Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-02-21 @ 10:11 PM
Study NCT ID:
NCT03627767
Status:
COMPLETED
Last Update Posted:
2021-09-20
First Post:
2018-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D004485', 'term': 'Eczema'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D007154', 'term': 'Immune System Diseases'}], 'ancestors': [{'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, '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}, 'limitationsAndCaveats': {'description': 'For outcome measure, Time to loss of response, the data collection window was extended for 45 days beyond the scheduled visit due to COVID 19.'}}, 'adverseEventsModule': {'timeFrame': 'From screening up to 28 days after last dose of study treatment (maximum up to Week 56)', 'description': 'Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'PF-04965842 200 mg OL', 'description': 'Participants received 12 weeks induction treatment of 200 mg oral tablets (each tablet of 100 mg) PF-04965842 QD during an OL run-in period. Responders at the end of the 12-week open-label run-in period entered the 40 weeks, DB, maintenance treatment period. Responder criteria was defined as a) achieving an IGA of clear (0) or almost clear (1) (on a 5-point scale), b) a reduction from IGA baseline of \\>= 2 points, and c) reaching an EASI-75 response compared to baseline score. Baseline score was the IGA score and EASI score obtained prior to dosing on Day 1. Non-responders had a choice to enroll into the PF-04965842 LTE study B7451015 (NCT03422822) otherwise, they were permanently discontinued from treatment and were followed-up for 4-week in this study.', 'otherNumAtRisk': 1233, 'deathsNumAtRisk': 1233, 'otherNumAffected': 482, 'seriousNumAtRisk': 1233, 'deathsNumAffected': 1, 'seriousNumAffected': 20}, {'id': 'EG001', 'title': 'PF-04965842 200 mg OL to Placebo DB', 'description': 'Responders from open-label run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.', 'otherNumAtRisk': 267, 'deathsNumAtRisk': 267, 'otherNumAffected': 158, 'seriousNumAtRisk': 267, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB', 'description': 'Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.', 'otherNumAtRisk': 265, 'deathsNumAtRisk': 265, 'otherNumAffected': 130, 'seriousNumAtRisk': 265, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG003', 'title': 'PF-04965842 200 mg OL to PF-04965842 200 mg DB', 'description': 'Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.', 'otherNumAtRisk': 266, 'deathsNumAtRisk': 266, 'otherNumAffected': 152, 'seriousNumAtRisk': 266, 'deathsNumAffected': 0, 'seriousNumAffected': 14}, {'id': 'EG004', 'title': 'PF-04965842 200 mg Rescue Period', 'description': 'Participants who met the protocol defined flare criteria in DB period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during open-label Rescue Period for up to 12 weeks. After completing the 12-week rescue period, participants had the choice to enter the LTE study B7451015 (NCT03422822), if eligible. Participants who discontinued early from treatment, or who were otherwise ineligible for the LTE study, were followed-up for 4 week in this study.', 'otherNumAtRisk': 351, 'deathsNumAtRisk': 351, 'otherNumAffected': 75, 'seriousNumAtRisk': 351, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 25}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 119}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 31}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 199}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 49}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 31}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 88}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 56}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 36}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 28}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 22}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Vitello-intestinal duct remnant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Microcytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Retinal vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Ulcerative keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Haemarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Myositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abscess neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Eczema herpeticum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastrointestinal viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hepatitis E', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Peritonsillar abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Ligament injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Multiple fractures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Adenocarcinoma gastric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Adnexa uteri cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Loss of Response: Double-blind (DB) Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '266', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 200 mg OL to Placebo DB', 'description': 'Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB', 'description': 'Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG002', 'title': 'PF-04965842 200 mg OL to PF-04965842 200 mg DB', 'description': 'Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '77.5', 'groupId': 'OG000'}, {'value': '39.6', 'groupId': 'OG001'}, {'value': '16.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 of up to Week 40 of double blind period', 'description': "Percentage of participants with loss of response requiring rescue treatment during double blind period was determined. Loss of response denoted as flare and was define as a loss of at least 50% of EASI total score at Week 12 and with an IGA score of 2 or higher. EASI quantifies severity of participant's atopic dermatitis (AD) based on both severity of lesion clinical signs and % of body surface area (BSA) affected. EASI is a composite scoring by AD clinical evaluator of degree of erythema, induration/papulation, excoriation, and lichenification for each of 4 body regions. EASI total score range from 0.0 to 72.0, with higher scores representing greater severity of AD. IGA assesses severity of AD on 5-point scale (0 to 4, higher scores = more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate and 4 = severe.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set-randomized (FAS-RA) included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Missing event times were considered as right censored (CAR) on last date of randomized treatment.'}, {'type': 'SECONDARY', 'title': "Time to First Loss of Response Based on Investigator's Global Assessment (IGA) Score of 2 or Higher: Double-blind Period", 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 200 mg OL to Placebo DB', 'description': 'Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB', 'description': 'Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG002', 'title': 'PF-04965842 200 mg OL to PF-04965842 200 mg DB', 'description': 'Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.0', 'spread': '26.0', 'groupId': 'OG000', 'lowerLimit': '26.0', 'upperLimit': '28.0'}, {'value': '78.0', 'spread': '32.0', 'groupId': 'OG001', 'lowerLimit': '32.0', 'upperLimit': '112.0'}, {'value': '201.0', 'spread': '177.0', 'groupId': 'OG002', 'lowerLimit': '177.0', 'upperLimit': '282.0'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.35', 'ciLowerLimit': '0.286', 'ciUpperLimit': '0.424', 'pValueComment': 'A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.', 'groupDescription': 'A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.22', 'ciLowerLimit': '0.176', 'ciUpperLimit': '0.270', 'pValueComment': 'A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.', 'groupDescription': 'A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.63', 'ciLowerLimit': '0.503', 'ciUpperLimit': '0.780', 'pValueComment': 'A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.', 'groupDescription': 'A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of first dose of randomized treatment until the last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) (maximum up to Week 40, visit window +/- 7 Days)', 'description': 'Time (in days) to loss of response based on achieving IGA \\>=2 (for the first time) as measured from date of first dose of randomized treatment until the last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue). IGA assesses severity of AD on a 5-point scale (0 to 4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear, AD is cleared; 1 = almost clear, AD not entirely cleared, light pink residual lesions; 2 = mild, AD with light red lesions; 3 = moderate, AD with red lesions; 4 = severe, AD with deep, dark red lesions.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS-RA included as all participants who were randomized at Week 12 and received at least one dose of study medication within the double-blind phase. Missing event times were considered as right censored (CAR) on last date of randomized treatment. Here, Overall 'Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': "Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period", 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '266', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 200 mg OL to Placebo DB', 'description': 'Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB', 'description': 'Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG002', 'title': 'PF-04965842 200 mg OL to PF-04965842 200 mg DB', 'description': 'Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '265', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000', 'lowerLimit': '98.9', 'upperLimit': '100.0'}, {'value': '99.6', 'groupId': 'OG001', 'lowerLimit': '98.9', 'upperLimit': '100.0'}, {'value': '99.2', 'groupId': 'OG002', 'lowerLimit': '98.2', 'upperLimit': '100.0'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}, {'value': '266', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000', 'lowerLimit': '11.0', 'upperLimit': '19.7'}, {'value': '55.5', 'groupId': 'OG001', 'lowerLimit': '49.5', 'upperLimit': '61.5'}, {'value': '77.8', 'groupId': 'OG002', 'lowerLimit': '72.8', 'upperLimit': '82.8'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '262', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '14.2'}, {'value': '45.0', 'groupId': 'OG001', 'lowerLimit': '39.0', 'upperLimit': '51.0'}, {'value': '61.8', 'groupId': 'OG002', 'lowerLimit': '55.9', 'upperLimit': '67.7'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '259', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '14.3'}, {'value': '42.3', 'groupId': 'OG001', 'lowerLimit': '36.3', 'upperLimit': '48.3'}, {'value': '57.1', 'groupId': 'OG002', 'lowerLimit': '51.1', 'upperLimit': '63.2'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000', 'lowerLimit': '7.9', 'upperLimit': '15.6'}, {'value': '36.8', 'groupId': 'OG001', 'lowerLimit': '30.9', 'upperLimit': '42.7'}, {'value': '54.1', 'groupId': 'OG002', 'lowerLimit': '48.0', 'upperLimit': '60.2'}]}]}], 'analyses': [{'pValue': '= 0.9495', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '1.1', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.5717', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '0.9', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '-0.4', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '0.9', 'groupDescription': 'Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '40.5', 'ciLowerLimit': '33.1', 'ciUpperLimit': '47.8', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata', 'groupDescription': 'Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '62.6', 'ciLowerLimit': '56.1', 'ciUpperLimit': '69.2', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '22.1', 'ciLowerLimit': '14.3', 'ciUpperLimit': '29.9', 'groupDescription': 'Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.1', 'ciLowerLimit': '28.1', 'ciUpperLimit': '42.0', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '51.5', 'ciLowerLimit': '44.6', 'ciUpperLimit': '58.4', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '16.5', 'ciLowerLimit': '8.1', 'ciUpperLimit': '24.8', 'groupDescription': 'Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32.2', 'ciLowerLimit': '25.2', 'ciUpperLimit': '39.2', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '46.9', 'ciLowerLimit': '39.9', 'ciUpperLimit': '53.8', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '14.2', 'ciLowerLimit': '5.9', 'ciUpperLimit': '22.6', 'groupDescription': 'Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.5', 'ciLowerLimit': '18.5', 'ciUpperLimit': '32.5', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '42.5', 'ciLowerLimit': '35.3', 'ciUpperLimit': '49.7', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '17.1', 'ciLowerLimit': '8.6', 'ciUpperLimit': '25.5', 'groupDescription': 'Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', 'description': 'IGA assessed severity of AD on a 5-point scale (0 to 4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear, AD is cleared; 1 = almost clear, AD not entirely cleared, light pink residual lesions; 2 = mild, AD with light red lesions; 3 = moderate, AD with red lesions; 4 = severe, AD with deep dark red lesions.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified time points."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '266', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 200 mg OL to Placebo DB', 'description': 'Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB', 'description': 'Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG002', 'title': 'PF-04965842 200 mg OL to PF-04965842 200 mg DB', 'description': 'Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '265', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.6', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '98.6', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.6', 'upperLimit': '100.0'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}, {'value': '266', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '40.8', 'groupId': 'OG000', 'lowerLimit': '34.9', 'upperLimit': '46.7'}, {'value': '83.3', 'groupId': 'OG001', 'lowerLimit': '78.8', 'upperLimit': '87.8'}, {'value': '96.2', 'groupId': 'OG002', 'lowerLimit': '94.0', 'upperLimit': '98.5'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '262', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22.8', 'groupId': 'OG000', 'lowerLimit': '17.8', 'upperLimit': '27.9'}, {'value': '68.1', 'groupId': 'OG001', 'lowerLimit': '62.4', 'upperLimit': '73.7'}, {'value': '85.9', 'groupId': 'OG002', 'lowerLimit': '81.7', 'upperLimit': '90.1'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '259', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '16.6', 'groupId': 'OG000', 'lowerLimit': '12.1', 'upperLimit': '21.1'}, {'value': '57.3', 'groupId': 'OG001', 'lowerLimit': '51.3', 'upperLimit': '63.3'}, {'value': '74.9', 'groupId': 'OG002', 'lowerLimit': '69.6', 'upperLimit': '80.2'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000', 'lowerLimit': '11.5', 'upperLimit': '20.3'}, {'value': '50.8', 'groupId': 'OG001', 'lowerLimit': '44.7', 'upperLimit': '56.9'}, {'value': '71.2', 'groupId': 'OG002', 'lowerLimit': '65.7', 'upperLimit': '76.