Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-31 @ 7:49 PM
Study NCT ID:
NCT03349060
Status:
COMPLETED
Last Update Posted:
2019-12-10
First Post:
2017-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D004485', 'term': 'Eczema'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000634427', 'term': 'abrocitinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to Week 16', 'description': 'Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.', 'eventGroups': [{'id': 'EG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.', 'otherNumAtRisk': 156, 'deathsNumAtRisk': 156, 'otherNumAffected': 65, 'seriousNumAtRisk': 156, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.', 'otherNumAtRisk': 154, 'deathsNumAtRisk': 154, 'otherNumAffected': 65, 'seriousNumAtRisk': 154, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 77, 'otherNumAffected': 26, 'seriousNumAtRisk': 77, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}], 'seriousEvents': [{'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Inflammatory bowel disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Peritonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Meniscal degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to 2 Points Improvement From Baseline at Week 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.7', 'groupId': 'OG000'}, {'value': '43.8', 'groupId': 'OG001'}, {'value': '7.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0037', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.8', 'ciLowerLimit': '6.8', 'ciUpperLimit': '24.8', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'The estimate and confidence interval (CI) for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '36.0', 'ciLowerLimit': '26.2', 'ciUpperLimit': '45.7', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 12', 'description': 'IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response of >=75 Percent (%) Improvement From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.7', 'groupId': 'OG000'}, {'value': '62.7', 'groupId': 'OG001'}, {'value': '11.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.9', 'ciLowerLimit': '17.4', 'ciUpperLimit': '38.3', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '51.0', 'ciLowerLimit': '40.5', 'ciUpperLimit': '61.5', 'groupDescription': 'The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 12', 'description': "EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \\[including axillae and groin)\\] and lower limbs \\[including buttocks\\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\\>0 to \\<10%), 2 (10 to \\<30%), 3 (30 to \\<50%), 4 (50 to \\<70%), 5 (70 to \\<90%) and 6 (90 to 100%). Total EASI score =0.1\\*Ah\\*(Eh+Ih+Exh+Lh) + 0.2\\*Au\\*(Eu+Iu+ExU+Lu) + 0.3\\*At\\*(Et+It+Ext+Lt) + 0.4\\*Al\\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least 4 Points Improvement From Baseline in the Numerical Rating Scale (NRS) for Severity of Pruritus at Week 2, 4, 8 and 12: Full Analysis Set (FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '20.4', 'groupId': 'OG000'}, {'value': '45.6', 'groupId': 'OG001'}, {'value': '2.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '32.2', 'groupId': 'OG000'}, {'value': '58.8', 'groupId': 'OG001'}, {'value': '17.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '34.3', 'groupId': 'OG000'}, {'value': '59.9', 'groupId': 'OG001'}, {'value': '14.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '37.7', 'groupId': 'OG000'}, {'value': '57.2', 'groupId': 'OG001'}, {'value': '15.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.0', 'ciLowerLimit': '10.2', 'ciUpperLimit': '25.8', 'groupDescription': "Week 2: Each complete imputed data set was analyzed using the Cochran-Mantel-Haenszel (CMH) risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.", 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '42.5', 'ciLowerLimit': '33.6', 'ciUpperLimit': '51.4', 'groupDescription': "Week 2: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.", 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0251', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.0', 'ciLowerLimit': '1.9', 'ciUpperLimit': '28.0', 'groupDescription': "Week 4: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.", 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '41.1', 'ciLowerLimit': '27.8', 'ciUpperLimit': '54.4', 'groupDescription': "Week 4: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.", 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0019', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.0', 'ciLowerLimit': '7.4', 'ciUpperLimit': '32.7', 'groupDescription': "Week 8: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.", 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '45.3', 'ciLowerLimit': '32.7', 'ciUpperLimit': '57.8', 'groupDescription': "Week 8: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.", 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.5', 'ciLowerLimit': '10.3', 'ciUpperLimit': '34.8', 'groupDescription': "Week 12: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.", 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '41.7', 'ciLowerLimit': '29.6', 'ciUpperLimit': '53.9', 'groupDescription': "Week 12: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.", 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least 4 Points Improvement From Baseline in the Numerical Rating Scale for Severity of Pruritus at Week 2, 4 and 12: Per Protocol Analysis Set (PPAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000'}, {'value': '47.6', 'groupId': 'OG001'}, {'value': '3.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '34.0', 'groupId': 'OG000'}, {'value': '63.3', 'groupId': 'OG001'}, {'value': '20.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '41.1', 'groupId': 'OG000'}, {'value': '60.6', 'groupId': 'OG001'}, {'value': '12.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0055', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.3', 'ciLowerLimit': '7.4', 'ciUpperLimit': '25.2', 'groupDescription': "Week 2: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.", 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '43.3', 'ciLowerLimit': '33.1', 'ciUpperLimit': '53.6', 'groupDescription': "Week 2: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.", 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1138', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.5', 'ciLowerLimit': '-3.0', 'ciUpperLimit': '28.0', 'groupDescription': "Week 4: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.", 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '41.8', 'ciLowerLimit': '26.2', 'ciUpperLimit': '57.4', 'groupDescription': "Week 4: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.", 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.7', 'ciLowerLimit': '15.3', 'ciUpperLimit': '42.1', 'groupDescription': "Week 12: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.", 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '47.8', 'ciLowerLimit': '34.6', 'ciUpperLimit': '61.1', 'groupDescription': "Week 12: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.", 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, 4, 12', 'description': 'Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol analysis set included all randomized participants who received at least 1 dose of study medication and who had no major protocol violations. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 2, 4, 8 and 12: Full Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-1.5', 'groupId': 'OG000', 'lowerLimit': '-1.7', 'upperLimit': '-1.2'}, {'value': '-2.1', 'groupId': 'OG001', 'lowerLimit': '-2.3', 'upperLimit': '-1.8'}, {'value': '-0.5', 'groupId': 'OG002', 'lowerLimit': '-0.8', 'upperLimit': '-0.1'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-1.8', 'groupId': 'OG000', 'lowerLimit': '-2.1', 'upperLimit': '-1.5'}, {'value': '-3.0', 'groupId': 'OG001', 'lowerLimit': '-3.2', 'upperLimit': '-2.7'}, {'value': '-0.7', 'groupId': 'OG002', 'lowerLimit': '-1.1', 'upperLimit': '-0.3'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-2.2', 'groupId': 'OG000', 'lowerLimit': '-2.5', 'upperLimit': '-1.8'}, {'value': '-3.1', 'groupId': 'OG001', 'lowerLimit': '-3.5', 'upperLimit': '-2.8'}, {'value': '-1.2', 'groupId': 'OG002', 'lowerLimit': '-1.7', 'upperLimit': '-0.7'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-2.2', 'groupId': 'OG000', 'lowerLimit': '-2.6', 'upperLimit': '-1.9'}, {'value': '-3.2', 'groupId': 'OG001', 'lowerLimit': '-3.6', 'upperLimit': '-2.8'}, {'value': '-1.1', 'groupId': 'OG002', 'lowerLimit': '-1.7', 'upperLimit': '-0.6'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in least squares (LS) mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '-0.6', 'groupDescription': 'Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '-1.2', 'groupDescription': 'Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '-0.6', 'groupDescription': 'Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.2', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '-1.7', 'groupDescription': 'Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0035', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '-0.3', 'groupDescription': 'Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '-1.3', 'groupDescription': 'Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0010', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '-0.4', 'groupDescription': 'Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.1', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '-1.4', 'groupDescription': 'Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin \\[lighter or darker\\], bleeding from skin, seeping or oozing fluid from skin \\[other than blood\\], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis Total Score at Week 12: Per Protocol Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.4', 'groupId': 'OG000', 'lowerLimit': '-2.8', 'upperLimit': '-2.1'}, {'value': '-3.4', 'groupId': 'OG001', 'lowerLimit': '-3.8', 'upperLimit': '-3.0'}, {'value': '-1.1', 'groupId': 'OG002', 'lowerLimit': '-1.7', 'upperLimit': '-0.5'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '-0.6', 'groupDescription': 'MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.3', 'ciLowerLimit': '-3.0', 'ciUpperLimit': '-1.6', 'groupDescription': 'MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin \\[lighter or darker\\], bleeding from skin, seeping or oozing fluid from skin \\[other than blood\\], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol analysis set included all randomized participants who received at least 1 dose of study medication and who had no major protocol violations. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to Achieve >=4 Points Improvement From Baseline in Numerical Rating Scale for Severity of Pruritus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.0', 'comment': 'Upper limit was not evaluable since very less events were observed.', 'groupId': 'OG000', 'lowerLimit': '56.0', 'upperLimit': 'NA'}, {'value': '14.0', 'groupId': 'OG001', 'lowerLimit': '11.0', 'upperLimit': '29.0'}, {'value': '92.0', 'comment': 'Upper limit was not evaluable since very less events were observed.', 'groupId': 'OG002', 'lowerLimit': '85.0', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0071', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value was controlled by randomization strata.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'P-value was controlled by randomization strata.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to Week 12', 'description': 'Participants were asked to assess their worst itching/pruritus due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst itch imaginable), where higher scores indicated greater severity. 95% CI was based on the Brookmeyer and Crowley method.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement From Baseline at Week 2, 4 and 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000'}, {'value': '24.0', 'groupId': 'OG001'}, {'value': '3.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '27.6', 'groupId': 'OG000'}, {'value': '47.4', 'groupId': 'OG001'}, {'value': '14.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '38.3', 'groupId': 'OG000'}, {'value': '57.8', 'groupId': 'OG001'}, {'value': '13.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0869', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.5', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '13.3', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.3', 'ciLowerLimit': '12.0', 'ciUpperLimit': '28.6', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0259', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.1', 'ciLowerLimit': '2.6', 'ciUpperLimit': '23.6', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.0', 'ciLowerLimit': '21.7', 'ciUpperLimit': '44.2', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.0', 'ciLowerLimit': '14.2', 'ciUpperLimit': '35.8', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '44.6', 'ciLowerLimit': '33.6', 'ciUpperLimit': '55.6', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, 4, 8', 'description': "EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \\[including axillae and groin)\\] and lower limbs \\[including buttocks\\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\\>0 to \\<10%), 2 (10 to \\<30%), 3 (30 to \\<50%), 4 (50 to \\<70%), 5 (70 to \\<90%) and 6 (90 to 100%). Total EASI score =0.1\\*Ah\\*(Eh+Ih+Exh+Lh) + 0.2\\*Au\\*(Eu+Iu+ExU+Lu) + 0.3\\*At\\*(Et+It+Ext+Lt) + 0.4\\*Al\\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies the number of participants evaluable for the specified time points.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 2, 4 and 8", 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000'}, {'value': '9.7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000'}, {'value': '27.0', 'groupId': 'OG001'}, {'value': '5.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20.3', 'groupId': 'OG000'}, {'value': '35.7', 'groupId': 'OG001'}, {'value': '6.