Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-31 @ 12:08 AM
Study NCT ID:
NCT01490632
Status:
COMPLETED
Last Update Posted:
2019-09-27
First Post:
2011-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 2b Study of Baricitinib in Participants With Moderate to Severe Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D058225', 'term': 'Plaque, Amyloid'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000596027', 'term': 'baricitinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Part A: Placebo', 'description': "Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.", 'otherNumAtRisk': 34, 'otherNumAffected': 11, 'seriousNumAtRisk': 34, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Part A: Baricitinib 2 mg', 'description': "Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.", 'otherNumAtRisk': 32, 'otherNumAffected': 9, 'seriousNumAtRisk': 32, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Part A: Baricitinib 4 mg', 'description': "Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.", 'otherNumAtRisk': 72, 'otherNumAffected': 12, 'seriousNumAtRisk': 72, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Part A: Baricitinib 8 mg', 'description': "Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.", 'otherNumAtRisk': 64, 'otherNumAffected': 21, 'seriousNumAtRisk': 64, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Part A: Baricitinib 10 mg', 'description': 'Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.', 'otherNumAtRisk': 69, 'otherNumAffected': 23, 'seriousNumAtRisk': 69, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Part B: Placebo', 'description': 'Placebo PO QD maintained on placebo PO QD.', 'otherNumAtRisk': 8, 'otherNumAffected': 4, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Part B: Low Dose', 'description': 'All participants in the following groups (as described in the Participant Flow):\n\n* Responder Low Dose\n* Partial Responder Low Dose to Low Dose groups.', 'otherNumAtRisk': 45, 'otherNumAffected': 13, 'seriousNumAtRisk': 45, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Part B: High Dose', 'description': 'All participants in the following groups (as described in the Participant Flow):\n\n* Responder High Dose\n* Partial and Non-responder Placebo to High Dose\n* Partial and Non-responder Low Dose to High Dose\n* Partial and Non-responder High Dose to High Dose', 'otherNumAtRisk': 176, 'otherNumAffected': 41, 'seriousNumAtRisk': 176, 'seriousNumAffected': 2}, {'id': 'EG008', 'title': 'Part C: Placebo', 'description': 'All placebo participant groups after study drug re-randomized.', 'otherNumAtRisk': 70, 'otherNumAffected': 11, 'seriousNumAtRisk': 70, 'seriousNumAffected': 1}, {'id': 'EG009', 'title': 'Part C: Baricitinib', 'description': 'All baricitinib participant groups after study drug re-randomized to various doses.', 'otherNumAtRisk': 71, 'otherNumAffected': 16, 'seriousNumAtRisk': 71, 'seriousNumAffected': 1}, {'id': 'EG010', 'title': 'Part D: All Baricitinib Doses', 'description': 'All participant dosages following baricitinib retreatment with Part B efficacious dose for 52 weeks.', 'otherNumAtRisk': 72, 'otherNumAffected': 37, 'seriousNumAtRisk': 72, 'seriousNumAffected': 1}, {'id': 'EG011', 'title': 'Follow-up: Always Placebo', 'description': 'Participants in follow-up with exposure to placebo only during the study. No placebo received during follow-up.', 'otherNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG012', 'title': 'Follow-up: Ever Used Baricitinib', 'description': 'Participants in follow-up with exposure to any dose of baricitinib during study. No baricitinib received during follow-up.', 'otherNumAtRisk': 185, 'otherNumAffected': 8, 'seriousNumAtRisk': 185, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG010', 'numAtRisk': 72, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 72, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vulvovaginal mycotic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Menopausal symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hysterectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Salpingo-oophorectomy bilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Oesophageal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ovarian adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Psoriasis Area and Severity Index Score ≥75% (PASI 75) Improvement (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '61', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Placebo', 'description': "Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks."}, {'id': 'OG001', 'title': 'Part A: Baricitinib 2 mg', 'description': "Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks."}, {'id': 'OG002', 'title': 'Part A: Baricitinib 4 mg', 'description': "Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks."}, {'id': 'OG003', 'title': 'Part A: Baricitinib 8 mg', 'description': "Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks."}, {'id': 'OG004', 'title': 'Part A: Baricitinib 10 mg', 'description': 'Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '28.6', 'groupId': 'OG002'}, {'value': '42.9', 'groupId': 'OG003'}, {'value': '54.1', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema (redness), and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease.', 'unitOfMeasure': 'Percent of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'North American (NA) modified intent-to-treat (mITT) population: All NA randomized participants who received at least one dose of study drug. Non-responders and participants who discontinued study drug any time prior to time point of interest, or discontinued from study, were defined as non-responders for the non-responder imputation (NRI) analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}, {'value': '69', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Placebo', 'description': "Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks."}, {'id': 'OG001', 'title': 'Part A: Baricitinib 2 mg', 'description': "Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks."}, {'id': 'OG002', 'title': 'Part A: Baricitinib 4 mg', 'description': "Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks."}, {'id': 'OG003', 'title': 'Part A: Baricitinib 8 mg', 'description': "Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks."}, {'id': 'OG004', 'title': 'Part A: Baricitinib 10 mg', 'description': 'Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000'}, {'value': '15.6', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}, {'value': '29.7', 'groupId': 'OG003'}, {'value': '34.8', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline in sPGA score.", 'unitOfMeasure': 'Percent of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug. Non-Responders, as well as all participants who discontinue study treatment at any time prior to the time point of interest, were defined as Non-Responders for the NRI analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving an sPGA of (0, 1) (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '43', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Responder - Low Dose', 'description': 'Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.'}, {'id': 'OG001', 'title': 'Part B: Responder - High Dose', 'description': 'Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.'}, {'id': 'OG002', 'title': 'Part B: Partial- and Non-responder - Placebo to High Dose', 'description': 'Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.'}, {'id': 'OG003', 'title': 'Part B: Partial-responder - Low Dose to Low Dose', 'description': 'Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.'}, {'id': 'OG004', 'title': 'Part B: Partial- and Non-responder - Low Dose to High Dose', 'description': 'Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.'}, {'id': 'OG005', 'title': 'Part B: Partial- and Non-responder - High Dose to High Dose', 'description': 'Baricitinib administered 8 mg or 10 mg PO QD.'}, {'id': 'OG006', 'title': 'Part B: Placebo Extension', 'description': 'Placebo PO QD maintained on placebo PO QD.'}], 'classes': [{'categories': [{'measurements': [{'value': '55.2', 'groupId': 'OG000'}, {'value': '64.1', 'groupId': 'OG001'}, {'value': '47.4', 'groupId': 'OG002'}, {'value': '37.5', 'groupId': 'OG003'}, {'value': '24.0', 'groupId': 'OG004'}, {'value': '27.9', 'groupId': 'OG005'}, {'value': '50.0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline in sPGA score.", 'unitOfMeasure': 'Percent of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug. Non-Responders, as well as all participants who discontinue study treatment at any time prior to the time point of interest, were defined as Non-Responders for the NRI analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving an sPGA of (0, 1) (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part D: Baricitinib 2 mg - Retreatment', 'description': 'Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.'