Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-02-22 @ 5:23 PM
Study NCT ID:
NCT01640951
Status:
COMPLETED
Last Update Posted:
2018-05-25
First Post:
2012-07-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
4 Year Extension Study of Efficacy and Safety of Secukinumab in Patients With Moderate to Severe Chronic Plaque-type Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['India']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D058225', 'term': 'Plaque, Amyloid'}, {'id': 'D003872', 'term': 'Dermatitis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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 4 years and 7 months.', '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': 'Any AIN457 150 mg', 'otherNumAtRisk': 132, 'deathsNumAtRisk': 132, 'otherNumAffected': 93, 'seriousNumAtRisk': 132, 'deathsNumAffected': 0, 'seriousNumAffected': 25}, {'id': 'EG001', 'title': 'Any AIN457 300 mg', 'description': 'Any AIN457 300 mg', 'otherNumAtRisk': 543, 'deathsNumAtRisk': 543, 'otherNumAffected': 449, 'seriousNumAtRisk': 543, 'deathsNumAffected': 4, 'seriousNumAffected': 119}, {'id': 'EG002', 'title': 'Any AIN457 Dose', 'description': 'Any AIN457 dose', 'otherNumAtRisk': 675, 'deathsNumAtRisk': 675, 'otherNumAffected': 542, 'seriousNumAtRisk': 675, 'deathsNumAffected': 4, 'seriousNumAffected': 144}], 'otherEvents': [{'term': 'TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'HYPERTHYROIDISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 3}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'DENTAL CARIES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 40}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'GASTRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'GASTROOESOPHAGEAL REFLUX DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'TOOTHACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'NON-CARDIAC CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'HEPATIC STEATOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 12}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'SEASONAL ALLERGY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 16}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 51}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 58}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'CELLULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'CONJUNCTIVITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'FOLLICULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'FURUNCLE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 29}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'HERPES ZOSTER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 54}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 185}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 216}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'ORAL HERPES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'PHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 33}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'RHINITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 38}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'TINEA PEDIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'TONSILLITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'TOOTH ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 62}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 75}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'VIRAL UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'ARTHROPOD BITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 14}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'CONTUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 24}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'FALL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 11}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'LIGAMENT SPRAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 13}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'MUSCLE STRAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 20}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'GAMMA-GLUTAMYLTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'HEPATIC ENZYME INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'DIABETES MELLITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 21}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'DYSLIPIDAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'GOUT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'HYPERCHOLESTEROLAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'HYPERGLYCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 63}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 72}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 62}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'BURSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'MUSCULOSKELETAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 18}], 'organSystem': 'Musculoskeletal 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'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'DERMATITIS ALLERGIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'PSORIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'ALCOHOL USE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'AORTIC DILATATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'PERIPHERAL ARTERY STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'VARICOSE VEIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 543, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 675, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Long-term Safety and Tolerability of Secukinumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '95', 'groupId': 'OG004'}, {'value': '60', 'groupId': 'OG005'}, {'value': '112', 'groupId': 'OG006'}, {'value': '33', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN150FI', 'description': 'AIN457 150 mg - Fixed Interval (FI)'}, {'id': 'OG001', 'title': 'AIN150 FI_AIN300 FI', 'description': 'AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)'}, {'id': 'OG002', 'title': 'AIN300 FI', 'description': 'AIN457 300 mg - Fixed Interval (FI)'}, {'id': 'OG003', 'title': 'AIN150 SoR', 'description': 'AIN457 150 mg - Start of Relapse (SoR)'}, {'id': 'OG004', 'title': 'AIN150 SOR_AIN300 FI', 'description': 'AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)'}, {'id': 'OG005', 'title': 'AIN300 SoR', 'description': 'AIN457 300 mg - Start of Relapse (SoR)'}, {'id': 'OG006', 'title': 'AIN300 SoR _ AIN300 FI', 'description': 'AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)'}, {'id': 'OG007', 'title': 'AIN300 OL', 'description': 'AIN457 300 mg Open-label (OL)'}], 'classes': [{'title': 'AEs by Primary System Organ Class (SOC)', 'categories': [{'measurements': [{'value': '88.3', 'groupId': 'OG000'}, {'value': '92.0', 'groupId': 'OG001'}, {'value': '92.9', 'groupId': 'OG002'}, {'value': '78.2', 'groupId': 'OG003'}, {'value': '87.4', 'groupId': 'OG004'}, {'value': '80.0', 'groupId': 'OG005'}, {'value': '94.6', 'groupId': 'OG006'}, {'value': '93.9', 'groupId': 'OG007'}]}]}, {'title': 'SAEs by Primary System Organ Class (SOC)', 'categories': [{'measurements': [{'value': '20.8', 'groupId': 'OG000'}, {'value': '24.0', 'groupId': 'OG001'}, {'value': '23.8', 'groupId': 'OG002'}, {'value': '16.4', 'groupId': 'OG003'}, {'value': '20.0', 'groupId': 'OG004'}, {'value': '18.3', 'groupId': 'OG005'}, {'value': '17.0', 'groupId': 'OG006'}, {'value': '36.4', 'groupId': 'OG007'}]}]}, {'title': 'Deaths by Primary System Organ Class (SOC)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}, {'value': '0.6', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '6.1', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 268', 'description': 'Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set. All subjects who took at least one dose of study treatment during the extension treatment period. A subject with multiple adverse events within a primary system organ class was counted only once in the total row. Deaths up to 28 days after the last dose are included. Only descriptive analysis done.