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '0.0', 'ciUpperLimit': '0.0', 'groupDescription': 'Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '0.0', 'ciUpperLimit': '0.0', 'groupDescription': 'Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions. P-value was adjusted by disease severity at baseline and randomization strata.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '0.0', 'ciUpperLimit': '0.0', 'groupDescription': 'Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '42.7', 'ciLowerLimit': '35.3', 'ciUpperLimit': '50.1', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '55.4', 'ciLowerLimit': '49.1', 'ciUpperLimit': '61.7', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '12.9', 'ciLowerLimit': '7.9', 'ciUpperLimit': '17.9', 'groupDescription': 'Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '45.5', 'ciLowerLimit': '37.9', 'ciUpperLimit': '53.0', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '63.0', 'ciLowerLimit': '56.4', 'ciUpperLimit': '69.5', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '17.7', 'ciLowerLimit': '10.7', 'ciUpperLimit': '24.7', 'groupDescription': 'Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '41.0', 'ciLowerLimit': '33.6', 'ciUpperLimit': '48.5', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '58.3', 'ciLowerLimit': '51.3', 'ciUpperLimit': '65.2', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '17.5', 'ciLowerLimit': '9.6', 'ciUpperLimit': '25.5', 'groupDescription': 'Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.3', 'ciLowerLimit': '27.8', 'ciUpperLimit': '42.8', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '55.3', 'ciLowerLimit': '48.3', 'ciUpperLimit': '62.4', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.3', 'ciLowerLimit': '12.1', 'ciUpperLimit': '28.5', 'groupDescription': 'Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', 'description': "EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema \\[E\\], induration/papulation \\[I\\], excoriation \\[Ex\\] and lichenification \\[L\\]) was scored separately for each of 4 body regions (head and neck \\[h\\], upper limbs \\[u\\], trunk \\[t\\] \\[including axillae and groin\\] and lower limbs \\[l\\] \\[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); where A = area score. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '266', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 200 mg OL to Placebo DB', 'description': 'Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB', 'description': 'Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG002', 'title': 'PF-04965842 200 mg OL to PF-04965842 200 mg DB', 'description': 'Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '265', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000', 'lowerLimit': '98.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '98.6', 'upperLimit': '100.0'}, {'value': '99.6', 'groupId': 'OG002', 'lowerLimit': '98.9', 'upperLimit': '100.0'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}, {'value': '266', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '27.0', 'groupId': 'OG000', 'lowerLimit': '21.6', 'upperLimit': '32.3'}, {'value': '76.0', 'groupId': 'OG001', 'lowerLimit': '70.9', 'upperLimit': '81.2'}, {'value': '92.5', 'groupId': 'OG002', 'lowerLimit': '89.3', 'upperLimit': '95.7'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '262', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000', 'lowerLimit': '13.4', 'upperLimit': '22.6'}, {'value': '60.4', 'groupId': 'OG001', 'lowerLimit': '54.4', 'upperLimit': '66.3'}, {'value': '80.5', 'groupId': 'OG002', 'lowerLimit': '75.7', 'upperLimit': '85.3'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '259', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.1', 'groupId': 'OG000', 'lowerLimit': '10.8', 'upperLimit': '19.4'}, {'value': '54.2', 'groupId': 'OG001', 'lowerLimit': '48.2', 'upperLimit': '60.3'}, {'value': '71.8', 'groupId': 'OG002', 'lowerLimit': '66.3', 'upperLimit': '77.3'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000', 'lowerLimit': '9.8', 'upperLimit': '18.2'}, {'value': '46.5', 'groupId': 'OG001', 'lowerLimit': '40.4', 'upperLimit': '52.6'}, {'value': '65.8', 'groupId': 'OG002', 'lowerLimit': '60.0', 'upperLimit': '71.6'}]}]}], 'analyses': [{'pValue': '= 0.1848', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '1.7', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.5971', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '1.6', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '-0.4', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '0.4', 'groupDescription': 'Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '49.4', 'ciLowerLimit': '42.0', 'ciUpperLimit': '56.8', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '65.5', 'ciLowerLimit': '59.3', 'ciUpperLimit': '71.7', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '16.3', 'ciLowerLimit': '10.3', 'ciUpperLimit': '22.3', 'groupDescription': 'Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '42.7', 'ciLowerLimit': '35.2', 'ciUpperLimit': '50.2', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '62.6', 'ciLowerLimit': '56.0', 'ciUpperLimit': '69.2', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '19.8', 'ciLowerLimit': '12.3', 'ciUpperLimit': '27.4', 'groupDescription': 'Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '39.5', 'ciLowerLimit': '32.1', 'ciUpperLimit': '46.9', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '56.7', 'ciLowerLimit': '49.8', 'ciUpperLimit': '63.7', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '17.4', 'ciLowerLimit': '9.3', 'ciUpperLimit': '25.5', 'groupDescription': 'Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.0', 'ciLowerLimit': '25.7', 'ciUpperLimit': '40.4', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '51.7', 'ciLowerLimit': '44.6', 'ciUpperLimit': '58.8', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '19.2', 'ciLowerLimit': '10.8', 'ciUpperLimit': '27.6', 'groupDescription': 'Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', 'description': "EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of 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). Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '266', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 200 mg OL to Placebo DB', 'description': 'Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB', 'description': 'Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG002', 'title': 'PF-04965842 200 mg OL to PF-04965842 200 mg DB', 'description': 'Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '265', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '84.6', 'groupId': 'OG000', 'lowerLimit': '80.2', 'upperLimit': '88.9'}, {'value': '87.1', 'groupId': 'OG001', 'lowerLimit': '83.1', 'upperLimit': '91.2'}, {'value': '86.4', 'groupId': 'OG002', 'lowerLimit': '82.3', 'upperLimit': '90.5'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}, {'value': '266', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000', 'lowerLimit': '9.7', 'upperLimit': '18.0'}, {'value': '51.3', 'groupId': 'OG001', 'lowerLimit': '45.3', 'upperLimit': '57.4'}, {'value': '77.1', 'groupId': 'OG002', 'lowerLimit': '72.0', 'upperLimit': '82.1'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '262', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '14.2'}, {'value': '46.9', 'groupId': 'OG001', 'lowerLimit': '40.9', 'upperLimit': '53.0'}, {'value': '64.5', 'groupId': 'OG002', 'lowerLimit': '58.7', 'upperLimit': '70.3'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '259', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '16.0'}, {'value': '41.5', 'groupId': 'OG001', 'lowerLimit': '35.5', 'upperLimit': '47.5'}, {'value': '58.7', 'groupId': 'OG002', 'lowerLimit': '52.7', 'upperLimit': '64.7'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '14.3'}, {'value': '37.6', 'groupId': 'OG001', 'lowerLimit': '31.7', 'upperLimit': '43.5'}, {'value': '54.5', 'groupId': 'OG002', 'lowerLimit': '48.4', 'upperLimit': '60.6'}]}]}], 'analyses': [{'pValue': '= 0.3994', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.6', 'ciLowerLimit': '-3.3', 'ciUpperLimit': '8.4', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.5542', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '-4.1', 'ciUpperLimit': '7.8', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '-0.8', 'ciLowerLimit': '-6.5', 'ciUpperLimit': '5.0', 'groupDescription': 'Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '37.5', 'ciLowerLimit': '30.2', 'ciUpperLimit': '44.9', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '63.3', 'ciLowerLimit': '56.8', 'ciUpperLimit': '69.8', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '25.5', 'ciLowerLimit': '17.7', 'ciUpperLimit': '33.4', 'groupDescription': 'Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '36.9', 'ciLowerLimit': '29.9', 'ciUpperLimit': '44.0', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '54.2', 'ciLowerLimit': '47.3', 'ciUpperLimit': '61.0', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '17.2', 'ciLowerLimit': '8.9', 'ciUpperLimit': '25.5', 'groupDescription': 'Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.8', 'ciLowerLimit': '22.7', 'ciUpperLimit': '37.0', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '46.7', 'ciLowerLimit': '39.6', 'ciUpperLimit': '53.8', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '16.9', 'ciLowerLimit': '8.5', 'ciUpperLimit': '25.3', 'groupDescription': 'Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.4', 'ciLowerLimit': '20.4', 'ciUpperLimit': '34.3', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '43.8', 'ciLowerLimit': '36.7', 'ciUpperLimit': '50.9', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '16.8', 'ciLowerLimit': '8.4', 'ciUpperLimit': '25.2', 'groupDescription': 'Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', 'description': "EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of 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). Total EASI score ranged from 0.0 to 72.0, higher scores=greater severity of AD.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '266', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 200 mg OL to Placebo DB', 'description': 'Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB', 'description': 'Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG002', 'title': 'PF-04965842 200 mg OL to PF-04965842 200 mg DB', 'description': 'Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '265', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '30.5', 'groupId': 'OG000', 'lowerLimit': '24.9', 'upperLimit': '36.0'}, {'value': '30.3', 'groupId': 'OG001', 'lowerLimit': '24.8', 'upperLimit': '35.8'}, {'value': '28.3', 'groupId': 'OG002', 'lowerLimit': '22.9', 'upperLimit': '33.7'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}, {'value': '266', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '6.0'}, {'value': '15.2', 'groupId': 'OG001', 'lowerLimit': '10.9', 'upperLimit': '19.5'}, {'value': '28.9', 'groupId': 'OG002', 'lowerLimit': '23.5', 'upperLimit': '34.4'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '262', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '6.5'}, {'value': '16.5', 'groupId': 'OG001', 'lowerLimit': '12.0', 'upperLimit': '21.1'}, {'value': '30.2', 'groupId': 'OG002', 'lowerLimit': '24.6', 'upperLimit': '35.7'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '259', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '7.0'}, {'value': '15.8', 'groupId': 'OG001', 'lowerLimit': '11.3', 'upperLimit': '20.2'}, {'value': '30.1', 'groupId': 'OG002', 'lowerLimit': '24.5', 'upperLimit': '35.7'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '7.1'}, {'value': '18.6', 'groupId': 'OG001', 'lowerLimit': '13.9', 'upperLimit': '23.4'}, {'value': '28.8', 'groupId': 'OG002', 'lowerLimit': '23.3', 'upperLimit': '34.3'}]}]}], 'analyses': [{'pValue': '= 0.9313', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-7.5', 'ciUpperLimit': '8.1', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.6043', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.1', 'ciLowerLimit': '-9.8', 'ciUpperLimit': '5.7', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '-2.3', 'ciLowerLimit': '-10.0', 'ciUpperLimit': '5.4', 'groupDescription': 'Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.6', 'ciLowerLimit': '6.6', 'ciUpperLimit': '16.5', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '25.3', 'ciLowerLimit': '19.4', 'ciUpperLimit': '31.2', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '13.5', 'ciLowerLimit': '6.6', 'ciUpperLimit': '20.4', 'groupDescription': 'Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.9', 'ciLowerLimit': '7.7', 'ciUpperLimit': '18.0', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '26.0', 'ciLowerLimit': '19.9', 'ciUpperLimit': '32.0', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '13.4', 'ciLowerLimit': '6.3', 'ciUpperLimit': '20.6', 'groupDescription': 'Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.7', 'ciLowerLimit': '6.5', 'ciUpperLimit': '16.8', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '25.7', 'ciLowerLimit': '19.6', 'ciUpperLimit': '31.8', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '14.1', 'ciLowerLimit': '7.0', 'ciUpperLimit': '21.2', 'groupDescription': 'Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.6', 'ciLowerLimit': '9.2', 'ciUpperLimit': '20.0', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '24.5', 'ciLowerLimit': '18.4', 'ciUpperLimit': '30.5', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '10.0', 'ciLowerLimit': '2.7', 'ciUpperLimit': '17.2', 'groupDescription': 'Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', 'description': "EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of 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). Total EASI score ranged from 0.0 to 72.0, higher scores=greater severity of AD.