}, {'id': 'OG001', 'title': 'Part D: Baricitinib 4 mg - Retreatment', 'description': 'Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.'}, {'id': 'OG002', 'title': 'Part D: Baricitinib 8 mg - Retreatment', 'description': 'Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.'}, {'id': 'OG003', 'title': 'Part D: Baricitinib 10 mg - Retreatment', 'description': 'Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '23.1', 'groupId': 'OG001'}, {'value': '21.1', 'groupId': 'OG002'}, {'value': '27.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 92', 'description': "The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline in sPGA score.", 'unitOfMeasure': 'Percent of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug. Non-Responders, as well as all participants who discontinue study treatment at any time prior to the time point of interest, were defined as Non-Responders for the NRI analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Part A in Mean Psoriasis Area and Severity Index (PASI) Total Score to Week 12 (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}, {'value': '69', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Placebo', 'description': "Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks."}, {'id': 'OG001', 'title': 'Part A: Baricitinib 2 mg', 'description': "Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks."}, {'id': 'OG002', 'title': 'Part A: Baricitinib 4 mg', 'description': "Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks."}, {'id': 'OG003', 'title': 'Part A: Baricitinib 8 mg', 'description': "Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks"}, {'id': 'OG004', 'title': 'Part A: Baricitinib 10 mg', 'description': 'Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.14', 'spread': '1.370', 'groupId': 'OG000'}, {'value': '9.40', 'spread': '1.413', 'groupId': 'OG001'}, {'value': '9.46', 'spread': '0.941', 'groupId': 'OG002'}, {'value': '11.52', 'spread': '0.997', 'groupId': 'OG003'}, {'value': '13.93', 'spread': '0.962', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline Part A, Week 12', 'description': 'The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. Least Squares Means (LS Means) were calculated using an analysis of covariance (ANCOVA) model on the last observation carried forward (LOCF) with treatment group as a fixed effect and baseline PASI score as a continuous covariate.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug. Missing values were imputed with the last observation carried forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Part A in Mean Psoriasis Area and Severity Index (PASI) Total Score to Week 24 (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis: Measure: Psoriasis Area and Severity Index [PASI])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '43', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Responder - Low Dose', 'description': 'Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.'}, {'id': 'OG001', 'title': 'Part B: Responder - High Dose', 'description': 'Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.'}, {'id': 'OG002', 'title': 'Part B: Partial- and Non-responder - Placebo to High Dose', 'description': 'Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.'}, {'id': 'OG003', 'title': 'Part B: Partial-responder - Low Dose to Low Dose', 'description': 'Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.'}, {'id': 'OG004', 'title': 'Part B: Partial- and Non-responder - Low Dose to High Dose', 'description': 'Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.'}, {'id': 'OG005', 'title': 'Part B: Partial- and Non-responder - High Dose to High Dose', 'description': 'Baricitinib administered 8 mg or 10 mg PO QD.'}, {'id': 'OG006', 'title': 'Part B: Placebo Extension', 'description': 'Placebo PO QD maintained on placebo PO QD.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.62', 'spread': '5.480', 'groupId': 'OG000'}, {'value': '16.69', 'spread': '7.399', 'groupId': 'OG001'}, {'value': '12.94', 'spread': '6.711', 'groupId': 'OG002'}, {'value': '12.23', 'spread': '7.510', 'groupId': 'OG003'}, {'value': '14.55', 'spread': '10.493', 'groupId': 'OG004'}, {'value': '13.67', 'spread': '9.966', 'groupId': 'OG005'}, {'value': '13.43', 'spread': '5.599', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Part A, Week 24', 'description': 'The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and at least 1 post-baseline observation in Part A at or prior to week 24. Missing values were imputed with the last observation carried forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Part D in Mean Psoriasis Area and Severity Index (PASI) Total Score to Week 92 (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part D: Baricitinib 2 mg - Retreatment', 'description': 'Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.'}, {'id': 'OG001', 'title': 'Part D: Baricitinib 4 mg - Retreatment', 'description': 'Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.'}, {'id': 'OG002', 'title': 'Part D: Baricitinib 8 mg - Retreatment', 'description': 'Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.'}, {'id': 'OG003', 'title': 'Part D: Baricitinib 10 mg - Retreatment', 'description': 'Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.33', 'spread': '2.836', 'groupId': 'OG000'}, {'value': '3.25', 'spread': '4.447', 'groupId': 'OG001'}, {'value': '5.84', 'spread': '5.544', 'groupId': 'OG002'}, {'value': '6.98', 'spread': '6.456', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Part D, Week 92', 'description': 'The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received ≥1 dose of study drug and has 1 post-baseline observation at or prior to week 92. Missing values were imputed with the last observation carried forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Placebo', 'description': "Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks."}, {'id': 'OG001', 'title': 'Part A: Baricitinib 2 mg', 'description': "Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks."}, {'id': 'OG002', 'title': 'Part A: Baricitinib 4 mg', 'description': "Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks."}, {'id': 'OG003', 'title': 'Part A: Baricitinib 8 mg', 'description': "Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks."}, {'id': 'OG004', 'title': 'Part A: Baricitinib 10 mg', 'description': 'Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.7', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '1.00', 'groupId': 'OG001'}, {'value': '-4.6', 'spread': '0.67', 'groupId': 'OG002'}, {'value': '-4.0', 'spread': '0.71', 'groupId': 'OG003'}, {'value': '-5.1', 'spread': '0.69', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline Part A, Week 12', 'description': 'The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant. Least Square (LS) Means in total DLQI score were calculated using Mixed Model Repeated Measures (MMRM) with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline DLQI observation. Missing values were imputed with the last observation carried forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Responder - Low Dose', 'description': 'Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.'}, {'id': 'OG001', 'title': 'Part B: Responder - High Dose', 'description': 'Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.'}, {'id': 'OG002', 'title': 'Part B: Partial- and Non-responder - Placebo to High Dose', 'description': 'Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.'}, {'id': 'OG003', 'title': 'Part B: Partial-responder - Low Dose to Low Dose', 'description': 'Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.'}, {'id': 'OG004', 'title': 'Part B: Partial- and Non-responder - Low Dose to High Dose', 'description': 'Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.'}, {'id': 'OG005', 'title': 'Part B: Partial- and Non-responder - High Dose to High Dose', 'description': 'Baricitinib administered 8 mg or 10 mg PO QD.'}, {'id': 'OG006', 'title': 'Part B: Placebo Extension', 'description': 'Placebo PO QD maintained on placebo PO QD.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.9', 'spread': '7.53', 'groupId': 'OG000'}, {'value': '-7.0', 'spread': '8.18', 'groupId': 'OG001'}, {'value': '-3.8', 'spread': '6.27', 'groupId': 'OG002'}, {'value': '-1.5', 'spread': '5.92', 'groupId': 'OG003'}, {'value': '-7.8', 'spread': '6.89', 'groupId': 'OG004'}, {'value': '-4.5', 'spread': '8.99', 'groupId': 'OG005'}, {'value': '-3.5', 'spread': '11.76', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Part A, Week 24', 'description': 'The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received ≥1 dose of study drug in Part B and had ≥1 evaluable post-baseline DLQI observation. Missing values were imputed with the last observation carried forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Part D in Dermatology Life Quality Index (DLQI) Total Score to Week 92', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part D: Baricitinib 2 mg - Retreatment', 'description': 'Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.'