386, 'seriousNumAtRisk': 545, 'deathsNumAffected': 0, 'seriousNumAffected': 61}, {'id': 'EG001', 'title': 'Any AIN457 300 mg', 'description': 'safety data from patients while on AIN457 300 mg', 'otherNumAtRisk': 890, 'deathsNumAtRisk': 890, 'otherNumAffected': 679, 'seriousNumAtRisk': 890, 'deathsNumAffected': 2, 'seriousNumAffected': 143}, {'id': 'EG002', 'title': 'Any AIN457 Dose', 'description': 'safety data from patients while on any dose of AIN457', 'otherNumAtRisk': 1113, 'deathsNumAtRisk': 1113, 'otherNumAffected': 889, 'seriousNumAtRisk': 1113, 'deathsNumAffected': 2, 'seriousNumAffected': 198}, {'id': 'EG003', 'title': 'AIN457 150 mg - Placebo', 'description': 'safety data from patients of corresponding randomized withdrawal group while on placebo', 'otherNumAtRisk': 150, 'deathsNumAtRisk': 150, 'otherNumAffected': 75, 'seriousNumAtRisk': 150, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'AIN457 300 mg - Placebo', 'description': 'safety data from patients of corresponding randomized withdrawal group while on placebo', 'otherNumAtRisk': 181, 'deathsNumAtRisk': 181, 'otherNumAffected': 86, 'seriousNumAtRisk': 181, 'deathsNumAffected': 0, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 81}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 1113, 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{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 63}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 92}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 38}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 31}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 31}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 59}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 54}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 78}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 145}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 271}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 375}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 29}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 36}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 55}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 38}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 51}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 64}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Tinea pedis', 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'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Urethral stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Vaginal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Laryngeal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Nasal septum deviation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Nasal turbinate hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pulmonary alveolar haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Sinus polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Dermal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 545, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 890, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1113, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Participants With Loss of Psoriasis Area and Severity Index (PASI) 75 Response up to Week 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 150 mg -Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg'}, {'id': 'OG001', 'title': 'AIN457 300 mg -Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg'}, {'id': 'OG002', 'title': 'AIN457 150 mg Placebo - Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo'}, {'id': 'OG003', 'title': 'AIN457 300 mg Placebo - Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '49.8', 'groupId': 'OG000', 'lowerLimit': '25.8', 'upperLimit': '79.7'}, {'value': '25.4', 'groupId': 'OG001', 'lowerLimit': '9.8', 'upperLimit': '56.5'}, {'value': '74.3', 'groupId': 'OG002', 'lowerLimit': '56.9', 'upperLimit': '88.8'}, {'value': '64.7', 'groupId': 'OG003', 'lowerLimit': '52.0', 'upperLimit': '77.2'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.30', 'ciLowerLimit': '0.22', 'ciUpperLimit': '0.42', 'groupDescription': 'The following hypotheses were tested for 52 weeks≤ t ≤68 weeks\n\n* H1: p1(t) - p0,1(t) = 0 versus HA1: p1(t)- p0,1(t) ≥ 0,\n* H2: p2(t) - p0,2(t) = 0 versus HA2: p2(t) - p0,2(t) ≥ 0,', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'H1: Secukinumab 150 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68\n\n• H2: Secukinumab 300 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.20', 'ciLowerLimit': '0.14', 'ciUpperLimit': '0.29', 'groupDescription': 'The following hypotheses were tested for 52 weeks≤ t ≤68 weeks\n\n* H1: p1(t) - p0,1(t) = 0 versus HA1: p1(t)- p0,1(t) ≥ 0,\n* H2: p2(t) - p0,2(t) = 0 versus HA2: p2(t) - p0,2(t) ≥ 0,', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'H1: Secukinumab 150 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68\n\n• H2: Secukinumab 300 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68'}], 'paramType': 'NUMBER', 'timeFrame': 'At week 68 (16 weeks after week 52)', 'description': 'The primary variable was the cumulative rate of patients who lost PASI 75 response up to Week 68 (time=0 being defined as Week 52).\n\nLoss of PASI 75 response was analyzed by means of a survival analysis defining "loss of PASI 75 response" as "failure". The term cumulative rate corresponded to 1 minus the survival function within this survival analysis, and the cumulative rate and the survival functions were dependent on time t.\n\nPASI 75 response: patients achieving ≥ 75% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 75 responders.', 'unitOfMeasure': 'Cummulative rate', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): patients from randomized set with at least 1 post baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 150 mg -Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg'}, {'id': 'OG001', 'title': 'AIN457 300 mg -Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg'}, {'id': 'OG002', 'title': 'AIN457 150 mg Placebo - Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo'}, {'id': 'OG003', 'title': 'AIN457 300 mg Placebo - Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo'}], 'classes': [{'title': 'Wk 52 - IGA 0/1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '208', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '157', 'groupId': 'OG003'}]}]}, {'title': 'Wk 52 - PASI 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '297', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}]}, {'title': 'Wk 52 - PASI 75', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '296', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}]}, {'title': 'Wk 52 - PASI 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '190', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}, {'value': '156', 'groupId': 'OG003'}]}]}, {'title': 'Wk 52 - PASI 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}]}, {'title': 'Wk 104 - IGA 0/1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Wk 104 - PASI 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '254', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}]}, {'title': 'Wk 104 - PASI 75', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '209', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}]}, {'title': 'Wk 104 - PASI 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Wk 104 - PASI 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Wk 156 - IGA 0/1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Wk 156 - PASI 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '230', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}, {'title': 'Wk 156 - PASI 75', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '183', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Wk 156 - PASI 90 (n=239, 324, 10,15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Wk 156 - PASI 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52, 104, and 156', 'description': 'Psoriasis Area and Severity Index (PASI) 75 responder at week 52. Patients in the placebo groups were not evaluable after re-treatment with Secukinumab.\n\nPASI 75 Responders: patients with a PASI 75 response (patients achieving ≥75% improvement \\[reduction\\] in PASI score compared to baseline of the core study).\n\nPASI 50 response: patients achieving ≥ 50% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 50 responders.\n\nPASI 90 response: patients achieving ≥ 90% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 90 responders.