Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-02-23 @ 3:01 PM
Study NCT ID:
NCT03745651
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2018-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
TRuE AD2 - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D011537', 'term': 'Pruritus'}, {'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'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@incyte.com', 'phone': '1-855-463-3463', 'title': 'Study Director', 'organization': 'Incyte Corporation'}, 'certainAgreement': {'otherDetails': 'Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 60 weeks', 'description': 'For safety analysis, participants who crossed over treatment from vehicle to active arm (0.75% BID and 1.5% BID Ruxolitinib cream) in LTS Period are counted both in vehicle arm and active arms in the number of participants summaries', 'eventGroups': [{'id': 'EG000', 'title': 'Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 52. Participants applied cream BID to areas identified at Baseline even if the areas improved.', 'otherNumAtRisk': 124, 'deathsNumAtRisk': 124, 'otherNumAffected': 9, 'seriousNumAtRisk': 124, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 52. Participants applied cream BID to areas identified at Baseline even if the areas improved.', 'otherNumAtRisk': 301, 'deathsNumAtRisk': 301, 'otherNumAffected': 49, 'seriousNumAtRisk': 301, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 52. Participants applied cream BID to areas identified at Baseline even if the areas improved.', 'otherNumAtRisk': 298, 'deathsNumAtRisk': 298, 'otherNumAffected': 51, 'seriousNumAtRisk': 298, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Application site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'seriousEvents': [{'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Chronic tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ovarian cyst ruptured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8", 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '14.0'}, {'value': '39.0', 'groupId': 'OG001', 'lowerLimit': '32.6', 'upperLimit': '45.6'}, {'value': '51.3', 'groupId': 'OG002', 'lowerLimit': '44.6', 'upperLimit': '58.0'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.84', 'ciLowerLimit': '4.125', 'ciUpperLimit': '21.202', 'pValueComment': 'The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.', 'statisticalMethod': 'Exact Logistic Regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.80', 'ciLowerLimit': '7.354', 'ciUpperLimit': '38.061', 'pValueComment': 'The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.', 'statisticalMethod': 'Exact Logistic Regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 8', 'description': 'The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥ 2 grade improvement from Baseline.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded.'}, {'type': 'SECONDARY', 'title': 'VC Period: Percentage of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000', 'lowerLimit': '8.6', 'upperLimit': '22.1'}, {'value': '51.5', 'groupId': 'OG001', 'lowerLimit': '44.9', 'upperLimit': '58.1'}, {'value': '61.8', 'groupId': 'OG002', 'lowerLimit': '55.2', 'upperLimit': '68.2'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.84', 'ciLowerLimit': '3.723', 'ciUpperLimit': '13.184', 'pValueComment': 'The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.', 'statisticalMethod': 'Exact Logistic Regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.67', 'ciLowerLimit': '5.775', 'ciUpperLimit': '20.732', 'pValueComment': 'The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.', 'statisticalMethod': 'Exact Logistic Regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 8', 'description': 'EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). 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 and the severity strata are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI75 responder was defined as a participant achieving 75% or greater improvement from Baseline in EASI score.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded.'}, {'type': 'SECONDARY', 'title': 'VC Period: Percentage of Participants With a ≥ 4-Point Improvement in Itch Numerical Rating Scale (NRS) Score From Baseline to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.3', 'groupId': 'OG000'}, {'value': '42.7', 'groupId': 'OG001'}, {'value': '50.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.17', 'ciLowerLimit': '2.045', 'ciUpperLimit': '9.036', 'pValueComment': 'The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.', 'statisticalMethod': 'Exact Logistic Regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.80', 'ciLowerLimit': '2.833', 'ciUpperLimit': '12.657', 'pValueComment': 'The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.', 'statisticalMethod': 'Exact Logistic Regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 8', 'description': 'The Itch NRS is a daily participant-reported measure (24-hour recall), of the worst level of itch intensity using a diary. Participants are asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed included participants in the ITT population with a Baseline Itch NRS score ≥ 4.'}, {'type': 'SECONDARY', 'title': 'VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form - Sleep Disturbance (8b - 24-Hour Recall) Score at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}, {'value': '211', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.1', 'groupId': 'OG000'}, {'value': '20.7', 'groupId': 'OG001'}, {'value': '25.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.8553', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.598', 'ciUpperLimit': '2.094', 'pValueComment': 'The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.', 'statisticalMethod': 'Exact Logistic Regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2359', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.47', 'ciLowerLimit': '0.805', 'ciUpperLimit': '2.741', 'pValueComment': 'The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.', 'statisticalMethod': 'Exact Logistic Regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 8', 'description': "The PROMIS Short Form - Sleep Disturbance (8b) questionnaire assesses participant's self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This questionnaire is completed in the morning by the participant where each item asks the participant to rate the severity of the participant's sleep disturbance. It is a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep disturbance.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed included participants in the ITT population with a Baseline score ≥ 6.'}, {'type': 'SECONDARY', 'title': 'VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep-Related Impairment (8a - 24-Hour Recall) Score at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}, {'value': '212', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.5', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}, {'value': '23.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1784', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.62', 'ciLowerLimit': '0.827', 'ciUpperLimit': '3.342', 'pValueComment': 'The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.', 'statisticalMethod': 'Exact Logistic Regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0472', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.96', 'ciLowerLimit': '1.007', 'ciUpperLimit': '4.000', 'pValueComment': 'The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.', 'statisticalMethod': 'Exact Logistic Regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 8', 'description': "The PROMIS Short Form - Sleep-Related Impairment (8a) questionnaire assesses participant's self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. The questionnaire is filled in the evening where each item asks the participant to rate the severity of the participant's sleep impairment. It has 8 simple questions with a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep-related impairment. Each item asks the participant to rate the severity of the participant's sleep impairment.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed included participants in the ITT population with a Baseline score ≥ 6.'}, {'type': 'SECONDARY', 'title': 'VC Period: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Treatment-Emergent Serious Adverse Event (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}, {'value': '246', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'title': 'TEAE', 'categories': [{'measurements': [{'value': '31.5', 'groupId': 'OG000'}, {'value': '29.0', 'groupId': 'OG001'}, {'value': '23.6', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Emergent SAE', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}, {'value': '0.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization up to Week 8', 'description': 'An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or an important medical event may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above. A TEAE or treatment emergent SAE is any AE or SAE either reported for first time or worsening of a pre-existing event after first dose of study drug.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all randomized participants who applied at least 1 application of ruxolitinib cream or vehicle cream.'}, {'type': 'SECONDARY', 'title': 'LTS Period: Percentage of Participants With at Least One TEAE and Treatment Emergent SAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}, {'value': '221', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID', 'description': 'Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG001', 'title': 'LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID', 'description': 'Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG002', 'title': 'LTS Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants who applied ruxolitinib 0.75% cream during the VC Period, continued applying ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG003', 'title': 'LTS Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}], 'classes': [{'title': 'TEAE', 'categories': [{'measurements': [{'value': '58.5', 'groupId': 'OG000'}, {'value': '65.4', 'groupId': 'OG001'}, {'value': '66.2', 'groupId': 'OG002'}, {'value': '54.3', 'groupId': 'OG003'}]}]}, {'title': 'Treatment Emergent SAE', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '2.5', 'groupId': 'OG002'}, {'value': '1.4', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose date in LTS Period (Week 8) until last follow-up visit (up to 52 weeks)', 'description': 'An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or an important medical event may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above. A TEAE or treatment emergent SAE is any AE or SAE either reported for first time or worsening of a pre-existing event after first dose of study drug.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period.'}, {'type': 'SECONDARY', 'title': 'VC Period: Percentage of Participants Who Achieved an IGA-TS at Weeks 2 and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}, {'value': '17.3', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000'}, {'value': '35.5', 'groupId': 'OG001'}, {'value': '43.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Weeks 2 and 4', 'description': 'The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥ 2 grade improvement from Baseline.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded.'}, {'type': 'SECONDARY', 'title': 'VC Period: Percentage of Participants Achieving an IGA of 0 or 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000'}, {'value': '24.2', 'groupId': 'OG001'}, {'value': '34.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000'}, {'value': '45.9', 'groupId': 'OG001'}, {'value': '52.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '16.1', 'groupId': 'OG000'}, {'value': '51.1', 'groupId': 'OG001'}, {'value': '62.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 2, 4 and 8', 'description': 'The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded.'}, {'type': 'SECONDARY', 'title': 'LTS Period: Percentage of Participants Achieving an IGA of 0 or 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}, {'value': '203', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID', 'description': 'Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG001', 'title': 'LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID', 'description': 'Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG002', 'title': 'LTS Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants who applied ruxolitinib 0.75% cream during the VC Period, continued applying ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG003', 'title': 'LTS Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}], 'classes': [{'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '186', 'groupId': 'OG002'}, {'value': '203', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '26.0', 'groupId': 'OG000'}, {'value': '10.2', 'groupId': 'OG001'}, {'value': '57.5', 'groupId': 'OG002'}, {'value': '65.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}, {'value': '196', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '59.6', 'groupId': 'OG000'}, {'value': '45.8', 'groupId': 'OG001'}, {'value': '59.6', 'groupId': 'OG002'}, {'value': '73.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}, {'value': '193', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '59.6', 'groupId': 'OG000'}, {'value': '59.6', 'groupId': 'OG001'}, {'value': '68.9', 'groupId': 'OG002'}, {'value': '74.1', 'groupId': 'OG003'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '173', 'groupId': 'OG002'}, {'value': '188', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '69.0', 'groupId': 'OG000'}, {'value': '58.7', 'groupId': 'OG001'}, {'value': '71.1', 'groupId': 'OG002'}, {'value': '74.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}, {'value': '185', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '61.0', 'groupId': 'OG000'}, {'value': '67.4', 'groupId': 'OG001'}, {'value': '70.4', 'groupId': 'OG002'}, {'value': '72.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '162', 'groupId': 'OG002'}, {'value': '182', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '67.6', 'groupId': 'OG000'}, {'value': '67.4', 'groupId': 'OG001'}, {'value': '74.1', 'groupId': 'OG002'}, {'value': '72.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}, {'value': '172', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '77.1', 'groupId': 'OG000'}, {'value': '72.7', 'groupId': 'OG001'}, {'value': '74.2', 'groupId': 'OG002'}, {'value': '73.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}, {'value': '169', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '81.3', 'groupId': 'OG000'}, {'value': '69.8', 'groupId': 'OG001'}, {'value': '73.3', 'groupId': 'OG002'}, {'value': '79.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '169', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '77.1', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}, {'value': '76.0', 'groupId': 'OG002'}, {'value': '79.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}, {'value': '171', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '74.3', 'groupId': 'OG000'}, {'value': '70.5', 'groupId': 'OG001'}, {'value': '75.2', 'groupId': 'OG002'}, {'value': '80.1', 'groupId': 'OG003'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '166', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '79.4', 'groupId': 'OG000'}, {'value': '69.8', 'groupId': 'OG001'}, {'value': '75.2', 'groupId': 'OG002'}, {'value': '75.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '171', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '79.4', 'groupId': 'OG000'}, {'value': '74.4', 'groupId': 'OG001'}, {'value': '76.7', 'groupId': 'OG002'}, {'value': '80.1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52', 'description': 'The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.'}, {'type': 'SECONDARY', 'title': 'VC Period: Percentage of Participants With a ≥ 4-Point Improvement in Itch NRS Score From Baseline to Weeks 2 and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}, {'value': '27.4', 'groupId': 'OG001'}, {'value': '32.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '38.2', 'groupId': 'OG001'}, {'value': '45.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Weeks 2 and 4', 'description': 'The Itch NRS is a daily participant-reported measure (24-hour recall), of the worst level of itch intensity using a diary. Participants are asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed includes participants in the ITT population with a Baseline Itch NRS score ≥ 4.'