Ignite Creation Date:
2025-12-24 @ 5:51 PM
Ignite Modification Date:
2026-02-23 @ 12:21 AM
Study NCT ID:
NCT02974868
Status:
COMPLETED
Last Update Posted:
2020-05-26
First Post:
2016-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Subjects With Alopecia Areata
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000506', 'term': 'Alopecia Areata'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D000505', 'term': 'Alopecia'}, {'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000614924', 'term': 'PF-06651600'}, {'id': 'C000630838', 'term': 'PF-06700841'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study treatment up to 113 weeks', 'description': 'The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.\n\nParticipants were counted only once per treatment per event.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Period-Placebo', 'description': 'Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 26, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment Period-PF-06651600', 'description': 'Participants received PF-06651600 200 mg tablets QD for a 4-week induction period followed by PF-06651600 50 mg tablets QD for a 20-week maintenance period.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 23, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Treatment Period-PF-06700841', 'description': 'Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 28, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Single Blind Extension-Active Non-responders on PF-06651600', 'description': 'Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving ≥30% improvement from baseline in SALT \\[SALT 30\\]) who were continually assigned to PF-06651600 in the Non-Responder Segment of the SBE Period', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 8, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Single Blind Extension-Placebo Non-responders on PF-06651600', 'description': 'Participants initially treated with placebo in the Initial 24-Week Treatment Period (1 participant receiving placebo in the Initial 24-Week Treatment Period was responsive at Week 24 but did not enter the SBE Period) who were assigned to PF-06651600 in the Non-Responder Segment of the SBE Period', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 12, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Single Blind Extension-Active Non-responders on PF-06700841', 'description': 'Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving SALT 30) who were continually assigned to PF-06700841 in the Non-Responder Segment of the SBE Period', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 4, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Single Blind Extension-Placebo Non-responders on PF-06700841', 'description': 'Participants initially treated with placebo in the Initial 24-Week Treatment Period who were assigned to PF-06700841 in the Non-Responder Segment of the SBE Period', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 10, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'SBE-Non-Retreated PF-06651600 Responders in Withdrawal Segment', 'description': 'Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal) without entering the Retreatment Segment of the SBE Period', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 4, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'SBE-Retreated PF-06651600 Responders in Withdrawal Segment', 'description': 'Participants initially treated with PF-06651600 in the Initial 24- Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600.\n\nThis arm described AEs for retreated responders within withdrawal Segment.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 3, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'SBE-Non-Retreated PF-06700841 Responders (Withdrawal Segment)', 'description': 'Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal) without entering the Retreatment Segment of the SBE Period', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 6, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'SBE-Retreated PF-06700841 Responders in the Withdrawal Segment', 'description': 'Participants initially treated with PF06700841 in the Initial 24- Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841.This arm described AEs for retreated responders within Withdrawal Segment', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 9, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'SBE-Retreated PF-06651600 Responders in Retreatment Segment', 'description': 'Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 11, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG012', 'title': 'SBE-Retreated Responders on PF-06700841 in Retreatment Segment', 'description': 'Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 8, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG013', 'title': 'Cross Over Extension-PF-06651600', 'description': 'Participants not responsive to placebo or PF-06700841 at Week 24 in the Initial 24-Week Treatment Period and not responsive to PF-06700841 at Week 52 (ie, not achieving SALT 30) in the SBE Period who were assigned to PF-06651600 in the COE Period', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 4, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG014', 'title': 'Cross Over Extension-PF-06700841', 'description': 'Participants not responsive to placebo or PF-06651600 at Week 24 in the Initial 24-Week Treatment Period and not responsive to PF-06651600 at Week 52 (ie, not achieving SALT 30; except 1 PF-06651600 responder) in the SBE Period who were assigned to PF-06700841 in the COE Period', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 8, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Keratosis pilaris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Madarosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Papulopustular rosacea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Pseudofolliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Seborrhoeic dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 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'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Arthritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': "Bartholin's abscess", 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 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'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Orchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 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'EG011', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 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'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Gastroenteritis salmonella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06651600', 'description': 'Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.'}, {'id': 'OG001', 'title': 'PF-06700841', 'description': 'Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841'}], 'classes': [{'categories': [{'measurements': [{'value': '32.54', 'groupId': 'OG000', 'lowerLimit': '25.35', 'upperLimit': '39.74'}, {'value': '50.59', 'groupId': 'OG001', 'lowerLimit': '43.15', 'upperLimit': '58.02'}, {'value': '1.41', 'groupId': 'OG002', 'lowerLimit': '-6.03', 'upperLimit': '8.85'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean of Difference from Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31.14', 'ciLowerLimit': '18.78', 'ciUpperLimit': '43.50', 'pValueComment': 'Hochberg P-value (one-sided)', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.25', 'statisticalMethod': 'Mixed Model Repeated Measure (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.'}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean of Difference from Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '49.18', 'ciLowerLimit': '36.62', 'ciUpperLimit': '61.74', 'pValueComment': 'Hochberg P-value (one-sided)', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.35', 'statisticalMethod': 'Mixed Model Repeated Measure (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week24', 'description': 'SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. Score range: 0-100%. Higher score indicates more severe disease. Change from baseline is defined as the baseline value minus the value at a specific visit. Positive change from baseline signifies an improvement. Baseline is defined as the last measurement prior to first dosing (Day 1).', 'unitOfMeasure': 'units on a scale', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of Participants Analyzed: All randomized participants assigned to the study treatment. Number Analyzed: Number of Participants with observed data at Week 24'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 -AT/AU Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06651600-AT/AU', 'description': 'AT/AU Participants received PF-06651600 200 mg once daily (QD) for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.'}, {'id': 'OG001', 'title': 'PF-06700841-AT/AU', 'description': 'AT/AU Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.'}, {'id': 'OG002', 'title': 'Placebo-AT/AU', 'description': 'AT/AU Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.59', 'groupId': 'OG000', 'lowerLimit': '15.24', 'upperLimit': '39.94'}, {'value': '48.42', 'groupId': 'OG001', 'lowerLimit': '36.38', 'upperLimit': '60.47'}, {'value': '1.81', 'groupId': 'OG002', 'lowerLimit': '-11.00', 'upperLimit': '14.63'}]}]}], 'analyses': [{'pValue': '0.0094', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean of Difference from Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '25.78', 'ciLowerLimit': '7.98', 'ciUpperLimit': '43.58', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.64', 'statisticalMethod': 'Mixed Model Repeated Measure (MMRM)', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.'}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean of Difference from Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '46.61', 'ciLowerLimit': '29.02', 'ciUpperLimit': '64.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.51', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. Change from baseline is defined as the baseline value minus the value at a specific visit. Positive change from baseline implies an improvement. Alopecia totalis (AT): derived as SALT score = 100% at baseline only. Alopecia universalis (AU): derived as SALT score = 100% and both eyelash and eyebrow assessments were "none" at baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of Participants Analyzed: AT/AU participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received. Number Analyzed: Number of participants with observed data at Week 24.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Single-Blind Extension (SBE) Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '15', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Non-responders on PF-06651600', 'description': 'Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving ≥30% improvement from baseline in SALT \\[SALT 30\\]) who were continually assigned to PF-06651600 in the Non-Responder Segment of the SBE Period'}, {'id': 'OG001', 'title': 'Placebo Non-responders on PF-06651600', 'description': 'Participants initially treated with placebo in the Initial 24-Week Treatment Period (1 participant receiving placebo in the Initial 24-Week Treatment Period was responsive at Week 24 but did not enter the SBE Period) who were assigned to PF-06651600 in the Non-Responder Segment of the SBE Period'}, {'id': 'OG002', 'title': 'Active Non-responders on PF-06700841', 'description': 'Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving SALT 30) who were continually assigned to PF-06700841 in the Non-Responder Segment of the SBE Period'}, {'id': 'OG003', 'title': 'Placebo Non-responders on PF-06700841', 'description': 'Participants initially treated with placebo in the Initial 24-Week Treatment Period who were assigned to PF-06700841 in the Non-Responder Segment of the SBE Period'}, {'id': 'OG004', 'title': 'Non-Retreated PF-06651600 Responders in the Withdrawal Segment', 'description': 'Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal) without entering the Retreatment Segment of the SBE Period'}, {'id': 'OG005', 'title': 'Retreated PF-06651600 Responders in the Withdrawal Segment', 'description': 'Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600. This arm stands for retreated responders with TEAE within withdrawal Segment'}, {'id': 'OG006', 'title': 'Non-Retreated PF-06700841 Responders in the Withdrawal Segment', 'description': 'Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal) without entering the Retreatment Segment of the SBE Period'}, {'id': 'OG007', 'title': 'Retreated PF-06700841 Responders in the Withdrawal Segment', 'description': 'Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841. This arm stands for retreated responders with TEAE within withdrawal Segment'}, {'id': 'OG008', 'title': 'Retreated PF-06651600 Responders in the Retreatment Segment', 'description': 'Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600'}, {'id': 'OG009', 'title': 'Retreated Responders on PF-06700841 in the Retreatment Segment', 'description': 'Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841'}], 'classes': [{'title': 'TEAE (All Causalities)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}]}]}, {'title': 'TEAE (Treatment Related)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 28 up to Week 52', 'description': 'An AE (non-serious and serious) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent Adverse Event (TEAE). Treatment-related TEAE were determined by investigators. Arms end with "withdrawal Segment" and "retreatment segment" described the same population while in different treatment segment .The reason why count on PF-06700841 differ by 1 participant is that 1 responder directly entered the retreatment segment and skipped the withdrawal segment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set (SAS) was used , which was defined as all participants who received at least one dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Cross-Over Extension (COE) Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COE-PF-06651600', 'description': 'Participants not responsive to placebo or PF-06700841 at Week 24 in the Initial 24-Week Treatment Period and not responsive to PF-06700841 at Week 52 (ie, not achieving SALT 30) in the SBE Period who were assigned to PF-06651600 in the COE Period'}, {'id': 'OG001', 'title': 'COE-PF-06700841', 'description': 'Participants not responsive to placebo or PF-06651600 at Week 24 in the Initial 24-Week Treatment Period and not responsive to PF-06651600 at Week 52 (ie, not achieving SALT 30; except 1 PF-06651600 responder) in the SBE Period who were assigned to PF-06700841 in the COE Period'}], 'classes': [{'title': 'TEAE (All Causalities)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'TEAE (Treatment Related)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'COE day 1 up to end of study', 'description': 'An AE (non-serious and serious) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent Adverse Event (TEAE). Treatment-related TEAE were determined by investigators.