Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
Study NCT ID:
NCT03952559
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-20
First Post:
2019-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Switzerland'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D004485', 'term': 'Eczema'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000596027', 'term': 'baricitinib'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-595-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline Up to 16 Weeks', 'description': 'All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1) and double-blind treatment period (Study period 2). Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Double-blind', 'description': 'Participants 10 to \\< 18 years received placebo tablets. Participants 2 to \\< 10 years received placebo as oral suspension.', 'otherNumAtRisk': 122, 'deathsNumAtRisk': 122, 'otherNumAffected': 42, 'seriousNumAtRisk': 122, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Baricitinib Double-blind Low Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.', 'otherNumAtRisk': 120, 'deathsNumAtRisk': 120, 'otherNumAffected': 39, 'seriousNumAtRisk': 120, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Baricitinib Double-blind Mid Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.', 'otherNumAtRisk': 120, 'deathsNumAtRisk': 120, 'otherNumAffected': 44, 'seriousNumAtRisk': 120, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Baricitinib Double-blind High Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.', 'otherNumAtRisk': 120, 'deathsNumAtRisk': 120, 'otherNumAffected': 41, 'seriousNumAtRisk': 120, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Baricitinib Open-label High Dose PK Lead-in', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 11, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Molluscum contagiosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 20, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Chapped lips', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hair growth abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'seriousEvents': [{'term': 'Corneal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Ophthalmic herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Vertigo cns origin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥2 Point Improvement", 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Double-blind', 'description': 'Participants 10 to \\< 18 years received placebo tablets. Participants 2 to \\< 10 years received placebo as oral suspension.'}, {'id': 'OG001', 'title': 'Baricitinib Double-blind Low Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG002', 'title': 'Baricitinib Double-blind Medium Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG003', 'title': 'Baricitinib Double-blind High Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000'}, {'value': '18.2', 'groupId': 'OG001'}, {'value': '25.8', 'groupId': 'OG002'}, {'value': '41.7', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.7261', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '0.58', 'ciUpperLimit': '2.21', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0718', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.80', 'ciLowerLimit': '0.95', 'ciUpperLimit': '3.41', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.73', 'ciLowerLimit': '2.02', 'ciUpperLimit': '6.89', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': "Percentage of participants achieving IGA of 0 or 1 with a ≥2 point improvement is presented. The IGA measures the investigator's global assessment of the participant's overall severity of their Atopic Dermatitis, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the double-blind treatment period.'}, {'type': 'PRIMARY', 'title': 'Open Label Population Pharmacokinetics (Pop PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baricitinib Open Label High Dose 2 to <6', 'description': 'Participants 2 to \\< 6 years received Baricitinib high dose (2 mg) administered as oral suspension QD.'}, {'id': 'OG001', 'title': 'Baricitinib Open Label High Dose 6 to <10', 'description': 'Participants 6 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.'}, {'id': 'OG002', 'title': 'Baricitinib Open Label High Dose 10 to <18', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.2', 'spread': '30', 'groupId': 'OG000'}, {'value': '40.1', 'spread': '32', 'groupId': 'OG001'}, {'value': '50.6', 'spread': '29', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose; 0.25 hours (h); 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose', 'description': 'Open label Pop PK: Cmax,ss was derived by a population pharmacokinetics approach.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug in the PK Lead-in (PK LI) period and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Open Label Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baricitinib Open Label High Dose 2 to <6', 'description': 'Participants 2 to \\< 6 years received Baricitinib high dose (2 mg) administered as oral suspension QD.'}, {'id': 'OG001', 'title': 'Baricitinib Open Label High Dose 6 to <10', 'description': 'Participants 6 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.'}, {'id': 'OG002', 'title': 'Baricitinib Open Label High Dose 10 to <18', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) administered orally QD.'}], 'classes': [{'categories': [{'measurements': [{'value': '251', 'spread': '18', 'groupId': 'OG000'}, {'value': '178', 'spread': '18', 'groupId': 'OG001'}, {'value': '290', 'spread': '44', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose; 0.25 h; 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose', 'description': 'Open label Pop PK: AUCtau,ss was derived by a population pharmacokinetics approach.', 'unitOfMeasure': 'hour*nanogram per milliliter (h*ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug in the PK Lead-in (PK LI) period and had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Double-blind', 'description': 'Participants 10 to \\< 18 years received placebo tablets. Participants 2 to \\< 10 years received placebo as oral suspension.'}, {'id': 'OG001', 'title': 'Baricitinib Double-blind Low Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG002', 'title': 'Baricitinib Double-blind Medium Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG003', 'title': 'Baricitinib Double-blind High Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '32.2', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '52.5', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.9615', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.59', 'ciUpperLimit': '1.74', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2010', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.42', 'ciLowerLimit': '0.83', 'ciUpperLimit': '2.41', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0017', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.33', 'ciLowerLimit': '1.38', 'ciUpperLimit': '3.95', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.\n\nThe results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI75.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the double-blind treatment period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving EASI90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Double-blind', 'description': 'Participants 10 to \\< 18 years received placebo tablets. Participants 2 to \\< 10 years received placebo as oral suspension.'}, {'id': 'OG001', 'title': 'Baricitinib Double-blind Low Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG002', 'title': 'Baricitinib Double-blind Medium Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG003', 'title': 'Baricitinib Double-blind High Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000'}, {'value': '11.6', 'groupId': 'OG001'}, {'value': '21.7', 'groupId': 'OG002'}, {'value': '30.0', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.8544', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.43', 'ciUpperLimit': '2.01', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0561', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.96', 'ciLowerLimit': '0.98', 'ciUpperLimit': '3.91', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0012', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.99', 'ciLowerLimit': '1.54', 'ciUpperLimit': '5.82', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI90 is defined as a ≥ 90% improvement from baseline in the EASI score.\n\nThe results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI90.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the double-blind treatment period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EASI Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}, {'value': '115', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Double-blind', 'description': 'Participants 10 to \\< 18 years received placebo tablets. Participants 2 to \\< 10 years received placebo as oral suspension.'}, {'id': 'OG001', 'title': 'Baricitinib Double-blind Low Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG002', 'title': 'Baricitinib Double-blind Medium Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG003', 'title': 'Baricitinib Double-blind High Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.16', 'spread': '1.001', 'groupId': 'OG000'}, {'value': '-15.67', 'spread': '0.990', 'groupId': 'OG001'}, {'value': '-15.83', 'spread': '0.978', 'groupId': 'OG002'}, {'value': '-16.88', 'spread': '0.984', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.2627', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.51', 'ciLowerLimit': '-4.16', 'ciUpperLimit': '1.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.349', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2135', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.67', 'ciLowerLimit': '-4.31', 'ciUpperLimit': '0.97', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.342', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0443', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.72', 'ciLowerLimit': '-5.36', 'ciUpperLimit': '-0.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.347', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs (1) erythema (2)edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2 and 3. The final EASI score is obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).\n\nLeast Square (LS) Means were calculated using a mixed model repeated measures (MMRM) model with treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the double-blind treatment period and had evaluable EASI data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Double-blind', 'description': 'Participants 10 to \\< 18 years received placebo tablets. Participants 2 to \\< 10 years received placebo as oral suspension.'}, {'id': 'OG001', 'title': 'Baricitinib Double-blind Low Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG002', 'title': 'Baricitinib Double-blind Medium Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG003', 'title': 'Baricitinib Double-blind High Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}, {'value': '7.4', 'groupId': 'OG001'}, {'value': '15.8', 'groupId': 'OG002'}, {'value': '20.0', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.4943', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '0.30', 'ciUpperLimit': '1.78', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1677', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.72', 'ciLowerLimit': '0.80', 'ciUpperLimit': '3.70', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0336', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.24', 'ciLowerLimit': '1.06', 'ciUpperLimit': '4.70', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with visual analog scale (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \\& subjective symptoms (C: 0-20) combine using A/5 + 7\\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. The SCORAD75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the SCORAD score.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the double-blind treatment period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS) for Participants 10 to <18 Years Old at Study Entry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Double-blind', 'description': 'Participants 10 to \\< 18 years received placebo tablets.'}, {'id': 'OG001', 'title': 'Baricitinib Double-blind Low Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.'}, {'id': 'OG002', 'title': 'Baricitinib Double-blind Medium Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD.'