Viewing Study NCT03556202

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Ignite Creation Date: 2025-12-25 @ 3:57 AM
Ignite Modification Date: 2025-12-26 @ 2:49 AM
Study NCT ID: NCT03556202
Status: TERMINATED
Last Update Posted: 2023-03-21
First Post: 2018-06-04
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000708407', 'term': 'mirikizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This study was terminated before completion of the long-term extension trial, due to strategic business decision made by the company.'}}, 'adverseEventsModule': {'timeFrame': 'Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks', 'description': 'All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.', 'eventGroups': [{'id': 'EG000', 'title': '125 Milligram (mg) Mirikizumab Q8W', 'description': 'Participants received 125 mg mirikizumab administered subcutaneously (SC) every eight weeks (Q8W).', 'otherNumAtRisk': 527, 'deathsNumAtRisk': 527, 'otherNumAffected': 388, 'seriousNumAtRisk': 527, 'deathsNumAffected': 2, 'seriousNumAffected': 55}, {'id': 'EG001', 'title': '250 mg Mirikizumab Q8W Excluding Secukinumab', 'description': 'Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).', 'otherNumAtRisk': 1020, 'deathsNumAtRisk': 1020, 'otherNumAffected': 756, 'seriousNumAtRisk': 1020, 'deathsNumAffected': 6, 'seriousNumAffected': 88}, {'id': 'EG002', 'title': 'Secukinumab/250 mg Mirikizumab Q8W', 'description': 'Participants from previous originating study \\[who received secukinumab (AMAJ)\\] received 250 mg mirikizumab administered SC Q8W.', 'otherNumAtRisk': 389, 'deathsNumAtRisk': 389, 'otherNumAffected': 288, 'seriousNumAtRisk': 389, 'deathsNumAffected': 0, 'seriousNumAffected': 35}, {'id': 'EG003', 'title': '125 Milligram (mg) Mirikizumab Q8W Follow-up Period', 'description': 'Participants did not receive any intervention in post- treatment follow-up period.', 'otherNumAtRisk': 453, 'deathsNumAtRisk': 453, 'otherNumAffected': 70, 'seriousNumAtRisk': 453, 'deathsNumAffected': 1, 'seriousNumAffected': 7}, {'id': 'EG004', 'title': '250 mg Mirikizumab Q8W Excluding Secukinumab Follow-up Period', 'description': 'Participants did not receive any intervention in post- treatment follow-up period.', 'otherNumAtRisk': 861, 'deathsNumAtRisk': 861, 'otherNumAffected': 120, 'seriousNumAtRisk': 861, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG005', 'title': 'Secukinumab/250 mg Mirikizumab Q8W Follow-up Period', 'description': 'Participants did not receive any intervention in post- treatment follow-up period.', 'otherNumAtRisk': 333, 'deathsNumAtRisk': 333, 'otherNumAffected': 47, 'seriousNumAtRisk': 333, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Anaemia macrocytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Anaemia of chronic disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Bone marrow oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypercoagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Macrocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Neutrophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Aortic valve sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 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'MedDRA 24.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Blepharoplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cholecystectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Coronary revascularisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Gastric polypectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hysterectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Percutaneous coronary intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Peripheral revascularisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Stent placement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Stent removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Aortic aneurysm rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1020, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 861, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Percentage of Participants With a Static Physician's Global Assessment Among Those Who Entered the Study With a sPGA of 0,1", 'denoms': [{'units': 'Participants', 'counts': [{'value': '467', 'groupId': 'OG000'}, {'value': '820', 'groupId': 'OG001'}, {'value': '296', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '125 Milligram (mg) Mirikizumab Q8W', 'description': 'Participants received 125 mg mirikizumab administered SC Q8W.'}, {'id': 'OG001', 'title': '250 mg Mirikizumab Q8W Excluding Secukinumab', 'description': 'Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).'