Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
Study NCT ID:
NCT04006457
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-14
First Post:
2019-07-01
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Long-Term PF-06651600 for the Treatment of Alopecia Areata
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Hungary'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000506', 'term': 'Alopecia Areata'}, {'id': 'D000505', 'term': 'Alopecia'}, {'id': 'C537055', 'term': 'Alopecia universalis'}], 'ancestors': [{'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000614924', 'term': 'PF-06651600'}, {'id': 'D013745', 'term': 'Tetanus Toxoid'}, {'id': 'D014612', 'term': 'Vaccines'}], 'ancestors': [{'id': 'D014121', 'term': 'Toxoids'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '18007181021', 'title': 'Pfizer Clinical Trials.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 publication 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': 'Main Study: From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40). Vaccine Sub-study: From day of vaccination (Day 1) up to 35 days post last dose of vaccine (up to Day 36)', 'description': 'For all-cause mortality, FAS was used. SAS was defined as all participants who took at least 1 dose of study intervention in the main study or sub-study. Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.', 'eventGroups': [{'id': 'EG000', 'title': 'Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants)', 'description': 'Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.', 'otherNumAtRisk': 447, 'deathsNumAtRisk': 447, 'otherNumAffected': 309, 'seriousNumAtRisk': 447, 'deathsNumAffected': 1, 'seriousNumAffected': 33}, {'id': 'EG001', 'title': 'Main Study: Ritlecitinib 50 mg QD (Roll-over Participants)', 'description': 'Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.', 'otherNumAtRisk': 603, 'deathsNumAtRisk': 603, 'otherNumAffected': 372, 'seriousNumAtRisk': 603, 'deathsNumAffected': 1, 'seriousNumAffected': 43}, {'id': 'EG002', 'title': 'Vaccine Sub-study: Tdap Vaccination', 'description': 'Participants who have received atleast 6 months of treatment with PF-06651600 50mg QD in the study B7981032 were continued to receive the study intervention while participating in this vaccine sub-study. Eligible participants who received the Tdap vaccine with or without the meningococcal ACWY vaccine were enrolled in this sub-study.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 3, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Vaccine Sub-study: Meningococcal ACWY Vaccination', 'description': 'Participants who have received atleast 6 months of treatment with PF-06651600 50mg QD in the study B7981032 were continued to receive the study intervention while participating in this vaccine sub-study. Eligible participants who received the meningococcal ACWY vaccine with or without the Tdap vaccine were enrolled in this sub-study.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 1, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 64}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 99}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 65}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 73}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'SARS-CoV-2 test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 108}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 127}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 98}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 93}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 74}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 59}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Blindness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Retinal artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Impaired gastric emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Cyst rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Latent tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 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'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Vulval abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 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'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 0}, 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'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Foot deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Borderline mucinous tumour of ovary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Salivary gland adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Solitary fibrous tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Testis cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': "Bell's palsy", 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Abortion threatened', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Bipolar I disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Cervical polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Miscarriage of partner', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 447, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Main Study: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Until Follow-up Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '603', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants)', 'description': 'Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.'}, {'id': 'OG001', 'title': 'Main Study: Ritlecitinib 50 mg QD (Roll-over Participants)', 'description': 'Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '401', 'groupId': 'OG000'}, {'value': '515', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered treatment emergent if the event had start date on or after the first dosing date of this study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS was defined as all participants who took at least 1 dose of study intervention.'}, {'type': 'PRIMARY', 'title': 'Main Study: Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation Until Follow-up Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '603', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants)', 'description': 'Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.'}, {'id': 'OG001', 'title': 'Main Study: Ritlecitinib 50 mg QD (Roll-over Participants)', 'description': 'Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.'}], 'classes': [{'title': 'SAEs', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'AEs Leading to Discontinuation', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; other important medical events. AEs leading to discontinuation included participants who had an AE record that indicated that the AE caused the participant to be discontinued from the study or that action taken with study treatment was drug withdrawn.