}, {'id': 'OG003', 'title': 'Baricitinib Double-blind High Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000'}, {'value': '17.5', 'groupId': 'OG001'}, {'value': '25.8', 'groupId': 'OG002'}, {'value': '35.5', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.8866', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.42', 'ciUpperLimit': '2.77', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2316', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.73', 'ciLowerLimit': '0.70', 'ciUpperLimit': '4.26', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0328', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.59', 'ciLowerLimit': '1.08', 'ciUpperLimit': '6.22', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'The Itch Numeric Rating Scale (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 participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants (≥10 to \\<18 years old) in the double-blind treatment period and with baseline itch score \\>= 4.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving EASI50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Double-blind', 'description': 'Participants 10 to \\< 18 years received placebo tablets. Participants 2 to \\< 10 years received placebo as oral suspension.'}, {'id': 'OG001', 'title': 'Baricitinib Double-blind Low Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG002', 'title': 'Baricitinib Double-blind Medium Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG003', 'title': 'Baricitinib Double-blind High Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '55.7', 'groupId': 'OG000'}, {'value': '59.5', 'groupId': 'OG001'}, {'value': '60.8', 'groupId': 'OG002'}, {'value': '71.7', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.5361', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.18', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.98', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4417', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.23', 'ciLowerLimit': '0.73', 'ciUpperLimit': '2.06', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0121', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.00', 'ciLowerLimit': '1.16', 'ciUpperLimit': '3.43', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%) and the severity of 4 clinical signs (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2 and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI50 is defined as a ≥ 50% improvement from baseline in EASI score.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the double-blind treatment period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving IGA of 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Double-blind', 'description': 'Participants 10 to \\< 18 years received placebo tablets. Participants 2 to \\< 10 years received placebo as oral suspension.'}, {'id': 'OG001', 'title': 'Baricitinib Double-blind Low Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG002', 'title': 'Baricitinib Double-blind Medium Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG003', 'title': 'Baricitinib Double-blind High Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}, {'value': '5.0', 'groupId': 'OG002'}, {'value': '12.5', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.7706', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '0.37', 'ciUpperLimit': '3.78', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7409', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.22', 'ciLowerLimit': '0.38', 'ciUpperLimit': '3.86', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0253', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.15', 'ciLowerLimit': '1.15', 'ciUpperLimit': '8.63', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': "The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the double-blind treatment period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in SCORAD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Double-blind', 'description': 'Participants 10 to \\< 18 years received placebo tablets. Participants 2 to \\< 10 years received placebo as oral suspension.'}, {'id': 'OG001', 'title': 'Baricitinib Double-blind Low Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG002', 'title': 'Baricitinib Double-blind Medium Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG003', 'title': 'Baricitinib Double-blind High Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.93', 'spread': '1.894', 'groupId': 'OG000'}, {'value': '-24.82', 'spread': '1.880', 'groupId': 'OG001'}, {'value': '-26.08', 'spread': '1.857', 'groupId': 'OG002'}, {'value': '-28.55', 'spread': '1.867', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.1317', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.89', 'ciLowerLimit': '-8.95', 'ciUpperLimit': '1.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.576', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0451', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.15', 'ciLowerLimit': '-10.19', 'ciUpperLimit': '-0.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.564', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0031', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.62', 'ciLowerLimit': '-12.66', 'ciUpperLimit': '-2.58', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.566', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \\& subjective symptoms (C: 0-20) combine using A/5 + 7\\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease.\n\nLS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the double-blind treatment period and had evaluable SCORAD data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving SCORAD90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Double-blind', 'description': 'Participants 10 to \\< 18 years received placebo tablets. Participants 2 to \\< 10 years received placebo as oral suspension.'}, {'id': 'OG001', 'title': 'Baricitinib Double-blind Low Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG002', 'title': 'Baricitinib Double-blind Medium Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG003', 'title': 'Baricitinib Double-blind High Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}, {'value': '5.0', 'groupId': 'OG002'}, {'value': '12.5', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.4238', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.53', 'ciLowerLimit': '0.11', 'ciUpperLimit': '2.49', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5118', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.50', 'ciLowerLimit': '0.44', 'ciUpperLimit': '5.08', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0129', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.92', 'ciLowerLimit': '1.34', 'ciUpperLimit': '11.52', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \\& subjective symptoms (C: 0-20) combine using A/5 + 7\\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. SCORAD90 is defined as a ≥ 90% improvement from baseline in the SCORAD score.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the double-blind treatment period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Surface Area (BSA) Affected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}, {'value': '115', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Double-blind', 'description': 'Participants 10 to \\< 18 years received placebo tablets. Participants 2 to \\< 10 years received placebo as oral suspension.'}, {'id': 'OG001', 'title': 'Baricitinib Double-blind Low Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG002', 'title': 'Baricitinib Double-blind Medium Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG003', 'title': 'Baricitinib Double-blind High Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.31', 'spread': '1.622', 'groupId': 'OG000'}, {'value': '-21.83', 'spread': '1.608', 'groupId': 'OG001'}, {'value': '-22.06', 'spread': '1.581', 'groupId': 'OG002'}, {'value': '-25.66', 'spread': '1.593', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.4852', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.51', 'ciLowerLimit': '-5.77', 'ciUpperLimit': '2.75', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.168', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4205', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.74', 'ciLowerLimit': '-5.98', 'ciUpperLimit': '2.50', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.160', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0138', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.34', 'ciLowerLimit': '-9.59', 'ciUpperLimit': '-1.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.161', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'Body surface area affected by atopic dermatitis will be assessed for 4 separate body regions and is collected as part of the EASI assessment: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of atopic dermatitis. LS Means calculated using MMRM model with treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.', 'unitOfMeasure': 'percentage of body surface area', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the double-blind treatment period and had evaluable BSA data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Double-blind', 'description': 'Participants 10 to \\< 18 years received placebo tablets. Participants 2 to \\< 10 years received placebo as oral suspension.'}, {'id': 'OG001', 'title': 'Baricitinib Double-blind Low Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG002', 'title': 'Baricitinib Double-blind Medium Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG003', 'title': 'Baricitinib Double-blind High Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}, {'value': '3.3', 'groupId': 'OG002'}, {'value': '2.5', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.540', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.302', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'Percentage of participants developing skin infections requiring antibiotic treatment', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the double-blind treatment period.'}, {'type': 'SECONDARY', 'title': 'Mean Number of Days Without Use of Background Topical Corticosteroid (TCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Double-blind', 'description': 'Participants 10 to \\< 18 years received placebo tablets. Participants 2 to \\< 10 years received placebo as oral suspension.'}, {'id': 'OG001', 'title': 'Baricitinib Double-blind Low Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG002', 'title': 'Baricitinib Double-blind Medium Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG003', 'title': 'Baricitinib Double-blind High Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.74', 'spread': '4.06', 'groupId': 'OG000'}, {'value': '32.22', 'spread': '4.07', 'groupId': 'OG001'}, {'value': '30.86', 'spread': '4.06', 'groupId': 'OG002'}, {'value': '39.91', 'spread': '4.10', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.375', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.47', 'ciLowerLimit': '-5.41', 'ciUpperLimit': '14.35', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.03', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.536', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.12', 'ciLowerLimit': '-6.76', 'ciUpperLimit': '13.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.03', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.016', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.17', 'ciLowerLimit': '2.29', 'ciUpperLimit': '22.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.03', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline Through 16 Weeks', 'description': 'Mean number of days without use of background TCS was presented. The ANOVA model includes treatment, age cohort, region, and baseline disease severity (IGA) as factors.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the double-blind treatment period.'}, {'type': 'SECONDARY', 'title': 'Mean Gram Quantity of TCS Use (Tube Weights)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Double-blind', 'description': 'Participants 10 to \\< 18 years received placebo tablets. Participants 2 to \\< 10 years received placebo as oral suspension.'