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0802', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.9', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '8.5', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0045', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.8', 'ciLowerLimit': '4.0', 'ciUpperLimit': '15.7', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category)', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1888', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.2', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '12.4', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.7', 'ciLowerLimit': '13.0', 'ciUpperLimit': '30.5', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0071', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.8', 'ciLowerLimit': '5.2', 'ciUpperLimit': '22.4', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.3', 'ciLowerLimit': '19.8', 'ciUpperLimit': '38.7', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, 4, 8', 'description': 'IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies the number of participants evaluable for the specified time points.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) at Week 2, 4, 8 and 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6.6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000'}, {'value': '11.7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}, {'value': '13.1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-3.8', 'ciUpperLimit': '3.8', 'pValueComment': 'P-value could not be calculated since percentage of participants with event was 0.', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-3.8', 'ciUpperLimit': '3.8', 'pValueComment': 'P-value could not be calculated since percentage of participants with event was 0.', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-3.9', 'ciUpperLimit': '3.9', 'pValueComment': 'P-value could not be calculated since percentage of participants with event was 0.', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0234', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.5', 'ciLowerLimit': '1.3', 'ciUpperLimit': '11.7', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0592', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.6', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '9.5', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0022', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.7', 'ciLowerLimit': '5.5', 'ciUpperLimit': '17.9', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0190', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.0', 'ciLowerLimit': '1.7', 'ciUpperLimit': '12.3', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0010', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.1', 'ciLowerLimit': '6.7', 'ciUpperLimit': '19.4', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2, 4, 8, 12', 'description': 'IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies number of participants evaluable at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '34.2', 'groupId': 'OG000'}, {'value': '55.2', 'groupId': 'OG001'}, {'value': '10.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '54.6', 'groupId': 'OG000'}, {'value': '73.7', 'groupId': 'OG001'}, {'value': '21.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '57.8', 'groupId': 'OG000'}, {'value': '76.6', 'groupId': 'OG001'}, {'value': '24.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '57.7', 'groupId': 'OG000'}, {'value': '75.8', 'groupId': 'OG001'}, {'value': '22.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.0', 'ciLowerLimit': '13.9', 'ciUpperLimit': '34.1', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '45.1', 'ciLowerLimit': '34.7', 'ciUpperLimit': '55.5', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.5', 'ciLowerLimit': '21.6', 'ciUpperLimit': '45.4', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '52.7', 'ciLowerLimit': '41.2', 'ciUpperLimit': '64.2', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '34.1', 'ciLowerLimit': '21.9', 'ciUpperLimit': '46.3', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '52.9', 'ciLowerLimit': '41.3', 'ciUpperLimit': '64.6', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.3', 'ciLowerLimit': '23.3', 'ciUpperLimit': '47.4', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '53.5', 'ciLowerLimit': '42.0', 'ciUpperLimit': '65.0', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': "EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \\[including axillae and groin)\\] and lower limbs \\[including buttocks\\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\\>0 to \\<10%), 2 (10 to \\<30%), 3 (30 to \\<50%), 4 (50 to \\<70%), 5 (70 to \\<90%) and 6 (90 to 100%). Total EASI score =0.1\\*Ah\\*(Eh+Ih+Exh+Lh) + 0.2\\*Au\\*(Eu+Iu+ExU+Lu) + 0.3\\*At\\*(Et+It+Ext+Lt) + 0.4\\*Al\\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies number of participants evaluable at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement From Baseline at Week 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '5.2', 'groupId': 'OG001'}, {'value': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}, {'value': '24.3', 'groupId': 'OG001'}, {'value': '3.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '33.1', 'groupId': 'OG001'}, {'value': '5.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000'}, {'value': '38.6', 'groupId': 'OG001'}, {'value': '5.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.7285', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-3.9', 'ciUpperLimit': '5.2', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1448', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.0', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '9.2', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2576', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.9', 'ciLowerLimit': '-2.6', 'ciUpperLimit': '10.5', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.4', 'ciLowerLimit': '12.0', 'ciUpperLimit': '28.9', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0423', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.0', 'ciLowerLimit': '1.3', 'ciUpperLimit': '16.8', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.0', 'ciLowerLimit': '18.7', 'ciUpperLimit': '37.2', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0066', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.3', 'ciLowerLimit': '5.4', 'ciUpperLimit': '21.2', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.4', 'ciLowerLimit': '24.3', 'ciUpperLimit': '42.5', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': "EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \\[including axillae and groin)\\] and lower limbs \\[including buttocks\\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\\>0 to \\<10%), 2 (10 to \\<30%), 3 (30 to \\<50%), 4 (50 to \\<70%), 5 (70 to \\<90%) and 6 (90 to 100%). Total EASI score =0.1\\*Ah\\*(Eh+Ih+Exh+Lh) + 0.2\\*Au\\*(Eu+Iu+ExU+Lu) + 0.3\\*At\\*(Et+It+Ext+Lt) + 0.4\\*Al\\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies number of participants evaluable at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement From Baseline at Week 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6.6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '11.7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000'}, {'value': '13.1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-3.8', 'ciUpperLimit': '3.8', 'pValueComment': 'P-value could not be calculated since percentage of participants with events was 0.', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-3.8', 'ciUpperLimit': '3.8', 'pValueComment': 'P-value could not be calculated since percentage of participants with events was 0.', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-3.9', 'ciUpperLimit': '3.9', 'pValueComment': 'P-value could not be calculated since percentage of participants with events was 0.', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0234', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.5', 'ciLowerLimit': '1.3', 'ciUpperLimit': '11.7', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0604', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.6', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '9.5', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0022', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.7', 'ciLowerLimit': '5.5', 'ciUpperLimit': '17.9', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0255', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.4', 'ciLowerLimit': '1.2', 'ciUpperLimit': '11.6', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0010', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.1', 'ciLowerLimit': '6.7', 'ciUpperLimit': '19.4', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': "EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \\[including axillae and groin)\\] and lower limbs \\[including buttocks\\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\\>0 to \\<10%), 2 (10 to \\<30%), 3 (30 to \\<50%), 4 (50 to \\<70%), 5 (70 to \\<90%) and 6 (90 to 100%). Total EASI score =0.1\\*Ah\\*(Eh+Ih+Exh+Lh) + 0.2\\*Au\\*(Eu+Iu+ExU+Lu) + 0.3\\*At\\*(Et+It+Ext+Lt) + 0.4\\*Al\\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Eczema Area and Severity Index Total Score at Week 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-9.8', 'groupId': 'OG000', 'lowerLimit': '-11.3', 'upperLimit': '-8.4'}, {'value': '-14.7', 'groupId': 'OG001', 'lowerLimit': '-16.1', 'upperLimit': '-13.3'}, {'value': '-4.1', 'groupId': 'OG002', 'lowerLimit': '-6.1', 'upperLimit': '-2.1'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-14.7', 'groupId': 'OG000', 'lowerLimit': '-16.3', 'upperLimit': '-13.1'}, {'value': '-19.6', 'groupId': 'OG001', 'lowerLimit': '-21.2', 'upperLimit': '-17.9'}, {'value': '-6.8', 'groupId': 'OG002', 'lowerLimit': '-9.2', 'upperLimit': '-4.5'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-16.3', 'groupId': 'OG000', 'lowerLimit': '-18.1', 'upperLimit': '-14.6'}, {'value': '-21.3', 'groupId': 'OG001', 'lowerLimit': '-23.0', 'upperLimit': '-19.5'}, {'value': '-7.8', 'groupId': 'OG002', 'lowerLimit': '-10.3', 'upperLimit': '-5.3'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-16.6', 'groupId': 'OG000', 'lowerLimit': '-18.4', 'upperLimit': '-14.7'}, {'value': '-22.3', 'groupId': 'OG001', 'lowerLimit': '-24.1', 'upperLimit': '-20.4'}, {'value': '-8.2', 'groupId': 'OG002', 'lowerLimit': '-10.9', 'upperLimit': '-5.5'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.8', 'ciLowerLimit': '-8.2', 'ciUpperLimit': '-3.3', 'groupDescription': 'Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.6', 'ciLowerLimit': '-13.0', 'ciUpperLimit': '-8.1', 'groupDescription': 'Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.9', 'ciLowerLimit': '-10.7', 'ciUpperLimit': '-5.0', 'groupDescription': 'Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.7', 'ciLowerLimit': '-15.6', 'ciUpperLimit': '-9.9', 'groupDescription': 'Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.5', 'ciLowerLimit': '-11.6', 'ciUpperLimit': '-5.5', 'groupDescription': 'Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.5', 'ciLowerLimit': '-16.5', 'ciUpperLimit': '-10.4', 'groupDescription': 'Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.3', 'ciLowerLimit': '-11.6', 'ciUpperLimit': '-5.1', 'groupDescription': 'Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.0', 'ciLowerLimit': '-17.3', 'ciUpperLimit': '-10.8', 'groupDescription': 'Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': "EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \\[including axillae and groin)\\] and lower limbs \\[including buttocks\\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\\>0 to \\<10%), 2 (10 to \\<30%), 3 (30 to \\<50%), 4 (50 to \\<70%), 5 (70 to \\<90%) and 6 (90 to 100%). Total EASI score =0.1\\*Ah\\*(Eh+Ih+Exh+Lh) + 0.2\\*Au\\*(Eu+Iu+ExU+Lu) + 0.3\\*At\\*(Et+It+Ext+Lt) + 0.4\\*Al\\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percentage Body Surface Area at Week 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-11.8', 'groupId': 'OG000', 'lowerLimit': '-14.3', 'upperLimit': '-9.4'}, {'value': '-18.8', 'groupId': 'OG001', 'lowerLimit': '-21.3', 'upperLimit': '-16.4'}, {'value': '-4.0', 'groupId': 'OG002', 'lowerLimit': '-7.6', 'upperLimit': '-0.5'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-20.2', 'groupId': 'OG000', 'lowerLimit': '-23.0', 'upperLimit': '-17.4'}, {'value': '-27.0', 'groupId': 'OG001', 'lowerLimit': '-29.8', 'upperLimit': '-24.2'}, {'value': '-8.5', 'groupId': 'OG002', 'lowerLimit': '-12.5', 'upperLimit': '-4.5'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-23.2', 'groupId': 'OG000', 'lowerLimit': '-26.3', 'upperLimit': '-20.2'}, {'value': '-31.5', 'groupId': 'OG001', 'lowerLimit': '-34.6', 'upperLimit': '-28.5'}, {'value': '-8.9', 'groupId': 'OG002', 'lowerLimit': '-13.3', 'upperLimit': '-4.5'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-25.1', 'groupId': 'OG000', 'lowerLimit': '-28.3', 'upperLimit': '-22.0'}, {'value': '-33.4', 'groupId': 'OG001', 'lowerLimit': '-36.6', 'upperLimit': '-30.3'}, {'value': '-11.4', 'groupId': 'OG002', 'lowerLimit': '-16.0', 'upperLimit': '-6.8'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.8', 'ciLowerLimit': '-12.1', 'ciUpperLimit': '-3.5', 'groupDescription': 'Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.8', 'ciLowerLimit': '-19.0', 'ciUpperLimit': '-10.5', 'groupDescription': 'Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.7', 'ciLowerLimit': '-16.6', 'ciUpperLimit': '-6.9', 'groupDescription': 'Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.5', 'ciLowerLimit': '-23.4', 'ciUpperLimit': '-13.6', 'groupDescription': 'Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.3', 'ciLowerLimit': '-19.7', 'ciUpperLimit': '-9.0', 'groupDescription': 'Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22.6', 'ciLowerLimit': '-28.0', 'ciUpperLimit': '-17.3', 'groupDescription': 'Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.8', 'ciLowerLimit': '-19.3', 'ciUpperLimit': '-8.2', 'groupDescription': 'Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22.0', 'ciLowerLimit': '-27.6', 'ciUpperLimit': '-16.5', 'groupDescription': 'Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': "4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region \\* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.", 'unitOfMeasure': 'Percentage BSA', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Percentage Body Surface Area Less Than (<) 5% at Week 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '5.2', 'groupId': 'OG001'}, {'value': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000'}, {'value': '27.6', 'groupId': 'OG001'}, {'value': '3.