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS was defined as all participants who took at least 1 dose of study intervention.'}, {'type': 'PRIMARY', 'title': 'Main Study: Number of Participants According to Categorization of Vital Signs Data Until Follow-up Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '443', 'groupId': 'OG000'}, {'value': '600', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants)', 'description': 'Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.'}, {'id': 'OG001', 'title': 'Main Study: Ritlecitinib 50 mg QD (Roll-over Participants)', 'description': 'Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.'}], 'classes': [{'title': 'Diastolic blood pressure (mmHg): value <50', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure (mmHg): change >=20 increase', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure (mmHg): change >=20 decrease', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Pulse rate (bpm): Value <40', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Pulse rate (bpm): Value >120', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Systolic blood pressure (mmHg): Value <90', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Systolic blood pressure (mmHg): change>=30 increase', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Systolic blood pressure (mmHg): change>=30 decrease', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)', 'description': 'Vital signs including blood pressure included systolic blood pressure (SBP) \\[Millimeters of mercury, mmHg\\]) and diastolic blood pressure (DBP) and pulse rate \\[beats per minute (bpm)\\] were measured using an automated device in a sitting position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Criteria for vital sign abnormalities included: SBP\\<90mmHg, DBP\\<50 mmHg and pulse rate\\<40mmHg.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS was defined as all participants who took at least 1 dose of study intervention. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Main Study: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values Until Follow-up Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '602', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants)', 'description': 'Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.'}, {'id': 'OG001', 'title': 'Main Study: Ritlecitinib 50 mg QD (Roll-over Participants)', 'description': 'Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '390', 'groupId': 'OG000'}, {'value': '490', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)', 'description': 'Criteria for laboratory abnormalities included:Hemoglobin, Hematocrit, Erythrocytes (\\<0.8\\*LLN); Ery. Volume, Hemoglobin,Mean Corpuscular HGB Concentration \\<0.8\\*LLN or \\>1.5\\*LLN;Reticulocytes, Leukocytes, Lymphocytes, Neutrophils, Neutrophils, Basophils, Eosinophils, Monocytes (\\>1.2\\*ULN), Prothrombin Time(\\>1.1\\*ULN).Clinical Chemistry: Bilirubin, Direct Bilirubin, Indirect Bilirubin (1.5\\*ULN), Aspartate Aminotransferase, Alanine Aminotransferase, Gamma Glutamyl Transferase, Alkaline Phosphatase (\\>3.0\\*ULN); Albumin, Urate (\\<0.8\\*LLN and \\>1.2\\*ULN; Urea Nitrogen,Creatinine Cholesterol \\>1.3\\*ULN; Cholesterol \\<0.8\\*LLN or \\>1.2\\*LLN, Triglycerides,Potassium,Calcium \\< 0.9x LLN \\& \\> 1.1x ULN; Bicarbonate, Glucose, Creatine Kinase. Urinalysis: Glucose, Ketones, Protein, Hemoglobin, Urobilinogen, Bilirubin, Nitrite \\>=1; Leukocyte Erythrocytes, Leukocytes \\>=20; Epithelial Cells\\>=6, Hyaline Cast\\>1; Bacteria\\>20. Number of participants with any laboratory abnormality meeting specified criteria is included.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS was defined as all participants who took at least 1 dose of study intervention. Here, the "Overall number of participants analyzed" signifies the total number of participants evaluable for laboratory abnormalities, i.e. the number with at least one observation of the given laboratory test while on study treatment or during lag time (35 days after the last dose).'}, {'type': 'PRIMARY', 'title': 'Vaccine Sub-study: Percentage of Participants With Tetanus Booster Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccine Sub-study: Tdap Vaccination', 'description': 'Participants who have received atleast 6 months of treatment with PF-06651600 50mg QD in the study B7981032 were continued to receive the study intervention while participating in this vaccine sub-study. Eligible participants who received the Tdap vaccine with or without the meningococcal ACWY vaccine were enrolled in this sub-study.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000', 'lowerLimit': '35.4', 'upperLimit': '84.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 1', 'description': 'Booster response to tetanus toxoid was defined as: \\>=4-fold rise in anti-tetanus toxoid immunoglobulin G (IgG) antibody concentration at Month 1 if the pre-vaccination concentration was \\<=2.7 International Units per milliliter (IU/mL); OR \\>=2-fold rise in anti-tetanus toxoid IgG antibody concentration if the pre-vaccination concentration was \\>2.7 IU/mL. Two-sided 95% confidence interval (CI) was based on Clopper-Pearson exact method.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAS) was defined as all participants from this sub-study who received at least 1 vaccine (Tdap or meningococcal ACWY). Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Main Study: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Until End of Study', 'timeFrame': 'From start of study intervention (Day 1) until end of study', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered treatment emergent if the event had start date on or after the first dosing date of this study.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-01'}, {'type': 'SECONDARY', 'title': 'Main Study: Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation Until End of Study', 'timeFrame': 'From start of study intervention (Day 1) until end of study', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; other important medical events. AEs leading to discontinuation included participants who had an AE record that indicated that the AE caused the participant to be discontinued from the study or that action taken with study treatment was drug withdrawn.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-01'}, {'type': 'SECONDARY', 'title': 'Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs Until End of Study', 'timeFrame': 'From start of study intervention (Day 1) until end of study', 'description': 'Vital signs including blood pressure (systolic and diastolic blood pressure \\[Millimeters of mercury, mmHg\\]) and pulse rate (beats per minute \\[bpm\\]) were measured using an automated device in a sitting position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Clinically significant abnormalities will be determined by investigator.