}, {'type': 'SECONDARY', 'title': 'VC Period: Percentage of Participants Who Achieved EASI50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '16.1', 'groupId': 'OG000'}, {'value': '45.5', 'groupId': 'OG001'}, {'value': '53.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '28.8', 'groupId': 'OG000'}, {'value': '69.7', 'groupId': 'OG001'}, {'value': '71.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '33.9', 'groupId': 'OG000'}, {'value': '75.8', 'groupId': 'OG001'}, {'value': '79.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Weeks 2, 4 and 8', 'description': 'EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). 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 and the severity strata are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI50 responder was defined as a participant achieving 50% or greater improvement from Baseline in EASI score.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded.'}, {'type': 'SECONDARY', 'title': 'VC Period: Percentage of Participants Who Achieved EASI75 at Weeks 2 and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}, {'value': '25.5', 'groupId': 'OG001'}, {'value': '31.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000'}, {'value': '42.0', 'groupId': 'OG001'}, {'value': '50.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Weeks 2 and 4', 'description': 'EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). 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 and the severity strata are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI75 responder was defined as a participant achieving 75% or greater improvement from Baseline in EASI score.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded.'}, {'type': 'SECONDARY', 'title': 'VC Period: Percentage of Participants Who Achieved EASI90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '10.8', 'groupId': 'OG001'}, {'value': '15.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '25.5', 'groupId': 'OG001'}, {'value': '32.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}, {'value': '35.1', 'groupId': 'OG001'}, {'value': '43.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Weeks 2, 4 and 8', 'description': 'EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). 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 and the severity strata are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI90 responder was defined as a participant achieving 90% or greater improvement from Baseline in EASI score.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded.'}, {'type': 'SECONDARY', 'title': 'VC Period: Percent Change From Baseline in EASI Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'title': 'Percent Change From Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-13.95', 'spread': '4.02', 'groupId': 'OG000'}, {'value': '-45.86', 'spread': '2.84', 'groupId': 'OG001'}, {'value': '-49.08', 'spread': '2.86', 'groupId': 'OG002'}]}]}, {'title': 'Percent Change From Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-20.45', 'spread': '3.62', 'groupId': 'OG000'}, {'value': '-65.00', 'spread': '2.50', 'groupId': 'OG001'}, {'value': '-66.35', 'spread': '2.51', 'groupId': 'OG002'}]}]}, {'title': 'Percent Change From Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-28.84', 'spread': '3.57', 'groupId': 'OG000'}, {'value': '-73.37', 'spread': '2.50', 'groupId': 'OG001'}, {'value': '-74.84', 'spread': '2.46', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-31.91', 'ciLowerLimit': '-41.57', 'ciUpperLimit': '-22.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.92', 'groupDescription': 'Percent change from Baseline in EASI score at Week 2', 'statisticalMethod': 'Mixed-Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-35.13', 'ciLowerLimit': '-44.81', 'ciUpperLimit': '-25.44', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.93', 'groupDescription': 'Percent change from Baseline in EASI score at Week 2', 'statisticalMethod': 'Mixed-Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-44.56', 'ciLowerLimit': '-53.19', 'ciUpperLimit': '-35.92', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.40', 'groupDescription': 'Percent change from Baseline in EASI score at Week 4', 'statisticalMethod': 'Mixed-Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-45.91', 'ciLowerLimit': '-54.55', 'ciUpperLimit': '-37.26', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.40', 'groupDescription': 'Percent change from Baseline in EASI score at Week 4', 'statisticalMethod': 'Mixed-Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-44.53', 'ciLowerLimit': '-53.08', 'ciUpperLimit': '-35.98', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.35', 'groupDescription': 'Percent change from Baseline in EASI score at Week 8', 'statisticalMethod': 'Mixed-Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-46.00', 'ciLowerLimit': '-54.51', 'ciUpperLimit': '-37.48', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.33', 'groupDescription': 'Percent change from Baseline in EASI score at Week 8', 'statisticalMethod': 'Mixed-Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 2, 4 and 8', 'description': 'EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). 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 and the severity strata are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.'}, {'type': 'SECONDARY', 'title': 'VC Period: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'title': 'Percent Change From Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-13.87', 'spread': '24.816', 'groupId': 'OG000'}, {'value': '-39.62', 'spread': '28.061', 'groupId': 'OG001'}, {'value': '-45.22', 'spread': '28.461', 'groupId': 'OG002'}]}]}, {'title': 'Percent Change From Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-21.79', 'spread': '30.083', 'groupId': 'OG000'}, {'value': '-54.85', 'spread': '29.803', 'groupId': 'OG001'}, {'value': '-58.76', 'spread': '29.580', 'groupId': 'OG002'}]}]}, {'title': 'Percent Change From Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}, {'value': '216', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-23.63', 'spread': '33.918', 'groupId': 'OG000'}, {'value': '-63.71', 'spread': '28.494', 'groupId': 'OG001'}, {'value': '-67.39', 'spread': '29.098', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-39.4', 'ciLowerLimit': '-46.48', 'ciUpperLimit': '-32.38', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.59', 'groupDescription': 'Percent change from Baseline in SCORAD score at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-43.5', 'ciLowerLimit': '-50.51', 'ciUpperLimit': '-36.53', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.56', 'groupDescription': 'Percent change from Baseline in SCORAD score at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 2, 4 and 8', 'description': 'The SCORAD is a tool to assess extent and severity of eczema. To determine the extent, the rule of nines or handprint method is used to assess eczema affected area (A). To determine disease severity (B) it evaluates 6 clinical characteristics: 1. redness, 2. swelling, 3. oozing/crusting, 4. scratch marks, 5. lichenification, and 6. dryness on a 4-point scale of 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), added to give B with maximum score of 18. Subjective symptoms (C) of itch and sleeplessness are assessed using a visual analogue scale where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), added to give C with maximum score of 20. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \\& subjective symptoms (C: 0-20) combined using A/5 + 7\\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.'}, {'type': 'SECONDARY', 'title': 'VC Period: Change From Baseline in Itch NRS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'title': 'Change From Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.69', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-2.21', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '-2.43', 'spread': '0.15', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.03', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '-2.82', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '-3.00', 'spread': '0.17', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.39', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '-3.28', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '-3.09', 'spread': '0.17', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.52', 'ciLowerLimit': '-2.02', 'ciUpperLimit': '-1.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.26', 'groupDescription': 'Change from Baseline in Itch NRS score at Week 2', 'statisticalMethod': 'Mixed-Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.74', 'ciLowerLimit': '-2.24', 'ciUpperLimit': '-1.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.26', 'groupDescription': 'Change from Baseline in Itch NRS score at Week 2', 'statisticalMethod': 'Mixed-Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.79', 'ciLowerLimit': '-2.36', 'ciUpperLimit': '-1.23', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.29', 'groupDescription': 'Change from Baseline in Itch NRS score at Week 4', 'statisticalMethod': 'Mixed-Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.97', 'ciLowerLimit': '-2.53', 'ciUpperLimit': '-1.40', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.29', 'groupDescription': 'Change from Baseline in Itch NRS score at Week 4', 'statisticalMethod': 'Mixed-Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.89', 'ciLowerLimit': '-2.49', 'ciUpperLimit': '-1.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.31', 'groupDescription': 'Change from Baseline in Itch NRS score at Week 8', 'statisticalMethod': 'Mixed-Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.70', 'ciLowerLimit': '-2.30', 'ciUpperLimit': '-1.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.30', 'groupDescription': 'Change from Baseline in Itch NRS score at Week 8', 'statisticalMethod': 'Mixed-Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 2, 4 and 8', 'description': 'The Itch NRS is a daily participant-reported measure (24-hour recall), of the worst level of itch intensity using a diary. Participants are asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.'}, {'type': 'SECONDARY', 'title': 'VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2, 3, or 4 Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'title': '≥ 2-Point Improvement in Itch NRS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '13.0', 'upperLimit': '24.0'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '6.0'}, {'value': '4.0', 'groupId': 'OG002', 'lowerLimit': '4.0', 'upperLimit': '5.0'}]}]}, {'title': '≥ 3-Point Improvement in Itch NRS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '44.0', 'comment': 'The upper limit of 95% CI was not estimable', 'groupId': 'OG000', 'lowerLimit': '25.0', 'upperLimit': 'NA'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '6.0', 'upperLimit': '13.0'}, {'value': '8.0', 'groupId': 'OG002', 'lowerLimit': '6.0', 'upperLimit': '11.0'}]}]}, {'title': '≥ 4-Point Improvement in Itch NRS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median and 95% CI were not estimable because they were not achieved', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '22'}, {'value': '14', 'groupId': 'OG002', 'lowerLimit': '10', 'upperLimit': '18'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Week 8', 'description': 'The Itch NRS is a daily participant-reported measure (24-hour recall), of the worst level of itch intensity using a diary. Participants are asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours. Kaplan-Meier estimation method was used for analyses.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed included participants in the ITT population with a Baseline Itch NRS score ≥ 2, ≥ 3 or ≥ 4 and a daily Itch NRS assessment during the VC Period.'}, {'type': 'SECONDARY', 'title': 'VC Period: Change From Baseline in Skin Pain NRS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'title': 'Change From Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.53', 'spread': '1.677', 'groupId': 'OG000'}, {'value': '-1.78', 'spread': '2.145', 'groupId': 'OG001'}, {'value': '-1.73', 'spread': '2.125', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.93', 'spread': '1.964', 'groupId': 'OG000'}, {'value': '-2.28', 'spread': '2.449', 'groupId': 'OG001'}, {'value': '-2.27', 'spread': '2.262', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '185', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.35', 'spread': '2.540', 'groupId': 'OG000'}, {'value': '-2.45', 'spread': '2.575', 'groupId': 'OG001'}, {'value': '-2.37', 'spread': '2.428', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-1.94', 'ciUpperLimit': '-0.97', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'groupDescription': 'Change from Baseline in Skin Pain NRS score at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-1.72', 'ciUpperLimit': '-0.76', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'groupDescription': 'Change from Baseline in Skin Pain NRS score at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 2, 4 and 8', 'description': 'The Skin Pain NRS is a daily patient-reported measure (24-hour recall), of the worst level of pain intensity from 0 (no pain) to 10 (worst imaginable pain) using a diary. Participants will be asked, "Rate the pain severity from your atopic dermatitis skin changes by selecting a number that best describes your worst level of pain in the past 24 hours." A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.'}, {'type': 'SECONDARY', 'title': 'VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score at Weeks 2 and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}, {'value': '211', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}, {'value': '14.6', 'groupId': 'OG001'}, {'value': '18.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000'}, {'value': '16.9', 'groupId': 'OG001'}, {'value': '18.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 2 and 4', 'description': "The PROMIS Short Form - Sleep Disturbance (8b) questionnaire assesses participant's self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This questionnaire is completed in the morning by the participant where each item asks the participant to rate the severity of the participant's sleep disturbance. It is a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep disturbance.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed included participants in the ITT population with a Baseline score ≥ 6.'}, {'type': 'SECONDARY', 'title': 'VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score at Weeks 2 and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}, {'value': '212', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}, {'value': '13.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000'}, {'value': '13.0', 'groupId': 'OG001'}, {'value': '19.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 2 and 4', 'description': "The PROMIS Short Form - Sleep-Related Impairment (8a) questionnaire assesses participant's self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. The questionnaire is filled in the evening where each item asks the participant to rate the severity of the participant's sleep impairment. It has 8 simple questions with a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep-related impairment.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed included participants in the ITT population with a Baseline score ≥ 6.'}, {'type': 'SECONDARY', 'title': 'VC Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'title': 'Change From Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.32', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '-1.92', 'spread': '0.33', 'groupId': 'OG001'}, {'value': '-2.30', 'spread': '0.33', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.02', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '-2.32', 'spread': '0.35', 'groupId': 'OG001'}, {'value': '-2.88', 'spread': '0.35', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.60', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '-3.30', 'spread': '0.42', 'groupId': 'OG001'}, {'value': '-3.40', 'spread': '0.41', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2903', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.60', 'ciLowerLimit': '-1.71', 'ciUpperLimit': '0.51', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.57', 'groupDescription': 'Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 2', 'statisticalMethod': 'Mixed-Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.'