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set (SAS) was used , which was defined as all participants who received at least one dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Laboratory Abnormalities During SBE Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '15', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Non-responders on PF-06651600', 'description': 'Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving ≥30% improvement from baseline in SALT \\[SALT 30\\]) who were continually assigned to PF-06651600 in the Non-Responder Segment of the SBE Period'}, {'id': 'OG001', 'title': 'Placebo Non-responders on PF-06651600', 'description': 'Participants initially treated with placebo in the Initial 24-Week Treatment Period (1 participant receiving placebo in the Initial 24-Week Treatment Period was responsive at Week 24 but did not enter the SBE Period) who were assigned to PF-06651600 in the Non-Responder Segment of the SBE Period'}, {'id': 'OG002', 'title': 'Active Non-responders on PF-06700841', 'description': 'Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving SALT 30) who were continually assigned to PF-06700841 in the Non-Responder Segment of the SBE Period'}, {'id': 'OG003', 'title': 'Placebo Non-responders on PF-06700841', 'description': 'Participants initially treated with placebo in the Initial 24-Week Treatment Period who were assigned to PF-06700841 in the Non-Responder Segment of the SBE Period'}, {'id': 'OG004', 'title': 'Non-Retreated PF-06651600 Responders in the Withdrawal Segment', 'description': 'Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal) without entering the Retreatment Segment of the SBE Period'}, {'id': 'OG005', 'title': 'Retreated PF-06651600 Responders in the Withdrawal Segment', 'description': 'Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600. This arm stands for retreated responders with TEAE within withdrawal Segment'}, {'id': 'OG006', 'title': 'Non-Retreated PF-06700841 Responders in the Withdrawal Segment', 'description': 'Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal) without entering the Retreatment Segment of the SBE Period'}, {'id': 'OG007', 'title': 'Retreated PF-06700841 Responders in the Withdrawal Segment', 'description': 'Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841. This arm stands for retreated responders with TEAE within withdrawal Segment'}, {'id': 'OG008', 'title': 'Retreated PF-06651600 Responders in the Retreatment Segment', 'description': 'Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600'}, {'id': 'OG009', 'title': 'Retreated Responders on PF-06700841 in the Retreatment Segment', 'description': 'Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841'}], 'classes': [{'title': 'With abnormalities without regard to baseline', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}, {'value': '14', 'groupId': 'OG009'}]}]}, {'title': 'Meeting Retest Criteria', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}]}]}, {'title': 'Meeting Discontinuation Criteria', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 28 up to Week 52 for non-responders and responders in the withdrawal segment, AT day 1 up to AT Week 24 for retreatment segment (AT=active treatment)', 'description': 'Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology(Hemoglobin, Hematocrit, RBC count, Reticulocyte count, Platelet count, WBC count with differential, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes); serum chemistry (BUN and Creatinine, Cystatin C, Creatine Phosphokinase, Glucose , Na+, K+, Cl ,Ca++, Total CO2, AST, ALT, Total Indirect \\& Direct Bilirubin, Alkaline phosphatase, Uric acid, Albumin,Total protein, Fasting lipid Profile Panel; urinalysis(pH, Glucose, Protein, Nitrites, Leukocyte esterase, Microscopy culture);Other(HIV, HBsAg, HBcAb, HepB reflex (HbsAB), if applicable, HCVAb, Serum pregnancy test, Urine pregnancy test, FSH, QFT G or other IGRA, or PPD, EBV, CMV, HSV1, HSV2, VZV, Skin swab for herpetiform rash, Skin swab for potential drug related rash).Retest/discontinuation criteria are defined in Protocol Appendix 6.1 and 6.2 respectively.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set (SAS) was used. Arms end with "withdrawal Segment" and "retreatment segment" described the same population while in different treatment segment .The reason why count on PF-06700841 differ by 1 participant is that 1 responder skipped the withdrawal segment and entered the retreatment segment.'}, {'type': 'PRIMARY', 'title': 'Numbers of Participants With Specific Clinical Laboratory Abnormalities During COE Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COE-PF-06651600', 'description': 'Participants not responsive to placebo or PF-06700841 at Week 24 in the Initial 24-Week Treatment Period and not responsive to PF-06700841 at Week 52 (ie, not achieving SALT 30) in the SBE Period who were assigned to PF-06651600 in the COE Period'}, {'id': 'OG001', 'title': 'COE-PF-06700841', 'description': 'Participants not responsive to placebo or PF-06651600 at Week 24 in the Initial 24-Week Treatment Period and not responsive to PF-06651600 at Week 52 (ie, not achieving SALT 30; except 1 PF-06651600 responder) in the SBE Period who were assigned to PF-06700841 in the COE Period'}], 'classes': [{'title': 'With abnormalities without regard to baseline', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Meeting Retest Criteria', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Meeting Discontinuation Criteria', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'COE day 1 up to end of study', 'description': 'Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology(Hemoglobin, Hematocrit, RBC count, Reticulocyte count, Platelet count, WBC count with differential, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes); serum chemistry (BUN and Creatinine, Cystatin C, Creatine Phosphokinase, Glucose , Na+, K+, Cl ,Ca++, Total CO2, AST, ALT, Total Indirect \\& Direct Bilirubin, Alkaline phosphatase, Uric acid, Albumin,Total protein, Fasting lipid Profile Panel; urinalysis(pH, Glucose, Protein, Nitrites, Leukocyte esterase, Microscopy culture);Other(HIV, HBsAg, HBcAb, HepB reflex (HbsAB), if applicable, HCVAb, Serum pregnancy test, Urine pregnancy test, FSH, QFT G or other IGRA, or PPD, EBV, CMV, HSV1, HSV2, VZV, Skin swab for herpetiform rash, Skin swab for potential drug related rash).Retest/discontinuation criteria are defined in Protocol Appendix 6.1 and 6.2 respectively.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in safety analysis set (SAS) who received at least 1 dose of investigational product (PF-06651600, PF-06700841 or placebo) and had abnormal laboratory data in COE period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving SALT 30 at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06651600', 'description': 'Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.'}, {'id': 'OG001', 'title': 'PF-06700841', 'description': 'Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841'}], 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '37.6', 'upperLimit': '62.4'}, {'value': '63.8', 'groupId': 'OG001', 'lowerLimit': '51.3', 'upperLimit': '74.9'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '8.8'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage from Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '47.9', 'ciLowerLimit': '34.2', 'ciUpperLimit': '60.7', 'statisticalMethod': 'Chan and Zhang method', 'nonInferiorityType': 'OTHER'}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage from Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '61.7', 'ciLowerLimit': '48.2', 'ciUpperLimit': '73.6', 'statisticalMethod': 'Chan and Zhang method', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 24', 'description': 'SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 30 response is a 30% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The 90% CI was calculated using Chan and Zhang method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the Full analysis set (FAS) was used and have observed data at Week 24. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Severity of Alopecia Tool (SALT) Across Time (Treatment Period)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06651600', 'description': 'Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.'}, {'id': 'OG001', 'title': 'PF-06700841', 'description': 'Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.74', 'groupId': 'OG000', 'lowerLimit': '-2.06', 'upperLimit': '0.59'}, {'value': '-0.93', 'groupId': 'OG001', 'lowerLimit': '-2.27', 'upperLimit': '0.40'}, {'value': '1.18', 'groupId': 'OG002', 'lowerLimit': '0.23', 'upperLimit': '2.13'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.93', 'groupId': 'OG000', 'lowerLimit': '-1.32', 'upperLimit': '7.17'}, {'value': '7.70', 'groupId': 'OG001', 'lowerLimit': '3.43', 'upperLimit': '11.97'}, {'value': '0.85', 'groupId': 'OG002', 'lowerLimit': '-2.20', 'upperLimit': '3.90'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.44', 'groupId': 'OG000', 'lowerLimit': '5.42', 'upperLimit': '19.45'}, {'value': '19.37', 'groupId': 'OG001', 'lowerLimit': '12.29', 'upperLimit': '26.45'}, {'value': '1.32', 'groupId': 'OG002', 'lowerLimit': '-3.72', 'upperLimit': '6.35'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18.49', 'groupId': 'OG000', 'lowerLimit': '9.57', 'upperLimit': '27.41'}, {'value': '29.30', 'groupId': 'OG001', 'lowerLimit': '20.28', 'upperLimit': '38.32'}, {'value': '1.77', 'groupId': 'OG002', 'lowerLimit': '-4.63', 'upperLimit': '8.17'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '24.49', 'groupId': 'OG000', 'lowerLimit': '14.90', 'upperLimit': '34.09'}, {'value': '36.57', 'groupId': 'OG001', 'lowerLimit': '26.86', 'upperLimit': '46.29'}, {'value': '1.62', 'groupId': 'OG002', 'lowerLimit': '-5.26', 'upperLimit': '8.50'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '27.59', 'groupId': 'OG000', 'lowerLimit': '17.67', 'upperLimit': '37.50'}, {'value': '41.16', 'groupId': 'OG001', 'lowerLimit': '31.11', 'upperLimit': '51.22'}, {'value': '1.61', 'groupId': 'OG002', 'lowerLimit': '-5.49', 'upperLimit': '8.72'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29.32', 'groupId': 'OG000', 'lowerLimit': '19.06', 'upperLimit': '39.57'}, {'value': '45.55', 'groupId': 'OG001', 'lowerLimit': '35.14', 'upperLimit': '55.97'}, {'value': '1.62', 'groupId': 'OG002', 'lowerLimit': '-5.73', 'upperLimit': '8.98'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '31.14', 'groupId': 'OG000', 'lowerLimit': '20.79', 'upperLimit': '41.49'}, {'value': '49.18', 'groupId': 'OG001', 'lowerLimit': '38.66', 'upperLimit': '59.70'}, {'value': '1.41', 'groupId': 'OG002', 'lowerLimit': '-6.03', 'upperLimit': '8.85'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 2,4,6,8,12,16,20,24', 'description': 'SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. The SALT score can vary from 0 to 100% with higher score indicates more severe disease. Baseline is defined as the last measurement prior to first dosing (Day 1). Change from baseline is defined as the baseline value minus the value at a specific visit. Positive change from baseline implies an improvement. Least Square Mean and 90% Confidence Interval of Arms (PF-06651600 and PF-06700841) are the Least Square Mean and 90% Confidence Interval for difference from placebo respectively.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '"Number of participants analyzed": All randomized participants assigned to the study treatment. "Number analyzed" : Number of participants with observed data for each specified time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Severity of Alopecia Tool (SALT) Across Time (Treatment Period)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06651600', 'description': 'Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.'}, {'id': 'OG001', 'title': 'PF-06700841', 'description': 'Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.76', 'groupId': 'OG000', 'lowerLimit': '-2.26', 'upperLimit': '0.75'}, {'value': '-1.13', 'groupId': 'OG001', 'lowerLimit': '-2.64', 'upperLimit': '0.39'}, {'value': '1.26', 'groupId': 'OG002', 'lowerLimit': '0.18', 'upperLimit': '2.33'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.99', 'groupId': 'OG000', 'lowerLimit': '-0.86', 'upperLimit': '8.83'}, {'value': '9.70', 'groupId': 'OG001', 'lowerLimit': '4.83', 'upperLimit': '14.57'}, {'value': '0.53', 'groupId': 'OG002', 'lowerLimit': '-2.96', 'upperLimit': '4.01'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.88', 'groupId': 'OG000', 'lowerLimit': '7.84', 'upperLimit': '23.91'}, {'value': '22.88', 'groupId': 'OG001', 'lowerLimit': '14.77', 'upperLimit': '30.99'}, {'value': '1.02', 'groupId': 'OG002', 'lowerLimit': '-4.75', 'upperLimit': '6.80'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23.22', 'groupId': 'OG000', 'lowerLimit': '13.15', 'upperLimit': '33.29'}, {'value': '34.78', 'groupId': 'OG001', 'lowerLimit': '24.59', 'upperLimit': '44.96'}, {'value': '1.31', 'groupId': 'OG002', 'lowerLimit': '-5.91', 'upperLimit': '8.54'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '30.99', 'groupId': 'OG000', 'lowerLimit': '19.93', 'upperLimit': '42.05'}, {'value': '44.17', 'groupId': 'OG001', 'lowerLimit': '32.97', 'upperLimit': '55.37'}, {'value': '0.99', 'groupId': 'OG002', 'lowerLimit': '-6.94', 'upperLimit': '8.92'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '35.14', 'groupId': 'OG000', 'lowerLimit': '23.65', 'upperLimit': '46.62'}, {'value': '49.99', 'groupId': 'OG001', 'lowerLimit': '38.35', 'upperLimit': '61.64'}, {'value': '0.86', 'groupId': 'OG002', 'lowerLimit': '-7.38', 'upperLimit': '9.09'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '37.31', 'groupId': 'OG000', 'lowerLimit': '25.37', 'upperLimit': '49.25'}, {'value': '55.46', 'groupId': 'OG001', 'lowerLimit': '43.34', 'upperLimit': '67.58'}, {'value': '0.91', 'groupId': 'OG002', 'lowerLimit': '-7.65', 'upperLimit': '9.47'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '39.67', 'groupId': 'OG000', 'lowerLimit': '27.66', 'upperLimit': '51.68'}, {'value': '59.71', 'groupId': 'OG001', 'lowerLimit': '47.51', 'upperLimit': '71.92'}, {'value': '0.43', 'groupId': 'OG002', 'lowerLimit': '-8.20', 'upperLimit': '9.06'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 2,4,6,8,12,16,20,24', 'description': 'SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. The SALT score can vary from 0 to 100% with higher score indicates more severe disease. Baseline is defined as the last measurement prior to first dosing (Day 1). Percent change from baseline is defined as SALT baseline value minus SALT value at a specific visit divided by baseline and multiplying by 100. Positive change from baseline implies an improvement. Least Square Mean and 90% Confidence Interval of Arms (PF-06651600 and PF-06700841) are the Least Square Mean and 90% Confidence Interval for difference from placebo respectively.', 'unitOfMeasure': 'percent change', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '"Number of participants analyzed": All randomized participants assigned to the study treatment. "Number analyzed" : Number of participants with observed data for each specified time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving SALT 30 Across Time (Treatment Period)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06651600', 'description': 'Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.'