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Score of 75 at Weeks 52, 104, 156, 208 and 260', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}, {'value': '168', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '95', 'groupId': 'OG005'}, {'value': '60', 'groupId': 'OG006'}, {'value': '112', 'groupId': 'OG007'}, {'value': '33', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN150FI', 'description': 'AIN457 150 mg - Fixed Interval (FI)'}, {'id': 'OG001', 'title': 'AIN150 FI_AIN300 FI', 'description': 'AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)'}, {'id': 'OG002', 'title': 'AIN150FI (NSW+SW)', 'description': 'AIN457 150 mg - Fixed Interval combined non-switch and switch'}, {'id': 'OG003', 'title': 'AIN300 FI', 'description': 'AIN457 300 mg - Fixed Interval (FI)'}, {'id': 'OG004', 'title': 'AIN150 SoR', 'description': 'AIN457 150 mg - Start of Relapse (SoR)'}, {'id': 'OG005', 'title': 'AIN150 SOR_AIN300 FI', 'description': 'AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)'}, {'id': 'OG006', 'title': 'AIN300 SoR', 'description': 'AIN457 300 mg - Start of Relapse (SoR)'}, {'id': 'OG007', 'title': 'AIN300 SoR _ AIN300 FI', 'description': 'AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)'}, {'id': 'OG008', 'title': 'AIN300 OL', 'description': 'AIN457 300 mg Open-label (OL)'}], 'classes': [{'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}, {'value': '162', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '95', 'groupId': 'OG005'}, {'value': '58', 'groupId': 'OG006'}, {'value': '111', 'groupId': 'OG007'}, {'value': '33', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '69.7', 'groupId': 'OG000'}, {'value': '65.3', 'groupId': 'OG001'}, {'value': '67.5', 'groupId': 'OG002'}, {'value': '88.9', 'groupId': 'OG003'}, {'value': '38.2', 'groupId': 'OG004'}, {'value': '38.9', 'groupId': 'OG005'}, {'value': '51.7', 'groupId': 'OG006'}, {'value': '39.6', 'groupId': 'OG007'}, {'value': '63.6', 'groupId': 'OG008'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}, {'value': '94', 'groupId': 'OG005'}, {'value': '34', 'groupId': 'OG006'}, {'value': '110', 'groupId': 'OG007'}, {'value': '30', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '63.3', 'groupId': 'OG000'}, {'value': '54.8', 'groupId': 'OG001'}, {'value': '58.6', 'groupId': 'OG002'}, {'value': '80.9', 'groupId': 'OG003'}, {'value': '40.0', 'groupId': 'OG004'}, {'value': '39.4', 'groupId': 'OG005'}, {'value': '55.9', 'groupId': 'OG006'}, {'value': '44.5', 'groupId': 'OG007'}, {'value': '63.3', 'groupId': 'OG008'}]}]}, {'title': 'Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '94', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}, {'value': '111', 'groupId': 'OG007'}, {'value': '21', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '85.0', 'groupId': 'OG000'}, {'value': '49.3', 'groupId': 'OG001'}, {'value': '61.7', 'groupId': 'OG002'}, {'value': '78.4', 'groupId': 'OG003'}, {'value': '62.5', 'groupId': 'OG004'}, {'value': '35.1', 'groupId': 'OG005'}, {'value': '65.0', 'groupId': 'OG006'}, {'value': '41.4', 'groupId': 'OG007'}, {'value': '57.1', 'groupId': 'OG008'}]}]}, {'title': 'Week 208', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}, {'value': '132', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '87', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '100', 'groupId': 'OG007'}, {'value': '21', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000'}, {'value': '78.3', 'groupId': 'OG001'}, {'value': '78.8', 'groupId': 'OG002'}, {'value': '87.9', 'groupId': 'OG003'}, {'value': '63.6', 'groupId': 'OG004'}, {'value': '87.4', 'groupId': 'OG005'}, {'value': '41.7', 'groupId': 'OG006'}, {'value': '79.0', 'groupId': 'OG007'}, {'value': '61.9', 'groupId': 'OG008'}]}]}, {'title': 'Week 260', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '122', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '79', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '87', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '89.7', 'groupId': 'OG000'}, {'value': '71.4', 'groupId': 'OG001'}, {'value': '77.6', 'groupId': 'OG002'}, {'value': '88.5', 'groupId': 'OG003'}, {'value': '50.0', 'groupId': 'OG004'}, {'value': '86.1', 'groupId': 'OG005'}, {'value': '53.8', 'groupId': 'OG006'}, {'value': '81.6', 'groupId': 'OG007'}, {'value': '75.0', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52, Week 104, Week 156, Week 208, Week 260', 'description': 'PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area \\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4)', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Scores of 50, 90 and 100 Over Time at Weeks 52, 104, 156, 208 and 260', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}, {'value': '168', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '95', 'groupId': 'OG005'}, {'value': '60', 'groupId': 'OG006'}, {'value': '112', 'groupId': 'OG007'}, {'value': '33', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN150FI', 'description': 'AIN457 150 mg - Fixed Interval (FI)'}, {'id': 'OG001', 'title': 'AIN150 FI_AIN300 FI', 'description': 'AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)'}, {'id': 'OG002', 'title': 'AIN150FI (NSW+SW)', 'description': 'AIN457 150 mg - Fixed Interval combined non-switch and switch'}, {'id': 'OG003', 'title': 'AIN300 FI', 'description': 'AIN457 300 mg - Fixed Interval (FI)'}, {'id': 'OG004', 'title': 'AIN150 SoR', 'description': 'AIN457 150 mg - Start of Relapse (SoR)'}, {'id': 'OG005', 'title': 'AIN150 SOR_AIN300 FI', 'description': 'AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)'}, {'id': 'OG006', 'title': 'AIN300 SoR', 'description': 'AIN457 300 mg - Start of Relapse (SoR)'}, {'id': 'OG007', 'title': 'AIN300 SoR _ AIN300 FI', 'description': 'AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)'}, {'id': 'OG008', 'title': 'AIN300 OL', 'description': 'AIN457 300 mg Open-label (OL)'}], 'classes': [{'title': 'Week 52 / PASI 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}, {'value': '162', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '95', 'groupId': 'OG005'}, {'value': '58', 'groupId': 'OG006'}, {'value': '111', 'groupId': 'OG007'}, {'value': '33', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '89.5', 'groupId': 'OG000'}, {'value': '98.7', 'groupId': 'OG001'}, {'value': '94.0', 'groupId': 'OG002'}, {'value': '98.8', 'groupId': 'OG003'}, {'value': '80.0', 'groupId': 'OG004'}, {'value': '86.3', 'groupId': 'OG005'}, {'value': '91.4', 'groupId': 'OG006'}, {'value': '88.3', 'groupId': 'OG007'}, {'value': '93.9', 'groupId': 'OG008'}]}]}, {'title': 'Week 52 / PASI 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}, {'value': '162', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '95', 'groupId': 'OG005'}, {'value': '58', 'groupId': 'OG006'}, {'value': '111', 'groupId': 'OG007'}, {'value': '33', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '61.8', 'groupId': 'OG000'}, {'value': '38.7', 'groupId': 'OG001'}, {'value': '50.3', 'groupId': 'OG002'}, {'value': '68.5', 'groupId': 'OG003'}, {'value': '12.7', 'groupId': 'OG004'}, {'value': '11.6', 'groupId': 'OG005'}, {'value': '19.0', 'groupId': 'OG006'}, {'value': '12.6', 'groupId': 'OG007'}, {'value': '39.4', 'groupId': 'OG008'}]}]}, {'title': 'Week 52 / PASI 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}, {'value': '162', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '95', 'groupId': 'OG005'}, {'value': '58', 'groupId': 'OG006'}, {'value': '111', 'groupId': 'OG007'}, {'value': '33', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '31.6', 'groupId': 'OG000'}, {'value': '16.0', 'groupId': 'OG001'}, {'value': '23.8', 'groupId': 'OG002'}, {'value': '43.8', 'groupId': 'OG003'}, {'value': '3.6', 'groupId': 'OG004'}, {'value': '2.1', 'groupId': 'OG005'}, {'value': '8.6', 'groupId': 'OG006'}, {'value': '3.6', 'groupId': 'OG007'}, {'value': '9.1', 'groupId': 'OG008'}]}]}, {'title': 'Week 104 / PASI 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}, {'value': '94', 'groupId': 'OG005'}, {'value': '34', 'groupId': 'OG006'}, {'value': '110', 'groupId': 'OG007'}, {'value': '30', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '88.3', 'groupId': 'OG000'}, {'value': '84.9', 'groupId': 'OG001'}, {'value': '86.5', 'groupId': 'OG002'}, {'value': '96.7', 'groupId': 'OG003'}, {'value': '80.0', 'groupId': 'OG004'}, {'value': '87.2', 'groupId': 'OG005'}, {'value': '88.2', 'groupId': 'OG006'}, {'value': '85.5', 'groupId': 'OG007'}, {'value': '86.7', 'groupId': 'OG008'}]}]}, {'title': 'Week 104 / PASI 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}, {'value': '94', 'groupId': 'OG005'}, {'value': '34', 'groupId': 'OG006'}, {'value': '110', 'groupId': 'OG007'}, {'value': '30', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000'}, {'value': '23.3', 'groupId': 'OG001'}, {'value': '33.8', 'groupId': 'OG002'}, {'value': '64.5', 'groupId': 'OG003'}, {'value': '16.7', 'groupId': 'OG004'}, {'value': '9.6', 'groupId': 'OG005'}, {'value': '14.7', 'groupId': 'OG006'}, {'value': '18.2', 'groupId': 