}, {'id': 'OG001', 'title': 'Baricitinib Double-blind Low Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG002', 'title': 'Baricitinib Double-blind Medium Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG003', 'title': 'Baricitinib Double-blind High Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '265.79', 'spread': '22.04', 'groupId': 'OG000'}, {'value': '216.60', 'spread': '22.09', 'groupId': 'OG001'}, {'value': '228.41', 'spread': '22.05', 'groupId': 'OG002'}, {'value': '185.42', 'spread': '22.26', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.073', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-49.19', 'ciLowerLimit': '-102.81', 'ciUpperLimit': '4.42', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '27.28', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.172', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-37.38', 'ciLowerLimit': '-91.00', 'ciUpperLimit': '16.23', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '27.29', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-80.37', 'ciLowerLimit': '-133.98', 'ciUpperLimit': '-26.75', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '27.28', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through 16 Weeks', 'description': 'The dispensed TCS tubes were weighed with cap (without the carton) to determine the dispensed amount of TCS in grams. Returned tubes were weighed with cap (without the carton) to determine the amount of TCS in grams used at each visit. Analysis was done via analysis of variance (ANOVA), with geographic region, baseline disease severity, and treatment as factors in the model.', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the double-blind treatment period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Itch NRS for Participants 10 to <18 Years at Study Entry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Double-blind', 'description': 'Participants 10 to \\< 18 years received placebo tablets.'}, {'id': 'OG001', 'title': 'Baricitinib Double-blind Low Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.'}, {'id': 'OG002', 'title': 'Baricitinib Double-blind Medium Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD.'}, {'id': 'OG003', 'title': 'Baricitinib Double-blind High Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.15', 'spread': '0.276', 'groupId': 'OG000'}, {'value': '-1.80', 'spread': '0.266', 'groupId': 'OG001'}, {'value': '-1.65', 'spread': '0.261', 'groupId': 'OG002'}, {'value': '-2.25', 'spread': '0.258', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0829', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.65', 'ciLowerLimit': '-1.38', 'ciUpperLimit': '0.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.372', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1752', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.50', 'ciLowerLimit': '-1.22', 'ciUpperLimit': '0.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.368', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0029', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.10', 'ciLowerLimit': '-1.82', 'ciUpperLimit': '-0.38', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.366', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant\'s itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.\n\nLS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants (10 to \\<18 years) in the double-blind treatment period and had evaluable Itch NRS data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Parent-Reported Itch Severity Measure (PRISM) for Participants 2 to <10 Years at Study Entry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Double-blind', 'description': 'Participants 2 to \\< 10 years received placebo as oral suspension.'}, {'id': 'OG001', 'title': 'Baricitinib Double-blind Low Dose', 'description': 'Participants 2 to \\< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG002', 'title': 'Baricitinib Double-blind Medium Dose', 'description': 'Participants 2 to \\< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG003', 'title': 'Baricitinib Double-blind High Dose', 'description': 'Participants 2 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.139', 'groupId': 'OG000'}, {'value': '-0.24', 'spread': '0.146', 'groupId': 'OG001'}, {'value': '-0.49', 'spread': '0.145', 'groupId': 'OG002'}, {'value': '-0.37', 'spread': '0.158', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.2688', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-0.60', 'ciUpperLimit': '0.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.193', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0166', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciLowerLimit': '-0.85', 'ciUpperLimit': '-0.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.193', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0908', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '0.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.202', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'The Parent-Reported Itch Severity Measure (PRISM) is a single-item, parent/caregiver administered scale that reports the overall severity of their child\'s itching. Parent/Caregiver\'s report the overall severity of their child\'s itching based on observed actions of the child in the past 24 hours. Response options range include "No Itch," "Mild," "Moderate," "Severe," and "Very Severe." The PRISM will be completed for participants \\<10 years old by the parent/caregiver.\n\nLS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants (2 to \\<10 years old) in the double-blind treatment period and had evaluable PRISM data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the Patient-Oriented Eczema Measure (POEM) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Double-blind', 'description': 'Participants 10 to \\< 18 years received placebo tablets. Participants 2 to \\< 10 years received placebo as oral suspension.'}, {'id': 'OG001', 'title': 'Baricitinib Double-blind Low Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG002', 'title': 'Baricitinib Double-blind Medium Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG003', 'title': 'Baricitinib Double-blind High Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.02', 'spread': '0.708', 'groupId': 'OG000'}, {'value': '-3.93', 'spread': '0.704', 'groupId': 'OG001'}, {'value': '-4.58', 'spread': '0.696', 'groupId': 'OG002'}, {'value': '-4.58', 'spread': '0.702', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.3409', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.91', 'ciLowerLimit': '-2.79', 'ciUpperLimit': '0.97', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.956', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1022', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.56', 'ciLowerLimit': '-3.43', 'ciUpperLimit': '0.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.952', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1024', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.56', 'ciLowerLimit': '-3.43', 'ciUpperLimit': '0.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.953', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'The POEM is a simple, 7-item, patient-administered scale that assesses disease severity in children and adults. Participants respond to questions about the frequency of 7 symptoms (itching, sleep disturbance, bleeding, weeping/oozing, cracking, flaking, and dryness/roughness) over the last week on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). Scores range from 0-28 with higher total scores indicating greater disease severity.\n\nLS Means were calculated using MMRM model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the double-blind treatment period and had evaluable POEM data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD) Score for Participants 10 to <18 Years at Study Entry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Double-blind', 'description': 'Participants 10 to \\< 18 years received placebo tablets.'}, {'id': 'OG001', 'title': 'Baricitinib Double-blind Low Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.'}, {'id': 'OG002', 'title': 'Baricitinib Double-blind Medium Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD.'}, {'id': 'OG003', 'title': 'Baricitinib Double-blind High Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.115', 'groupId': 'OG000'}, {'value': '-0.56', 'spread': '0.112', 'groupId': 'OG001'}, {'value': '-0.64', 'spread': '0.109', 'groupId': 'OG002'}, {'value': '-0.83', 'spread': '0.108', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.1436', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '0.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.157', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0483', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.31', 'ciLowerLimit': '-0.61', 'ciUpperLimit': '-0.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.154', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0012', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.50', 'ciLowerLimit': '-0.80', 'ciUpperLimit': '-0.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.154', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'The PGI-S-AD is a single-item question asked to the participants on how they would rate their overall atopic dermatitis symptoms over the past 24 hours to evaluate the severity of the disease at that point in time. The 5 categories of responses range from "(0) no symptoms", "(1) very mild", "(2) mild" "(3) moderate", and "(4) severe".\n\nLS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants (10 to \\<18 years old) in the double-blind treatment period and had evaluable PGI-S-AD data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) - Pediatric Depression for Participants 5 to <18 Years at Study Entry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '107', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Double-blind', 'description': 'Participants 10 to \\< 18 years received placebo tablets. Participants 2 to \\< 10 years received placebo as oral suspension.'}, {'id': 'OG001', 'title': 'Baricitinib Double-blind Low Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG002', 'title': 'Baricitinib Double-blind Medium Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG003', 'title': 'Baricitinib Double-blind High Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}], 'classes': [{'title': '5 to <8 years old', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.95', 'spread': '2.629', 'groupId': 'OG000'}, {'value': '-2.54', 'spread': '2.138', 'groupId': 'OG001'}, {'value': '-7.07', 'spread': '2.644', 'groupId': 'OG002'}, {'value': '-2.83', 'spread': '2.033', 'groupId': 'OG003'}]}]}, {'title': '8 to <18 years old', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.60', 'spread': '1.190', 'groupId': 'OG000'}, {'value': '-3.42', 'spread': '1.343', 'groupId': 'OG001'}, {'value': '-4.68', 'spread': '1.034', 'groupId': 'OG002'}, {'value': '-5.30', 'spread': '1.436', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.9183', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.18', 'ciLowerLimit': '-3.27', 'ciUpperLimit': '3.63', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.755', 'groupDescription': 'for 8 to \\<18 years old', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4805', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.08', 'ciLowerLimit': '-4.09', 'ciUpperLimit': '1.93', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.529', 'groupDescription': 'for 8 to \\<18 years old', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3488', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.70', 'ciLowerLimit': '-5.26', 'ciUpperLimit': '1.86', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.812', 'groupDescription': 'for 8 to \\<18 years old', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2388', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.40', 'ciLowerLimit': '-4.85', 'ciUpperLimit': '7.66', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.120', 'groupDescription': 'for 5 to \\<8 years old', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0098', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.13', 'ciLowerLimit': '-10.23', 'ciUpperLimit': '3.98', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.542', 'groupDescription': 'for 5 to \\<8 years old', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1698', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '-5.18', 'ciUpperLimit': '7.42', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.140', 'groupDescription': 'for 5 to \\<8 years old', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'PROMIS is a set of person-centered measures that evaluates and monitors physical, mental and social health in adults and children. The PROMIS Depression item bank assesses self-reported negative mood (sadness, guilt), views on self (self-criticism, worthlessness), social cognition (loneliness, interpersonal alienation), decreased positive affect and engagement (loss of interest, meaning, and purpose). The PROMIS Depression Short Form (8a v2.0 and 6a v2.0) is available in pediatric self-report (ages 8 to \\<18 years) and for parents/caregivers serving as proxy reporters for children (ages 5 to \\<8 years). Children aged \\<5 years will not complete assessment. Both pediatric self-report and proxy-report versions assess depression "in past seven days." Response options range from 1 = Never;2 = Rarely;3 = Sometimes;4 = Often; to 5 = Almost always. Total raw scores were converted to T-Scores (mean= 50 and a standard deviation = 10) with higher scores representing greater depression.