\n\nPASI 100 response/remission: complete clearing of psoriasis (PASI=0)', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 150 mg Only', 'description': 'patients staying strictly on AIN457 150mg from Week 52'}, {'id': 'OG001', 'title': 'AIN457 300 mg Only', 'description': 'Patients staying strictly on AIN457 300mg from Week 52'}], 'classes': [{'title': 'Wk 52 - PASI 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '164', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}]}]}, {'title': 'Wk 52 - PASI 75', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}]}, {'title': 'Wk 52 - PASI 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}]}, {'title': 'Wk 52 - PASI 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}]}, {'title': 'Wk 104 - PASI 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '377', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '359', 'groupId': 'OG001'}]}]}, {'title': 'Wk 104 - PASI 75', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '377', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}]}]}, {'title': 'Wk 104 - PASI 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '377', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}]}, {'title': 'Wk 104 - PASI 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '377', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}]}, {'title': 'Wk 156 - PASI 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}]}]}, {'title': 'Wk 156 - PASI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '297', 'groupId': 'OG001'}]}]}, {'title': 'Wk 156 - PASI 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}]}, {'title': 'Wk 156 - PASI 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}]}, {'title': 'Wk 208 - PASI 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}]}]}, {'title': 'Wk 208 - PASI 75', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}]}, {'title': 'Wk 208 - PASI 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}]}, {'title': 'Wk 208 - PASI 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}]}, {'title': 'Wk 260 - PASI 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}]}]}, {'title': 'Wk 260 - PASI 75', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}]}, {'title': 'Wk 260 - PASI 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}]}, {'title': 'Wk 260 - PASI 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52, Week 104, Week 156, week 208, week 260', 'description': 'Psoriasis Area and Severity Index (PASI) scoring system: The average degree of severity of each sign in each of the four body regions was assigned a score of 0-4. The area covered by lesions on each body region was estimated as a percentage of the total area of that particular body region.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline for PASI Score Over Time (Observed Data) - Randomized Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 150 mg -Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg'}, {'id': 'OG001', 'title': 'AIN457 300 mg -Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg'}, {'id': 'OG002', 'title': 'AIN457 150 mg Placebo - Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo'}, {'id': 'OG003', 'title': 'AIN457 300 mg Placebo - Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo'}], 'classes': [{'title': 'Week 52 (baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-92.31', 'spread': '7.878', 'groupId': 'OG000'}, {'value': '-95.98', 'spread': '6.638', 'groupId': 'OG001'}, {'value': '-92.88', 'spread': '8.435', 'groupId': 'OG002'}, {'value': '-96.16', 'spread': '6.030', 'groupId': 'OG003'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-85.88', 'spread': '14.631', 'groupId': 'OG000'}, {'value': '-91.51', 'spread': '13.221', 'groupId': 'OG001'}, {'value': '-82.67', 'spread': '15.568', 'groupId': 'OG002'}, {'value': '-78.04', 'spread': '20.986', 'groupId': 'OG003'}]}]}, {'title': 'Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-83.32', 'spread': '17.341', 'groupId': 'OG000'}, {'value': '-90.50', 'spread': '11.660', 'groupId': 'OG001'}, {'value': '-79.77', 'spread': '15.172', 'groupId': 'OG002'}, {'value': '-86.35', 'spread': '15.602', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 52, 104, and 156', 'description': 'The improvement (decrease from baseline) in PASI total scores observed at Week 52.\n\nPerc. change = 100 x Abs. change /Base. (Abs. change = Post - Base) For each post-baseline visit only patients with a value at both baseline and the respective post-baseline visit are included.', 'unitOfMeasure': 'Percent change in PASI score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline for PASI Score Over Time (Observed Data) - Entire Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 150 mg Only', 'description': 'patients staying strictly on AIN457 150mg from Week 52'}, {'id': 'OG001', 'title': 'AIN457 300 mg Only', 'description': 'Patients staying strictly on AIN457 300mg from Week 52'}], 'classes': [{'title': 'Wk 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-85.93', 'spread': '14.815', 'groupId': 'OG000'}, {'value': '-91.82', 'spread': '11.889', 'groupId': 'OG001'}]}]}, {'title': 'Wk 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '377', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-85.97', 'spread': '18.811', 'groupId': 'OG000'}, {'value': '-88.86', 'spread': '16.151', 'groupId': 'OG001'}]}]}, {'title': 'Wk 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-93.03', 'spread': '12.338', 'groupId': 'OG000'}, {'value': '-87.78', 'spread': '15.114', 'groupId': 'OG001'}]}]}, {'title': 'Wk 208', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-95.71', 'spread': '7.868', 'groupId': 'OG000'}, {'value': '-88.25', 'spread': '14.496', 'groupId': 'OG001'}]}]}, {'title': 'Wk 260', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-93.65', 'spread': '9.959', 'groupId': 'OG000'}, {'value': '-88.08', 'spread': '14.983', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 52, Week 104, Week 156, week 208, week 260', 'description': 'Perc. change = 100 x Abs. change /Base. (Abs. change = Post - Base) For each post-baseline visit only patients with a value at both baseline and the respective post-baseline visit are included.', 'unitOfMeasure': 'Percent change in PASI score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 150 mg -Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg'}, {'id': 'OG001', 'title': 'AIN457 300 mg -Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg'}, {'id': 'OG002', 'title': 'AIN457 150 mg Placebo - Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo'}, {'id': 'OG003', 'title': 'AIN457 300 mg Placebo - Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo'}], 'classes': [{'title': 'Wk 52 - clear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}]}]}, {'title': 'Wk 52 - almost clear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}]}, {'title': 'Wk 52 - mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}]}, {'title': 'Wk 52 - moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Wk 52 - severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Wk 104 - clear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Wk 104 - almost clear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Wk 104 - mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Wk 104 - moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Wk 104 - severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Wk 156 - clear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Wk 156 - almost clear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Wk 156 - mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Wk 156 - moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Wk 156 - severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52 (baseline), 104, and 156', 'description': 'Investigator Global Assessment (IGA) mod 2011; scale from 0 - 4. Score 0: Clear (No signs of psoriasis. Post-inflammatory hyperpigmentation could be Present). Score 1: Almost clear (Normal to pink coloration of lesions; no thickening; no to minimal focal scaling), Score 2: Mild (Pink to light red coloration; just detectable to mild thickening; predominantly fine scaling). Score 3: Moderate (Dull bright red, clearly distinguishable erythema; clearly distinguishable to moderate thickening; moderate scaling). Score 4: Severe (Bright to deep dark red coloration; severe thickening with hard edges; severe /coarse scaling covering almost all or all lesions).\n\nPatients in the placebo groups were not evaluable after re-treatment with Secukinumab', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 150 mg Only', 'description': 'patients staying strictly on AIN457 150mg from Week 52'}, {'id': 'OG001', 'title': 'AIN457 300 mg Only', 'description': 'Patients staying strictly on AIN457 300mg from Week 52'}], 'classes': [{'title': 'Wk 52 - clear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}]}, {'title': 'Wk 52 - almost clear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}]}, {'title': 'Wk 52 - mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}, {'title': 'Wk 52 - moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Wk 52 - severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Wk 104 - clear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '377', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}]}, {'title': 'Wk 104 - almost clear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '377', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}, {'title': 'Wk 104 - mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '377', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}, {'title': 'Wk 104 - moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '377', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Wk 104 - severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '377', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Wk 156 - clear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}]}, {'title': 'Wk 156 - almost clear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}, {'title': 'Wk 156 - mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}, {'title': 'Wk 156 - moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Wk 156 - severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Wk 208 - clear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}]}, {'title': 'Wk 208 - almost clear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}, {'title': 'Wk 208 - mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}, {'title': 'Wk 208 - moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Wk 208 - severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Wk 