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-01'}, {'type': 'SECONDARY', 'title': 'Main Study: Number of Participants With Clinically Significant Laboratory Abnormalities Until End of Study', 'timeFrame': 'From start of study intervention (Day 1) until end of study', 'description': 'Following laboratory parameters were assessed: Hemoglobin, Hematocrit, Erythrocytes Erythrocyte (ery.) corpuscular volume, Ery. Mean Corpuscular hemoglobin concentration, Reticulocytes, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils, Monocytes, Prothrombin Time, Bilirubin, Direct Bilirubin, Indirect Bilirubin, Aspartate Aminotransferase, Alanine Aminotransferase, Gamma Glutamyl Transferase, Alkaline Phosphatase; Albumin, Urate; Urea Nitrogen, Creatinine, Cholesterol, Triglycerides, Potassium, Calcium, Bicarbonate, Glucose, Creatine Kinase. Urinalysis: Glucose, Ketones, Protein, Hemoglobin, Urobilinogen, Bilirubin, Nitrite, Leukocyte Erythrocytes, Leukocytes; Epithelial Cells, Hyaline Cast, Bacteria. Clinically significant abnormalities will be determined by investigator.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-01'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving Response Based on Severity of Alopecia Tool (SALT) Overall Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '603', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants)', 'description': 'Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.'}, {'id': 'OG001', 'title': 'Main Study: Ritlecitinib 50 mg QD (Roll-over Participants)', 'description': 'Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'OG000'}, {'value': '585', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '1.80'}, {'value': '27.9', 'groupId': 'OG001', 'lowerLimit': '24.23', 'upperLimit': '31.50'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}, {'value': '580', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.3', 'groupId': 'OG000', 'lowerLimit': '12.79', 'upperLimit': '19.83'}, {'value': '32.6', 'groupId': 'OG001', 'lowerLimit': '28.77', 'upperLimit': '36.40'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '542', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.7', 'groupId': 'OG000', 'lowerLimit': '33.07', 'upperLimit': '42.35'}, {'value': '39.1', 'groupId': 'OG001', 'lowerLimit': '35.01', 'upperLimit': '43.22'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.0', 'groupId': 'OG000', 'lowerLimit': '44.08', 'upperLimit': '53.91'}, {'value': '44.7', 'groupId': 'OG001', 'lowerLimit': '40.39', 'upperLimit': '49.02'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '385', 'groupId': 'OG000'}, {'value': '475', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.8', 'groupId': 'OG000', 'lowerLimit': '50.88', 'upperLimit': '60.80'}, {'value': '48.2', 'groupId': 'OG001', 'lowerLimit': '43.72', 'upperLimit': '52.70'}]}]}, {'title': 'Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'OG000'}, {'value': '448', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59.5', 'groupId': 'OG000', 'lowerLimit': '54.50', 'upperLimit': '64.53'}, {'value': '52.9', 'groupId': 'OG001', 'lowerLimit': '48.28', 'upperLimit': '57.52'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'OG000'}, {'value': '436', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.3', 'groupId': 'OG000', 'lowerLimit': '57.27', 'upperLimit': '67.31'}, {'value': '53.4', 'groupId': 'OG001', 'lowerLimit': '48.76', 'upperLimit': '58.12'}]}]}, {'title': 'Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.9', 'groupId': 'OG000', 'lowerLimit': '57.80', 'upperLimit': '68.00'}, {'value': '54.9', 'groupId': 'OG001', 'lowerLimit': '50.18', 'upperLimit': '59.59'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '420', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.4', 'groupId': 'OG000', 'lowerLimit': '61.32', 'upperLimit': '71.42'}, {'value': '56.4', 'groupId': 'OG001', 'lowerLimit': '51.69', 'upperLimit': '61.17'}]}]}, {'title': 'Month 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '410', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.3', 'groupId': 'OG000', 'lowerLimit': '63.23', 'upperLimit': '73.44'}, {'value': '59.3', 'groupId': 'OG001', 'lowerLimit': '54.51', 'upperLimit': '64.02'}]}]}, {'title': 'Month 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '397', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.9', 'groupId': 'OG000', 'lowerLimit': '64.79', 'upperLimit': '75.02'}, {'value': '61.0', 'groupId': 'OG001', 'lowerLimit': '56.16', 'upperLimit': '65.76'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '373', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.9', 'groupId': 'OG000', 'lowerLimit': '65.77', 'upperLimit': '76.12'}, {'value': '61.7', 'groupId': 'OG001', 'lowerLimit': '56.73', 'upperLimit': '66.60'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36', 'description': 'SALT is a quantitative assessment of AA severity based on the scalp terminal hair loss. A visual aid was utilized showing the division of the scalp hair into four quadrants (back, top of scalp, right side and left side), with each of the four quadrants given an accurate determination of the percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. The SALT overall score included any hair loss regardless of etiology (e.g., including scalp hair loss due to both androgenetic alopecia and AA). In this outcome measure, percentage of participants with SALT overall score \\<= 10 were reported. 95% CI was calculated based on normal approximation.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) was defined as all participants regardless of whether they received study intervention. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving Response Based on Alopecia Areata (AA) SALT Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '603', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants)', 'description': 'Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.'