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants (5 to \\<18 years old) in the double-blind treatment period and had evaluable (PROMIS) - Pediatric Depression data. LS Means were calculated using MMRM model, which includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline-by-visit-interaction as fixed continuous effects.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the PROMIS-Pediatric Anxiety for Participants 5 to <18 Years at Study Entry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '107', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Double-blind', 'description': 'Participants 10 to \\< 18 years received placebo tablets. Participants 2 to \\< 10 years received placebo as oral suspension.'}, {'id': 'OG001', 'title': 'Baricitinib Double-blind Low Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG002', 'title': 'Baricitinib Double-blind Medium Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG003', 'title': 'Baricitinib Double-blind High Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}], 'classes': [{'title': '5 to <8 years old', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4.65', 'spread': '2.864', 'groupId': 'OG000'}, {'value': '-3.03', 'spread': '2.318', 'groupId': 'OG001'}, {'value': '-5.09', 'spread': '2.931', 'groupId': 'OG002'}, {'value': '-3.15', 'spread': '2.214', 'groupId': 'OG003'}]}]}, {'title': '8 to <18 years old', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4.40', 'spread': '1.223', 'groupId': 'OG000'}, {'value': '-4.09', 'spread': '1.394', 'groupId': 'OG001'}, {'value': '-5.44', 'spread': '1.064', 'groupId': 'OG002'}, {'value': '-6.81', 'spread': '1.486', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.8611', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.32', 'ciLowerLimit': '-3.24', 'ciUpperLimit': '3.88', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.813', 'groupDescription': 'for 8 to \\<18 years old', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5098', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.04', 'ciLowerLimit': '-4.12', 'ciUpperLimit': '2.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.571', 'groupDescription': 'for 8 to \\<18 years old', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1997', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.40', 'ciLowerLimit': '-6.08', 'ciUpperLimit': '1.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.870', 'groupDescription': 'for 8 to \\<18 years old', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1957', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.62', 'ciLowerLimit': '-5.11', 'ciUpperLimit': '8.35', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.351', 'groupDescription': 'for 5 to \\<8 years old', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0881', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.44', 'ciLowerLimit': '-8.19', 'ciUpperLimit': '7.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.864', 'groupDescription': 'for 5 to \\<8 years old', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1604', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.51', 'ciLowerLimit': '-5.27', 'ciUpperLimit': '8.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.379', 'groupDescription': 'for 5 to \\<8 years old', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS Anxiety item bank assesses self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). The PROMIS Anxiety Short Form (8 questions, 8a v2.0) is available in a pediatric self-report (ages 8 to \\<18 years) and for parents/caregivers serving as proxy reporters for their children (youth ages 5 to \\<8 years old). Children aged \\<5 years will not complete this assessment. Both pediatric self-report and proxy-report versions assess anxiety "in the past seven days." Response options range from 1= Never; 2 = Rarely; 3 = Sometimes; 4 = Often; to 5 = Almost always. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants (5 to \\<18 years old) in the double-blind treatment period and had evaluable (PROMIS) - Pediatric Anxiety data. LS Means were calculated using the MMRM model, which includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline-by-visit-interaction as fixed continuous effects.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in the Children's Dermatology Life Quality Index (CDLQI) at Week 16 for Participants 4 to <18 Years at Study Entry", 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Double-blind', 'description': 'Participants 10 to \\< 18 years received placebo tablets. Participants 2 to \\< 10 years received placebo as oral suspension.'}, {'id': 'OG001', 'title': 'Baricitinib Double-blind Low Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG002', 'title': 'Baricitinib Double-blind Medium Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG003', 'title': 'Baricitinib Double-blind High Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.06', 'spread': '0.480', 'groupId': 'OG000'}, {'value': '-3.73', 'spread': '0.465', 'groupId': 'OG001'}, {'value': '-3.70', 'spread': '0.451', 'groupId': 'OG002'}, {'value': '-3.36', 'spread': '0.459', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.2987', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.67', 'ciLowerLimit': '-1.93', 'ciUpperLimit': '0.59', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.647', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3096', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.64', 'ciLowerLimit': '-1.88', 'ciUpperLimit': '0.60', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.632', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6341', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.30', 'ciLowerLimit': '-1.55', 'ciUpperLimit': '0.95', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.635', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'CDLQI is a validated 10 question tool to measure impact of skin disease on QOL in children by assessing how much the skin problem has affected the subjects over past week. Nine questions were scored as follows: Very much = 3, Quite a lot = 2, Only a little = 1, Not at all or unanswered = 0. Question 7 has an added possible response, which was scored as 3. CDLQI equals the sum of the score of each question (max. = 30, min. = 0). Higher the score, the greater the impact on QOL. A negative change from baseline indicated improvement. LS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants (4 to \\<18 years old) in the double-blind treatment period and had evaluable CDLQI data.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Infants' Dermatology Quality of Life Index (IDQOL) at Week 16 for Participants 2 to <4 Years at Study Entry", 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Double-blind', 'description': 'Participants 2 to \\< 10 years received placebo as oral suspension.'}, {'id': 'OG001', 'title': 'Baricitinib Double-blind Low Dose', 'description': 'Participants 2 to \\< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG002', 'title': 'Baricitinib Double-blind Medium Dose', 'description': 'Participants 2 to \\< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG003', 'title': 'Baricitinib Double-blind High Dose', 'description': 'Participants 2 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.40', 'spread': '1.743', 'groupId': 'OG000'}, {'value': '3.87', 'spread': '4.423', 'groupId': 'OG001'}, {'value': '3.33', 'spread': '3.752', 'groupId': 'OG002'}, {'value': '-6.40', 'spread': '3.601', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.2871', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.27', 'ciLowerLimit': '-6.54', 'ciUpperLimit': '17.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.323', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3093', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.73', 'ciLowerLimit': '-7.83', 'ciUpperLimit': '17.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.835', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2912', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.00', 'ciLowerLimit': '-18.22', 'ciUpperLimit': '8.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.788', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 16', 'description': "Infants' Dermatitis Quality of Life Index (IDQOL) is used to evaluate quality of life for subjects of age less than 4 years. IDQOL questionnaires were designed for infants (below the age of 4 years) with atopic dermatitis. The IDQOL was calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score in each questionnaire, the more quality of life is impaired. A negative change from baseline indicated improvement. LS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants (2 to \\<4 years old) in the double-blind treatment period and had evaluable IDQOL data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the Work Productivity and Activity Impairment: Atopic Dermatitis - Caregiver (WPAI-AD-CG) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Double-blind', 'description': 'Participants 10 to \\< 18 years received placebo tablets. Participants 2 to \\< 10 years received placebo as oral suspension.'}, {'id': 'OG001', 'title': 'Baricitinib Double-blind Low Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG002', 'title': 'Baricitinib Double-blind Medium Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG003', 'title': 'Baricitinib Double-blind High Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}], 'classes': [{'title': 'Absenteeism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.99', 'spread': '2.367', 'groupId': 'OG000'}, {'value': '2.39', 'spread': '2.135', 'groupId': 'OG001'}, {'value': '2.14', 'spread': '2.107', 'groupId': 'OG002'}, {'value': '-0.94', 'spread': '2.387', 'groupId': 'OG003'}]}]}, {'title': 'Presenteeism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4.69', 'spread': '2.719', 'groupId': 'OG000'}, {'value': '-5.62', 'spread': '2.452', 'groupId': 'OG001'}, {'value': '-9.99', 'spread': '2.451', 'groupId': 'OG002'}, {'value': '-11.44', 'spread': '2.797', 'groupId': 'OG003'}]}]}, {'title': 'Overall Work Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.38', 'spread': '3.473', 'groupId': 'OG000'}, {'value': '-3.80', 'spread': '3.119', 'groupId': 'OG001'}, {'value': '-5.86', 'spread': '3.086', 'groupId': 'OG002'}, {'value': '-11.15', 'spread': '3.515', 'groupId': 'OG003'}]}]}, {'title': 'Activity Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7.03', 'spread': '2.372', 'groupId': 'OG000'}, {'value': '-11.45', 'spread': '2.318', 'groupId': 'OG001'}, {'value': '-11.90', 'spread': '2.293', 'groupId': 'OG002'}, {'value': '-14.05', 'spread': '2.311', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.6079', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.60', 'ciLowerLimit': '-7.74', 'ciUpperLimit': '4.54', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.119', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Absenteeism Change from Baseline'}, {'pValue': '0.5492', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.85', 'ciLowerLimit': '-7.94', 'ciUpperLimit': '4.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.092', 'groupDescription': 'Absenteeism Change from Baseline', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1338', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.93', 'ciLowerLimit': '-11.39', 'ciUpperLimit': '1.53', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.281', 'groupDescription': 'Absenteeism Change from Baseline', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7928', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.94', 'ciLowerLimit': '-7.96', 'ciUpperLimit': '6.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.566', 'groupDescription': 'Presenteeism Change from Baseline', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1366', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.30', 'ciLowerLimit': '-12.30', 'ciUpperLimit': '1.69', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.553', 'groupDescription': 'Presenteeism Change from Baseline', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0760', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.75', 'ciLowerLimit': '-14.21', 'ciUpperLimit': '0.71', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.792', 'groupDescription': 'Presenteeism Change from Baseline', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3602', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.18', 'ciLowerLimit': '-13.16', 'ciUpperLimit': '4.80', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.561', 'groupDescription': 'Overall Work Impairment Change from Baseline', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1678', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.25', 'ciLowerLimit': '-15.14', 'ciUpperLimit': '2.65', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.516', 'groupDescription': 'Overall Work Impairment Change from Baseline', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0170', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.54', 'ciLowerLimit': '-21.00', 'ciUpperLimit': '-2.