}, {'id': 'OG001', 'title': 'PF-06700841', 'description': 'Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '-2.1', 'groupId': 'OG000', 'lowerLimit': '-9.7', 'upperLimit': '3.7'}, {'value': '-2.1', 'groupId': 'OG001', 'lowerLimit': '-9.7', 'upperLimit': '3.5'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '8.8'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000', 'lowerLimit': '-2.3', 'upperLimit': '15.8'}, {'value': '12.8', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '24.0'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '8.8'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '18.7', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '31.0'}, {'value': '27.7', 'groupId': 'OG001', 'lowerLimit': '15.4', 'upperLimit': '40.4'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '8.8'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '13.2', 'upperLimit': '37.4'}, {'value': '38.3', 'groupId': 'OG001', 'lowerLimit': '25.8', 'upperLimit': '51.4'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '8.8'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '39.5', 'groupId': 'OG000', 'lowerLimit': '26.4', 'upperLimit': '52.6'}, {'value': '48.9', 'groupId': 'OG001', 'lowerLimit': '35.8', 'upperLimit': '61.8'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '8.8'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '45.8', 'groupId': 'OG000', 'lowerLimit': '32.2', 'upperLimit': '58.7'}, {'value': '55.3', 'groupId': 'OG001', 'lowerLimit': '42.0', 'upperLimit': '67.8'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '8.8'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '47.9', 'groupId': 'OG000', 'lowerLimit': '34.2', 'upperLimit': '60.7'}, {'value': '59.6', 'groupId': 'OG001', 'lowerLimit': '46.3', 'upperLimit': '71.7'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '8.8'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '47.9', 'groupId': 'OG000', 'lowerLimit': '34.2', 'upperLimit': '60.7'}, {'value': '61.7', 'groupId': 'OG001', 'lowerLimit': '48.2', 'upperLimit': '73.6'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '8.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 2,4,6,8,12,16,20,24', 'description': 'SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 30 response is a 30% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) of Arms(PF-06651600 and PF-06700841) in this outcome measurement is the percentage and 90% CI for difference from placebo. The 90% CI was calculated using Chan and Zhang method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving SALT 50 Across Time (Treatment Period)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06651600', 'description': 'Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.'}, {'id': 'OG001', 'title': 'PF-06700841', 'description': 'Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.2', 'upperLimit': '6.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-6.2', 'upperLimit': '6.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '5.7'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.2', 'upperLimit': '6.1'}, {'value': '10.6', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '21.1'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '5.7'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '21.1'}, {'value': '17.0', 'groupId': 'OG001', 'lowerLimit': '6.5', 'upperLimit': '28.8'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '8.8'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '18.7', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '31.0'}, {'value': '29.8', 'groupId': 'OG001', 'lowerLimit': '17.2', 'upperLimit': '42.7'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '8.8'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '27.0', 'groupId': 'OG000', 'lowerLimit': '15.0', 'upperLimit': '39.6'}, {'value': '36.2', 'groupId': 'OG001', 'lowerLimit': '23.8', 'upperLimit': '49.2'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '8.8'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '20.3', 'upperLimit': '46.2'}, {'value': '40.4', 'groupId': 'OG001', 'lowerLimit': '27.8', 'upperLimit': '53.5'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '8.8'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '20.3', 'upperLimit': '46.2'}, {'value': '46.8', 'groupId': 'OG001', 'lowerLimit': '33.8', 'upperLimit': '59.8'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '8.8'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000', 'lowerLimit': '24.5', 'upperLimit': '50.6'}, {'value': '51.1', 'groupId': 'OG001', 'lowerLimit': '37.9', 'upperLimit': '63.8'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '8.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 2,4,6,8,12,16,20,24', 'description': 'SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 50 response is a 50% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) of Arms(PF-06651600 and PF-06700841) in this outcome measurement is the percentage and 90% CI for difference from placebo. The 90% CI was calculated using Chan and Zhang method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving SALT 75 Across Time (Treatment Period)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06651600', 'description': 'Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.'}, {'id': 'OG001', 'title': 'PF-06700841', 'description': 'Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.2', 'upperLimit': '6.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-6.2', 'upperLimit': '6.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '5.7'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.2', 'upperLimit': '6.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-6.2', 'upperLimit': '6.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '5.7'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '18.1'}, {'value': '10.6', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '21.1'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '5.7'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '23.6'}, {'value': '23.4', 'groupId': 'OG001', 'lowerLimit': '11.8', 'upperLimit': '36.2'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '8.8'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '16.6', 'groupId': 'OG000', 'lowerLimit': '6.3', 'upperLimit': '28.6'}, {'value': '27.7', 'groupId': 'OG001', 'lowerLimit': '15.4', 'upperLimit': '40.4'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '8.8'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '20.8', 'groupId': 'OG000', 'lowerLimit': '8.6', 'upperLimit': '33.0'}, {'value': '31.9', 'groupId': 'OG001', 'lowerLimit': '19.0', 'upperLimit': '44.9'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '8.8'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '13.2', 'upperLimit': '37.4'}, {'value': '38.3', 'groupId': 'OG001', 'lowerLimit': '25.8', 'upperLimit': '51.4'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '8.8'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '27.0', 'groupId': 'OG000', 'lowerLimit': '15.0', 'upperLimit': '39.6'}, {'value': '40.4', 'groupId': 'OG001', 'lowerLimit': '27.8', 'upperLimit': '53.5'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '8.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 2,4,6,8,12,16,20,24', 'description': 'SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 75 response is a 75% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) of Arms(PF-06651600 and PF-06700841) in this outcome measurement is the percentage and 90% CI for difference from placebo. The 90% CI was calculated using Chan and Zhang method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving SALT 90 Across Time (Treatment Period)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06651600', 'description': 'Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.'}, {'id': 'OG001', 'title': 'PF-06700841', 'description': 'Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.2', 'upperLimit': '6.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-6.2', 'upperLimit': '6.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '5.7'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.2', 'upperLimit': '6.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-6.2', 'upperLimit': '6.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '5.7'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.2', 'upperLimit': '6.1'}, {'value': '6.4', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '15.7'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '5.7'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '-2.0', 'upperLimit': '12.5'}, {'value': '12.8', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '23.6'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '5.7'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '20.7'}, {'value': '25.5', 'groupId': 'OG001', 'lowerLimit': '15.4', 'upperLimit': '38.1'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '5.7'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '8.6', 'upperLimit': '27.7'}, {'value': '27.7', 'groupId': 'OG001', 'lowerLimit': '17.2', 'upperLimit': '40.3'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '5.7'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '18.7', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '31.0'}, {'value': '29.8', 'groupId': 'OG001', 'lowerLimit': '17.2', 'upperLimit': '42.7'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '8.8'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '15.1', 'upperLimit': '37.3'}, {'value': '34.0', 'groupId': 'OG001', 'lowerLimit': '22.7', 'upperLimit': '47.0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '5.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 2,4,6,8,12,16,20,24', 'description': 'SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 90 response is a 90% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) of Arms(PF-06651600 and PF-06700841) in this outcome measurement is the percentage and 90% CI for difference from placebo. The 90% CI was calculated using Chan and Zhang method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving SALT 100 Across Time (Treatment Period)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06651600', 'description': 'Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.'}, {'id': 'OG001', 'title': 'PF-06700841', 'description': 'Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.2', 'upperLimit': '6.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-6.2', 'upperLimit': '6.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '5.7'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.2', 'upperLimit': '6.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-6.2', 'upperLimit': '6.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '5.7'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.2', 'upperLimit': '6.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-6.2', 'upperLimit': '6.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '5.7'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.2', 'upperLimit': '6.1'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '-3.5', 'upperLimit': '9.7'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '5.7'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '-3.8', 'upperLimit': '9.5'}, {'value': '6.4', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '15.7'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '5.7'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '-3.8', 'upperLimit': '9.5'}, {'value': '8.5', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '18.4'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '5.7'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '-2.0', 'upperLimit': '12.5'}, {'value': '12.8', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '23.6'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '5.7'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '5.1', 'upperLimit': '23.2'}, {'value': '12.8', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '23.6'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '5.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 2,4,6,8,12,16,20,24', 'description': 'SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 100 response is a 100% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) of Arms(PF-06651600 and PF-06700841) in this outcome measurement is the percentage and 90% CI for difference from placebo. The 90% CI was calculated using Chan and Zhang method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the IGA Score Change (Treatment Period)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06651600', 'description': 'Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.'