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}, {'value': '250', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 200 mg OL to Placebo DB', 'description': 'Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB', 'description': 'Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG002', 'title': 'PF-04965842 200 mg OL to PF-04965842 200 mg DB', 'description': 'Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '82.2', 'groupId': 'OG000', 'lowerLimit': '77.2', 'upperLimit': '87.1'}, {'value': '84.0', 'groupId': 'OG001', 'lowerLimit': '79.3', 'upperLimit': '88.6'}, {'value': '81.9', 'groupId': 'OG002', 'lowerLimit': '76.9', 'upperLimit': '86.9'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}, {'value': '250', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000', 'lowerLimit': '11.4', 'upperLimit': '20.4'}, {'value': '54.6', 'groupId': 'OG001', 'lowerLimit': '48.4', 'upperLimit': '60.7'}, {'value': '75.6', 'groupId': 'OG002', 'lowerLimit': '70.3', 'upperLimit': '80.9'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}, {'value': '245', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000', 'lowerLimit': '7.7', 'upperLimit': '15.5'}, {'value': '45.0', 'groupId': 'OG001', 'lowerLimit': '38.9', 'upperLimit': '51.2'}, {'value': '66.9', 'groupId': 'OG002', 'lowerLimit': '61.0', 'upperLimit': '72.8'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}, {'value': '246', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000', 'lowerLimit': '6.4', 'upperLimit': '13.8'}, {'value': '39.4', 'groupId': 'OG001', 'lowerLimit': '33.4', 'upperLimit': '45.4'}, {'value': '55.7', 'groupId': 'OG002', 'lowerLimit': '49.5', 'upperLimit': '61.9'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '11.7'}, {'value': '27.6', 'groupId': 'OG001', 'lowerLimit': '21.7', 'upperLimit': '33.6'}, {'value': '49.0', 'groupId': 'OG002', 'lowerLimit': '42.2', 'upperLimit': '55.9'}]}]}], 'analyses': [{'pValue': '= 0.6082', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '-5.0', 'ciUpperLimit': '8.5', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.9640', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-6.7', 'ciUpperLimit': '7.0', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '-2.4', 'ciLowerLimit': '-9.1', 'ciUpperLimit': '4.4', 'groupDescription': 'Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '38.9', 'ciLowerLimit': '31.2', 'ciUpperLimit': '46.5', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '59.7', 'ciLowerLimit': '52.7', 'ciUpperLimit': '66.7', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '20.9', 'ciLowerLimit': '12.7', 'ciUpperLimit': '29.0', 'groupDescription': 'Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.9', 'ciLowerLimit': '26.6', 'ciUpperLimit': '41.2', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '55.3', 'ciLowerLimit': '48.2', 'ciUpperLimit': '62.3', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '21.7', 'ciLowerLimit': '13.2', 'ciUpperLimit': '30.2', 'groupDescription': 'Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.7', 'ciLowerLimit': '22.7', 'ciUpperLimit': '36.7', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '45.5', 'ciLowerLimit': '38.4', 'ciUpperLimit': '52.7', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '16.0', 'ciLowerLimit': '7.4', 'ciUpperLimit': '24.6', 'groupDescription': 'Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.9', 'ciLowerLimit': '13.0', 'ciUpperLimit': '26.8', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '40.5', 'ciLowerLimit': '32.8', 'ciUpperLimit': '48.1', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '20.9', 'ciLowerLimit': '11.8', 'ciUpperLimit': '30.0', 'groupDescription': 'Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', 'description': 'Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itch) to 10 (worst itch imaginable), where higher scores indicated worse disease status.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points."}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '265', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 200 mg OL to Placebo DB', 'description': 'Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB', 'description': 'Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG002', 'title': 'PF-04965842 200 mg OL to PF-04965842 200 mg DB', 'description': 'Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}], 'classes': [{'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '265', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-95.6', 'groupId': 'OG000', 'lowerLimit': '-100.0', 'upperLimit': '-88.5'}, {'value': '-96.7', 'groupId': 'OG001', 'lowerLimit': '-100.0', 'upperLimit': '-91.5'}, {'value': '-96.7', 'groupId': 'OG002', 'lowerLimit': '-100.0', 'upperLimit': '-89.2'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}, {'value': '256', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-68.5', 'groupId': 'OG000', 'lowerLimit': '-89.8', 'upperLimit': '-37.5'}, {'value': '-90.9', 'groupId': 'OG001', 'lowerLimit': '-97.6', 'upperLimit': '-78.3'}, {'value': '-96.3', 'groupId': 'OG002', 'lowerLimit': '-100.0', 'upperLimit': '-88.7'}]}]}, {'title': 'Change at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-85.2', 'groupId': 'OG000', 'lowerLimit': '-95.8', 'upperLimit': '-63.5'}, {'value': '-93.8', 'groupId': 'OG001', 'lowerLimit': '-99.5', 'upperLimit': '-81.4'}, {'value': '-96.4', 'groupId': 'OG002', 'lowerLimit': '-100.0', 'upperLimit': '-85.7'}]}]}, {'title': 'Change at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-91.2', 'groupId': 'OG000', 'lowerLimit': '-100.0', 'upperLimit': '-77.9'}, {'value': '-95.8', 'groupId': 'OG001', 'lowerLimit': '-100.0', 'upperLimit': '-83.5'}, {'value': '-96.8', 'groupId': 'OG002', 'lowerLimit': '-100.0', 'upperLimit': '-88.8'}]}]}, {'title': 'Change at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '185', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-91.5', 'groupId': 'OG000', 'lowerLimit': '-100.0', 'upperLimit': '-77.9'}, {'value': '-96.9', 'groupId': 'OG001', 'lowerLimit': '-100.0', 'upperLimit': '-83.4'}, {'value': '-96.9', 'groupId': 'OG002', 'lowerLimit': '-100.0', 'upperLimit': '-88.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', 'description': "4 body regions evaluated: head and neck, upper limbs, trunk (including axillae, groin/genitals), lower limbs (including buttocks) excluding scalp, palms, soles. BSA calculated by handprint method. Number (No) of handprints (size of participant's hand with fingers in closed position) fitting in affected area of a body region was estimated. Maximum No of handprints were 10, 20, 30, 40 for head and neck, upper limbs, trunk, and lower limbs respectively. Surface area (SA) of body region equivalent to 1 handprint: 1 handprint=10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. %Change BSA for a body region was calculated as=total No of handprints in a body region\\* %SA equivalent to 1 handprint. %BSA for an individual: arithmetic mean of %BSA of all 4 body regions, ranged from 0-100%, higher values=greater AD severity.", 'unitOfMeasure': 'percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': "FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points."}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '265', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 200 mg OL to Placebo DB', 'description': 'Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB', 'description': 'Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG002', 'title': 'PF-04965842 200 mg OL to PF-04965842 200 mg DB', 'description': 'Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}], 'classes': [{'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '265', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-84.0', 'groupId': 'OG000', 'lowerLimit': '-94.7', 'upperLimit': '-73.5'}, {'value': '-84.4', 'groupId': 'OG001', 'lowerLimit': '-95.2', 'upperLimit': '-74.9'}, {'value': '-84.4', 'groupId': 'OG002', 'lowerLimit': '-93.8', 'upperLimit': '-74.2'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '256', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-50.4', 'groupId': 'OG000', 'lowerLimit': '-68.3', 'upperLimit': '-32.1'}, {'value': '-71.7', 'groupId': 'OG001', 'lowerLimit': '-87.8', 'upperLimit': '-60.5'}, {'value': '-83.6', 'groupId': 'OG002', 'lowerLimit': '-95.1', 'upperLimit': '-70.6'}]}]}, {'title': 'Change at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-63.4', 'groupId': 'OG000', 'lowerLimit': '-81.9', 'upperLimit': '-48.3'}, {'value': '-77.8', 'groupId': 'OG001', 'lowerLimit': '-90.2', 'upperLimit': '-62.6'}, {'value': '-83.8', 'groupId': 'OG002', 'lowerLimit': '-97.4', 'upperLimit': '-66.4'}]}]}, {'title': 'Change at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '196', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-74.4', 'groupId': 'OG000', 'lowerLimit': '-89.5', 'upperLimit': '-60.6'}, {'value': '-77.1', 'groupId': 'OG001', 'lowerLimit': '-94.1', 'upperLimit': '-64.3'}, {'value': '-84.6', 'groupId': 'OG002', 'lowerLimit': '-98.6', 'upperLimit': '-68.4'}]}]}, {'title': 'Change at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-73.3', 'groupId': 'OG000', 'lowerLimit': '-89.8', 'upperLimit': '-58.0'}, {'value': '-82.5', 'groupId': 'OG001', 'lowerLimit': '-97.7', 'upperLimit': '-64.1'}, {'value': '-83.2', 'groupId': 'OG002', 'lowerLimit': '-100.0', 'upperLimit': '-69.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', 'description': "SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3); severity scores added to give B (0-18). C: pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7\\*B/2+C; range (0-103); higher values=worse outcome.", 'unitOfMeasure': 'percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': "FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '261', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 200 mg OL to Placebo DB', 'description': 'Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB', 'description': 'Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG002', 'title': 'PF-04965842 200 mg OL to PF-04965842 200 mg DB', 'description': 'Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}], 'classes': [{'title': 'Pruritus VAS: Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '261', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.1', 'groupId': 'OG000', 'lowerLimit': '-6.3', 'upperLimit': '-5.9'}, {'value': '-6.1', 'groupId': 'OG001', 'lowerLimit': '-6.3', 'upperLimit': '-5.9'}, {'value': '-6.1', 'groupId': 'OG002', 'lowerLimit': '-6.3', 'upperLimit': '-5.9'}]}]}, {'title': 'Pruritus VAS: Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '261', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '3.7'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.5'}, {'value': '0.2', 'groupId': 'OG002', 'lowerLimit': '-0.1', 'upperLimit': '0.4'}]}]}, {'title': 'Pruritus VAS: Change at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '261', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '2.9'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '1.4'}, {'value': '0.5', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '0.8'}]}]}, {'title': 'Pruritus VAS: Change at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '261', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '2.8'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '1.6'}, {'value': '0.4', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '0.7'}]}]}, {'title': 'Pruritus VAS: Change at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '261', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '2.4'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '1.6'}, {'value': '0.5', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '0.8'}]}]}, {'title': 'Sleep Loss VAS: Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-5.0', 'groupId': 'OG000', 'lowerLimit': '-5.2', 'upperLimit': '-4.8'}, {'value': '-5.0', 'groupId': 'OG001', 'lowerLimit': '-5.2', 'upperLimit': '-4.8'}, {'value': '-5.1', 'groupId': 'OG002', 'lowerLimit': '-5.3', 'upperLimit': '-4.9'}]}]}, {'title': 'Sleep Loss VAS: Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '2.6'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '0.8'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-0.2', 'upperLimit': '0.2'}]}]}, {'title': 'Sleep Loss VAS: Change at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '1.7'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '0.9'}, {'value': '0.2', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '0.4'}]}]}, {'title': 'Sleep Loss VAS: Change at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '1.8'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '0.9'}, {'value': '0.2', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '0.4'}]}]}, {'title': 'Sleep Loss VAS: Change at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '1.8'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '1.2'}, {'value': '0.3', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '0.5'}]}]}], 'analyses': [{'pValue': '= 0.9207', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.3', 'groupDescription': 'Pruritus VAS: Week 12: The least squares mean (LSM) differences between treatment groups were derived from the statistical model. Mixed model repeated measure (MMRM) contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.9998', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.3', 'groupDescription': 'Pruritus VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.3', 'groupDescription': 'Pruritus VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.1', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '-1.7', 'groupDescription': 'Pruritus VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.2', 'ciLowerLimit': '-3.6', 'ciUpperLimit': '-2.8', 'groupDescription': 'Pruritus VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '-0.7', 'groupDescription': 'Pruritus VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '-0.8', 'groupDescription': 'Pruritus VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '-1.3', 'groupDescription': 'Pruritus VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '-0.1', 'groupDescription': 'Pruritus VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0039', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '-0.3', 'groupDescription': 'Pruritus VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '-1.2', 'groupDescription': 'Pruritus VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '-0.4', 'groupDescription': 'Pruritus VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.1488', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '0.2', 'groupDescription': 'Pruritus VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '-0.6', 'groupDescription': 'Pruritus VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.3', 'groupDescription': 'Pruritus VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.9294', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.2', 'groupDescription': 'Sleep Loss VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.4081', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.1', 'groupDescription': 'Sleep Loss VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.1', 'groupDescription': 'Sleep Loss VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '-1.4', 'groupDescription': 'Sleep Loss VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.3', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '-2.0', 'groupDescription': 'Sleep Loss VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '-0.2', 'groupDescription': 'Sleep Loss VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0035', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.2', 'groupDescription': 'Sleep Loss VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '-0.7', 'groupDescription': 'Sleep Loss VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '-0.1', 'groupDescription': 'Sleep Loss VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0136', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.1', 'groupDescription': 'Sleep Loss VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '-0.6', 'groupDescription': 'Sleep Loss VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.0', 'groupDescription': 'Sleep Loss VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.2887', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.3', 'groupDescription': 'Sleep Loss VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0025', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '-0.3', 'groupDescription': 'Sleep Loss VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '-0.2', 'groupDescription': 'Sleep Loss VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', 'description': "SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region-head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7\\*B/2+C; range (0-103); higher values=worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '266', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 200 mg OL to Placebo DB', 'description': 'Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB', 