}, {'id': 'OG001', 'title': 'Part D: Baricitinib 4 mg - Retreatment', 'description': 'Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.'}, {'id': 'OG002', 'title': 'Part D: Baricitinib 8 mg - Retreatment', 'description': 'Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.'}, {'id': 'OG003', 'title': 'Part D: Baricitinib 10 mg - Retreatment', 'description': 'Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.3', 'spread': '4.93', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '3.62', 'groupId': 'OG001'}, {'value': '-2.1', 'spread': '7.40', 'groupId': 'OG002'}, {'value': '-5.0', 'spread': '6.31', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Part D, Week 92', 'description': 'The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline DLQI observation. Missing values were imputed with the last observation carried forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}, {'value': '69', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Placebo', 'description': "Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks."}, {'id': 'OG001', 'title': 'Part A: Baricitinib 2 mg', 'description': "Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks"}, {'id': 'OG002', 'title': 'Part A: Baricitinib 4 mg', 'description': "Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks."}, {'id': 'OG003', 'title': 'Part A: Baricitinib 8 mg', 'description': "Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks."}, {'id': 'OG004', 'title': 'Part A: Baricitinib 10 mg', 'description': 'Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '0.49', 'groupId': 'OG001'}, {'value': '-3.3', 'spread': '0.33', 'groupId': 'OG002'}, {'value': '-3.8', 'spread': '0.35', 'groupId': 'OG003'}, {'value': '-4.7', 'spread': '0.34', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline Part A, Week 12', 'description': 'The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant\'s itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours. LS Means were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline Itch NRS observation. Missing values were imputed with the last observation carried forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '43', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Responder - Low Dose', 'description': 'Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.'}, {'id': 'OG001', 'title': 'Part B: Responder - High Dose', 'description': 'Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.'}, {'id': 'OG002', 'title': 'Part B: Partial- and Non-responder - Placebo to High Dose', 'description': 'Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.'}, {'id': 'OG003', 'title': 'Part B: Partial-responder - Low Dose to Low Dose', 'description': 'Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.'}, {'id': 'OG004', 'title': 'Part B: Partial- and Non-responder - Low Dose to High Dose', 'description': 'Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.'}, {'id': 'OG005', 'title': 'Part B: Partial- and Non-responder - High Dose to High Dose', 'description': 'Baricitinib administered 8 mg or 10 mg PO QD.'}, {'id': 'OG006', 'title': 'Part B: Placebo Extension', 'description': 'Placebo PO QD maintained on placebo PO QD.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.7', 'spread': '3.52', 'groupId': 'OG000'}, {'value': '-5.6', 'spread': '2.96', 'groupId': 'OG001'}, {'value': '-5.4', 'spread': '3.83', 'groupId': 'OG002'}, {'value': '-3.4', 'spread': '3.69', 'groupId': 'OG003'}, {'value': '-4.1', 'spread': '3.33', 'groupId': 'OG004'}, {'value': '-3.5', 'spread': '3.03', 'groupId': 'OG005'}, {'value': '-2.5', 'spread': '4.11', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Part A, Week 24', 'description': 'The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant\'s itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline Itch NRS observation. Missing values were imputed with the last observation carried forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Part D in Itch Numeric Rating Scale (Itch NRS) Score to Week 92', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part D: Baricitinib 2 mg - Retreatment', 'description': 'Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.'}, {'id': 'OG001', 'title': 'Part D: Baricitinib 4 mg - Retreatment', 'description': 'Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.'}, {'id': 'OG002', 'title': 'Part D: Baricitinib 8 mg - Retreatment', 'description': 'Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.'}, {'id': 'OG003', 'title': 'Part D: Baricitinib 10 mg - Retreatment', 'description': 'Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.3', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '3.23', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '2.91', 'groupId': 'OG002'}, {'value': '-3.1', 'spread': '3.38', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Part D, Week 92', 'description': 'The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant\'s itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline Itch NRS observation. Missing values were imputed with the last observation carried forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}, {'value': '64', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Placebo', 'description': "Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks."}, {'id': 'OG001', 'title': 'Part A: Baricitinib 2 mg', 'description': "Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks."}, {'id': 'OG002', 'title': 'Part A: Baricitinib 4 mg', 'description': "Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks."}, {'id': 'OG003', 'title': 'Part A: Baricitinib 8 mg', 'description': "Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks."}, {'id': 'OG004', 'title': 'Part A: Baricitinib 10 mg', 'description': 'Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '0.39', 'groupId': 'OG002'}, {'value': '-0.7', 'spread': '0.40', 'groupId': 'OG003'}, {'value': '-0.9', 'spread': '0.40', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline Part A, Week 12', 'description': 'The 16-item QIDS-SR16 version is a widely used validated scale designed to assess the severity of depressive symptoms. The participant was asked to rate the severity and frequency of specific symptoms present over the last 7 days. The QIDS-SR16 total scores range from 0 to 27, where higher scores indicate higher severity of symptoms. LS Means were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline QIDS-SR16 observation. Missing values were imputed with the last observation carried forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Responder - Low Dose', 'description': 'Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.'}, {'id': 'OG001', 'title': 'Part B: Responder - High Dose', 'description': 'Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.'}, {'id': 'OG002', 'title': 'Part B: Partial- and Non-responder - Placebo to High Dose', 'description': 'Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.'}, {'id': 'OG003', 'title': 'Part B: Partial-responder - Low Dose to Low Dose', 'description': 'Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.'}, {'id': 'OG004', 'title': 'Part B: Partial- and Non-responder - Low Dose to High Dose', 'description': 'Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.'}, {'id': 'OG005', 'title': 'Part B: Partial- and Non-responder - High Dose to High Dose', 'description': 'Baricitinib administered 8 mg or 10 mg PO QD.'}, {'id': 'OG006', 'title': 'Part B: Placebo Extension', 'description': 'Placebo PO QD maintained on placebo PO QD.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '2.48', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '3.80', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '3.15', 'groupId': 'OG002'}, {'value': '-1.2', 'spread': '2.67', 'groupId': 'OG003'}, {'value': '-1.6', 'spread': '2.99', 'groupId': 'OG004'}, {'value': '-2.2', 'spread': '4.64', 'groupId': 'OG005'}, {'value': '-3.0', 'spread': '6.16', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Part A, Week 24', 'description': "The QIDS-SR16 is a 16-item, self-report instrument intended to assess the existence and severity of symptoms of depression as listed in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) (APA 1994). A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 to 3. The 16 items corresponding to 9 depression domains are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. The domains assessed by the instrument include: (1) sad mood, (2) concentration, (3) self-criticism, (4) suicidal ideation, (5) interest, (6) energy/fatigue, (7) sleep disturbance (initial, middle, and late insomnia or hypersomnia), (8) decrease/increase in appetite/weight, and (9) psychomotor agitation/retardation.", 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline QIDS-SR16 observation. As observed values were used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Part D in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 92', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part D: Baricitinib 2 mg - Retreatment', 'description': 'Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.'