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000'}, {'value': '33.1', 'groupId': 'OG001'}, {'value': '6.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21.2', 'groupId': 'OG000'}, {'value': '38.6', 'groupId': 'OG001'}, {'value': '5.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.5210', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '-3.4', 'ciUpperLimit': '6.0', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1416', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.0', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '9.3', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.6', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '11.2', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.6', 'ciLowerLimit': '15.1', 'ciUpperLimit': '32.2', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0434', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.6', 'ciLowerLimit': '1.3', 'ciUpperLimit': '17.9', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.6', 'ciLowerLimit': '17.1', 'ciUpperLimit': '36.2', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0019', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.8', 'ciLowerLimit': '7.5', 'ciUpperLimit': '24.0', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.3', 'ciLowerLimit': '24.0', 'ciUpperLimit': '42.7', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2, 4, 8, 12', 'description': "4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limb, 3.33% for trunk and 2.5% for lower limb. % BSA for a body region was calculated as = total number of handprints in a body region \\* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies number of participants evaluable at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000'}, {'value': '34.0', 'groupId': 'OG001'}, {'value': '4.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '34.5', 'groupId': 'OG000'}, {'value': '50.7', 'groupId': 'OG001'}, {'value': '12.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '36.3', 'groupId': 'OG000'}, {'value': '54.1', 'groupId': 'OG001'}, {'value': '12.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '36.6', 'groupId': 'OG000'}, {'value': '56.8', 'groupId': 'OG001'}, {'value': '16.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0151', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.8', 'ciLowerLimit': '3.3', 'ciUpperLimit': '18.3', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.0', 'ciLowerLimit': '21.0', 'ciUpperLimit': '39.0', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0010', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.2', 'ciLowerLimit': '10.2', 'ciUpperLimit': '32.3', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '37.9', 'ciLowerLimit': '26.6', 'ciUpperLimit': '49.3', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.5', 'ciLowerLimit': '12.6', 'ciUpperLimit': '34.3', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '41.7', 'ciLowerLimit': '30.7', 'ciUpperLimit': '52.7', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0026', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.6', 'ciLowerLimit': '8.1', 'ciUpperLimit': '31.1', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '40.0', 'ciLowerLimit': '28.3', 'ciUpperLimit': '51.7', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give \'C\' (0-20). The SCORAD for an individual was calculated: A/5 + 7\\*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Scoring Atopic Dermatitis Response of >=75% Improvement From Baseline at Week 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '6.0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '18.2', 'groupId': 'OG001'}, {'value': '2.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000'}, {'value': '23.6', 'groupId': 'OG001'}, {'value': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.4', 'groupId': 'OG000'}, {'value': '30.8', 'groupId': 'OG001'}, {'value': '4.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.3151', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '5.6', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0292', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.0', 'ciLowerLimit': '0.7', 'ciUpperLimit': '11.3', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9402', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-5.9', 'ciUpperLimit': '5.5', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0019', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.3', 'ciLowerLimit': '7.3', 'ciUpperLimit': '23.2', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0078', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.8', 'ciLowerLimit': '4.2', 'ciUpperLimit': '17.4', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.2', 'ciLowerLimit': '14.2', 'ciUpperLimit': '30.1', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0528', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.2', 'ciLowerLimit': '1.0', 'ciUpperLimit': '15.3', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.4', 'ciLowerLimit': '17.6', 'ciUpperLimit': '35.3', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give \'C\' (0-20). The SCORAD for an individual was calculated: A/5 + 7\\*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Scoring Atopic Dermatitis: Visual Analogue Scale of Sleep Loss at Week 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-2.1', 'groupId': 'OG000', 'lowerLimit': '-2.4', 'upperLimit': '-1.7'}, {'value': '-3.1', 'groupId': 'OG001', 'lowerLimit': '-3.5', 'upperLimit': '-2.8'}, {'value': '-0.8', 'groupId': 'OG002', 'lowerLimit': '-1.3', 'upperLimit': '-0.3'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-2.5', 'groupId': 'OG000', 'lowerLimit': '-2.9', 'upperLimit': '-2.1'}, {'value': '-3.7', 'groupId': 'OG001', 'lowerLimit': '-4.1', 'upperLimit': '-3.3'}, {'value': '-1.0', 'groupId': 'OG002', 'lowerLimit': '-1.5', 'upperLimit': '-0.4'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-2.8', 'groupId': 'OG000', 'lowerLimit': '-3.2', 'upperLimit': '-2.4'}, {'value': '-3.8', 'groupId': 'OG001', 'lowerLimit': '-4.2', 'upperLimit': '-3.4'}, {'value': '-1.3', 'groupId': 'OG002', 'lowerLimit': '-1.9', 'upperLimit': '-0.7'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-2.9', 'groupId': 'OG000', 'lowerLimit': '-3.4', 'upperLimit': '-2.5'}, {'value': '-3.7', 'groupId': 'OG001', 'lowerLimit': '-4.2', 'upperLimit': '-3.3'}, {'value': '-1.6', 'groupId': 'OG002', 'lowerLimit': '-2.2', 'upperLimit': '-1.0'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '-0.6', 'groupDescription': 'Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.3', 'ciLowerLimit': '-3.0', 'ciUpperLimit': '-1.7', 'groupDescription': 'Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '-0.9', 'groupDescription': 'Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.7', 'ciLowerLimit': '-3.4', 'ciUpperLimit': '-2.0', 'groupDescription': 'Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '-0.8', 'groupDescription': 'Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.5', 'ciLowerLimit': '-3.2', 'ciUpperLimit': '-1.8', 'groupDescription': 'Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '-0.6', 'groupDescription': 'Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.1', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '-1.4', 'groupDescription': 'Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give \'C\' (0-20). The SCORAD for an individual was calculated: A/5 + 7\\*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Scoring Atopic Dermatitis: Total Score at Week 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-16.4', 'groupId': 'OG000', 'lowerLimit': '-18.7', 'upperLimit': '-14.2'}, {'value': '-24.4', 'groupId': 'OG001', 'lowerLimit': '-26.7', 'upperLimit': '-22.2'}, {'value': '-5.5', 'groupId': 'OG002', 'lowerLimit': '-8.7', 'upperLimit': '-2.4'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-23.1', 'groupId': 'OG000', 'lowerLimit': '-25.8', 'upperLimit': '-20.4'}, {'value': '-32.6', 'groupId': 'OG001', 'lowerLimit': '-35.3', 'upperLimit': '-29.9'}, {'value': '-10.5', 'groupId': 'OG002', 'lowerLimit': '-14.4', 'upperLimit': '-6.7'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-26.0', 'groupId': 'OG000', 'lowerLimit': '-29.1', 'upperLimit': '-23.0'}, {'value': '-33.7', 'groupId': 'OG001', 'lowerLimit': '-36.7', 'upperLimit': '-30.7'}, {'value': '-11.7', 'groupId': 'OG002', 'lowerLimit': '-16.0', 'upperLimit': '-7.4'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-27.0', 'groupId': 'OG000', 'lowerLimit': '-30.2', 'upperLimit': '-23.7'}, {'value': '-35.5', 'groupId': 'OG001', 'lowerLimit': '-38.7', 'upperLimit': '-32.3'}, {'value': '-13.6', 'groupId': 'OG002', 'lowerLimit': '-18.3', 'upperLimit': '-9.0'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.9', 'ciLowerLimit': '-14.8', 'ciUpperLimit': '-7.0', 'groupDescription': 'Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.9', 'ciLowerLimit': '-22.7', 'ciUpperLimit': '-15.1', 'groupDescription': 'Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.6', 'ciLowerLimit': '-17.3', 'ciUpperLimit': '-7.8', 'groupDescription': 'Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22.1', 'ciLowerLimit': '-26.8', 'ciUpperLimit': '-17.3', 'groupDescription': 'Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.3', 'ciLowerLimit': '-19.5', 'ciUpperLimit': '-9.0', 'groupDescription': 'Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22.0', 'ciLowerLimit': '-27.2', 'ciUpperLimit': '-16.7', 'groupDescription': 'Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.3', 'ciLowerLimit': '-19.0', 'ciUpperLimit': '-7.7', 'groupDescription': 'Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.9', 'ciLowerLimit': '-27.5', 'ciUpperLimit': '-16.3', 'groupDescription': 'Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give \'C\' (0-20). The SCORAD for an individual was calculated: A/5 + 7\\*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving >=1 Point Improvement From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis at Week 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '51.1', 'groupId': 'OG000'}, {'value': '68.9', 'groupId': 'OG001'}, {'value': '28.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '62.7', 'groupId': 'OG000'}, {'value': '77.3', 'groupId': 'OG001'}, {'value': '44.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '60.9', 'groupId': 'OG000'}, {'value': '69.1', 'groupId': 'OG001'}, {'value': '44.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '61.4', 'groupId': 'OG000'}, {'value': '70.3', 'groupId': 'OG001'}, {'value': '40.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0028', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.3', 'ciLowerLimit': '8.7', 'ciUpperLimit': '35.9', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '40.1', 'ciLowerLimit': '27.1', 'ciUpperLimit': '53.2', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0217', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.1', 'ciLowerLimit': '2.8', 'ciUpperLimit': '31.4', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32.2', 'ciLowerLimit': '18.5', 'ciUpperLimit': '45.9', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0363', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.7', 'ciLowerLimit': '1.4', 'ciUpperLimit': '30.0', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0011', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.7', 'ciLowerLimit': '9.8', 'ciUpperLimit': '37.7', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0080', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.1', 'ciLowerLimit': '5.8', 'ciUpperLimit': '34.5', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.1', 'ciLowerLimit': '15.0', 'ciUpperLimit': '43.3', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin \\[lighter or darker\\], bleeding from skin, seeping or oozing fluid from skin \\[other than blood\\], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-5.9', 'groupId': 'OG000', 'lowerLimit': '-6.9', 'upperLimit': '-5.0'}, {'value': '-7.6', 'groupId': 'OG001', 'lowerLimit': '-8.6', 'upperLimit': '-6.7'}, {'value': '-2.1', 'groupId': 'OG002', 'lowerLimit': '-3.5', 'upperLimit': '-0.8'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-6.8', 'groupId': 'OG000', 'lowerLimit': '-7.8', 'upperLimit': '-5.9'}, {'value': '-9.6', 'groupId': 'OG001', 'lowerLimit': '-10.6', 'upperLimit': '-8.7'}, {'value': '-3.5', 'groupId': 'OG002', 'lowerLimit': '-4.9', 'upperLimit': '-2.1'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-6.8', 'groupId': 'OG000', 'lowerLimit': '-7.9', 'upperLimit': '-5.6'}, {'value': '-9.3', 'groupId': 'OG001', 'lowerLimit': '-10.5', 'upperLimit': '-8.2'}, {'value': '-4.0', 'groupId': 'OG002', 'lowerLimit': '-5.6', 'upperLimit': '-2.3'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-7.0', 'groupId': 'OG000', 'lowerLimit': '-8.1', 'upperLimit': '-5.8'}, {'value': '-9.1', 'groupId': 'OG001', 'lowerLimit': '-10.3', 'upperLimit': '-8.0'}, {'value': '-4.2', 'groupId': 'OG002', 'lowerLimit': '-5.9', 'upperLimit': '-2.5'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.8', 'ciLowerLimit': '-5.4', 'ciUpperLimit': '-2.2', 'groupDescription': 'Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.5', 'ciLowerLimit': '-7.1', 'ciUpperLimit': '-3.9', 'groupDescription': 'Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.3', 'ciLowerLimit': '-5.0', 'ciUpperLimit': '-1.7', 'groupDescription': 'Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.1', 'ciLowerLimit': '-7.8', 'ciUpperLimit': '-4.5', 'groupDescription': 'Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0075', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.8', 'ciLowerLimit': '-4.8', 'ciUpperLimit': '-0.7', 'groupDescription': 'Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.3', 'ciLowerLimit': '-7.4', 'ciUpperLimit': '-3.3', 