}, {'pValue': '0.0837', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.98', 'ciLowerLimit': '-2.09', 'ciUpperLimit': '0.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.57', 'groupDescription': 'Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 2', 'statisticalMethod': 'Mixed-Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.'}, {'pValue': '0.6272', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.30', 'ciLowerLimit': '-1.50', 'ciUpperLimit': '0.91', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.61', 'groupDescription': 'Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 4', 'statisticalMethod': 'Mixed-Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.'}, {'pValue': '0.1609', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.86', 'ciLowerLimit': '-2.07', 'ciUpperLimit': '0.34', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.61', 'groupDescription': 'Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 4', 'statisticalMethod': 'Mixed-Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.'}, {'pValue': '0.3362', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.70', 'ciLowerLimit': '-2.13', 'ciUpperLimit': '0.73', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.73', 'groupDescription': 'Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 8', 'statisticalMethod': 'Mixed-Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.'}, {'pValue': '0.2690', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.80', 'ciLowerLimit': '-2.23', 'ciUpperLimit': '0.62', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.73', 'groupDescription': 'Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 8', 'statisticalMethod': 'Mixed-Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 2, 4 and 8', 'description': "The PROMIS Short Form - Sleep Disturbance (8b) questionnaire assesses participant's self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This questionnaire is completed in the morning by the participant where each item asks the participant to rate the severity of the participant's sleep disturbance. It is a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep disturbance. A negative change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.'}, {'type': 'SECONDARY', 'title': 'VC Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'title': 'Change From Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.80', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '-1.87', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '-2.00', 'spread': '0.31', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '186', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.37', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '-2.13', 'spread': '0.35', 'groupId': 'OG001'}, {'value': '-2.91', 'spread': '0.35', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.08', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '-3.26', 'spread': '0.39', 'groupId': 'OG001'}, {'value': '-3.31', 'spread': '0.38', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0482', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.07', 'ciLowerLimit': '-2.13', 'ciUpperLimit': '-0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.54', 'groupDescription': 'Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 2', 'statisticalMethod': 'Mixed-Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.'}, {'pValue': '0.0271', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.20', 'ciLowerLimit': '-2.26', 'ciUpperLimit': '-0.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.54', 'groupDescription': 'Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 2', 'statisticalMethod': 'Mixed-Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.'}, {'pValue': '0.2091', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.76', 'ciLowerLimit': '-1.94', 'ciUpperLimit': '0.42', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.60', 'groupDescription': 'Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 4', 'statisticalMethod': 'Mixed-Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.'}, {'pValue': '0.0111', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.53', 'ciLowerLimit': '-2.71', 'ciUpperLimit': '-0.35', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.60', 'groupDescription': 'Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 4', 'statisticalMethod': 'Mixed-Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.'}, {'pValue': '0.0802', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.18', 'ciLowerLimit': '-2.51', 'ciUpperLimit': '0.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.68', 'groupDescription': 'Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 8', 'statisticalMethod': 'Mixed-Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.'}, {'pValue': '0.0666', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.24', 'ciLowerLimit': '-2.56', 'ciUpperLimit': '0.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.67', 'groupDescription': 'Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 8', 'statisticalMethod': 'Mixed-Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 2, 4 and 8', 'description': "The PROMIS Short Form - Sleep-Related Impairment (8a) questionnaire assesses participant's self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. The questionnaire is filled in the evening where each item asks the participant to rate the severity of the participant's sleep impairment. It has 8 simple questions with a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep-related impairment. A negative change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.'}, {'type': 'SECONDARY', 'title': 'LTS Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 7-Day Recall Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}, {'value': '203', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID', 'description': 'Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG001', 'title': 'LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID', 'description': 'Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG002', 'title': 'LTS Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants who applied ruxolitinib 0.75% cream during the VC Period, continued applying ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG003', 'title': 'LTS Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}], 'classes': [{'title': 'Change From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '171', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.73', 'spread': '4.019', 'groupId': 'OG000'}, {'value': '-2.04', 'spread': '6.282', 'groupId': 'OG001'}, {'value': '-0.32', 'spread': '4.724', 'groupId': 'OG002'}, {'value': '-0.04', 'spread': '3.914', 'groupId': 'OG003'}]}]}, {'title': 'Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '161', 'groupId': 'OG002'}, {'value': '176', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.47', 'spread': '4.695', 'groupId': 'OG000'}, {'value': '-1.04', 'spread': '5.969', 'groupId': 'OG001'}, {'value': '-0.11', 'spread': '5.136', 'groupId': 'OG002'}, {'value': '0.22', 'spread': '4.868', 'groupId': 'OG003'}]}]}, {'title': 'Change From Baseline at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}, {'value': '159', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.48', 'spread': '5.304', 'groupId': 'OG000'}, {'value': '-2.33', 'spread': '6.582', 'groupId': 'OG001'}, {'value': '-0.24', 'spread': '5.660', 'groupId': 'OG002'}, {'value': '-0.69', 'spread': '5.483', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 12, 24, and 52', 'description': "The PROMIS Short Form - Sleep-Related Impairment (8a) questionnaire assesses participant's self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. The questionnaire is filled in the evening where each item asks the participant to rate the severity of the participant's sleep impairment. It has 8 simple questions with a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep-related impairment. A negative change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.'}, {'type': 'SECONDARY', 'title': 'LTS Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 7-Day Recall Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}, {'value': '203', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID', 'description': 'Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG001', 'title': 'LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID', 'description': 'Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG002', 'title': 'LTS Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants who applied ruxolitinib 0.75% cream during the VC Period, continued applying ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG003', 'title': 'LTS Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}], 'classes': [{'title': 'Change From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '171', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.00', 'spread': '4.973', 'groupId': 'OG000'}, {'value': '-1.80', 'spread': '5.588', 'groupId': 'OG001'}, {'value': '-0.37', 'spread': '4.621', 'groupId': 'OG002'}, {'value': '-0.32', 'spread': '4.466', 'groupId': 'OG003'}]}]}, {'title': 'Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '161', 'groupId': 'OG002'}, {'value': '176', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.97', 'spread': '6.188', 'groupId': 'OG000'}, {'value': '-1.87', 'spread': '5.691', 'groupId': 'OG001'}, {'value': '-0.03', 'spread': '4.688', 'groupId': 'OG002'}, {'value': '0.06', 'spread': '5.376', 'groupId': 'OG003'}]}]}, {'title': 'Change From Baseline at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}, {'value': '159', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.39', 'spread': '7.198', 'groupId': 'OG000'}, {'value': '-2.88', 'spread': '7.235', 'groupId': 'OG001'}, {'value': '-0.36', 'spread': '6.049', 'groupId': 'OG002'}, {'value': '-0.42', 'spread': '5.950', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 12, 24, and 52', 'description': "The PROMIS Short Form - Sleep Disturbance (8b) questionnaire assesses participant's self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This questionnaire is completed in the morning by the participant where each item asks the participant to rate the severity of the participant's sleep disturbance. It is a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep disturbance. A negative change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.'}, {'type': 'SECONDARY', 'title': 'VC Period: Change From Baseline in Atopic Dermatitis Afflicted Percentage of Body Surface Area (%BSA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'title': 'Change From Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.48', 'spread': '3.008', 'groupId': 'OG000'}, {'value': '-2.92', 'spread': '3.944', 'groupId': 'OG001'}, {'value': '-3.99', 'spread': '4.636', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.62', 'spread': '3.338', 'groupId': 'OG000'}, {'value': '-4.77', 'spread': '4.711', 'groupId': 'OG001'}, {'value': '-5.45', 'spread': '5.223', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.13', 'spread': '4.671', 'groupId': 'OG000'}, {'value': '-6.00', 'spread': '4.845', 'groupId': 'OG001'}, {'value': '-6.61', 'spread': '5.479', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.9', 'ciLowerLimit': '-4.84', 'ciUpperLimit': '-2.97', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.48', 'groupDescription': 'Change from Baseline in %BSA at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.5', 'ciLowerLimit': '-5.47', 'ciUpperLimit': '-3.63', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.47', 'groupDescription': 'Change from Baseline in %BSA at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 2, 4 and 8', 'description': 'Body surface area affected by AD was 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 was assessed for disease extent ranging from 0% to 100% involvement. The overall total percentage was reported based off of all 4 body regions combined, after applying specific multipliers to the different body regions to account for the percent of the total BSA represented by each of the 4 regions. Use the percentage of skin affected for each region (0 to 100%) in EASI as follows: BSA Total = 0.1\\*BSA head and neck + 0.3\\*BSA trunk + 0.2\\* BSA upper limbs + 0.4\\*BSA lower limbs. A negative change from Baseline indicates improvement.', 'unitOfMeasure': '% BSA', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.'}, {'type': 'SECONDARY', 'title': 'LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}, {'value': '203', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID', 'description': 'Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG001', 'title': 'LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID', 'description': 'Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG002', 'title': 'LTS Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants who applied ruxolitinib 0.75% cream during the VC Period, continued applying ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG003', 'title': 'LTS Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}], 'classes': [{'title': 'Change From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}, {'value': '196', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.89', 'spread': '5.530', 'groupId': 'OG000'}, {'value': '-4.71', 'spread': '4.980', 'groupId': 'OG001'}, {'value': '-6.61', 'spread': '4.395', 'groupId': 'OG002'}, {'value': '-7.69', 'spread': '5.106', 'groupId': 'OG003'}]}]}, {'title': 'Change From Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}, {'value': '193', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4.41', 'spread': '5.553', 'groupId': 'OG000'}, {'value': '-5.47', 'spread': '5.289', 'groupId': 'OG001'}, {'value': '-6.77', 'spread': '5.270', 'groupId': 'OG002'}, {'value': '-7.80', 'spread': '5.096', 'groupId': 'OG003'}]}]}, {'title': 'Change From Baseline at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '173', 'groupId': 'OG002'}, {'value': '188', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4.88', 'spread': '5.210', 'groupId': 'OG000'}, {'value': '-6.27', 'spread': '6.193', 'groupId': 'OG001'}, {'value': '-7.48', 'spread': '4.900', 'groupId': 'OG002'}, {'value': '-8.05', 'spread': '4.920', 'groupId': 'OG003'}]}]}, {'title': 'Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}, {'value': '185', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4.70', 'spread': '4.775', 'groupId': 'OG000'}, {'value': '-6.37', 'spread': '5.817', 'groupId': 'OG001'}, {'value': '-7.49', 'spread': '4.988', 'groupId': 'OG002'}, {'value': '-8.00', 'spread': '5.071', 'groupId': 'OG003'}]}]}, {'title': 'Change From Baseline at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}, {'value': '182', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4.59', 'spread': '4.677', 'groupId': 'OG000'}, {'value': '-6.21', 'spread': '6.597', 'groupId': 'OG001'}, {'value': '-7.48', 'spread': '4.827', 'groupId': 'OG002'}, {'value': '-8.07', 'spread': '5.099', 'groupId': 'OG003'}]}]}, {'title': 'Change From Baseline at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}, {'value': '172', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-5.10', 'spread': '5.203', 'groupId': 'OG000'}, {'value': '-6.79', 'spread': '5.960', 'groupId': 'OG001'}, {'value': '-7.69', 'spread': '4.891', 'groupId': 'OG002'}, {'value': '-7.89', 'spread': '5.004', 'groupId': 'OG003'}]}]}, {'title': 'Change From Baseline at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '169', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4.65', 'spread': '5.266', 'groupId': 'OG000'}, {'value': '-6.16', 'spread': '6.045', 'groupId': 'OG001'}, {'value': '-7.79', 'spread': '4.856', 'groupId': 'OG002'}, {'value': '-8.38', 'spread': '5.119', 'groupId': 'OG003'}]}]}, {'title': 'Change From Baseline at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '169', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4.59', 'spread': '5.196', 'groupId': 'OG000'}, {'value': '-6.42', 'spread': '5.887', 'groupId': 'OG001'}, {'value': '-7.83', 'spread': '4.976', 'groupId': 'OG002'}, {'value': '-8.44', 'spread': '5.090', 'groupId': 'OG003'}]}]}, {'title': 'Change From Baseline at Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}, {'value': '171', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-5.18', 'spread': '4.901', 'groupId': 'OG000'}, {'value': '-6.56', 'spread': '6.200', 'groupId': 'OG001'}, {'value': '-7.92', 'spread': '5.082', 'groupId': 'OG002'}, {'value': '-8.43', 'spread': '5.122', 'groupId': 'OG003'}]}]}, {'title': 'Change From Baseline at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '166', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-5.30', 'spread': '5.130', 'groupId': 'OG000'}, {'value': '-6.61', 'spread': '5.897', 'groupId': 'OG001'}, {'value': '-7.64', 'spread': '5.380', 'groupId': 'OG002'}, {'value': '-8.33', 'spread': '5.204', 'groupId': 'OG003'}]}]}, {'title': 'Change From Baseline at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '172', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-5.12', 'spread': '5.114', 'groupId': 'OG000'}, {'value': '-6.83', 'spread': '5.837', 'groupId': 'OG001'}, {'value': '-7.92', 'spread': '4.823', 'groupId': 'OG002'}, {'value': '-8.42', 'spread': '4.973', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52', 'description': 'Body surface area affected by AD was 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 was assessed for disease extent ranging from 0% to 100% involvement. The overall total percentage was reported based off of all 4 body regions combined, after applying specific multipliers to the different body regions to account for the percent of the total BSA represented by each of the 4 regions. Use the percentage of skin affected for each region (0 to 100%) in EASI as follows: BSA Total = 0.1\\*BSA head and neck + 0.3\\*BSA trunk + 0.2\\* BSA upper limbs + 0.4\\*BSA lower limbs. A negative change from Baseline indicates improvement.', 'unitOfMeasure': '% BSA', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.'