}, {'id': 'OG001', 'title': 'PF-06700841', 'description': 'Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'title': '0 (NO CHANGE OR FURTHER LOSS)', 'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}, {'title': '1 (1-24% REGROWTH)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '2 (25-49% REGROWTH)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '3 (50-74% REGROWTH)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '4 (75-99% REGROWTH)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '5 (100% REGROWTH)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'title': '0 (NO CHANGE OR FURTHER LOSS)', 'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}, {'title': '1 (1-24% REGROWTH)', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}, {'title': '2 (25-49% REGROWTH)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': '3 (50-74% REGROWTH)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '4 (75-99% REGROWTH)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '5 (100% REGROWTH)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'title': '0 (NO CHANGE OR FURTHER LOSS)', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}, {'title': '1 (1-24% REGROWTH)', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': '2 (25-49% REGROWTH)', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': '3 (50-74% REGROWTH)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '4 (75-99% REGROWTH)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '5 (100% REGROWTH)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'title': '0 (NO CHANGE OR FURTHER LOSS)', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}, {'title': '1 (1-24% REGROWTH)', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': '2 (25-49% REGROWTH)', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': '3 (50-74% REGROWTH)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': '4 (75-99% REGROWTH)', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '5 (100% REGROWTH)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'categories': [{'title': '0 (NO CHANGE OR FURTHER LOSS)', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}, {'title': '1 (1-24% REGROWTH)', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}, {'title': '2 (25-49% REGROWTH)', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': '3 (50-74% REGROWTH)', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '4 (75-99% REGROWTH)', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': '5 (100% REGROWTH)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'categories': [{'title': '0 (NO CHANGE OR FURTHER LOSS)', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}, {'title': '1 (1-24% REGROWTH)', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}, {'title': '2 (25-49% REGROWTH)', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': '3 (50-74% REGROWTH)', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '4 (75-99% REGROWTH)', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': '5 (100% REGROWTH)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'categories': [{'title': '0 (NO CHANGE OR FURTHER LOSS)', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}, {'title': '1 (1-24% REGROWTH)', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}, {'title': '2 (25-49% REGROWTH)', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': '3 (50-74% REGROWTH)', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '4 (75-99% REGROWTH)', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': '5 (100% REGROWTH)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'title': '0 (NO CHANGE OR FURTHER LOSS)', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}, {'title': '1 (1-24% REGROWTH)', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}, {'title': '2 (25-49% REGROWTH)', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': '3 (50-74% REGROWTH)', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '4 (75-99% REGROWTH)', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': '5 (100% REGROWTH)', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'categories': [{'title': '0 (NO CHANGE OR FURTHER LOSS)', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}, {'title': '1 (1-24% REGROWTH)', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': '2 (25-49% REGROWTH)', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': '3 (50-74% REGROWTH)', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '4 (75-99% REGROWTH)', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': '5 (100% REGROWTH)', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline, Week 2,4,6,8,12,16,20,24', 'description': 'The clinical evaluator of alopecia areata (AA) will perform an assessment of the overall improvement of AA and assign an Investigator Global Assessment (IGA) score(ranging from 0 to 5) with higher score representing higher regrowth rate. Baseline is defined as the last measurement prior to first dosing (Day 1).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '"Number of participants analyzed": All randomized participants assigned to the study treatment. "Number analyzed" : Number of participants with observed data for each specified time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06651600', 'description': 'Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.'}, {'id': 'OG001', 'title': 'PF-06700841', 'description': 'Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841'}], 'classes': [{'title': 'TEAE (All Causalities)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}, {'title': 'TEAE (Treatment Related)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline up to Week 24', 'description': 'An AE (non-serious and serious) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent Adverse Event (TEAE). Treatment-related TEAE were determined by investigators.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of investigational product (PF-06651600, PF-06700841 or placebo) in Treatment Period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Abnormalities During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06651600', 'description': 'Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.'}, {'id': 'OG001', 'title': 'PF-06700841', 'description': 'Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841'}], 'classes': [{'title': 'With abnormalities without regard to baseline', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': 'Meeting Safety Criteria', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Meeting Retest Criteria', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Meeting Discontinuation Criteria', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 24', 'description': 'Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology(Hemoglobin, Hematocrit, RBC count, Reticulocyte count, Platelet count, WBC count with differential, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes); serum chemistry (BUN and Creatinine, Cystatin C, Creatine Phosphokinase, Glucose , Na+, K+, Cl ,Ca++, Total CO2, AST, ALT, Total Indirect \\& Direct Bilirubin, Alkaline phosphatase, Uric acid, Albumin,Total protein, Fasting lipid Profile Panel; urinalysis(pH, Glucose, Protein, Nitrites, Leukocyte esterase, Microscopy culture);Other(HIV, HBsAg, HBcAb, HepB reflex (HbsAB), if applicable, HCVAb, Serum pregnancy test, Urine pregnancy test, FSH, QFT G or other IGRA, or PPD, EBV, CMV, HSV1, HSV2, VZV, Skin swab for herpetiform rash, Skin swab for potential drug related rash).Retest/discontinuation criteria are defined in Protocol Appendix 6.1 and 6.2 respectively.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in safety analysis set (SAS) who received at least 1 dose of investigational product (PF-06651600, PF-06700841 or placebo) and had abnormal laboratory data in treatment period.'}, {'type': 'SECONDARY', 'title': 'Time to Achieve the Retreatment Criteria During the Withdrawal/Retreatment Part of the Extension Period Among Subjects Who Achieved Primary Endpoint at Week 24 (SBE Period)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06651600 Responders', 'description': 'Participants received PF-06651600 200 mg once daily (QD) for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal)'}, {'id': 'OG001', 'title': 'PF-06700841 Responders', 'description': 'Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal)'}], 'classes': [{'title': 'Q1 time to retreatment (25th percentile of time)', 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '12.6'}, {'value': '11.0', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '16.1'}]}]}, {'title': 'Median time to retreatment', 'categories': [{'measurements': [{'value': '16.1', 'groupId': 'OG000', 'lowerLimit': '10.1', 'upperLimit': '20.3'}, {'value': '24.1', 'comment': 'NA indicates not estimable. The withdrawal segment is not lengthy enough to observe upper limit of the 95% CI for the median time to retreatment (ie. 50% of participants meeting the criterion).', 'groupId': 'OG001', 'lowerLimit': '14.6', 'upperLimit': 'NA'}]}]}, {'title': 'Q3 time to retreatment (75th percentile of time)', 'categories': [{'measurements': [{'value': '21.1', 'comment': 'NA indicates not estimable. The withdrawal segment is not lengthy enough to observe upper limit of the 95% CI for the Q3 time to retreatment (ie. 75% of participants meeting the criterion).', 'groupId': 'OG000', 'lowerLimit': '16.1', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA indicates not estimable. The withdrawal segment is not lengthy enough to observe Q3 time to retreatment (ie. 75% of participants meeting the criterion) and corresponding upper limit of the 95% CI.', 'groupId': 'OG001', 'lowerLimit': '24.3', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24 up to Week 52', 'description': 'Time to re-treatment (weeks) = (date of re-treatment criteria met - date at Week 24 +1)/7. The calendar time to retreatment was calculated. Baseline is defined as Week 24 measurement. The duration in Drug Holiday #1 (ranging from 2-6 weeks) is counted in the Kaplan-Meier analysis. One subject directly entered the re-treatment period and hence is censored at baseline in the Kaplan-Meier analysis.', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who were responsive at Week 24 (ie, achieving SALT30 at Week 24).All randomized participants who were responsive at Week 24 (ie, achieving SALT30 at Week 24).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in SALT Across Time (SBE Period)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Non-responders on PF-06651600', 'description': 'Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving ≥30% improvement from baseline in SALT \\[SALT 30\\]) who were continually assigned to PF-06651600 in the Non-Responder Segment of the SBE Period'}, {'id': 'OG001', 'title': 'Active Non-responders on PF-06700841', 'description': 'Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving SALT 30) who were continually assigned to PF-06700841 in the Non-Responder Segment of the SBE Period'}, {'id': 'OG002', 'title': 'Placebo Non-responders on PF-06651600', 'description': 'Participants initially treated with placebo in the Initial 24-Week Treatment Period (1 participant receiving placebo in the Initial 24-Week Treatment Period was responsive at Week 24 but did not enter the SBE Period) who were assigned to PF-06651600 in the Non-Responder Segment of the SBE Period'}, {'id': 'OG003', 'title': 'Placebo Non-responders on PF-06700841', 'description': 'Participants initially treated with placebo in the Initial 24-Week Treatment Period who were assigned to PF-06700841 in the Non-Responder Segment of the SBE Period'}, {'id': 'OG004', 'title': 'Retreated PF-06651600 Responders in the Retreatment Segment', 'description': 'Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600'}, {'id': 'OG005', 'title': 'Retreated Responders on PF-06700841 in the Retreatment Segment', 'description': 'Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841'}], 'classes': [{'title': 'Week 30/ AT Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.76', 'groupId': 'OG000', 'lowerLimit': '-4.47', 'upperLimit': '7.99'}, {'value': '0.09', 'groupId': 'OG001', 'lowerLimit': '-9.83', 'upperLimit': '10.01'}, {'value': '2.99', 'groupId': 'OG002', 'lowerLimit': '-4.56', 'upperLimit': '10.54'}, {'value': '-0.31', 'groupId': 'OG003', 'lowerLimit': '-9.53', 'upperLimit': '8.92'}, {'value': '25.04', 'groupId': 'OG004', 'lowerLimit': '15.01', 'upperLimit': '35.08'}, {'value': '19.83', 'groupId': 'OG005', 'lowerLimit': '10.00', 'upperLimit': '29.66'}]}]}, {'title': 'Week 32/ AT Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.85', 'groupId': 'OG000', 'lowerLimit': '-4.37', 'upperLimit': '8.07'}, {'value': '2.22', 'groupId': 'OG001', 'lowerLimit': '-7.78', 'upperLimit': '12.21'}, {'value': '3.37', 'groupId': 'OG002', 'lowerLimit': '-4.06', 'upperLimit': '10.79'}, {'value': '3.71', 'groupId': 'OG003', 'lowerLimit': '-4.93', 'upperLimit': '12.35'}, {'value': '27.63', 'groupId': 'OG004', 'lowerLimit': '17.67', 'upperLimit': '37.59'}, {'value': '15.66', 'groupId': 'OG005', 'lowerLimit': '5.82', 'upperLimit': '25.51'}]}]}, {'title': 'Week 34/ AT Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.80', 'groupId': 'OG000', 'lowerLimit': '-4.42', 'upperLimit': '8.02'}, {'value': '3.16', 'groupId': 'OG001', 'lowerLimit': '-6.90', 'upperLimit': '13.23'}, {'value': '10.16', 'groupId': 'OG002', 'lowerLimit': '2.55', 'upperLimit': '17.77'}, {'value': '24.67', 'groupId': 'OG003', 'lowerLimit': '16.00', 'upperLimit': '33.34'}, {'value': '33.78', 'groupId': 'OG004', 'lowerLimit': '23.72', 'upperLimit': '43.83'}, {'value': '20.09', 'groupId': 'OG005', 'lowerLimit': '10.17', 'upperLimit': '30.02'}]}]}, {'title': 'Week 36/ AT Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.16', 'groupId': 'OG000', 'lowerLimit': '-4.09', 'upperLimit': '8.40'}, {'value': '3.01', 'groupId': 'OG001', 'lowerLimit': '-7.12', 'upperLimit': '13.14'}, {'value': '8.93', 'groupId': 'OG002', 'lowerLimit': '1.34', 'upperLimit': '16.52'}, {'value': '42.32', 'groupId': 'OG003', 'lowerLimit': '33.37', 'upperLimit': '51.28'}, {'value': '38.80', 'groupId': 'OG004', 'lowerLimit': '28.75', 'upperLimit': '48.84'}, {'value': '27.35', 'groupId': 'OG005', 'lowerLimit': '17.42', 'upperLimit': '37.27'}]}]}, {'title': 'Week 40/ AT Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3.35', 'groupId': 'OG000', 'lowerLimit': '-2.91', 'upperLimit': '9.61'}, {'value': '3.19', 'groupId': 'OG001', 'lowerLimit': '-7.00', 'upperLimit': '13.38'}, {'value': '18.30', 'groupId': 'OG002', 'lowerLimit': '10.73', 'upperLimit': '25.86'}, {'value': '50.27', 'groupId': 'OG003', 'lowerLimit': '41.65', 'upperLimit': '58.90'}, {'value': '43.70', 'groupId': 'OG004', 'lowerLimit': '33.58', 'upperLimit': '53.82'}, {'value': '39.28', 'groupId': 'OG005', 'lowerLimit': '29.36', 'upperLimit': '49.19'}]}]}, {'title': 'Week 44/ AT Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3.41', 'groupId': 'OG000', 'lowerLimit': '-2.84', 'upperLimit': '9.67'}, {'value': '3.12', 'groupId': 'OG001', 'lowerLimit': '-7.19', 'upperLimit': '13.43'}, {'value': '25.71', 'groupId': 'OG002', 'lowerLimit': '17.70', 'upperLimit': '33.72'}, {'value': '54.69', 'groupId': 'OG003', 'lowerLimit': '45.73', 