'groupDescription': 'Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0072', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.8', 'ciLowerLimit': '-4.8', 'ciUpperLimit': '-0.8', 'groupDescription': 'Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.9', 'ciLowerLimit': '-6.9', 'ciUpperLimit': '-2.9', 'groupDescription': 'Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': "DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's (aged above 17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2, 4, 8 and 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-4.5', 'groupId': 'OG000', 'lowerLimit': '-5.8', 'upperLimit': '-3.2'}, {'value': '-5.8', 'groupId': 'OG001', 'lowerLimit': '-7.1', 'upperLimit': '-4.5'}, {'value': '-3.3', 'groupId': 'OG002', 'lowerLimit': '-5.1', 'upperLimit': '-1.4'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-5.3', 'groupId': 'OG000', 'lowerLimit': '-6.7', 'upperLimit': '-4.0'}, {'value': '-8.2', 'groupId': 'OG001', 'lowerLimit': '-9.5', 'upperLimit': '-6.8'}, {'value': '-1.8', 'groupId': 'OG002', 'lowerLimit': '-3.8', 'upperLimit': '0.2'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-5.2', 'groupId': 'OG000', 'lowerLimit': '-6.9', 'upperLimit': '-3.6'}, {'value': '-7.5', 'groupId': 'OG001', 'lowerLimit': '-9.2', 'upperLimit': '-5.9'}, {'value': '-3.1', 'groupId': 'OG002', 'lowerLimit': '-5.6', 'upperLimit': '-0.6'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-6.4', 'groupId': 'OG000', 'lowerLimit': '-7.9', 'upperLimit': '-5.0'}, {'value': '-7.5', 'groupId': 'OG001', 'lowerLimit': '-8.9', 'upperLimit': '-6.0'}, {'value': '-3.9', 'groupId': 'OG002', 'lowerLimit': '-6.1', 'upperLimit': '-1.7'}]}]}], 'analyses': [{'pValue': '0.2750', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-3.5', 'ciUpperLimit': '1.0', 'groupDescription': 'Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0280', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.5', 'ciLowerLimit': '-4.8', 'ciUpperLimit': '-0.3', 'groupDescription': 'Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0051', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.5', 'ciLowerLimit': '-5.9', 'ciUpperLimit': '-1.1', 'groupDescription': 'Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.4', 'ciLowerLimit': '-8.8', 'ciUpperLimit': '-4.0', 'groupDescription': 'Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1706', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.1', 'ciLowerLimit': '-5.1', 'ciUpperLimit': '0.9', 'groupDescription': 'Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0048', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.4', 'ciLowerLimit': '-7.4', 'ciUpperLimit': '-1.4', 'groupDescription': 'Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0629', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.5', 'ciLowerLimit': '-5.2', 'ciUpperLimit': '0.1', 'groupDescription': 'Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0100', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.6', 'ciLowerLimit': '-6.2', 'ciUpperLimit': '-0.9', 'groupDescription': 'Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'CDLQI is a 10-item questionnaire that measures the impact of skin disease on adolescents (aged 12-17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Baseline Dermatology Life Quality Index Score >=2 and Achieving <2 DLQI Score at Week 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}, {'value': '23.5', 'groupId': 'OG001'}, {'value': '3.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000'}, {'value': '32.5', 'groupId': 'OG001'}, {'value': '8.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '17.8', 'groupId': 'OG000'}, {'value': '35.3', 'groupId': 'OG001'}, {'value': '8.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20.2', 'groupId': 'OG000'}, {'value': '31.9', 'groupId': 'OG001'}, {'value': '12.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1238', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.6', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '13.9', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0008', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.1', 'ciLowerLimit': '11.0', 'ciUpperLimit': '29.2', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2091', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.8', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '16.4', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0005', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.0', 'ciLowerLimit': '12.9', 'ciUpperLimit': '35.0', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1161', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.1', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '19.1', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0002', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.5', 'ciLowerLimit': '15.3', 'ciUpperLimit': '37.7', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1837', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.1', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '19.1', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0046', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.8', 'ciLowerLimit': '8.1', 'ciUpperLimit': '31.6', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': "DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's (aged above 17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2 and Achieving <2 CDLQI Score at Week 2, 4, 8 and 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}, {'value': '9.7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000'}, {'value': '12.9', 'groupId': 'OG001'}, {'value': '7.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19.4', 'groupId': 'OG000'}, {'value': '9.7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.4795', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.2', 'ciLowerLimit': '-10.3', 'ciUpperLimit': '16.6', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-12.7', 'ciUpperLimit': '12.7', 'pValueComment': 'P-value could not be calculated since percentage of participants with events was 0.', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1452', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.3', 'ciLowerLimit': '-3.6', 'ciUpperLimit': '30.3', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2232', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.7', 'ciLowerLimit': '-6.1', 'ciUpperLimit': '25.4', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5707', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.8', 'ciLowerLimit': '-13.7', 'ciUpperLimit': '25.4', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5777', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.8', 'ciLowerLimit': '-13.6', 'ciUpperLimit': '25.1', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0744', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.3', 'ciLowerLimit': '1.0', 'ciUpperLimit': '37.5', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2232', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.7', 'ciLowerLimit': '-6.1', 'ciUpperLimit': '25.4', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'CDLQI is a 10-item questionnaire that measures the impact of skin disease on adolescents (aged 12-17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Baseline Dermatology Life Quality Index Score >=4 and Achieving >=4 Point Improvement From Baseline in DLQI Score at Week 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '67.5', 'groupId': 'OG000'}, {'value': '71.8', 'groupId': 'OG001'}, {'value': '35.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '72.2', 'groupId': 'OG000'}, {'value': '85.2', 'groupId': 'OG001'}, {'value': '51.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '64.7', 'groupId': 'OG000'}, {'value': '82.1', 'groupId': 'OG001'}, {'value': '48.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '67.2', 'groupId': 'OG000'}, {'value': '72.6', 'groupId': 'OG001'}, {'value': '43.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31.6', 'ciLowerLimit': '17.2', 'ciUpperLimit': '46.0', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.7', 'ciLowerLimit': '21.5', 'ciUpperLimit': '49.9', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0090', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.4', 'ciLowerLimit': '5.2', 'ciUpperLimit': '35.6', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.3', 'ciLowerLimit': '19.0', 'ciUpperLimit': '47.7', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0421', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.5', 'ciLowerLimit': '0.6', 'ciUpperLimit': '32.4', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.8', 'ciLowerLimit': '18.9', 'ciUpperLimit': '48.8', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0035', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.5', 'ciLowerLimit': '8.2', 'ciUpperLimit': '38.8', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0002', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.8', 'ciLowerLimit': '13.8', 'ciUpperLimit': '43.9', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': "DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's (aged above 17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participant who were evaluable for this measure and "Number Analyzed" signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2.5 and Achieving >=2.5 Point Improvement From Baseline in CDLQI Score at Week 2, 4, 8 and 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000'}, {'value': '74.2', 'groupId': 'OG001'}, {'value': '56.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '69.0', 'groupId': 'OG000'}, {'value': '83.9', 'groupId': 'OG001'}, {'value': '40.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '77.4', 'groupId': 'OG001'}, {'value': '35.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000'}, {'value': '83.9', 'groupId': 'OG001'}, {'value': '53.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2497', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.1', 'ciLowerLimit': '-9.1', 'ciUpperLimit': '43.2', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2371', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.1', 'ciLowerLimit': '-9.0', 'ciUpperLimit': '43.3', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0697', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.8', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '58.3', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0030', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '43.9', 'ciLowerLimit': '16.2', 'ciUpperLimit': '71.7', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0583', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31.0', 'ciLowerLimit': '2.0', 'ciUpperLimit': '59.9', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0085', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '41.2', 'ciLowerLimit': '13.2', 'ciUpperLimit': '69.1', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1948', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.3', 'ciLowerLimit': '-9.8', 'ciUpperLimit': '48.5', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0296', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.6', 'ciLowerLimit': '2.8', 'ciUpperLimit': '58.5', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'CDLQI is a 10-item questionnaire that measures the impact of skin disease on adolescents (aged 12-17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hospital Anxiety and Depression Scale (HADS): Depression Subscale at Week 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-0.7', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '-0.3'}, {'value': '-1.3', 'groupId': 'OG001', 'lowerLimit': '-1.6', 'upperLimit': '-0.9'}, {'value': '-0.2', 'groupId': 'OG002', 'lowerLimit': '-0.7', 'upperLimit': '0.3'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-1.1', 'groupId': 'OG000', 'lowerLimit': '-1.6', 'upperLimit': '-0.7'}, {'value': '-1.7', 'groupId': 'OG001', 'lowerLimit': '-2.1', 'upperLimit': '-1.3'}, {'value': '0.1', 'groupId': 'OG002', 'lowerLimit': '-0.5', 'upperLimit': '0.7'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-1.4', 'upperLimit': '-0.6'}, {'value': '-2.0', 'groupId': 'OG001', 'lowerLimit': '-2.4', 'upperLimit': '-1.6'}, {'value': '-0.3', 'groupId': 'OG002', 'lowerLimit': '-0.9', 'upperLimit': '0.3'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-1.4', 'groupId': 'OG000', 'lowerLimit': '-1.8', 'upperLimit': '-0.9'}, {'value': '-1.8', 'groupId': 'OG001', 'lowerLimit': '-2.2', 'upperLimit': '-1.4'}, {'value': '-0.2', 'groupId': 'OG002', 'lowerLimit': '-0.8', 'upperLimit': '0.4'}]}]}], 'analyses': [{'pValue': '0.1718', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '0.2', 'groupDescription': 'Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0018', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '-0.4', 'groupDescription': 'Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '-0.6', 'groupDescription': 'Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '-1.1', 'groupDescription': 'Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0476', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '-0.0', 'groupDescription': 'Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '-1.0', 'groupDescription': 'Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0028', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '-0.4', 'groupDescription': 'Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '-0.9', 'groupDescription': 'Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-1.1', 'groupId': 'OG000', 'lowerLimit': '-1.5', 'upperLimit': '-0.7'}, {'value': '-1.7', 'groupId': 'OG001', 'lowerLimit': '-2.0', 'upperLimit': '-1.3'}, {'value': '-0.9', 'groupId': 'OG002', 'lowerLimit': '-1.5', 'upperLimit': '-0.4'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-1.4', 'groupId': 'OG000', 'lowerLimit': '-1.9', 'upperLimit': '-1.0'}, {'value': '-2.2', 'groupId': 'OG001', 'lowerLimit': '-2.6', 'upperLimit': '-1.8'}, {'value': '-1.0', 'groupId': 'OG002', 'lowerLimit': '-1.6', 'upperLimit': '-0.4'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-1.5', 'groupId': 'OG000', 'lowerLimit': '-1.9', 'upperLimit': '-1.0'}, {'value': '-2.3', 'groupId': 'OG001', 'lowerLimit': '-2.7', 'upperLimit': '-1.8'}, {'value': '-1.0', 'groupId': 'OG002', 'lowerLimit': '-1.7', 'upperLimit': '-0.4'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-1.6', 'groupId': 'OG000', 'lowerLimit': '-2.0', 'upperLimit': '-1.1'}, {'value': '-2.1', 'groupId': 'OG001', 'lowerLimit': '-2.5', 'upperLimit': '-1.6'}, {'value': '-1.0', 'groupId': 'OG002', 'lowerLimit': '-1.7', 'upperLimit': '-0.4'}]}]}], 'analyses': [{'pValue': '0.6134', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '0.5', 'groupDescription': 'Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0422', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '-0.0', 'groupDescription': 'Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2050', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '0.3', 'groupDescription': 'Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0012', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '-0.5', 'groupDescription': 'Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2657', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '0.3', 'groupDescription': 'Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0019', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '-0.5', 'groupDescription': 'Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1675', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '0.2', 'groupDescription': 'Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0085', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '-0.3', 'groupDescription': 'Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With >=8 Points at Baseline and Achieving Score of <8 Points in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '48.5', 'groupId': 'OG000'}, {'value': '64.7', 'groupId': 'OG001'}, {'value': '38.