}, {'id': 'OG002', 'title': 'Secukinumab/250 mg Mirikizumab Q8W', 'description': 'Participants from previous originating study \\[who received secukinumab (AMAJ)\\] received 250 mg mirikizumab administered SC Q8W.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000', 'lowerLimit': '42.2', 'upperLimit': '51.2'}, {'value': '55.7', 'groupId': 'OG001', 'lowerLimit': '52.3', 'upperLimit': '59.1'}, {'value': '38.9', 'groupId': 'OG002', 'lowerLimit': '33.3', 'upperLimit': '44.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 104', 'description': 'The sPGA is the physician\'s determination of the participant\'s psoriasis (PsO) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant\'s PsO was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline. Participants who did not meet the clinical response criteria or had missing data at Week 104 were considered non-responders for non-responder Imputation (NRI) analysis.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of drug and who entered Study AMAH with sPGA (0,1).'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Maintained a ≥90% Improvements in Psoriasis Area and Severity Index (PASI) 90 Among Those Who Entered the Study With a PASI 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '460', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '302', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '125 Milligram (mg) Mirikizumab Q8W', 'description': 'Participants received 125 mg mirikizumab administered SC Q8W.'}, {'id': 'OG001', 'title': '250 mg Mirikizumab Q8W Excluding Secukinumab', 'description': 'Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).'}, {'id': 'OG002', 'title': 'Secukinumab/250 mg Mirikizumab Q8W', 'description': 'Participants from previous originating study \\[who received secukinumab (AMAJ)\\] received 250 mg mirikizumab administered SC Q8W.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.3', 'groupId': 'OG000', 'lowerLimit': '44.8', 'upperLimit': '53.9'}, {'value': '56.8', 'groupId': 'OG001', 'lowerLimit': '53.4', 'upperLimit': '60.2'}, {'value': '39.4', 'groupId': 'OG002', 'lowerLimit': '33.9', 'upperLimit': '44.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 104', 'description': 'PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \\* area score \\* weighing factor \\[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\\]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and who entered AMAH with PASI 90 Response.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '527', 'groupId': 'OG000'}, {'value': '1020', 'groupId': 'OG001'}, {'value': '389', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '125 Milligram (mg) Mirikizumab Q8W', 'description': 'Participants received 125 mg mirikizumab administered SC Q8W.'}, {'id': 'OG001', 'title': '250 mg Mirikizumab Q8W Excluding Secukinumab', 'description': 'Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).'}, {'id': 'OG002', 'title': 'Secukinumab/250 mg Mirikizumab Q8W', 'description': 'Participants from previous originating study \\[who received secukinumab (AMAJ)\\] received 250 mg mirikizumab administered SC Q8W.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.4', 'groupId': 'OG000', 'lowerLimit': '26.4', 'upperLimit': '34.3'}, {'value': '36.4', 'groupId': 'OG001', 'lowerLimit': '33.4', 'upperLimit': '39.3'}, {'value': '22.6', 'groupId': 'OG002', 'lowerLimit': '18.5', 'upperLimit': '26.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 104', 'description': 'PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \\* area score \\* weighing factor \\[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\\]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 (Free of Itch, Pain, Stinging, and Burning) in Those With a PSS Symptoms Score ≥1 at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '518', 'groupId': 'OG000'}, {'value': '1008', 'groupId': 'OG001'}, {'value': '376', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '125 Milligram (mg) Mirikizumab Q8W', 'description': 'Participants received 125 mg mirikizumab administered SC Q8W.'}, {'id': 'OG001', 'title': '250 mg Mirikizumab Q8W Excluding Secukinumab', 'description': 'Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).'}, {'id': 'OG002', 'title': 'Secukinumab/250 mg Mirikizumab Q8W', 'description': 'Participants from previous originating study \\[who received secukinumab (AMAJ)\\] received 250 mg mirikizumab administered SC Q8W.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.1', 'groupId': 'OG000', 'lowerLimit': '27.1', 'upperLimit': '35.1'}, {'value': '33.6', 'groupId': 'OG001', 'lowerLimit': '30.7', 'upperLimit': '36.5'}, {'value': '23.4', 'groupId': 'OG002', 'lowerLimit': '19.1', 'upperLimit': '27.