'OG007'}, {'value': '26.7', 'groupId': 'OG008'}]}]}, {'title': 'Week 104 / PASI 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}, {'value': '94', 'groupId': 'OG005'}, {'value': '34', 'groupId': 'OG006'}, {'value': '110', 'groupId': 'OG007'}, {'value': '30', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '28.3', 'groupId': 'OG000'}, {'value': '6.8', 'groupId': 'OG001'}, {'value': '16.5', 'groupId': 'OG002'}, {'value': '43.4', 'groupId': 'OG003'}, {'value': '10.0', 'groupId': 'OG004'}, {'value': '1.1', 'groupId': 'OG005'}, {'value': '5.9', 'groupId': 'OG006'}, {'value': '4.5', 'groupId': 'OG007'}, {'value': '13.3', 'groupId': 'OG008'}]}]}, {'title': 'Week 156 / PASI 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '94', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}, {'value': '111', 'groupId': 'OG007'}, {'value': '21', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '86.7', 'groupId': 'OG001'}, {'value': '91.3', 'groupId': 'OG002'}, {'value': '97.1', 'groupId': 'OG003'}, {'value': '93.8', 'groupId': 'OG004'}, {'value': '88.3', 'groupId': 'OG005'}, {'value': '85.0', 'groupId': 'OG006'}, {'value': '90.1', 'groupId': 'OG007'}, {'value': '90.5', 'groupId': 'OG008'}]}]}, {'title': 'Week 156 / PASI 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '94', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}, {'value': '111', 'groupId': 'OG007'}, {'value': '21', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000'}, {'value': '17.3', 'groupId': 'OG001'}, {'value': '32.2', 'groupId': 'OG002'}, {'value': '61.9', 'groupId': 'OG003'}, {'value': '31.3', 'groupId': 'OG004'}, {'value': '10.6', 'groupId': 'OG005'}, {'value': '30.0', 'groupId': 'OG006'}, {'value': '10.8', 'groupId': 'OG007'}, {'value': '28.6', 'groupId': 'OG008'}]}]}, {'title': 'Week 156 / PASI 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '94', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}, {'value': '111', 'groupId': 'OG007'}, {'value': '21', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '45.0', 'groupId': 'OG000'}, {'value': '8.0', 'groupId': 'OG001'}, {'value': '20.9', 'groupId': 'OG002'}, {'value': '41.7', 'groupId': 'OG003'}, {'value': '6.3', 'groupId': 'OG004'}, {'value': '4.3', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '3.6', 'groupId': 'OG007'}, {'value': '19.0', 'groupId': 'OG008'}]}]}, {'title': 'Week 208 / PASI 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}, {'value': '132', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '87', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '100', 'groupId': 'OG007'}, {'value': '21', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '97.1', 'groupId': 'OG001'}, {'value': '98.1', 'groupId': 'OG002'}, {'value': '97.0', 'groupId': 'OG003'}, {'value': '72.7', 'groupId': 'OG004'}, {'value': '98.9', 'groupId': 'OG005'}, {'value': '100.0', 'groupId': 'OG006'}, {'value': '95.0', 'groupId': 'OG007'}, {'value': '95.2', 'groupId': 'OG008'}]}]}, {'title': 'Week 208 / PASI 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}, {'value': '132', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '87', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '100', 'groupId': 'OG007'}, {'value': '21', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '51.4', 'groupId': 'OG000'}, {'value': '49.3', 'groupId': 'OG001'}, {'value': '50.0', 'groupId': 'OG002'}, {'value': '65.9', 'groupId': 'OG003'}, {'value': '27.3', 'groupId': 'OG004'}, {'value': '64.4', 'groupId': 'OG005'}, {'value': '16.7', 'groupId': 'OG006'}, {'value': '53.0', 'groupId': 'OG007'}, {'value': '23.8', 'groupId': 'OG008'}]}]}, {'title': 'Week 208 / PASI 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}, {'value': '132', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '87', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '100', 'groupId': 'OG007'}, {'value': '21', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '20.3', 'groupId': 'OG001'}, {'value': '23.1', 'groupId': 'OG002'}, {'value': '43.2', 'groupId': 'OG003'}, {'value': '9.1', 'groupId': 'OG004'}, {'value': '23.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '24.0', 'groupId': 'OG007'}, {'value': '23.8', 'groupId': 'OG008'}]}]}, {'title': 'Week 260 / PASI 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '122', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '79', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '87', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '96.4', 'groupId': 'OG001'}, {'value': '97.6', 'groupId': 'OG002'}, {'value': '97.5', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}, {'value': '97.5', 'groupId': 'OG005'}, {'value': '100.0', 'groupId': 'OG006'}, {'value': '93.1', 'groupId': 'OG007'}, {'value': '87.5', 'groupId': 'OG008'}]}]}, {'title': 'Week 260 / PASI 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '122', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '79', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '87', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '51.7', 'groupId': 'OG000'}, {'value': '46.4', 'groupId': 'OG001'}, {'value': '48.2', 'groupId': 'OG002'}, {'value': '66.4', 'groupId': 'OG003'}, {'value': '30.0', 'groupId': 'OG004'}, {'value': '57.0', 'groupId': 'OG005'}, {'value': '7.7', 'groupId': 'OG006'}, {'value': '54.0', 'groupId': 'OG007'}, {'value': '43.8', 'groupId': 'OG008'}]}]}, {'title': 'Week 260 / PASI 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '122', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '79', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '87', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '31.0', 'groupId': 'OG000'}, {'value': '17.9', 'groupId': 'OG001'}, {'value': '22.4', 'groupId': 'OG002'}, {'value': '41.0', 'groupId': 'OG003'}, {'value': '10.0', 'groupId': 'OG004'}, {'value': '29.1', 'groupId': 'OG005'}, {'value': '7.7', 'groupId': 'OG006'}, {'value': '18.4', 'groupId': 'OG007'}, {'value': '25.0', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52, Week 104, Week 156, Week 208, Week 260', 'description': 'PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area \\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4)', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Weeks 52, 104, 156, 208 and 260', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}, {'value': '168', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '95', 'groupId': 'OG005'}, {'value': '60', 'groupId': 'OG006'}, {'value': '112', 'groupId': 'OG007'}, {'value': '33', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN150FI', 'description': 'AIN457 150 mg - Fixed Interval (FI)'}, {'id': 'OG001', 'title': 'AIN150 FI_AIN300 FI', 'description': 'AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)'}, {'id': 'OG002', 'title': 'AIN150FI (NSW+SW)', 'description': 'AIN457 150 mg - Fixed Interval combined non-switch and switch'}, {'id': 'OG003', 'title': 'AIN300 FI', 'description': 'AIN457 300 mg - Fixed Interval (FI)'}, {'id': 'OG004', 'title': 'AIN150 SoR', 'description': 'AIN457 150 mg - Start of Relapse (SoR)'}, {'id': 'OG005', 'title': 'AIN150 SOR_AIN300 FI', 'description': 'AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)'}, {'id': 'OG006', 'title': 'AIN300 SoR', 'description': 'AIN457 300 mg - Start of Relapse (SoR)'}, {'id': 'OG007', 'title': 'AIN300 SoR _ AIN300 FI', 'description': 'AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)'}, {'id': 'OG008', 'title': 'AIN300 OL', 'description': 'AIN457 300 mg Open-label (OL)'}], 'classes': [{'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}, {'value': '162', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '95', 'groupId': 'OG005'}, {'value': '58', 'groupId': 'OG006'}, {'value': '111', 'groupId': 'OG007'}, {'value': '33', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '-83.54', 'spread': '21.744', 'groupId': 'OG000'}, {'value': '-81.47', 'spread': '16.179', 'groupId': 'OG001'}, {'value': '-82.51', 'spread': '19.147', 'groupId': 'OG002'}, {'value': '-91.14', 'spread': '13.377', 'groupId': 'OG003'}, {'value': '-65.13', 'spread': '23.452', 'groupId': 'OG004'}, {'value': '-67.91', 'spread': '21.521', 'groupId': 'OG005'}, {'value': '-75.63', 'spread': '16.970', 'groupId': 'OG006'}, {'value': '-69.13', 'spread': '18.976', 'groupId': 'OG007'}, {'value': '-79.75', 'spread': '17.045', 'groupId': 'OG008'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}, {'value': '94', 'groupId': 'OG005'}, {'value': '34', 'groupId': 'OG006'}, {'value': '110', 'groupId': 'OG007'}, {'value': '30', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '-78.13', 'spread': '26.278', 