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '54.5', 'groupId': 'OG001'}, {'value': '55.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '42.4', 'groupId': 'OG000'}, {'value': '58.8', 'groupId': 'OG001'}, {'value': '22.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '39.4', 'groupId': 'OG000'}, {'value': '48.5', 'groupId': 'OG001'}, {'value': '38.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.5539', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.8', 'ciLowerLimit': '-19.6', 'ciUpperLimit': '37.2', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0561', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.9', 'ciLowerLimit': '0.8', 'ciUpperLimit': '55.1', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7460', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.9', 'ciLowerLimit': '-33.4', 'ciUpperLimit': '23.7', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.0000', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-28.3', 'ciUpperLimit': '28.3', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1474', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.8', 'ciLowerLimit': '-4.5', 'ciUpperLimit': '46.2', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0123', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '37.3', 'ciLowerLimit': '12.1', 'ciUpperLimit': '62.5', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9760', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-28.5', 'ciUpperLimit': '27.6', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5965', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.8', 'ciLowerLimit': '-20.4', 'ciUpperLimit': '36.1', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With >=8 Points at Baseline and Achieving Score of <8 Points in Hospital Anxiety and Depression Scale: Depression Subscale at Week 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000'}, {'value': '60.0', 'groupId': 'OG001'}, {'value': '22.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '68.2', 'groupId': 'OG000'}, {'value': '68.4', 'groupId': 'OG001'}, {'value': '55.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}, {'value': '70.0', 'groupId': 'OG001'}, {'value': '66.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2278', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.0', 'ciLowerLimit': '-9.9', 'ciUpperLimit': '58.0', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0996', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.2', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '72.4', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4449', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.5', 'ciLowerLimit': '-21.6', 'ciUpperLimit': '50.6', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4139', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.9', 'ciLowerLimit': '-21.6', 'ciUpperLimit': '55.5', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7290', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.7', 'ciLowerLimit': '-40.7', 'ciUpperLimit': '27.4', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6585', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.7', 'ciLowerLimit': '-27.3', 'ciUpperLimit': '44.6', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3638', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.2', 'ciLowerLimit': '-18.7', 'ciUpperLimit': '55.1', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0550', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '40.5', 'ciLowerLimit': '2.4', 'ciUpperLimit': '78.5', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With >=11 Points at Baseline and Achieving Score of <11 Points in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '56.3', 'groupId': 'OG000'}, {'value': '46.2', 'groupId': 'OG001'}, {'value': '75.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '56.3', 'groupId': 'OG000'}, {'value': '58.3', 'groupId': 'OG001'}, {'value': '75.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '56.3', 'groupId': 'OG000'}, {'value': '53.8', 'groupId': 'OG001'}, {'value': '75.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '43.8', 'groupId': 'OG000'}, {'value': '46.2', 'groupId': 'OG001'}, {'value': '37.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.4036', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.8', 'ciLowerLimit': '-58.4', 'ciUpperLimit': '20.9', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1580', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-35.3', 'ciLowerLimit': '-75.9', 'ciUpperLimit': '5.3', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5140', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.2', 'ciLowerLimit': '-53.5', 'ciUpperLimit': '25.1', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4149', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.8', 'ciLowerLimit': '-63.3', 'ciUpperLimit': '23.7', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4036', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.8', 'ciLowerLimit': '-58.4', 'ciUpperLimit': '20.9', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2092', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-30.7', 'ciLowerLimit': '-70.9', 'ciUpperLimit': '9.6', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5982', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.9', 'ciLowerLimit': '-29.1', 'ciUpperLimit': '53.0', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8647', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.2', 'ciLowerLimit': '-36.3', 'ciUpperLimit': '44.7', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With >=11 Points at Baseline and Achieving Score of <11 Points in Hospital Anxiety and Depression Scale: Depression Subscale at Week 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}, {'value': '66.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}, {'value': '66.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}, {'value': '66.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0546', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-78.6', 'ciLowerLimit': '-117.5', 'ciUpperLimit': '-39.6', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3573', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-27.9', 'ciLowerLimit': '-62.5', 'ciUpperLimit': '6.7', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9219', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.6', 'ciLowerLimit': '-55.6', 'ciUpperLimit': '48.5', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3173', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.6', 'ciLowerLimit': '-14.4', 'ciUpperLimit': '63.6', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5408', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-25.0', 'ciLowerLimit': '-77.0', 'ciUpperLimit': '27.0', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3173', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.6', 'ciLowerLimit': '-14.4', 'ciUpperLimit': '63.6', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5408', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-25.0', 'ciLowerLimit': '-77.0', 'ciUpperLimit': '27.0', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3173', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.6', 'ciLowerLimit': '-14.4', 'ciUpperLimit': '63.6', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-4.6', 'groupId': 'OG000', 'lowerLimit': '-5.5', 'upperLimit': '-3.7'}, {'value': '-8.1', 'groupId': 'OG001', 'lowerLimit': '-9.0', 'upperLimit': '-7.2'}, {'value': '-1.8', 'groupId': 'OG002', 'lowerLimit': '-3.1', 'upperLimit': '-0.5'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-6.2', 'groupId': 'OG000', 'lowerLimit': '-7.2', 'upperLimit': '-5.1'}, {'value': '-10.8', 'groupId': 'OG001', 'lowerLimit': '-11.8', 'upperLimit': '-9.8'}, {'value': '-2.4', 'groupId': 'OG002', 'lowerLimit': '-3.9', 'upperLimit': '-0.9'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-6.1', 'groupId': 'OG000', 'lowerLimit': '-7.3', 'upperLimit': '-4.9'}, {'value': '-10.6', 'groupId': 'OG001', 'lowerLimit': '-11.8', 'upperLimit': '-9.5'}, {'value': '-3.4', 'groupId': 'OG002', 'lowerLimit': '-5.1', 'upperLimit': '-1.7'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-6.8', 'groupId': 'OG000', 'lowerLimit': '-8.0', 'upperLimit': '-5.6'}, {'value': '-10.6', 'groupId': 'OG001', 'lowerLimit': '-11.8', 'upperLimit': '-9.4'}, {'value': '-3.7', 'groupId': 'OG002', 'lowerLimit': '-5.5', 'upperLimit': '-1.9'}]}]}], 'analyses': [{'pValue': '0.0006', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.8', 'ciLowerLimit': '-4.4', 'ciUpperLimit': '-1.2', 'groupDescription': 'Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.3', 'ciLowerLimit': '-7.9', 'ciUpperLimit': '-4.7', 'groupDescription': 'Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.8', 'ciLowerLimit': '-5.6', 'ciUpperLimit': '-2.0', 'groupDescription': 'Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.4', 'ciLowerLimit': '-10.2', 'ciUpperLimit': '-6.6', 'groupDescription': 'Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0096', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.7', 'ciLowerLimit': '-4.7', 'ciUpperLimit': '-0.7', 'groupDescription': 'Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.2', 'ciLowerLimit': '-9.3', 'ciUpperLimit': '-5.2', 'groupDescription': 'Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0049', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.1', 'ciLowerLimit': '-5.2', 'ciUpperLimit': '-0.9', 'groupDescription': 'Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.9', 'ciLowerLimit': '-9.0', 'ciUpperLimit': '-4.7', 'groupDescription': 'Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'POEM is a 7-item participant reported outcome (PRO) measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item is scored as "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28, where higher score indicated greater severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-0.6', 'groupId': 'OG000', 'lowerLimit': '-0.8', 'upperLimit': '-0.5'}, {'value': '-1.1', 'groupId': 'OG001', 'lowerLimit': '-1.2', 'upperLimit': '-0.9'}, {'value': '-0.3', 'groupId': 'OG002', 'lowerLimit': '-0.5', 'upperLimit': '-0.1'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-0.8', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '-0.7'}, {'value': '-1.3', 'groupId': 'OG001', 'lowerLimit': '-1.5', 'upperLimit': '-1.2'}, {'value': '-0.4', 'groupId': 'OG002', 'lowerLimit': '-0.6', 'upperLimit': '-0.1'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-1.1', 'upperLimit': '-0.8'}, {'value': '-1.4', 'groupId': 'OG001', 'lowerLimit': '-1.6', 'upperLimit': '-1.2'}, {'value': '-0.5', 'groupId': 'OG002', 'lowerLimit': '-0.7', 'upperLimit': '-0.2'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-1.2', 'upperLimit': '-0.9'}, {'value': '-1.5', 'groupId': 'OG001', 'lowerLimit': '-1.7', 'upperLimit': '-1.3'}, {'value': '-0.5', 'groupId': 'OG002', 'lowerLimit': '-0.8', 'upperLimit': '-0.3'}]}]}], 'analyses': [{'pValue': '0.0020', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '-0.1', 'groupDescription': 'Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '-0.6', 'groupDescription': 'Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0011', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '-0.2', 'groupDescription': 'Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.7', 'groupDescription': 'Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0020', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '-0.2', 'groupDescription': 'Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.6', 'groupDescription': 'Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0014', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '-0.2', 'groupDescription': 'Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '-0.6', 'groupDescription': 'Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'Participant responded to "Overall, how would you describe your Atopic Dermatitis right now?" on a scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants Achieving 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000'}, {'value': '19.2', 'groupId': 'OG001'}, {'value': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000'}, {'value': '31.5', 'groupId': 'OG001'}, {'value': '5.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '17.2', 'groupId': 'OG000'}, {'value': '34.4', 'groupId': 'OG001'}, {'value': '8.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000'}, {'value': '36.0', 'groupId': 'OG001'}, {'value': '6.