260 - clear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}, {'title': 'Wk 260 - almost clear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}, {'title': 'Wk 260 - mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}, {'title': 'Wk 260 - moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'Wk 260 - severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52, Week 104, Week 156, week 208, week 260', 'description': "Investigator's Global Assessment (IGA) mod 2011; scale from 0 - 4. Score 0= clear (no signs of psoriasis) Score 1 = almost clear no to minimal local scaling) Score 2 = mild (predominantly fine scaling) Score 3 = moderate (moderate scaling) Score 4 = severe (severe/coarse scaling covering almost all or all lesions)", 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Number of Participants With IGA Mod 2011 0/1 Response (Observed Data) - Entire Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 150 mg Only', 'description': 'patients staying strictly on AIN457 150mg from Week 52'}, {'id': 'OG001', 'title': 'AIN457 300 mg Only', 'description': 'Patients staying strictly on AIN457 300mg from Week 52'}], 'classes': [{'title': 'Wk 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '311', 'groupId': 'OG001'}]}]}, {'title': 'Wk 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '377', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}]}, {'title': 'Wk 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}]}, {'title': 'Wk 208', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}]}, {'title': 'Wk 260', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52, Week 104, Week 156, week 208, week 260', 'description': "Investigator's Global Assessment (IGA) mod 2011 0/1. Score 0= clear (no signs of psoriasis) Score 1 = almost clear no to minimal local scaling) Score 2 = mild (predominantly fine scaling) Score 3 = moderate (moderate scaling) Score 4 = severe (severe/coarse scaling covering almost all or all lesions) Based on this scale, a patient was considered as IGA mod 2011 0/1 responder if the patient achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline.", 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Loss of IGA Mod 2011 0 or 1 Response Over Time for Subjects With IGA Mod 2011 0 or 1 Response at Week 52 - Randomized Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 150 mg -Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg'}, {'id': 'OG001', 'title': 'AIN457 300 mg -Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg'}, {'id': 'OG002', 'title': 'AIN457 150 mg Placebo - Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo'}, {'id': 'OG003', 'title': 'AIN457 300 mg Placebo - Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '38.1', 'groupId': 'OG000', 'lowerLimit': '29.8', 'upperLimit': '47.7'}, {'value': '33.4', 'groupId': 'OG001', 'lowerLimit': '25.7', 'upperLimit': '42.6'}, {'value': '82.1', 'groupId': 'OG002', 'lowerLimit': '71.2', 'upperLimit': '90.8'}, {'value': '65.5', 'groupId': 'OG003', 'lowerLimit': '53.8', 'upperLimit': '77.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 68', 'description': 'Summary for loss of IGA mod 2011 0 or 1 response over time for patients with response at Week 52.\n\ntime = 0 refers to Week 52', 'unitOfMeasure': 'Percent of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With PASI 75 Response - Treatment Period for Re-treated After Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - AIN457 150 mg', 'description': 'Patients randomized to placebo at Week 52, treated with AIN457 150mg after they relapsed'}, {'id': 'OG001', 'title': 'Placebo - AIN457 300 mg', 'description': 'Patients randomized to placebo at Week 52, treated with AIN457 300mg after they relapsed'}], 'classes': [{'title': '0 to <=4 wks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.5', 'groupId': 'OG000', 'lowerLimit': '30.7', 'upperLimit': '47.4'}, {'value': '51.0', 'groupId': 'OG001', 'lowerLimit': '43.2', 'upperLimit': '59.5'}]}]}, {'title': '>12 to <=16 wks (n=21,13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.2', 'groupId': 'OG000', 'lowerLimit': '85.5', 'upperLimit': '95.3'}, {'value': '95.1', 'groupId': 'OG001', 'lowerLimit': '90.7', 'upperLimit': '97.8'}]}]}, {'title': '>80 to <=84 wks (n=2,1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.8', 'groupId': 'OG000', 'lowerLimit': '92.6', 'upperLimit': '98.9'}, {'value': '98.8', 'groupId': 'OG001', 'lowerLimit': '94.8', 'upperLimit': '99.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to week 260', 'description': 'PASI 75 response since reinitiating treatment after relapse. time = 0 refers to Week 52', 'unitOfMeasure': 'Percent of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With IGA Mod 0 or 1 Response - Treatment Period for Re-treated After Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - AIN457 150 mg', 'description': 'Patients randomized to placebo at Week 52, treated with AIN457 150mg after they relapsed'}, {'id': 'OG001', 'title': 'Placebo - AIN457 300 mg', 'description': 'Patients randomized to placebo at Week 52, treated with AIN457 300mg after they relapsed'}], 'classes': [{'title': '0 to <=4 wks (n=96,123)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '7.3', 'upperLimit': '21.0'}, {'value': '28.1', 'groupId': 'OG001', 'lowerLimit': '21.0', 'upperLimit': '37.0'}]}]}, {'title': '>12 to <=16 wks (n=40,32)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '66.0', 'upperLimit': '83.1'}, {'value': '83.5', 'groupId': 'OG001', 'lowerLimit': '76.3', 'upperLimit': '89.4'}]}]}, {'title': '>84 to <=88 wks (n=7,4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.9', 'groupId': 'OG000', 'lowerLimit': '80.0', 'upperLimit': '93.8'}, {'value': '90.8', 'groupId': 'OG001', 'lowerLimit': '84.5', 'upperLimit': '95.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to week 260', 'description': 'IGA mod 2011 0 or 1 response since reinitiating treatment after relapse for subjects with IGA 0 or 1 response at week 52 and not have IGA 0 or 1 response at relapse.\n\ntime = 0 refers to Week 52', 'unitOfMeasure': 'Percent of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Percent pf Participants With Relapse Over Time - Randomized Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 150 mg -Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg'}, {'id': 'OG001', 'title': 'AIN457 300 mg -Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg'}, {'id': 'OG002', 'title': 'AIN457 150 mg Placebo - Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo'}, {'id': 'OG003', 'title': 'AIN457 300 mg Placebo - Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo'}], 'classes': [{'title': '0 to <=4 wks (n=286,353,150,180)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.4'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.9'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': '>12 to <=16 wks (n=297,363,124,160)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}, {'value': '160', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '5.9'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '4.4'}, {'value': '19.8', 'groupId': 'OG002', 'lowerLimit': '13.9', 'upperLimit': '27.7'}, {'value': '12.1', 'groupId': 'OG003', 'lowerLimit': '8.0', 'upperLimit': '18.1'}]}]}, {'title': '>92 to <=96 wks (n=188,292,11,15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '21.5', 'groupId': 'OG000', 'lowerLimit': '16.9', 'upperLimit': '27.0'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '6.8', 'upperLimit': '13.1'}, {'value': '88.1', 'groupId': 'OG002', 'lowerLimit': '80.9', 'upperLimit': '93.5'}, {'value': '86.1', 'groupId': 'OG003', 'lowerLimit': '79.6', 'upperLimit': '91.4'}]}]}, {'title': '>104 to <=108 wks (n=156,297,8,9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '297', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '21.9', 'groupId': 'OG000', 'lowerLimit': '17.3', 'upperLimit': '27.5'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '6.8', 'upperLimit': '13.1'}, {'value': '88.1', 'groupId': 'OG002', 'lowerLimit': '80.9', 'upperLimit': '93.5'}, {'value': '86.1', 'groupId': 'OG003', 'lowerLimit': '79.6', 'upperLimit': '91.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to week 156', 'description': 'Time 0 = week 52', 'unitOfMeasure': 'Percent of participants with relapses', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Relapse After Last Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 150 mg Only', 'description': 'patients staying strictly on AIN457 150mg from Week 52'}, {'id': 'OG001', 'title': 'AIN457 300 mg Only', 'description': 'Patients staying strictly on AIN457 300mg from Week 52'}], 'classes': [{'title': '0 to <=4 wks (n=158,415)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '12.6'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '3.9'}]}]}, {'title': '>12 to <=16 wks (n=66,208)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.0', 'groupId': 'OG000', 'lowerLimit': '22.6', 'upperLimit': '48.9'}, {'value': '28.4', 'groupId': 'OG001', 'lowerLimit': '21.8', 'upperLimit': '36.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to week 16', 'description': 'Relapse: when the achieved maximal PASI improvement from baseline of core study was reduced by \\>50%.