}, {'type': 'SECONDARY', 'title': 'VC Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'title': 'Change From Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}, {'value': '212', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.06', 'spread': '5.371', 'groupId': 'OG000'}, {'value': '-8.21', 'spread': '6.694', 'groupId': 'OG001'}, {'value': '-8.86', 'spread': '6.807', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}, {'value': '211', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.01', 'spread': '6.125', 'groupId': 'OG000'}, {'value': '-9.59', 'spread': '6.883', 'groupId': 'OG001'}, {'value': '-9.97', 'spread': '6.839', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}, {'value': '210', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.18', 'spread': '6.574', 'groupId': 'OG000'}, {'value': '-10.34', 'spread': '6.835', 'groupId': 'OG001'}, {'value': '-10.08', 'spread': '7.167', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.1', 'ciLowerLimit': '-7.38', 'ciUpperLimit': '-4.86', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.64', 'groupDescription': 'Change from Baseline in POEM score at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.9', 'ciLowerLimit': '-7.17', 'ciUpperLimit': '-4.67', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.64', 'groupDescription': 'Change from Baseline in POEM score at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 2, 4 and 8', 'description': 'The POEM is a 7-question quality-of-life assessment that asks how many days the participant has been bothered by various aspects of their skin condition during the past 7 days. It assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.'}, {'type': 'SECONDARY', 'title': 'LTS Period: Change From Baseline in POEM Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}, {'value': '203', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID', 'description': 'Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG001', 'title': 'LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID', 'description': 'Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG002', 'title': 'LTS Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants who applied ruxolitinib 0.75% cream during the VC Period, continued applying ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG003', 'title': 'LTS Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}], 'classes': [{'title': 'Change From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-5.65', 'spread': '7.460', 'groupId': 'OG000'}, {'value': '-6.04', 'spread': '7.269', 'groupId': 'OG001'}, {'value': '-9.72', 'spread': '6.571', 'groupId': 'OG002'}, {'value': '-10.58', 'spread': '6.883', 'groupId': 'OG003'}]}]}, {'title': 'Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4.03', 'spread': '7.006', 'groupId': 'OG000'}, {'value': '-5.71', 'spread': '6.567', 'groupId': 'OG001'}, {'value': '-10.30', 'spread': '6.675', 'groupId': 'OG002'}, {'value': '-10.58', 'spread': '6.848', 'groupId': 'OG003'}]}]}, {'title': 'Change From Baseline at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}, {'value': '161', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6.15', 'spread': '7.304', 'groupId': 'OG000'}, {'value': '-6.28', 'spread': '7.340', 'groupId': 'OG001'}, {'value': '-10.29', 'spread': '6.187', 'groupId': 'OG002'}, {'value': '-10.65', 'spread': '6.699', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 12, 24 and 52', 'description': 'The POEM is a 7-question quality-of-life assessment that asks how many days the participant has been bothered by various aspects of their skin condition during the past 7 days. It assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.'}, {'type': 'SECONDARY', 'title': 'VC Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'title': 'Change From Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.91', 'spread': '4.679', 'groupId': 'OG000'}, {'value': '-5.40', 'spread': '5.874', 'groupId': 'OG001'}, {'value': '-5.14', 'spread': '5.394', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '186', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.00', 'spread': '4.962', 'groupId': 'OG000'}, {'value': '-6.62', 'spread': '5.966', 'groupId': 'OG001'}, {'value': '-6.16', 'spread': '5.771', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '185', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.30', 'spread': '5.353', 'groupId': 'OG000'}, {'value': '-7.18', 'spread': '6.004', 'groupId': 'OG001'}, {'value': '-6.41', 'spread': '5.731', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.3', 'ciLowerLimit': '-4.19', 'ciUpperLimit': '-2.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.48', 'groupDescription': 'Change from Baseline in total DLQI score at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.8', 'ciLowerLimit': '-3.67', 'ciUpperLimit': '-1.83', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.47', 'groupDescription': 'Change from Baseline in total DLQI score at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, and 8', 'description': 'The DLQI is a simple, 10 question (Q) validated quality-of-life questionnaire to measure how much the skin problem has affected the participant. It covers 6 domains including symptoms and feelings (Q1 and Q2), daily activities (Q3 and Q4), leisure (Q5 and Q6), work and school (Q7), personal relationships (Q8 and Q9), and treatment(Q10). The recall Period of this scale is over the last week. Response categories include 0-not at all, 1-a little, 2-a lot, and 3-very much, and unanswered or not relevant responses scored as 0. Scores range from 0 ("no impact on participant\'s life") to 30 ("extremely large effect on participant\'s life"), and a 4-point change from Baseline is considered as the minimal clinically important difference threshold. A negative change from Baseline indicates less impact of the skin problem on participant\'s life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to the study. Participants in the ITT population with age \\>= 16 were included. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.'}, {'type': 'SECONDARY', 'title': 'LTS Period: Change From Baseline in DLQI Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID', 'description': 'Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG001', 'title': 'LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID', 'description': 'Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG002', 'title': 'LTS Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants who applied ruxolitinib 0.75% cream during the VC Period, continued applying ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG003', 'title': 'LTS Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}], 'classes': [{'title': 'Change From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}, {'value': '170', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.09', 'spread': '3.611', 'groupId': 'OG000'}, {'value': '-2.79', 'spread': '5.542', 'groupId': 'OG001'}, {'value': '-7.07', 'spread': '5.931', 'groupId': 'OG002'}, {'value': '-7.06', 'spread': '6.044', 'groupId': 'OG003'}]}]}, {'title': 'Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}, {'value': '159', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.22', 'spread': '3.293', 'groupId': 'OG000'}, {'value': '-3.08', 'spread': '3.759', 'groupId': 'OG001'}, {'value': '-7.17', 'spread': '6.152', 'groupId': 'OG002'}, {'value': '-7.01', 'spread': '5.754', 'groupId': 'OG003'}]}]}, {'title': 'Change From Baseline at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '147', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.09', 'spread': '3.753', 'groupId': 'OG000'}, {'value': '-3.20', 'spread': '4.234', 'groupId': 'OG001'}, {'value': '-7.49', 'spread': '5.776', 'groupId': 'OG002'}, {'value': '-7.28', 'spread': '6.196', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 12, 24, and 52', 'description': 'The DLQI is a simple, 10 question (Q) validated quality-of-life questionnaire to measure how much the skin problem has affected the participant. It covers 6 domains including symptoms and feelings (Q1 and Q2), daily activities (Q3 and Q4), leisure (Q5 and Q6), work and school (Q7), personal relationships (Q8 and Q9), and treatment(Q10). The recall Period of this scale is over the last week. Response categories include 0-not at all, 1-a little, 2-a lot, and 3-very much, and unanswered or not relevant responses scored as 0. Scores range from 0 ("no impact on participant\'s life") to 30 ("extremely large effect on participant\'s life"), and a 4-point change from Baseline is considered as the minimal clinically important difference threshold. A negative change from Baseline indicates less impact of the skin problem on participant\'s life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period. Participants in the LTS evaluable population with age \\>= 16 were included. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.'}, {'type': 'SECONDARY', 'title': 'VC Period: Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'title': 'Change From Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.67', 'spread': '5.416', 'groupId': 'OG000'}, {'value': '-3.45', 'spread': '4.570', 'groupId': 'OG001'}, {'value': '-3.58', 'spread': '4.032', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.10', 'spread': '6.488', 'groupId': 'OG000'}, {'value': '-4.82', 'spread': '4.934', 'groupId': 'OG001'}, {'value': '-4.52', 'spread': '5.221', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.36', 'spread': '7.500', 'groupId': 'OG000'}, {'value': '-4.56', 'spread': '5.061', 'groupId': 'OG001'}, {'value': '-4.12', 'spread': '6.418', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0099', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.1', 'ciLowerLimit': '-7.24', 'ciUpperLimit': '-1.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.55', 'groupDescription': 'Change from Baseline in total CDLQI score at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.'}, {'pValue': '0.0542', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.1', 'ciLowerLimit': '-6.30', 'ciUpperLimit': '0.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.59', 'groupDescription': 'Change from Baseline in total CDLQI score at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, and 8', 'description': "CDLQI is the youth/children's version of the DLQI. The CDLQI is a simple 10 question (Q) validated quality-of-life questionnaire. It covers 6 domains including symptoms and feelings (Q1 and Q2), leisure (Q4, Q5, and Q6), school or holidays (Q7), personal relationships (Q3 and Q8), sleep (Q9) and treatment (Q10). Response categories include 0-not at all, 1-a little, 2-a lot, and 3-very much, and unanswered or not relevant responses scored as 0. The total DLQI score is calculated by adding the score of each question resulting in a maximum score of 30 (extremely large effect on participant's life) and a minimum score of 0 (no impact on participant's life) and a 4-point change from Baseline is considered as the minimal clinically important difference threshold. A negative change from Baseline indicates less impact of the skin problem on participant's life.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to the study. Participants in the ITT population with age \\< 16 were included. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.'}, {'type': 'SECONDARY', 'title': 'LTS Period: Change From Baseline in CDLQI Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID', 'description': 'Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52.Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG001', 'title': 'LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID', 'description': 'Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG002', 'title': 'LTS Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants who applied ruxolitinib 0.75% cream during the VC Period, continued applying ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG003', 'title': 'LTS Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}], 'classes': [{'title': 'Change From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7.50', 'spread': '2.121', 'groupId': 'OG000'}, {'value': '-4.88', 'spread': '5.436', 'groupId': 'OG001'}, {'value': '-5.54', 'spread': '5.153', 'groupId': 'OG002'}, {'value': '-5.57', 'spread': '5.482', 'groupId': 'OG003'}]}]}, {'title': 'Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-8.50', 'spread': '2.121', 'groupId': 'OG000'}, {'value': '-4.88', 'spread': '4.549', 'groupId': 'OG001'}, {'value': '-5.72', 'spread': '6.066', 'groupId': 'OG002'}, {'value': '-5.68', 'spread': '7.326', 'groupId': 'OG003'}]}]}, {'title': 'Change From Baseline at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-8.00', 'spread': '1.414', 'groupId': 'OG000'}, {'value': '-6.38', 'spread': '9.023', 'groupId': 'OG001'}, {'value': '-5.35', 'spread': '4.902', 'groupId': 'OG002'}, {'value': '-6.57', 'spread': '5.983', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 12, 24, and 52', 'description': "CDLQI is the youth/children's version of the DLQI. The CDLQI is a simple 10 question (Q) validated quality-of-life questionnaire. It covers 6 domains including symptoms and feelings (Q1 and Q2), leisure (Q4, Q5, and Q6), school or holidays (Q7), personal relationships (Q3 and Q8), sleep (Q9) and treatment (Q10). Response categories include 0-not at all, 1-a little, 2-a lot, and 3-very much, and unanswered or not relevant responses scored as 0. The total DLQI score is calculated by adding the score of each question resulting in a maximum score of 30 (extremely large effect on participant's life) and a minimum score of 0 (no impact on participant's life) and a 4-point change from Baseline is considered as the minimal clinically important difference threshold. A negative change from Baseline indicates less impact of the skin problem on participant's life.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period. Participants in the LTS evaluable population with age \\< 16 were included. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.'}, {'type': 'SECONDARY', 'title': 'VC Period: Mean Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, and 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.32', 'spread': '1.268', 'groupId': 'OG000'}, {'value': '2.19', 'spread': '1.019', 'groupId': 'OG001'}, {'value': '1.95', 'spread': '0.980', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}, {'value': '216', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.99', 'spread': '1.259', 'groupId': 'OG000'}, {'value': '1.95', 'spread': '0.980', 'groupId': 'OG001'}, {'value': '1.71', 'spread': '0.852', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.93', 'spread': '1.380', 'groupId': 'OG000'}, {'value': '1.73', 'spread': '0.906', 'groupId': 'OG001'}, {'value': '1.70', 'spread': '0.909', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 2, 4 and 8', 'description': "The PGIC is a participants' self-reporting measure that reflects their belief about the efficacy of treatment. It is a 7-point scale where participants rate the questions as: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The lower score indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.'