}, {'id': 'OG001', 'title': 'Part D: Baricitinib 4 mg - Retreatment', 'description': 'Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.'}, {'id': 'OG002', 'title': 'Part D: Baricitinib 8 mg - Retreatment', 'description': 'Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.'}, {'id': 'OG003', 'title': 'Part D: Baricitinib 10 mg - Retreatment', 'description': 'Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.25', 'spread': '1.708', 'groupId': 'OG001'}, {'value': '-0.13', 'spread': '3.796', 'groupId': 'OG002'}, {'value': '-0.86', 'spread': '2.143', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Part D, Week 92', 'description': "The QIDS-SR16 is a 16-item, self-report instrument intended to assess the existence and severity of symptoms of depression as listed in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) (APA 1994). A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 to 3. The 16 items corresponding to 9 depression domains are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. The domains assessed by the instrument include: (1) sad mood, (2) concentration, (3) self-criticism, (4) suicidal ideation, (5) interest, (6) energy/fatigue, (7) sleep disturbance (initial, middle, and late insomnia or hypersomnia), (8) decrease/increase in appetite/weight, and (9) psychomotor agitation/retardation.", 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline QIDS-SR16 observation. Missing values were imputed with the last observation carried forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '62', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Placebo', 'description': "Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks."}, {'id': 'OG001', 'title': 'Part A: Baricitinib 2 mg', 'description': "Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks."}, {'id': 'OG002', 'title': 'Part A: Baricitinib 4 mg', 'description': "Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks."}, {'id': 'OG003', 'title': 'Part A: Baricitinib 8 mg', 'description': "Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks."}, {'id': 'OG004', 'title': 'Part A: Baricitinib 10 mg', 'description': 'Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '2.55', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '2.46', 'groupId': 'OG001'}, {'value': '6.4', 'spread': '1.62', 'groupId': 'OG002'}, {'value': '9.5', 'spread': '1.71', 'groupId': 'OG003'}, {'value': '7.8', 'spread': '1.69', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline Part A, Week 12', 'description': 'The EQ-5D-5L is a standardized measure of health status of the participant. One of two portions of the EQ-5D-5L was used in which a self-perceived health score is assessed using a visual analogue scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the "worst health you can imagine" and 100 mm indicated the "best health you can imagine". This information is used as a quantitative measure of health outcome. LS Means were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.', 'unitOfMeasure': 'Millimeter (mm)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline EQ-5D-5L observation. As observed values were used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Responder - Low Dose', 'description': 'Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.'}, {'id': 'OG001', 'title': 'Part B: Responder - High Dose', 'description': 'Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.'}, {'id': 'OG002', 'title': 'Part B: Partial- and Non-responder - Placebo to High Dose', 'description': 'Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.'}, {'id': 'OG003', 'title': 'Part B: Partial-responder - Low Dose to Low Dose', 'description': 'Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.'}, {'id': 'OG004', 'title': 'Part B: Partial- and Non-responder - Low Dose to High Dose', 'description': 'Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.'}, {'id': 'OG005', 'title': 'Part B: Partial- and Non-responder - High Dose to High Dose', 'description': 'Baricitinib administered 8 mg or 10 mg PO QD.'}, {'id': 'OG006', 'title': 'Part B: Placebo Extension', 'description': 'Placebo PO QD maintained on placebo PO QD.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'spread': '11.41', 'groupId': 'OG000'}, {'value': '13.2', 'spread': '22.06', 'groupId': 'OG001'}, {'value': '9.6', 'spread': '10.78', 'groupId': 'OG002'}, {'value': '9.4', 'spread': '20.95', 'groupId': 'OG003'}, {'value': '7.5', 'spread': '14.47', 'groupId': 'OG004'}, {'value': '10.5', 'spread': '19.94', 'groupId': 'OG005'}, {'value': '7.8', 'spread': '11.92', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Part A, Week 24', 'description': 'The EQ-5D-5L is a standardized measure of health status of the participant. One of two portions of the EQ-5D-5L was used in which a self-perceived health score is assessed using a visual analogue scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the "worst health you can imagine" and 100 mm indicated the "best health you can imagine". This information is used as a quantitative measure of health outcome.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline EQ-5D-5L observation. As observed values were used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Part D in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part D: Baricitinib 2 mg - Retreatment', 'description': 'Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.'}, {'id': 'OG001', 'title': 'Part D: Baricitinib 4 mg - Retreatment', 'description': 'Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.'}, {'id': 'OG002', 'title': 'Part D: Baricitinib 8 mg - Retreatment', 'description': 'Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.'}, {'id': 'OG003', 'title': 'Part D: Baricitinib 10 mg - Retreatment', 'description': 'Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.67', 'spread': '10.263', 'groupId': 'OG000'}, {'value': '4.00', 'spread': '26.920', 'groupId': 'OG001'}, {'value': '4.78', 'spread': '13.571', 'groupId': 'OG002'}, {'value': '4.19', 'spread': '19.727', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Part D, Week 92', 'description': 'The EQ-5D-5L is a standardized measure of health status of the participant. One of two portions of the EQ-5D-5L was used in which a self-perceived health score is assessed using a visual analogue scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the "worst health you can imagine" and 100 mm indicated the "best health you can imagine". This information is used as a quantitative measure of health outcome.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline EQ-5D-5L observation. Missing values were imputed with the last observation carried forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Experiencing Rebound Upon Discontinuation of Study Drug in Part C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Responder - Low Dose to Placebo', 'description': 'Baricitinib 2 mg or 4 mg PO QD re-randomized to placebo PO QD.'}, {'id': 'OG001', 'title': 'Part C: Responder - Low Dose to ½ Low Dose', 'description': 'Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 1 mg or 2 mg PO QD.'}, {'id': 'OG002', 'title': 'Part C: Responder - High Dose to Placebo', 'description': 'Baricitinib administered 8 mg or 10 mg PO QD re-randomized to placebo PO QD.'}, {'id': 'OG003', 'title': 'Part C: Responder - High Dose to Low Dose', 'description': 'Baricitinib administered 8 mg PO QD re-randomized to baricitinib 4 mg PO QD. Baricitinib administered 10 mg PO QD re-randomized to baricitinib 4 mg PO QD.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 40', 'description': 'Rebound was defined as worsening of psoriasis compared to baseline at Week 0 (for example, PASI score \\>125% of baseline value) or new pustular, erythrodermic, or more inflammatory psoriasis occurring within 3 months of stopping study drug.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received ≥1 dose of study drug in Part A and participated in Part C.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of Baricitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Baricitinib 2 mg', 'description': "Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks."}, {'id': 'OG001', 'title': 'Baricitinib 4 mg', 'description': "Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks."}, {'id': 'OG002', 'title': 'Baricitinib 8 mg', 'description': "Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks"}, {'id': 'OG003', 'title': 'Baricitinib 10 mg', 'description': 'Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.4', 'spread': '24.7', 'groupId': 'OG000'}, {'value': '106', 'spread': '25.9', 'groupId': 'OG001'}, {'value': '222', 'spread': '24.4', 'groupId': 'OG002'}, {'value': '260', 'spread': '22.9', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1:15 minutes(m) to 30m and 1hour(h) to 3h Postdose; Week 1:Predose; Week 4:Predose; Week 8:Predose; 15m to 30m and 1h to 3h Postdose, Week 12:Predose; Weeks 14 and 20; Week 24:Predose; Week 28; Week 40. If applicable: Weeks 4, 24, and 52 Post-Relapse', 'unitOfMeasure': 'nanomole (nM)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received ≥1 dose of study drug in Part A, had evaluable PK, and participated in Part C. Some participants received 4mg or 8 mg and increased to 8mg or 10 mg, depending on the response at week 12. Those participants are treated as separate participants in each dose group.'}, {'type': 'SECONDARY', 'title': 'PK: Area Under the Concentration-Time Curve Versus Time During One Dosing Interval at Steady State (AUC τ,ss)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Baricitinib 2 mg', 'description': "Baricitinib 2 milligram (mg) administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks."}, {'id': 'OG001', 'title': 'Baricitinib 4 mg', 'description': "Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks."}, {'id': 'OG002', 'title': 'Baricitinib 8 mg', 'description': "Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks"}, {'id': 'OG003', 'title': 'Baricitinib 10 mg', 'description': 'Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '462', 'spread': '40.7', 'groupId': 'OG000'}, {'value': '975', 'spread': '41.1', 'groupId': 'OG001'}, {'value': '2030', 'spread': '43.3', 'groupId': 'OG002'}, {'value': '2440', 'spread': '42.2', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1:15 minutes(m) to 30m and 1hour(h) to 3h Postdose; Week 1:Predose; Week 4:Predose; Week 8:Predose; 15m to 30m and 1h to 3h Postdose, Week 12:Predose; Weeks 14 and 20; Week 24:Predose; Week 28; Week 40. If applicable: Weeks 4, 24, and 52 Post-Relapse', 'unitOfMeasure': 'nanomole*hour (nM*h)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received ≥1 dose of study drug in Part A, had evaluable PK, and participated in Part A, B or C. Some participants received 4mg or 8 mg and increased to 8mg or 10 mg, depending on the response at week 12. Those participants are treated as separate participants in each dose group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A: Placebo', 'description': "Placebo administered orally (PO) once daily (QD) for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks."}, {'id': 'FG001', 'title': 'Part A: Baricitinib 2 mg', 'description': "Baricitinib 2 milligram (mg) administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks."}, {'id': 'FG002', 'title': 'Part A: Baricitinib 4 mg', 'description': "Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks."}, {'id': 'FG003', 'title': 'Part A: Baricitinib 8 mg', 'description': "Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks."}, {'id': 'FG004', 'title': 'Part A: Baricitinib 10 mg', 'description': 'Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.'}, {'id': 'FG005', 'title': 'Part B: Responder - Low Dose', 'description': 'Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.'}, {'id': 'FG006', 'title': 'Part B: Responder - High Dose', 'description': 'Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.'}, {'id': 'FG007', 'title': 'Part B: Partial- and Non-responder - Placebo to High Dose', 'description': 'Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.'}, {'id': 'FG008', 'title': 'Part B: Partial-responder - Low Dose to Low Dose', 'description': 'Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.'}, {'id': 'FG009', 'title': 'Part B: Partial- and Non-responder - Low Dose to High Dose', 'description': 'Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.'}, {'id': 'FG010', 'title': 'Part B: Partial- and Non-responder - High Dose to High Dose', 'description': 'Baricitinib administered 8 mg or 10 mg PO QD.'}, {'id': 'FG011', 'title': 'Part B: Placebo Extension', 'description': 'Placebo PO QD maintained on placebo PO QD.'}, {'id': 'FG012', 'title': 'Part C: Responder - Low Dose to Placebo', 'description': 'Baricitinib 2 mg or 4 mg PO QD re-randomized to placebo PO QD.'}, {'id': 'FG013', 'title': 'Part C: Responder - Low Dose to ½ Low Dose', 'description': 'Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 1 mg or 2 mg PO QD.'}, {'id': 'FG014', 'title': 'Part C: Responder - High Dose to Placebo', 'description': 'Baricitinib administered 8 mg or 10 mg PO QD re-randomized to placebo PO QD.'}, {'id': 'FG015', 'title': 'Part C: Responder - High Dose to Low Dose', 'description': 'Baricitinib administered 8 mg PO QD re-randomized to baricitinib 4 mg PO QD. Baricitinib administered 10 mg PO QD re-randomized to baricitinib 4 mg PO QD.'}, {'id': 'FG016', 'title': 'Part D: Baricitinib 2 mg - Retreatment', 'description': 'Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.'}, {'id': 'FG017', 'title': 'Part D: Baricitinib 4 mg - Retreatment', 'description': 'Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.'}, {'id': 'FG018', 'title': 'Part D: Baricitinib 8 mg - Retreatment', 'description': 'Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.'}, {'id': 'FG019', 'title': 'Part D: Baricitinib 10 mg - Retreatment', 'description': 'Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.'}], 'periods': [{'title': 'Part A: Initial Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '72'}, {'groupId': 'FG003', 'numSubjects': '64'}, {'groupId': 'FG004', 'numSubjects': '69'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '72'}, {'groupId': 'FG003', 'numSubjects': '64'}, {'groupId': 'FG004', 'numSubjects': '69'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '67'}, {'groupId': 'FG003', 'numSubjects': '55'}, {'comment': 'Includes participants who completed Part A, but discontinued per protocol using Part A PASI score.', 'groupId': 'FG004', 'numSubjects': '52'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'Discontinued at Week 12 per protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}]}, {'title': 'Part B: Extension or Step-Up Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'See Recruitment Details for explanation of Part B participant assignment.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'See Recruitment Details for explanation of Part B participant assignment.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'See Recruitment Details for explanation of Part B participant assignment.', 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'See Recruitment Details for explanation of Part B participant assignment.', 'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'See Recruitment Details for explanation of Part B participant assignment.', 'groupId': 'FG004', 'numSubjects': '0'}, {'comment': 'Part A participants randomized to 2 mg or 4 mg with a PASI ≥75 remained on 2 mg or 4 mg.', 'groupId': 'FG005', 'numSubjects': '29'}, {'comment': 'Part A participants randomized to 8 mg or 10 mg with a PASI ≥75 remained on 8 mg or 10 mg.', 'groupId': 'FG006', 'numSubjects': '64'}, {'comment': 'Placebo participants in Part A with a PASI \\<75 were re-randomized to 8 mg or 10 mg.', 'groupId': 'FG007', 'numSubjects': '19'}, {'comment': 'Part A participants randomized to 2 mg or 4 mg with a PASI ≥50 to \\<75 remained on 2 mg or 4 mg.', 'groupId': 'FG008', 'numSubjects': '16'}, {'comment': 'Part A participants randomized to 2 mg or 4 mg with a PASI \\<50 were re-randomized to 8 mg or 10 mg.', 'groupId': 'FG009', 'numSubjects': '50'}, {'comment': 'Part A 10 mg non-responders were discontinued from the study.', 'groupId': 'FG010', 'numSubjects': '43'}, {'comment': 'Part A participants randomized to Placebo remained on Placebo.', 'groupId': 'FG011', 'numSubjects': '8'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '25'}, {'groupId': 'FG006', 'numSubjects': '51'}, {'groupId': 'FG007', 'numSubjects': '13'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '25'}, {'groupId': 'FG010', 'numSubjects': '22'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '13'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '10'}, {'groupId': 'FG009', 'numSubjects': '25'}, {'groupId': 'FG010', 'numSubjects': '21'}, {'groupId': 'FG011', 'numSubjects': '8'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '2'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'Completed Part B and Not Moving to PartC', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '8'}, {'groupId': 'FG009', 'numSubjects': '19'}, {'groupId': 'FG010', 'numSubjects': '16'}, {'groupId': 'FG011', 'numSubjects': '5'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}]}, {'title': 'Part C: Washout or Step-Down Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'One participant completed Part B but discontinued without receiving a Part C treatment assignment.', 'groupId': 'FG004', 'numSubjects': '0'}, {'comment': 'Part A participants randomized to 2 mg or 4 mg with a PASI ≥75 remained on 2 mg or 4 mg.', 'groupId': 'FG005', 'numSubjects': '0'}, {'comment': 'Part A participants randomized to 8 mg or 10 mg with a PASI ≥75 remained