\n\nTime 0 = week 52', 'unitOfMeasure': 'Percent of participants with relapse', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Rebound After Last Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 150 mg Only', 'description': 'patients staying strictly on AIN457 150mg from Week 52'}, {'id': 'OG001', 'title': 'AIN457 300 mg Only', 'description': 'Patients staying strictly on AIN457 300mg from Week 52'}], 'classes': [{'title': 'Rebound (<8 wks after last inj.; n=108,320)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '15.6'}, {'value': '6.6', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '10.0'}]}]}, {'title': 'RLE (< 12 wks after last inj., n=110,326)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '6.7', 'upperLimit': '19.7'}, {'value': '9.5', 'groupId': 'OG001', 'lowerLimit': '6.7', 'upperLimit': '13.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to week 68', 'description': 'Rebound: PASI increases to \\> 125% of baseline (where baseline is the PASI at the randomization of the core study) or presence of new pustular psoriasis, new erythrodermic psoriasis or more inflammatory psoriasis occurring within 8 Weeks of stopping therapy (after the last dose of study treatment received). Rebound like event (RLE) was defined as increase of PASI of \\> 125% from baseline value or occurrence of new pustular, new erythrodermic or more inflammatory psoriasis any time after stopping therapy (last treatment administered) up to Week 68. Rebound was evaluated for the patients randomized to the placebo groups in the extension study; hence these patients received the last dose of secukinumab during the core studies.', 'unitOfMeasure': 'Percent of participants with rebound', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '359', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 150 mg -Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg'}, {'id': 'OG001', 'title': 'AIN457 300 mg -Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg'}, {'id': 'OG002', 'title': 'AIN457 150 mg Placebo - Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo'}, {'id': 'OG003', 'title': 'AIN457 300 mg Placebo - Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo'}], 'classes': [{'title': 'Week 52 (baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '359', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '196', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '162', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '170', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '352', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '163', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}]}, {'title': 'Week 88', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '346', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '157', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '337', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '146', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'Week 116', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Week 128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Week 140', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '327', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156', 'description': 'Dermatology Life Quality Index (DLQI) scores range from 0 to 30. Lower absolute scores on DLQI indicate better/improved health-related quality-of life impairment.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Entire Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 150 mg Only', 'description': 'patients staying strictly on AIN457 150mg from Week 52'}, {'id': 'OG001', 'title': 'AIN457 300 mg Only', 'description': 'Patients staying strictly on AIN457 300mg from Week 52'}], 'classes': [{'title': 'Week 52 (baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '412', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '377', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}]}, {'title': 'week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}]}, {'title': 'Week 208', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '328', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}]}, {'title': 'week 260', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '286', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156', 'description': 'Dermatology Life Quality Index (DLQI) scores range from 0 to 30. Lower absolute scores on DLQI indicate better/improved health-related quality-of life impairment.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 150 mg -Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg'}, {'id': 'OG001', 'title': 'AIN457 300 mg -Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg'}, {'id': 'OG002', 'title': 'AIN457 150 mg Placebo - Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo'}, {'id': 'OG003', 'title': 'AIN457 300 mg Placebo - Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo'}], 'classes': [{'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '348', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '162', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '21.603', 'groupId': 'OG000'}, {'value': '2.09', 'spread': '28.358', 'groupId': 'OG001'}, {'value': '-9.58', 'spread': '20.339', 'groupId': 'OG002'}, {'value': '-5.57', 'spread': '27.889', 'groupId': 'OG003'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '337', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.79', 'spread': '25.605', 'groupId': 'OG000'}, {'value': '2.76', 'spread': '29.715', 'groupId': 'OG001'}, {'value': '-13.73', 'spread': '23.295', 'groupId': 'OG002'}, {'value': '-9.27', 'spread': '35.302', 'groupId': 'OG003'}]}]}, {'title': 'Week 88', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '21.421', 'groupId': 'OG000'}, {'value': '2.15', 'spread': '29.702', 'groupId': 'OG001'}, {'value': '-10.24', 'spread': '26.026', 'groupId': 'OG002'}, {'value': '-14.67', 'spread': '27.975', 'groupId': 'OG003'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.37', 'spread': '24.075', 'groupId': 'OG000'}, {'value': '1.57', 'spread': '23.941', 'groupId': 'OG001'}, {'value': '-2.81', 'spread': '27.303', 'groupId': 'OG002'}, {'value': '-9.65', 'spread': '17.794', 'groupId': 'OG003'}]}]}, {'title': 'Week 116', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.12', 'spread': '31.724', 'groupId': 'OG000'}, {'value': '2.06', 'spread': '24.814', 'groupId': 'OG001'}, {'value': '-4.82', 'spread': '20.921', 'groupId': 'OG002'}, {'value': '-3.44', 'spread': '11.846', 'groupId': 'OG003'}]}]}, {'title': 'Week 128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.06', 'spread': '33.078', 'groupId': 'OG000'}, {'value': '3.17', 'spread': '29.615', 'groupId': 'OG001'}, {'value': '-5.59', 'spread': '21.756', 'groupId': 'OG002'}, {'value': '-5.97', 'spread': '13.207', 'groupId': 'OG003'}]}]}, {'title': 'Week 140', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.20', 'spread': '25.801', 'groupId': 'OG000'}, {'value': '0.71', 'spread': '18.151', 'groupId': 'OG001'}, {'value': '-5.90', 'spread': '27.335', 'groupId': 'OG002'}, {'value': '-8.86', 'spread': '18.344', 'groupId': 'OG003'}]}]}, {'title': 'Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.53', 'spread': '34.259', 'groupId': 'OG000'}, {'value': '2.23', 'spread': '22.581', 'groupId': 'OG001'}, {'value': '3.68', 'spread': '26.836', 'groupId': 'OG002'}, {'value': '-7.60', 'spread': '20.683', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156', 'description': "EQ-5D: EuroQOL 5-Dimension Health Status Questionnaire. The EQ-5D© is a generic instrument to assess each patient's health status. It provides a simple descriptive profile and a single index value for health status. The EQ visual analog scale records the respondent's self-rated health on a vertical scale where the endpoints are labeled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.", 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'EQ-5D Health State Assessment (Observed Value) - Entire Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 150 mg Only', 'description': 'patients staying strictly on AIN457 150mg from Week 52'}, {'id': 'OG001', 'title': 'AIN457 300 mg Only', 'description': 'Patients staying strictly on AIN457 300mg from Week 52'}], 'classes': [{'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '404', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.33', 'spread': '22.506', 'groupId': 'OG000'}, {'value': '1.44', 'spread': '26.815', 'groupId': 'OG001'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '398', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.99', 'spread': '22.339', 'groupId': 'OG000'}, {'value': '2.10', 'spread': '28.493', 'groupId': 'OG001'}]}]}, {'title': 'Week 88', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '387', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.66', 'spread': '24.558', 'groupId': 'OG000'}, {'value': '1.45', 'spread': '28.269', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.15', 'spread': '27.823', 'groupId': 'OG000'}, {'value': '0.65', 'spread': '23.454', 'groupId': 'OG001'}]}]}, {'title': 'Week 116', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.19', 'spread': '21.022', 'groupId': 'OG000'}, {'value': '1.21', 'spread': '23.681', 'groupId': 'OG001'}]}]}, {'title': 'Week 128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.85', 'spread': '23.584', 'groupId': 'OG000'}, {'value': '1.93', 'spread': '27.840', 'groupId': 'OG001'}]}]}, {'title': 'Week 140', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '367', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.09', 'spread': '20.814', 'groupId': 'OG000'}, {'value': '-0.44', 'spread': '18.504', 'groupId': 'OG001'}]}]}, {'title': 'Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.13', 'spread': '32.326', 'groupId': 'OG000'}, {'value': '1.19', 'spread': '21.548', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 64, 76, 88, 104, 116, 128, 140, and 156', 'description': "EQ-5D: EuroQOL 5-Dimension Health Status