'upperLimit': '63.64'}, {'value': '48.93', 'groupId': 'OG004', 'lowerLimit': '38.59', 'upperLimit': '59.27'}, {'value': '50.58', 'groupId': 'OG005', 'lowerLimit': '40.48', 'upperLimit': '60.69'}]}]}, {'title': 'Week 48/ AT Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4.70', 'groupId': 'OG000', 'lowerLimit': '-1.57', 'upperLimit': '10.97'}, {'value': '2.97', 'groupId': 'OG001', 'lowerLimit': '-7.39', 'upperLimit': '13.34'}, {'value': '25.28', 'groupId': 'OG002', 'lowerLimit': '17.42', 'upperLimit': '33.13'}, {'value': '62.45', 'groupId': 'OG003', 'lowerLimit': '53.13', 'upperLimit': '71.77'}, {'value': '53.74', 'groupId': 'OG004', 'lowerLimit': '43.39', 'upperLimit': '64.09'}, {'value': '53.79', 'groupId': 'OG005', 'lowerLimit': '43.57', 'upperLimit': '64.02'}]}]}, {'title': 'Week 52/ AT Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '7.06', 'groupId': 'OG000', 'lowerLimit': '0.75', 'upperLimit': '13.38'}, {'value': '3.01', 'groupId': 'OG001', 'lowerLimit': '-7.47', 'upperLimit': '13.49'}, {'value': '28.88', 'groupId': 'OG002', 'lowerLimit': '20.20', 'upperLimit': '37.56'}, {'value': '58.53', 'groupId': 'OG003', 'lowerLimit': '49.42', 'upperLimit': '67.63'}, {'value': '55.94', 'groupId': 'OG004', 'lowerLimit': '45.42', 'upperLimit': '66.46'}, {'value': '58.37', 'groupId': 'OG005', 'lowerLimit': '48.11', 'upperLimit': '68.64'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)', 'description': 'SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. The SALT score can vary from 0 to 100% with higher score indicates more severe disease. Baseline is defined as the last measurement prior to first dosing (Day 1). Change from baseline is defined as the baseline value minus the value at a specific visit. Positive change from baseline implies an improvement. Least Square Mean and 90% confidence interval in this outcome measurement is the LSM and 90%CI for difference from initial 24-week treatment period placebo respectively.', 'unitOfMeasure': 'unit on a scale', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of Participants Analyzed: All randomized participants assigned to the study treatment. Number Analyzed: Number of Participants with observed data. 6 groups of participants were each compared with initial 24-week treatment period placebo.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving SALT 30 Across Time (SBE Period)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Non-responders on PF-06651600', 'description': 'Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving ≥30% improvement from baseline in SALT \\[SALT 30\\]) who were continually assigned to PF-06651600 in the Non-Responder Segment of the SBE Period'}, {'id': 'OG001', 'title': 'Active Non-responders on PF-06700841', 'description': 'Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving SALT 30) who were continually assigned to PF-06700841 in the Non-Responder Segment of the SBE Period'}, {'id': 'OG002', 'title': 'Placebo Non-responders on PF-06651600', 'description': 'Participants initially treated with placebo in the Initial 24-Week Treatment Period (1 participant receiving placebo in the Initial 24-Week Treatment Period was responsive at Week 24 but did not enter the SBE Period) who were assigned to PF-06651600 in the Non-Responder Segment of the SBE Period'}, {'id': 'OG003', 'title': 'Placebo Non-responders on PF-06700841', 'description': 'Participants initially treated with placebo in the Initial 24-Week Treatment Period who were assigned to PF-06700841 in the Non-Responder Segment of the SBE Period'}, {'id': 'OG004', 'title': 'Retreated PF-06651600 Responders in the Retreatment Segment', 'description': 'Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600'}, {'id': 'OG005', 'title': 'Retreated Responders on PF-06700841 in the Retreatment Segment', 'description': 'Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841'}], 'classes': [{'title': 'Week 30/ AT Week 2', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '-5.3', 'upperLimit': '23.0'}, {'value': '-2.1', 'groupId': 'OG001', 'lowerLimit': '-10.9', 'upperLimit': '40.0'}, {'value': '3.8', 'groupId': 'OG002', 'lowerLimit': '-5.5', 'upperLimit': '21.6'}, {'value': '-2.1', 'groupId': 'OG003', 'lowerLimit': '-9.7', 'upperLimit': '18.9'}, {'value': '47.9', 'groupId': 'OG004', 'lowerLimit': '25.3', 'upperLimit': '70.0'}, {'value': '31.2', 'groupId': 'OG005', 'lowerLimit': '12.8', 'upperLimit': '54.0'}]}]}, {'title': 'Week 32/ AT Week 4', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '-5.3', 'upperLimit': '23.0'}, {'value': '-2.1', 'groupId': 'OG001', 'lowerLimit': '-10.9', 'upperLimit': '40.0'}, {'value': '9.6', 'groupId': 'OG002', 'lowerLimit': '-2.4', 'upperLimit': '30.2'}, {'value': '14.5', 'groupId': 'OG003', 'lowerLimit': '0.4', 'upperLimit': '39.4'}, {'value': '62.2', 'groupId': 'OG004', 'lowerLimit': '38.2', 'upperLimit': '81.5'}, {'value': '11.2', 'groupId': 'OG005', 'lowerLimit': '-1.0', 'upperLimit': '33.5'}]}]}, {'title': 'Week 34/ AT Week 6', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '-5.3', 'upperLimit': '23.0'}, {'value': '-2.1', 'groupId': 'OG001', 'lowerLimit': '-10.9', 'upperLimit': '40.0'}, {'value': '21.4', 'groupId': 'OG002', 'lowerLimit': '4.8', 'upperLimit': '43.2'}, {'value': '31.2', 'groupId': 'OG003', 'lowerLimit': '10.9', 'upperLimit': '57.0'}, {'value': '69.3', 'groupId': 'OG004', 'lowerLimit': '45.3', 'upperLimit': '86.5'}, {'value': '31.2', 'groupId': 'OG005', 'lowerLimit': '12.8', 'upperLimit': '54.0'}]}]}, {'title': 'Week 36/ AT Week 8', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '-5.3', 'upperLimit': '23.0'}, {'value': '-2.1', 'groupId': 'OG001', 'lowerLimit': '-10.9', 'upperLimit': '40.0'}, {'value': '21.4', 'groupId': 'OG002', 'lowerLimit': '4.8', 'upperLimit': '43.2'}, {'value': '56.2', 'groupId': 'OG003', 'lowerLimit': '30.8', 'upperLimit': '78.2'}, {'value': '69.3', 'groupId': 'OG004', 'lowerLimit': '45.3', 'upperLimit': '86.5'}, {'value': '44.5', 'groupId': 'OG005', 'lowerLimit': '23.2', 'upperLimit': '66.5'}]}]}, {'title': 'Week 40/ AT Week 12', 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000', 'lowerLimit': '-1.5', 'upperLimit': '31.8'}, {'value': '-2.1', 'groupId': 'OG001', 'lowerLimit': '-10.9', 'upperLimit': '40.0'}, {'value': '27.3', 'groupId': 'OG002', 'lowerLimit': '8.5', 'upperLimit': '49.6'}, {'value': '81.2', 'groupId': 'OG003', 'lowerLimit': '55.6', 'upperLimit': '94.4'}, {'value': '62.2', 'groupId': 'OG004', 'lowerLimit': '38.2', 'upperLimit': '81.5'}, {'value': '51.2', 'groupId': 'OG005', 'lowerLimit': '28.9', 'upperLimit': '72.2'}]}]}, {'title': 'Week 44/ AT Week 16', 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000', 'lowerLimit': '-1.5', 'upperLimit': '31.8'}, {'value': '-2.1', 'groupId': 'OG001', 'lowerLimit': '-10.9', 'upperLimit': '40.0'}, {'value': '33.2', 'groupId': 'OG002', 'lowerLimit': '15.2', 'upperLimit': '54.5'}, {'value': '64.5', 'groupId': 'OG003', 'lowerLimit': '38.4', 'upperLimit': '84.5'}, {'value': '62.2', 'groupId': 'OG004', 'lowerLimit': '38.2', 'upperLimit': '81.5'}, {'value': '51.2', 'groupId': 'OG005', 'lowerLimit': '28.9', 'upperLimit': '72.2'}]}]}, {'title': 'Week 48/ AT Week 20', 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000', 'lowerLimit': '-1.5', 'upperLimit': '31.8'}, {'value': '-2.1', 'groupId': 'OG001', 'lowerLimit': '-10.9', 'upperLimit': '40.0'}, {'value': '39.0', 'groupId': 'OG002', 'lowerLimit': '20.0', 'upperLimit': '60.1'}, {'value': '64.5', 'groupId': 'OG003', 'lowerLimit': '38.4', 'upperLimit': '84.5'}, {'value': '69.3', 'groupId': 'OG004', 'lowerLimit': '45.3', 'upperLimit': '86.5'}, {'value': '51.2', 'groupId': 'OG005', 'lowerLimit': '28.9', 'upperLimit': '72.2'}]}]}, {'title': 'Week 52/ AT Week 24', 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000', 'lowerLimit': '-1.5', 'upperLimit': '31.8'}, {'value': '-2.1', 'groupId': 'OG001', 'lowerLimit': '-10.9', 'upperLimit': '40.0'}, {'value': '27.3', 'groupId': 'OG002', 'lowerLimit': '8.5', 'upperLimit': '49.6'}, {'value': '64.5', 'groupId': 'OG003', 'lowerLimit': '38.4', 'upperLimit': '84.5'}, {'value': '55.0', 'groupId': 'OG004', 'lowerLimit': '31.6', 'upperLimit': '76.0'}, {'value': '51.2', 'groupId': 'OG005', 'lowerLimit': '28.9', 'upperLimit': '72.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)', 'description': 'SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 30 response is a 30% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) in this outcome measurement is the percentage and 90% CI for difference from initial 24-week treatment period placebo. The 90% CI was calculated using Chan and Zhang method.', 'unitOfMeasure': 'percent of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving SALT 50 Across Time (SBE Period)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Non-responders on PF-06651600', 'description': 'Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving ≥30% improvement from baseline in SALT \\[SALT 30\\]) who were continually assigned to PF-06651600 in the Non-Responder Segment of the SBE Period'}, {'id': 'OG001', 'title': 'Active Non-responders on PF-06700841', 'description': 'Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving SALT 30) who were continually assigned to PF-06700841 in the Non-Responder Segment of the SBE Period'}, {'id': 'OG002', 'title': 'Placebo Non-responders on PF-06651600', 'description': 'Participants initially treated with placebo in the Initial 24-Week Treatment Period (1 participant receiving placebo in the Initial 24-Week Treatment Period was responsive at Week 24 but did not enter the SBE Period) who were assigned to PF-06651600 in the Non-Responder Segment of the SBE Period'}, {'id': 'OG003', 'title': 'Placebo Non-responders on PF-06700841', 'description': 'Participants initially treated with placebo in the Initial 24-Week Treatment Period who were assigned to PF-06700841 in the Non-Responder Segment of the SBE Period'}, {'id': 'OG004', 'title': 'Retreated PF-06651600 Responders in the Retreatment Segment', 'description': 'Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600'}, {'id': 'OG005', 'title': 'Retreated Responders on PF-06700841 in the Retreatment Segment', 'description': 'Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841'}], 'classes': [{'title': 'Week 30/ AT Week 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.3', 'upperLimit': '17.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-7.4', 'upperLimit': '45.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-6.2', 'upperLimit': '16.2'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '-6.3', 'upperLimit': '22.1'}, {'value': '14.3', 'groupId': 'OG004', 'lowerLimit': '2.4', 'upperLimit': '38.5'}, {'value': '20.0', 'groupId': 'OG005', 'lowerLimit': '5.7', 'upperLimit': '44.0'}]}]}, {'title': 'Week 32/ AT Week 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.3', 'upperLimit': '17.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-7.4', 'upperLimit': '45.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-6.2', 'upperLimit': '16.2'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '-6.3', 'upperLimit': '22.1'}, {'value': '21.4', 'groupId': 'OG004', 'lowerLimit': '6.1', 'upperLimit': '46.6'}, {'value': '6.7', 'groupId': 'OG005', 'lowerLimit': '-2.1', 'upperLimit': '27.9'}]}]}, {'title': 'Week 34/ AT Week 6', 'categories': [{'measurements': [{'value': '-2.1', 'groupId': 'OG000', 'lowerLimit': '-9.7', 'upperLimit': '13.8'}, {'value': '-2.1', 'groupId': 'OG001', 'lowerLimit': '-10.9', 'upperLimit': '40.0'}, {'value': '9.6', 'groupId': 'OG002', 'lowerLimit': '-2.4', 'upperLimit': '30.2'}, {'value': '31.2', 'groupId': 'OG003', 'lowerLimit': '10.9', 'upperLimit': '57.0'}, {'value': '26.4', 'groupId': 'OG004', 'lowerLimit': '6.1', 'upperLimit': '50.0'}, {'value': '11.2', 'groupId': 'OG005', 'lowerLimit': '-1.0', 'upperLimit': '33.5'}]}]}, {'title': 'Week 36/ AT Week 8', 'categories': [{'measurements': [{'value': '-2.1', 'groupId': 'OG000', 'lowerLimit': '-9.7', 'upperLimit': '13.8'}, {'value': '-2.1', 'groupId': 'OG001', 'lowerLimit': '-10.9', 'upperLimit': '40.0'}, {'value': '3.8', 'groupId': 'OG002', 'lowerLimit': '-5.5', 'upperLimit': '21.6'}, {'value': '56.2', 'groupId': 'OG003', 'lowerLimit': '30.8', 'upperLimit': '78.2'}, {'value': '33.6', 'groupId': 'OG004', 'lowerLimit': '14.1', 'upperLimit': '57.2'}, {'value': '24.5', 'groupId': 'OG005', 'lowerLimit': '5.6', 'upperLimit': '47.1'}]}]}, {'title': 'Week 40/ AT Week 12', 'categories': [{'measurements': [{'value': '-2.1', 'groupId': 'OG000', 'lowerLimit': '-9.7', 'upperLimit': '13.8'}, {'value': '-2.1', 'groupId': 'OG001', 'lowerLimit': '-10.9', 'upperLimit': '40.0'}, {'value': '15.5', 'groupId': 'OG002', 'lowerLimit': '1.1', 'upperLimit': '36.8'}, {'value': '56.2', 'groupId': 'OG003', 'lowerLimit': '30.8', 'upperLimit': '78.2'}, {'value': '47.9', 'groupId': 'OG004', 'lowerLimit': '25.3', 'upperLimit': '70.0'}, {'value': '44.5', 'groupId': 'OG005', 'lowerLimit': '23.2', 'upperLimit': '66.5'}]}]}, {'title': 'Week 44/ AT Week 16', 'categories': [{'measurements': [{'value': '-2.1', 'groupId': 'OG000', 'lowerLimit': '-9.7', 'upperLimit': '13.8'}, {'value': '-2.1', 'groupId': 'OG001', 'lowerLimit': '-10.9', 'upperLimit': '40.0'}, {'value': '21.4', 'groupId': 'OG002', 'lowerLimit': '4.8', 'upperLimit': '43.2'}, {'value': '64.5', 'groupId': 'OG003', 'lowerLimit': '38.4', 'upperLimit': '84.5'}, {'value': '47.9', 'groupId': 'OG004', 'lowerLimit': '25.3', 'upperLimit': '70.0'}, {'value': '44.5', 'groupId': 'OG005', 'lowerLimit': '23.2', 'upperLimit': '66.5'}]}]}, {'title': 'Week 48/ AT Week 20', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '-5.3', 'upperLimit': '23.0'}, {'value': '-2.1', 'groupId': 'OG001', 'lowerLimit': '-10.9', 'upperLimit': '40.0'}, {'value': '27.3', 'groupId': 'OG002', 'lowerLimit': '8.5', 'upperLimit': '49.6'}, {'value': '64.5', 'groupId': 'OG003', 'lowerLimit': '38.4', 'upperLimit': '84.5'}, {'value': '47.9', 'groupId': 'OG004', 'lowerLimit': '25.3', 'upperLimit': '70.0'}, {'value': '37.9', 'groupId': 'OG005', 'lowerLimit': '17.9', 'upperLimit': '60.3'}]}]}, {'title': 'Week 52/ AT Week 24', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '-5.3', 'upperLimit': '23.0'}, {'value': '-2.1', 'groupId': 'OG001', 'lowerLimit': '-10.9', 'upperLimit': '40.0'}, {'value': '27.3', 'groupId': 'OG002', 'lowerLimit': '8.5', 'upperLimit': '49.6'}, {'value': '64.5', 'groupId': 'OG003', 'lowerLimit': '38.4', 'upperLimit': '84.5'}, {'value': '47.9', 'groupId': 'OG004', 'lowerLimit': '25.3', 'upperLimit': '70.0'}, {'value': '44.5', 'groupId': 'OG005', 'lowerLimit': '23.2', 'upperLimit': '66.