on 8 mg or 10 mg.', 'groupId': 'FG006', 'numSubjects': '0'}, {'comment': 'Placebo participants in Part A with a PASI \\<75 were re-randomized to 8 mg or 10 mg.', 'groupId': 'FG007', 'numSubjects': '0'}, {'comment': 'Part A participants randomized to 2 mg or 4 mg with a PASI ≥50 to \\<75 remained on 2 mg or 4 mg.', 'groupId': 'FG008', 'numSubjects': '0'}, {'comment': 'Part A participants randomized to 2 mg or 4 mg with a PASI \\<50 were re-randomized to 8 mg or 10 mg.', 'groupId': 'FG009', 'numSubjects': '0'}, {'comment': 'Part A 10 mg non-responders were discontinued from the study.', 'groupId': 'FG010', 'numSubjects': '0'}, {'comment': 'Part A participants randomized to Placebo remained on Placebo.', 'groupId': 'FG011', 'numSubjects': '0'}, {'comment': 'Responders receiving 2 or 4 mg were re-randomized to receive placebo.', 'groupId': 'FG012', 'numSubjects': '15'}, {'comment': 'Responders receiving 2 or 4 mg were re-randomized to receive half of the dose from Part B.', 'groupId': 'FG013', 'numSubjects': '16'}, {'comment': 'Responders receiving 8 or 10 mg were re-randomized to receive placebo.', 'groupId': 'FG014', 'numSubjects': '55'}, {'comment': 'Responders receiving 8 or 10 mg were re-randomized to receive 4 mg.', 'groupId': 'FG015', 'numSubjects': '55'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '10'}, {'groupId': 'FG013', 'numSubjects': '6'}, {'groupId': 'FG014', 'numSubjects': '37'}, {'groupId': 'FG015', 'numSubjects': '18'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '5'}, {'groupId': 'FG013', 'numSubjects': '10'}, {'groupId': 'FG014', 'numSubjects': '18'}, {'groupId': 'FG015', 'numSubjects': '37'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '2'}, {'groupId': 'FG015', 'numSubjects': '2'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '2'}, {'groupId': 'FG015', 'numSubjects': '1'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'Did Not Qualify for Part D Per Protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '5'}, {'groupId': 'FG013', 'numSubjects': '9'}, {'groupId': 'FG014', 'numSubjects': '14'}, {'groupId': 'FG015', 'numSubjects': '34'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}]}, {'title': 'Part D: Re-Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'comment': 'Responders receiving 2 or 4 mg were re-randomized to receive placebo.', 'groupId': 'FG012', 'numSubjects': '0'}, {'comment': 'Responders receiving 2 or 4 mg were re-randomized to receive half of the dose from Part B.', 'groupId': 'FG013', 'numSubjects': '0'}, {'comment': 'Responders receiving 8 or 10 mg were re-randomized to receive placebo.', 'groupId': 'FG014', 'numSubjects': '0'}, {'comment': 'Responders receiving 8 or 10 mg were re-randomized to receive 4 mg.', 'groupId': 'FG015', 'numSubjects': '0'}, {'comment': 'Responders who experienced a relapse or flare proceeded for retreatment with 2 mg.', 'groupId': 'FG016', 'numSubjects': '3'}, {'comment': 'Responders who experienced a relapse or flare proceeded for retreatment with 4 mg.', 'groupId': 'FG017', 'numSubjects': '13'}, {'comment': 'Responders who experienced a relapse or flare proceeded for retreatment with 8 mg.', 'groupId': 'FG018', 'numSubjects': '19'}, {'comment': 'Responders who experienced a relapse or flare proceeded for retreatment with 10 mg.', 'groupId': 'FG019', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '3'}, {'groupId': 'FG017', 'numSubjects': '8'}, {'groupId': 'FG018', 'numSubjects': '12'}, {'groupId': 'FG019', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '5'}, {'groupId': 'FG018', 'numSubjects': '7'}, {'groupId': 'FG019', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '1'}, {'groupId': 'FG018', 'numSubjects': '1'}, {'groupId': 'FG019', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '1'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '3'}, {'groupId': 'FG018', 'numSubjects': '1'}, {'groupId': 'FG019', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '1'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '1'}, {'groupId': 'FG019', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '1'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '1'}, {'groupId': 'FG018', 'numSubjects': '1'}, {'groupId': 'FG019', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participant Psoriasis Area and Severity Index (PASI) score at the conclusion of Part A stratified participants as either Responder (PASI ≥75), Partial Responder (PASI 50 - PASI 74), or Non-Responder (PASI \\<50).', 'preAssignmentDetails': 'Part A: Initial Treatment Period (Weeks 0 up to 12) Part B: Extension or Step-Up Period (Week 12 up to Week 24) Part C: Washout or Step-Down Period (Week 24 up to Week 40) Part D: (Re-Treatment Period up to 52 Weeks)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}, {'value': '69', 'groupId': 'BG004'}, {'value': '271', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A: Placebo', 'description': "Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks."}, {'id': 'BG001', 'title': 'Part A: Baricitinib 2 mg', 'description': "Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks."}, {'id': 'BG002', 'title': 'Part A: Baricitinib 4 mg', 'description': "Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks."}, {'id': 'BG003', 'title': 'Part A: Baricitinib 8 mg', 'description': "Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks."}, {'id': 'BG004', 'title': 'Part A: Baricitinib 10 mg', 'description': 'Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '46.70', 'spread': '15.144', 'groupId': 'BG000'}, {'value': '47.81', 'spread': '15.165', 'groupId': 'BG001'}, {'value': '47.21', 'spread': '11.650', 'groupId': 'BG002'}, {'value': '47.37', 'spread': '15.829', 'groupId': 'BG003'}, {'value': '47.43', 'spread': '10.425', 'groupId': 'BG004'}, {'value': '47.31', 'spread': '13.268', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '74', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '197', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '43', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '59', 'groupId': 'BG004'}, {'value': '228', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '45', 'groupId': 'BG005'}]}, {'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': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}, {'value': '215', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '33', 'groupId': 'BG005'}]}]}, {'title': 'North America', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}, {'value': '61', 'groupId': 'BG004'}, {'value': '238', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of Psoriasis (Ps)', 'classes': [{'categories': [{'measurements': [{'value': '16.42', 'spread': '14.297', 'groupId': 'BG000'}, {'value': '15.00', 'spread': '9.951', 'groupId': 'BG001'}, {'value': '19.90', 'spread': '12.766', 'groupId': 'BG002'}, {'value': '16.56', 'spread': '11.948', 'groupId': 'BG003'}, {'value': '16.60', 'spread': '10.653', 'groupId': 'BG004'}, {'value': '17.26', 'spread': '11.995', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Percent Body Surface Area (BSA) Affected by Psoriasis', 'classes': [{'categories': [{'measurements': [{'value': '23.18', 'spread': '11.890', 'groupId': 'BG000'}, {'value': '30.78', 'spread': '20.523', 'groupId': 'BG001'}, {'value': '28.61', 'spread': '18.797', 'groupId': 'BG002'}, {'value': '28.23', 'spread': '15.726', 'groupId': 'BG003'}, {'value': '24.45', 'spread': '12.079', 'groupId': 'BG004'}, {'value': '27.04', 'spread': '16.101', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percent of BSA', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Psoriasis Area and Severity Index (PASI) Score', 'classes': [{'categories': [{'measurements': [{'value': '19.06', 'spread': '6.805', 'groupId': 'BG000'}, {'value': '21.36', 'spread': '11.056', 'groupId': 'BG001'}, {'value': '20.58', 'spread': '9.438', 'groupId': 'BG002'}, {'value': '20.24', 'spread': '7.827', 'groupId': 'BG003'}, {'value': '19.01', 'spread': '6.177', 'groupId': 'BG004'}, {'value': '20.00', 'spread': '8.228', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized participants who received at least one dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 271}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'dispFirstSubmitDate': '2013-01-11', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-10', 'studyFirstSubmitDate': '2011-12-09', 'dispFirstSubmitQcDate': '2013-01-25', 'resultsFirstSubmitDate': '2017-03-10', 'studyFirstSubmitQcDate': '2011-12-09', 'dispFirstPostDateStruct': {'date': '2013-01-29', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-19', 'studyFirstPostDateStruct': {'date': '2011-12-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Psoriasis Area and Severity Index Score ≥75% (PASI 75) Improvement (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])', 'timeFrame': 'Week 12', 'description': 'The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema (redness), and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])', 'timeFrame': 'Week 12', 'description': "The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline in sPGA score."