Questionnaire. The EQ-5D© is a generic instrument to assess each patient's health status. It provides a simple descriptive profile and a single index value for health status. The EQ visual analog scale records the respondent's self-rated health on a vertical scale where the endpoints are labeled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.", 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '181', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 150 mg -Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg'}, {'id': 'OG001', 'title': 'AIN457 300 mg -Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg'}, {'id': 'OG002', 'title': 'AIN457 150 mg Placebo - Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo'}, {'id': 'OG003', 'title': 'AIN457 300 mg Placebo - Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo'}], 'classes': [{'title': 'Leukocytes (< LLN - 3.0 x 10E9/L)', 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '10.1'}, {'value': '4.9', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '7.0'}, {'value': '7.2', 'groupId': 'OG002', 'lowerLimit': '2.6', 'upperLimit': '15.6'}, {'value': '8.6', 'groupId': 'OG003', 'lowerLimit': '4.1', 'upperLimit': '15.8'}]}]}, {'title': 'Leukocytes (< 3.0 - 2.0 x 10E9/L)', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '3.0'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '1.9'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.3'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.1'}]}]}, {'title': 'Leukocytes (< 2.0 - 1.0 x 10E9/L)', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.6'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.3'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.1'}]}]}, {'title': 'Leukocytes (< 1.0 x 10E9/L)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.8'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.6'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.3'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.1'}]}]}, {'title': 'Lymphocytes (<LLN-0.8x10e9 /L)', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '9.4'}, {'value': '6.1', 'groupId': 'OG001', 'lowerLimit': '4.3', 'upperLimit': '8.5'}, {'value': '4.9', 'groupId': 'OG002', 'lowerLimit': '1.3', 'upperLimit': '12.6'}, {'value': '6.0', 'groupId': 'OG003', 'lowerLimit': '2.4', 'upperLimit': '12.4'}]}]}, {'title': 'Lymphocytes (<0.8-0.5x10e9 /L)', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '5.2'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '3.2'}, {'value': '6.3', 'groupId': 'OG002', 'lowerLimit': '2.1', 'upperLimit': '14.7'}, {'value': '3.4', 'groupId': 'OG003', 'lowerLimit': '0.9', 'upperLimit': '8.6'}]}]}, {'title': 'Lymphocytes (<0.5-0.2 x 10e9 /L)', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.6'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.5'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.1'}]}]}, {'title': 'Lymphocytes (<0.2x10e9 /L)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.8'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.6'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.5'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.1'}]}]}, {'title': 'Neutrophils (<LLN-1.5x10e9 /L)', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '8.7'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '3.8', 'upperLimit': '7.8'}, {'value': '8.7', 'groupId': 'OG002', 'lowerLimit': '3.5', 'upperLimit': '18.0'}, {'value': '11.3', 'groupId': 'OG003', 'lowerLimit': '6.0', 'upperLimit': '19.3'}]}]}, {'title': 'Neutrophils (<1.5-1.0x10e9 /L)', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '3.0'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '3.2'}, {'value': '2.4', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '8.8'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.1'}]}]}, {'title': 'Neutrophils (<1.0 - 0.5x10e9 /L)', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '2.4'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '1.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.5'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.1'}]}]}, {'title': 'Neutrophils (<0.5x10e9 /L)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.8'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.6'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.5'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.1'}]}]}, {'title': 'Platelets (LLN-75 x10e9 /L)', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '5.5'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '4.9'}, {'value': '2.4', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '8.6'}, {'value': '5.4', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '11.9'}]}]}, {'title': 'Platelets (<75-50 x 10e9 /L)', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.3'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.9'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.4'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.2'}]}]}, {'title': 'Platelets (<50-25 x 10e9 /L)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.8'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.6'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.4'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.2'}]}]}, {'title': 'Platelets (<25x10e9 /L)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.8'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.9'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.4'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52-156', 'description': 'CTCAE: common terminology criteria for adverse events. A subject with multiple variable measurements is counted only once under the worst condition. LLN = lower limit of normal.\n\nIR=incidence rate per 100 subject years', 'unitOfMeasure': 'IR', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set'}, {'type': 'SECONDARY', 'title': 'Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '890', 'groupId': 'OG001'}, {'value': '1113', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Any AIN457 150 mg', 'description': 'Safety data from patients while on AIN457 150 mg'}, {'id': 'OG001', 'title': 'Any AIN457 300 mg', 'description': 'Safety data from patients while on AIN457 300 mg'}, {'id': 'OG002', 'title': 'Any AIN457', 'description': 'safety data from patients while on any dose of AIN457'}], 'classes': [{'title': 'Leukocytes (<LLN-3.0x10e9 /L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '832', 'groupId': 'OG001'}, {'value': '1037', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}]}]}, {'title': 'Leukocytes (<3.0-2.0 x 10e9 /L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '866', 'groupId': 'OG001'}, {'value': '1080', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'Leukocytes (<2.0-1.0x10e9 /L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '870', 'groupId': 'OG001'}, {'value': '1085', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Leukocytes (<1.0x10e9 /L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '870', 'groupId': 'OG001'}, {'value': '1085', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes (<LLN-0.8x10e9 /L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '840', 'groupId': 'OG001'}, {'value': '1041', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes (<0.8-0.5x10e9 /L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '861', 'groupId': 'OG001'}, {'value': '1071', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes (<0.5-0.2 x 10e9 /L, n=545,864,1075)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '864', 'groupId': 'OG001'}, {'value': '1075', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes (<0.2x10e9 /L, n=545,864,1075)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '864', 'groupId': 'OG001'}, {'value': '1075', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils (<LLN-1.5x10e9 /L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '831', 'groupId': 'OG001'}, {'value': '1037', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils (<1.5-1.0x10e9 /L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '861', 'groupId': 'OG001'}, {'value': '1071', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils (<1.0 - 0.5x10e9 /L,)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '863', 'groupId': 'OG001'}, {'value': '1074', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils (<0.5x10e9 /L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '864', 'groupId': 'OG001'}, {'value': '1075', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Platelets (LLN-75x10e9 /L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '836', 'groupId': 'OG001'}, {'value': '1042', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}]}, {'title': 'Platelets (<75-50x10e9 /L,)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '862', 'groupId': 'OG001'}, {'value': '1074', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Platelets (<50-25 x 10e9 /L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '862', 'groupId': 'OG001'}, {'value': '1074', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Platelets (<25x10e9 /L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '862', 'groupId': 'OG001'}, {'value': '1074', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'approximately 4 years', 'description': 'CTCAE: common terminology criteria for adverse events. A subject with multiple variable measurements is counted only once under the worst condition. LLN = lower limit of normal.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set: The safety set included all patients who took at least one dose of study treatment during the treatment period. Patients were be analyzed according to treatment received.'