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0575', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.0', 'ciLowerLimit': '0.3', 'ciUpperLimit': '11.7', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0002', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.1', 'ciLowerLimit': '10.7', 'ciUpperLimit': '25.5', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0411', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.2', 'ciLowerLimit': '1.3', 'ciUpperLimit': '17.1', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.2', 'ciLowerLimit': '16.9', 'ciUpperLimit': '35.5', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0781', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.9', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '18.0', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.2', 'ciLowerLimit': '16.2', 'ciUpperLimit': '36.3', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0075', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.2', 'ciLowerLimit': '5.3', 'ciUpperLimit': '23.2', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.3', 'ciLowerLimit': '19.6', 'ciUpperLimit': '38.9', 'pValueComment': 'P-value was adjusted by randomization strata (baseline disease severity and age category).', 'groupDescription': 'Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'Participant responded to "Overall, how would you describe your Atopic Dermatitis right now?" on a scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies the number of participants evaluable for the specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L): Index Value at Week 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '0.049', 'groupId': 'OG000', 'lowerLimit': '0.030', 'upperLimit': '0.068'}, {'value': '0.084', 'groupId': 'OG001', 'lowerLimit': '0.065', 'upperLimit': '0.103'}, {'value': '0.016', 'groupId': 'OG002', 'lowerLimit': '-0.011', 'upperLimit': '0.043'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '0.062', 'groupId': 'OG000', 'lowerLimit': '0.041', 'upperLimit': '0.084'}, {'value': '0.092', 'groupId': 'OG001', 'lowerLimit': '0.070', 'upperLimit': '0.114'}, {'value': '0.037', 'groupId': 'OG002', 'lowerLimit': '0.007', 'upperLimit': '0.067'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '0.053', 'groupId': 'OG000', 'lowerLimit': '0.029', 'upperLimit': '0.077'}, {'value': '0.097', 'groupId': 'OG001', 'lowerLimit': '0.074', 'upperLimit': '0.121'}, {'value': '0.005', 'groupId': 'OG002', 'lowerLimit': '-0.029', 'upperLimit': '0.039'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '0.058', 'groupId': 'OG000', 'lowerLimit': '0.034', 'upperLimit': '0.083'}, {'value': '0.078', 'groupId': 'OG001', 'lowerLimit': '0.054', 'upperLimit': '0.103'}, {'value': '0.014', 'groupId': 'OG002', 'lowerLimit': '-0.021', 'upperLimit': '0.050'}]}]}], 'analyses': [{'pValue': '0.0453', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.034', 'ciLowerLimit': '0.001', 'ciUpperLimit': '0.066', 'groupDescription': 'Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.068', 'ciLowerLimit': '0.036', 'ciUpperLimit': '0.101', 'groupDescription': 'Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1821', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.025', 'ciLowerLimit': '-0.012', 'ciUpperLimit': '0.062', 'groupDescription': 'Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0038', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.055', 'ciLowerLimit': '0.018', 'ciUpperLimit': '0.092', 'groupDescription': 'Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0241', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.048', 'ciLowerLimit': '0.006', 'ciUpperLimit': '0.090', 'groupDescription': 'Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.093', 'ciLowerLimit': '0.051', 'ciUpperLimit': '0.134', 'groupDescription': 'Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0461', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.044', 'ciLowerLimit': '0.001', 'ciUpperLimit': '0.087', 'groupDescription': 'Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0037', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.064', 'ciLowerLimit': '0.021', 'ciUpperLimit': '0.107', 'groupDescription': 'Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'EQ-5D-5L: standardized participant (aged \\>17 years) completed questionnaire consisted of 2 components: a health state profile and an optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study, range from 1 to -0.109. Higher (positive) scores = better health state.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L)- Visual Analogue Scale Score at Week 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '5.586', 'groupId': 'OG000', 'lowerLimit': '3.203', 'upperLimit': '7.969'}, {'value': '9.697', 'groupId': 'OG001', 'lowerLimit': '7.294', 'upperLimit': '12.100'}, {'value': '1.038', 'groupId': 'OG002', 'lowerLimit': '-2.361', 'upperLimit': '4.437'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '6.207', 'groupId': 'OG000', 'lowerLimit': '3.473', 'upperLimit': '8.940'}, {'value': '11.931', 'groupId': 'OG001', 'lowerLimit': '9.174', 'upperLimit': '14.688'}, {'value': '1.846', 'groupId': 'OG002', 'lowerLimit': '-2.005', 'upperLimit': '5.696'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '6.982', 'groupId': 'OG000', 'lowerLimit': '3.847', 'upperLimit': '10.117'}, {'value': '10.740', 'groupId': 'OG001', 'lowerLimit': '7.642', 'upperLimit': '13.838'}, {'value': '0.937', 'groupId': 'OG002', 'lowerLimit': '-3.528', 'upperLimit': '5.402'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '8.604', 'groupId': 'OG000', 'lowerLimit': '5.509', 'upperLimit': '11.699'}, {'value': '10.409', 'groupId': 'OG001', 'lowerLimit': '7.328', 'upperLimit': '13.489'}, {'value': '-1.035', 'groupId': 'OG002', 'lowerLimit': '-3.451', 'upperLimit': '5.520'}]}]}], 'analyses': [{'pValue': '0.0319', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.548', 'ciLowerLimit': '0.397', 'ciUpperLimit': '8.700', 'groupDescription': 'Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.659', 'ciLowerLimit': '4.496', 'ciUpperLimit': '12.822', 'groupDescription': 'Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0702', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.361', 'ciLowerLimit': '-0.362', 'ciUpperLimit': '9.084', 'groupDescription': 'Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.085', 'ciLowerLimit': '5.349', 'ciUpperLimit': '14.821', 'groupDescription': 'Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0300', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.045', 'ciLowerLimit': '0.589', 'ciUpperLimit': '11.501', 'groupDescription': 'Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0005', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.803', 'ciLowerLimit': '4.368', 'ciUpperLimit': '15.237', 'groupDescription': 'Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0067', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.569', 'ciLowerLimit': '2.119', 'ciUpperLimit': '13.019', 'groupDescription': 'Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0008', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.374', 'ciLowerLimit': '3.933', 'ciUpperLimit': '14.815', 'groupDescription': 'Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': "EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D VAS was used to record a participant's (aged above 17 years) rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Index Value at Week 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '0.115', 'groupId': 'OG000', 'lowerLimit': '0.039', 'upperLimit': '0.191'}, {'value': '0.209', 'groupId': 'OG001', 'lowerLimit': '0.134', 'upperLimit': '0.284'}, {'value': '0.119', 'groupId': 'OG002', 'lowerLimit': '0.009', 'upperLimit': '0.228'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '0.168', 'groupId': 'OG000', 'lowerLimit': '0.071', 'upperLimit': '0.265'}, {'value': '0.278', 'groupId': 'OG001', 'lowerLimit': '0.183', 'upperLimit': '0.374'}, {'value': '-0.006', 'groupId': 'OG002', 'lowerLimit': '-0.149', 'upperLimit': '0.137'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '0.122', 'groupId': 'OG000', 'lowerLimit': '0.017', 'upperLimit': '0.228'}, {'value': '0.198', 'groupId': 'OG001', 'lowerLimit': '0.093', 'upperLimit': '0.304'}, {'value': '0.118', 'groupId': 'OG002', 'lowerLimit': '-0.040', 'upperLimit': '0.275'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '0.160', 'groupId': 'OG000', 'lowerLimit': '0.056', 'upperLimit': '0.265'}, {'value': '0.215', 'groupId': 'OG001', 'lowerLimit': '0.109', 'upperLimit': '0.322'}, {'value': '0.153', 'groupId': 'OG002', 'lowerLimit': '-0.007', 'upperLimit': '0.314'}]}]}], 'analyses': [{'pValue': '0.9568', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.004', 'ciLowerLimit': '-0.137', 'ciUpperLimit': '0.130', 'groupDescription': 'Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1782', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.090', 'ciLowerLimit': '-0.042', 'ciUpperLimit': '0.223', 'groupDescription': 'Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0491', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.174', 'ciLowerLimit': '0.001', 'ciUpperLimit': '0.347', 'groupDescription': 'Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0015', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.284', 'ciLowerLimit': '0.112', 'ciUpperLimit': '0.456', 'groupDescription': 'Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9638', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.004', 'ciLowerLimit': '-0.185', 'ciUpperLimit': '0.194', 'groupDescription': 'Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4016', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.080', 'ciLowerLimit': '-0.109', 'ciUpperLimit': '0.270', 'groupDescription': 'Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9429', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.007', 'ciLowerLimit': '-0.184', 'ciUpperLimit': '0.198', 'groupDescription': 'Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5212', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.062', 'ciLowerLimit': '-0.130', 'ciUpperLimit': '0.254', 'groupDescription': 'Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'EQ-5D-Y: standardized participant (aged 12-17 years) completed questionnaire consisted of 2 components: a health state profile and an optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. UK value sets (with all possible health states) was used for adolescents in the study, range from 1 to -0.594. Higher (positive) scores = better health state.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Visual Analogue Scale Score at Week 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '5.515', 'groupId': 'OG000', 'lowerLimit': '0.318', 'upperLimit': '10.712'}, {'value': '14.933', 'groupId': 'OG001', 'lowerLimit': '9.742', 'upperLimit': '20.124'}, {'value': '3.384', 'groupId': 'OG002', 'lowerLimit': '-4.217', 'upperLimit': '10.985'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '5.359', 'groupId': 'OG000', 'lowerLimit': '-0.339', 'upperLimit': '11.057'}, {'value': '15.496', 'groupId': 'OG001', 'lowerLimit': '9.803', 'upperLimit': '21.188'}, {'value': '-1.494', 'groupId': 'OG002', 'lowerLimit': '-10.060', 'upperLimit': '7.072'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '11.828', 'groupId': 'OG000', 'lowerLimit': '5.736', 'upperLimit': '17.919'}, {'value': '12.510', 'groupId': 'OG001', 'lowerLimit': '6.345', 'upperLimit': '18.674'}, {'value': '3.156', 'groupId': 'OG002', 'lowerLimit': '-6.213', 'upperLimit': '12.524'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '10.347', 'groupId': 'OG000', 'lowerLimit': '5.347', 'upperLimit': '15.347'}, {'value': '17.224', 'groupId': 'OG001', 'lowerLimit': '12.151', 'upperLimit': '22.297'}, {'value': '4.276', 'groupId': 'OG002', 'lowerLimit': '-3.397', 'upperLimit': '11.948'}]}]}], 'analyses': [{'pValue': '0.6467', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.131', 'ciLowerLimit': '-7.095', 'ciUpperLimit': '11.358', 'groupDescription': 'Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0147', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.549', 'ciLowerLimit': '2.338', 'ciUpperLimit': '20.761', 'groupDescription': 'Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1894', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.853', 'ciLowerLimit': '-3.453', 'ciUpperLimit': '17.159', 'groupDescription': 'Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0015', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.990', 'ciLowerLimit': '6.699', 'ciUpperLimit': '27.281', 'groupDescription': 'Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1267', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.672', 'ciLowerLimit': '-2.518', 'ciUpperLimit': '19.862', 'groupDescription': 'Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1009', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.354', 'ciLowerLimit': '-1.866', 'ciUpperLimit': '20.573', 'groupDescription': 'Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1915', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.071', 'ciLowerLimit': '-3.107', 'ciUpperLimit': '15.249', 'groupDescription': 'Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0064', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.948', 'ciLowerLimit': '3.754', 'ciUpperLimit': '22.143', 'groupDescription': 'Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': "EQ-5D-Y is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score specifically developed and validated for use by youths age 12-17 years. EQ-5D-Y consists of two components: a health state profile and an optional VAS. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '3.9'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '4.8'}, {'value': '-1.3', 'groupId': 'OG002', 'lowerLimit': '-3.6', 'upperLimit': '1.0'}]}]}], 'analyses': [{'pValue': '0.0102', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.6', 'ciLowerLimit': '0.9', 'ciUpperLimit': '6.4', 'pValueComment': 'Analysis of covariance (ANCOVA) model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0013', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.5', 'ciLowerLimit': '1.8', 'ciUpperLimit': '7.3', 'pValueComment': 'ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': "FACIT-F is a 13-item questionnaire. Participants (aged above 17 years) scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Higher the participant's response to the questions (with the exception of 2 negatively stated) greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (the best score) where higher scores indicated better overall health status (less fatigue).", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '3.9'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '3.8'}, {'value': '1.2', 'groupId': 'OG002', 'lowerLimit': '-1.4', 'upperLimit': '3.9'}]}]}], 'analyses': [{'pValue': '0.5241', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '4.2', 'pValueComment': 'ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5821', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '4.1', 'pValueComment': 'ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': "Peds-FACIT-F is a 13-item questionnaire for adolescents of 12-17 years of age. Participants scored each item on a 5-point scale: 0 (none of the time) to 4 (all of the time). Higher the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the Peds-FACIT-F score for a total possible score of 0 (worse score) to 52 (the best score) where higher scores indicated better overall health status (less fatigue).", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Short Form-36v2 (SF-36v2) Acute Summary Score at Week 12: Physical Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '5.6'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '3.9', 'upperLimit': '6.5'}, {'value': '0.5', 'groupId': 'OG002', 'lowerLimit': '-1.4', 'upperLimit': '2.4'}]}]}], 'analyses': [{'pValue': '0.0013', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.8', 'ciLowerLimit': '1.5', 'ciUpperLimit': '6.1', 'pValueComment': 'ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.7', 'ciLowerLimit': '2.4', 'ciUpperLimit': '7.0', 'pValueComment': 'ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'SF-36v2 health survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. These domains were also summarized as physical and mental component summary scores. Physical component summary: the minimum score is 0 and the maximum score is 100. Higher scores indicates a better health state.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Short Form-36v2 Acute Summary Score at Week 12: Mental Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '3.0'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '4.3'}, {'value': '-0.2', 'groupId': 'OG002', 'lowerLimit': '-2.5', 'upperLimit': '2.0'}]}]}], 'analyses': [{'pValue': '0.2256', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '4.4', 'pValueComment': 'ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0275', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.0', 'ciLowerLimit': '0.3', 'ciUpperLimit': '5.8', 'pValueComment': 'ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'SF-36v2 health survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. These domains were also summarized as physical and mental component summary scores. Mental component summary: the minimum score is 0 and the maximum score is 100. Higher scores indicates a better health state.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration Versus Time Summary of PF-04965842', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'classes': [{'title': 'Week 4: 0 Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.57', 'spread': '65.044', 'groupId': 'OG000'}, {'value': '58.16', 'spread': '162.11', 'groupId': 'OG001'}]}]}, {'title': 'Week 4: 0.5 Hour post dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '485.3', 'spread': '393.36', 'groupId': 'OG000'}, {'value': '889.7', 'spread': '786.96', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: 0.5 Hour Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '440.6', 'spread': '373.81', 'groupId': 'OG000'}, {'value': '933.9', 'spread': '741.09', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: 4 Hour Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '273.1', 'spread': '176.37', 'groupId': 'OG000'}, {'value': '838.9', 'spread': '544.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of Week 4: 0 hour(Pre-dose), 0.5 hours post-dose; Day 1 of Week 12: 0.5, 4 hours post-dose', 'description': 'Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLQ) = =1.00 nanogram per milliliter (ng/mL) to zero.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis set included all randomized participants who received at least 1 dose of PF-04965842 and had pharmacokinetic measurements. Here, 'Number Analyzed' = participants evaluable for the specified time points."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'FG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '156'}, {'groupId': 'FG001', 'numSubjects': '154'}, {'groupId': 'FG002', 'numSubjects': '77'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '135'}, {'groupId': 'FG001', 'numSubjects': '137'}, {'groupId': 'FG002', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Medication error,no linked adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal By Parent/Guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants with age greater than or equal to (\\>=) 12 years with moderate to severe atopic dermatitis (AD) and a body weight of \\>=40 kilogram were enrolled in the study. Eligible participants had an option to enter into a long-term extension (LTE) study after completing 12 weeks of treatment in this study.', 'preAssignmentDetails': 'This study was conducted from 07-December-2017 to 26-March-2019 at 76 sites in 8 countries.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '387', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'PF-04965842 100 mg', 'description': 'Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'BG001', 'title': 'PF-04965842 200 mg', 'description': 'Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.6', 'spread': '15.4', 'groupId': 'BG000'}, {'value': '33.0', 'spread': '17.4', 'groupId': 'BG001'}, {'value': '31.5', 'spread': '14.4', 'groupId': 'BG002'}, {'value': '32.5', 'spread': '16.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '167', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '220', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '364', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '279', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-26', 'size': 3829812, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-11-15T13:39', 'hasProtocol': False}, {'date': '2018-06-05', 'size': 6080014, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-11-20T13:27', 'hasProtocol': True}]}}, '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': 387}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-20', 'studyFirstSubmitDate': '2017-11-17', 'resultsFirstSubmitDate': '2019-11-20', 'studyFirstSubmitQcDate': '2017-11-17', 'lastUpdatePostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-20', 'studyFirstPostDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to 2 Points Improvement From Baseline at Week 12", 'timeFrame': 'Baseline, Week 12', 'description': 'IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp.'}, {'measure': 'Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response of >=75 Percent (%) Improvement From Baseline at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': "EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \\[including axillae and groin)\\] and lower limbs \\[including buttocks\\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\\>0 to \\<10%), 2 (10 to \\<30%), 3 (30 to \\<50%), 4 (50 to \\<70%), 5 (70 to \\<90%) and 6 (90 to 100%). Total EASI score =0.1\\*Ah\\*(Eh+Ih+Exh+Lh) + 0.2\\*Au\\*(Eu+Iu+ExU+Lu) + 0.3\\*At\\*(Et+It+Ext+Lt) + 0.4\\*Al\\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With at Least 4 Points Improvement From Baseline in the Numerical Rating Scale (NRS) for Severity of Pruritus at Week 2, 4, 8 and 12: Full Analysis Set (FAS)', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity.'}, {'measure': 'Percentage of Participants With at Least 4 Points Improvement From Baseline in the Numerical Rating Scale for Severity of Pruritus at Week 2, 4 and 12: Per Protocol Analysis Set (PPAS)', 'timeFrame': 'Baseline, Week 2, 4, 12', 'description': 'Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity.'}, {'measure': 'Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 2, 4, 8 and 12: Full Analysis Set', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin \\[lighter or darker\\], bleeding from skin, seeping or oozing fluid from skin \\[other than blood\\], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.'}, {'measure': 'Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis Total Score at Week 12: Per Protocol Analysis Set', 'timeFrame': 'Baseline, Week 12', 'description': 'PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin \\[lighter or darker\\], bleeding from skin, seeping or oozing fluid from skin \\[other than blood\\], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.'}, {'measure': 'Time to Achieve >=4 Points Improvement From Baseline in Numerical Rating Scale for Severity of Pruritus', 'timeFrame': 'Baseline up to Week 12', 'description': 'Participants were asked to assess their worst itching/pruritus due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst itch imaginable), where higher scores indicated greater severity. 95% CI was based on the Brookmeyer and Crowley method.'}, {'measure': 'Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement From Baseline at Week 2, 4 and 8', 'timeFrame': 'Baseline, Week 2, 4, 8', 'description': "EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \\[including axillae and groin)\\] and lower limbs \\[including buttocks\\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\\>0 to \\<10%), 2 (10 to \\<30%), 3 (30 to \\<50%), 4 (50 to \\<70%), 5 (70 to \\<90%) and 6 (90 to 100%). Total EASI score =0.1\\*Ah\\*(Eh+Ih+Exh+Lh) + 0.2\\*Au\\*(Eu+Iu+ExU+Lu) + 0.3\\*At\\*(Et+It+Ext+Lt) + 0.4\\*Al\\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD."}, {'measure': "Percentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 2, 4 and 8", 'timeFrame': 'Baseline, Week 2, 4, 8', 'description': 'IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp.'}, {'measure': "Percentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) at Week 2, 4, 8 and 12", 'timeFrame': 'Week 2, 4, 8, 12', 'description': 'IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp.'}, {'measure': 'Percentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': "EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \\[including axillae and groin)\\] and lower limbs \\[including buttocks\\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\\>0 to \\<10%), 2 (10 to \\<30%), 3 (30 to \\<50%), 4 (50 to \\<70%), 5 (70 to \\<90%) and 6 (90 to 100%). Total EASI score =0.1\\*Ah\\*(Eh+Ih+Exh+Lh) + 0.2\\*Au\\*(Eu+Iu+ExU+Lu) + 0.3\\*At\\*(Et+It+Ext+Lt) + 0.4\\*Al\\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD."}, {'measure': 'Percentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement From Baseline at Week 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': "EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \\[including axillae and groin)\\] and lower limbs \\[including buttocks\\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\\>0 to \\<10%), 2 (10 to \\<30%), 3 (30 to \\<50%), 4 (50 to \\<70%), 5 (70 to \\<90%) and 6 (90 to 100%). Total EASI score =0.1\\*Ah\\*(Eh+Ih+Exh+Lh) + 0.2\\*Au\\*(Eu+Iu+ExU+Lu) + 0.3\\*At\\*(Et+It+Ext+Lt) + 0.4\\*Al\\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD."}, {'measure': 'Percentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement From Baseline at Week 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': "EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \\[including axillae and groin)\\] and lower limbs \\[including buttocks\\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\\>0 to \\<10%), 2 (10 to \\<30%), 3 (30 to \\<50%), 4 (50 to \\<70%), 5 (70 to \\<90%) and 6 (90 to 100%). Total EASI score =0.1\\*Ah\\*(Eh+Ih+Exh+Lh) + 0.2\\*Au\\*(Eu+Iu+ExU+Lu) + 0.3\\*At\\*(Et+It+Ext+Lt) + 0.4\\*Al\\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD."}, {'measure': 'Change From Baseline in Eczema Area and Severity Index Total Score at Week 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': "EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \\[including axillae and groin)\\] and lower limbs \\[including buttocks\\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\\>0 to \\<10%), 2 (10 to \\<30%), 3 (30 to \\<50%), 4 (50 to \\<70%), 5 (70 to \\<90%) and 6 (90 to 100%). Total EASI score =0.1\\*Ah\\*(Eh+Ih+Exh+Lh) + 0.2\\*Au\\*(Eu+Iu+ExU+Lu) + 0.3\\*At\\*(Et+It+Ext+Lt) + 0.4\\*Al\\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD."}, {'measure': 'Change From Baseline in Percentage Body Surface Area at Week 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': "4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region \\* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD."}, {'measure': 'Percentage of Participants With Percentage Body Surface Area Less Than (<) 5% at Week 2, 4, 8 and 12', 'timeFrame': 'Week 2, 4, 8, 12', 'description': "4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limb, 3.33% for trunk and 2.5% for lower limb. % BSA for a body region was calculated as = total number of handprints in a body region \\* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD."}, {'measure': 'Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give \'C\' (0-20). The SCORAD for an individual was calculated: A/5 + 7\\*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.'}, {'measure': 'Percentage of Participants With Scoring Atopic Dermatitis Response of >=75% Improvement From Baseline at Week 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give \'C\' (0-20). The SCORAD for an individual was calculated: A/5 + 7\\*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.'}, {'measure': 'Change From Baseline in Scoring Atopic Dermatitis: Visual Analogue Scale of Sleep Loss at Week 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give \'C\' (0-20). The SCORAD for an individual was calculated: A/5 + 7\\*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.'