}, {'id': 'OG001', 'title': 'Main Study: Ritlecitinib 50 mg QD (Roll-over Participants)', 'description': 'Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'OG000'}, {'value': '533', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.03', 'upperLimit': '2.02'}, {'value': '28.5', 'groupId': 'OG001', 'lowerLimit': '24.68', 'upperLimit': '32.35'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.7', 'groupId': 'OG000', 'lowerLimit': '13.88', 'upperLimit': '21.57'}, {'value': '33.5', 'groupId': 'OG001', 'lowerLimit': '29.52', 'upperLimit': '37.52'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.6', 'groupId': 'OG000', 'lowerLimit': '34.65', 'upperLimit': '44.60'}, {'value': '39.8', 'groupId': 'OG001', 'lowerLimit': '35.56', 'upperLimit': '44.05'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '483', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.7', 'groupId': 'OG000', 'lowerLimit': '45.52', 'upperLimit': '55.87'}, {'value': '45.3', 'groupId': 'OG001', 'lowerLimit': '40.90', 'upperLimit': '49.78'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'OG000'}, {'value': '454', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.8', 'groupId': 'OG000', 'lowerLimit': '51.56', 'upperLimit': '61.98'}, {'value': '49.3', 'groupId': 'OG001', 'lowerLimit': '44.74', 'upperLimit': '53.94'}]}]}, {'title': 'Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'OG000'}, {'value': '432', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61.4', 'groupId': 'OG000', 'lowerLimit': '56.16', 'upperLimit': '66.60'}, {'value': '53.9', 'groupId': 'OG001', 'lowerLimit': '49.23', 'upperLimit': '58.64'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '425', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.0', 'groupId': 'OG000', 'lowerLimit': '59.81', 'upperLimit': '70.09'}, {'value': '54.1', 'groupId': 'OG001', 'lowerLimit': '49.38', 'upperLimit': '58.86'}]}]}, {'title': 'Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.2', 'groupId': 'OG000', 'lowerLimit': '60.05', 'upperLimit': '70.41'}, {'value': '55.1', 'groupId': 'OG001', 'lowerLimit': '50.37', 'upperLimit': '59.89'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.6', 'groupId': 'OG000', 'lowerLimit': '62.47', 'upperLimit': '72.75'}, {'value': '57.2', 'groupId': 'OG001', 'lowerLimit': '52.39', 'upperLimit': '61.96'}]}]}, {'title': 'Month 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '403', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.2', 'groupId': 'OG000', 'lowerLimit': '64.00', 'upperLimit': '74.36'}, {'value': '59.6', 'groupId': 'OG001', 'lowerLimit': '54.76', 'upperLimit': '64.35'}]}]}, {'title': 'Month 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '391', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.3', 'groupId': 'OG000', 'lowerLimit': '65.16', 'upperLimit': '75.50'}, {'value': '61.6', 'groupId': 'OG001', 'lowerLimit': '56.82', 'upperLimit': '66.46'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '372', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.1', 'groupId': 'OG000', 'lowerLimit': '65.91', 'upperLimit': '76.27'}, {'value': '62.1', 'groupId': 'OG001', 'lowerLimit': '57.17', 'upperLimit': '67.03'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36', 'description': 'SALT is a quantitative assessment of AA severity based on scalp terminal hair loss. Scalp hair was divided into four quadrants (back, top of scalp, right side and left side), with each given an accurate determination of the percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of scalp in that area. SALT score=sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. SALT AA Score = SALT overall score minus SALT AGA score, where SALT overall score included any hair loss regardless of etiology and SALT AGA score included scalp hair loss only due to androgenetic alopecia. SALT AA score ranged from 0 (no hair loss) to 100 (complete scalp hair loss), with lower score indicating less hair loss. 95% CI was calculated based on normal approximation.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was defined as all participants regardless of whether they received study intervention. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Overall Number Analyzed" signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving Response Based on SALT Overall Score <= 20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '603', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants)', 'description': 'Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.'}, {'id': 'OG001', 'title': 'Main Study: Ritlecitinib 50 mg QD (Roll-over Participants)', 'description': 'Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'OG000'}, {'value': '585', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '1.05', 'upperLimit': '3.98'}, {'value': '35.6', 'groupId': 'OG001', 'lowerLimit': '31.68', 'upperLimit': '39.43'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}, {'value': '580', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.7', 'groupId': 'OG000', 'lowerLimit': '23.40', 'upperLimit': '31.92'}, {'value': '40.2', 'groupId': 'OG001', 'lowerLimit': '36.18', 'upperLimit': '44.16'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '542', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.1', 'groupId': 'OG000', 'lowerLimit': '45.33', 'upperLimit': '54.91'}, {'value': '50.4', 'groupId': 'OG001', 'lowerLimit': '46.16', 'upperLimit': '54.58'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59.5', 'groupId': 'OG000', 'lowerLimit': '54.73', 'upperLimit': '64.37'}, {'value': '55.9', 'groupId': 'OG001', 'lowerLimit': '51.57', 'upperLimit': '60.19'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '385', 'groupId': 'OG000'}, {'value': '475', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.5', 'groupId': 'OG000', 'lowerLimit': '60.70', 'upperLimit': '70.20'}, {'value': '60.0', 'groupId': 'OG001', 'lowerLimit': '55.59', 'upperLimit': '64.41'}]}]}, {'title': 'Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'OG000'}, {'value': '448', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.7', 'groupId': 'OG000', 'lowerLimit': '66.00', 'upperLimit': '75.30'}, {'value': '62.3', 'groupId': 'OG001', 'lowerLimit': '57.79', 'upperLimit': '66.77'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'OG000'}, {'value': '436', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.8', 'groupId': 'OG000', 'lowerLimit': '67.13', 'upperLimit': '76.45'}, {'value': '63.5', 'groupId': 'OG001', 'lowerLimit': '59.01', 'upperLimit': '68.05'}]}]}, {'title': 'Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.8', 'groupId': 'OG000', 'lowerLimit': '68.06', 'upperLimit': '77.45'}, {'value': '66.3', 'groupId': 'OG001', 'lowerLimit': '61.81', 'upperLimit': '70.75'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '420', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.5', 'groupId': 'OG000', 'lowerLimit': '68.79', 'upperLimit': '78.23'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '62.16', 'upperLimit': '71.18'}]}]}, {'title': 'Month 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '410', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.8', 'groupId': 'OG000', 'lowerLimit': '72.17', 'upperLimit': '81.43'}, {'value': '69.0', 'groupId': 'OG001', 'lowerLimit': '64.55', 'upperLimit': '73.50'}]}]}, {'title': 'Month 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '397', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.0', 