'description': 'Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG002', 'title': 'PF-04965842 200 mg OL to PF-04965842 200 mg DB', 'description': 'Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '265', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '97.4', 'groupId': 'OG000', 'lowerLimit': '95.4', 'upperLimit': '99.3'}, {'value': '98.5', 'groupId': 'OG001', 'lowerLimit': '97.0', 'upperLimit': '100.0'}, {'value': '97.0', 'groupId': 'OG002', 'lowerLimit': '94.9', 'upperLimit': '99.0'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '266', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25.6', 'groupId': 'OG000', 'lowerLimit': '20.3', 'upperLimit': '30.8'}, {'value': '72.0', 'groupId': 'OG001', 'lowerLimit': '66.6', 'upperLimit': '77.4'}, {'value': '89.1', 'groupId': 'OG002', 'lowerLimit': '85.4', 'upperLimit': '92.8'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '263', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000', 'lowerLimit': '11.4', 'upperLimit': '20.2'}, {'value': '56.8', 'groupId': 'OG001', 'lowerLimit': '50.7', 'upperLimit': '62.8'}, {'value': '75.7', 'groupId': 'OG002', 'lowerLimit': '70.5', 'upperLimit': '80.9'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000', 'lowerLimit': '10.2', 'upperLimit': '18.6'}, {'value': '51.2', 'groupId': 'OG001', 'lowerLimit': '45.1', 'upperLimit': '57.2'}, {'value': '69.0', 'groupId': 'OG002', 'lowerLimit': '63.3', 'upperLimit': '74.6'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000', 'lowerLimit': '10.5', 'upperLimit': '19.1'}, {'value': '44.6', 'groupId': 'OG001', 'lowerLimit': '38.5', 'upperLimit': '50.6'}, {'value': '65.8', 'groupId': 'OG002', 'lowerLimit': '60.0', 'upperLimit': '71.6'}]}]}], 'analyses': [{'pValue': '= 0.4244', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '3.4', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.8092', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '2.4', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '-1.5', 'ciLowerLimit': '-4.1', 'ciUpperLimit': '1.0', 'groupDescription': 'Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '46.7', 'ciLowerLimit': '39.2', 'ciUpperLimit': '54.2', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '63.6', 'ciLowerLimit': '57.2', 'ciUpperLimit': '70.0', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '17.0', 'ciLowerLimit': '10.4', 'ciUpperLimit': '23.5', 'groupDescription': 'Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '41.3', 'ciLowerLimit': '33.9', 'ciUpperLimit': '48.7', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '59.9', 'ciLowerLimit': '53.1', 'ciUpperLimit': '66.7', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '18.7', 'ciLowerLimit': '10.8', 'ciUpperLimit': '26.6', 'groupDescription': 'Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '37.0', 'ciLowerLimit': '29.6', 'ciUpperLimit': '44.4', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '54.6', 'ciLowerLimit': '47.6', 'ciUpperLimit': '61.7', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '17.7', 'ciLowerLimit': '9.4', 'ciUpperLimit': '26.0', 'groupDescription': 'Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.0', 'ciLowerLimit': '22.6', 'ciUpperLimit': '37.4', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '50.9', 'ciLowerLimit': '43.8', 'ciUpperLimit': '58.1', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '21.1', 'ciLowerLimit': '12.8', 'ciUpperLimit': '29.5', 'groupDescription': 'Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', 'description': "SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7\\*B/2+C; range (0-103); higher values=worse outcome.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With >=75% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '266', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 200 mg OL to Placebo DB', 'description': 'Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB', 'description': 'Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG002', 'title': 'PF-04965842 200 mg OL to PF-04965842 200 mg DB', 'description': 'Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '265', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '73.6', 'groupId': 'OG000', 'lowerLimit': '68.3', 'upperLimit': '78.9'}, {'value': '75.0', 'groupId': 'OG001', 'lowerLimit': '69.8', 'upperLimit': '80.2'}, {'value': '71.3', 'groupId': 'OG002', 'lowerLimit': '65.9', 'upperLimit': '76.8'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '266', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '12.9'}, {'value': '38.3', 'groupId': 'OG001', 'lowerLimit': '32.4', 'upperLimit': '44.1'}, {'value': '67.3', 'groupId': 'OG002', 'lowerLimit': '61.7', 'upperLimit': '72.9'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '263', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '10.7'}, {'value': '37.8', 'groupId': 'OG001', 'lowerLimit': '31.9', 'upperLimit': '43.7'}, {'value': '56.3', 'groupId': 'OG002', 'lowerLimit': '50.3', 'upperLimit': '62.3'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '11.7'}, {'value': '32.7', 'groupId': 'OG001', 'lowerLimit': '27.0', 'upperLimit': '38.4'}, {'value': '47.7', 'groupId': 'OG002', 'lowerLimit': '41.6', 'upperLimit': '53.8'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000', 'lowerLimit': '4.4', 'upperLimit': '10.8'}, {'value': '31.8', 'groupId': 'OG001', 'lowerLimit': '26.1', 'upperLimit': '37.5'}, {'value': '45.9', 'groupId': 'OG002', 'lowerLimit': '39.8', 'upperLimit': '52.0'}]}]}], 'analyses': [{'pValue': '= 0.7232', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-6.1', 'ciUpperLimit': '8.8', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.5694', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.2', 'ciLowerLimit': '-9.8', 'ciUpperLimit': '5.4', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '-3.7', 'ciLowerLimit': '-11.2', 'ciUpperLimit': '3.8', 'groupDescription': 'Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.0', 'ciLowerLimit': '22.2', 'ciUpperLimit': '35.8', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '57.9', 'ciLowerLimit': '51.2', 'ciUpperLimit': '64.5', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '28.9', 'ciLowerLimit': '20.8', 'ciUpperLimit': '37.0', 'groupDescription': 'Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.5', 'ciLowerLimit': '23.9', 'ciUpperLimit': '37.2', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '48.9', 'ciLowerLimit': '42.1', 'ciUpperLimit': '55.6', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '18.2', 'ciLowerLimit': '9.8', 'ciUpperLimit': '26.6', 'groupDescription': 'Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.0', 'ciLowerLimit': '18.4', 'ciUpperLimit': '31.5', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '39.6', 'ciLowerLimit': '32.7', 'ciUpperLimit': '46.5', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '14.5', 'ciLowerLimit': '6.3', 'ciUpperLimit': '22.8', 'groupDescription': 'Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.7', 'ciLowerLimit': '18.1', 'ciUpperLimit': '31.2', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '38.5', 'ciLowerLimit': '31.6', 'ciUpperLimit': '45.3', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '13.9', 'ciLowerLimit': '5.6', 'ciUpperLimit': '22.3', 'groupDescription': 'Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', 'description': "SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7\\*B/2+C; range (0-103); higher values=worse outcome.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 200 mg Rescue Period', 'description': 'Participants who met the protocol defined flare criteria in DB period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during open-label Rescue Period for up to 12 weeks. After completing the 12-week rescue period, participants had the choice to enter the LTE study B7451015 (NCT03422822), if eligible. Participants who discontinued early from treatment, or who were otherwise ineligible for the LTE study, were followed-up for 4 week in this study.'}], 'classes': [{'title': 'Rescue Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.7', 'groupId': 'OG000', 'lowerLimit': '25.8', 'upperLimit': '35.7'}]}]}, {'title': 'Rescue Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54.6', 'groupId': 'OG000', 'lowerLimit': '49.3', 'upperLimit': '59.9'}]}]}, {'title': 'Rescue Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60.2', 'groupId': 'OG000', 'lowerLimit': '55.0', 'upperLimit': '65.4'}]}]}, {'title': 'Rescue Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64.1', 'groupId': 'OG000', 'lowerLimit': '59.0', 'upperLimit': '69.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12', 'description': 'IGA assessed severity of AD on a 5-point scale (0-4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0=clear, AD is cleared; 1 = almost clear, AD not entirely cleared, light pink residual lesions; 2 = mild, AD with light red lesions; 3 = moderate, AD with red lesions; 4 = severe, AD with deep, dark red lesions.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set-rescue (FAS-RE) included all participants who met the protocol definition of a flare during the DB phase and received at least 1 dose of rescue treatment. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified time points."}, {'type': 'SECONDARY', 'title': 'Percent Change From Rescue Baseline in Total Eczema Area and Severity Index (EASI) Score at Rescue Weeks 2, 4, 8 and 12: Rescue Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 200 mg Rescue Period', 'description': 'Participants who met the protocol defined flare criteria in DB period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during open-label Rescue Period for up to 12 weeks. After completing the 12-week rescue period, participants had the choice to enter the LTE study B7451015 (NCT03422822), if eligible. Participants who discontinued early from treatment, or who were otherwise ineligible for the LTE study, were followed-up for 4 week in this study.'}], 'classes': [{'title': 'Change at Rescue Week 2', 'categories': [{'measurements': [{'value': '-71.1', 'spread': '-73.7', 'groupId': 'OG000', 'lowerLimit': '-73.7', 'upperLimit': '-68.5'}]}]}, {'title': 'Change at Rescue Week 4', 'categories': [{'measurements': [{'value': '-82.0', 'spread': '-84.2', 'groupId': 'OG000', 'lowerLimit': '-84.2', 'upperLimit': '-79.7'}]}]}, {'title': 'Change at Rescue Week 8', 'categories': [{'measurements': [{'value': '-86.4', 'spread': '-88.2', 'groupId': 'OG000', 'lowerLimit': '-88.2', 'upperLimit': '-84.6'}]}]}, {'title': 'Change at Rescue Week 12', 'categories': [{'measurements': [{'value': '-87.3', 'spread': '-89.4', 'groupId': 'OG000', 'lowerLimit': '-89.4', 'upperLimit': '-85.3'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12', 'description': "EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of 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). Total EASI score ranged from 0.0 to 72.0, higher scores=greater severity of AD.", 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS-RE included all participants who met the protocol definition of a flare during the DB phase and received at least 1 dose of rescue treatment. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Greater Than or Equal to 4 Points Improvement From Rescue Baseline in Peak Pruritus Numeric Rating Scale (PP-NRS) at Rescue Weeks 2, 4, 8 and 12: Rescue Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 200 mg Rescue Period', 'description': 'Participants who met the protocol defined flare criteria in DB period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during open-label Rescue Period for up to 12 weeks. After completing the 12-week rescue period, participants had the choice to enter the LTE study B7451015 (NCT03422822), if eligible. Participants who discontinued early from treatment, or who were otherwise ineligible for the LTE study, were followed-up for 4 week in this study.'}], 'classes': [{'title': 'Rescue Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '56.6', 'groupId': 'OG000', 'lowerLimit': '50.7', 'upperLimit': '62.5'}]}]}, {'title': 'Rescue Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '63.2', 'groupId': 'OG000', 'lowerLimit': '57.2', 'upperLimit': '69.2'}]}]}, {'title': 'Rescue Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67.2', 'groupId': 'OG000', 'lowerLimit': '61.4', 'upperLimit': '73.0'}]}]}, {'title': 'Rescue Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '56.2', 'groupId': 'OG000', 'lowerLimit': '48.3', 'upperLimit': '64.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12', 'description': 'Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itch) to 10 (worst itch imaginable), where higher scores indicated greater severity.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS-RE included all participants who met the protocol definition of a flare during the DB phase and received at least 1 dose of rescue treatment. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified time points."}, {'type': 'SECONDARY', 'title': 'Percent Change From Rescue Baseline in Percent Body Surface Area (BSA) at Rescue Weeks 2, 4, 8 and 12: Rescue Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 200 mg Rescue Period', 'description': 'Participants who met the protocol defined flare criteria in DB period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during open-label Rescue Period for up to 12 weeks. After completing the 12-week rescue period, participants had the choice to enter the LTE study B7451015 (NCT03422822), if eligible. Participants who discontinued early from treatment, or who were otherwise ineligible for the LTE study, were followed-up for 4 week in this study.'}], 'classes': [{'title': 'Change at Rescue Week 2', 'categories': [{'measurements': [{'value': '-62.8', 'groupId': 'OG000', 'lowerLimit': '-66.0', 'upperLimit': '-59.6'}]}]}, {'title': 'Change at Rescue Week 4', 'categories': [{'measurements': [{'value': '-76.4', 'groupId': 'OG000', 'lowerLimit': '-79.1', 'upperLimit': '-73.7'}]}]}, {'title': 'Change at Rescue Week 8', 'categories': [{'measurements': [{'value': '-82.1', 'groupId': 'OG000', 'lowerLimit': '-84.5', 'upperLimit': '-79.6'}]}]}, {'title': 'Change at Rescue Week 12', 'categories': [{'measurements': [{'value': '-83.3', 'groupId': 'OG000', 'lowerLimit': '-86.0', 'upperLimit': '-80.5'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12', 'description': "4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin/genitals) 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 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. Overall % BSA for an individual % BSA of all 4 body regions, ranged from 0 to 100%, with higher values representing greater severity of AD.", 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS-RE included all participants who met the protocol definition of a flare during the DB phase and received at least 1 dose of rescue treatment. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percent Change From Rescue Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Score of Itch and Sleep Loss at Rescue Weeks 2, 4, 8 and 12: Rescue Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 200 mg Rescue Period', 'description': 'Participants who met the protocol defined flare criteria in DB period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during open-label Rescue Period for up to 12 weeks. After completing the 12-week rescue period, participants had the choice to enter the LTE study B7451015 (NCT03422822), if eligible. Participants who discontinued early from treatment, or who were otherwise ineligible for the LTE study, were followed-up for 4 week in this study.'