}, {'measure': 'Percentage of Participants Achieving an sPGA of (0, 1) (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])', 'timeFrame': 'Week 24', 'description': "The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline in sPGA score."}, {'measure': 'Percentage of Participants Achieving an sPGA of (0, 1) (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])', 'timeFrame': 'Week 92', 'description': "The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline in sPGA score."}, {'measure': 'Change From Baseline in Part A in Mean Psoriasis Area and Severity Index (PASI) Total Score to Week 12 (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])', 'timeFrame': 'Baseline Part A, Week 12', 'description': 'The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. Least Squares Means (LS Means) were calculated using an analysis of covariance (ANCOVA) model on the last observation carried forward (LOCF) with treatment group as a fixed effect and baseline PASI score as a continuous covariate.'}, {'measure': 'Change From Baseline in Part A in Mean Psoriasis Area and Severity Index (PASI) Total Score to Week 24 (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis: Measure: Psoriasis Area and Severity Index [PASI])', 'timeFrame': 'Baseline Part A, Week 24', 'description': 'The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.'}, {'measure': 'Change From Baseline in Part D in Mean Psoriasis Area and Severity Index (PASI) Total Score to Week 92 (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])', 'timeFrame': 'Baseline Part D, Week 92', 'description': 'The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.'}, {'measure': 'Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 12', 'timeFrame': 'Baseline Part A, Week 12', 'description': 'The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant. Least Square (LS) Means in total DLQI score were calculated using Mixed Model Repeated Measures (MMRM) with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.'}, {'measure': 'Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 24', 'timeFrame': 'Baseline Part A, Week 24', 'description': 'The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant.'}, {'measure': 'Change From Baseline Part D in Dermatology Life Quality Index (DLQI) Total Score to Week 92', 'timeFrame': 'Baseline Part D, Week 92', 'description': 'The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant.'}, {'measure': 'Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score at Week 12', 'timeFrame': 'Baseline Part A, Week 12', 'description': 'The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant\'s itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours. LS Means were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.'}, {'measure': 'Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score to Week 24', 'timeFrame': 'Baseline Part A, Week 24', 'description': 'The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant\'s itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.'}, {'measure': 'Change From Baseline Part D in Itch Numeric Rating Scale (Itch NRS) Score to Week 92', 'timeFrame': 'Baseline Part D, Week 92', 'description': 'The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant\'s itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.'}, {'measure': 'Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score at Week 12', 'timeFrame': 'Baseline Part A, Week 12', 'description': 'The 16-item QIDS-SR16 version is a widely used validated scale designed to assess the severity of depressive symptoms. The participant was asked to rate the severity and frequency of specific symptoms present over the last 7 days. The QIDS-SR16 total scores range from 0 to 27, where higher scores indicate higher severity of symptoms. LS Means were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.'}, {'measure': 'Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 24', 'timeFrame': 'Baseline Part A, Week 24', 'description': "The QIDS-SR16 is a 16-item, self-report instrument intended to assess the existence and severity of symptoms of depression as listed in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) (APA 1994). A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 to 3. The 16 items corresponding to 9 depression domains are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. The domains assessed by the instrument include: (1) sad mood, (2) concentration, (3) self-criticism, (4) suicidal ideation, (5) interest, (6) energy/fatigue, (7) sleep disturbance (initial, middle, and late insomnia or hypersomnia), (8) decrease/increase in appetite/weight, and (9) psychomotor agitation/retardation."}, {'measure': 'Change From Baseline Part D in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 92', 'timeFrame': 'Baseline Part D, Week 92', 'description': "The QIDS-SR16 is a 16-item, self-report instrument intended to assess the existence and severity of symptoms of depression as listed in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) (APA 1994). A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 to 3. The 16 items corresponding to 9 depression domains are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. The domains assessed by the instrument include: (1) sad mood, (2) concentration, (3) self-criticism, (4) suicidal ideation, (5) interest, (6) energy/fatigue, (7) sleep disturbance (initial, middle, and late insomnia or hypersomnia), (8) decrease/increase in appetite/weight, and (9) psychomotor agitation/retardation."}, {'measure': 'Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores', 'timeFrame': 'Baseline Part A, Week 12', 'description': 'The EQ-5D-5L is a standardized measure of health status of the participant. One of two portions of the EQ-5D-5L was used in which a self-perceived health score is assessed using a visual analogue scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the "worst health you can imagine" and 100 mm indicated the "best health you can imagine". This information is used as a quantitative measure of health outcome. LS Means were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.'}, {'measure': 'Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores', 'timeFrame': 'Baseline Part A, Week 24', 'description': 'The EQ-5D-5L is a standardized measure of health status of the participant. One of two portions of the EQ-5D-5L was used in which a self-perceived health score is assessed using a visual analogue scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the "worst health you can imagine" and 100 mm indicated the "best health you can imagine". This information is used as a quantitative measure of health outcome.'}, {'measure': 'Change From Baseline Part D in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores', 'timeFrame': 'Baseline Part D, Week 92', 'description': 'The EQ-5D-5L is a standardized measure of health status of the participant. One of two portions of the EQ-5D-5L was used in which a self-perceived health score is assessed using a visual analogue scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the "worst health you can imagine" and 100 mm indicated the "best health you can imagine". This information is used as a quantitative measure of health outcome.'}, {'measure': 'Percentage of Participants Experiencing Rebound Upon Discontinuation of Study Drug in Part C', 'timeFrame': 'Week 40', 'description': 'Rebound was defined as worsening of psoriasis compared to baseline at Week 0 (for example, PASI score \\>125% of baseline value) or new pustular, erythrodermic, or more inflammatory psoriasis occurring within 3 months of stopping study drug.'