'groupId': 'OG000', 'lowerLimit': '73.37', 'upperLimit': '82.61'}, {'value': '69.5', 'groupId': 'OG001', 'lowerLimit': '64.99', 'upperLimit': '74.05'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '373', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.1', 'groupId': 'OG000', 'lowerLimit': '74.42', 'upperLimit': '83.69'}, {'value': '69.7', 'groupId': 'OG001', 'lowerLimit': '65.04', 'upperLimit': '74.37'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36', 'description': 'SALT is a quantitative assessment of AA severity based on the scalp terminal hair loss. A visual aid was utilized showing the division of the scalp hair into four quadrants (back, top of scalp, right side and left side), with each of the four quadrants given an accurate determination of the percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. The SALT overall score included any hair loss regardless of etiology (e.g., including scalp hair loss due to both androgenetic alopecia and AA). In this outcome measure, percentage of participants with SALT overall score \\<=20 were reported. 95% CI was calculated based on normal approximation.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was defined as all participants regardless of whether they received study intervention. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving Response Based on AA SALT Score <=20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '603', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants)', 'description': 'Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.'}, {'id': 'OG001', 'title': 'Main Study: Ritlecitinib 50 mg QD (Roll-over Participants)', 'description': 'Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'OG000'}, {'value': '533', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '0.99', 'upperLimit': '4.11'}, {'value': '36.6', 'groupId': 'OG001', 'lowerLimit': '32.50', 'upperLimit': '40.67'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.8', 'groupId': 'OG000', 'lowerLimit': '23.26', 'upperLimit': '32.29'}, {'value': '41.2', 'groupId': 'OG001', 'lowerLimit': '37.02', 'upperLimit': '45.37'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.2', 'groupId': 'OG000', 'lowerLimit': '46.13', 'upperLimit': '56.30'}, {'value': '51.0', 'groupId': 'OG001', 'lowerLimit': '46.64', 'upperLimit': '55.32'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '483', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.4', 'groupId': 'OG000', 'lowerLimit': '55.39', 'upperLimit': '65.50'}, {'value': '56.5', 'groupId': 'OG001', 'lowerLimit': '52.10', 'upperLimit': '60.94'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'OG000'}, {'value': '454', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.0', 'groupId': 'OG000', 'lowerLimit': '61.01', 'upperLimit': '70.98'}, {'value': '61.2', 'groupId': 'OG001', 'lowerLimit': '56.75', 'upperLimit': '65.72'}]}]}, {'title': 'Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'OG000'}, {'value': '432', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.2', 'groupId': 'OG000', 'lowerLimit': '67.35', 'upperLimit': '76.96'}, {'value': '63.4', 'groupId': 'OG001', 'lowerLimit': '58.88', 'upperLimit': '67.97'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '425', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.0', 'groupId': 'OG000', 'lowerLimit': '69.29', 'upperLimit': '78.74'}, {'value': '64.5', 'groupId': 'OG001', 'lowerLimit': '59.92', 'upperLimit': '69.02'}]}]}, {'title': 'Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.2', 'groupId': 'OG000', 'lowerLimit': '69.39', 'upperLimit': '78.91'}, {'value': '66.6', 'groupId': 'OG001', 'lowerLimit': '62.07', 'upperLimit': '71.10'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.8', 'groupId': 'OG000', 'lowerLimit': '70.07', 'upperLimit': '79.61'}, {'value': '66.9', 'groupId': 'OG001', 'lowerLimit': '62.36', 'upperLimit': '71.46'}]}]}, {'title': 'Month 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '403', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.7', 'groupId': 'OG000', 'lowerLimit': '73.03', 'upperLimit': '82.38'}, {'value': '69.2', 'groupId': 'OG001', 'lowerLimit': '64.72', 'upperLimit': '73.74'}]}]}, {'title': 'Month 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '391', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.7', 'groupId': 'OG000', 'lowerLimit': '74.03', 'upperLimit': '83.30'}, {'value': '69.3', 'groupId': 'OG001', 'lowerLimit': '64.74', 'upperLimit': '73.88'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '372', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.3', 'groupId': 'OG000', 'lowerLimit': '74.62', 'upperLimit': '83.89'}, {'value': '69.9', 'groupId': 'OG001', 'lowerLimit': '65.23', 'upperLimit': '74.55'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36', 'description': 'SALT is a quantitative assessment of AA severity based on scalp terminal hair loss. Scalp hair was divided into four quadrants (back, top of scalp, right side and left side), with each given an accurate determination of the percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of scalp in that area. SALT score=sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. SALT AA Score = SALT overall score minus SALT AGA score, where SALT overall score included any hair loss regardless of etiology and SALT AGA score included scalp hair loss only due to androgenetic alopecia. SALT AA score ranged from 0 (no hair loss) to 100 (complete scalp hair loss), with lower score indicating less hair loss. 95% CI was calculated based on normal approximation.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was defined as all participants regardless of whether they received study intervention. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Main Study: Change From Baseline in SALT Overall Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '603', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants)', 'description': 'Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.'