'groupId': 'OG000'}, {'value': '-72.47', 'spread': '24.099', 'groupId': 'OG001'}, {'value': '-75.02', 'spread': '25.168', 'groupId': 'OG002'}, {'value': '-88.48', 'spread': '16.273', 'groupId': 'OG003'}, {'value': '-63.17', 'spread': '28.596', 'groupId': 'OG004'}, {'value': '-68.40', 'spread': '18.057', 'groupId': 'OG005'}, {'value': '-67.62', 'spread': '40.039', 'groupId': 'OG006'}, {'value': '-70.98', 'spread': '19.720', 'groupId': 'OG007'}, {'value': '-76.10', 'spread': '19.342', 'groupId': 'OG008'}]}]}, {'title': 'Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '94', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}, {'value': '111', 'groupId': 'OG007'}, {'value': '21', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '-90.27', 'spread': '11.543', 'groupId': 'OG000'}, {'value': '-71.48', 'spread': '19.892', 'groupId': 'OG001'}, {'value': '-78.02', 'spread': '19.576', 'groupId': 'OG002'}, {'value': '-88.34', 'spread': '15.555', 'groupId': 'OG003'}, {'value': '-78.97', 'spread': '16.709', 'groupId': 'OG004'}, {'value': '-68.71', 'spread': '18.094', 'groupId': 'OG005'}, {'value': '-77.40', 'spread': '18.714', 'groupId': 'OG006'}, {'value': '-69.77', 'spread': '18.586', 'groupId': 'OG007'}, {'value': '-76.12', 'spread': '20.437', 'groupId': 'OG008'}]}]}, {'title': 'Week 208', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}, {'value': '132', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '87', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '100', 'groupId': 'OG007'}, {'value': '21', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '-87.60', 'spread': '12.296', 'groupId': 'OG000'}, {'value': '-85.06', 'spread': '14.082', 'groupId': 'OG001'}, {'value': '-85.91', 'spread': '13.501', 'groupId': 'OG002'}, {'value': '-90.46', 'spread': '14.116', 'groupId': 'OG003'}, {'value': '-72.64', 'spread': '24.394', 'groupId': 'OG004'}, {'value': '-89.36', 'spread': '12.978', 'groupId': 'OG005'}, {'value': '-74.38', 'spread': '13.817', 'groupId': 'OG006'}, {'value': '-85.25', 'spread': '17.018', 'groupId': 'OG007'}, {'value': '-79.12', 'spread': '16.827', 'groupId': 'OG008'}]}]}, {'title': 'Week 260', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '122', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '79', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '87', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '-88.75', 'spread': '10.928', 'groupId': 'OG000'}, {'value': '-84.10', 'spread': '15.012', 'groupId': 'OG001'}, {'value': '-85.68', 'spread': '13.867', 'groupId': 'OG002'}, {'value': '-90.06', 'spread': '14.639', 'groupId': 'OG003'}, {'value': '-76.20', 'spread': '17.418', 'groupId': 'OG004'}, {'value': '-89.40', 'spread': '12.763', 'groupId': 'OG005'}, {'value': '-78.13', 'spread': '10.197', 'groupId': 'OG006'}, {'value': '-85.48', 'spread': '17.116', 'groupId': 'OG007'}, {'value': '-81.47', 'spread': '21.335', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52, Week 104, Week 156, Week 208, Week 260', 'description': 'PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area \\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4)', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants Achieving Investigator's Global Assessment Modified 2011 (IGA) 2011 Score of 0 or 1 Over Time at Weeks 52, 104, 156, 208 and 260", 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}, {'value': '168', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '95', 'groupId': 'OG005'}, {'value': '60', 'groupId': 'OG006'}, {'value': '112', 'groupId': 'OG007'}, {'value': '33', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN150FI', 'description': 'AIN457 150 mg - Fixed Interval (FI)'}, {'id': 'OG001', 'title': 'AIN150 FI_AIN300 FI', 'description': 'AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)'}, {'id': 'OG002', 'title': 'AIN150FI (NSW+SW)', 'description': 'AIN457 150 mg - Fixed Interval combined non-switch and switch'}, {'id': 'OG003', 'title': 'AIN300 FI', 'description': 'AIN457 300 mg - Fixed Interval (FI)'}, {'id': 'OG004', 'title': 'AIN150 SoR', 'description': 'AIN457 150 mg - Start of Relapse (SoR)'}, {'id': 'OG005', 'title': 'AIN150 SOR_AIN300 FI', 'description': 'AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)'}, {'id': 'OG006', 'title': 'AIN300 SoR', 'description': 'AIN457 300 mg - Start of Relapse (SoR)'}, {'id': 'OG007', 'title': 'AIN300 SoR _ AIN300 FI', 'description': 'AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)'}, {'id': 'OG008', 'title': 'AIN300 OL', 'description': 'AIN457 300 mg Open-label (OL)'}], 'classes': [{'title': 'Week 52 / IGA 0/1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}, {'value': '165', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '95', 'groupId': 'OG005'}, {'value': '60', 'groupId': 'OG006'}, {'value': '111', 'groupId': 'OG007'}, {'value': '33', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '59.2', 'groupId': 'OG000'}, {'value': '50.7', 'groupId': 'OG001'}, {'value': '55.0', 'groupId': 'OG002'}, {'value': '69.1', 'groupId': 'OG003'}, {'value': '20.0', 'groupId': 'OG004'}, {'value': '20.0', 'groupId': 'OG005'}, {'value': '28.3', 'groupId': 'OG006'}, {'value': '19.8', 'groupId': 'OG007'}, {'value': '42.4', 'groupId': 'OG008'}]}]}, {'title': 'Week 104 / IGA 0/1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}, {'value': '94', 'groupId': 'OG005'}, {'value': '34', 'groupId': 'OG006'}, {'value': '110', 'groupId': 'OG007'}, {'value': '30', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '51.7', 'groupId': 'OG000'}, {'value': '30.1', 'groupId': 'OG001'}, {'value': '39.8', 'groupId': 'OG002'}, {'value': '66.4', 'groupId': 'OG003'}, {'value': '20.0', 'groupId': 'OG004'}, {'value': '16.0', 'groupId': 'OG005'}, {'value': '17.6', 'groupId': 'OG006'}, {'value': '17.3', 'groupId': 'OG007'}, {'value': '23.3', 'groupId': 'OG008'}]}]}, {'title': 'Week 156 / IGA 0/1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '94', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}, {'value': '111', 'groupId': 'OG007'}, {'value': '21', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000'}, {'value': '21.3', 'groupId': 'OG001'}, {'value': '35.7', 'groupId': 'OG002'}, {'value': '56.8', 'groupId': 'OG003'}, {'value': '37.5', 'groupId': 'OG004'}, {'value': '14.9', 'groupId': 'OG005'}, {'value': '25.0', 'groupId': 'OG006'}, {'value': '15.3', 'groupId': 'OG007'}, {'value': '28.6', 'groupId': 'OG008'}]}]}, {'title': 'Week 208 / IGA 0/1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '132', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '87', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '100', 'groupId': 'OG007'}, {'value': '21', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}, {'value': '47.1', 'groupId': 'OG001'}, {'value': '50.5', 'groupId': 'OG002'}, {'value': '62.1', 'groupId': 'OG003'}, {'value': '41.7', 'groupId': 'OG004'}, {'value': '63.2', 'groupId': 'OG005'}, {'value': '8.3', 'groupId': 'OG006'}, {'value': '52.0', 'groupId': 'OG007'}, {'value': '23.8', 'groupId': 'OG008'}]}]}, {'title': 'Week 260 / IGA 0/1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '79', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '87', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '55.2', 'groupId': 'OG000'}, {'value': '48.2', 'groupId': 'OG001'}, {'value': '50.6', 'groupId': 'OG002'}, {'value': '65.0', 'groupId': 'OG003'}, {'value': '40.0', 'groupId': 'OG004'}, {'value': '58.2', 'groupId': 'OG005'}, {'value': '30.8', 'groupId': 'OG006'}, {'value': '54.0', 'groupId': 'OG007'}, {'value': '37.5', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52, Week 104, Week 156, Week 208, Week 260', 'description': "The IGA mod 2011 is a static scale, i.e., it refers exclusively to the participant's disease state at the time of the assessments and does not attempt a comparison to any of the participant's previous disease states at prior visits. The score ranges from 0 (clear) to 4 (severe). The score 0 is clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 is severe.