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.808', 'groupDescription': 'Overall Work Impairment Change from Baseline', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1645', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.42', 'ciLowerLimit': '-10.66', 'ciUpperLimit': '1.82', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.174', 'groupDescription': 'Activity Impairment Change from Baseline', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1240', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.87', 'ciLowerLimit': '-11.07', 'ciUpperLimit': '1.34', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.158', 'groupDescription': 'Activity Impairment Change from Baseline', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0270', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.02', 'ciLowerLimit': '-13.23', 'ciUpperLimit': '-0.80', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.163', 'groupDescription': 'Activity Impairment Change from Baseline', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': "The Atopic Dermatitis Caregiver (WPAI-AD-CG) assesses the effect of a child's atopic dermatitis on the parent/caregiver's work productivity during the past 7 days. The WPAI-AD consists of 6 items grouped in 4 domains: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment, that range from 0% to 100%, Scores are calculated as impairment percentages with higher scores indicating greater impairment and less productivity.\n\nLS Mean were calculated using a MMRM model with treatment, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the double-blind treatment period and who had at least 1 post-baseline WPAI measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the European Quality of Life-5 Dimensions-Youth (EQ-5D-Y) for Participants 4 to <18 Years at Study Entry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Double-blind', 'description': 'Participants 10 to \\< 18 years received placebo tablets. Participants 2 to \\< 10 years received placebo as oral suspension.'}, {'id': 'OG001', 'title': 'Baricitinib Double-blind Low Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG002', 'title': 'Baricitinib Double-blind Medium Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'OG003', 'title': 'Baricitinib Double-blind High Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.15', 'spread': '2.090', 'groupId': 'OG000'}, {'value': '5.12', 'spread': '2.025', 'groupId': 'OG001'}, {'value': '5.16', 'spread': '1.969', 'groupId': 'OG002'}, {'value': '7.67', 'spread': '2.000', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.4778', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.97', 'ciLowerLimit': '-3.49', 'ciUpperLimit': '7.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.778', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4649', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.01', 'ciLowerLimit': '-3.38', 'ciUpperLimit': '7.39', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.743', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1013', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.52', 'ciLowerLimit': '-0.89', 'ciUpperLimit': '9.94', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.755', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'The EQ-5D-Y questionnaire is health status related and self-completed for pediatric participants ≥8 years old and completed by parents/caregivers for children 4 to \\<8 years old. Health state profile assessed health in 5 dimensions (Mobility,selfcare,usual activities,pain/discomfort, anxiety/depression) to obtain index score, each with three levels of response (no problems,some problems,a lot of problems). Participants indicated their health state by choosing appropriate level from each dimension. Visual analog scale on which participant rates their perceived health state from 0 ("worst health you can imagine") to 100 ("best health you can imagine") is presented.Higher the score the better the health status. LS Means uses MMRM model which includes treatment,age cohort,region,baseline disease severity(IGA),visit,treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants (4 to \\<18 years old) in the double-blind treatment period with week 16 EQ-5D-Y data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS) for Participants 10 to <18 Years at Study Entry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Double-blind', 'description': 'Participants 10 to \\< 18 years received placebo tablets.'}, {'id': 'OG001', 'title': 'Baricitinib Double-blind Low Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.'}, {'id': 'OG002', 'title': 'Baricitinib Double-blind Medium Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD.'}, {'id': 'OG003', 'title': 'Baricitinib Double-blind High Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.42', 'spread': '0.130', 'groupId': 'OG000'}, {'value': '-0.35', 'spread': '0.126', 'groupId': 'OG001'}, {'value': '-0.43', 'spread': '0.123', 'groupId': 'OG002'}, {'value': '-0.55', 'spread': '0.122', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.6574', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.42', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.174', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9488', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '0.33', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.172', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4546', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '0.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.172', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'Atopic Dermatitis Sleep Scale (ADSS) is a 3-item, participant-administered questionnaire developed to assess the impact of itch on sleep including difficulty falling asleep, frequency of waking, and difficulty getting back to sleep last night. Item 2, frequency of waking last night is reported by selecting the number of times they woke up each night, ranging from 0 to 29 times, where the higher a number indicates a worse outcome. The ADSS is designed to be completed daily, using a daily diary, with respondents thinking about sleep "last night." Each item is scored individually.\n\nLS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by- visit-interaction as fixed continuous effects.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants (10 to \\<18 years old) in the double-blind treatment period with week 16 ADSS Item 2 (frequency of waking) data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Skin Pain NRS for Participants 10 to <18 Years at Study Entry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Double-blind', 'description': 'Participants 10 to \\< 18 years received placebo tablets.'}, {'id': 'OG001', 'title': 'Baricitinib Double-blind Low Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.'}, {'id': 'OG002', 'title': 'Baricitinib Double-blind Medium Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD.'}, {'id': 'OG003', 'title': 'Baricitinib Double-blind High Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.15', 'spread': '0.267', 'groupId': 'OG000'}, {'value': '-1.23', 'spread': '0.259', 'groupId': 'OG001'}, {'value': '-1.56', 'spread': '0.254', 'groupId': 'OG002'}, {'value': '-1.77', 'spread': '0.251', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.8133', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.79', 'ciUpperLimit': '0.62', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.360', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2517', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.41', 'ciLowerLimit': '-1.11', 'ciUpperLimit': '0.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.355', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0803', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.62', 'ciLowerLimit': '-1.32', 'ciUpperLimit': '0.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.354', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'Skin Pain NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Overall severity of a participant\'s skin pain is indicated by selecting the number, using a daily diary, that best describes the worst level of skin pain in the past 24 hours.\n\nLS Means were calculated using a MMRM model with treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants (10 to \\<18 years old) in the double-blind treatment period with Week 16 Skin Pain NRS data.'}, {'type': 'SECONDARY', 'title': 'Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old at Study Entry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Baricitinib Open Label High Dose', 'description': 'Participants 2 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.'}], 'classes': [{'title': 'Question 1- Liked Very Much:', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Question 1- Liked', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Question 1- Neither Liked nor Disliked', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Question 1- Disliked', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Question 1- Disliked Very Much', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Question 2- Liked Very Much:', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Question 2- Liked', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Question 2- Neither Liked nor Disliked', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Question 2- Disliked', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Question 2- Disliked Very Much', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Question 3- Very Easy', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Question 3- Easy', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Question 3- Neither Easy nor Hard', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Question 3- Difficult (or Hard)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Question 3- Very Difficult (or Hard)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Question 4- Very Easy', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Question 4- Easy', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Question 4- Neither Easy nor Hard', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Question 4- Difficult (or Hard)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Question 4- Very Difficult (or Hard)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2', 'description': 'The questionnaire for Suspension acceptability and palatability assessed the participants ability to swallow the oral suspension product, experience relating to the taste, smell and ease of administering and taking the suspension. The questionnaire contained following Questions: Question 1) How did you (your child) like the taste of the medicine? Question 2) How did you (your child) like the smell of the medicine? Question 3) How easy was it for you (your child) to take the medicine today? Question 4) How easy was it for you to use the oral syringe to give your child the dose today? Responses: Liked Very Much, Liked, Neither Liked nor Disliked, Disliked, Disliked Very Much, Very Easy, Easy, Neither Easy nor Hard, Difficult (or Hard) and Very Difficult (or Hard). The number of participants with these responses are presented. Data is presented as "Question Number-Response-Time point".', 'unitOfMeasure': 'Participant responses', 'reportingStatus': 'POSTED', 'populationDescription': 'All PK lead-in participants (2 to \\<10 years old) with data for suspension acceptability and palatability assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participant Responses With Tablet Acceptability and Palatability Assessment (PK Lead-In) for Participants >=10 Years Old at Study Entry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Baricitinib Open Label High Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.'}], 'classes': [{'title': 'Question 1- Very Easy', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Question 1- Easy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Question 1- Neither Easy nor Hard', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Question 1- Difficult (or Hard)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Question 1- Very Difficult (or Hard)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2', 'description': 'The questionnaire for tablet acceptability and palatability assessed the participants ability to swallow the tablet. The questionnaire contained the question 1) How easy was it for you (your child) to swallow the medicine today? Responses: Very Easy, Easy, Neither Easy nor Hard, Difficult (or Hard) and Very Difficult (or Hard). The number of participants with these responses are presented. Data is presented as "Question Number-Response-Time point".', 'unitOfMeasure': 'Participant responses', 'reportingStatus': 'POSTED', 'populationDescription': 'All PK Lead-In participants \\>=10 years old, who had data for tablet acceptability and palatability at given time point.'