}], 'classes': [{'title': 'Pruritus VAS: Change at Rescue Week 2', 'categories': [{'measurements': [{'value': '-57.3', 'spread': '-61.7', 'groupId': 'OG000', 'lowerLimit': '-61.7', 'upperLimit': '-52.9'}]}]}, {'title': 'Pruritus VAS: Change at Rescue Week 4', 'categories': [{'measurements': [{'value': '-67.5', 'spread': '-71.3', 'groupId': 'OG000', 'lowerLimit': '-71.3', 'upperLimit': '-63.7'}]}]}, {'title': 'Pruritus VAS: Change at Rescue Week 8', 'categories': [{'measurements': [{'value': '-68.6', 'spread': '-73.6', 'groupId': 'OG000', 'lowerLimit': '-73.6', 'upperLimit': '-63.7'}]}]}, {'title': 'Pruritus VAS: Change at Rescue Week 12', 'categories': [{'measurements': [{'value': '-67.3', 'spread': '-72.8', 'groupId': 'OG000', 'lowerLimit': '-72.8', 'upperLimit': '-61.8'}]}]}, {'title': 'Sleep Loss VAS: Change at Rescue Week 2', 'categories': [{'measurements': [{'value': '-62.5', 'spread': '-69.1', 'groupId': 'OG000', 'lowerLimit': '-69.1', 'upperLimit': '-55.9'}]}]}, {'title': 'Sleep Loss VAS: Change at Rescue Week 4', 'categories': [{'measurements': [{'value': '-72.4', 'spread': '-78.6', 'groupId': 'OG000', 'lowerLimit': '-78.6', 'upperLimit': '-66.3'}]}]}, {'title': 'Sleep Loss VAS: Change at Rescue Week 8', 'categories': [{'measurements': [{'value': '-75.8', 'spread': '-82.0', 'groupId': 'OG000', 'lowerLimit': '-82.0', 'upperLimit': '-69.5'}]}]}, {'title': 'Sleep Loss VAS: Change at Rescue Week 12', 'categories': [{'measurements': [{'value': '-74.5', 'spread': '-81.4', 'groupId': 'OG000', 'lowerLimit': '-81.4', 'upperLimit': '-67.5'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12', 'description': "SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7\\*B/2+C; range (0-103); higher values=worse outcome.", 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS-RE included all participants who met the protocol definition of a flare during the DB phase and received at least 1 dose of rescue treatment.. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With 50% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 200 mg Rescue Period', 'description': 'Participants who met the protocol defined flare criteria in DB period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during open-label Rescue Period for up to 12 weeks. After completing the 12-week rescue period, participants had the choice to enter the LTE study B7451015 (NCT03422822), if eligible. Participants who discontinued early from treatment, or who were otherwise ineligible for the LTE study, were followed-up for 4 week in this study.'}], 'classes': [{'title': 'Rescue Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55.0', 'groupId': 'OG000', 'lowerLimit': '49.6', 'upperLimit': '60.3'}]}]}, {'title': 'Rescue Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '76.1', 'groupId': 'OG000', 'lowerLimit': '71.6', 'upperLimit': '80.6'}]}]}, {'title': 'Rescue Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.6', 'groupId': 'OG000', 'lowerLimit': '75.3', 'upperLimit': '83.9'}]}]}, {'title': 'Rescue Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.8', 'groupId': 'OG000', 'lowerLimit': '75.5', 'upperLimit': '84.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12', 'description': "SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7\\*B/2+C; range (0-103); higher values=worse outcome.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS-RE included all participants who met the protocol definition of a flare during the DB phase and received at least 1 dose of rescue treatment. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified time points."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With 75% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 200 mg Rescue Period', 'description': 'Participants who met the protocol defined flare criteria in DB period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during open-label Rescue Period for up to 12 weeks. After completing the 12-week rescue period, participants had the choice to enter the LTE study B7451015 (NCT03422822), if eligible. Participants who discontinued early from treatment, or who were otherwise ineligible for the LTE study, were followed-up for 4 week in this study.'}], 'classes': [{'title': 'Rescue Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000', 'lowerLimit': '12.9', 'upperLimit': '21.0'}]}]}, {'title': 'Rescue Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.9', 'groupId': 'OG000', 'lowerLimit': '28.9', 'upperLimit': '39.0'}]}]}, {'title': 'Rescue Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000', 'lowerLimit': '39.1', 'upperLimit': '49.7'}]}]}, {'title': 'Rescue Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45.4', 'groupId': 'OG000', 'lowerLimit': '40.1', 'upperLimit': '50.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12', 'description': "SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7\\*B/2+C; range (0-103); higher values=worse outcome.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS-RE included all participants who met the protocol definition of a flare during the DB phase and received at least 1 dose of rescue treatment. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified time points."}, {'type': 'SECONDARY', 'title': "Percentage of Participants Achieving Patient Global Assessment (PtGA) Response of 'Clear (0)' or 'Almost Clear (1)' and Greater Than or Equal to 2 Points Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period", 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}, {'value': '259', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 200 mg OL to Placebo DB', 'description': 'Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB', 'description': 'Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG002', 'title': 'PF-04965842 200 mg OL to PF-04965842 200 mg DB', 'description': 'Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '61.7', 'groupId': 'OG000', 'lowerLimit': '55.7', 'upperLimit': '67.7'}, {'value': '64.5', 'groupId': 'OG001', 'lowerLimit': '58.7', 'upperLimit': '70.3'}, {'value': '59.7', 'groupId': 'OG002', 'lowerLimit': '53.7', 'upperLimit': '65.7'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}, {'value': '259', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '8.8'}, {'value': '29.8', 'groupId': 'OG001', 'lowerLimit': '24.2', 'upperLimit': '35.3'}, {'value': '48.3', 'groupId': 'OG002', 'lowerLimit': '42.2', 'upperLimit': '54.3'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '256', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '9.3'}, {'value': '30.9', 'groupId': 'OG001', 'lowerLimit': '25.3', 'upperLimit': '36.5'}, {'value': '46.9', 'groupId': 'OG002', 'lowerLimit': '40.8', 'upperLimit': '53.0'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}, {'value': '250', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '10.8'}, {'value': '26.1', 'groupId': 'OG001', 'lowerLimit': '20.7', 'upperLimit': '31.4'}, {'value': '42.0', 'groupId': 'OG002', 'lowerLimit': '35.9', 'upperLimit': '48.1'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}, {'value': '247', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '10.8'}, {'value': '25.8', 'groupId': 'OG001', 'lowerLimit': '20.4', 'upperLimit': '31.1'}, {'value': '39.7', 'groupId': 'OG002', 'lowerLimit': '33.6', 'upperLimit': '45.8'}]}]}], 'analyses': [{'pValue': '= 0.4815', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.0', 'ciLowerLimit': '-5.3', 'ciUpperLimit': '11.3', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.6748', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-10.3', 'ciUpperLimit': '6.6', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '-5.1', 'ciLowerLimit': '-13.4', 'ciUpperLimit': '3.2', 'groupDescription': 'Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.0', 'ciLowerLimit': '17.8', 'ciUpperLimit': '30.3', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '42.3', 'ciLowerLimit': '35.6', 'ciUpperLimit': '49.0', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '18.4', 'ciLowerLimit': '10.2', 'ciUpperLimit': '26.6', 'groupDescription': 'Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.6', 'ciLowerLimit': '18.2', 'ciUpperLimit': '31.0', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '40.5', 'ciLowerLimit': '33.7', 'ciUpperLimit': '47.3', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '15.9', 'ciLowerLimit': '7.6', 'ciUpperLimit': '24.1', 'groupDescription': 'Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.8', 'ciLowerLimit': '12.6', 'ciUpperLimit': '25.1', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '34.5', 'ciLowerLimit': '27.6', 'ciUpperLimit': '41.5', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '15.6', 'ciLowerLimit': '7.5', 'ciUpperLimit': '23.7', 'groupDescription': 'Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.7', 'ciLowerLimit': '12.4', 'ciUpperLimit': '25.0', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '32.3', 'ciLowerLimit': '25.4', 'ciUpperLimit': '39.2', 'pValueComment': 'P-value was adjusted by disease severity at baseline and randomization strata.', 'groupDescription': 'Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline 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': '13.7', 'ciLowerLimit': '5.6', 'ciUpperLimit': '21.7', 'groupDescription': 'Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', 'description': 'Participant responded to the following question: "Overall, how would you describe your Atopic Dermatitis right now?" on a 5-point scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 200 mg OL to Placebo DB', 'description': 'Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB', 'description': 'Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG002', 'title': 'PF-04965842 200 mg OL to PF-04965842 200 mg DB', 'description': 'Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}], 'classes': [{'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-13.5', 'spread': '-13.9', 'groupId': 'OG000', 'lowerLimit': '-13.9', 'upperLimit': '-13.0'}, {'value': '-13.4', 'spread': '-13.8', 'groupId': 'OG001', 'lowerLimit': '-13.8', 'upperLimit': '-12.9'}, {'value': '-13.5', 'spread': '-14.0', 'groupId': 'OG002', 'lowerLimit': '-14.0', 'upperLimit': '-13.1'}]}]}, {'title': 'Change at Week 16', 'categories': [{'measurements': [{'value': '6.9', 'spread': '6.1', 'groupId': 'OG000', 'lowerLimit': '6.1', 'upperLimit': '7.8'}, {'value': '1.9', 'spread': '1.2', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '2.5'}, {'value': '0.4', 'spread': '-0.2', 'groupId': 'OG002', 'lowerLimit': '-0.2', 'upperLimit': '1.0'}]}]}, {'title': 'Change at Week 28', 'categories': [{'measurements': [{'value': '6.1', 'spread': '5.0', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '7.1'}, {'value': '2.1', 'spread': '1.4', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '2.7'}, {'value': '0.9', 'spread': '0.3', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '1.5'}]}]}, {'title': 'Change at Week 40', 'categories': [{'measurements': [{'value': '4.4', 'spread': '3.0', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '5.7'}, {'value': '2.5', 'spread': '1.7', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '3.2'}, {'value': '1.1', 'spread': '0.5', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '1.8'}]}]}, {'title': 'Change at Week 52', 'categories': [{'measurements': [{'value': '3.6', 'spread': '2.1', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '5.0'}, {'value': '2.8', 'spread': '2.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '3.6'}, {'value': '0.9', 'spread': '0.2', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '1.6'}]}]}], 'analyses': [{'pValue': '= 0.7373', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.7', 'groupDescription': 'Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.8092', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.5', 'groupDescription': 'Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.4', 'groupDescription': 'Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.1', 'ciLowerLimit': '-6.1', 'ciUpperLimit': '-4.0', 'groupDescription': 'Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.6', 'ciLowerLimit': '-7.6', 'ciUpperLimit': '-5.5', 'groupDescription': 'Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '-0.6', 'groupDescription': 'Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.0', 'ciLowerLimit': '-5.3', 'ciUpperLimit': '-2.7', 'groupDescription': 'Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.2', 'ciLowerLimit': '-6.4', 'ciUpperLimit': '-3.9', 'groupDescription': 'Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '-0.3', 'groupDescription': 'Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0150', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-3.5', 'ciUpperLimit': '-0.4', 'groupDescription': 'Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.2', 'ciLowerLimit': '-4.7', 'ciUpperLimit': '-1.7', 'groupDescription': 'Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '-0.3', 'groupDescription': 'Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.3616', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '0.9', 'groupDescription': 'Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0012', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.7', 'ciLowerLimit': '-4.3', 'ciUpperLimit': '-1.1', 'groupDescription': 'Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-3.0', 'ciUpperLimit': '-0.8', 'groupDescription': 'Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', 'description': 'DLQI was a 10-item questionnaire that measures the impact of skin disease. Each question was evaluated on a 4-point scale (range 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were 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': "FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for adults, aged 18 years and above."