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Dermatology Life Quality Index (DLQI©) Response at Weeks 52, 104, 156, 208 and 260', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}, {'value': '168', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '95', 'groupId': 'OG005'}, {'value': '60', 'groupId': 'OG006'}, {'value': '112', 'groupId': 'OG007'}, {'value': '33', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN150FI', 'description': 'AIN457 150 mg - Fixed Interval (FI)'}, {'id': 'OG001', 'title': 'AIN150 FI_AIN300 FI', 'description': 'AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)'}, {'id': 'OG002', 'title': 'AIN150FI (NSW+SW)', 'description': 'AIN457 150 mg - Fixed Interval combined non-switch and switch'}, {'id': 'OG003', 'title': 'AIN300 FI', 'description': 'AIN457 300 mg - Fixed Interval (FI)'}, {'id': 'OG004', 'title': 'AIN150 SoR', 'description': 'AIN457 150 mg - Start of Relapse (SoR)'}, {'id': 'OG005', 'title': 'AIN150 SOR_AIN300 FI', 'description': 'AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)'}, {'id': 'OG006', 'title': 'AIN300 SoR', 'description': 'AIN457 300 mg - Start of Relapse (SoR)'}, {'id': 'OG007', 'title': 'AIN300 SoR _ AIN300 FI', 'description': 'AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)'}, {'id': 'OG008', 'title': 'AIN300 OL', 'description': 'AIN457 300 mg Open-label (OL)'}], 'classes': [{'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}, {'value': '164', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}, {'value': '95', 'groupId': 'OG005'}, {'value': '60', 'groupId': 'OG006'}, {'value': '108', 'groupId': 'OG007'}, {'value': '33', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '-77.3', 'groupId': 'OG000', 'lowerLimit': '-87.5', 'upperLimit': '-68.3'}, {'value': '-85.7', 'groupId': 'OG001', 'lowerLimit': '-90.0', 'upperLimit': '-77.8'}, {'value': '-81.8', 'groupId': 'OG002', 'lowerLimit': '-87.5', 'upperLimit': '-75.0'}, {'value': '-93.3', 'groupId': 'OG003', 'lowerLimit': '-95.5', 'upperLimit': '-90.3'}, {'value': '-65.0', 'groupId': 'OG004', 'lowerLimit': '-74.7', 'upperLimit': '-55.6'}, {'value': '-68.2', 'groupId': 'OG005', 'lowerLimit': '-75.0', 'upperLimit': '-61.0'}, {'value': '-66.7', 'groupId': 'OG006', 'lowerLimit': '-75.0', 'upperLimit': '-52.9'}, {'value': '-72.8', 'groupId': 'OG007', 'lowerLimit': '-79.0', 'upperLimit': '-65.0'}, {'value': '-79.2', 'groupId': 'OG008', 'lowerLimit': '-89.6', 'upperLimit': '-65.0'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '91', 'groupId': 'OG005'}, {'value': '40', 'groupId': 'OG006'}, {'value': '103', 'groupId': 'OG007'}, {'value': '29', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '-70.8', 'groupId': 'OG000', 'lowerLimit': '-83.3', 'upperLimit': '-63.3'}, {'value': '-73.8', 'groupId': 'OG001', 'lowerLimit': '-80.4', 'upperLimit': '-65.9'}, {'value': '-73.3', 'groupId': 'OG002', 'lowerLimit': '-78.1', 'upperLimit': '-67.3'}, {'value': '-87.5', 'groupId': 'OG003', 'lowerLimit': '-93.3', 'upperLimit': '-83.3'}, {'value': '-71.9', 'groupId': 'OG004', 'lowerLimit': '-80.2', 'upperLimit': '-58.6'}, {'value': '-63.6', 'groupId': 'OG005', 'lowerLimit': '-70.8', 'upperLimit': '-56.3'}, {'value': '-68.8', 'groupId': 'OG006', 'lowerLimit': '-78.9', 'upperLimit': '-51.8'}, {'value': '-74.9', 'groupId': 'OG007', 'lowerLimit': '-81.2', 'upperLimit': '-66.7'}, {'value': '-77.2', 'groupId': 'OG008', 'lowerLimit': '-88.9', 'upperLimit': '-62.0'}]}]}, {'title': 'Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}, {'value': '137', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '93', 'groupId': 'OG005'}, {'value': '21', 'groupId': 'OG006'}, {'value': '107', 'groupId': 'OG007'}, {'value': '22', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '-89.3', 'groupId': 'OG000', 'lowerLimit': '-97.4', 'upperLimit': '-81.0'}, {'value': '-67.9', 'groupId': 'OG001', 'lowerLimit': '-75.0', 'upperLimit': '-60.0'}, {'value': '-75.0', 'groupId': 'OG002', 'lowerLimit': '-80.0', 'upperLimit': '-69.3'}, {'value': '-91.7', 'groupId': 'OG003', 'lowerLimit': '-93.8', 'upperLimit': '-86.4'}, {'value': '-79.6', 'groupId': 'OG004', 'lowerLimit': '-91.7', 'upperLimit': '-58.3'}, {'value': '-60.6', 'groupId': 'OG005', 'lowerLimit': '-67.7', 'upperLimit': '-53.3'}, {'value': '-73.9', 'groupId': 'OG006', 'lowerLimit': '-84.6', 'upperLimit': '-62.5'}, {'value': '-66.7', 'groupId': 'OG007', 'lowerLimit': '-74.2', 'upperLimit': '-59.4'}, {'value': '-80.0', 'groupId': 'OG008', 'lowerLimit': '-90.5', 'upperLimit': '-61.5'}]}]}, {'title': 'Week 208', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '131', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '88', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}, {'value': '98', 'groupId': 'OG007'}, {'value': '21', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '-87.5', 'groupId': 'OG000', 'lowerLimit': '-97.4', 'upperLimit': '-82.1'}, {'value': '-81.3', 'groupId': 'OG001', 'lowerLimit': '-88.9', 'upperLimit': '-72.4'}, {'value': '-83.3', 'groupId': 'OG002', 'lowerLimit': '-89.3', 'upperLimit': '-78.2'}, {'value': '-92.1', 'groupId': 'OG003', 'lowerLimit': '-96.0', 'upperLimit': '-88.3'}, {'value': '-75.0', 'groupId': 'OG004', 'lowerLimit': '-86.1', 'upperLimit': '-56.5'}, {'value': '-85.7', 'groupId': 'OG005', 'lowerLimit': '-90.5', 'upperLimit': '-80.1'}, {'value': '-74.1', 'groupId': 'OG006', 'lowerLimit': '-85.6', 'upperLimit': '-55.4'}, {'value': '-84.6', 'groupId': 'OG007', 'lowerLimit': '-88.1', 'upperLimit': '-78.9'}, {'value': '-81.7', 'groupId': 'OG008', 'lowerLimit': '-90.5', 'upperLimit': '-66.7'}]}]}, {'title': 'Week 260', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '79', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '85', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '-90.9', 'groupId': 'OG000', 'lowerLimit': '-95.5', 'upperLimit': '-76.2'}, {'value': '-84.8', 'groupId': 'OG001', 'lowerLimit': '-91.7', 'upperLimit': '-76.2'}, {'value': '-86.1', 'groupId': 'OG002', 'lowerLimit': '-91.7', 'upperLimit': '-78.3'}, {'value': '-92.3', 'groupId': 'OG003', 'lowerLimit': '-95.0', 'upperLimit': '-83.3'}, {'value': '-75.0', 'groupId': 'OG004', 'lowerLimit': '-100.0', 'upperLimit': '-44.9'}, {'value': '-82.3', 'groupId': 'OG005', 'lowerLimit': '-90.6', 'upperLimit': '-74.3'}, {'value': '-63.9', 'groupId': 'OG006', 'lowerLimit': '-78.4', 'upperLimit': '-44.4'}, {'value': '-83.3', 'groupId': 'OG007', 'lowerLimit': '-89.1', 'upperLimit': '-76.2'}, {'value': '-80.0', 'groupId': 'OG008', 'lowerLimit': '-95.0', 'upperLimit': '-59.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 52, Week 104, Week 156, Week 208, Week 260', 'description': 'The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Dermatology Life Quality Index (DLQI©) Response (DLQI 0 or 1) Over Time at Weeks 52, 104, 156, 208 and 260', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}, {'value': '168', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '95', 'groupId': 'OG005'}, {'value': '60', 'groupId': 'OG006'}, {'value': '112', 'groupId': 'OG007'}, {'value': '33', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN150FI', 'description': 'AIN457 150 mg - Fixed Interval (FI)'}, {'id': 'OG001', 'title': 'AIN150 FI_AIN300 FI', 'description': 'AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)'}, {'id': 'OG002', 'title': 'AIN150FI (NSW+SW)', 'description': 'AIN457 150 mg - Fixed Interval combined non-switch and switch'}, {'id': 'OG003', 'title': 'AIN300 FI', 'description': 'AIN457 300 mg - Fixed Interval (FI)'}, {'id': 'OG004', 'title': 'AIN150 SoR', 'description': 'AIN457 150 mg - Start of Relapse (SoR)'}, {'id': 'OG005', 'title': 'AIN150 SOR_AIN300 FI', 'description': 'AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)'}, {'id': 'OG006', 'title': 'AIN300 SoR', 'description': 'AIN457 300 mg - Start of Relapse (SoR)'}, {'id': 'OG007', 'title': 'AIN300 SoR _ AIN300 FI', 'description': 'AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)'}, {'id': 'OG008', 'title': 'AIN300 OL', 'description': 'AIN457 300 mg Open-label (OL)'}], 'classes': [{'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}, {'value': '165', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '95', 'groupId': 'OG005'}, {'value': '60', 'groupId': 'OG006'}, {'value': '111', 'groupId': 'OG007'}, {'value': '33', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '59.7', 'groupId': 'OG000'}, {'value': '57.3', 'groupId': 'OG001'}, {'value': '58.6', 'groupId': 'OG002'}, {'value': '72.7', 'groupId': 'OG003'}, {'value': '32.7', 'groupId': 'OG004'}, {'value': '34.7', 'groupId': 'OG005'}, {'value': '28.3', 'groupId': 'OG006'}, {'value': '41.4', 'groupId': 'OG007'}, {'value': '54.5', 'groupId': 'OG008'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}, {'value': '153', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '91', 'groupId': 'OG005'}, {'value': '40', 'groupId': 'OG006'}, {'value': '106', 'groupId': 'OG007'}, {'value': '30', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000'}, {'value': '47.2', 'groupId': 'OG001'}, {'value': '50.7', 'groupId': 'OG002'}, {'value': '64.7', 'groupId': 'OG003'}, {'value': '41.2', 'groupId': 