}, {'type': 'SECONDARY', 'title': 'Height, Weight and Body Mass Index (BMI) Growth Rate', 'timeFrame': '124 Weeks', 'description': 'Height, Weight and BMI Growth Rate will be reported.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-05'}, {'type': 'SECONDARY', 'title': 'Change of Immunoglobulin G (IgG) Titers', 'timeFrame': 'Baseline Through End of Study Completion', 'description': 'Number of participants with change of IgG titers for tetanus vaccine and pneumococcal conjugate will be presented. A primary immune response was assessed in participants who had never received tetanus or pneumococcal conjugate vaccines previously and secondary/booster responses were assessed if the participants had previously received the vaccines. For pneumococcal conjugate vaccine, number of participants with \\>= 2-fold increase in \\>=6 pneumococcal serotypes from pre-vaccination timepoint to specified post-vaccination timepoints through the end of the study will be presented. For tetanus vaccine, number of participants with \\>= 2-fold increase in participants with baseline titer \\>=0.1 IU/mL from pre-vaccination timepoint to specified post-vaccination timepoints through the end of the study will be presented.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-05'}, {'type': 'SECONDARY', 'title': 'Pop PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}, {'value': '87', 'groupId': 'OG006'}, {'value': '86', 'groupId': 'OG007'}, {'value': '108', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Baricitinib (0.5 mg): Low Dose (2 to<6 Years)', 'description': 'Participants 2 to \\< 6 years of age received Baricitinib low dose (0.5 mg) administered as oral suspension QD.'}, {'id': 'OG001', 'title': 'Baricitinib (1 mg): Medium Dose (2 to<6 Years)', 'description': 'Participants 2 to \\< 6 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.'}, {'id': 'OG002', 'title': 'Baricitinib (2 mg): High Dose (2 to<6 Years)', 'description': 'Participants 2 to \\< 6 years received Baricitinib high dose (2 mg) administered as oral suspension QD.'}, {'id': 'OG003', 'title': 'Baricitinib (0.5mg): Low Dose (6 to <10 Years)', 'description': 'Participants 6 to \\< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD.'}, {'id': 'OG004', 'title': 'Baricitinib (1 mg): Medium Dose (6 to <10 Years)', 'description': 'Participants 6 to \\< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.'}, {'id': 'OG005', 'title': 'Baricitinib (2 mg): High Dose (6 to <10 Years)', 'description': 'Participants 6 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.'}, {'id': 'OG006', 'title': 'Baricitinib (1 mg): Low Dose (10 to <18 Years)', 'description': 'Participants 10 to \\< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.'}, {'id': 'OG007', 'title': 'Baricitinib (2 mg): Medium Dose (10 to <18 Years)', 'description': 'Participants 10 to \\< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.'}, {'id': 'OG008', 'title': 'Baricitinib (4 mg): High Dose (10 to <18 Years)', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.9', 'spread': '29', 'groupId': 'OG000'}, {'value': '35.1', 'spread': '21', 'groupId': 'OG001'}, {'value': '64.8', 'spread': '22', 'groupId': 'OG002'}, {'value': '11.6', 'spread': '29', 'groupId': 'OG003'}, {'value': '23.1', 'spread': '23', 'groupId': 'OG004'}, {'value': '44.0', 'spread': '41', 'groupId': 'OG005'}, {'value': '13.2', 'spread': '34', 'groupId': 'OG006'}, {'value': '27.8', 'spread': '34', 'groupId': 'OG007'}, {'value': '50.7', 'spread': '28', 'groupId': 'OG008'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose; 0.25 hours (h); 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose', 'description': 'Pop PK: Cmax,ss was derived by a population pharmacokinetics approach.', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug in the open-label PK lead-in and double-blind treatment period and had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}, {'value': '87', 'groupId': 'OG006'}, {'value': '86', 'groupId': 'OG007'}, {'value': '108', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Baricitinib (0.5mg): Low Dose (2 to<6 Years)', 'description': 'Participants 2 to \\< 6 years of age received Baricitinib low dose (0.5 mg) administered as oral suspension QD.'}, {'id': 'OG001', 'title': 'Baricitinib (1 mg): Medium Dose (2 to<6 Years)', 'description': 'Participants 2 to \\< 6 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.'}, {'id': 'OG002', 'title': 'Baricitinib (2 mg): High Dose (2 to<6 Years)', 'description': 'Participants 2 to \\< 6 years received Baricitinib high dose (2 mg) administered as oral suspension QD.'}, {'id': 'OG003', 'title': 'Baricitinib (0.5mg): Low Dose (6 to <10 Years)', 'description': 'Participants 6 to \\< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD.'}, {'id': 'OG004', 'title': 'Baricitinib (1 mg): Medium Dose (6 to <10 Years)', 'description': 'Participants 6 to \\< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD.'}, {'id': 'OG005', 'title': 'Baricitinib (2 mg): High Dose (6 to <10 Years)', 'description': 'Participants 6 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.'}, {'id': 'OG006', 'title': 'Baricitinib (1 mg): Low Dose (10 to <18 Years)', 'description': 'Participants 10 to \\< 18 years received Baricitinib low dose (1 mg) administered orally in tablet form QD.'}, {'id': 'OG007', 'title': 'Baricitinib (2 mg): Medium Dose (10 to <18 Years)', 'description': 'Participants 10 to \\< 18 years received Baricitinib medium dose (2 mg) administered orally in tablet form QD.'}, {'id': 'OG008', 'title': 'Baricitinib (4 mg): High Dose (10 to <18years)', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.3', 'spread': '108', 'groupId': 'OG000'}, {'value': '200', 'spread': '63', 'groupId': 'OG001'}, {'value': '298', 'spread': '51', 'groupId': 'OG002'}, {'value': '74.8', 'spread': '64', 'groupId': 'OG003'}, {'value': '155', 'spread': '65', 'groupId': 'OG004'}, {'value': '276', 'spread': '76', 'groupId': 'OG005'}, {'value': '109', 'spread': '63', 'groupId': 'OG006'}, {'value': '222', 'spread': '66', 'groupId': 'OG007'}, {'value': '383', 'spread': '61', 'groupId': 'OG008'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose; 0.25 hours (h); 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose', 'description': 'Pop PK: AUCtau,ss was derived by a population pharmacokinetics approach.', 'unitOfMeasure': 'hour*nanogram per milliliter (h*ng/ mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug in the open-label PK lead-in and double-blind treatment period and had evaluable PK data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Baricitinib Open Label High Dose (PK Lead-in)', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.'}, {'id': 'FG001', 'title': 'Placebo Double-blind', 'description': 'Participants 10 to \\< 18 years received placebo tablets. Participants 2 to \\< 10 years received placebo as oral suspension.'}, {'id': 'FG002', 'title': 'Baricitinib Double-blind Low Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'FG003', 'title': 'Baricitinib Double-blind Medium Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'FG004', 'title': 'Baricitinib Double-blind High Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}], 'periods': [{'title': 'High Dose Open Label - PK Lead-in', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', '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'}]}]}, {'title': 'Double Blind Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants who completed the Open-label PK Lead-in (Week 2) continued into the long-term extension study.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Participants were assigned to this arm during double blind treatment period.', 'groupId': 'FG001', 'numSubjects': '122'}, {'comment': 'Participants were assigned to this arm during double blind treatment period.', 'groupId': 'FG002', 'numSubjects': '121'}, {'comment': 'Participants were assigned to this arm during double blind treatment period.', 'groupId': 'FG003', 'numSubjects': '120'}, {'comment': 'Participants were assigned to this arm during double blind treatment period.', 'groupId': 'FG004', 'numSubjects': '120'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '122'}, {'groupId': 'FG002', 'numSubjects': '120'}, {'groupId': 'FG003', 'numSubjects': '120'}, {'groupId': 'FG004', 'numSubjects': '120'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '115'}, {'groupId': 'FG002', 'numSubjects': '116'}, {'groupId': 'FG003', 'numSubjects': '117'}, {'groupId': 'FG004', 'numSubjects': '119'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Inadvertently randomized', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 516 participants (33+483=516) were enrolled in the study. Of which 483 participants were randomized to one of the four double-blind treatment arms, and 33 participants received open label baricitinib as part of pharmacokinetics (PK) lead-in (not randomized).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}, {'value': '120', 'groupId': 'BG003'}, {'value': '120', 'groupId': 'BG004'}, {'value': '516', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Baricitinib Open Label High Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD.'}, {'id': 'BG001', 'title': 'Placebo Double-blind', 'description': 'Participants 10 to \\< 18 years received placebo tablets. Participants 2 to \\< 10 years received placebo as oral suspension.'}, {'id': 'BG002', 'title': 'Baricitinib Double-blind Low Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'BG003', 'title': 'Baricitinib Double-blind Medium Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib medium dose (2 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib medium dose (1 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'BG004', 'title': 'Baricitinib Double-blind High Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '11.28', 'spread': '4.296', 'groupId': 'BG000'}, {'value': '11.75', 'spread': '4.012', 'groupId': 'BG001'}, {'value': '12.35', 'spread': '4.052', 'groupId': 'BG002'}, {'value': '11.81', 'spread': '3.661', 'groupId': 'BG003'}, {'value': '11.93', 'spread': '3.829', 'groupId': 'BG004'}, {'value': '11.92', 'spread': '3.914', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '2 to <6 years', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '46', 'groupId': 'BG005'}]}]}, {'title': '6 to <10 years', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '100', 'groupId': 'BG005'}]}]}, {'title': '10 to <18 years', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}, {'value': '88', 'groupId': 'BG004'}, {'value': '370', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}, {'value': '262', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}, {'value': '254', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '92', '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': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}, {'value': '88', 'groupId': 'BG004'}, {'value': '382', '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': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Argentina', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '70', 'groupId': 'BG005'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}]}]}, {'title': 'Czechia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '38', 'groupId': 'BG005'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}]}, {'title': 'Russia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '45', 'groupId': 'BG005'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '36', 'groupId': 'BG005'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '41', 'groupId': 'BG005'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '34', 'groupId': 'BG005'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '89', 'groupId': 'BG005'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '34', 'groupId': 'BG005'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '39', 'groupId': 'BG005'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants who received at least one dose of study drug in the PK Lead-in period (Study period 1).\n\nAll randomized participants in the double-blind treatment period (Study period 2).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-14', 'size': 2797989, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-04-20T07:34', 'hasProtocol': True}, {'date': '2022-06-01', 'size': 5714554, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-12-05T11:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Participants were randomized to one of the four double-blind treatment arms. A separate group of 33 participants received open label baricitinib as part of pharmacokinetic (PK) lead-in (not randomized) period.