}, {'type': 'SECONDARY', 'title': 'VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'title': 'Week 2 - Very Much Improved: 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000'}, {'value': '32.1', 'groupId': 'OG001'}, {'value': '41.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 2 - Much Improved: 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20.2', 'groupId': 'OG000'}, {'value': '27.1', 'groupId': 'OG001'}, {'value': '30.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 2 - Minimally Improved: 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '38.5', 'groupId': 'OG000'}, {'value': '32.1', 'groupId': 'OG001'}, {'value': '20.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 2 - No Change: 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000'}, {'value': '7.8', 'groupId': 'OG001'}, {'value': '6.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 2 - Minimally Worse: 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000'}, {'value': '0.5', 'groupId': 'OG001'}, {'value': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 2 - Much Worse: 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000'}, {'value': '0.5', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 2 - Very Much Worse: 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 - Very Much Improved: 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}, {'value': '216', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}, {'value': '41.9', 'groupId': 'OG001'}, {'value': '49.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 - Much Improved: 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}, {'value': '216', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29.0', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '35.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 - Minimally Improved: 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}, {'value': '216', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29.0', 'groupId': 'OG000'}, {'value': '22.1', 'groupId': 'OG001'}, {'value': '12.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 - No Change: 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}, {'value': '216', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '6.9', 'groupId': 'OG001'}, {'value': '2.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 - Minimally Worse: 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}, {'value': '216', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}, {'value': '0.5', 'groupId': 'OG001'}, {'value': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 - Much Worse: 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}, {'value': '216', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 - Very Much Worse: 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}, {'value': '216', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 - Very Much Improved: 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '16.8', 'groupId': 'OG000'}, {'value': '52.7', 'groupId': 'OG001'}, {'value': '51.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 - Much Improved: 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '24.8', 'groupId': 'OG000'}, {'value': '26.1', 'groupId': 'OG001'}, {'value': '32.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 - Minimally Improved: 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23.8', 'groupId': 'OG000'}, {'value': '16.3', 'groupId': 'OG001'}, {'value': '12.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 - No Change: 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22.8', 'groupId': 'OG000'}, {'value': '4.9', 'groupId': 'OG001'}, {'value': '1.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 - Minimally Worse: 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 - Much Worse: 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 - Very Much Worse: 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 2, 4 and 8', 'description': "The PGIC is a participants' self-reporting measure that reflects their belief about the efficacy of treatment. It is a 7-point scale where participants rate the questions as: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The lower score indicates improvement.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.'}, {'type': 'SECONDARY', 'title': 'VC Period: Percentage of Participants With a Score of Either 1 or 2 on the PGIC at Weeks 2, 4, and 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '24.8', 'groupId': 'OG000', 'lowerLimit': '17.0', 'upperLimit': '34.0'}, {'value': '59.2', 'groupId': 'OG001', 'lowerLimit': '52.3', 'upperLimit': '65.8'}, {'value': '71.9', 'groupId': 'OG002', 'lowerLimit': '65.4', 'upperLimit': '77.8'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}, {'value': '216', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '39.0', 'groupId': 'OG000', 'lowerLimit': '29.4', 'upperLimit': '49.3'}, {'value': '70.5', 'groupId': 'OG001', 'lowerLimit': '64.0', 'upperLimit': '76.5'}, {'value': '84.3', 'groupId': 'OG002', 'lowerLimit': '78.7', 'upperLimit': '88.8'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41.6', 'groupId': 'OG000', 'lowerLimit': '31.9', 'upperLimit': '51.8'}, {'value': '78.8', 'groupId': 'OG001', 'lowerLimit': '72.5', 'upperLimit': '84.2'}, {'value': '84.2', 'groupId': 'OG002', 'lowerLimit': '78.6', 'upperLimit': '88.8'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.16', 'ciLowerLimit': '2.987', 'ciUpperLimit': '9.049', 'pValueComment': 'The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.', 'groupDescription': 'Percentage of participants with a score of either 1 or 2 on the PGIC at Week 8', 'statisticalMethod': 'Exact Logistic Regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.47', 'ciLowerLimit': '4.230', 'ciUpperLimit': '13.415', 'pValueComment': 'The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.', 'groupDescription': 'Percentage of participants with a score of either 1 or 2 on the PGIC at Week 8', 'statisticalMethod': 'Exact Logistic Regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 2, 4 and 8', 'description': "The PGIC is a participants' self-reporting measure that reflects their belief about the efficacy of treatment. It is a 7-point scale where participants rate the questions as: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The lower score indicates improvement.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.'}, {'type': 'SECONDARY', 'title': 'VC Period: Change From Baseline in EuroQuality of Life Five Dimensions (EQ-5D-5L) Visual Analogue Scale (VAS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'title': 'Change From Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.43', 'spread': '13.975', 'groupId': 'OG000'}, {'value': '6.16', 'spread': '14.409', 'groupId': 'OG001'}, {'value': '6.98', 'spread': '15.956', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}, {'value': '216', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.31', 'spread': '15.061', 'groupId': 'OG000'}, {'value': '6.38', 'spread': '17.512', 'groupId': 'OG001'}, {'value': '8.55', 'spread': '17.244', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.97', 'spread': '15.946', 'groupId': 'OG000'}, {'value': '7.16', 'spread': '18.245', 'groupId': 'OG001'}, {'value': '8.36', 'spread': '16.767', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0150', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.4', 'ciLowerLimit': '0.85', 'ciUpperLimit': '7.86', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.78', 'groupDescription': 'Change from Baseline in EQ VAS score at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.'}, {'pValue': '0.0044', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.1', 'ciLowerLimit': '1.59', 'ciUpperLimit': '8.54', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.77', 'groupDescription': 'Change from Baseline in EQ VAS score at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 2, 4 and 8', 'description': 'EQ-5D-5L questionnaire has 2 parts: EQ-5D-5L descriptive system \\& EQ-VAS. EQ-5D is a validated, self-administered, generic utility questionnaire wherein participants rate their current health state based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. 5L indicates that for each dimension, there are 5 levels:1=no problems,2=slight problems,3=moderate problems,4=severe problems, and 5=extreme problems. EQ-5D-5L score is assessed using VAS that ranges from 0 to 100 millimetres (mm), where 0 indicates "worst health you can imagine" and 100 indicates "best health you can imagine". The participant was asked to indicate his/her health state over past 7 days in each of the 5 dimensions. Digits for the 5 dimensions can be combined into a 5-digit number that describes the participant\'s health state. In the EQ-VAS, participants had to record their health state on a scale ranging from 0 to 100. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.'}, {'type': 'SECONDARY', 'title': 'VC Period: Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) Version 2.0 (v2.0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'title': 'Percent Work Time Missed Due to AD: Change From Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.77', 'spread': '23.348', 'groupId': 'OG000'}, {'value': '0.64', 'spread': '19.190', 'groupId': 'OG001'}, {'value': '2.53', 'spread': '17.803', 'groupId': 'OG002'}]}]}, {'title': 'Percent Work Time Missed Due to AD: Change From Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.22', 'spread': '22.497', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '22.299', 'groupId': 'OG001'}, {'value': '4.31', 'spread': '19.679', 'groupId': 'OG002'}]}]}, {'title': 'Percent Work Time Missed Due to AD: Change From Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.03', 'spread': '24.477', 'groupId': 'OG000'}, {'value': '3.50', 'spread': '24.760', 'groupId': 'OG001'}, {'value': '3.51', 'spread': '18.479', 'groupId': 'OG002'}]}]}, {'title': 'Percent Impairment While Working Due to AD: Change From Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.49', 'spread': '25.500', 'groupId': 'OG000'}, {'value': '-12.76', 'spread': '21.371', 'groupId': 'OG001'}, {'value': '-13.24', 'spread': '19.958', 'groupId': 'OG002'}]}]}, {'title': 'Percent Impairment While Working Due to AD: Change From Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-12.05', 'spread': '24.514', 'groupId': 'OG000'}, {'value': '-15.25', 'spread': '22.648', 'groupId': 'OG001'}, {'value': '-18.10', 'spread': '19.832', 'groupId': 'OG002'}]}]}, {'title': 'Percent Impairment While Working Due to AD: Change From Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-10.93', 'spread': '25.618', 'groupId': 'OG000'}, {'value': '-18.83', 'spread': '23.365', 'groupId': 'OG001'}, {'value': '-17.32', 'spread': '19.013', 'groupId': 'OG002'}]}]}, {'title': 'Percent Overall Work Impairment Due to AD: Change From Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.78', 'spread': '31.057', 'groupId': 'OG000'}, {'value': '-12.58', 'spread': '24.670', 'groupId': 'OG001'}, {'value': '-11.10', 'spread': '23.717', 'groupId': 'OG002'}]}]}, {'title': 'Percent Overall Work Impairment Due to AD: Change From Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-10.41', 'spread': '26.627', 'groupId': 'OG000'}, {'value': '-15.14', 'spread': '25.543', 'groupId': 'OG001'}, {'value': '-16.19', 'spread': '22.037', 'groupId': 'OG002'}]}]}, {'title': 'Percent Overall Work Impairment Due to AD: Change From Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.06', 'spread': '29.625', 'groupId': 'OG000'}, {'value': '-17.00', 'spread': '25.916', 'groupId': 'OG001'}, {'value': '-13.65', 'spread': '22.476', 'groupId': 'OG002'}]}]}, {'title': 'Percent Activity Impairment Due to AD: Change From Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.63', 'spread': '21.243', 'groupId': 'OG000'}, {'value': '-12.79', 'spread': '23.462', 'groupId': 'OG001'}, {'value': '-16.68', 'spread': '23.295', 'groupId': 'OG002'}]}]}, {'title': 'Percent Activity Impairment Due to AD: Change From Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}, {'value': '216', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-8.38', 'spread': '20.981', 'groupId': 'OG000'}, {'value': '-17.24', 'spread': '24.715', 'groupId': 'OG001'}, {'value': '-18.70', 'spread': '23.550', 'groupId': 'OG002'}]}]}, {'title': 'Percent Activity Impairment Due to AD: Change From Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-9.50', 'spread': '25.361', 'groupId': 'OG000'}, {'value': '-19.66', 'spread': '25.157', 'groupId': 'OG001'}, {'value': '-18.60', 'spread': '25.557', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1420', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.6', 'ciLowerLimit': '-13.12', 'ciUpperLimit': '1.89', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.81', 'groupDescription': 'Percent work time missed due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.'}, {'pValue': '0.0375', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.0', 'ciLowerLimit': '-15.51', 'ciUpperLimit': '-0.47', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.82', 'groupDescription': 'Percent work time missed due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.'}, {'pValue': '0.0012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.1', 'ciLowerLimit': '-14.48', 'ciUpperLimit': '-3.63', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.75', 'groupDescription': 'Percent impairment while working due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.'}, {'pValue': '0.0095', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.2', 'ciLowerLimit': '-12.58', 'ciUpperLimit': '-1.77', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.74', 'groupDescription': 'Percent impairment while working due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.2', 'ciLowerLimit': '-22.69', 'ciUpperLimit': '-7.73', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.80', 'groupDescription': 'Percent overall work impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.'}, {'pValue': '0.0010', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.6', 'ciLowerLimit': '-20.10', 'ciUpperLimit': '-5.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.79', 'groupDescription': 'Percent overall work impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.1', 'ciLowerLimit': '-16.18', 'ciUpperLimit': '-7.95', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.09', 'groupDescription': 'Percent activity impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.4', 'ciLowerLimit': '-14.53', 'ciUpperLimit': '-6.37', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.08', 'groupDescription': 'Percent activity impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, and 8', 'description': 'The WPAI-SHP is a 6-item participant questionnaire developed to measure the effect of overall health and specific symptoms on productivity at work and regular activities outside of it in the past 7 days. The WPAI-SHP consists of 6 questions as follows: 1=currently employed; 2=hours missed due to AD; 3=hours missed other reasons; 4=hours actually worked; 5=degree AD affected productivity while working; 6=degree AD affected regular activities and the computed percentage, range for each sub scale is from 0 to 100, with higher values indicating greater impairment and less productivity. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to the study. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.'}, {'type': 'SECONDARY', 'title': 'LTS Period: Change From Baseline in WPAI-SHP v2.