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)', 'description': 'SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 50 response is a 50% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) in this outcome measurement is the percentage and 90% CI for difference from initial 24-week treatment period placebo. The 90% CI was calculated using Chan and Zhang method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving SALT 75 Across Time (SBE Period)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Non-responders on PF-06651600', 'description': 'Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving ≥30% improvement from baseline in SALT \\[SALT 30\\]) who were continually assigned to PF-06651600 in the Non-Responder Segment of the SBE Period'}, {'id': 'OG001', 'title': 'Active Non-responders on PF-06700841', 'description': 'Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving SALT 30) who were continually assigned to PF-06700841 in the Non-Responder Segment of the SBE Period'}, {'id': 'OG002', 'title': 'Placebo Non-responders on PF-06651600', 'description': 'Participants initially treated with placebo in the Initial 24-Week Treatment Period (1 participant receiving placebo in the Initial 24-Week Treatment Period was responsive at Week 24 but did not enter the SBE Period) who were assigned to PF-06651600 in the Non-Responder Segment of the SBE Period'}, {'id': 'OG003', 'title': 'Placebo Non-responders on PF-06700841', 'description': 'Participants initially treated with placebo in the Initial 24-Week Treatment Period who were assigned to PF-06700841 in the Non-Responder Segment of the SBE Period'}, {'id': 'OG004', 'title': 'Retreated PF-06651600 Responders in the Retreatment Segment', 'description': 'Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600'}, {'id': 'OG005', 'title': 'Retreated Responders on PF-06700841 in the Retreatment Segment', 'description': 'Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841'}], 'classes': [{'title': 'Week 30/ AT Week 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.3', 'upperLimit': '17.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-7.4', 'upperLimit': '45.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-6.2', 'upperLimit': '16.2'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '-6.3', 'upperLimit': '22.1'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '-6.8', 'upperLimit': '19.3'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '-6.6', 'upperLimit': '18.1'}]}]}, {'title': 'Week 32/ AT Week 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.3', 'upperLimit': '17.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-7.4', 'upperLimit': '45.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-6.2', 'upperLimit': '16.2'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '-6.3', 'upperLimit': '22.1'}, {'value': '7.1', 'groupId': 'OG004', 'lowerLimit': '-1.9', 'upperLimit': '29.7'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '-6.6', 'upperLimit': '18.1'}]}]}, {'title': 'Week 34/ AT Week 6', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.3', 'upperLimit': '17.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-7.4', 'upperLimit': '45.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-6.2', 'upperLimit': '16.2'}, {'value': '8.3', 'groupId': 'OG003', 'lowerLimit': '-1.5', 'upperLimit': '33.9'}, {'value': '14.3', 'groupId': 'OG004', 'lowerLimit': '2.4', 'upperLimit': '38.5'}, {'value': '6.7', 'groupId': 'OG005', 'lowerLimit': '-2.1', 'upperLimit': '27.9'}]}]}, {'title': 'Week 36/ AT Week 8', 'categories': [{'measurements': [{'value': '-2.1', 'groupId': 'OG000', 'lowerLimit': '-9.7', 'upperLimit': '13.8'}, {'value': '-2.1', 'groupId': 'OG001', 'lowerLimit': '-10.9', 'upperLimit': '40.0'}, {'value': '-2.1', 'groupId': 'OG002', 'lowerLimit': '-9.7', 'upperLimit': '13.3'}, {'value': '22.9', 'groupId': 'OG003', 'lowerLimit': '2.8', 'upperLimit': '48.7'}, {'value': '26.4', 'groupId': 'OG004', 'lowerLimit': '6.1', 'upperLimit': '50.0'}, {'value': '17.9', 'groupId': 'OG005', 'lowerLimit': '1.8', 'upperLimit': '40.6'}]}]}, {'title': 'Week 40/ AT Week 12', 'categories': [{'measurements': [{'value': '-2.1', 'groupId': 'OG000', 'lowerLimit': '-9.7', 'upperLimit': '13.8'}, {'value': '-2.1', 'groupId': 'OG001', 'lowerLimit': '-10.9', 'upperLimit': '40.0'}, {'value': '3.8', 'groupId': 'OG002', 'lowerLimit': '-5.5', 'upperLimit': '21.6'}, {'value': '39.5', 'groupId': 'OG003', 'lowerLimit': '17.0', 'upperLimit': '64.5'}, {'value': '26.4', 'groupId': 'OG004', 'lowerLimit': '6.1', 'upperLimit': '50.0'}, {'value': '31.2', 'groupId': 'OG005', 'lowerLimit': '12.8', 'upperLimit': '54.0'}]}]}, {'title': 'Week 44/ AT Week 16', 'categories': [{'measurements': [{'value': '-2.1', 'groupId': 'OG000', 'lowerLimit': '-9.7', 'upperLimit': '13.8'}, {'value': '-2.1', 'groupId': 'OG001', 'lowerLimit': '-10.9', 'upperLimit': '40.0'}, {'value': '15.5', 'groupId': 'OG002', 'lowerLimit': '1.1', 'upperLimit': '36.8'}, {'value': '56.2', 'groupId': 'OG003', 'lowerLimit': '30.8', 'upperLimit': '78.2'}, {'value': '26.4', 'groupId': 'OG004', 'lowerLimit': '6.1', 'upperLimit': '50.0'}, {'value': '37.9', 'groupId': 'OG005', 'lowerLimit': '17.9', 'upperLimit': '60.3'}]}]}, {'title': 'Week 48/ AT Week 20', 'categories': [{'measurements': [{'value': '-2.1', 'groupId': 'OG000', 'lowerLimit': '-9.7', 'upperLimit': '13.8'}, {'value': '-2.1', 'groupId': 'OG001', 'lowerLimit': '-10.9', 'upperLimit': '40.0'}, {'value': '15.5', 'groupId': 'OG002', 'lowerLimit': '1.1', 'upperLimit': '36.8'}, {'value': '64.5', 'groupId': 'OG003', 'lowerLimit': '38.4', 'upperLimit': '84.5'}, {'value': '28.6', 'groupId': 'OG004', 'lowerLimit': '6.1', 'upperLimit': '50.0'}, {'value': '37.9', 'groupId': 'OG005', 'lowerLimit': '17.9', 'upperLimit': '60.3'}]}]}, {'title': 'Week 52/ AT Week 24', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '-5.3', 'upperLimit': '23.0'}, {'value': '-2.1', 'groupId': 'OG001', 'lowerLimit': '-10.9', 'upperLimit': '40.0'}, {'value': '27.3', 'groupId': 'OG002', 'lowerLimit': '8.5', 'upperLimit': '49.6'}, {'value': '64.5', 'groupId': 'OG003', 'lowerLimit': '38.4', 'upperLimit': '84.5'}, {'value': '33.6', 'groupId': 'OG004', 'lowerLimit': '14.1', 'upperLimit': '57.2'}, {'value': '37.9', 'groupId': 'OG005', 'lowerLimit': '17.9', 'upperLimit': '60.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)', 'description': 'SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 75 response is a 75% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) in this outcome measurement is the percentage and 90% CI for difference from initial 24-week treatment period placebo. The 90% CI was calculated using Chan and Zhang method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving SALT 90 Across Time (SBE Period)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Non-responders on PF-06651600', 'description': 'Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving ≥30% improvement from baseline in SALT \\[SALT 30\\]) who were continually assigned to PF-06651600 in the Non-Responder Segment of the SBE Period'}, {'id': 'OG001', 'title': 'Active Non-responders on PF-06700841', 'description': 'Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving SALT 30) who were continually assigned to PF-06700841 in the Non-Responder Segment of the SBE Period'}, {'id': 'OG002', 'title': 'Placebo Non-responders on PF-06651600', 'description': 'Participants initially treated with placebo in the Initial 24-Week Treatment Period (1 participant receiving placebo in the Initial 24-Week Treatment Period was responsive at Week 24 but did not enter the SBE Period) who were assigned to PF-06651600 in the Non-Responder Segment of the SBE Period'}, {'id': 'OG003', 'title': 'Placebo Non-responders on PF-06700841', 'description': 'Participants initially treated with placebo in the Initial 24-Week Treatment Period who were assigned to PF-06700841 in the Non-Responder Segment of the SBE Period'}, {'id': 'OG004', 'title': 'Retreated PF-06651600 Responders in the Retreatment Segment', 'description': 'Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600'}, {'id': 'OG005', 'title': 'Retreated Responders on PF-06700841 in the Retreatment Segment', 'description': 'Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841'}], 'classes': [{'title': 'Week 30/ AT Week 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.3', 'upperLimit': '17.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-7.4', 'upperLimit': '45.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-6.2', 'upperLimit': '16.2'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '-6.3', 'upperLimit': '22.1'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '-6.8', 'upperLimit': '19.3'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '-6.6', 'upperLimit': '18.1'}]}]}, {'title': 'Week 32/ AT Week 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.3', 'upperLimit': '17.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-7.4', 'upperLimit': '45.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-6.2', 'upperLimit': '16.2'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '-6.3', 'upperLimit': '22.1'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '-6.8', 'upperLimit': '19.3'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '-6.6', 'upperLimit': '18.1'}]}]}, {'title': 'Week 34/ AT Week 6', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.3', 'upperLimit': '17.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-7.4', 'upperLimit': '45.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-6.2', 'upperLimit': '16.2'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '-6.3', 'upperLimit': '22.1'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '-6.8', 'upperLimit': '19.3'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '-6.6', 'upperLimit': '18.1'}]}]}, {'title': 'Week 36/ AT Week 8', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.3', 'upperLimit': '17.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-7.4', 'upperLimit': '45.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-6.2', 'upperLimit': '16.2'}, {'value': '8.3', 'groupId': 'OG003', 'lowerLimit': '-1.5', 'upperLimit': '33.9'}, {'value': '7.1', 'groupId': 'OG004', 'lowerLimit': '-1.9', 'upperLimit': '29.7'}, {'value': '6.7', 'groupId': 'OG005', 'lowerLimit': '-2.1', 'upperLimit': '27.9'}]}]}, {'title': 'Week 40/ AT Week 12', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.3', 'upperLimit': '17.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-7.4', 'upperLimit': '45.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-6.2', 'upperLimit': '16.2'}, {'value': '25.0', 'groupId': 'OG003', 'lowerLimit': '7.2', 'upperLimit': '52.7'}, {'value': '14.3', 'groupId': 'OG004', 'lowerLimit': '2.4', 'upperLimit': '38.5'}, {'value': '13.3', 'groupId': 'OG005', 'lowerLimit': '2.1', 'upperLimit': '36.3'}]}]}, {'title': 'Week 44/ AT Week 16', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.3', 'upperLimit': '17.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-7.4', 'upperLimit': '45.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-6.2', 'upperLimit': '16.2'}, {'value': '33.3', 'groupId': 'OG003', 'lowerLimit': '12.3', 'upperLimit': '60.9'}, {'value': '21.4', 'groupId': 'OG004', 'lowerLimit': '6.1', 'upperLimit': '46.6'}, {'value': '20.0', 'groupId': 'OG005', 'lowerLimit': '5.7', 'upperLimit': '44.0'}]}]}, {'title': 'Week 48/ AT Week 20', 'categories': [{'measurements': [{'value': '-2.1', 'groupId': 'OG000', 'lowerLimit': '-9.7', 'upperLimit': '13.8'}, {'value': '-2.1', 'groupId': 'OG001', 'lowerLimit': '-10.9', 'upperLimit': '40.0'}, {'value': '3.8', 'groupId': 'OG002', 'lowerLimit': '-5.5', 'upperLimit': '21.6'}, {'value': '47.9', 'groupId': 'OG003', 'lowerLimit': '23.6', 'upperLimit': '71.6'}, {'value': '26.4', 'groupId': 'OG004', 'lowerLimit': '6.1', 'upperLimit': '50.0'}, {'value': '24.5', 'groupId': 'OG005', 'lowerLimit': '5.6', 'upperLimit': '47.1'}]}]}, {'title': 'Week 52/ AT Week 24', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.3', 'upperLimit': '17.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-7.4', 'upperLimit': '45.1'}, {'value': '17.6', 'groupId': 'OG002', 'lowerLimit': '5.0', 'upperLimit': '39.6'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '24.5', 'upperLimit': '75.5'}, {'value': '28.6', 'groupId': 'OG004', 'lowerLimit': '10.4', 'upperLimit': '54.0'}, {'value': '40.0', 'groupId': 'OG005', 'lowerLimit': '19.1', 'upperLimit': '64.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)', 'description': 'SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 90 response is a 90% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) in this outcome measurement is the percentage and 90% CI for difference from initial 24-week treatment period placebo. The 90% CI was calculated using Chan and Zhang method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving SALT 100 Across Time (SBE Period)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Non-responders on PF-06651600', 'description': 'Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving ≥30% improvement from baseline in SALT \\[SALT 30\\]) who were continually assigned to PF-06651600 in the Non-Responder Segment of the SBE Period'}, {'id': 'OG001', 'title': 'Active Non-responders on PF-06700841', 'description': 'Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving SALT 30) who were continually assigned to PF-06700841 in the Non-Responder Segment of the SBE Period'}, {'id': 'OG002', 'title': 'Placebo Non-responders on PF-06651600', 'description': 'Participants initially treated with placebo in the Initial 24-Week Treatment Period (1 participant receiving placebo in the Initial 24-Week Treatment Period was responsive at Week 24 but did not enter the SBE Period) who were assigned to PF-06651600 in the Non-Responder Segment of the SBE Period'}, {'id': 'OG003', 'title': 'Placebo Non-responders on PF-06700841', 'description': 'Participants initially treated with placebo in the Initial 24-Week Treatment Period who were assigned to PF-06700841 in the Non-Responder Segment of the SBE Period'}, {'id': 'OG004', 'title': 'Retreated PF-06651600 Responders in the Retreatment Segment', 'description': 'Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600'}, {'id': 'OG005', 'title': 'Retreated Responders on PF-06700841 in the Retreatment Segment', 'description': 'Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841'}], 'classes': [{'title': 'Week 30/ AT Week 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.3', 'upperLimit': '17.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-7.4', 'upperLimit': '45.