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 516}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2019-05-15', 'resultsFirstSubmitDate': '2023-04-23', 'studyFirstSubmitQcDate': '2019-05-15', 'lastUpdatePostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-09', 'studyFirstPostDateStruct': {'date': '2019-05-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥2 Point Improvement", 'timeFrame': 'Week 16', 'description': "Percentage of participants achieving IGA of 0 or 1 with a ≥2 point improvement is presented. The IGA measures the investigator's global assessment of the participant's overall severity of their Atopic Dermatitis, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification."}, {'measure': 'Open Label Population Pharmacokinetics (Pop PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104', 'timeFrame': 'Predose; 0.25 hours (h); 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose', 'description': 'Open label Pop PK: Cmax,ss was derived by a population pharmacokinetics approach.'}, {'measure': 'Open Label Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104', 'timeFrame': 'Predose; 0.25 h; 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose', 'description': 'Open label Pop PK: AUCtau,ss was derived by a population pharmacokinetics approach.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)', 'timeFrame': 'Week 16', 'description': 'The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.\n\nThe results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI75.'}, {'measure': 'Percentage of Participants Achieving EASI90', 'timeFrame': 'Week 16', 'description': 'The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI90 is defined as a ≥ 90% improvement from baseline in the EASI score.\n\nThe results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI90.'}, {'measure': 'Change From Baseline in EASI Score', 'timeFrame': 'Baseline, Week 16', 'description': 'The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs (1) erythema (2)edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2 and 3. The final EASI score is obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).\n\nLeast Square (LS) Means were calculated using a mixed model repeated measures (MMRM) model with treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.'}, {'measure': 'Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)', 'timeFrame': 'Week 16', 'description': 'The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with visual analog scale (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \\& subjective symptoms (C: 0-20) combine using A/5 + 7\\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. The SCORAD75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the SCORAD score.'}, {'measure': 'Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS) for Participants 10 to <18 Years Old at Study Entry', 'timeFrame': 'Week 16', 'description': 'The Itch Numeric Rating Scale (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 participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.'}, {'measure': 'Percentage of Participants Achieving EASI50', 'timeFrame': 'Week 16', 'description': 'The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%) and the severity of 4 clinical signs (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2 and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI50 is defined as a ≥ 50% improvement from baseline in EASI score.'}, {'measure': 'Percentage of Participants Achieving IGA of 0', 'timeFrame': 'Week 16', 'description': "The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification."}, {'measure': 'Change From Baseline in SCORAD', 'timeFrame': 'Baseline, Week 16', 'description': 'The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \\& subjective symptoms (C: 0-20) combine using A/5 + 7\\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease.\n\nLS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.'}, {'measure': 'Percentage of Participants Achieving SCORAD90', 'timeFrame': 'Week 16', 'description': 'The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \\& subjective symptoms (C: 0-20) combine using A/5 + 7\\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. SCORAD90 is defined as a ≥ 90% improvement from baseline in the SCORAD score.'}, {'measure': 'Change From Baseline in Body Surface Area (BSA) Affected', 'timeFrame': 'Baseline, Week 16', 'description': 'Body surface area affected by atopic dermatitis will be assessed for 4 separate body regions and is collected as part of the EASI assessment: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of atopic dermatitis. LS Means calculated using MMRM model with treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.'}, {'measure': 'Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment', 'timeFrame': 'Week 16', 'description': 'Percentage of participants developing skin infections requiring antibiotic treatment'}, {'measure': 'Mean Number of Days Without Use of Background Topical Corticosteroid (TCS)', 'timeFrame': 'Baseline Through 16 Weeks', 'description': 'Mean number of days without use of background TCS was presented. The ANOVA model includes treatment, age cohort, region, and baseline disease severity (IGA) as factors.'}, {'measure': 'Mean Gram Quantity of TCS Use (Tube Weights)', 'timeFrame': 'Baseline through 16 Weeks', 'description': 'The dispensed TCS tubes were weighed with cap (without the carton) to determine the dispensed amount of TCS in grams. Returned tubes were weighed with cap (without the carton) to determine the amount of TCS in grams used at each visit. Analysis was done via analysis of variance (ANOVA), with geographic region, baseline disease severity, and treatment as factors in the model.'}, {'measure': 'Change From Baseline in Itch NRS for Participants 10 to <18 Years at Study Entry', 'timeFrame': 'Baseline, Week 16', 'description': 'The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant\'s itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.\n\nLS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.'}, {'measure': 'Change From Baseline in the Parent-Reported Itch Severity Measure (PRISM) for Participants 2 to <10 Years at Study Entry', 'timeFrame': 'Baseline, Week 16', 'description': 'The Parent-Reported Itch Severity Measure (PRISM) is a single-item, parent/caregiver administered scale that reports the overall severity of their child\'s itching. Parent/Caregiver\'s report the overall severity of their child\'s itching based on observed actions of the child in the past 24 hours. Response options range include "No Itch," "Mild," "Moderate," "Severe," and "Very Severe." The PRISM will be completed for participants \\<10 years old by the parent/caregiver.\n\nLS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.'}, {'measure': 'Change From Baseline on the Patient-Oriented Eczema Measure (POEM) Total Score', 'timeFrame': 'Baseline, Week 16', 'description': 'The POEM is a simple, 7-item, patient-administered scale that assesses disease severity in children and adults. Participants respond to questions about the frequency of 7 symptoms (itching, sleep disturbance, bleeding, weeping/oozing, cracking, flaking, and dryness/roughness) over the last week on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). Scores range from 0-28 with higher total scores indicating greater disease severity.\n\nLS Means were calculated using MMRM model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.'}, {'measure': 'Change From Baseline in Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD) Score for Participants 10 to <18 Years at Study Entry', 'timeFrame': 'Baseline, Week 16', 'description': 'The PGI-S-AD is a single-item question asked to the participants on how they would rate their overall atopic dermatitis symptoms over the past 24 hours to evaluate the severity of the disease at that point in time. The 5 categories of responses range from "(0) no symptoms", "(1) very mild", "(2) mild" "(3) moderate", and "(4) severe".\n\nLS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.'}, {'measure': 'Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) - Pediatric Depression for Participants 5 to <18 Years at Study Entry', 'timeFrame': 'Baseline, Week 16', 'description': 'PROMIS is a set of person-centered measures that evaluates and monitors physical, mental and social health in adults and children. The PROMIS Depression item bank assesses self-reported negative mood (sadness, guilt), views on self (self-criticism, worthlessness), social cognition (loneliness, interpersonal alienation), decreased positive affect and engagement (loss of interest, meaning, and purpose). The PROMIS Depression Short Form (8a v2.0 and 6a v2.0) is available in pediatric self-report (ages 8 to \\<18 years) and for parents/caregivers serving as proxy reporters for children (ages 5 to \\<8 years). Children aged \\<5 years will not complete assessment. Both pediatric self-report and proxy-report versions assess depression "in past seven days." Response options range from 1 = Never;2 = Rarely;3 = Sometimes;4 = Often; to 5 = Almost always. Total raw scores were converted to T-Scores (mean= 50 and a standard deviation = 10) with higher scores representing greater depression.'}, {'measure': 'Change From Baseline in the PROMIS-Pediatric Anxiety for Participants 5 to <18 Years at Study Entry', 'timeFrame': 'Baseline, Week 16', 'description': 'PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS Anxiety item bank assesses self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). The PROMIS Anxiety Short Form (8 questions, 8a v2.0) is available in a pediatric self-report (ages 8 to \\<18 years) and for parents/caregivers serving as proxy reporters for their children (youth ages 5 to \\<8 years old). Children aged \\<5 years will not complete this assessment. Both pediatric self-report and proxy-report versions assess anxiety "in the past seven days." Response options range from 1= Never; 2 = Rarely; 3 = Sometimes; 4 = Often; to 5 = Almost always. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety.'}, {'measure': "Change From Baseline in the Children's Dermatology Life Quality Index (CDLQI) at Week 16 for Participants 4 to <18 Years at Study Entry", 'timeFrame': 'Baseline, Week 16', 'description': 'CDLQI is a validated 10 question tool to measure impact of skin disease on QOL in children by assessing how much the skin problem has affected the subjects over past week. Nine questions were scored as follows: Very much = 3, Quite a lot = 2, Only a little = 1, Not at all or unanswered = 0. Question 7 has an added possible response, which was scored as 3. CDLQI equals the sum of the score of each question (max. = 30, min. = 0). Higher the score, the greater the impact on QOL. A negative change from baseline indicated improvement. LS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.'}, {'measure': "Change From Baseline in Infants' Dermatology Quality of Life Index (IDQOL) at Week 16 for Participants 2 to <4 Years at Study Entry", 'timeFrame': 'Week 16', 'description': "Infants' Dermatitis Quality of Life Index (IDQOL) is used to evaluate quality of life for subjects of age less than 4 years. IDQOL questionnaires were designed for infants (below the age of 4 years) with atopic dermatitis. The IDQOL was calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score in each questionnaire, the more quality of life is impaired. A negative change from baseline indicated improvement. LS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects."}, {'measure': 'Change From Baseline on the Work Productivity and Activity Impairment: Atopic Dermatitis - Caregiver (WPAI-AD-CG) Score', 'timeFrame': 'Baseline, Week 16', 'description': "The Atopic Dermatitis Caregiver (WPAI-AD-CG) assesses the effect of a child's atopic dermatitis on the parent/caregiver's work productivity during the past 7 days. The WPAI-AD consists of 6 items grouped in 4 domains: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment, that range from 0% to 100%, Scores are calculated as impairment percentages with higher scores indicating greater impairment and less productivity.\n\nLS Mean were calculated using a MMRM model with treatment, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects."}, {'measure': 'Change From Baseline on the European Quality of Life-5 Dimensions-Youth (EQ-5D-Y) for Participants 4 to <18 Years at Study Entry', 'timeFrame': 'Baseline, Week 16', 'description': 'The EQ-5D-Y questionnaire is health status related and self-completed for pediatric participants ≥8 years old and completed by parents/caregivers for children 4 to \\<8 years old. Health state profile assessed health in 5 dimensions (Mobility,selfcare,usual activities,pain/discomfort, anxiety/depression) to obtain index score, each with three levels of response (no problems,some problems,a lot of problems). Participants indicated their health state by choosing appropriate level from each dimension. Visual analog scale on which participant rates their perceived health state from 0 ("worst health you can imagine") to 100 ("best health you can imagine") is presented.Higher the score the better the health status. LS Means uses MMRM model which includes treatment,age cohort,region,baseline disease severity(IGA),visit,treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.'}, {'measure': 'Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS) for Participants 10 to <18 Years at Study Entry', 'timeFrame': 'Baseline, Week 16', 'description': 'Atopic Dermatitis Sleep Scale (ADSS) is a 3-item, participant-administered questionnaire developed to assess the impact of itch on sleep including difficulty falling asleep, frequency of waking, and difficulty getting back to sleep last night. Item 2, frequency of waking last night is reported by selecting the number of times they woke up each night, ranging from 0 to 29 times, where the higher a number indicates a worse outcome. The ADSS is designed to be completed daily, using a daily diary, with respondents thinking about sleep "last night." Each item is scored individually.\n\nLS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by- visit-interaction as fixed continuous effects.'}, {'measure': 'Change From Baseline in Skin Pain NRS for Participants 10 to <18 Years at Study Entry', 'timeFrame': 'Baseline, Week 16', 'description': 'Skin Pain NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Overall severity of a participant\'s skin pain is indicated by selecting the number, using a daily diary, that best describes the worst level of skin pain in the past 24 hours.\n\nLS Means were calculated using a MMRM model with treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.'}, {'measure': 'Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old at Study Entry', 'timeFrame': 'Week 2', 'description': 'The questionnaire for Suspension acceptability and palatability assessed the participants ability to swallow the oral suspension product, experience relating to the taste, smell and ease of administering and taking the suspension. The questionnaire contained following Questions: Question 1) How did you (your child) like the taste of the medicine? Question 2) How did you (your child) like the smell of the medicine? Question 3) How easy was it for you (your child) to take the medicine today? Question 4) How easy was it for you to use the oral syringe to give your child the dose today? Responses: Liked Very Much, Liked, Neither Liked nor Disliked, Disliked, Disliked Very Much, Very Easy, Easy, Neither Easy nor Hard, Difficult (or Hard) and Very Difficult (or Hard). The number of participants with these responses are presented. Data is presented as "Question Number-Response-Time point".'}, {'measure': 'Number of Participant Responses With Tablet Acceptability and Palatability Assessment (PK Lead-In) for Participants >=10 Years Old at Study Entry', 'timeFrame': 'Week 2', 'description': 'The questionnaire for tablet acceptability and palatability assessed the participants ability to swallow the tablet. The questionnaire contained the question 1) How easy was it for you (your child) to swallow the medicine today? Responses: Very Easy, Easy, Neither Easy nor Hard, Difficult (or Hard) and Very Difficult (or Hard). The number of participants with these responses are presented. Data is presented as "Question Number-Response-Time point".'}, {'measure': 'Height, Weight and Body Mass Index (BMI) Growth Rate', 'timeFrame': '124 Weeks', 'description': 'Height, Weight and BMI Growth Rate will be reported.'}, {'measure': 'Change of Immunoglobulin G (IgG) Titers', 'timeFrame': 'Baseline Through End of Study Completion', 'description': 'Number of participants with change of IgG titers for tetanus vaccine and pneumococcal conjugate will be presented. A primary immune response was assessed in participants who had never received tetanus or pneumococcal conjugate vaccines previously and secondary/booster responses were assessed if the participants had previously received the vaccines. For pneumococcal conjugate vaccine, number of participants with \\>= 2-fold increase in \\>=6 pneumococcal serotypes from pre-vaccination timepoint to specified post-vaccination timepoints through the end of the study will be presented. For tetanus vaccine, number of participants with \\>= 2-fold increase in participants with baseline titer \\>=0.1 IU/mL from pre-vaccination timepoint to specified post-vaccination timepoints through the end of the study will be presented.'}, {'measure': 'Pop PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104', 'timeFrame': 'Predose; 0.25 hours (h); 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose', 'description': 'Pop PK: Cmax,ss was derived by a population pharmacokinetics approach.'}, {'measure': 'Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104', 'timeFrame': 'Predose; 0.25 hours (h); 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose', 'description': 'Pop PK: AUCtau,ss was derived by a population pharmacokinetics approach.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['eczema', 'atopic eczema'], 'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'references': [{'pmid': '39522957', 'type': 'DERIVED', 'citation': 'Wollenberg A, Ikeda M, Chu CY, Eichenfield LF, Seyger MMB, Prakash A, Angle R, Zhu D, Pontes M, Paller AS. Longer-term safety and efficacy of baricitinib for atopic dermatitis in pediatric patients 2 to <18 years old: a randomized clinical trial of extended treatment to 3.6 years. J Dermatolog Treat. 2024 Dec;35(1):2411834. doi: 10.1080/09546634.2024.2411834. Epub 2024 Nov 10.'}], 'seeAlsoLinks': [{'url': 'https://trials.lillytrialguide.com/en-US/trial/B796sBY99npuSW6LYeHAk', 'label': 'A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis (BREEZE-AD-PEDS)'}]}, 'descriptionModule': {'briefSummary': 'The reason for this study is to see if the study drug called baricitinib works and is safe in children and teenage participants with atopic dermatitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At or above the 5th percentile of weight for age.\n* Have been diagnosed with moderate to severe atopic dermatitis for at least 12 months (if 6 years old or older) or at least 6 months (if 2 up to 6 years old).\n* Have had inadequate response or intolerance to existing topical (applied to the skin) medications within 6 months preceding screening.\n* Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period).\n* Agree to use emollients daily.\n\nExclusion Criteria:\n\n* Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections.\n* A history of eczema herpeticum within 12 months, and/or a history of 2 or more episode of eczema herpeticum in the past.\n* Participants who are currently experiencing a skin infection that requires treatment, or is currently being treated, with topical or systemic antibiotics.\n* Have any serious illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma).\n* Have been treated with the following therapies:\n\n * Monoclonal antibody for less than 5 half-lives prior to beginning study treatment.\n * Received prior treatment with any oral Janus kinase (JAK) inhibitor.\n * Received any parenteral corticosteroids administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned initiation of study drug or are anticipated to require parenteral injection of corticosteroids during the study.\n* Have had an intra-articular corticosteroid injection within 2 weeks prior to study entry or within 6 weeks prior to planned initiation of study drug.\n* Have high blood pressure characterized by a repeated systolic or diastolic blood pressure \\>95th percentile based on age, sex and height.\n* Have had major surgery within the past eight weeks or are planning major surgery during the study.\n* Have experienced any of the following within 12 weeks of screening: venous thromboembolic event (VTE), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.\n* Have a history of VTE or are considered at high risk of VTE as deemed by the investigator.\n* Have a history or presence of cardiovascular, respiratory, hepatic, chronic liver disease gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness.\n* Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection including herpes zoster (shingles or chicken pox), tuberculosis.\n* Have specific laboratory abnormalities.\n* Have received certain treatments that are contraindicated.\n* Pregnant or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT03952559', 'acronym': 'BREEZE-AD-PEDS', 'briefTitle': 'A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Outpatient Study Evaluating the Pharmacokinetics, Efficacy, and Safety of Baricitinib in Pediatric Patients With Moderate to Severe Atopic Dermatitis', 'orgStudyIdInfo': {'id': '16966'}, 'secondaryIdInfos': [{'id': 'I4V-MC-JAIP', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2018-000349-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Baricitinib Open Label High Dose (PK Lead-in)', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension (1 mL) QD.', 'interventionNames': ['Drug: Baricitinib', 'Drug: Topical corticosteroid']}, {'type': 'EXPERIMENTAL', 'label': 'Baricitinib High Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.', 'interventionNames': ['Drug: Baricitinib', 'Drug: Topical corticosteroid']}, {'type': 'EXPERIMENTAL', 'label': 'Baricitinib Medium Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.', 'interventionNames': ['Drug: Baricitinib', 'Drug: Topical corticosteroid']}, {'type': 'EXPERIMENTAL', 'label': 'Baricitinib Low Dose', 'description': 'Participants 10 to \\< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.\n\nParticipants 2 to \\< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.', 'interventionNames': ['Drug: Baricitinib', 'Drug: Topical corticosteroid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants 10 to \\< 18 years received placebo tablets. Participants 2 to \\< 10 years received placebo as oral suspension.', 'interventionNames': ['Drug: Placebo', 'Drug: Topical corticosteroid']}], 'interventions': [{'name': 'Baricitinib', 'type': 'DRUG', 'otherNames': ['LY3009104'], 'description': 'Administered orally', 'armGroupLabels': ['Baricitinib High Dose', 'Baricitinib Low Dose', 'Baricitinib Medium Dose', 'Baricitinib Open Label High Dose (PK Lead-in)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Placebo']}, {'name': 'Topical corticosteroid', 'type': 'DRUG', 'description': 'Administered as standard-of-care', 'armGroupLabels': ['Baricitinib High Dose', 'Baricitinib Low Dose', 'Baricitinib Medium Dose', 'Baricitinib Open Label High Dose (PK Lead-in)', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1425', 'city': 'Capital Federal', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Instituto de Neumonología Y Dermatología'}, {'zip': '1027', 'city': 'Ciudad Autónoma de Buenos Aires', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Centro de Investigaciones Metabólicas (CINME)'}, {'zip': 'C1121ABE', 'city': 'Buenos Aires', 'state': 'Ciudad Autonoma Buenos Aires', 'country': 'Argentina', 'facility': 'Fundacion CIDEA', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1426ABP', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Fundación Respirar', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': "The Children's Hospital at Westmead", 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '4102', 'city': 'Woolloongabba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Veracity Clinical Research', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '3052', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': "Royal Children's Hospital", 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '8036', 'city': 'Graz', 'state': 'Styria', 'country': 'Austria', 'facility': 'Medizinische Universität Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'facility': 'Medizinische Universität Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1220', 'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'facility': 'Sozialmedizinisches Zentrum Ost/Donauspital', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '90035-903', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital de Clinicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '09060-870', 'city': 'Santo André', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Faculdade de Medicina do ABC', 'geoPoint': {'lat': -23.66389, 'lon': -46.53833}}, {'zip': '22241-180', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'IBPClin - 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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'}}}}