}, {'type': 'SECONDARY', 'title': 'Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '181', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 150 mg -Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg'}, {'id': 'OG001', 'title': 'AIN457 300 mg -Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg'}, {'id': 'OG002', 'title': 'AIN457 150 mg Placebo - Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo'}, {'id': 'OG003', 'title': 'AIN457 300 mg Placebo - Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo'}], 'classes': [{'title': 'QTcB>450 msec', 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '14.3'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '7.0', 'upperLimit': '12.4'}, {'value': '11.3', 'groupId': 'OG002', 'lowerLimit': '4.9', 'upperLimit': '22.3'}, {'value': '14.1', 'groupId': 'OG003', 'lowerLimit': '7.5', 'upperLimit': '24.0'}]}]}, {'title': 'QTcB>480 msec', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '2.0'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '2.3'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.3'}]}]}, {'title': 'QTcB>500 msec', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.3'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.9'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.3'}]}]}, {'title': 'QTcB change from baseline>30 ms', 'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000', 'lowerLimit': '11.9', 'upperLimit': '20.1'}, {'value': '14.3', 'groupId': 'OG001', 'lowerLimit': '11.4', 'upperLimit': '17.9'}, {'value': '21.6', 'groupId': 'OG002', 'lowerLimit': '12.3', 'upperLimit': '35.0'}, {'value': '15.7', 'groupId': 'OG003', 'lowerLimit': '9.0', 'upperLimit': '25.5'}]}]}, {'title': 'QTcB change from baseline>60 ms', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '2.0'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '1.9'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.3'}]}]}, {'title': 'QTcF>450 msec', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '4.7'}, {'value': '2.6', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '9.5'}, {'value': '4.7', 'groupId': 'OG003', 'lowerLimit': '1.5', 'upperLimit': '10.9'}]}]}, {'title': 'QTcF>480 msec', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '1.7'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.9'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0.9', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '5.0'}]}]}, {'title': 'QTcF>500 msec', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.8'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.6'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.3'}]}]}, {'title': 'QTcF change from baseline>30 ms', 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': '9.9'}, {'value': '6.8', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '9.2'}, {'value': '7.9', 'groupId': 'OG002', 'lowerLimit': '2.9', 'upperLimit': '17.2'}, {'value': '9.5', 'groupId': 'OG003', 'lowerLimit': '4.6', 'upperLimit': '17.5'}]}]}, {'title': 'QTcF change from baseline>60 ms', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.3'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.9'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.3'}]}]}, {'title': 'PR>250 msec', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.6'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.9'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52 - 156', 'description': "QTcB: QT interval corrected using Bazett's formula QTcF: QT interval corrected using Fridericia's formula A patient with multiple variable measurements is counted only once under the worst condition.\n\nIR=incidence rate per 100 subject years.", 'unitOfMeasure': 'IR', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set'}, {'type': 'SECONDARY', 'title': 'Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '890', 'groupId': 'OG001'}, {'value': '1113', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Any AIN457 150 mg', 'description': 'Safety data from patients while on AIN457 150 mg'}, {'id': 'OG001', 'title': 'Any AIN457 300 mg', 'description': 'Safety data from patients while on AIN457 300 mg'}, {'id': 'OG002', 'title': 'Any AIN457', 'description': 'safety data from patients while on any dose of AIN457'}], 'classes': [{'title': 'QTcB>500 msec', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '851', 'groupId': 'OG001'}, {'value': '1060', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'QTcB>480 msec', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '848', 'groupId': 'OG001'}, {'value': '1056', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}, {'title': 'QTcB>450 msec', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '804', 'groupId': 'OG001'}, {'value': '1004', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}]}]}, {'title': 'QTcB changes from baseline>30 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '851', 'groupId': 'OG001'}, {'value': '1060', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}, {'value': '316', 'groupId': 'OG002'}]}]}, {'title': 'QTcB changes from baseline>60 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '851', 'groupId': 'OG001'}, {'value': '1060', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'QTcF>500 msec', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '851', 'groupId': 'OG001'}, {'value': '1060', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'QTcF>480 msec', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '851', 'groupId': 'OG001'}, {'value': '1059', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'QTcF>450 msec (n=545,838,1043)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '838', 'groupId': 'OG001'}, {'value': '1043', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}]}, {'title': 'QTcF changes from baseline>30 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '851', 'groupId': 'OG001'}, {'value': '1060', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}]}, {'title': 'QTcF changes from baseline>60 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '851', 'groupId': 'OG001'}, {'value': '1060', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'PR>250 msec', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '845', 'groupId': 'OG001'}, {'value': '1051', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately 4 years', 'description': "QTcB: QT interval corrected using Bazett's formula QTcF: QT interval corrected using Fridericia's formula A patient with multiple variable measurements is counted only once under the worst condition.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AIN457 150 mg -Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg'}, {'id': 'FG001', 'title': 'AIN457 300 mg -Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg'}, {'id': 'FG002', 'title': 'AIN457 150 mg Placebo - Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo'}, {'id': 'FG003', 'title': 'AIN457 300 mg Placebo - Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo'}, {'id': 'FG004', 'title': 'AIN457 150 mg - Partial Responders', 'description': 'PASI 50 responders / PASI 75 non responders at Week 52, treated with AIN 150 mg in core and extension study'}, {'id': 'FG005', 'title': 'AIN457 300 mg - Partial Responders', 'description': 'PASI 50 responders / PASI 75 non responders at Week 52, treated with AIN 300 mg in core and extension study'}], 'periods': [{'title': 'Status at Week 68', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '301'}, {'groupId': 'FG001', 'numSubjects': '363'}, {'groupId': 'FG002', 'numSubjects': '150'}, {'groupId': 'FG003', 'numSubjects': '181'}, {'comment': 'These patients were not in the study arms at this time point.', 'groupId': 'FG004', 'numSubjects': '0'}, {'comment': 'These patients were not in the study arms at this time point.', 'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'comment': 'Week 68', 'achievements': [{'groupId': 'FG000', 'numSubjects': '262'}, {'groupId': 'FG001', 'numSubjects': '346'}, {'groupId': 'FG002', 'numSubjects': '87'}, {'groupId': 'FG003', 'numSubjects': '130'}, {'comment': 'These patients were not in the study arms at this time point.', 'groupId': 'FG004', 'numSubjects': '0'}, {'comment': 'These patients were not in the study arms at this time point.', 'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '63'}, {'groupId': 'FG003', 'numSubjects': '51'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Non-compliance with study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Technical problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Moved to treatment period ≤ wk 68', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '60'}, {'groupId': 'FG003', 'numSubjects': '46'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Status at Week 156', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '301'}, {'groupId': 'FG001', 'numSubjects': '363'}, {'groupId': 'FG002', 'numSubjects': '150'}, {'groupId': 'FG003', 'numSubjects': '181'}, {'groupId': 'FG004', 'numSubjects': '98'}, {'groupId': 'FG005', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'comment': 'Week 156', 'achievements': [{'groupId': 'FG000', 'numSubjects': '184'}, {'groupId': 'FG001', 'numSubjects': '285'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '60'}, {'groupId': 'FG005', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '117'}, {'groupId': 'FG001', 'numSubjects': '78'}, {'groupId': 'FG002', 'numSubjects': '140'}, {'groupId': 'FG003', 'numSubjects': '166'}, {'groupId': 'FG004', 'numSubjects': '38'}, {'groupId': 'FG005', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '20'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Non-compliance with study treatement', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Technical problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Moved to treatment period ≤ wk 156', 'reasons': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '131'}, {'groupId': 'FG003', 'numSubjects': '145'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Among the 1146 patients who completed the screening phase, 995 "PASI 75 responder at week 52" patients were randomized in a double blind fashion to either active treatment or placebo \\& entered the randomized withdrawal period and 151 "partial responders at week 52" patients entered treatment period of the Extension.', 'preAssignmentDetails': '1366 patients who completed the core studies (CAIN457A2302 or CAIN457A2303) and provided consent for participation in the extension study were screened, and 1146 (83.9%) completed the screening phase and entered the extension.