}, {'type': 'SECONDARY', 'title': "Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score for Adolescents at Weeks 12, 16, 28, 40 and 52: Double-blind Period", 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 200 mg OL to Placebo DB', 'description': 'Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB', 'description': 'Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG002', 'title': 'PF-04965842 200 mg OL to PF-04965842 200 mg DB', 'description': 'Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}], 'classes': [{'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-9.8', 'spread': '-10.6', 'groupId': 'OG000', 'lowerLimit': '-10.6', 'upperLimit': '-8.9'}, {'value': '-9.2', 'spread': '-10.0', 'groupId': 'OG001', 'lowerLimit': '-10.0', 'upperLimit': '-8.3'}, {'value': '-9.3', 'spread': '-10.2', 'groupId': 'OG002', 'lowerLimit': '-10.2', 'upperLimit': '-8.5'}]}]}, {'title': 'Change at Week 16', 'categories': [{'measurements': [{'value': '5.9', 'spread': '4.4', 'groupId': 'OG000', 'lowerLimit': '4.4', 'upperLimit': '7.5'}, {'value': '1.7', 'spread': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '2.9'}, {'value': '-0.3', 'spread': '-1.4', 'groupId': 'OG002', 'lowerLimit': '-1.4', 'upperLimit': '0.8'}]}]}, {'title': 'Change at Week 28', 'categories': [{'measurements': [{'value': '1.5', 'spread': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '3.2'}, {'value': '1.6', 'spread': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '2.6'}, {'value': '0.4', 'spread': '-0.5', 'groupId': 'OG002', 'lowerLimit': '-0.5', 'upperLimit': '1.3'}]}]}, {'title': 'Change at Week 40', 'categories': [{'measurements': [{'value': '2.1', 'spread': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '3.8'}, {'value': '1.7', 'spread': '0.7', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '2.7'}, {'value': '0.0', 'spread': '-0.9', 'groupId': 'OG002', 'lowerLimit': '-0.9', 'upperLimit': '0.9'}]}]}, {'title': 'Change at Week 52', 'categories': [{'measurements': [{'value': '2.3', 'spread': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '4.4'}, {'value': '1.3', 'spread': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.6'}, {'value': '0.4', 'spread': '-0.6', 'groupId': 'OG002', 'lowerLimit': '-0.6', 'upperLimit': '1.4'}]}]}], 'analyses': [{'pValue': '= 0.3339', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '1.8', 'groupDescription': 'Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.4653', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '1.7', 'groupDescription': 'Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '1.1', 'groupDescription': 'Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.3', 'ciLowerLimit': '-6.2', 'ciUpperLimit': '-2.3', 'groupDescription': 'Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.2', 'ciLowerLimit': '-8.2', 'ciUpperLimit': '-4.3', 'groupDescription': 'Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.0', 'ciLowerLimit': '-3.6', 'ciUpperLimit': '-0.3', 'groupDescription': 'Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.9083', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '2.1', 'groupDescription': 'Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.2439', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-3.0', 'ciUpperLimit': '0.8', 'groupDescription': 'Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-2.6', 'ciUpperLimit': '0.1', 'groupDescription': 'Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.7405', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '1.7', 'groupDescription': 'Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0410', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.1', 'ciLowerLimit': '-4.1', 'ciUpperLimit': '-0.1', 'groupDescription': 'Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '-0.4', 'groupDescription': 'Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.4026', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-3.5', 'ciUpperLimit': '1.4', 'groupDescription': 'Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0944', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-4.2', 'ciUpperLimit': '0.3', 'groupDescription': 'Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '0.7', 'groupDescription': 'Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', '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 (range 0 to 3) where, 0 = not at all , 1 = only a little, 2 = quite a lot, 3 = very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give CDLQI total score range 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': "FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for adolescents, aged 12-17 years."}, {'type': 'PRIMARY', 'title': 'Time to Loss of Response: Double-blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 200 mg OL to Placebo DB', 'description': 'Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB', 'description': 'Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG002', 'title': 'PF-04965842 200 mg OL to PF-04965842 200 mg DB', 'description': 'Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.0', 'groupId': 'OG000', 'lowerLimit': '28.0', 'upperLimit': '29.0'}, {'value': '323.0', 'groupId': 'OG001', 'lowerLimit': '282.0', 'upperLimit': '323.0'}, {'value': 'NA', 'comment': 'Median and 95% CI were not estimable as there were only few participant who had events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '0.211', 'ciUpperLimit': '0.341', 'pValueComment': 'A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate p-value.', 'groupDescription': 'A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% confidence interval (CI).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '0.070', 'ciUpperLimit': '0.136', 'pValueComment': 'A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.', 'groupDescription': 'A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.36', 'ciLowerLimit': '0.255', 'ciUpperLimit': '0.516', 'pValueComment': 'A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.', 'groupDescription': 'A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of first dose of randomized treatment until the last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) (maximum up to Week 40, visit window was extended +/- 45 Days due to COVID 19)', 'description': 'Time (in days) to loss of response based on achieving IGA \\>=2 was measured from date of first dose of randomized treatment until last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) and based on EASI, loss of at least 50% of EASI response at Week 12 and IGA score of 2 or higher. IGA assesses severity of AD on 5-point scale (0 to 4, higher scores=more severity), reflecting global consideration of erythema, induration and scaling with scores 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe. EASI quantifies severity of AD based on severity of lesion clinical signs and % of BSA affected. EASI composite score evaluates degree of erythema, induration/papulation, excoriation, and lichenification.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Missing event times were considered as right censored (CAR) on last date of randomized treatment. Here 'Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}, {'value': '264', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 200 mg OL to Placebo DB', 'description': 'Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB', 'description': 'Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG002', 'title': 'PF-04965842 200 mg OL to PF-04965842 200 mg DB', 'description': 'Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}], 'classes': [{'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-2.7', 'spread': '-3.0', 'groupId': 'OG000', 'lowerLimit': '-3.0', 'upperLimit': '-2.3'}, {'value': '-2.6', 'spread': '-2.9', 'groupId': 'OG001', 'lowerLimit': '-2.9', 'upperLimit': '-2.3'}, {'value': '-2.6', 'spread': '-2.9', 'groupId': 'OG002', 'lowerLimit': '-2.9', 'upperLimit': '-2.3'}]}]}, {'title': 'Change at Week 16', 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '1.8'}, {'value': '0.3', 'spread': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.6'}, {'value': '0.0', 'spread': '-0.3', 'groupId': 'OG002', 'lowerLimit': '-0.3', 'upperLimit': '0.3'}]}]}, {'title': 'Change at Week 28', 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '1.5'}, {'value': '0.4', 'spread': '0.1', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '0.7'}, {'value': '0.1', 'spread': '-0.2', 'groupId': 'OG002', 'lowerLimit': '-0.2', 'upperLimit': '0.4'}]}]}, {'title': 'Change at Week 40', 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '1.6'}, {'value': '0.4', 'spread': '0.1', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '0.8'}, {'value': '0.1', 'spread': '-0.3', 'groupId': 'OG002', 'lowerLimit': '-0.3', 'upperLimit': '0.4'}]}]}, {'title': 'Change at Week 52', 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '1.4'}, {'value': '0.4', 'spread': '0.1', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '0.8'}, {'value': '0.2', 'spread': '-0.1', 'groupId': 'OG002', 'lowerLimit': '-0.1', 'upperLimit': '0.5'}]}]}], 'analyses': [{'pValue': '= 0.7556', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.6', 'groupDescription': 'Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.7484', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.6', 'groupDescription': 'Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.5', 'groupDescription': 'Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '-0.6', 'groupDescription': 'Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '-0.9', 'groupDescription': 'Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.1', 'groupDescription': 'Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0242', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.1', 'groupDescription': 'Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0012', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '-0.4', 'groupDescription': 'Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.1', 'groupDescription': 'Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.1240', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '0.2', 'groupDescription': 'Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0107', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '-0.2', 'groupDescription': 'Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.1', 'groupDescription': 'Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.3139', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '0.3', 'groupDescription': 'Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0853', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '0.1', 'groupDescription': 'Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.2', 'groupDescription': 'Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', 'description': 'HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-Anxiety (HADS-A) scale and HADS-Depression (HADS-D) scale, 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-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': "FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}, {'value': '264', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 200 mg OL to Placebo DB', 'description': 'Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB', 'description': 'Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG002', 'title': 'PF-04965842 200 mg OL to PF-04965842 200 mg DB', 'description': 'Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}], 'classes': [{'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-2.0', 'spread': '-2.3', 'groupId': 'OG000', 'lowerLimit': '-2.3', 'upperLimit': '-1.7'}, {'value': '-1.6', 'spread': '-1.9', 'groupId': 'OG001', 'lowerLimit': '-1.9', 'upperLimit': '-1.3'}, {'value': '-1.7', 'spread': '-2.0', 'groupId': 'OG002', 'lowerLimit': '-2.0', 'upperLimit': '-1.4'}]}]}, {'title': 'Change at Week 16', 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '1.8'}, {'value': '0.0', 'spread': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '0.3'}, {'value': '0.0', 'spread': '-0.2', 'groupId': 'OG002', 'lowerLimit': '-0.2', 'upperLimit': '0.3'}]}]}, {'title': 'Change at Week 28', 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '1.1'}, {'value': '0.3', 'spread': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.5'}, {'value': '0.1', 'spread': '-0.2', 'groupId': 'OG002', 'lowerLimit': '-0.2', 'upperLimit': '0.4'}]}]}, {'title': 'Change at Week 40', 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '1.4'}, {'value': '-0.1', 'spread': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-0.4', 'upperLimit': '0.3'}, {'value': '0.2', 'spread': '-0.1', 'groupId': 'OG002', 'lowerLimit': '-0.1', 'upperLimit': '0.5'}]}]}, {'title': 'Change at Week 52', 'categories': [{'measurements': [{'value': '0.4', 'spread': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.9'}, {'value': '-0.1', 'spread': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-0.4', 'upperLimit': '0.2'}, {'value': '0.1', 'spread': '-0.2', 'groupId': 'OG002', 'lowerLimit': '-0.2', 'upperLimit': '0.3'}]}]}], 'analyses': [{'pValue': '= 0.0674', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.0', 'ciUpperLimit': '0.8', 'groupDescription': 'Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.1437', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.7', 'groupDescription': 'Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.3', 'groupDescription': 'Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '-0.9', 'groupDescription': 'Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '-0.9', 'groupDescription': 'Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.4', 'groupDescription': 'Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.1136', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.1', 'groupDescription': 'Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0276', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '-0.1', 'groupDescription': 'Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.2', 'groupDescription': 'Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0108', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '-0.2', 'groupDescription': 'Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0677', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '0.0', 'groupDescription': 'Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.7', 'groupDescription': 'Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.1320', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '0.1', 'groupDescription': 'Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.2975', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '0.3', 'groupDescription': 'Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.6', 'groupDescription': 'Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', 'description': 'HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, 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-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': "FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}, {'value': '263', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 200 mg OL to Placebo DB', 'description': 'Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB', 'description': 'Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG002', 'title': 'PF-04965842 200 mg OL to PF-04965842 200 mg DB', 'description': 'Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}], 'classes': [{'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-15.4', 'spread': '-16.0', 'groupId': 'OG000', 'lowerLimit': '-16.0', 'upperLimit': '-14.8'}, {'value': '-15.8', 'spread': '-16.4', 'groupId': 'OG001', 'lowerLimit': '-16.4', 'upperLimit': '-15.2'}, {'value': '-15.4', 'spread': '-16.0', 'groupId': 'OG002', 'lowerLimit': '-16.0', 'upperLimit': '-14.8'}]}]}, {'title': 'Change at Week 16', 'categories': [{'measurements': [{'value': '9.8', 'spread': '8.9', 'groupId': 'OG000', 'lowerLimit': '8.9', 'upperLimit': '10.7'}, {'value': '3.7', 'spread': '3.0', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '4.4'}, {'value': '0.6', 'spread': '-0.1', 'groupId': 'OG002', 'lowerLimit': '-0.1', 'upperLimit': '1.2'}]}]}, {'title': 'Change at Week 28', 'categories': [{'measurements': [{'value': '8.3', 'spread': '6.9', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '9.7'}, {'value': '3.7', 'spread': '2.8', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '4.6'}, {'value': '1.6', 'spread': '0.8', 'groupId': 'OG002', 'lowerLimit': '0.8', 'upperLimit': '2.4'}]}]}, {'title': 'Change at Week 40', 'categories': [{'measurements': [{'value': '7.4', 'spread': '5.8', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '9.1'}, {'value': '4.8', 'spread': '3.9', 'groupId': 'OG001', 'lowerLimit': '3.9', 'upperLimit': '5.8'}, {'value': '1.9', 'spread': '1.1', 'groupId': 'OG002', 'lowerLimit': '1.1', 'upperLimit': '2.8'}]}]}, {'title': 'Change at Week 52', 'categories': [{'measurements': [{'value': '7.3', 'spread': '5.4', 'groupId': 