'OG004'}, {'value': '33.0', 'groupId': 'OG005'}, {'value': '32.5', 'groupId': 'OG006'}, {'value': '41.5', 'groupId': 'OG007'}, {'value': '36.7', 'groupId': 'OG008'}]}]}, {'title': 'Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '93', 'groupId': 'OG005'}, {'value': '21', 'groupId': 'OG006'}, {'value': '109', 'groupId': 'OG007'}, {'value': '22', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '37.3', 'groupId': 'OG001'}, {'value': '47.4', 'groupId': 'OG002'}, {'value': '67.4', 'groupId': 'OG003'}, {'value': '43.8', 'groupId': 'OG004'}, {'value': '35.5', 'groupId': 'OG005'}, {'value': '38.1', 'groupId': 'OG006'}, {'value': '38.5', 'groupId': 'OG007'}, {'value': '50.0', 'groupId': 'OG008'}]}]}, {'title': 'Week 208', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '132', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '88', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}, {'value': '100', 'groupId': 'OG007'}, {'value': '21', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '62.2', 'groupId': 'OG000'}, {'value': '52.9', 'groupId': 'OG001'}, {'value': '56.1', 'groupId': 'OG002'}, {'value': '70.5', 'groupId': 'OG003'}, {'value': '30.8', 'groupId': 'OG004'}, {'value': '62.5', 'groupId': 'OG005'}, {'value': '42.9', 'groupId': 'OG006'}, {'value': '59.0', 'groupId': 'OG007'}, {'value': '52.4', 'groupId': 'OG008'}]}]}, {'title': 'Week 260', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '119', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '79', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '87', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '55.2', 'groupId': 'OG000'}, {'value': '54.4', 'groupId': 'OG001'}, {'value': '54.7', 'groupId': 'OG002'}, {'value': '65.5', 'groupId': 'OG003'}, {'value': '60.0', 'groupId': 'OG004'}, {'value': '55.7', 'groupId': 'OG005'}, {'value': '15.6', 'groupId': 'OG006'}, {'value': '56.3', 'groupId': 'OG007'}, {'value': '50.0', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52, Week 104, Week 156, Week 208, Week 260', 'description': 'The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.'}, {'type': 'SECONDARY', 'title': 'EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D©) Score and Percent Change From Baseline at Weeks 52, 104 and 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}, {'value': '168', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '95', 'groupId': 'OG005'}, {'value': '60', 'groupId': 'OG006'}, {'value': '112', 'groupId': 'OG007'}, {'value': '33', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN150FI', 'description': 'AIN457 150 mg - Fixed Interval (FI)'}, {'id': 'OG001', 'title': 'AIN150 FI_AIN300 FI', 'description': 'AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)'}, {'id': 'OG002', 'title': 'AIN150FI (NSW+SW)', 'description': 'AIN457 150 mg - Fixed Interval combined non-switch and switch'}, {'id': 'OG003', 'title': 'AIN300 FI', 'description': 'AIN457 300 mg - Fixed Interval (FI)'}, {'id': 'OG004', 'title': 'AIN150 SoR', 'description': 'AIN457 150 mg - Start of Relapse (SoR)'}, {'id': 'OG005', 'title': 'AIN150 SOR_AIN300 FI', 'description': 'AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)'}, {'id': 'OG006', 'title': 'AIN300 SoR', 'description': 'AIN457 300 mg - Start of Relapse (SoR)'}, {'id': 'OG007', 'title': 'AIN300 SoR _ AIN300 FI', 'description': 'AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)'}, {'id': 'OG008', 'title': 'AIN300 OL', 'description': 'AIN457 300 mg Open-label (OL)'}], 'classes': [{'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}, {'value': '165', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}, {'value': '93', 'groupId': 'OG005'}, {'value': '58', 'groupId': 'OG006'}, {'value': '110', 'groupId': 'OG007'}, {'value': '33', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '68.8', 'spread': '137.47', 'groupId': 'OG000'}, {'value': '57.0', 'spread': '137.79', 'groupId': 'OG001'}, {'value': '63.0', 'spread': '137.30', 'groupId': 'OG002'}, {'value': '115.8', 'spread': '666.41', 'groupId': 'OG003'}, {'value': '40.2', 'spread': '94.91', 'groupId': 'OG004'}, {'value': '76.9', 'spread': '222.97', 'groupId': 'OG005'}, {'value': '41.3', 'spread': '140.42', 'groupId': 'OG006'}, {'value': '98.8', 'spread': '359.93', 'groupId': 'OG007'}, {'value': '60.9', 'spread': '74.18', 'groupId': 'OG008'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}, {'value': '153', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '89', 'groupId': 'OG005'}, {'value': '40', 'groupId': 'OG006'}, {'value': '106', 'groupId': 'OG007'}, {'value': '30', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '58.6', 'spread': '122.96', 'groupId': 'OG000'}, {'value': '62.4', 'spread': '156.21', 'groupId': 'OG001'}, {'value': '60.6', 'spread': '140.91', 'groupId': 'OG002'}, {'value': '118.5', 'spread': '689.52', 'groupId': 'OG003'}, {'value': '29.5', 'spread': '70.63', 'groupId': 'OG004'}, {'value': '152.9', 'spread': '902.21', 'groupId': 'OG005'}, {'value': '46.7', 'spread': '142.85', 'groupId': 'OG006'}, {'value': '77.2', 'spread': '150.86', 'groupId': 'OG007'}, {'value': '54.3', 'spread': '84.82', 'groupId': 'OG008'}]}]}, {'title': 'Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '91', 'groupId': 'OG005'}, {'value': '21', 'groupId': 'OG006'}, {'value': '107', 'groupId': 'OG007'}, {'value': '22', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '61.0', 'spread': '114.81', 'groupId': 'OG000'}, {'value': '52.1', 'spread': '115.04', 'groupId': 'OG001'}, {'value': '55.2', 'spread': '114.53', 'groupId': 'OG002'}, {'value': '125.3', 'spread': '677.23', 'groupId': 'OG003'}, {'value': '45.1', 'spread': '102.64', 'groupId': 'OG004'}, {'value': '140.3', 'spread': '778.86', 'groupId': 'OG005'}, {'value': '13.7', 'spread': '25.16', 'groupId': 'OG006'}, {'value': '109.5', 'spread': '373.51', 'groupId': 'OG007'}, {'value': '68.1', 'spread': '96.22', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52, Week 104, Week 156', 'description': 'ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Anti-drug Antibodies (ADA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '95', 'groupId': 'OG004'}, {'value': '60', 'groupId': 'OG005'}, {'value': '112', 'groupId': 'OG006'}, {'value': '33', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN150FI', 'description': 'AIN457 150 mg - Fixed Interval (FI)'}, {'id': 'OG001', 'title': 'AIN150 FI_AIN300 FI', 'description': 'AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)'}, {'id': 'OG002', 'title': 'AIN300 FI', 'description': 'AIN457 300 mg - Fixed Interval (FI)'}, {'id': 'OG003', 'title': 'AIN150 SoR', 'description': 'AIN457 150 mg - Start of Relapse (SoR)'}, {'id': 'OG004', 'title': 'AIN150 SOR_AIN300 FI', 'description': 'AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)'}, {'id': 'OG005', 'title': 'AIN300 SoR', 'description': 'AIN457 300 mg - Start of Relapse (SoR)'}, {'id': 'OG006', 'title': 'AIN300 SoR _ AIN300 FI', 'description': 'AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)'}, {'id': 'OG007', 'title': 'AIN300 OL', 'description': 'AIN457 300 mg Open-label (OL)'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 268', 'description': "The development of anti-secunimubab anti-bodies will decrease a participant's ability to respond to secukinumab treatment.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only descriptive analysis done.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Experiencing a Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '95', 'groupId': 'OG004'}, {'value': '60', 'groupId': 'OG005'}, {'value': '112', 'groupId': 'OG006'}, {'value': '33', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN150FI', 'description': 'AIN457 150 mg - Fixed Interval (FI)'}, {'id': 'OG001', 'title': 'AIN150 FI_AIN300 FI', 'description': 'AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)'}, {'id': 'OG002', 'title': 'AIN300 FI', 'description': 'AIN457 300 mg - Fixed Interval (FI)'}, {'id': 'OG003', 'title': 'AIN150 SoR', 'description': 'AIN457 150 mg - Start of Relapse (SoR)'}, {'id': 'OG004', 'title': 'AIN150 SOR_AIN300 FI', 'description': 'AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)'}, {'id': 'OG005', 'title': 'AIN300 SoR', 'description': 'AIN457 300 mg - Start of Relapse (SoR)'}, {'id': 'OG006', 'title': 'AIN300 SoR _ AIN300 FI', 'description': 'AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)'}, {'id': 'OG007', 'title': 'AIN300 OL', 'description': 'AIN457 300 mg Open-label (OL)'}], 'classes': [{'categories': [{'measurements': [{'value': '31.2', 'groupId': 'OG000'}, {'value': '40.0', 'groupId': 'OG001'}, {'value': '19.6', 'groupId': 'OG002'}, {'value': '61.8', 'groupId': 'OG003'}, {'value': '52.6', 'groupId': 'OG004'}, {'value': '43.3', 'groupId': 'OG005'}, {'value': '56.3', 'groupId': 'OG006'}, {'value': '36.4', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 260', 'description': 'Relapse is defined as greater than 50% loss of the maximal PASI improvement from baseline.