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}, {'value': '363', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}, {'value': '181', 'groupId': 'BG003'}, {'value': '98', 'groupId': 'BG004'}, {'value': '53', 'groupId': 'BG005'}, {'value': '1146', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'AIN457 150 mg -Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg'}, {'id': 'BG001', 'title': 'AIN457 300 mg -Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg'}, {'id': 'BG002', 'title': 'AIN457 150 mg Placebo - Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo'}, {'id': 'BG003', 'title': 'AIN457 300 mg Placebo - Randomized Withdrawal Period', 'description': 'PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo'}, {'id': 'BG004', 'title': 'AIN457 150 mg - Partial Responders', 'description': 'PASI 50 responders / PASI 75 non responders at Week 52, treated with AIN 150 mg in core and extension study'}, {'id': 'BG005', 'title': 'AIN457 300 mg - Partial Responders', 'description': 'PASI 50 responders / PASI 75 non responders at Week 52, treated with AIN 300 mg in core and extension study'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.9', 'spread': '12.93', 'groupId': 'BG000'}, {'value': '45.8', 'spread': '12.92', 'groupId': 'BG001'}, {'value': '47.1', 'spread': '13.34', 'groupId': 'BG002'}, {'value': '45.4', 'spread': '13.09', 'groupId': 'BG003'}, {'value': '46.8', 'spread': '12.78', 'groupId': 'BG004'}, {'value': '48.5', 'spread': '11.98', 'groupId': 'BG005'}, {'value': '46.2', 'spread': '12.84', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '330', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '218', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}, {'value': '119', 'groupId': 'BG003'}, {'value': '70', 'groupId': 'BG004'}, {'value': '43', 'groupId': 'BG005'}, {'value': '816', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '213', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}, {'value': '73', 'groupId': 'BG004'}, {'value': '42', 'groupId': 'BG005'}, {'value': '855', 'groupId': 'BG006'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '18', 'groupId': 'BG006'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '173', 'groupId': 'BG006'}]}]}, {'title': 'Native American', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '75', 'groupId': 'BG006'}]}]}, {'title': 'Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Randomized set was defined as all patients who were randomized.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-04-29', 'size': 1331516, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-06-25T05:49', 'hasProtocol': True}, {'date': '2017-11-02', 'size': 880456, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-06-25T05:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1147}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-27', 'studyFirstSubmitDate': '2012-02-28', 'resultsFirstSubmitDate': '2018-06-25', 'studyFirstSubmitQcDate': '2012-02-29', 'lastUpdatePostDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-27', 'studyFirstPostDateStruct': {'date': '2012-03-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Participants With Loss of Psoriasis Area and Severity Index (PASI) 75 Response up to Week 68', 'timeFrame': 'At week 68 (16 weeks after week 52)', 'description': 'The primary variable was the cumulative rate of patients who lost PASI 75 response up to Week 68 (time=0 being defined as Week 52).\n\nLoss of PASI 75 response was analyzed by means of a survival analysis defining "loss of PASI 75 response" as "failure". The term cumulative rate corresponded to 1 minus the survival function within this survival analysis, and the cumulative rate and the survival functions were dependent on time t.\n\nPASI 75 response: patients achieving ≥ 75% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 75 responders.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period', 'timeFrame': 'Week 52, 104, and 156', 'description': 'Psoriasis Area and Severity Index (PASI) 75 responder at week 52. Patients in the placebo groups were not evaluable after re-treatment with Secukinumab.\n\nPASI 75 Responders: patients with a PASI 75 response (patients achieving ≥75% improvement \\[reduction\\] in PASI score compared to baseline of the core study).\n\nPASI 50 response: patients achieving ≥ 50% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 50 responders.\n\nPASI 90 response: patients achieving ≥ 90% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 90 responders.\n\nPASI 100 response/remission: complete clearing of psoriasis (PASI=0)'}, {'measure': 'Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period', 'timeFrame': 'Week 52, Week 104, Week 156, week 208, week 260', 'description': 'Psoriasis Area and Severity Index (PASI) scoring system: The average degree of severity of each sign in each of the four body regions was assigned a score of 0-4. The area covered by lesions on each body region was estimated as a percentage of the total area of that particular body region.'}, {'measure': 'Percent Change From Baseline for PASI Score Over Time (Observed Data) - Randomized Withdrawal Period', 'timeFrame': 'Week 52, 104, and 156', 'description': 'The improvement (decrease from baseline) in PASI total scores observed at Week 52.\n\nPerc. change = 100 x Abs. change /Base. (Abs. change = Post - Base) For each post-baseline visit only patients with a value at both baseline and the respective post-baseline visit are included.'}, {'measure': 'Percent Change From Baseline for PASI Score Over Time (Observed Data) - Entire Study Period', 'timeFrame': 'Week 52, Week 104, Week 156, week 208, week 260', 'description': 'Perc. change = 100 x Abs. change /Base. (Abs. change = Post - Base) For each post-baseline visit only patients with a value at both baseline and the respective post-baseline visit are included.'}, {'measure': 'Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period', 'timeFrame': 'Week 52 (baseline), 104, and 156', 'description': 'Investigator Global Assessment (IGA) mod 2011; scale from 0 - 4. Score 0: Clear (No signs of psoriasis. Post-inflammatory hyperpigmentation could be Present). Score 1: Almost clear (Normal to pink coloration of lesions; no thickening; no to minimal focal scaling), Score 2: Mild (Pink to light red coloration; just detectable to mild thickening; predominantly fine scaling). Score 3: Moderate (Dull bright red, clearly distinguishable erythema; clearly distinguishable to moderate thickening; moderate scaling). Score 4: Severe (Bright to deep dark red coloration; severe thickening with hard edges; severe /coarse scaling covering almost all or all lesions).\n\nPatients in the placebo groups were not evaluable after re-treatment with Secukinumab'}, {'measure': 'Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period', 'timeFrame': 'Week 52, Week 104, Week 156, week 208, week 260', 'description': "Investigator's Global Assessment (IGA) mod 2011; scale from 0 - 4. Score 0= clear (no signs of psoriasis) Score 1 = almost clear no to minimal local scaling) Score 2 = mild (predominantly fine scaling) Score 3 = moderate (moderate scaling) Score 4 = severe (severe/coarse scaling covering almost all or all lesions)"}, {'measure': 'Number of Participants With IGA Mod 2011 0/1 Response (Observed Data) - Entire Study Period', 'timeFrame': 'Week 52, Week 104, Week 156, week 208, week 260', 'description': "Investigator's Global Assessment (IGA) mod 2011 0/1. Score 0= clear (no signs of psoriasis) Score 1 = almost clear no to minimal local scaling) Score 2 = mild (predominantly fine scaling) Score 3 = moderate (moderate scaling) Score 4 = severe (severe/coarse scaling covering almost all or all lesions) Based on this scale, a patient was considered as IGA mod 2011 0/1 responder if the patient achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline."}, {'measure': 'Percent of Participants With Loss of IGA Mod 2011 0 or 1 Response Over Time for Subjects With IGA Mod 2011 0 or 1 Response at Week 52 - Randomized Withdrawal Period', 'timeFrame': 'Week 68', 'description': 'Summary for loss of IGA mod 2011 0 or 1 response over time for patients with response at Week 52.\n\ntime = 0 refers to Week 52'}, {'measure': 'Percent of Participants With PASI 75 Response - Treatment Period for Re-treated After Relapse', 'timeFrame': 'up to week 260', 'description': 'PASI 75 response since reinitiating treatment after relapse. time = 0 refers to Week 52'}, {'measure': 'Percent of Participants With IGA Mod 0 or 1 Response - Treatment Period for Re-treated After Relapse', 'timeFrame': 'up to week 260', 'description': 'IGA mod 2011 0 or 1 response since reinitiating treatment after relapse for subjects with IGA 0 or 1 response at week 52 and not have IGA 0 or 1 response at relapse.