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}, {'value': '203', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID', 'description': 'Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG001', 'title': 'LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID', 'description': 'Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG002', 'title': 'LTS Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants who applied ruxolitinib 0.75% cream during the VC Period, continued applying ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG003', 'title': 'LTS Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}], 'classes': [{'title': 'Percent Work Time Missed Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4.26', 'spread': '24.958', 'groupId': 'OG000'}, {'value': '-0.81', 'spread': '17.257', 'groupId': 'OG001'}, {'value': '-0.17', 'spread': '24.581', 'groupId': 'OG002'}, {'value': '3.48', 'spread': '16.470', 'groupId': 'OG003'}]}]}, {'title': 'Percent Work Time Missed Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.06', 'spread': '28.778', 'groupId': 'OG000'}, {'value': '-11.35', 'spread': '22.947', 'groupId': 'OG001'}, {'value': '-0.38', 'spread': '23.511', 'groupId': 'OG002'}, {'value': '5.13', 'spread': '24.419', 'groupId': 'OG003'}]}]}, {'title': 'Percent Work Time Missed Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.04', 'spread': '23.312', 'groupId': 'OG000'}, {'value': '-5.44', 'spread': '27.625', 'groupId': 'OG001'}, {'value': '-0.02', 'spread': '20.410', 'groupId': 'OG002'}, {'value': '3.37', 'spread': '20.967', 'groupId': 'OG003'}]}]}, {'title': 'Percent Work Time Missed Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.29', 'spread': '25.148', 'groupId': 'OG000'}, {'value': '3.60', 'spread': '24.186', 'groupId': 'OG001'}, {'value': '0.50', 'spread': '28.348', 'groupId': 'OG002'}, {'value': '6.36', 'spread': '21.806', 'groupId': 'OG003'}]}]}, {'title': 'Percent Impairment While Working Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-5.91', 'spread': '10.075', 'groupId': 'OG000'}, {'value': '-13.50', 'spread': '29.784', 'groupId': 'OG001'}, {'value': '-19.87', 'spread': '21.572', 'groupId': 'OG002'}, {'value': '-22.02', 'spread': '19.652', 'groupId': 'OG003'}]}]}, {'title': 'Percent Impairment While Working Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7.14', 'spread': '22.835', 'groupId': 'OG000'}, {'value': '-16.47', 'spread': '18.007', 'groupId': 'OG001'}, {'value': '-19.74', 'spread': '23.719', 'groupId': 'OG002'}, {'value': '-22.56', 'spread': '22.433', 'groupId': 'OG003'}]}]}, {'title': 'Percent Impairment While Working Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7.33', 'spread': '15.337', 'groupId': 'OG000'}, {'value': '-11.43', 'spread': '21.432', 'groupId': 'OG001'}, {'value': '-18.79', 'spread': '21.232', 'groupId': 'OG002'}, {'value': '-24.61', 'spread': '20.359', 'groupId': 'OG003'}]}]}, {'title': 'Percent Impairment While Working Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-16.00', 'spread': '24.129', 'groupId': 'OG000'}, {'value': '-13.85', 'spread': '17.578', 'groupId': 'OG001'}, {'value': '-20.00', 'spread': '25.312', 'groupId': 'OG002'}, {'value': '-21.86', 'spread': '25.836', 'groupId': 'OG003'}]}]}, {'title': 'Percent Overall Work Impairment Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-11.64', 'spread': '20.194', 'groupId': 'OG000'}, {'value': '-10.72', 'spread': '23.285', 'groupId': 'OG001'}, {'value': '-17.40', 'spread': '23.123', 'groupId': 'OG002'}, {'value': '-17.91', 'spread': '24.692', 'groupId': 'OG003'}]}]}, {'title': 'Percent Overall Work Impairment Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-10.99', 'spread': '33.070', 'groupId': 'OG000'}, {'value': '-25.22', 'spread': '25.009', 'groupId': 'OG001'}, {'value': '-17.83', 'spread': '27.226', 'groupId': 'OG002'}, {'value': '-19.31', 'spread': '26.893', 'groupId': 'OG003'}]}]}, {'title': 'Percent Overall Work Impairment Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7.77', 'spread': '25.443', 'groupId': 'OG000'}, {'value': '-15.27', 'spread': '30.360', 'groupId': 'OG001'}, {'value': '-17.70', 'spread': '23.161', 'groupId': 'OG002'}, {'value': '-21.84', 'spread': '27.812', 'groupId': 'OG003'}]}]}, {'title': 'Percent Overall Work Impairment Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-17.29', 'spread': '33.754', 'groupId': 'OG000'}, {'value': '-10.17', 'spread': '27.793', 'groupId': 'OG001'}, {'value': '-18.62', 'spread': '28.397', 'groupId': 'OG002'}, {'value': '-16.20', 'spread': '32.591', 'groupId': 'OG003'}]}]}, {'title': 'Percent Activity Impairment Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}, {'value': '193', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7.78', 'spread': '24.016', 'groupId': 'OG000'}, {'value': '-11.74', 'spread': '22.736', 'groupId': 'OG001'}, {'value': '-21.17', 'spread': '25.287', 'groupId': 'OG002'}, {'value': '-21.92', 'spread': '26.378', 'groupId': 'OG003'}]}]}, {'title': 'Percent Activity Impairment Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}, {'value': '181', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7.18', 'spread': '26.552', 'groupId': 'OG000'}, {'value': '-13.78', 'spread': '19.690', 'groupId': 'OG001'}, {'value': '-22.42', 'spread': '25.547', 'groupId': 'OG002'}, {'value': '-22.32', 'spread': '26.481', 'groupId': 'OG003'}]}]}, {'title': 'Percent Activity Impairment Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}, {'value': '161', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-10.65', 'spread': '23.655', 'groupId': 'OG000'}, {'value': '-15.24', 'spread': '20.150', 'groupId': 'OG001'}, {'value': '-23.43', 'spread': '25.748', 'groupId': 'OG002'}, {'value': '-25.34', 'spread': '26.927', 'groupId': 'OG003'}]}]}, {'title': 'Percent Activity Impairment Due to AD: Change From Baseline in WPAI-SHP v2.0 at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}, {'value': '163', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-10.88', 'spread': '28.001', 'groupId': 'OG000'}, {'value': '-14.88', 'spread': '20.044', 'groupId': 'OG001'}, {'value': '-22.95', 'spread': '24.656', 'groupId': 'OG002'}, {'value': '-23.93', 'spread': '27.743', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 12, 24, 36, and 52', 'description': 'The WPAI-SHP is a 6-item participant questionnaire developed to measure the effect of overall health and specific symptoms on productivity at work and regular activities outside of it in the past 7 days. The WPAI-SHP consists of 6 questions as follows: 1=currently employed; 2=hours missed due to AD; 3=hours missed other reasons; 4=hours actually worked; 5=degree AD affected productivity while working; 6=degree AD affected regular activities and the computed percentage, range for each sub scale is from 0 to 100, with higher values indicating greater impairment and less productivity. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'LTS evaluable population included all participants who applied ruxolitinib 0.75% or 1.5% cream at least once during the LTS Period. Data from participants enrolled at Site 461 were excluded. Number analyzed is the number of participants with data available for analyses at the specified time point.'}, {'type': 'SECONDARY', 'title': 'VC Period: Trough Plasma Concentrations of Ruxolitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'OG001', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.2', 'spread': '37.4', 'groupId': 'OG000'}, {'value': '38.5', 'spread': '64.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.6', 'spread': '35.2', 'groupId': 'OG000'}, {'value': '41.8', 'spread': '83.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.4', 'spread': '36.1', 'groupId': 'OG000'}, {'value': '36.1', 'spread': '66.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose at Weeks 2, 4 and 8', 'description': 'Plasma samples were collected just before the morning application of study drug during each specified time point.', 'unitOfMeasure': 'nanomole per litre (nM)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) evaluable population included all participants who applied at least 1 application of ruxolitinib cream and provided at least 1 postdose plasma sample (1 PK measurement) that complies with the instruction in the Protocol. Number analyzed is the number of participants with data available for analyses at the specified time point.'}, {'type': 'SECONDARY', 'title': 'LTS Period: Trough Plasma Concentrations of Ruxolitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}, {'value': '215', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID', 'description': 'Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG001', 'title': 'LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID', 'description': 'Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG002', 'title': 'LTS Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants who applied ruxolitinib 0.75% cream during the VC Period, continued applying ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'OG003', 'title': 'LTS Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '189', 'groupId': 'OG002'}, {'value': '206', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.8', 'spread': '22.7', 'groupId': 'OG000'}, {'value': '23.9', 'spread': '55.2', 'groupId': 'OG001'}, {'value': '14.3', 'spread': '26.9', 'groupId': 'OG002'}, {'value': '22.6', 'spread': '46.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}, {'value': '203', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.3', 'spread': '22.8', 'groupId': 'OG000'}, {'value': '16.1', 'spread': '27.7', 'groupId': 'OG001'}, {'value': '15.1', 'spread': '28.3', 'groupId': 'OG002'}, {'value': '23.9', 'spread': '45.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}, {'value': '202', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.8', 'spread': '41.0', 'groupId': 'OG000'}, {'value': '25.3', 'spread': '43.9', 'groupId': 'OG001'}, {'value': '13.6', 'spread': '20.5', 'groupId': 'OG002'}, {'value': '26.8', 'spread': '55.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '194', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.7', 'spread': '26.0', 'groupId': 'OG000'}, {'value': '27.6', 'spread': '62.4', 'groupId': 'OG001'}, {'value': '18.5', 'spread': '49.8', 'groupId': 'OG002'}, {'value': '25.7', 'spread': '56.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}, {'value': '196', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '20.4', 'spread': '39.9', 'groupId': 'OG000'}, {'value': '17.6', 'spread': '32.2', 'groupId': 'OG001'}, {'value': '16.1', 'spread': '36.1', 'groupId': 'OG002'}, {'value': '20.8', 'spread': '39.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}, {'value': '176', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.6', 'spread': '30.6', 'groupId': 'OG000'}, {'value': '26.4', 'spread': '51.3', 'groupId': 'OG001'}, {'value': '14.0', 'spread': '23.2', 'groupId': 'OG002'}, {'value': '25.9', 'spread': '67.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}, {'value': '167', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.4', 'spread': '23.7', 'groupId': 'OG000'}, {'value': '29.9', 'spread': '52.8', 'groupId': 'OG001'}, {'value': '15.0', 'spread': '28.4', 'groupId': 'OG002'}, {'value': '22.0', 'spread': '40.1', 'groupId': 'OG003'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}, {'value': '163', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.6', 'spread': '36.7', 'groupId': 'OG000'}, {'value': '32.8', 'spread': '59.4', 'groupId': 'OG001'}, {'value': '20.0', 'spread': '51.1', 'groupId': 'OG002'}, {'value': '26.3', 'spread': '59.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}, {'value': '160', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.9', 'spread': '31.9', 'groupId': 'OG000'}, {'value': '23.0', 'spread': '33.7', 'groupId': 'OG001'}, {'value': '14.8', 'spread': '28.8', 'groupId': 'OG002'}, {'value': '24.1', 'spread': '40.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}, {'value': '155', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.8', 'spread': '38.6', 'groupId': 'OG000'}, {'value': '35.7', 'spread': '64.5', 'groupId': 'OG001'}, {'value': '23.4', 'spread': '58.1', 'groupId': 'OG002'}, {'value': '26.3', 'spread': '54.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '164', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.9', 'spread': '21.8', 'groupId': 'OG000'}, {'value': '35.7', 'spread': '65.2', 'groupId': 'OG001'}, {'value': '17.7', 'spread': '33.9', 'groupId': 'OG002'}, {'value': '23.3', 'spread': '48.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose at Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52', 'description': 'Plasma samples were collected just before the morning application of study drug during each specified time point.', 'unitOfMeasure': 'nM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK evaluable population included all participants who applied at least 1 application of ruxolitinib cream and provided at least 1 postdose plasma sample (1 PK measurement) that complies with the instruction in the Protocol. Number analyzed is the number of participants with data available for analyses at the specified time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'FG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'FG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'FG003', 'title': 'LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID', 'description': 'Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'FG004', 'title': 'LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID', 'description': 'Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'FG005', 'title': 'LTS Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants who applied ruxolitinib 0.75% cream during the VC Period, continued applying ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}, {'id': 'FG006', 'title': 'LTS Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.'}], 'periods': [{'title': 'Vehicle Control Period (Day 1 to Week 8)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '248'}, {'groupId': 'FG002', 'numSubjects': '246'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '209'}, {'groupId': 'FG002', 'numSubjects': '224'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'Long-Term Safety Period (Weeks 8 to 52)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '53'}, {'groupId': 'FG004', 'numSubjects': '52'}, {'groupId': 'FG005', 'numSubjects': '204'}, {'groupId': 'FG006', 'numSubjects': '221'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '33'}, {'groupId': 'FG004', 'numSubjects': '41'}, {'groupId': 'FG005', 'numSubjects': '151'}, {'groupId': 'FG006', 'numSubjects': '170'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '20'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '53'}, {'groupId': 'FG006', 'numSubjects': '51'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '13'}, {'groupId': 'FG006', 'numSubjects': '10'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '2'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '26'}, {'groupId': 'FG006', 'numSubjects': '34'}]}, {'type': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 618 participants were enrolled at 65 investigative sites in North America and Europe from December 20, 2018 to November 09, 2020.', 'preAssignmentDetails': 'Participants who completed Week 8 assessments of the Vehicle Control (VC) Period with no safety concerns continued in the 44-week Long Term Safety (LTS) Period. Participants who were on active treatment during the VC Period continued with the same treatment regimen in the LTS Period and those who applied vehicle cream during the VC Period were equally randomized into 1 of the 2 active treatment groups: ruxolitinib 0.75%, ruxolitinib 1.5% cream during the LTS Period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'BG000'}, {'value': '248', 'groupId': 'BG001'}, {'value': '246', 'groupId': 'BG002'}, {'value': '618', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'VC Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'BG001', 'title': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'BG002', 'title': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.9', 'spread': '18.90', 'groupId': 'BG000'}, {'value': '35.8', 'spread': '18.45', 'groupId': 'BG001'}, {'value': '35.9', 'spread': '18.01', 'groupId': 'BG002'}, {'value': '36.4', 'spread': '18.38', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}, {'value': '380', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}, {'value': '238', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White/Caucasian', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}, {'value': '437', 'groupId': 'BG003'}]}, {'title': 'Black/African-American', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '152', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'American-Indian/Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian/Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '27.75', 'spread': '6.737', 'groupId': 'BG000'}, {'value': '27.60', 'spread': '7.091', 'groupId': 'BG001'}, {'value': '28.01', 'spread': '7.495', 'groupId': 'BG002'}, {'value': '27.80', 'spread': '7.177', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilograms per square metre (kg/m^2)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Intent-to-treat (ITT) population included all participants who were randomized to the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-13', 'size': 3599089, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-10-20T09:10', 'hasProtocol': True}, {'date': '2019-11-08', 'size': 948910, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-10-20T09:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 618}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'dispFirstSubmitDate': '2020-11-17', 'completionDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-21', 'studyFirstSubmitDate': '2018-11-15', 'dispFirstSubmitQcDate': '2020-11-17', 'resultsFirstSubmitDate': '2021-10-20', 'studyFirstSubmitQcDate': '2018-11-15', 'dispFirstPostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-19', 'studyFirstPostDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8", 'timeFrame': 'Baseline to Week 8', 'description': 'The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥ 2 grade improvement from Baseline.'