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-6.2', 'upperLimit': '16.2'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '-6.3', 'upperLimit': '22.1'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '-6.8', 'upperLimit': '19.3'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '-6.6', 'upperLimit': '18.1'}]}]}, {'title': 'Week 32/ AT Week 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.3', 'upperLimit': '17.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-7.4', 'upperLimit': '45.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-6.2', 'upperLimit': '16.2'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '-6.3', 'upperLimit': '22.1'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '-6.8', 'upperLimit': '19.3'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '-6.6', 'upperLimit': '18.1'}]}]}, {'title': 'Week 34/ AT Week 6', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.3', 'upperLimit': '17.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-7.4', 'upperLimit': '45.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-6.2', 'upperLimit': '16.2'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '-6.3', 'upperLimit': '22.1'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '-6.8', 'upperLimit': '19.3'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '-6.6', 'upperLimit': '18.1'}]}]}, {'title': 'Week 36/ AT Week 8', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.3', 'upperLimit': '17.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-7.4', 'upperLimit': '45.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-6.2', 'upperLimit': '16.2'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '-6.3', 'upperLimit': '22.1'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '-6.8', 'upperLimit': '19.3'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '-6.6', 'upperLimit': '18.1'}]}]}, {'title': 'Week 40/ AT Week 12', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.3', 'upperLimit': '17.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-7.4', 'upperLimit': '45.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-6.2', 'upperLimit': '16.2'}, {'value': '8.3', 'groupId': 'OG003', 'lowerLimit': '-1.5', 'upperLimit': '33.9'}, {'value': '7.1', 'groupId': 'OG004', 'lowerLimit': '-1.9', 'upperLimit': '29.7'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '-6.6', 'upperLimit': '18.1'}]}]}, {'title': 'Week 44/ AT Week 16', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.3', 'upperLimit': '17.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-7.4', 'upperLimit': '45.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-6.2', 'upperLimit': '16.2'}, {'value': '8.3', 'groupId': 'OG003', 'lowerLimit': '-1.5', 'upperLimit': '33.9'}, {'value': '7.1', 'groupId': 'OG004', 'lowerLimit': '-1.9', 'upperLimit': '29.7'}, {'value': '13.3', 'groupId': 'OG005', 'lowerLimit': '2.1', 'upperLimit': '36.3'}]}]}, {'title': 'Week 48/ AT Week 20', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.3', 'upperLimit': '17.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-7.4', 'upperLimit': '45.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-6.2', 'upperLimit': '16.2'}, {'value': '8.3', 'groupId': 'OG003', 'lowerLimit': '-1.5', 'upperLimit': '33.9'}, {'value': '7.1', 'groupId': 'OG004', 'lowerLimit': '-1.9', 'upperLimit': '29.7'}, {'value': '20.0', 'groupId': 'OG005', 'lowerLimit': '5.7', 'upperLimit': '44.0'}]}]}, {'title': 'Week 52/ AT Week 24', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.3', 'upperLimit': '17.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-7.4', 'upperLimit': '45.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-6.2', 'upperLimit': '16.2'}, {'value': '8.3', 'groupId': 'OG003', 'lowerLimit': '-1.5', 'upperLimit': '33.9'}, {'value': '14.3', 'groupId': 'OG004', 'lowerLimit': '2.4', 'upperLimit': '38.5'}, {'value': '20.0', 'groupId': 'OG005', 'lowerLimit': '5.7', 'upperLimit': '44.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)', 'description': 'SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 100 response is a 100% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) in this outcome measurement is the percentage and 90% CI for difference from initial 24-week treatment period placebo. The 90% CI was calculated using Chan and Zhang method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo for PF-06651600', 'description': 'Participants received placebo tablets QD matching for PF-06651600.'}, {'id': 'FG001', 'title': 'Placebo for PF-06700841', 'description': 'Participants received placebo tablets QD matching for PF-06700841.'}, {'id': 'FG002', 'title': 'PF-06651600', 'description': 'Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.'}, {'id': 'FG003', 'title': 'PF-06700841', 'description': 'Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.'}], 'periods': [{'title': 'Initial 24-Week Treatment Period (TP)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '48'}, {'groupId': 'FG003', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '45'}, {'groupId': 'FG003', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'others', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '8'}]}]}, {'title': 'Single-Blind Extension (SBE) Period', 'milestones': [{'type': 'STARTED', 'comment': 'Among 114 participants completed initial treatment period, 96 participants entered SBE period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'comment': 'Week 28-52 and additional 24 weeks(AT Day 1 -AT Week 24) for those retreated with active treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'AE & Withdraw by participants', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '6'}]}]}, {'title': 'Cross-Over Extension (COE) Period', 'milestones': [{'type': 'STARTED', 'comment': 'Among 76 participants completed SBE period, 23 participants entered COE period.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'comment': 'Participants who were PF-06651600 non-responders at Week 52 received PF-06700841, vice versa.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study had a 24 week Treatment Period, a 4 week Drug Holiday, an up to 48 weeks(24 weeks + additional 24 Weeks for those received active retreatment) Single Blind Extension Period, a 4 week Drug Holiday, a 24 weeks Cross Over Open Label Extension Period.', 'preAssignmentDetails': 'Criteria for entering SBE: complete the former period without showing Key Exclusion defined in CSR Section 9.3.2.\n\nCriteria for entering COE: non-responders (SALT change from baseline \\<30%) at Week 24 and continued to be non-responders at Week 52 in SBE period without showing Key Exclusion defined in CSR Section 9.3.2.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '142', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'TP:Placebo', 'description': 'Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841.'}, {'id': 'BG001', 'title': 'TP:PF-06651600', 'description': 'Participants received PF-06651600 200 mg tablets QD for a 4-week induction period followed by PF-06651600 50 mg tablets QD for a 20-week maintenance period.'}, {'id': 'BG002', 'title': 'TP:PF-06700841', 'description': 'Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.17', 'spread': '14.22', 'groupId': 'BG000'}, {'value': '36.88', 'spread': '12.62', 'groupId': 'BG001'}, {'value': '33.94', 'spread': '11.43', 'groupId': 'BG002'}, {'value': '36.33', 'spread': '12.84', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '18-44 Years', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '104', 'groupId': 'BG003'}]}]}, {'title': '45-64 Years', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}]}, {'title': '>=65 Years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '132', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '119', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants received at least 1 dose of PF-06651600,PF-06700841 or matching placebo.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-06', 'size': 3946800, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-05-06T12:54', 'hasProtocol': True}, {'date': '2018-06-12', 'size': 11672177, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-05-06T12:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModelDescription': 'The first 24 weeks are parallel. The single-blind extension period will have a segment for non-responder and a withdrawal/retreatment segment for responder. The cross-over extension period is parallel for non-responders.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-06', 'studyFirstSubmitDate': '2016-11-23', 'resultsFirstSubmitDate': '2020-05-06', 'studyFirstSubmitQcDate': '2016-11-23', 'lastUpdatePostDateStruct': {'date': '2020-05-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-06', 'studyFirstPostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24', 'timeFrame': 'Baseline, Week24', 'description': 'SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. Score range: 0-100%. Higher score indicates more severe disease. Change from baseline is defined as the baseline value minus the value at a specific visit. Positive change from baseline signifies an improvement. Baseline is defined as the last measurement prior to first dosing (Day 1).'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Single-Blind Extension (SBE) Period', 'timeFrame': 'Week 28 up to Week 52', 'description': 'An AE (non-serious and serious) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent Adverse Event (TEAE). Treatment-related TEAE were determined by investigators. Arms end with "withdrawal Segment" and "retreatment segment" described the same population while in different treatment segment .The reason why count on PF-06700841 differ by 1 participant is that 1 responder directly entered the retreatment segment and skipped the withdrawal segment.'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Cross-Over Extension (COE) Period', 'timeFrame': 'COE day 1 up to end of study', 'description': 'An AE (non-serious and serious) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent Adverse Event (TEAE). Treatment-related TEAE were determined by investigators.'}, {'measure': 'Number of Participants With Laboratory Abnormalities During SBE Period', 'timeFrame': 'Week 28 up to Week 52 for non-responders and responders in the withdrawal segment, AT day 1 up to AT Week 24 for retreatment segment (AT=active treatment)', 'description': 'Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology(Hemoglobin, Hematocrit, RBC count, Reticulocyte count, Platelet count, WBC count with differential, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes); serum chemistry (BUN and Creatinine, Cystatin C, Creatine Phosphokinase, Glucose , Na+, K+, Cl ,Ca++, Total CO2, AST, ALT, Total Indirect \\& Direct Bilirubin, Alkaline phosphatase, Uric acid, Albumin,Total protein, Fasting lipid Profile Panel; urinalysis(pH, Glucose, Protein, Nitrites, Leukocyte esterase, Microscopy culture);Other(HIV, HBsAg, HBcAb, HepB reflex (HbsAB), if applicable, HCVAb, Serum pregnancy test, Urine pregnancy test, FSH, QFT G or other IGRA, or PPD, EBV, CMV, HSV1, HSV2, VZV, Skin swab for herpetiform rash, Skin swab for potential drug related rash).Retest/discontinuation criteria are defined in Protocol Appendix 6.1 and 6.2 respectively.'}, {'measure': 'Numbers of Participants With Specific Clinical Laboratory Abnormalities During COE Period', 'timeFrame': 'COE day 1 up to end of study', 'description': 'Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology(Hemoglobin, Hematocrit, RBC count, Reticulocyte count, Platelet count, WBC count with differential, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes); serum chemistry (BUN and Creatinine, Cystatin C, Creatine Phosphokinase, Glucose , Na+, K+, Cl ,Ca++, Total CO2, AST, ALT, Total Indirect \\& Direct Bilirubin, Alkaline phosphatase, Uric acid, Albumin,Total protein, Fasting lipid Profile Panel; urinalysis(pH, Glucose, Protein, Nitrites, Leukocyte esterase, Microscopy culture);Other(HIV, HBsAg, HBcAb, HepB reflex (HbsAB), if applicable, HCVAb, Serum pregnancy test, Urine pregnancy test, FSH, QFT G or other IGRA, or PPD, EBV, CMV, HSV1, HSV2, VZV, Skin swab for herpetiform rash, Skin swab for potential drug related rash).Retest/discontinuation criteria are defined in Protocol Appendix 6.1 and 6.2 respectively.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 -AT/AU Participants', 'timeFrame': 'Baseline, Week 24', 'description': 'SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. Change from baseline is defined as the baseline value minus the value at a specific visit. Positive change from baseline implies an improvement. Alopecia totalis (AT): derived as SALT score = 100% at baseline only. Alopecia universalis (AU): derived as SALT score = 100% and both eyelash and eyebrow assessments were "none" at baseline.'}, {'measure': 'Percentage of Participants Achieving SALT 30 at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 30 response is a 30% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The 90% CI was calculated using Chan and Zhang method.'}, {'measure': 'Change From Baseline in Severity of Alopecia Tool (SALT) Across Time (Treatment Period)', 'timeFrame': 'Baseline, Weeks 2,4,6,8,12,16,20,24', 'description': 'SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. The SALT score can vary from 0 to 100% with higher score indicates more severe disease. Baseline is defined as the last measurement prior to first dosing (Day 1). Change from baseline is defined as the baseline value minus the value at a specific visit. Positive change from baseline implies an improvement. Least Square Mean and 90% Confidence Interval of Arms (PF-06651600 and PF-06700841) are the Least Square Mean and 90% Confidence Interval for difference from placebo respectively.'}, {'measure': 'Percent Change From Baseline in Severity of Alopecia Tool (SALT) Across Time (Treatment Period)', 'timeFrame': 'Baseline, Weeks 2,4,6,8,12,16,20,24', 'description': 'SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. The SALT score can vary from 0 to 100% with higher score indicates more severe disease. Baseline is defined as the last measurement prior to first dosing (Day 1). Percent change from baseline is defined as SALT baseline value minus SALT value at a specific visit divided by baseline and multiplying by 100. Positive change from baseline implies an improvement. Least Square Mean and 90% Confidence Interval of Arms (PF-06651600 and PF-06700841) are the Least Square Mean and 90% Confidence Interval for difference from placebo respectively.'