'OG000', 'lowerLimit': '5.4', 'upperLimit': '9.2'}, {'value': '4.9', 'spread': '3.8', 'groupId': 'OG001', 'lowerLimit': '3.8', 'upperLimit': '6.0'}, {'value': '2.2', 'spread': '1.3', 'groupId': 'OG002', 'lowerLimit': '1.3', 'upperLimit': '3.2'}]}]}], 'analyses': [{'pValue': '= 0.3531', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '0.4', 'groupDescription': 'Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.9282', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.9', 'groupDescription': 'Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '1.3', 'groupDescription': 'Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.1', 'ciLowerLimit': '-7.3', 'ciUpperLimit': '-5.0', 'groupDescription': 'Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.2', 'ciLowerLimit': '-10.3', 'ciUpperLimit': '-8.1', 'groupDescription': 'Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.1', 'ciLowerLimit': '-4.0', 'ciUpperLimit': '-2.1', 'groupDescription': 'Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.6', 'ciLowerLimit': '-6.2', 'ciUpperLimit': '-2.9', 'groupDescription': 'Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.7', 'ciLowerLimit': '-8.3', 'ciUpperLimit': '-5.1', 'groupDescription': 'Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.1', 'ciLowerLimit': '-3.3', 'ciUpperLimit': '-0.9', 'groupDescription': 'Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0082', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.6', 'ciLowerLimit': '-4.5', 'ciUpperLimit': '-0.7', 'groupDescription': 'Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.5', 'ciLowerLimit': '-7.4', 'ciUpperLimit': '-3.6', 'groupDescription': 'Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.9', 'ciLowerLimit': '-4.2', 'ciUpperLimit': '-1.6', 'groupDescription': 'Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0313', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.4', 'ciLowerLimit': '-4.5', 'ciUpperLimit': '-0.2', 'groupDescription': 'Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.1', 'ciLowerLimit': '-7.1', 'ciUpperLimit': '-3.0', 'groupDescription': 'Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.7', 'ciLowerLimit': '-4.1', 'ciUpperLimit': '-1.3', 'groupDescription': 'Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', 'description': 'POEM was 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 scored as following: no days = 0, 1-2 days = 1, 3-4 days = 2, 5-6 days = 3 and, every day = 4. The total POEM score ranges from 0 to 28, where higher score indicated greater severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '254', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04965842 200 mg OL to Placebo DB', 'description': 'Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG001', 'title': 'PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB', 'description': 'Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'OG002', 'title': 'PF-04965842 200 mg OL to PF-04965842 200 mg DB', 'description': 'Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}], 'classes': [{'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-4.1', 'spread': '-4.3', 'groupId': 'OG000', 'lowerLimit': '-4.3', 'upperLimit': '-3.9'}, {'value': '-4.2', 'spread': '-4.4', 'groupId': 'OG001', 'lowerLimit': '-4.4', 'upperLimit': '-4.0'}, {'value': '-4.2', 'spread': '-4.4', 'groupId': 'OG002', 'lowerLimit': '-4.4', 'upperLimit': '-4.0'}]}]}, {'title': 'Change at Week 16', 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.9', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '2.2'}, {'value': '0.8', 'spread': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '0.9'}, {'value': '0.1', 'spread': '-0.1', 'groupId': 'OG002', 'lowerLimit': '-0.1', 'upperLimit': '0.3'}]}]}, {'title': 'Change at Week 28', 'categories': [{'measurements': [{'value': '2.3', 'spread': '2.0', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '2.6'}, {'value': '1.0', 'spread': '0.8', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '1.2'}, {'value': '0.1', 'spread': '-0.1', 'groupId': 'OG002', 'lowerLimit': '-0.1', 'upperLimit': '0.3'}]}]}, {'title': 'Change at Week 40', 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.7', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '2.4'}, {'value': '1.0', 'spread': '0.8', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '1.3'}, {'value': '0.3', 'spread': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '0.5'}]}]}, {'title': 'Change at Week 52', 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.5', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '2.3'}, {'value': '1.2', 'spread': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '1.4'}, {'value': '0.2', 'spread': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '0.5'}]}]}], 'analyses': [{'pValue': '= 0.4832', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.2', 'groupDescription': 'Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.6553', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.2', 'groupDescription': 'Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.3', 'groupDescription': 'Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '-1.1', 'groupDescription': 'Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.0', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '-1.7', 'groupDescription': 'Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '-0.4', 'groupDescription': 'Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '-1.0', 'groupDescription': 'Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.2', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '-1.8', 'groupDescription': 'Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '-0.5', 'groupDescription': 'Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '-0.6', 'groupDescription': 'Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '-1.4', 'groupDescription': 'Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '-0.5', 'groupDescription': 'Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0020', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.3', 'groupDescription': 'Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '-1.2', 'groupDescription': 'Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '-0.6', 'groupDescription': 'Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', '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 \\[darker or lighter\\], bleeding from skin, seeping or oozing fluid from skin \\[other than blood\\], and skin swelling). Participants 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': "FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PF-04965842 200 mg OL', 'description': "Participants received 12 weeks induction treatment of 200 milligram (mg) oral tablets (each tablet of 100 mg) PF-04965842 once daily (QD) during an OL run-in period. Responders at the end of the 12-week OL run-in period entered the 40 week, double-blind (DB), maintenance treatment period. Responder criteria was defined as a) achieving an Investigator's Global Assessment (IGA) of clear (0) or almost clear (1) (on a 5-point scale), b) a reduction from IGA baseline of greater than or equal to (\\>= 2) points, and c) reaching an Eczema Area and Severity Index (EASI)-75 response compared to baseline score. Baseline score was the IGA score and EASI score obtained prior to dosing on Day 1. Non-responders had a choice to enroll into the PF-04965842 Long Term Extension (LTE) study B7451015 (NCT03422822) otherwise, they were permanently discontinued from treatment and were followed-up for 4-week in this study."}, {'id': 'FG001', 'title': 'PF-04965842 200 mg OL to Placebo DB', 'description': 'Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'FG002', 'title': 'PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB', 'description': 'Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'FG003', 'title': 'PF-04965842 200 mg OL to PF-04965842 200 mg DB', 'description': 'Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'FG004', 'title': 'PF-04965842 200 mg Rescue Period', 'description': 'Participants who met the protocol defined flare criteria in DB period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during open-label Rescue Period for up to 12 weeks. After completing the 12-week rescue period, participants had the choice to enter the LTE study B7451015 (NCT03422822), if eligible. Participants who discontinued early from treatment, or who were otherwise ineligible for the LTE study, were followed-up for 4 week in this study.'}], 'periods': [{'title': 'Open-label (OL) Run-in Period (12 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1235'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1233'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '798'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '437'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '315'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Medication Error Without Associated Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal By Parent/Guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Double-blind Treatment Period (40 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants did not enter into the DB period.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Participants who met the pre-defined criteria for DB.', 'groupId': 'FG001', 'numSubjects': '267'}, {'comment': 'Participants who met the pre-defined criteria for DB.', 'groupId': 'FG002', 'numSubjects': '265'}, {'comment': 'Participants who met the pre-defined criteria for DB.', 'groupId': 'FG003', 'numSubjects': '266'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Participants Entered Rescue Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '208'}, {'groupId': 'FG002', 'numSubjects': '109'}, {'groupId': 'FG003', 'numSubjects': '44'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Completed After Entering Rescue Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '201'}, {'groupId': 'FG002', 'numSubjects': '99'}, {'groupId': 'FG003', 'numSubjects': '41'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Completed Without Entering Rescue Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '134'}, {'groupId': 'FG003', 'numSubjects': '187'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': '208 entered RP+43 completed study in DB period', 'groupId': 'FG001', 'numSubjects': '251'}, {'comment': '109 entered RP+134 completed study in DB period', 'groupId': 'FG002', 'numSubjects': '243'}, {'comment': '44 entered RP+187 completed study in DB period', 'groupId': 'FG003', 'numSubjects': '231'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '35'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal By Parent/Guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Open-label Rescue Period (12 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Participants did not enter into the OL- Rescue Period.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Participants did not enter into the OL- Rescue Period.', 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'Participants did not enter into the OL- Rescue Period.', 'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'Participants who met the pre-defined criteria for OL- Rescue Period.', 'groupId': 'FG004', 'numSubjects': '361'}]}, {'type': 'Met Protocol-defined Flare Criteria', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '351'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '341'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '9'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Total 1235 participants were enrolled in 236 sites in 21 countries. Study started from 11 June 2018 and completed on 07 October 2020.', 'preAssignmentDetails': 'Study Baseline: was defined as the last observation collected on or prior to Day 1 (first dose day) of study treatment. Randomization Baseline: was defined as the last observation collected between last dose of run-in treatment and Day 1 (first dose day) of randomized treatment. Rescue Baseline: was defined as the last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'BG000'}, {'value': '265', 'groupId': 'BG001'}, {'value': '266', 'groupId': 'BG002'}, {'value': '798', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'PF-04965842 200 mg OL to Placebo DB', 'description': 'Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'BG001', 'title': 'PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB', 'description': 'Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'BG002', 'title': 'PF-04965842 200 mg OL to PF-04965842 200 mg DB', 'description': 'Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'title': '<18 years', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '145', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '210', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}, {'value': '623', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '359', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}, {'value': '439', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '179', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '200', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}, {'value': '617', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '124', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '209', 'groupId': 'BG000'}, {'value': '208', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}, {'value': '621', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '10', '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': 'Full analysis set-randomized (FAS-RA) included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within Double-blind (DB) phase.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-28', 'size': 29293328, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-08-03T11:40', 'hasProtocol': True}, {'date': '2020-09-22', 'size': 3211149, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-08-03T13:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1235}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-10-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-17', 'studyFirstSubmitDate': '2018-05-29', 'resultsFirstSubmitDate': '2021-08-03', 'studyFirstSubmitQcDate': '2018-08-08', 'lastUpdatePostDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-17', 'studyFirstPostDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Loss of Response: Double-blind (DB) Period', 'timeFrame': 'From Day 1 of up to Week 40 of double blind period', 'description': "Percentage of participants with loss of response requiring rescue treatment during double blind period was determined. Loss of response denoted as flare and was define as a loss of at least 50% of EASI total score at Week 12 and with an IGA score of 2 or higher. EASI quantifies severity of participant's atopic dermatitis (AD) based on both severity of lesion clinical signs and % of body surface area (BSA) affected. EASI is a composite scoring by AD clinical evaluator of degree of erythema, induration/papulation, excoriation, and lichenification for each of 4 body regions. EASI total score range from 0.0 to 72.0, with higher scores representing greater severity of AD. IGA assesses severity of AD on 5-point scale (0 to 4, higher scores = more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate and 4 = severe."