\n\nPASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Experiencing a Rebound', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '95', 'groupId': 'OG004'}, {'value': '60', 'groupId': 'OG005'}, {'value': '112', 'groupId': 'OG006'}, {'value': '33', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN150FI', 'description': 'AIN457 150 mg - Fixed Interval (FI)'}, {'id': 'OG001', 'title': 'AIN150 FI_AIN300 FI', 'description': 'AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)'}, {'id': 'OG002', 'title': 'AIN300 FI', 'description': 'AIN457 300 mg - Fixed Interval (FI)'}, {'id': 'OG003', 'title': 'AIN150 SoR', 'description': 'AIN457 150 mg - Start of Relapse (SoR)'}, {'id': 'OG004', 'title': 'AIN150 SOR_AIN300 FI', 'description': 'AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)'}, {'id': 'OG005', 'title': 'AIN300 SoR', 'description': 'AIN457 300 mg - Start of Relapse (SoR)'}, {'id': 'OG006', 'title': 'AIN300 SoR _ AIN300 FI', 'description': 'AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)'}, {'id': 'OG007', 'title': 'AIN300 OL', 'description': 'AIN457 300 mg Open-label (OL)'}], 'classes': [{'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000', 'lowerLimit': '5.1', 'upperLimit': '22.8'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '14.9'}, {'value': '5.0', 'groupId': 'OG002', 'lowerLimit': '2.2', 'upperLimit': '10.3'}, {'value': '9.4', 'groupId': 'OG003', 'lowerLimit': '2.5', 'upperLimit': '26.2'}, {'value': '1.1', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '7.0'}, {'value': '6.9', 'groupId': 'OG005', 'lowerLimit': '1.2', 'upperLimit': '24.2'}, {'value': '10.6', 'groupId': 'OG006', 'lowerLimit': '5.7', 'upperLimit': '18.5'}, {'value': '13.0', 'groupId': 'OG007', 'lowerLimit': '3.4', 'upperLimit': '34.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 264 (8 weeks post last dose)', 'description': 'Rebound of disease is defined as a worsening of PASI of \\> 125% of the value at baseline (core study), or new pustular, erythrodermic or more inflammatory psoriasis occurring within 8 weeks of stopping therapy (i.e., if this definition was fulfilled at more than 8 weeks after last study treatment administration, this was defined as rebound like event).\n\nPASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AIN150FI', 'description': 'AIN457 150 mg - Fixed Interval (FI)'}, {'id': 'FG001', 'title': 'AIN150 FI_AIN300 FI', 'description': 'AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)'}, {'id': 'FG002', 'title': 'AIN300 FI', 'description': 'AIN457 300 mg - Fixed Interval (FI)'}, {'id': 'FG003', 'title': 'AIN150 SoR', 'description': 'AIN457 150 mg - Start of Relapse (SoR)'}, {'id': 'FG004', 'title': 'AIN150 SOR_AIN300 FI', 'description': 'AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)'}, {'id': 'FG005', 'title': 'AIN300 SoR', 'description': 'AIN457 300 mg - Start of Relapse (SoR)'}, {'id': 'FG006', 'title': 'AIN300 SoR _ AIN300 FI', 'description': 'AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)'}, {'id': 'FG007', 'title': 'AIN300 OL', 'description': 'AIN457 300 mg Open-label (OL)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'All randomized patients (Full Analysis Set and Safety Set)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '75'}, {'groupId': 'FG002', 'numSubjects': '168'}, {'groupId': 'FG003', 'numSubjects': '55'}, {'groupId': 'FG004', 'numSubjects': '95'}, {'groupId': 'FG005', 'numSubjects': '60'}, {'groupId': 'FG006', 'numSubjects': '112'}, {'groupId': 'FG007', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '126'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '82'}, {'groupId': 'FG005', 'numSubjects': '13'}, {'groupId': 'FG006', 'numSubjects': '94'}, {'groupId': 'FG007', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '42'}, {'groupId': 'FG003', 'numSubjects': '45'}, {'groupId': 'FG004', 'numSubjects': '13'}, {'groupId': 'FG005', 'numSubjects': '47'}, {'groupId': 'FG006', 'numSubjects': '18'}, {'groupId': 'FG007', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '11'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'Non-compliance with study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Subject/Guardian decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '19'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}]}]}], 'recruitmentDetails': '675 subjects from the core studies (CAIN457A2304 and CAIN457A2307) were enrolled at 112 sites. Subjects enrolled in the secukinumab 300 mg Open-Label (OL) arm came only from the CAIN457A2307 study, as such they were partial responders at Week 12, while all other subjects in the extension were PASI 75 responders at Week 12 in the core study.', 'preAssignmentDetails': 'At Week 156, subjects who rolled over from the CAIN457A2304 study were unblinded and provided an option to switch to one of the treatment options described below upon investigator judgment; subjects from the CAIN457A2307 study could administer study drug at home every 4 weeks, but were required to come for office visits every 12-16 weeks.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}, {'value': '60', 'groupId': 'BG005'}, {'value': '112', 'groupId': 'BG006'}, {'value': '33', 'groupId': 'BG007'}, {'value': '675', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'AIN150FI', 'description': 'AIN457 150 mg - Fixed Interval (FI)'}, {'id': 'BG001', 'title': 'AIN150 FI_AIN300 FI', 'description': 'AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)'}, {'id': 'BG002', 'title': 'AIN300 FI', 'description': 'AIN457 300 mg - Fixed Interval (FI)'}, {'id': 'BG003', 'title': 'AIN150 SoR', 'description': 'AIN457 150 mg - Start of Relapse (SoR)'}, {'id': 'BG004', 'title': 'AIN150 SOR_AIN300 FI', 'description': 'AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)'}, {'id': 'BG005', 'title': 'AIN300 SoR', 'description': 'AIN457 300 mg - Start of Relapse (SoR)'}, {'id': 'BG006', 'title': 'AIN300 SoR _ AIN300 FI', 'description': 'AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)'}, {'id': 'BG007', 'title': 'AIN300 OL', 'description': 'AIN457 300 mg Open-label (OL)'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.3', 'spread': '13.24', 'groupId': 'BG000'}, {'value': '46.0', 'spread': '12.03', 'groupId': 'BG001'}, {'value': '48.5', 'spread': '12.54', 'groupId': 'BG002'}, {'value': '42.7', 'spread': '12.23', 'groupId': 'BG003'}, {'value': '48.0', 'spread': '12.13', 'groupId': 'BG004'}, {'value': '45.2', 'spread': '12.08', 'groupId': 'BG005'}, {'value': '44.6', 'spread': '13.09', 'groupId': 'BG006'}, {'value': '46.5', 'spread': '13.99', 'groupId': 'BG007'}, {'value': '45.9', 'spread': '12.74', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '35', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}, {'value': '231', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}, {'value': '42', 'groupId': 'BG005'}, {'value': '77', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}, {'value': '444', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}]}, {'title': 'Asian', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '26', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '123', 'groupId': 'BG008'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '12', 'groupId': 'BG008'}]}, {'title': 'White', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}, {'value': '45', 'groupId': 'BG005'}, {'value': '84', 'groupId': 'BG006'}, {'value': '29', 'groupId': 'BG007'}, {'value': '528', 'groupId': 'BG008'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-04-29', 'size': 1163787, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-04-23T06:51', 'hasProtocol': True}, {'date': '2018-04-11', 'size': 660639, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-04-23T06:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 675}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-24', 'studyFirstSubmitDate': '2012-07-12', 'resultsFirstSubmitDate': '2018-04-23', 'studyFirstSubmitQcDate': '2012-07-13', 'lastUpdatePostDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-24', 'studyFirstPostDateStruct': {'date': '2012-07-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long-term Safety and Tolerability of Secukinumab', 'timeFrame': 'Week 268', 