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 104', 'description': "PSS is a patient-administered assessment of 4 symptoms (itch, pain, stinging, and burning); 3 signs (redness, scaling, and cracking); and 1 item on the discomfort related to symptoms/signs. The overall severity for each individual symptom/sign from the patient's psoriasis is indicated by selecting the number from a numeric rating scale (NRS) of 0 to 10 that best describes the worst level of each symptom/sign in the past 24 hours, where 0=no symptom/sign and 10=worst imaginable symptom/sign. In addition, a symptoms score ranging from 0 (no symptoms) to 40 (worst imaginable symptoms), and a sign score of 0 (no signs) to 30 (worst imaginable signs) will be reported.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PSS symptom score of ≥1 at baseline.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Total Score of (0,1) With at Least a 5-Point Improvement (Reduction) From Baseline in Participants With a Baseline DLQI Total Score ≥5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '477', 'groupId': 'OG000'}, {'value': '922', 'groupId': 'OG001'}, {'value': '345', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '125 Milligram (mg) Mirikizumab Q8W', 'description': 'Participants received 125 mg mirikizumab administered SC Q8W.'}, {'id': 'OG001', 'title': '250 mg Mirikizumab Q8W Excluding Secukinumab', 'description': 'Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).'}, {'id': 'OG002', 'title': 'Secukinumab/250 mg Mirikizumab Q8W', 'description': 'Participants from previous originating study \\[who received secukinumab (AMAJ)\\] received 250 mg mirikizumab administered SC Q8W.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.5', 'groupId': 'OG000', 'lowerLimit': '37.1', 'upperLimit': '45.9'}, {'value': '47.3', 'groupId': 'OG001', 'lowerLimit': '44.1', 'upperLimit': '50.5'}, {'value': '34.5', 'groupId': 'OG002', 'lowerLimit': '29.5', 'upperLimit': '39.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 104', 'description': 'The DLQI is a patient-reported, 10-question, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Totals range from 0 to 30 (less to more impairment). A DLQI total score of 0 to 1 is considered as having no effect on a patient\'s health-related quality of life (HRQoL), and a 5-point change from baseline is considered as the minimal clinically important difference (MCID) threshold.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had a baseline DLQI Total Score ≥5.'}, {'type': 'SECONDARY', 'title': 'Change in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '125 Milligram (mg) Mirikizumab Q8W', 'description': 'Participants received 125 mg mirikizumab administered SC Q8W.'}, {'id': 'OG001', 'title': '250 mg Mirikizumab Q8W Excluding Secukinumab', 'description': 'Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).'}, {'id': 'OG002', 'title': 'Secukinumab/250 mg Mirikizumab Q8W', 'description': 'Participants from previous originating study \\[who received secukinumab (AMAJ)\\] received 250 mg mirikizumab administered SC Q8W.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.55', 'spread': '7.058', 'groupId': 'OG000'}, {'value': '-6.80', 'spread': '8.391', 'groupId': 'OG001'}, {'value': '-7.38', 'spread': '6.632', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 104', 'description': 'The PPASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no PPASI) to 72 (most severe PPASI). The PPASI was only assessed if participants have palmoplantar psoriasis at baseline.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had palmoplantar involvement at baseline.'}, {'type': 'SECONDARY', 'title': 'Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '454', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '125 Milligram (mg) Mirikizumab Q8W', 'description': 'Participants received 125 mg mirikizumab administered SC Q8W.'}, {'id': 'OG001', 'title': '250 mg Mirikizumab Q8W Excluding Secukinumab', 'description': 'Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).'}, {'id': 'OG002', 'title': 'Secukinumab/250 mg Mirikizumab Q8W', 'description': 'Participants from previous originating study \\[who received secukinumab (AMAJ)\\] received 250 mg mirikizumab administered SC Q8W.'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.9', 'spread': '15.79', 'groupId': 'OG000'}, {'value': '-19.5', 'spread': '13.48', 'groupId': 'OG001'}, {'value': '-19.6', 'spread': '13.44', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 104', 'description': 'The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (\\<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had Scalp Involvement at baseline.'}, {'type': 'SECONDARY', 'title': 'Change in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '125 Milligram (mg) Mirikizumab Q8W', 'description': 'Participants received 125 mg mirikizumab administered SC Q8W.'