}], 'secondaryOutcomes': [{'measure': 'VC Period: Percentage of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75) at Week 8', 'timeFrame': 'Baseline to Week 8', 'description': 'EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). 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 and the severity strata are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI75 responder was defined as a participant achieving 75% or greater improvement from Baseline in EASI score.'}, {'measure': 'VC Period: Percentage of Participants With a ≥ 4-Point Improvement in Itch Numerical Rating Scale (NRS) Score From Baseline to Week 8', 'timeFrame': 'Baseline to Week 8', 'description': 'The Itch NRS is a daily participant-reported measure (24-hour recall), of the worst level of itch intensity using a diary. Participants are asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours.'}, {'measure': 'VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form - Sleep Disturbance (8b - 24-Hour Recall) Score at Week 8', 'timeFrame': 'Baseline to Week 8', 'description': "The PROMIS Short Form - Sleep Disturbance (8b) questionnaire assesses participant's self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This questionnaire is completed in the morning by the participant where each item asks the participant to rate the severity of the participant's sleep disturbance. It is a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep disturbance."}, {'measure': 'VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep-Related Impairment (8a - 24-Hour Recall) Score at Week 8', 'timeFrame': 'Baseline to Week 8', 'description': "The PROMIS Short Form - Sleep-Related Impairment (8a) questionnaire assesses participant's self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. The questionnaire is filled in the evening where each item asks the participant to rate the severity of the participant's sleep impairment. It has 8 simple questions with a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep-related impairment. Each item asks the participant to rate the severity of the participant's sleep impairment."}, {'measure': 'VC Period: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Treatment-Emergent Serious Adverse Event (SAE)', 'timeFrame': 'From date of randomization up to Week 8', 'description': 'An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or an important medical event may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above. A TEAE or treatment emergent SAE is any AE or SAE either reported for first time or worsening of a pre-existing event after first dose of study drug.'}, {'measure': 'LTS Period: Percentage of Participants With at Least One TEAE and Treatment Emergent SAE', 'timeFrame': 'From first dose date in LTS Period (Week 8) until last follow-up visit (up to 52 weeks)', 'description': 'An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or an important medical event may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above. A TEAE or treatment emergent SAE is any AE or SAE either reported for first time or worsening of a pre-existing event after first dose of study drug.'}, {'measure': 'VC Period: Percentage of Participants Who Achieved an IGA-TS at Weeks 2 and 4', 'timeFrame': 'Baseline to Weeks 2 and 4', 'description': 'The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥ 2 grade improvement from Baseline.'}, {'measure': 'VC Period: Percentage of Participants Achieving an IGA of 0 or 1', 'timeFrame': 'Weeks 2, 4 and 8', 'description': 'The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting.'}, {'measure': 'LTS Period: Percentage of Participants Achieving an IGA of 0 or 1', 'timeFrame': 'Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52', 'description': 'The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting.'}, {'measure': 'VC Period: Percentage of Participants With a ≥ 4-Point Improvement in Itch NRS Score From Baseline to Weeks 2 and 4', 'timeFrame': 'Baseline to Weeks 2 and 4', 'description': 'The Itch NRS is a daily participant-reported measure (24-hour recall), of the worst level of itch intensity using a diary. Participants are asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours.'}, {'measure': 'VC Period: Percentage of Participants Who Achieved EASI50', 'timeFrame': 'Baseline to Weeks 2, 4 and 8', 'description': 'EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). 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 and the severity strata are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI50 responder was defined as a participant achieving 50% or greater improvement from Baseline in EASI score.'}, {'measure': 'VC Period: Percentage of Participants Who Achieved EASI75 at Weeks 2 and 4', 'timeFrame': 'Baseline to Weeks 2 and 4', 'description': 'EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). 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 and the severity strata are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI75 responder was defined as a participant achieving 75% or greater improvement from Baseline in EASI score.'}, {'measure': 'VC Period: Percentage of Participants Who Achieved EASI90', 'timeFrame': 'Baseline to Weeks 2, 4 and 8', 'description': 'EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). 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 and the severity strata are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI90 responder was defined as a participant achieving 90% or greater improvement from Baseline in EASI score.'}, {'measure': 'VC Period: Percent Change From Baseline in EASI Score', 'timeFrame': 'Baseline, Weeks 2, 4 and 8', 'description': 'EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). 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 and the severity strata are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. A negative change from Baseline indicates improvement.'}, {'measure': 'VC Period: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score', 'timeFrame': 'Baseline, Weeks 2, 4 and 8', 'description': 'The SCORAD is a tool to assess extent and severity of eczema. To determine the extent, the rule of nines or handprint method is used to assess eczema affected area (A). To determine disease severity (B) it evaluates 6 clinical characteristics: 1. redness, 2. swelling, 3. oozing/crusting, 4. scratch marks, 5. lichenification, and 6. dryness on a 4-point scale of 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), added to give B with maximum score of 18. Subjective symptoms (C) of itch and sleeplessness are assessed using a visual analogue scale where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), added to give C with maximum score of 20. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \\& subjective symptoms (C: 0-20) combined using A/5 + 7\\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. A negative change from Baseline indicates improvement.'}, {'measure': 'VC Period: Change From Baseline in Itch NRS Score', 'timeFrame': 'Baseline, Weeks 2, 4 and 8', 'description': 'The Itch NRS is a daily participant-reported measure (24-hour recall), of the worst level of itch intensity using a diary. Participants are asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours. A negative change from Baseline indicates improvement.'}, {'measure': 'VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2, 3, or 4 Points', 'timeFrame': 'Up to Week 8', 'description': 'The Itch NRS is a daily participant-reported measure (24-hour recall), of the worst level of itch intensity using a diary. Participants are asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours. Kaplan-Meier estimation method was used for analyses.'}, {'measure': 'VC Period: Change From Baseline in Skin Pain NRS Score', 'timeFrame': 'Baseline, Weeks 2, 4 and 8', 'description': 'The Skin Pain NRS is a daily patient-reported measure (24-hour recall), of the worst level of pain intensity from 0 (no pain) to 10 (worst imaginable pain) using a diary. Participants will be asked, "Rate the pain severity from your atopic dermatitis skin changes by selecting a number that best describes your worst level of pain in the past 24 hours." A negative change from Baseline indicates improvement.'}, {'measure': 'VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score at Weeks 2 and 4', 'timeFrame': 'Weeks 2 and 4', 'description': "The PROMIS Short Form - Sleep Disturbance (8b) questionnaire assesses participant's self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This questionnaire is completed in the morning by the participant where each item asks the participant to rate the severity of the participant's sleep disturbance. It is a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep disturbance."}, {'measure': 'VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score at Weeks 2 and 4', 'timeFrame': 'Weeks 2 and 4', 'description': "The PROMIS Short Form - Sleep-Related Impairment (8a) questionnaire assesses participant's self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. The questionnaire is filled in the evening where each item asks the participant to rate the severity of the participant's sleep impairment. It has 8 simple questions with a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep-related impairment."}, {'measure': 'VC Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 24-Hour Recall Score', 'timeFrame': 'Baseline, Weeks 2, 4 and 8', 'description': "The PROMIS Short Form - Sleep Disturbance (8b) questionnaire assesses participant's self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This questionnaire is completed in the morning by the participant where each item asks the participant to rate the severity of the participant's sleep disturbance. It is a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep disturbance. A negative change from Baseline indicates improvement."}, {'measure': 'VC Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-Hour Recall Score', 'timeFrame': 'Baseline, Weeks 2, 4 and 8', 'description': "The PROMIS Short Form - Sleep-Related Impairment (8a) questionnaire assesses participant's self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. The questionnaire is filled in the evening where each item asks the participant to rate the severity of the participant's sleep impairment. It has 8 simple questions with a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep-related impairment. A negative change from Baseline indicates improvement."}, {'measure': 'LTS Period: Change From Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 7-Day Recall Score', 'timeFrame': 'Baseline, Weeks 12, 24, and 52', 'description': "The PROMIS Short Form - Sleep-Related Impairment (8a) questionnaire assesses participant's self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. The questionnaire is filled in the evening where each item asks the participant to rate the severity of the participant's sleep impairment. It has 8 simple questions with a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep-related impairment. A negative change from Baseline indicates improvement."}, {'measure': 'LTS Period: Change From Baseline in PROMIS Short Form - Sleep Disturbance (8b) 7-Day Recall Score', 'timeFrame': 'Baseline, Weeks 12, 24, and 52', 'description': "The PROMIS Short Form - Sleep Disturbance (8b) questionnaire assesses participant's self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This questionnaire is completed in the morning by the participant where each item asks the participant to rate the severity of the participant's sleep disturbance. It is a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep disturbance. A negative change from Baseline indicates improvement."}, {'measure': 'VC Period: Change From Baseline in Atopic Dermatitis Afflicted Percentage of Body Surface Area (%BSA)', 'timeFrame': 'Baseline, Weeks 2, 4 and 8', 'description': 'Body surface area affected by AD was 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 was assessed for disease extent ranging from 0% to 100% involvement. The overall total percentage was reported based off of all 4 body regions combined, after applying specific multipliers to the different body regions to account for the percent of the total BSA represented by each of the 4 regions. Use the percentage of skin affected for each region (0 to 100%) in EASI as follows: BSA Total = 0.1\\*BSA head and neck + 0.3\\*BSA trunk + 0.2\\* BSA upper limbs + 0.4\\*BSA lower limbs. A negative change from Baseline indicates improvement.'}, {'measure': 'LTS Period: Change From Baseline in Atopic Dermatitis Afflicted %BSA', 'timeFrame': 'Baseline, Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52', 'description': 'Body surface area affected by AD was 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 was assessed for disease extent ranging from 0% to 100% involvement. The overall total percentage was reported based off of all 4 body regions combined, after applying specific multipliers to the different body regions to account for the percent of the total BSA represented by each of the 4 regions. Use the percentage of skin affected for each region (0 to 100%) in EASI as follows: BSA Total = 0.1\\*BSA head and neck + 0.3\\*BSA trunk + 0.2\\* BSA upper limbs + 0.4\\*BSA lower limbs. A negative change from Baseline indicates improvement.'}, {'measure': 'VC Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score', 'timeFrame': 'Baseline, Weeks 2, 4 and 8', 'description': 'The POEM is a 7-question quality-of-life assessment that asks how many days the participant has been bothered by various aspects of their skin condition during the past 7 days. It assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life. A negative change from Baseline indicates improvement.'}, {'measure': 'LTS Period: Change From Baseline in POEM Score', 'timeFrame': 'Baseline, Weeks 12, 24 and 52', 'description': 'The POEM is a 7-question quality-of-life assessment that asks how many days the participant has been bothered by various aspects of their skin condition during the past 7 days. It assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life. A negative change from Baseline indicates improvement.'}, {'measure': 'VC Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Score', 'timeFrame': 'Baseline, Weeks 2, 4, and 8', 'description': 'The DLQI is a simple, 10 question (Q) validated quality-of-life questionnaire to measure how much the skin problem has affected the participant. It covers 6 domains including symptoms and feelings (Q1 and Q2), daily activities (Q3 and Q4), leisure (Q5 and Q6), work and school (Q7), personal relationships (Q8 and Q9), and treatment(Q10). The recall Period of this scale is over the last week. Response categories include 0-not at all, 1-a little, 2-a lot, and 3-very much, and unanswered or not relevant responses scored as 0. Scores range from 0 ("no impact on participant\'s life") to 30 ("extremely large effect on participant\'s life"), and a 4-point change from Baseline is considered as the minimal clinically important difference threshold. A negative change from Baseline indicates less impact of the skin problem on participant\'s life.'}, {'measure': 'LTS Period: Change From Baseline in DLQI Score', 'timeFrame': 'Baseline, Weeks 12, 24, and 52', 'description': 'The DLQI is a simple, 10 question (Q) validated quality-of-life questionnaire to measure how much the skin problem has affected the participant. It covers 6 domains including symptoms and feelings (Q1 and Q2), daily activities (Q3 and Q4), leisure (Q5 and Q6), work and school (Q7), personal relationships (Q8 and Q9), and treatment(Q10). The recall Period of this scale is over the last week. Response categories include 0-not at all, 1-a little, 2-a lot, and 3-very much, and unanswered or not relevant responses scored as 0. Scores range from 0 ("no impact on participant\'s life") to 30 ("extremely large effect on participant\'s life"), and a 4-point change from Baseline is considered as the minimal clinically important difference threshold. A negative change from Baseline indicates less impact of the skin problem on participant\'s life.'