}, {'id': 'OG001', 'title': 'Main Study: Ritlecitinib 50 mg QD (Roll-over Participants)', 'description': 'Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'OG000'}, {'value': '585', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '9.94', 'groupId': 'OG000'}, {'value': '-41.8', 'spread': '37.34', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}, {'value': '580', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-23.6', 'spread': '26.51', 'groupId': 'OG000'}, {'value': '-46.0', 'spread': '37.32', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '542', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-36.6', 'spread': '32.07', 'groupId': 'OG000'}, {'value': '-52.0', 'spread': '37.26', 'groupId': 'OG001'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-44.2', 'spread': '32.71', 'groupId': 'OG000'}, {'value': '-56.8', 'spread': '35.89', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '385', 'groupId': 'OG000'}, {'value': '475', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-47.5', 'spread': '32.34', 'groupId': 'OG000'}, {'value': '-60.1', 'spread': '35.17', 'groupId': 'OG001'}]}]}, {'title': 'Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'OG000'}, {'value': '448', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-50.6', 'spread': '31.89', 'groupId': 'OG000'}, {'value': '-62.8', 'spread': '33.88', 'groupId': 'OG001'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'OG000'}, {'value': '436', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-52.5', 'spread': '31.98', 'groupId': 'OG000'}, {'value': '-64.2', 'spread': '33.64', 'groupId': 'OG001'}]}]}, {'title': 'Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-53.3', 'spread': '31.70', 'groupId': 'OG000'}, {'value': '-65.8', 'spread': '32.43', 'groupId': 'OG001'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '420', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-53.6', 'spread': '31.79', 'groupId': 'OG000'}, {'value': '-65.5', 'spread': '32.67', 'groupId': 'OG001'}]}]}, {'title': 'Month 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '410', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-54.8', 'spread': '31.81', 'groupId': 'OG000'}, {'value': '-67.2', 'spread': '32.49', 'groupId': 'OG001'}]}]}, {'title': 'Month 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '397', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-55.8', 'spread': '31.48', 'groupId': 'OG000'}, {'value': '-67.8', 'spread': '32.42', 'groupId': 'OG001'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '373', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-56.6', 'spread': '31.99', 'groupId': 'OG000'}, {'value': '-68.1', 'spread': '32.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36', 'description': 'SALT is a quantitative assessment of AA severity based on the scalp terminal hair loss. A visual aid was utilized showing division of scalp hair into four quadrants (back, top of scalp, right side and left side), with each of four quadrants given an accurate determination of the percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of scalp in that area. SALT score is sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. SALT overall score included any hair loss regardless of etiology (e.g., including scalp hair loss due to both androgenetic alopecia and AA). For roll-over participants originating from Study B7931005 or B7981015, baseline is day 1 from Study B7931005 or B7981015. For de novo participants, baseline is day 1 from Study B7981032.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was defined as all participants regardless of whether they received study intervention. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Main Study: Change From Baseline in AA SALT Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '603', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants)', 'description': 'Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.'}, {'id': 'OG001', 'title': 'Main Study: Ritlecitinib 50 mg QD (Roll-over Participants)', 'description': 'Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'OG000'}, {'value': '533', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '10.32', 'groupId': 'OG000'}, {'value': '-42.8', 'spread': '37.48', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-23.8', 'spread': '26.88', 'groupId': 'OG000'}, {'value': '-47.0', 'spread': '37.33', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-37.3', 'spread': '32.12', 'groupId': 'OG000'}, {'value': '-52.8', 'spread': '37.05', 'groupId': 'OG001'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '483', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-44.8', 'spread': '32.73', 'groupId': 'OG000'}, {'value': '-57.4', 'spread': '35.81', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'OG000'}, {'value': '454', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-48.5', 'spread': '32.20', 'groupId': 'OG000'}, {'value': '-61.1', 'spread': '34.82', 'groupId': 'OG001'}]}]}, {'title': 'Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'OG000'}, {'value': '432', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-51.6', 'spread': '31.43', 'groupId': 'OG000'}, {'value': '-63.8', 'spread': '33.41', 'groupId': 'OG001'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '425', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-53.5', 'spread': '31.39', 'groupId': 'OG000'}, {'value': '-65.0', 'spread': '33.16', 'groupId': 'OG001'}]}]}, {'title': 'Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-53.8', 'spread': '31.57', 'groupId': 'OG000'}, {'value': '-66.0', 'spread': '32.43', 'groupId': 'OG001'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-54.1', 'spread': '31.93', 'groupId': 'OG000'}, {'value': '-65.9', 'spread': '32.62', 'groupId': 'OG001'}]}]}, {'title': 'Month 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '403', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-55.2', 'spread': '32.01', 'groupId': 'OG000'}, {'value': '-67.4', 'spread': '32.53', 'groupId': 'OG001'}]}]}, {'title': 'Month 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '391', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-56.0', 'spread': '31.69', 'groupId': 'OG000'}, {'value': '-67.8', 'spread': '32.55', 'groupId': 'OG001'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '371', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-56.5', 'spread': '32.04', 'groupId': 'OG000'}, {'value': '-68.2', 'spread': '32.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36', 'description': 'SALT=quantitative assessment of AA severity based on scalp terminal hair loss. Scalp hair was divided into 4 quadrants (back, top of scalp, right side and left side), with each given an accurate determination of percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of scalp in that area. SALT score=sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss). SALT AA Score = SALT overall score minus SALT AGA score, where SALT overall score included any hair loss regardless of etiology and SALT AGA score included scalp hair loss only due to androgenetic alopecia. SALT AA score ranged from 0 (no hair loss) to 100 (complete scalp hair loss), lower score= less hair loss. Baseline (Roll-over participants: Day 1 from Study B7931005 or B7981015; De novo participants: Day 1 from Study B7981032).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was defined as all participants regardless of whether they received study intervention. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving Atleast 75% Improvement in Overall SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '603', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants)', 'description': 'Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.'}, {'id': 'OG001', 'title': 'Main Study: Ritlecitinib 50 mg QD (Roll-over Participants)', 'description': 'Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'OG000'}, {'value': '585', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '1.80'}, {'value': '37.4', 'groupId': 'OG001', 'lowerLimit': '33.51', 'upperLimit': '41.36'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}, {'value': '580', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.5', 'groupId': 'OG000', 'lowerLimit': '17.60', 'upperLimit': '25.43'}, {'value': '42.6', 'groupId': 'OG001', 'lowerLimit': '38.56', 'upperLimit': '46.61'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '542', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.2', 'groupId': 'OG000', 'lowerLimit': '39.40', 'upperLimit': '48.91'}, {'value': '51.3', 'groupId': 'OG001', 'lowerLimit': '47.08', 'upperLimit': '55.50'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.5', 'groupId': 'OG000', 'lowerLimit': '50.65', 'upperLimit': '60.41'}, {'value': '56.9', 'groupId': 'OG001', 'lowerLimit': '52.56', 'upperLimit': '61.16'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '385', 'groupId': 'OG000'}, {'value': '475', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61.8', 'groupId': 'OG000', 'lowerLimit': '56.97', 'upperLimit': '66.67'}, {'value': '61.3', 'groupId': 'OG001', 'lowerLimit': '56.88', 'upperLimit': '65.64'}]}]}, {'title': 'Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'OG000'}, {'value': '448', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.4', 'groupId': 'OG000', 'lowerLimit': '62.60', 'upperLimit': '72.18'}, {'value': '64.7', 'groupId': 'OG001', 'lowerLimit': '60.31', 'upperLimit': '69.16'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'OG000'}, {'value': '436', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.4', 'groupId': 'OG000', 'lowerLimit': '63.62', 'upperLimit': '73.25'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '62.32', 'upperLimit': '71.17'}]}]}, {'title': 'Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.3', 'groupId': 'OG000', 'lowerLimit': '64.41', 'upperLimit': '74.14'}, {'value': '67.9', 'groupId': 'OG001', 'lowerLimit': '63.49', 'upperLimit': '72.32'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '420', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.9', 'groupId': 'OG000', 'lowerLimit': '65.04', 'upperLimit': '74.84'}, {'value': '68.1', 'groupId': 'OG001', 'lowerLimit': '63.64', 'upperLimit': '72.55'}]}]}, {'title': 'Month 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '410', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.4', 'groupId': 'OG000', 'lowerLimit': '68.50', 'upperLimit': '78.21'}, {'value': '70.2', 'groupId': 'OG001', 'lowerLimit': '65.82', 'upperLimit': '74.67'}]}]}, {'title': 'Month 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '397', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.4', 'groupId': 'OG000', 'lowerLimit': '71.64', 'upperLimit': '81.11'}, {'value': '70.5', 'groupId': 'OG001', 'lowerLimit': '66.04', 'upperLimit': '75.01'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '373', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.7', 'groupId': 'OG000', 'lowerLimit': '71.87', 'upperLimit': '81.51'}, {'value': '70.8', 'groupId': 'OG001', 'lowerLimit': '66.16', 'upperLimit': '75.39'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36', 'description': 'SALT is a quantitative assessment of AA severity based on the scalp terminal hair loss. A visual aid was utilized showing the division of the scalp hair into four quadrants (back, top of scalp, right side and left side), with each of the four quadrants given an accurate determination of the percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. The SALT overall score included any hair loss regardless of etiology (e.g., including scalp hair loss due to both androgenetic alopecia and AA). An Overall SALT 75 response was a 75% or greater reduction from baseline in SALT score.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was defined as all participants regardless of whether they received study intervention. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving Atleast 75% Improvement in AA SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '603', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants)', 'description': 'Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.'}, {'id': 'OG001', 'title': 'Main Study: Ritlecitinib 50 mg QD (Roll-over Participants)', 'description': 'Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'OG000'}, {'value': '533', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.03', 'upperLimit': '2.02'}, {'value': '38.6', 'groupId': 'OG001', 'lowerLimit': '34.52', 'upperLimit': '42.78'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.8', 'groupId': 'OG000', 'lowerLimit': '18.53', 'upperLimit': '26.98'}, {'value': '43.6', 'groupId': 'OG001', 'lowerLimit': '39.43', 'upperLimit': '47.84'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.6', 'groupId': 'OG000', 'lowerLimit': '40.48', 'upperLimit': '50.62'}, {'value': '51.8', 'groupId': 'OG001', 'lowerLimit': '47.43', 'upperLimit': '56.10'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '483', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000', 'lowerLimit': '51.98', 'upperLimit': '62.22'}, {'value': '57.3', 'groupId': 'OG001', 'lowerLimit': '52.94', 'upperLimit': '61.76'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'OG000'}, {'value': '454', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.8', 'groupId': 'OG000', 'lowerLimit': '57.74', 'upperLimit': '67.91'}, {'value': '62.3', 'groupId': 'OG001', 'lowerLimit': '57.88', 'upperLimit': '66.79'}]}]}, {'title': 'Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'OG000'}, {'value': '432', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.2', 'groupId': 'OG000', 'lowerLimit': '64.21', 'upperLimit': '74.11'}, {'value': '65.5', 'groupId': 'OG001', 'lowerLimit': '61.03', 'upperLimit': '69.99'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '425', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.7', 'groupId': 'OG000', 'lowerLimit': '65.79', 'upperLimit': '75.60'}, {'value': '67.5', 'groupId': 'OG001', 'lowerLimit': '63.08', 'upperLimit': '71.98'}]}]}, {'title': 'Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.8', 'groupId': 'OG000', 'lowerLimit': '65.82', 'upperLimit': '75.71'}, {'value': '68.0', 'groupId': 'OG001', 'lowerLimit': '63.55', 'upperLimit': '72.48'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.0', 