}, {'measure': 'Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of Baricitinib', 'timeFrame': 'Day 1:15 minutes(m) to 30m and 1hour(h) to 3h Postdose; Week 1:Predose; Week 4:Predose; Week 8:Predose; 15m to 30m and 1h to 3h Postdose, Week 12:Predose; Weeks 14 and 20; Week 24:Predose; Week 28; Week 40. If applicable: Weeks 4, 24, and 52 Post-Relapse'}, {'measure': 'PK: Area Under the Concentration-Time Curve Versus Time During One Dosing Interval at Steady State (AUC τ,ss)', 'timeFrame': 'Day 1:15 minutes(m) to 30m and 1hour(h) to 3h Postdose; Week 1:Predose; Week 4:Predose; Week 8:Predose; 15m to 30m and 1h to 3h Postdose, Week 12:Predose; Weeks 14 and 20; Week 24:Predose; Week 28; Week 40. If applicable: Weeks 4, 24, and 52 Post-Relapse'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Moderate', 'Severe', 'Plaque', 'Chronic'], 'conditions': ['Psoriasis', 'Skin Diseases', 'Skin Diseases, Papulosquamous']}, 'descriptionModule': {'briefSummary': 'This is a dose-ranging study designed to investigate the efficacy and safety of Baricitinib in the treatment of participants with moderate to severe, chronic plaque psoriasis as assessed by the Psoriasis Area and Severity Index (PASI) score and routine safety assessments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* You must have active chronic plaque psoriasis for at least 6 months prior to entry into the study\n* You are a candidate for systemic therapy and/or phototherapy\n* You must have active plaque psoriasis covering at least 12% body surface area\n* You must have Psoriasis Area and Severity Index (PASI) score of at least 12\n* You must have Static Physician's Global Assessment (sPGA) score of at least 3\n\nExclusion Criteria:\n\n* You must not have received a biologic agent/monoclonal antibody within 8 weeks prior to entry into the study\n* You must not have prior treatment with an oral Janus kinase (JAK) inhibitor\n* You must not have received a systemic psoriasis (Ps) therapy within 4 weeks prior to entry into the study\n* You must not have received a phototherapy within 4 weeks prior to entry into the study\n* You must not have received a topical Ps therapy with psoralens within 4 weeks prior to entry into the study\n* You must not be pregnant or nursing\n* If female of childbearing potential or a male, and do not agree to use 2 forms of highly effective methods of birth control for at least 28 days following the last dose of investigational product\n* You must not have had symptomatic herpes zoster or herpes simplex infection within 12 weeks or have a history of disseminated/complicated herpes zoster\n* You must not have evidence of active infection, such as fever ≥38.0ºC (100.4ºF)\n* You must not have a history of active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)\n* You must not be immunocompromised and, in the opinion of the investigator, are at an unacceptable risk for participating in the study\n* You must not have known history hypogammaglobulinemia\n* You must not have had a serious systemic or local infection within 12 weeks prior to entry into the study\n* You must not have been exposed to a live vaccine within 12 weeks prior to entry into the study, or expected to need/receive a live vaccine (including herpes zoster vaccination) during the course of the study\n* You must not have had household contact with a person with active tuberculosis (TB) and did not receive appropriate and documented prophylaxis for TB\n* You must not have a serious and/or unstable illness that, in the opinion of the investigator, poses an unacceptable risk for the your participation in the study\n* You must not have or have had a history of lymphoproliferative disease; or signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or active primary or recurrent malignant disease; or been in remission from clinically significant malignancy for less than 5 years\n* You must not have a history of chronic alcohol abuse or intravenous (IV) drug abuse within the last 2 years\n* You must not have donated blood of more than 500 mL within 4 weeks\n* You must not have received a topical Ps treatment within 2 weeks prior to entry into the study\n\n * Exceptions:\n * class 6 (mild, such as desonide) or class 7 (least potent, such as hydrocortisone) topical steroids used on the face, axilla, palms, soles, and/or genitalia\n * non-medicated shampoos (for example, that do not contain corticosteroids, coal tar, or vitamin D3 analogues)\n * emollients that do not contain alpha or beta hydroxyl acids"}, 'identificationModule': {'nctId': 'NCT01490632', 'briefTitle': 'A Phase 2b Study of Baricitinib in Participants With Moderate to Severe Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Phase 2b Study of Baricitinib in Patients With Moderate-to-Severe Plaque Psoriasis', 'orgStudyIdInfo': {'id': '14455'}, 'secondaryIdInfos': [{'id': 'I4V-MC-JADP', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Part A: Placebo administered orally (PO) once daily (QD) for 12 weeks. Part B: Placebo participants stayed on placebo or re-randomized to baricitinib 8 milligram (mg) or 10 mg PO QD for 12 weeks. Part C: Baricitinib participants re-randomized to 4 mg or placebo PO QD for 16 weeks. Part D: Retreated with Part B efficacious dose.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Baricitinib 2 mg', 'description': "Part A: Baricitinib administered PO QD for initial 12 weeks. Part B: Depending on participant's response, participant was maintained on current dose, or re-randomized to increased dose PO QD for 12 weeks. Part C: Participants re-randomized to half dose or placebo PO QD for 16 weeks. Part D: Participants retreated with Part B efficacious dose for 52 weeks.", 'interventionNames': ['Drug: Baricitinib']}, {'type': 'EXPERIMENTAL', 'label': 'Baricitinib 4 mg', 'description': "Part A: Baricitinib administered PO QD for initial 12 weeks. Part B: Depending on participant's response, participant was maintained on current dose, or re-randomized to increased dose PO QD for 12 weeks. Part C: Participants re-randomized to half dose or placebo PO QD for 16 weeks. Part D: Participants retreated with Part B efficacious dose for 52 weeks.", 'interventionNames': ['Drug: Baricitinib']}, {'type': 'EXPERIMENTAL', 'label': 'Baricitinib 8 mg', 'description': "Part A: Baricitinib administered PO QD for initial 12 weeks. Part B: Depending on participant's response, participant was maintained on current dose, or re-randomized to increased dose PO QD for 12 weeks. Part C: Participants re-randomized to half dose or placebo PO QD for 16 weeks. Part D: Participants retreated with Part B efficacious dose for 52 weeks.", 'interventionNames': ['Drug: Baricitinib']}, {'type': 'EXPERIMENTAL', 'label': 'Baricitinib 10 mg', 'description': "Part A: Baricitinib administered PO QD for initial 12 weeks. Part B: Depending on participant's response, participant was maintained on current dose, or discontinued from the study for 12 weeks. Part C: Participants re-randomized to 4mg dose or placebo PO QD for 16 weeks. Part D: Participants retreated with Part B efficacious dose for 52 weeks.", 'interventionNames': ['Drug: Baricitinib']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Placebo']}, {'name': 'Baricitinib', 'type': 'DRUG', 'otherNames': ['LY3009104', 'INCB028050'], 'description': 'Administered orally', 'armGroupLabels': ['Baricitinib 10 mg', 'Baricitinib 2 mg', 'Baricitinib 4 mg', 'Baricitinib 8 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '33175', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33027', 'city': 'Miramar', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 25.98731, 'lon': -80.23227}}, {'zip': '34471', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '30022', 'city': 'Alpharetta', 'state': 'Georgia', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.07538, 'lon': -84.29409}}, {'zip': '60005', 'city': 'Arlington Heights', 'state': 'Illinois', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.08836, 'lon': -87.98063}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '08520', 'city': 'East Windsor', 'state': 'New Jersey', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.268, 'lon': -74.54043}}, {'zip': '87104', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '14623', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '19341', 'city': 'Exton', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.029, 'lon': -75.62077}}, {'zip': '19103', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'V1Y 4X3', 'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}, {'zip': 'V3R 6A7', 'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'K9J 1Z2', 'city': 'Peterborough', 'state': 'Ontario', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.30012, 'lon': -78.31623}}, {'zip': 'L4B 1A5', 'city': 'Richmond Hill', 'state': 'Ontario', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.87111, 'lon': -79.43725}}, {'zip': 'N2J 1C4', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}, {'zip': 'J1H1Z1', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': 'G1V4X7', 'city': 'Québec', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '292-8535', 'city': 'Chiba', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '814-0180', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '923-8560', 'city': 'Ishikawa', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 26.42333, 'lon': 127.82139}}, {'zip': '2308765', 'city': 'Kanagawa', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'zip': '545-8586', 'city': 'Osaka', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '350-0495', 'city': 'Saitama', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '329- 0498', 'city': 'Tochigi', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.38333, 'lon': 139.73333}}, {'zip': '162-8543', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '9330871', 'city': 'Toyama', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.7, 'lon': 137.21667}}, {'zip': '00985', 'city': 'Carolina', 'country': 'Puerto Rico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 18.38078, 'lon': -65.95739}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Incyte Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}