}, {'measure': 'Change From Baseline in Scoring Atopic Dermatitis: Total Score at Week 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give \'C\' (0-20). The SCORAD for an individual was calculated: A/5 + 7\\*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.'}, {'measure': 'Percentage of Participants Achieving >=1 Point Improvement From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis at Week 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin \\[lighter or darker\\], bleeding from skin, seeping or oozing fluid from skin \\[other than blood\\], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.'}, {'measure': 'Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': "DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's (aged above 17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants."}, {'measure': "Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2, 4, 8 and 12", 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'CDLQI is a 10-item questionnaire that measures the impact of skin disease on adolescents (aged 12-17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.'}, {'measure': 'Percentage of Participants With Baseline Dermatology Life Quality Index Score >=2 and Achieving <2 DLQI Score at Week 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': "DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's (aged above 17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants."}, {'measure': "Percentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2 and Achieving <2 CDLQI Score at Week 2, 4, 8 and 12", 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'CDLQI is a 10-item questionnaire that measures the impact of skin disease on adolescents (aged 12-17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.'}, {'measure': 'Percentage of Participants With Baseline Dermatology Life Quality Index Score >=4 and Achieving >=4 Point Improvement From Baseline in DLQI Score at Week 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': "DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's (aged above 17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants."}, {'measure': "Percentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2.5 and Achieving >=2.5 Point Improvement From Baseline in CDLQI Score at Week 2, 4, 8 and 12", 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'CDLQI is a 10-item questionnaire that measures the impact of skin disease on adolescents (aged 12-17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.'}, {'measure': 'Change From Baseline in Hospital Anxiety and Depression Scale (HADS): Depression Subscale at Week 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms.'}, {'measure': 'Change From Baseline in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.'}, {'measure': 'Percentage of Participants With >=8 Points at Baseline and Achieving Score of <8 Points in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.'}, {'measure': 'Percentage of Participants With >=8 Points at Baseline and Achieving Score of <8 Points in Hospital Anxiety and Depression Scale: Depression Subscale at Week 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms.'}, {'measure': 'Percentage of Participants With >=11 Points at Baseline and Achieving Score of <11 Points in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.'}, {'measure': 'Percentage of Participants With >=11 Points at Baseline and Achieving Score of <11 Points in Hospital Anxiety and Depression Scale: Depression Subscale at Week 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms.'}, {'measure': 'Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'POEM is a 7-item participant reported outcome (PRO) measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item is scored as "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28, where higher score indicated greater severity.'}, {'measure': 'Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'Participant responded to "Overall, how would you describe your Atopic Dermatitis right now?" on a scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity.'}, {'measure': "Percentage of Participants Achieving 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12", 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'Participant responded to "Overall, how would you describe your Atopic Dermatitis right now?" on a scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity.'}, {'measure': 'Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L): Index Value at Week 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'EQ-5D-5L: standardized participant (aged \\>17 years) completed questionnaire consisted of 2 components: a health state profile and an optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study, range from 1 to -0.109. Higher (positive) scores = better health state.'}, {'measure': 'Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L)- Visual Analogue Scale Score at Week 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': "EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D VAS was used to record a participant's (aged above 17 years) rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state."}, {'measure': 'Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Index Value at Week 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': 'EQ-5D-Y: standardized participant (aged 12-17 years) completed questionnaire consisted of 2 components: a health state profile and an optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. UK value sets (with all possible health states) was used for adolescents in the study, range from 1 to -0.594. Higher (positive) scores = better health state.'}, {'measure': 'Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Visual Analogue Scale Score at Week 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 2, 4, 8, 12', 'description': "EQ-5D-Y is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score specifically developed and validated for use by youths age 12-17 years. EQ-5D-Y consists of two components: a health state profile and an optional VAS. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state."}, {'measure': 'Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': "FACIT-F is a 13-item questionnaire. Participants (aged above 17 years) scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Higher the participant's response to the questions (with the exception of 2 negatively stated) greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (the best score) where higher scores indicated better overall health status (less fatigue)."}, {'measure': 'Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': "Peds-FACIT-F is a 13-item questionnaire for adolescents of 12-17 years of age. Participants scored each item on a 5-point scale: 0 (none of the time) to 4 (all of the time). Higher the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the Peds-FACIT-F score for a total possible score of 0 (worse score) to 52 (the best score) where higher scores indicated better overall health status (less fatigue)."}, {'measure': 'Change From Baseline in Short Form-36v2 (SF-36v2) Acute Summary Score at Week 12: Physical Component Summary', 'timeFrame': 'Baseline, Week 12', 'description': 'SF-36v2 health survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. These domains were also summarized as physical and mental component summary scores. Physical component summary: the minimum score is 0 and the maximum score is 100. Higher scores indicates a better health state.'}, {'measure': 'Change From Baseline in Short Form-36v2 Acute Summary Score at Week 12: Mental Component Summary', 'timeFrame': 'Baseline, Week 12', 'description': 'SF-36v2 health survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. These domains were also summarized as physical and mental component summary scores. Mental component summary: the minimum score is 0 and the maximum score is 100. Higher scores indicates a better health state.'}, {'measure': 'Plasma Concentration Versus Time Summary of PF-04965842', 'timeFrame': 'Day 1 of Week 4: 0 hour(Pre-dose), 0.5 hours post-dose; Day 1 of Week 12: 0.5, 4 hours post-dose', 'description': 'Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLQ) = =1.00 nanogram per milliliter (ng/mL) to zero.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['atopic dermatitis', 'atopic eczema', 'eczema', 'JAK', 'janus kinase'], 'conditions': ['Dermatitis, Atopic']}, 'referencesModule': {'references': [{'pmid': '40028832', 'type': 'DERIVED', 'citation': 'Paller AS, Eichenfield LF, Irvine AD, Flohr C, Wollenberg A, Barbarot S, Bangert C, Spergel JM, Selfridge A, Biswas P, Fan H, Alderfer J, Watkins M, Koppensteiner H. Integrated Efficacy and Safety Analysis of Abrocitinib in Adolescents With Moderate-to-Severe Atopic Dermatitis. Allergy. 2025 Aug;80(8):2213-2224. doi: 10.1111/all.16512. Epub 2025 Mar 3.'}, {'pmid': '39104653', 'type': 'DERIVED', 'citation': 'Silverberg JI, Thyssen JP, Lazariciu I, Myers DE, Guler E, Chovatiya R. Abrocitinib may improve itch and quality of life in patients with itch-dominant atopic dermatitis. Skin Health Dis. 2024 May 5;4(4):e382. doi: 10.1002/ski2.382. eCollection 2024 Aug.'}, {'pmid': '38896380', 'type': 'DERIVED', 'citation': 'Armstrong AW, Alexis AF, Blauvelt A, Silverberg JI, Feeney C, Levenberg M, Chan G, Zhang F, Fostvedt L. Predicting Abrocitinib Efficacy at Week 12 Based on Clinical Response at Week 4: A Post Hoc Analysis of Four Randomized Studies in Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 Jul;14(7):1849-1861. doi: 10.1007/s13555-024-01183-3. Epub 2024 Jun 19.'}, {'pmid': '37988255', 'type': 'DERIVED', 'citation': 'Schmid-Grendelmeier P, Gooderham MJ, Hartmann K, Konstantinou GN, Fellmann M, Koulias C, Clibborn C, Biswas P, Brunner PM. Efficacy and safety of abrocitinib in patients with moderate-to-severe atopic dermatitis and comorbid allergies. Allergy. 2024 Jan;79(1):174-183. doi: 10.1111/all.15952. Epub 2023 Nov 21.'}, {'pmid': '37949351', 'type': 'DERIVED', 'citation': 'Alexis AF, Silverberg JI, Rice ZP, Armstrong AW, Desai SR, Fonacier L, Kabashima K, Biswas P, Cella RR, Chan GL, Levenberg M. Abrocitinib efficacy and safety in moderate-to-severe atopic dermatitis by race, ethnicity, and Fitzpatrick skin type. Ann Allergy Asthma Immunol. 2024 Mar;132(3):383-389.e3. doi: 10.1016/j.anai.2023.11.002. Epub 2023 Nov 10.'}, {'pmid': '35763326', 'type': 'DERIVED', 'citation': "Blauvelt A, Boguniewicz M, Brunner PM, Luna PC, Biswas P, DiBonaventura M, Farooqui SA, Rojo R, Cameron MC. Abrocitinib monotherapy in Investigator's Global Assessment nonresponders: improvement in signs and symptoms of atopic dermatitis and quality of life. J Dermatolog Treat. 2022 Aug;33(5):2605-2613. doi: 10.1080/09546634.2022.2059053. Epub 2022 Jul 6."}, {'pmid': '35462428', 'type': 'DERIVED', 'citation': 'Stander S, Bhatia N, Gooderham MJ, Silverberg JI, Thyssen JP, Biswas P, DiBonaventura M, Romero W, Farooqui SA. High threshold efficacy responses in moderate-to-severe atopic dermatitis are associated with additional quality of life benefits: pooled analyses of abrocitinib monotherapy studies in adults and adolescents. J Eur Acad Dermatol Venereol. 2022 Aug;36(8):1308-1317. doi: 10.1111/jdv.18170. Epub 2022 May 6.'}, {'pmid': '35342978', 'type': 'DERIVED', 'citation': 'Wojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population pharmacokinetic-pharmacodynamic modelling of platelet time-courses following administration of abrocitinib. Br J Clin Pharmacol. 2022 Aug;88(8):3856-3871. doi: 10.1111/bcp.15334. Epub 2022 Apr 11.'}, {'pmid': '35061234', 'type': 'DERIVED', 'citation': 'Wojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population Pharmacokinetics of Abrocitinib in Healthy Individuals and Patients with Psoriasis or Atopic Dermatitis. Clin Pharmacokinet. 2022 May;61(5):709-723. doi: 10.1007/s40262-021-01104-z. Epub 2022 Jan 21.'}, {'pmid': '34743361', 'type': 'DERIVED', 'citation': 'Cork MJ, McMichael A, Teng J, Valdez H, Rojo R, Chan G, Zhang F, Myers DE, DiBonaventura M. Impact of oral abrocitinib on signs, symptoms and quality of life among adolescents with moderate-to-severe atopic dermatitis: an analysis of patient-reported outcomes. J Eur Acad Dermatol Venereol. 2022 Mar;36(3):422-433. doi: 10.1111/jdv.17792. Epub 2021 Dec 4.'}, {'pmid': '34406619', 'type': 'DERIVED', 'citation': 'Simpson EL, Silverberg JI, Nosbaum A, Winthrop KL, Guttman-Yassky E, Hoffmeister KM, Egeberg A, Valdez H, Zhang M, Farooqui SA, Romero W, Thorpe AJ, Rojo R, Johnson S. Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-Severe Atopic Dermatitis From the Phase II and Phase III Clinical Trial Program. Am J Clin Dermatol. 2021 Sep;22(5):693-707. doi: 10.1007/s40257-021-00618-3. Epub 2021 Aug 18.'}, {'pmid': '33954933', 'type': 'DERIVED', 'citation': 'Silverberg JI, Thyssen JP, Simpson EL, Yosipovitch G, Stander S, Valdez H, Rojo R, Biswas P, Myers DE, Feeney C, DiBonaventura M. Impact of Oral Abrocitinib Monotherapy on Patient-Reported Symptoms and Quality of Life in Adolescents and Adults with Moderate-to-Severe Atopic Dermatitis: A Pooled Analysis of Patient-Reported Outcomes. Am J Clin Dermatol. 2021 Jul;22(4):541-554. doi: 10.1007/s40257-021-00604-9. Epub 2021 May 5.'}, {'pmid': '32711801', 'type': 'DERIVED', 'citation': 'Simpson EL, Sinclair R, Forman S, Wollenberg A, Aschoff R, Cork M, Bieber T, Thyssen JP, Yosipovitch G, Flohr C, Magnolo N, Maari C, Feeney C, Biswas P, Tatulych S, Valdez H, Rojo R. Efficacy and safety of abrocitinib in adults and adolescents with moderate-to-severe atopic dermatitis (JADE MONO-1): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet. 2020 Jul 25;396(10246):255-266. doi: 10.1016/S0140-6736(20)30732-7.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=B7451012', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'B7451012 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily, will be evaluated relative to placebo over 12 weeks of study participation. 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