}, {'measure': 'Time to Loss of Response: Double-blind Period', 'timeFrame': 'From date of first dose of randomized treatment until the last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) (maximum up to Week 40, visit window was extended +/- 45 Days due to COVID 19)', 'description': 'Time (in days) to loss of response based on achieving IGA \\>=2 was measured from date of first dose of randomized treatment until last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) and based on EASI, loss of at least 50% of EASI response at Week 12 and IGA score of 2 or higher. IGA assesses severity of AD on 5-point scale (0 to 4, higher scores=more severity), reflecting global consideration of erythema, induration and scaling with scores 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe. EASI quantifies severity of AD based on severity of lesion clinical signs and % of BSA affected. EASI composite score evaluates degree of erythema, induration/papulation, excoriation, and lichenification.'}], 'secondaryOutcomes': [{'measure': "Time to First Loss of Response Based on Investigator's Global Assessment (IGA) Score of 2 or Higher: Double-blind Period", 'timeFrame': 'From date of first dose of randomized treatment until the last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) (maximum up to Week 40, visit window +/- 7 Days)', 'description': 'Time (in days) to loss of response based on achieving IGA \\>=2 (for the first time) as measured from date of first dose of randomized treatment until the last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue). IGA assesses severity of AD on a 5-point scale (0 to 4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear, AD is cleared; 1 = almost clear, AD not entirely cleared, light pink residual lesions; 2 = mild, AD with light red lesions; 3 = moderate, AD with red lesions; 4 = severe, AD with deep, dark red lesions.'}, {'measure': "Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period", 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', 'description': 'IGA assessed severity of AD on a 5-point scale (0 to 4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear, AD is cleared; 1 = almost clear, AD not entirely cleared, light pink residual lesions; 2 = mild, AD with light red lesions; 3 = moderate, AD with red lesions; 4 = severe, AD with deep dark red lesions.'}, {'measure': 'Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', 'description': "EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema \\[E\\], induration/papulation \\[I\\], excoriation \\[Ex\\] and lichenification \\[L\\]) was scored separately for each of 4 body regions (head and neck \\[h\\], upper limbs \\[u\\], trunk \\[t\\] \\[including axillae and groin\\] and lower limbs \\[l\\] \\[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); where A = area score. 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 (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', 'description': "EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of 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). 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 (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', 'description': "EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of 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). 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 (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', 'description': "EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of 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). Total EASI score ranged from 0.0 to 72.0, higher scores=greater severity of AD."}, {'measure': 'Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', 'description': 'Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itch) to 10 (worst itch imaginable), where higher scores indicated worse disease status.'}, {'measure': 'Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', 'description': "4 body regions evaluated: head and neck, upper limbs, trunk (including axillae, groin/genitals), lower limbs (including buttocks) excluding scalp, palms, soles. BSA calculated by handprint method. Number (No) of handprints (size of participant's hand with fingers in closed position) fitting in affected area of a body region was estimated. Maximum No of handprints were 10, 20, 30, 40 for head and neck, upper limbs, trunk, and lower limbs respectively. Surface area (SA) of body region equivalent to 1 handprint: 1 handprint=10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. %Change BSA for a body region was calculated as=total No of handprints in a body region\\* %SA equivalent to 1 handprint. %BSA for an individual: arithmetic mean of %BSA of all 4 body regions, ranged from 0-100%, higher values=greater AD severity."}, {'measure': 'Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', 'description': "SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3); severity scores added to give B (0-18). C: pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7\\*B/2+C; range (0-103); higher values=worse outcome."}, {'measure': 'Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', 'description': "SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region-head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7\\*B/2+C; range (0-103); higher values=worse outcome."}, {'measure': 'Percentage of Participants With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', 'description': "SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7\\*B/2+C; range (0-103); higher values=worse outcome."}, {'measure': 'Percentage of Participants With >=75% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', 'description': "SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7\\*B/2+C; range (0-103); higher values=worse outcome."}, {'measure': 'Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period', 'timeFrame': 'Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12', 'description': 'IGA assessed severity of AD on a 5-point scale (0-4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0=clear, AD is cleared; 1 = almost clear, AD not entirely cleared, light pink residual lesions; 2 = mild, AD with light red lesions; 3 = moderate, AD with red lesions; 4 = severe, AD with deep, dark red lesions.'}, {'measure': 'Percent Change From Rescue Baseline in Total Eczema Area and Severity Index (EASI) Score at Rescue Weeks 2, 4, 8 and 12: Rescue Period', 'timeFrame': 'Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12', 'description': "EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of 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). Total EASI score ranged from 0.0 to 72.0, higher scores=greater severity of AD."}, {'measure': 'Percentage of Participants Achieving Greater Than or Equal to 4 Points Improvement From Rescue Baseline in Peak Pruritus Numeric Rating Scale (PP-NRS) at Rescue Weeks 2, 4, 8 and 12: Rescue Period', 'timeFrame': 'Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12', 'description': 'Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itch) to 10 (worst itch imaginable), where higher scores indicated greater severity.'}, {'measure': 'Percent Change From Rescue Baseline in Percent Body Surface Area (BSA) at Rescue Weeks 2, 4, 8 and 12: Rescue Period', 'timeFrame': 'Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12', 'description': "4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin/genitals) 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 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. Overall % BSA for an individual % BSA of all 4 body regions, ranged from 0 to 100%, with higher values representing greater severity of AD."}, {'measure': 'Percent Change From Rescue Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Score of Itch and Sleep Loss at Rescue Weeks 2, 4, 8 and 12: Rescue Period', 'timeFrame': 'Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12', 'description': "SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7\\*B/2+C; range (0-103); higher values=worse outcome."}, {'measure': 'Percentage of Participants With 50% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period', 'timeFrame': 'Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12', 'description': "SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7\\*B/2+C; range (0-103); higher values=worse outcome."}, {'measure': 'Percentage of Participants With 75% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period', 'timeFrame': 'Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12', 'description': "SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7\\*B/2+C; range (0-103); higher values=worse outcome."}, {'measure': "Percentage of Participants Achieving Patient Global Assessment (PtGA) Response of 'Clear (0)' or 'Almost Clear (1)' and Greater Than or Equal to 2 Points Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period", 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', 'description': 'Participant responded to the following question: "Overall, how would you describe your Atopic Dermatitis right now?" on a 5-point scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity.'}, {'measure': 'Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', 'description': 'DLQI was a 10-item questionnaire that measures the impact of skin disease. Each question was evaluated on a 4-point scale (range 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were 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) Score for Adolescents at Weeks 12, 16, 28, 40 and 52: Double-blind Period", 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', '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 (range 0 to 3) where, 0 = not at all , 1 = only a little, 2 = quite a lot, 3 = very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give CDLQI total score range 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) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', 'description': 'HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-Anxiety (HADS-A) scale and HADS-Depression (HADS-D) scale, 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-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': 'Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', 'description': 'HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, 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-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) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', 'description': 'POEM was 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 scored as following: no days = 0, 1-2 days = 1, 3-4 days = 2, 5-6 days = 3 and, every day = 4. The total POEM score ranges from 0 to 28, where higher score indicated greater severity.'}, {'measure': 'Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period', 'timeFrame': 'Baseline, Weeks 12, 16, 28, 40 and 52', '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 \\[darker or lighter\\], bleeding from skin, seeping or oozing fluid from skin \\[other than blood\\], and skin swelling). Participants 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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['atopic dermatitis', 'atopic eczema', 'eczema', 'JAK', 'janus kinase'], 'conditions': ['Dermatitis', 'Dermatitis, Atopic', 'Eczema', 'Skin Diseases', 'Skin Diseases, Genetic', 'Genetic Diseases, Inborn', 'Skin Diseases, Eczematous', 'Hypersensitivity', 'Hypersensitivity, Immediate', 'Immune System Diseases']}, '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': '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': '37036183', 'type': 'DERIVED', 'citation': 'Flohr C, Cork MJ, Ardern-Jones MR, Eichenfield LF, Barbarot S, Feeney C, Rojo R, Lazariciu I, Nesnas J. Efficacy and safety of abrocitinib monotherapy in adolescents and adults: a post hoc analysis of the phase 3 JAK1 atopic dermatitis efficacy and safety (JADE) REGIMEN clinical trial. J Dermatolog Treat. 2023 Dec;34(1):2200866. doi: 10.1080/09546634.2023.2200866.'}, {'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': '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.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=B7451014', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'B7451014 is a Phase 3 study to investigate PF-04965842 in patients aged 12 years and over with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. Subjects responding well to an initial open-label 12 week treatment of PF-04965842 (200 mg) taken orally once daily (QD) will be identified and randomized in a double-blind manner to receive 200 mg QD PF-04965842, 100 mg QD PF-04965842, or QD placebo. Efficacy and safety of 2 doses of PF-04965842 will be evaluated relative to placebo over 40 weeks. Subjects experiencing significant worsening of their symptoms, i.e., protocol-defined flare, enter 12 weeks rescue treatment and receive 200 mg PF-04965842 together with a marketed topical medicine. Eligible patients will have the option to enter a long-term extension study after completing the initial 12 week treatment, the 12 week rescue treatment, and the 40 week blinded treatment.', 'detailedDescription': 'Responder criteria for randomization at week 12 are defined as a) achieving an IGA of clear (0) or almost clear (1) (on a 5 point scale), b) a reduction from IGA baseline of 2 or more points, and c) reaching an EASI-75 response compared to baseline. Flare requiring rescue treatment is defined as a loss of at least 50% of the EASI response at Week 12 and an IGA score of 2 or higher.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 12 years of age or older with a minimum body weight of 40 kg\n* Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (\\>= the following scores: BSA10%, IGA 3, EASI 16, Pruritus NRS 4)\n* Recent history of inadequate response or inability to tolerate topical AD treatments or require systemic treatments for AD control\n\nExclusion Criteria:\n\n* Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study\n* Prior treatment with JAK inhibitors\n* Other active nonAD inflammatory skin diseases or conditions affecting skin\n* Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator\n* Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception'}, 'identificationModule': {'nctId': 'NCT03627767', 'briefTitle': 'Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 3 RANDOMIZED WITHDRAWAL, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY AND SAFETY OF PF-04965842 IN SUBJECTS AGED 12 YEARS AND OVER, WITH MODERATE TO SEVERE ATOPIC DERMATITIS WITH THE OPTION OF RESCUE TREATMENT IN FLARING SUBJECTS', 'orgStudyIdInfo': {'id': 'B7451014'}, 'secondaryIdInfos': [{'id': 'JADE REGIMEN', 'type': 'OTHER', 'domain': 'Alias Study Number'}, {'id': '2018-000501-23', 'type': 'EUDRACT_NUMBER'}, {'id': 'REGIMEN', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-04965842 100 mg QD', 'description': 'Double-blind randomized treatment following open label run-in period.', 'interventionNames': ['Drug: PF-04965842 100 mg']}, {'type': 'EXPERIMENTAL', 'label': 'PF-04965842 200 mg QD', 'description': 'Double-blind randomized treatment following open label run-in period.', 'interventionNames': ['Drug: PF-04965842 200 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo QD', 'description': 'Double-blind randomized treatment following open label run-in period.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'PF-04965842 100 mg', 'type': 'DRUG', 'otherNames': ['Abrocitinib'], 'description': 'PF-04965842 100 mg, administered as two tablets 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