}, {'measure': 'Percentage of Participants Achieving SALT 30 Across Time (Treatment Period)', 'timeFrame': 'Baseline, Weeks 2,4,6,8,12,16,20,24', 'description': 'SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 30 response is a 30% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) of Arms(PF-06651600 and PF-06700841) in this outcome measurement is the percentage and 90% CI for difference from placebo. The 90% CI was calculated using Chan and Zhang method.'}, {'measure': 'Percentage of Participants Achieving SALT 50 Across Time (Treatment Period)', 'timeFrame': 'Baseline, Weeks 2,4,6,8,12,16,20,24', 'description': 'SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 50 response is a 50% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) of Arms(PF-06651600 and PF-06700841) in this outcome measurement is the percentage and 90% CI for difference from placebo. The 90% CI was calculated using Chan and Zhang method.'}, {'measure': 'Percentage of Participants Achieving SALT 75 Across Time (Treatment Period)', 'timeFrame': 'Baseline, Weeks 2,4,6,8,12,16,20,24', 'description': 'SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 75 response is a 75% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) of Arms(PF-06651600 and PF-06700841) in this outcome measurement is the percentage and 90% CI for difference from placebo. The 90% CI was calculated using Chan and Zhang method.'}, {'measure': 'Percentage of Participants Achieving SALT 90 Across Time (Treatment Period)', 'timeFrame': 'Baseline, Weeks 2,4,6,8,12,16,20,24', 'description': 'SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 90 response is a 90% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) of Arms(PF-06651600 and PF-06700841) in this outcome measurement is the percentage and 90% CI for difference from placebo. The 90% CI was calculated using Chan and Zhang method.'}, {'measure': 'Percentage of Participants Achieving SALT 100 Across Time (Treatment Period)', 'timeFrame': 'Baseline, Weeks 2,4,6,8,12,16,20,24', 'description': 'SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 100 response is a 100% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) of Arms(PF-06651600 and PF-06700841) in this outcome measurement is the percentage and 90% CI for difference from placebo. The 90% CI was calculated using Chan and Zhang method.'}, {'measure': 'Number of Participants With the IGA Score Change (Treatment Period)', 'timeFrame': 'baseline, Week 2,4,6,8,12,16,20,24', 'description': 'The clinical evaluator of alopecia areata (AA) will perform an assessment of the overall improvement of AA and assign an Investigator Global Assessment (IGA) score(ranging from 0 to 5) with higher score representing higher regrowth rate. Baseline is defined as the last measurement prior to first dosing (Day 1).'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Treatment Period', 'timeFrame': 'baseline up to Week 24', 'description': 'An AE (non-serious and serious) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent Adverse Event (TEAE). Treatment-related TEAE were determined by investigators.'}, {'measure': 'Number of Participants With Laboratory Abnormalities During Treatment Period', 'timeFrame': 'Baseline up to Week 24', 'description': 'Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology(Hemoglobin, Hematocrit, RBC count, Reticulocyte count, Platelet count, WBC count with differential, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes); serum chemistry (BUN and Creatinine, Cystatin C, Creatine Phosphokinase, Glucose , Na+, K+, Cl ,Ca++, Total CO2, AST, ALT, Total Indirect \\& Direct Bilirubin, Alkaline phosphatase, Uric acid, Albumin,Total protein, Fasting lipid Profile Panel; urinalysis(pH, Glucose, Protein, Nitrites, Leukocyte esterase, Microscopy culture);Other(HIV, HBsAg, HBcAb, HepB reflex (HbsAB), if applicable, HCVAb, Serum pregnancy test, Urine pregnancy test, FSH, QFT G or other IGRA, or PPD, EBV, CMV, HSV1, HSV2, VZV, Skin swab for herpetiform rash, Skin swab for potential drug related rash).Retest/discontinuation criteria are defined in Protocol Appendix 6.1 and 6.2 respectively.'}, {'measure': 'Time to Achieve the Retreatment Criteria During the Withdrawal/Retreatment Part of the Extension Period Among Subjects Who Achieved Primary Endpoint at Week 24 (SBE Period)', 'timeFrame': 'Week 24 up to Week 52', 'description': 'Time to re-treatment (weeks) = (date of re-treatment criteria met - date at Week 24 +1)/7. The calendar time to retreatment was calculated. Baseline is defined as Week 24 measurement. The duration in Drug Holiday #1 (ranging from 2-6 weeks) is counted in the Kaplan-Meier analysis. One subject directly entered the re-treatment period and hence is censored at baseline in the Kaplan-Meier analysis.'}, {'measure': 'Change From Baseline in SALT Across Time (SBE Period)', 'timeFrame': 'Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)', 'description': 'SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. The SALT score can vary from 0 to 100% with higher score indicates more severe disease. Baseline is defined as the last measurement prior to first dosing (Day 1). Change from baseline is defined as the baseline value minus the value at a specific visit. Positive change from baseline implies an improvement. Least Square Mean and 90% confidence interval in this outcome measurement is the LSM and 90%CI for difference from initial 24-week treatment period placebo respectively.'}, {'measure': 'Percentage of Participants Achieving SALT 30 Across Time (SBE Period)', 'timeFrame': 'Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)', 'description': 'SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 30 response is a 30% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) in this outcome measurement is the percentage and 90% CI for difference from initial 24-week treatment period placebo. The 90% CI was calculated using Chan and Zhang method.'}, {'measure': 'Percentage of Participants Achieving SALT 50 Across Time (SBE Period)', 'timeFrame': 'Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)', 'description': 'SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 50 response is a 50% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) in this outcome measurement is the percentage and 90% CI for difference from initial 24-week treatment period placebo. The 90% CI was calculated using Chan and Zhang method.'}, {'measure': 'Percentage of Participants Achieving SALT 75 Across Time (SBE Period)', 'timeFrame': 'Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)', 'description': 'SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 75 response is a 75% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) in this outcome measurement is the percentage and 90% CI for difference from initial 24-week treatment period placebo. The 90% CI was calculated using Chan and Zhang method.'}, {'measure': 'Percentage of Participants Achieving SALT 90 Across Time (SBE Period)', 'timeFrame': 'Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)', 'description': 'SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 90 response is a 90% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) in this outcome measurement is the percentage and 90% CI for difference from initial 24-week treatment period placebo. The 90% CI was calculated using Chan and Zhang method.'}, {'measure': 'Percentage of Participants Achieving SALT 100 Across Time (SBE Period)', 'timeFrame': 'Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)', 'description': 'SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 100 response is a 100% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) in this outcome measurement is the percentage and 90% CI for difference from initial 24-week treatment period placebo. The 90% CI was calculated using Chan and Zhang method.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Phase 2', 'randomized', 'double-blind', 'placebo', 'alopecia areata', 'safety', 'efficacy', 'JAK', 'janus kinase', 'moderate', 'severe'], 'conditions': ['Alopecia Areata']}, 'referencesModule': {'references': [{'pmid': '40654284', 'type': 'DERIVED', 'citation': 'Xi L, Peeva E, Yamaguchi Y, Ye Z, Lejeune A, Hyde C, Guttman-Yassky E. Multiomics Analysis of the Response to Ritlecitinib in Alopecia Areata Subtypes and Correlation With Efficacy. Allergy. 2025 Aug;80(8):2348-2360. doi: 10.1111/all.16659. Epub 2025 Jul 14.'}, {'pmid': '38263353', 'type': 'DERIVED', 'citation': 'King B, Soung J, Tziotzios C, Rudnicka L, Joly P, Gooderham M, Sinclair R, Mesinkovska NA, Paul C, Gong Y, Anway SD, Tran H, Wolk R, Zwillich SH, Lejeune A. Integrated Safety Analysis of Ritlecitinib, an Oral JAK3/TEC Family Kinase Inhibitor, for the Treatment of Alopecia Areata from the ALLEGRO Clinical Trial Program. Am J Clin Dermatol. 2024 Mar;25(2):299-314. doi: 10.1007/s40257-024-00846-3. Epub 2024 Jan 23.'}, {'pmid': '37917289', 'type': 'DERIVED', 'citation': 'Wojciechowski J, S Purohit V, Huh Y, Banfield C, Nicholas T. Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. Clin Pharmacokinet. 2023 Dec;62(12):1765-1779. doi: 10.1007/s40262-023-01318-3. Epub 2023 Nov 2.'}, {'pmid': '36045513', 'type': 'DERIVED', 'citation': 'Hughes JH, Qiu R, Banfield C, Dowty ME, Nicholas T. Population Pharmacokinetics of Oral Brepocitinib in Healthy Volunteers and Patients. Clin Pharmacol Drug Dev. 2022 Dec;11(12):1447-1456. doi: 10.1002/cpdd.1163. Epub 2022 Aug 31.'}, {'pmid': '34915057', 'type': 'DERIVED', 'citation': 'Peeva E, Guttman-Yassky E, Banerjee A, Sinclair R, Cox LA, Zhu L, Zhu H, Vincent M, King B. Maintenance, withdrawal, and re-treatment with ritlecitinib and brepocitinib in patients with alopecia areata in a single-blind extension of a phase 2a randomized clinical trial. J Am Acad Dermatol. 2022 Aug;87(2):390-393. doi: 10.1016/j.jaad.2021.12.008. Epub 2021 Dec 13. No abstract available.'}, {'pmid': '34863853', 'type': 'DERIVED', 'citation': 'Guttman-Yassky E, Pavel AB, Diaz A, Zhang N, Del Duca E, Estrada Y, King B, Banerjee A, Banfield C, Cox LA, Dowty ME, Page K, Vincent MS, Zhang W, Zhu L, Peeva E. Ritlecitinib and brepocitinib demonstrate significant improvement in scalp alopecia areata biomarkers. J Allergy Clin Immunol. 2022 Apr;149(4):1318-1328. doi: 10.1016/j.jaci.2021.10.036. Epub 2021 Dec 1.'}, {'pmid': '30113844', 'type': 'DERIVED', 'citation': 'Fensome A, Ambler CM, Arnold E, Banker ME, Brown MF, Chrencik J, Clark JD, Dowty ME, Efremov IV, Flick A, Gerstenberger BS, Gopalsamy A, Hayward MM, Hegen M, Hollingshead BD, Jussif J, Knafels JD, Limburg DC, Lin D, Lin TH, Pierce BS, Saiah E, Sharma R, Symanowicz PT, Telliez JB, Trujillo JI, Vajdos FF, Vincent F, Wan ZK, Xing L, Yang X, Yang X, Zhang L. Dual Inhibition of TYK2 and JAK1 for the Treatment of Autoimmune Diseases: Discovery of (( S)-2,2-Difluorocyclopropyl)((1 R,5 S)-3-(2-((1-methyl-1 H-pyrazol-4-yl)amino)pyrimidin-4-yl)-3,8-diazabicyclo[3.2.1]octan-8-yl)methanone (PF-06700841). J Med Chem. 2018 Oct 11;61(19):8597-8612. doi: 10.1021/acs.jmedchem.8b00917. Epub 2018 Aug 16.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=B7931005', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 2a, randomized, double blind, parallel group, multicenter study with an extension period. The study will have a maximum duration of approximately 113 weeks. This includes an up to 5 weeks Screening Period, a 24 week Treatment Period, a 4 week Drug Holiday (#1), an up to 12 month Single Blind (investigator open, sponsor open and subject blind) Extension Period, a 4 week drug holiday (#2), a 6 month Cross Over Open Label Extension Period and a 4 week Follow up Period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects between 18 75 years of age, inclusive, at time of informed consent.\n* Must have moderate to severe alopecia areata:\n\nExclusion Criteria:\n\n* History of human immunodeficiency virus (HIV) or positive HIV serology at screening,\n* Infected with hepatitis B or hepatitis C viruses.\n* Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)\n* Have received any of the following treatment regiments specified in the timeframes outlined below:\n\nWithin 6 months of first dose of study drug: Any cell depleting agents Within 12 weeks of first dose of study drug: Any studies with JAK inhibitors; Other biologics Within 8 weeks of first dose of study drug: Participation in other studies involving investigational drug(s) Within 6 weeks of first dose of study drug: Have been vaccinated with live or attenuated live vaccine.\n\nWithin 4 weeks of first dose of study drug: Use of oral immune suppressants; Phototherapy (NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning booth/parlor.\n\nWithin 2 week of first dose of study drug: Topical treatments that could affect AA; Herbal medications with unknown properties or known beneficial effects for AA.'}, 'identificationModule': {'nctId': 'NCT02974868', 'briefTitle': 'Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Subjects With Alopecia Areata', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 2A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06651600 AND PF-06700841 IN SUBJECTS WITH MODERATE TO SEVERE ALOPECIA AREATA WITH A SINGLE-BLIND EXTENSION PERIOD AND A CROSS-OVER OPEN LABEL EXTENSION PERIOD', 'orgStudyIdInfo': {'id': 'B7931005'}, 'secondaryIdInfos': [{'id': '2016-004048-13', 'type': 'EUDRACT_NUMBER'}, {'id': 'ALLEGRO', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'PF-06651600', 'interventionNames': ['Drug: PF-06651600']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'PF-06700841', 'interventionNames': ['Drug: PF-06700841']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort placebo', 'description': 'placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'PF-06651600', 'type': 'DRUG', 'description': '200 mg QD during induction and 50 mg QD during Maintenance', 'armGroupLabels': ['Cohort 1']}, {'name': 'PF-06700841', 'type': 'DRUG', 'description': '60 mg QD during induction and 30 mg QD during maintenance', 'armGroupLabels': ['Cohort 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Cohort placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham, Dermatology at the Whitaker Clinic', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham, The Kirklin Clinic', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92701', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Dermatology, Inc.', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Science Institute', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Office of F. 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