}, {'id': 'OG001', 'title': '250 mg Mirikizumab Q8W Excluding Secukinumab', 'description': 'Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).'}, {'id': 'OG002', 'title': 'Secukinumab/250 mg Mirikizumab Q8W', 'description': 'Participants from previous originating study \\[who received secukinumab (AMAJ)\\] received 250 mg mirikizumab administered SC Q8W.'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.4', 'spread': '17.75', 'groupId': 'OG000'}, {'value': '-21.0', 'spread': '17.69', 'groupId': 'OG001'}, {'value': '-22.2', 'spread': '18.75', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 104', 'description': 'The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix PsO by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed PsO 0 (none) to 4 (PsO in 4 quadrants of the fingernail) and fingernail matrix PsO 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix PsO in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had Nail Psoriasis involvement at baseline.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '125 Milligram (mg) Mirikizumab Q8W', 'description': 'Participants received 125 mg mirikizumab administered subcutaneously (SC) every eight weeks (Q8W).'}, {'id': 'FG001', 'title': '250 mg Mirikizumab Q8W Excluding Secukinumab', 'description': 'Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).'}, {'id': 'FG002', 'title': 'Secukinumab/250 mg Mirikizumab Q8W', 'description': 'Participants from previous originating study \\[who received secukinumab (AMAJ)\\] received 250 mg mirikizumab administered SC Q8W.'}], 'periods': [{'title': 'Extension Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '527'}, {'groupId': 'FG001', 'numSubjects': '1020'}, {'groupId': 'FG002', 'numSubjects': '389'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '527'}, {'groupId': 'FG001', 'numSubjects': '1020'}, {'groupId': 'FG002', 'numSubjects': '389'}]}, {'type': 'From AMAF', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '132'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'From AMAK', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '390'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'From AMAJ', 'achievements': [{'groupId': 'FG000', 'numSubjects': '409'}, {'groupId': 'FG001', 'numSubjects': '498'}, {'groupId': 'FG002', 'numSubjects': '389'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '527'}, {'groupId': 'FG001', 'numSubjects': '1020'}, {'groupId': 'FG002', 'numSubjects': '389'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '469'}, {'groupId': 'FG001', 'numSubjects': '907'}, {'groupId': 'FG002', 'numSubjects': '331'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'Due to Exclusion Criteria of AMAJ study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Follow-Up Period (12 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants were assigned to this arm during follow-up period.', 'groupId': 'FG000', 'numSubjects': '453'}, {'comment': 'Participants were assigned to this arm during follow-up period.', 'groupId': 'FG001', 'numSubjects': '861'}, {'comment': 'Participants were assigned to this arm during follow-up period.', 'groupId': 'FG002', 'numSubjects': '333'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '453'}, {'groupId': 'FG001', 'numSubjects': '861'}, {'groupId': 'FG002', 'numSubjects': '333'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '396'}, {'groupId': 'FG001', 'numSubjects': '750'}, {'groupId': 'FG002', 'numSubjects': '273'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '31'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Site Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Study Discontinued by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Second Follow-up Visit: Patient Refused', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Study terminated & Subject Missed Follow-up Visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'To Meet Exclusion Criteria of the AMAJ Study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Second Follow-up Not Done, unable to reach Patient', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Participants who completed an originating study: I6T-MC-AMAF (NCT02899988), I6T-MC-AMAK (NCT03482011) and I6T-MC-AMAJ (NCT03535194) were eligible for enrollment into study AMAH.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '527', 'groupId': 'BG000'}, {'value': '1020', 'groupId': 'BG001'}, {'value': '389', 'groupId': 'BG002'}, {'value': '1936', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '125 Milligram (mg) Mirikizumab Q8W', 'description': 'Participants received 125 mg mirikizumab administered SC Q8W.'