\n\ntime = 0 refers to Week 52'}, {'measure': 'Percent pf Participants With Relapse Over Time - Randomized Withdrawal Period', 'timeFrame': 'up to week 156', 'description': 'Time 0 = week 52'}, {'measure': 'Percent of Participants With Relapse After Last Injection', 'timeFrame': 'up to week 16', 'description': 'Relapse: when the achieved maximal PASI improvement from baseline of core study was reduced by \\>50%.\n\nTime 0 = week 52'}, {'measure': 'Percent of Participants With Rebound After Last Injection', 'timeFrame': 'up to week 68', 'description': 'Rebound: PASI increases to \\> 125% of baseline (where baseline is the PASI at the randomization of the core study) or presence of new pustular psoriasis, new erythrodermic psoriasis or more inflammatory psoriasis occurring within 8 Weeks of stopping therapy (after the last dose of study treatment received). Rebound like event (RLE) was defined as increase of PASI of \\> 125% from baseline value or occurrence of new pustular, new erythrodermic or more inflammatory psoriasis any time after stopping therapy (last treatment administered) up to Week 68. Rebound was evaluated for the patients randomized to the placebo groups in the extension study; hence these patients received the last dose of secukinumab during the core studies.'}, {'measure': 'Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data)', 'timeFrame': 'Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156', 'description': 'Dermatology Life Quality Index (DLQI) scores range from 0 to 30. Lower absolute scores on DLQI indicate better/improved health-related quality-of life impairment.'}, {'measure': 'Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Entire Treatment Period', 'timeFrame': 'Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156', 'description': 'Dermatology Life Quality Index (DLQI) scores range from 0 to 30. Lower absolute scores on DLQI indicate better/improved health-related quality-of life impairment.'}, {'measure': 'EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period', 'timeFrame': 'Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156', 'description': "EQ-5D: EuroQOL 5-Dimension Health Status Questionnaire. The EQ-5D© is a generic instrument to assess each patient's health status. It provides a simple descriptive profile and a single index value for health status. The EQ visual analog scale records the respondent's self-rated health on a vertical scale where the endpoints are labeled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents."}, {'measure': 'EQ-5D Health State Assessment (Observed Value) - Entire Study Period', 'timeFrame': 'week 64, 76, 88, 104, 116, 128, 140, and 156', 'description': "EQ-5D: EuroQOL 5-Dimension Health Status Questionnaire. The EQ-5D© is a generic instrument to assess each patient's health status. It provides a simple descriptive profile and a single index value for health status. The EQ visual analog scale records the respondent's self-rated health on a vertical scale where the endpoints are labeled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents."}, {'measure': 'Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period', 'timeFrame': 'Week 52-156', 'description': 'CTCAE: common terminology criteria for adverse events. A subject with multiple variable measurements is counted only once under the worst condition. LLN = lower limit of normal.\n\nIR=incidence rate per 100 subject years'}, {'measure': 'Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period', 'timeFrame': 'approximately 4 years', 'description': 'CTCAE: common terminology criteria for adverse events. A subject with multiple variable measurements is counted only once under the worst condition. LLN = lower limit of normal.'}, {'measure': 'Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period', 'timeFrame': 'Week 52 - 156', 'description': "QTcB: QT interval corrected using Bazett's formula QTcF: QT interval corrected using Fridericia's formula A patient with multiple variable measurements is counted only once under the worst condition.\n\nIR=incidence rate per 100 subject years."}, {'measure': 'Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period', 'timeFrame': 'Approximately 4 years', 'description': "QTcB: QT interval corrected using Bazett's formula QTcF: QT interval corrected using Fridericia's formula A patient with multiple variable measurements is counted only once under the worst condition."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psoriasis, inflammatory skin disease', 'scaly patches', 'secukinumab (AIN457)', 'Psoriasis Area and Severity Index (PASI)', 'Investigator Global Assessment (IGA) mod 2011'], 'conditions': ['Moderate to Severe Plaque-type Psoriasis']}, 'referencesModule': {'references': [{'pmid': '36763857', 'type': 'DERIVED', 'citation': 'Langley RG, Sofen H, Dei-Cas I, Reich K, Sigurgeirsson B, Warren RB, Paul C, Szepietowski JC, Tsai TF, Hampele I, You R, Charef P, Papavassilis C. Secukinumab long-term efficacy and safety in psoriasis through to year 5 of treatment: results of a randomized extension of the phase III ERASURE and FIXTURE trials. Br J Dermatol. 2023 Feb 10;188(2):198-207. doi: 10.1093/bjd/ljac040.'}]}, 'descriptionModule': {'briefSummary': 'This was an extension study of secukinumab prefilled syringes in subjects with moderate to severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with secukinumab. Subjects on secukinumab at the end of treatment period in phase III studies (e.g., ongoing CAIN457A2302 and CAIN457A2303 and potentially other secukinumab phase III studies) were eligible to join this extension study. This extension study was planned to collect an additional 2 years of long-term efficacy, safety, and tolerability data of secukinumab in either continuous or interrupted therapy (randomized withdrawal period) in subjects showing at least partial response to secukinumab and completing treatment period on secukinumab in previous phase III studies. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab were used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\nCompleted the full study treatment period of 52 weeks in preceding phase III studies, and have been receiving secukinumab treatment during the maintenance phase of the preceding phase III studies, and show at least a partial response (PASI 50 or better) at Week 52 of the preceding phase III studies.\n\nWritten informed consent form.\n\nKey Exclusion Criteria:\n\nA protocol deviation in either of the preceding phase III studies which according to the investigator prevented the meaningful analysis of the extension study for the individual subject.\n\nOngoing use of prohibited psoriasis or non-psoriasis treatments.\n\nPregnant 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 hCG laboratory test (\\>10 mIU/mL).\n\nWomen of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for 16 weeks after stopping treatment.'}, 'identificationModule': {'nctId': 'NCT01544595', 'briefTitle': 'Extension Study of Secukinumab Prefilled Syringes in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multicenter, Double-blind, Randomized Withdrawal Extension Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Long-term Efficacy, Safety, and Tolerability up to 4 Years in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab', 'orgStudyIdInfo': {'id': 'CAIN457A2302E1'}, 'secondaryIdInfos': [{'id': '2012-000533-39'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'PASI 75 Responders', 'description': 'PASI 75 responders participated in "randomized withdrawal". Subjects who were PASI 75 responders at Week 52 visit of the core studies (e.g.CAIN457A2302 or CAIN457A2303) and have been on secukinumab s.c. 150 mg or 300 mg in core studies were randomized to continue same s.c. doses of secukinumab in PFS or receive placebo every 4 weeks up to Week 152 or until relapse. Participants on first full relapse received loading dose followed by routine dosing with secukinumab s.c. 150 mg or 300 mg regimen.', 'interventionNames': ['Drug: Secukinumab (AIN457)', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Partial responders', 'description': 'Partial responders were not randomized. Subjects who were partial responders at Week 52 visit in core studies (e.g.CAIN457A2302 or CAIN457A2303) and have been on secukinumab s.c. 150 mg or 300 mg in core studies did not participate in the randomized withdrawal. These subjects continued same treatment s.c. dose in PFS (secukinumab s.c. 150 mg or 300 mg) as they were receiving at the time of completing the maintenance period (Week 52) in the core studies.', 'interventionNames': ['Drug: Secukinumab (AIN457)']}], 'interventions': [{'name': 'Secukinumab (AIN457)', 'type': 'DRUG', 'description': 'Secukinumab is a new type of psoriasis medication called a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17). IL-17 is believed to be partly responsible for inflammation (pain, swelling, redness). Researchers believe that IL-17 causes symptoms of plaque-type psoriasis like plaques and scales. A product that targets IL-17 therefore may help to relieve these symptoms and conditions.', 'armGroupLabels': ['PASI 75 Responders', 'Partial responders']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['PASI 75 Responders']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.44838, 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