'description': 'Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC)'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Score of 75 at Weeks 52, 104, 156, 208 and 260', 'timeFrame': 'Week 52, Week 104, Week 156, Week 208, Week 260', 'description': 'PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area \\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4)'}, {'measure': 'Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Scores of 50, 90 and 100 Over Time at Weeks 52, 104, 156, 208 and 260', 'timeFrame': 'Week 52, Week 104, Week 156, Week 208, Week 260', 'description': 'PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area \\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4)'}, {'measure': 'Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Weeks 52, 104, 156, 208 and 260', 'timeFrame': 'Baseline, Week 52, Week 104, Week 156, Week 208, Week 260', 'description': 'PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area \\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4)'}, {'measure': "Percentage of Participants Achieving Investigator's Global Assessment Modified 2011 (IGA) 2011 Score of 0 or 1 Over Time at Weeks 52, 104, 156, 208 and 260", 'timeFrame': 'Week 52, Week 104, Week 156, Week 208, Week 260', 'description': "The IGA mod 2011 is a static scale, i.e., it refers exclusively to the participant's disease state at the time of the assessments and does not attempt a comparison to any of the participant's previous disease states at prior visits. The score ranges from 0 (clear) to 4 (severe). The score 0 is clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 is severe."}, {'measure': 'Percentage Change From Baseline in Dermatology Life Quality Index (DLQI©) Response at Weeks 52, 104, 156, 208 and 260', 'timeFrame': 'Baseline, Week 52, Week 104, Week 156, Week 208, Week 260', 'description': 'The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions'}, {'measure': 'Percentage of Participants With Dermatology Life Quality Index (DLQI©) Response (DLQI 0 or 1) Over Time at Weeks 52, 104, 156, 208 and 260', 'timeFrame': 'Week 52, Week 104, Week 156, Week 208, Week 260', 'description': 'The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions'}, {'measure': 'EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D©) Score and Percent Change From Baseline at Weeks 52, 104 and 156', 'timeFrame': 'Baseline, Week 52, Week 104, Week 156', 'description': 'ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)'}, {'measure': 'Number of Participants With Treatment Emergent Anti-drug Antibodies (ADA)', 'timeFrame': 'Week 268', 'description': "The development of anti-secunimubab anti-bodies will decrease a participant's ability to respond to secukinumab treatment."}, {'measure': 'Percentage of Patients With Experiencing a Relapse', 'timeFrame': 'Week 260', 'description': 'Relapse is defined as greater than 50% loss of the maximal PASI improvement from baseline.\n\nPASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement.'}, {'measure': 'Percentage of Patients With Experiencing a Rebound', 'timeFrame': 'Up to Week 264 (8 weeks post last dose)', 'description': 'Rebound of disease is defined as a worsening of PASI of \\> 125% of the value at baseline (core study), or new pustular, erythrodermic or more inflammatory psoriasis occurring within 8 weeks of stopping therapy (i.e., if this definition was fulfilled at more than 8 weeks after last study treatment administration, this was defined as rebound like event).\n\nPASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psoriasis', 'Plaque', 'Inflammatory skin disease', 'Scaly patches', 'AIN457', 'Secukinumab', 'Moderate to Severe Plaque-type Psoriasis'], 'conditions': ['Moderate to Severe Chronic Plaque-Type Psoriasis']}, 'referencesModule': {'references': [{'pmid': '28580579', 'type': 'DERIVED', 'citation': 'Bissonnette R, Luger T, Thaci D, Toth D, Messina I, You R, Guana A, Fox T, Papavassilis C, Gilloteau I, Mrowietz U. Secukinumab sustains good efficacy and favourable safety in moderate-to-severe psoriasis after up to 3 years of treatment: results from a double-blind extension study. Br J Dermatol. 2017 Oct;177(4):1033-1042. doi: 10.1111/bjd.15706. Epub 2017 Sep 4.'}]}, 'descriptionModule': {'briefSummary': 'CAIN457A2304E1 was an extension study to two phase III studies, CAIN457A2304 and CAIN457A2307 (core studies). This extension study planned to collect up to four years of long-term safety, tolerability and efficacy data of secukinumab in both the fixed interval regimen and the retreatment at start of relapse regimen. All subjects who completed the full study treatment period (52 weeks) in the cores studies CAIN457A2304 and CAIN457A2307 were eligible to participate in this extension study. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab was used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed consent according to local laws and regulations.\n2. Subjects who complete Week 52 of study CAIN457A2304 or complete Week 40 of study CAIN457A2307\n3. Subjects expected to benefit from participation in the extension study, as assessed by the subject and investigator\n\nExclusion Criteria:\n\n1. A protocol deviation in the core studies which according to the investigator will prevent the meaningful analysis of the extension study for the individual subject\n2. Ongoing use of prohibited psoriasis or non-psoriasis treatments. Time period from last use of prohibited treatments in the core study to first dose of study drug in this extension study.\n3. Subjects expected to be exposed to an undue safety risk if participating in the trial\n4. Current severe progressive or uncontrolled disease which in the judgment of the investigator renders the subject unsuitable for the trial\n5. Plans for administration of live vaccines during the study period\n6. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\\>10 mIU/mL).'}, 'identificationModule': {'nctId': 'NCT01640951', 'briefTitle': '4 Year Extension Study of Efficacy and Safety of Secukinumab in Patients With Moderate to Severe Chronic Plaque-type Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multicenter, Double-blind and Open Label, 4 Year Extension Study of Subcutaneous Secukinumab in Prefilled Syringes, Assessing Long-term Safety, Tolerability and Efficacy in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Treated With Either a Fixed Dose Regimen or on a Retreatment at Start of Relapse Regimen', 'orgStudyIdInfo': {'id': 'CAIN457A2304E1'}, 'secondaryIdInfos': [{'id': '2012-000985-39', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AIN457 150 mg - Fixed Interval (FI)', 'description': '1 s.c. Secukinumab 150 mg Pre-filled seringue (PFS) injection + 1 s.c. Placebo (PBO) Secukinumab PFS injection every 4 weeks', 'interventionNames': ['Drug: AIN457 150 mg', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'AIN457 150 mg - Start of relapse (SoR)', 'description': 'Start of relapse: 1 s.c. Secukinumab 150 mg PFS injection + 1 s.c. PBO Secukinumab PFS injection every 4 weeks\n\nOtherwise: 2 s.c. PBO Secukinumab PFS injections every 4 weeks', 'interventionNames': ['Drug: AIN457 150 mg', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'AIN457 300 mg - Fixed Interval (FI)', 'description': '2 s.c. Secukinumab 150 mg PFS injections every 4 weeks', 'interventionNames': ['Drug: AIN457 300 mg']}, {'type': 'EXPERIMENTAL', 'label': 'AIN457 300 mg - Start of Relapse (SoR)', 'description': 'Start of relapse: 2 s.c. Secukinumab 150 mg PFS injection every 4 weeks\n\nOtherwise: 2 s.c. PBO Secukinumab PFS injections every 4 weeks', 'interventionNames': ['Drug: AIN457 300 mg', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'AIN457 300 mg - Open Label (OL)', 'description': 'Open Label - Secukinumab 300mg every 4 weeks', 'interventionNames': ['Drug: AIN457 300 mg']}], 'interventions': [{'name': 'AIN457 150 mg', 'type': 'DRUG', 'otherNames': ['Secukinumab 150 mg'], 'description': '(1 injection per dose) and placebo to Secukinumab 150 mg', 'armGroupLabels': ['AIN457 150 mg - Fixed Interval (FI)', 'AIN457 150 mg - Start of relapse (SoR)']}, {'name': 'AIN457 300 mg', 'type': 'DRUG', 'otherNames': ['Secukinumab 300 mg'], 'description': 'Secukinumab 150 mg (2 injections per dose)', 'armGroupLabels': ['AIN457 300 mg - Fixed Interval (FI)', 'AIN457 300 mg - Open Label (OL)', 'AIN457 300 mg - Start of Relapse (SoR)']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['AIN457 150 mg - Fixed Interval (FI)', 'AIN457 150 mg - Start of relapse (SoR)', 'AIN457 300 mg - 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