}, {'id': 'BG001', 'title': '250 mg Mirikizumab Q8W Excluding Secukinumab', 'description': 'Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).'}, {'id': 'BG002', 'title': 'Secukinumab/250 mg Mirikizumab Q8W', 'description': 'Participants from previous originating study \\[who received secukinumab (AMAJ)\\] received 250 mg mirikizumab administered SC Q8W.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.90', 'spread': '13.81', 'groupId': 'BG000'}, {'value': '47.00', 'spread': '12.87', 'groupId': 'BG001'}, {'value': '46.50', 'spread': '14.41', 'groupId': 'BG002'}, {'value': '47.10', 'spread': '13.45', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '159', 'groupId': 'BG000'}, {'value': '309', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}, {'value': '578', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '368', 'groupId': 'BG000'}, {'value': '711', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}, {'value': '1358', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '112', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '282', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '419', 'groupId': 'BG000'}, {'value': '807', 'groupId': 'BG001'}, {'value': '316', 'groupId': 'BG002'}, {'value': '1542', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '369', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '415', 'groupId': 'BG000'}, {'value': '734', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}, {'value': '1464', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Argentina', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}]}]}, {'title': 'Czechia', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '243', 'groupId': 'BG003'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '162', 'groupId': 'BG003'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '279', 'groupId': 'BG003'}]}]}, {'title': 'Russia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}]}, {'title': 'South Korea', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}]}, 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'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-15', 'size': 898193, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-01-31T02:42', 'hasProtocol': True}, {'date': '2020-02-13', 'size': 935401, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-01-31T02:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Initially double-blind (until original, pivotal studies AMAK \\[NCT03482011\\] and AMAJ \\[NCT03535194\\] are locked and unblinded), then open-label.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1936}}, 'statusModule': {'whyStopped': 'The study was terminated due to a strategic business decision made by the Sponsor.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-17', 'studyFirstSubmitDate': '2018-06-04', 'resultsFirstSubmitDate': '2023-02-03', 'studyFirstSubmitQcDate': '2018-06-04', 'lastUpdatePostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-17', 'studyFirstPostDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Percentage of Participants With a Static Physician's Global Assessment Among Those Who Entered the Study With a sPGA of 0,1", 'timeFrame': 'Week 104', 'description': 'The sPGA is the physician\'s determination of the participant\'s psoriasis (PsO) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant\'s PsO was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline. Participants who did not meet the clinical response criteria or had missing data at Week 104 were considered non-responders for non-responder Imputation (NRI) analysis.'}, {'measure': 'Percentage of Participants Who Maintained a ≥90% Improvements in Psoriasis Area and Severity Index (PASI) 90 Among Those Who Entered the Study With a PASI 90', 'timeFrame': 'Week 104', 'description': 'PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \\* area score \\* weighing factor \\[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\\]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)', 'timeFrame': 'Week 104', 'description': 'PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \\* area score \\* weighing factor \\[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\\]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).'}, {'measure': 'Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 (Free of Itch, Pain, Stinging, and Burning) in Those With a PSS Symptoms Score ≥1 at Baseline', 'timeFrame': 'Week 104', 'description': "PSS is a patient-administered assessment of 4 symptoms (itch, pain, stinging, and burning); 3 signs (redness, scaling, and cracking); and 1 item on the discomfort related to symptoms/signs. The overall severity for each individual symptom/sign from the patient's psoriasis is indicated by selecting the number from a numeric rating scale (NRS) of 0 to 10 that best describes the worst level of each symptom/sign in the past 24 hours, where 0=no symptom/sign and 10=worst imaginable symptom/sign. In addition, a symptoms score ranging from 0 (no symptoms) to 40 (worst imaginable symptoms), and a sign score of 0 (no signs) to 30 (worst imaginable signs) will be reported."