}, {'measure': 'VC Period: Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score', 'timeFrame': 'Baseline, Weeks 2, 4, and 8', 'description': "CDLQI is the youth/children's version of the DLQI. The CDLQI is a simple 10 question (Q) validated quality-of-life questionnaire. It covers 6 domains including symptoms and feelings (Q1 and Q2), leisure (Q4, Q5, and Q6), school or holidays (Q7), personal relationships (Q3 and Q8), sleep (Q9) and treatment (Q10). Response categories include 0-not at all, 1-a little, 2-a lot, and 3-very much, and unanswered or not relevant responses scored as 0. The total DLQI score is calculated by adding the score of each question resulting in a maximum score of 30 (extremely large effect on participant's life) and a minimum score of 0 (no impact on participant's life) and a 4-point change from Baseline is considered as the minimal clinically important difference threshold. A negative change from Baseline indicates less impact of the skin problem on participant's life."}, {'measure': 'LTS Period: Change From Baseline in CDLQI Score', 'timeFrame': 'Baseline, Weeks 12, 24, and 52', 'description': "CDLQI is the youth/children's version of the DLQI. The CDLQI is a simple 10 question (Q) validated quality-of-life questionnaire. It covers 6 domains including symptoms and feelings (Q1 and Q2), leisure (Q4, Q5, and Q6), school or holidays (Q7), personal relationships (Q3 and Q8), sleep (Q9) and treatment (Q10). Response categories include 0-not at all, 1-a little, 2-a lot, and 3-very much, and unanswered or not relevant responses scored as 0. The total DLQI score is calculated by adding the score of each question resulting in a maximum score of 30 (extremely large effect on participant's life) and a minimum score of 0 (no impact on participant's life) and a 4-point change from Baseline is considered as the minimal clinically important difference threshold. A negative change from Baseline indicates less impact of the skin problem on participant's life."}, {'measure': 'VC Period: Mean Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, and 8', 'timeFrame': 'Weeks 2, 4 and 8', 'description': "The PGIC is a participants' self-reporting measure that reflects their belief about the efficacy of treatment. It is a 7-point scale where participants rate the questions as: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The lower score indicates improvement."}, {'measure': 'VC Period: Percentage of Participants With Each Score on the PGIC at Weeks 2, 4, and 8', 'timeFrame': 'Weeks 2, 4 and 8', 'description': "The PGIC is a participants' self-reporting measure that reflects their belief about the efficacy of treatment. It is a 7-point scale where participants rate the questions as: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The lower score indicates improvement."}, {'measure': 'VC Period: Percentage of Participants With a Score of Either 1 or 2 on the PGIC at Weeks 2, 4, and 8', 'timeFrame': 'Weeks 2, 4 and 8', 'description': "The PGIC is a participants' self-reporting measure that reflects their belief about the efficacy of treatment. It is a 7-point scale where participants rate the questions as: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The lower score indicates improvement."}, {'measure': 'VC Period: Change From Baseline in EuroQuality of Life Five Dimensions (EQ-5D-5L) Visual Analogue Scale (VAS) Score', 'timeFrame': 'Baseline, Weeks 2, 4 and 8', 'description': 'EQ-5D-5L questionnaire has 2 parts: EQ-5D-5L descriptive system \\& EQ-VAS. EQ-5D is a validated, self-administered, generic utility questionnaire wherein participants rate their current health state based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. 5L indicates that for each dimension, there are 5 levels:1=no problems,2=slight problems,3=moderate problems,4=severe problems, and 5=extreme problems. EQ-5D-5L score is assessed using VAS that ranges from 0 to 100 millimetres (mm), where 0 indicates "worst health you can imagine" and 100 indicates "best health you can imagine". The participant was asked to indicate his/her health state over past 7 days in each of the 5 dimensions. Digits for the 5 dimensions can be combined into a 5-digit number that describes the participant\'s health state. In the EQ-VAS, participants had to record their health state on a scale ranging from 0 to 100. A positive change from Baseline indicates improvement.'}, {'measure': 'VC Period: Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) Version 2.0 (v2.0)', 'timeFrame': 'Baseline, Weeks 2, 4, and 8', 'description': 'The WPAI-SHP is a 6-item participant questionnaire developed to measure the effect of overall health and specific symptoms on productivity at work and regular activities outside of it in the past 7 days. The WPAI-SHP consists of 6 questions as follows: 1=currently employed; 2=hours missed due to AD; 3=hours missed other reasons; 4=hours actually worked; 5=degree AD affected productivity while working; 6=degree AD affected regular activities and the computed percentage, range for each sub scale is from 0 to 100, with higher values indicating greater impairment and less productivity. A negative change from Baseline indicates improvement.'}, {'measure': 'LTS Period: Change From Baseline in WPAI-SHP v2.0', 'timeFrame': 'Baseline, Weeks 12, 24, 36, and 52', 'description': 'The WPAI-SHP is a 6-item participant questionnaire developed to measure the effect of overall health and specific symptoms on productivity at work and regular activities outside of it in the past 7 days. The WPAI-SHP consists of 6 questions as follows: 1=currently employed; 2=hours missed due to AD; 3=hours missed other reasons; 4=hours actually worked; 5=degree AD affected productivity while working; 6=degree AD affected regular activities and the computed percentage, range for each sub scale is from 0 to 100, with higher values indicating greater impairment and less productivity. A negative change from Baseline indicates improvement.'}, {'measure': 'VC Period: Trough Plasma Concentrations of Ruxolitinib', 'timeFrame': 'Pre-dose at Weeks 2, 4 and 8', 'description': 'Plasma samples were collected just before the morning application of study drug during each specified time point.'}, {'measure': 'LTS Period: Trough Plasma Concentrations of Ruxolitinib', 'timeFrame': 'Pre-dose at Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52', 'description': 'Plasma samples were collected just before the morning application of study drug during each specified time point.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atopic dermatitis', 'pruritus', 'eczema', 'topical therapy', 'JAK inhibitor'], 'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'references': [{'pmid': '39546129', 'type': 'DERIVED', 'citation': 'Simpson EL, Augustin M, Thaci D, Misery L, Armstrong AW, Blauvelt A, Papp KA, Szepietowski JC, Boguniewicz M, Kwatra SG, Kallender H, Sturm D, Ren H, Kircik L. Ruxolitinib Cream Monotherapy Improved Symptoms and Quality of Life in Adults and Adolescents with Mild-to-Moderate Atopic Dermatitis: Patient-Reported Outcomes from Two Phase III Studies. Am J Clin Dermatol. 2025 Jan;26(1):121-137. doi: 10.1007/s40257-024-00901-z. Epub 2024 Nov 15.'}, {'pmid': '39375281', 'type': 'DERIVED', 'citation': 'Blauvelt A, Kallender H, Sturm D, Li Q, Ren H, Eichenfield LF. Efficacy and Safety of Ruxolitinib Cream in Atopic Dermatitis Based on Previous Medication History. Dermatol Ther (Heidelb). 2024 Nov;14(11):3161-3174. doi: 10.1007/s13555-024-01272-3. Epub 2024 Oct 7.'}, {'pmid': '38995504', 'type': 'DERIVED', 'citation': 'Simpson EL, Kircik L, Blauvelt A, Kallender H, Sturm D, Wang M, Eichenfield LF. Ruxolitinib Cream in Adolescents/Adults with Atopic Dermatitis Meeting Severity Thresholds for Systemic Therapy: Exploratory Analysis of Pooled Results from Two Phase 3 Studies. Dermatol Ther (Heidelb). 2024 Aug;14(8):2139-2151. doi: 10.1007/s13555-024-01219-8. Epub 2024 Jul 12.'}, {'pmid': '38698175', 'type': 'DERIVED', 'citation': 'Eichenfield LF, Simpson EL, Papp K, Szepietowski JC, Blauvelt A, Kircik L, Silverberg JI, Siegfried EC, Kuligowski ME, Venturanza ME, Kallender H, Ren H, Paller AS. Efficacy, Safety, and Long-Term Disease Control of Ruxolitinib Cream Among Adolescents with Atopic Dermatitis: Pooled Results from Two Randomized Phase 3 Studies. Am J Clin Dermatol. 2024 Jul;25(4):669-683. doi: 10.1007/s40257-024-00855-2. Epub 2024 May 2.'}, {'pmid': '36574595', 'type': 'DERIVED', 'citation': 'Papp K, Szepietowski JC, Kircik L, Toth D, Eichenfield LF, Forman SB, Kuligowski ME, Kallender H, Sun K, Ren H, Simpson EL. Long-term safety and disease control with ruxolitinib cream in atopic dermatitis: Results from two phase 3 studies. J Am Acad Dermatol. 2023 May;88(5):1008-1016. doi: 10.1016/j.jaad.2022.09.060. Epub 2022 Nov 26.'}, {'pmid': '36264430', 'type': 'DERIVED', 'citation': 'Bloudek L, Eichenfield LF, Silverberg JI, Joish VN, Lofland JH, Sun K, Augustin M, Migliaccio-Walle K, Sullivan SD. Impact of Ruxolitinib Cream on Work Productivity and Activity Impairment and Associated Indirect Costs in Patients with Atopic Dermatitis: Pooled Results From Two Phase III Studies. Am J Clin Dermatol. 2023 Jan;24(1):109-117. doi: 10.1007/s40257-022-00734-8. Epub 2022 Oct 20.'}, {'pmid': '33982267', 'type': 'DERIVED', 'citation': 'Gong X, Chen X, Kuligowski ME, Liu X, Liu X, Cimino E, McGee R, Yeleswaram S. Pharmacokinetics of Ruxolitinib in Patients with Atopic Dermatitis Treated With Ruxolitinib Cream: Data from Phase II and III Studies. Am J Clin Dermatol. 2021 Jul;22(4):555-566. doi: 10.1007/s40257-021-00610-x. Epub 2021 May 12.'}, {'pmid': '33957195', 'type': 'DERIVED', 'citation': 'Papp K, Szepietowski JC, Kircik L, Toth D, Eichenfield LF, Leung DYM, Forman SB, Venturanza ME, Sun K, Kuligowski ME, Simpson EL. Efficacy and safety of ruxolitinib cream for the treatment of atopic dermatitis: Results from 2 phase 3, randomized, double-blind studies. J Am Acad Dermatol. 2021 Oct;85(4):863-872. doi: 10.1016/j.jaad.2021.04.085. Epub 2021 May 4.'}, {'pmid': '33658996', 'type': 'DERIVED', 'citation': 'Scuron MD, Fay BL, Connell AJ, Peel MT, Smith PA. Ruxolitinib Cream Has Dual Efficacy on Pruritus and Inflammation in Experimental Dermatitis. Front Immunol. 2021 Feb 15;11:620098. doi: 10.3389/fimmu.2020.620098. eCollection 2020.'}], 'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217471&parentIdentifier=INCB%2018424-304&attachmentIdentifier=061851fa-a439-4436-8d9f-0b252f3007e6&fileName=INCB18424-304_Plain_Language_Summary.pdf&versionIdentifier=90e1fe05-9680-4580-ab7d-6aadf96820fd', 'label': 'Plain Language Summary of Results'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy of ruxolitinib cream in adolescents and adults with atopic dermatitis (AD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adolescents aged ≥ 12 to 17 years, inclusive, and men and women aged ≥ 18 years.\n* Participants diagnosed with atopic dermatitis (AD) as defined by the Hanifin and Rajka criteria.\n* AD duration of at least 2 years.\n* Participants with an Investigator\'s Global Assessment (IGA) score of 2 to 3 at Screening and Baseline (VC Period) and 0 to 4 at Week 8 (LTS Period).\n* Participants with percentage body surface area (%BSA) (excluding scalp) of AD involvement of 3% to 20% at Screening and Baseline (VC Period) and 0% to 20% at Week 8 (LTS Period).\n* Participants who agree to discontinue all agents used to treat AD from Screening through the final follow-up visit.\n* Participants who have at least 1 "target lesion" that measures approximately 10 cm\\^2 or more at Screening and Baseline. Lesion must be representative of the participant\'s disease state and not be located on the hands, feet, or genitalia.\n* Willingness to avoid pregnancy or fathering of children.\n\nExclusion Criteria:\n\n* Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to Baseline.\n* Concurrent conditions and history of other diseases:\n\n * Immunocompromised.\n * Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before Baseline.\n * Active acute bacterial, fungal, or viral skin infection within 1 week before Baseline.\n * Any other concomitant skin disorder, pigmentation, or extensive scarring that, in the opinion of the investigator, may interfere with the evaluation of AD lesions or compromise participant safety.\n * Presence of AD lesions only on the hands or feet without prior history of involvement of other classical areas of involvement such as the face or the folds.\n * Other types of eczema.\n* Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator\'s opinion, would interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.\n* Use of any of the following treatments within the indicated washout period before Baseline:\n\n * 5 half-lives or 12 weeks, whichever is longer - biologic agents (e.g. dupilumab).\n * 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (e.g. mycophenolate or tacrolimus).\n * 2 weeks - immunizations and sedating antihistamines, unless on long-term stable regimen (nonsedating antihistamines are permitted).\n * 1 week - use of other topical treatments for AD (other than bland emollients). Diluted sodium hypochlorite "bleach" baths are allowed as long as they do not exceed 2 baths per week and their frequency remains the same throughout the study.\n* Participants who have previously received Janus kinase (JAK) inhibitors, systemic or topical.\n* Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation within 2 weeks prior to Baseline and/or intention to have such exposure during the study, which is thought by the investigator to potentially impact the participant\'s AD.\n* Positive serology test results at screening for human immunodeficiency virus (HIV) antibody.\n* Liver function tests: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2 × upper limit of normal (ULN); alkaline phosphatase and/or bilirubin \\> 1.5 × ULN (isolated bilirubin \\> 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin \\< 35%).\n* Pregnant or lactating participants, or those considering pregnancy.\n* History of alcoholism or drug addiction within 1 year before screening or current alcohol or drug use that, in the opinion of the investigator, will interfere with the participant\'s ability to comply with the administration schedule and study assessments.\n* Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before Baseline with another investigational medication or current enrollment in another investigational drug protocol.'}, 'identificationModule': {'nctId': 'NCT03745651', 'briefTitle': 'TRuE AD2 - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 2 (TRuE AD2) - A Phase 3, Double-Blind, Randomized, 8-Week, Vehicle-Controlled Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Adolescents and Adults With Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'INCB 18424-304'}, 'secondaryIdInfos': [{'id': '2018-003713-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Control (VC) Period: Vehicle Cream BID', 'description': 'Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.', 'interventionNames': ['Drug: Vehicle cream']}, {'type': 'EXPERIMENTAL', 'label': 'VC Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.', 'interventionNames': ['Drug: Ruxolitinib cream']}, {'type': 'EXPERIMENTAL', 'label': 'VC Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.', 'interventionNames': ['Drug: Ruxolitinib cream']}, {'type': 'EXPERIMENTAL', 'label': 'Long-Term Safety (LTS) Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID', 'description': 'Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.', 'interventionNames': ['Drug: Ruxolitinib cream']}, {'type': 'EXPERIMENTAL', 'label': 'LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID', 'description': 'Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.', 'interventionNames': ['Drug: Ruxolitinib cream']}, {'type': 'EXPERIMENTAL', 'label': 'LTS Period: Ruxolitinib 0.75% Cream BID', 'description': 'Participants who applied ruxolitinib 0.75% cream during the VC Period, continued applying ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.', 'interventionNames': ['Drug: Ruxolitinib cream']}, {'type': 'EXPERIMENTAL', 'label': 'LTS Period: Ruxolitinib 1.5% Cream BID', 'description': 'Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. 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