}, {'measure': 'Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Total Score of (0,1) With at Least a 5-Point Improvement (Reduction) From Baseline in Participants With a Baseline DLQI Total Score ≥5', 'timeFrame': 'Week 104', 'description': 'The DLQI is a patient-reported, 10-question, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Totals range from 0 to 30 (less to more impairment). A DLQI total score of 0 to 1 is considered as having no effect on a patient\'s health-related quality of life (HRQoL), and a 5-point change from baseline is considered as the minimal clinically important difference (MCID) threshold.'}, {'measure': 'Change in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline', 'timeFrame': 'Baseline, Week 104', 'description': 'The PPASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no PPASI) to 72 (most severe PPASI). The PPASI was only assessed if participants have palmoplantar psoriasis at baseline.'}, {'measure': 'Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline', 'timeFrame': 'Baseline, Week 104', 'description': 'The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (\\<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity).'}, {'measure': 'Change in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline', 'timeFrame': 'Baseline, Week 104', 'description': 'The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix PsO by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed PsO 0 (none) to 4 (PsO in 4 quadrants of the fingernail) and fingernail matrix PsO 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix PsO in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IL-23', 'Interleukin-23', 'Psoriasis'], 'conditions': ['Psoriasis']}, 'referencesModule': {'references': [{'pmid': '39073712', 'type': 'DERIVED', 'citation': 'Hsieh CY, Hsu FL, Tsai TF. Comparison of Drug-Free Remission after the End of Phase III Trials of Three Different Anti-IL-23 Inhibitors in Psoriasis. Dermatol Ther (Heidelb). 2024 Sep;14(9):2607-2620. doi: 10.1007/s13555-024-01229-6. Epub 2024 Jul 29.'}], 'seeAlsoLinks': [{'url': 'https://trials.lillytrialguide.com/en-US/trial/5ZNG4OpNpmWK8CeycIMWaA', 'label': 'A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the long-term safety and maintenance of efficacy of mirikizumab in participants with moderate-to-severe plaque psoriasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant must have completed the last visit of an eligible study period of originating study.\n* Participant must be willing to follow the birth control measures during and after study treatment if woman of childbearing potential.\n\nExclusion Criteria:\n\n* Participant must not have an unstable or uncontrolled illness, including but not limited to a cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic disease or abnormal lab results, that the study investigator thinks makes it unsafe or inappropriate for the participant to participate in this study.\n* Participant must not have stopped taking mirikizumab during a previous study or if the study investigator thinks restarting mirikizumab would create an unacceptable risk to the participant.'}, 'identificationModule': {'nctId': 'NCT03556202', 'briefTitle': 'A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Multicenter, Long-Term Extension to Evaluate the Long-term Safety and Maintenance of Treatment Effect of LY3074828 in Patients With Moderate-to-Severe Plaque Psoriasis OASIS-3', 'orgStudyIdInfo': {'id': '16491'}, 'secondaryIdInfos': [{'id': 'I6T-MC-AMAH', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2017-003299-30', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '125 Milligram (mg) Mirikizumab Q8W', 'description': 'Participants received 125 mg mirikizumab administered subcutaneously (SC) every eight weeks (Q8W).', 'interventionNames': ['Drug: Mirikizumab']}, {'type': 'EXPERIMENTAL', 'label': '250 mg Mirikizumab Q8W Excluding Secukinumab', 'description': 'Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ)', 'interventionNames': ['Drug: Mirikizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Secukinumab/250 mg Mirikizumab Q8W', 'description': 'Participants from previous originating study \\[who received secukinumab (AMAJ)\\] received 250 mg mirikizumab administered SC Q8W.', 'interventionNames': ['Drug: Mirikizumab']}], 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