'groupId': 'OG000', 'lowerLimit': '67.08', 'upperLimit': '76.95'}, {'value': '68.4', 'groupId': 'OG001', 'lowerLimit': '63.87', 'upperLimit': '72.87'}]}]}, {'title': 'Month 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '403', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.8', 'groupId': 'OG000', 'lowerLimit': '69.88', 'upperLimit': '79.63'}, {'value': '70.5', 'groupId': 'OG001', 'lowerLimit': '66.02', 'upperLimit': '74.93'}]}]}, {'title': 'Month 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '391', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.3', 'groupId': 'OG000', 'lowerLimit': '72.60', 'upperLimit': '82.07'}, {'value': '70.3', 'groupId': 'OG001', 'lowerLimit': '65.80', 'upperLimit': '74.86'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '371', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.2', 'groupId': 'OG000', 'lowerLimit': '72.42', 'upperLimit': '82.01'}, {'value': '70.9', 'groupId': 'OG001', 'lowerLimit': '66.27', 'upperLimit': '75.51'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36', 'description': 'SALT=quantitative assessment of AA severity based on scalp terminal hair loss. Scalp hair was divided into four quadrants (back, top of scalp, right side and left side), with each given an accurate determination of percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of scalp in that area. SALT score=sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. SALT AA Score= SALT overall score minus SALT AGA score, where SALT overall score included any hair loss regardless of etiology and SALT AGA score included scalp hair loss only due to androgenetic alopecia. SALT AA score ranged from 0 (no hair loss) to 100 (complete scalp hair loss), where lower score=less hair loss. SALT 75 response= 75% or greater reduction from baseline in AA SALT score.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was defined as all participants regardless of whether they received study intervention. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving Atleast 2-Grade Improvement From Baseline or Absolute Score of 3 in the Eyebrow Assessment (EBA) at Months 1, 3, 6, 12, 18, 24 and 36 in Participants Without Normal EBA Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '603', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants)', 'description': 'Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.'}, {'id': 'OG001', 'title': 'Main Study: Ritlecitinib 50 mg QD (Roll-over Participants)', 'description': 'Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '482', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '2.11', 'upperLimit': '6.53'}, {'value': '38.8', 'groupId': 'OG001', 'lowerLimit': '34.45', 'upperLimit': '43.15'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '475', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.3', 'groupId': 'OG000', 'lowerLimit': '17.69', 'upperLimit': '26.90'}, {'value': '43.4', 'groupId': 'OG001', 'lowerLimit': '38.91', 'upperLimit': '47.83'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '446', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.6', 'groupId': 'OG000', 'lowerLimit': '32.24', 'upperLimit': '43.00'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '45.36', 'upperLimit': '54.64'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.0', 'groupId': 'OG000', 'lowerLimit': '49.17', 'upperLimit': '60.83'}, {'value': '60.3', 'groupId': 'OG001', 'lowerLimit': '55.44', 'upperLimit': '65.18'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59.5', 'groupId': 'OG000', 'lowerLimit': '53.55', 'upperLimit': '65.39'}, {'value': '64.2', 'groupId': 'OG001', 'lowerLimit': '59.28', 'upperLimit': '69.21'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61.2', 'groupId': 'OG000', 'lowerLimit': '55.12', 'upperLimit': '67.33'}, {'value': '67.9', 'groupId': 'OG001', 'lowerLimit': '62.99', 'upperLimit': '72.87'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.6', 'groupId': 'OG000', 'lowerLimit': '59.23', 'upperLimit': '71.93'}, {'value': '69.9', 'groupId': 'OG001', 'lowerLimit': '64.79', 'upperLimit': '75.02'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Months 1, 3, 6, 12, 18, 24 and 36', 'description': 'EBA is a numeric rating scale developed to characterize eyebrow hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal), where 0= no eyebrow, 1=minimal eyebrow, 2=moderate eyebrow and 3= normal eyebrow. Higher scores represent lesser loss of eyebrow hair. 95% CI was based on normal approximation.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was defined as all participants regardless of whether they received study intervention. All participants reported under "Number of Participants Analyzed" included all participants from FAS without normal EBA score at baseline who contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving Atleast 2-Grade Improvement From Baseline or Absolute Score of 3 in the Eyelash Assessment (ELA) at Months 1, 3, 6, 12, 18, 24 and 36 in Participants Without Normal ELA Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '603', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants)', 'description': 'Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.'}, {'id': 'OG001', 'title': 'Main Study: Ritlecitinib 50 mg QD (Roll-over Participants)', 'description': 'Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '440', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '1.34', 'upperLimit': '5.53'}, {'value': '37.7', 'groupId': 'OG001', 'lowerLimit': '33.20', 'upperLimit': '42.26'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '435', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.7', 'groupId': 'OG000', 'lowerLimit': '13.27', 'upperLimit': '22.19'}, {'value': '42.5', 'groupId': 'OG001', 'lowerLimit': '37.88', 'upperLimit': '47.17'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '410', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.7', 'groupId': 'OG000', 'lowerLimit': '31.03', 'upperLimit': '42.36'}, {'value': '47.1', 'groupId': 'OG001', 'lowerLimit': '42.24', 'upperLimit': '51.90'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.8', 'groupId': 'OG000', 'lowerLimit': '48.63', 'upperLimit': '60.97'}, {'value': '56.5', 'groupId': 'OG001', 'lowerLimit': '51.33', 'upperLimit': '61.66'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '327', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.1', 'groupId': 'OG000', 'lowerLimit': '55.93', 'upperLimit': '68.33'}, {'value': '61.2', 'groupId': 'OG001', 'lowerLimit': '55.88', 'upperLimit': '66.44'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '313', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.2', 'groupId': 'OG000', 'lowerLimit': '59.90', 'upperLimit': '72.51'}, {'value': '68.1', 'groupId': 'OG001', 'lowerLimit': '62.89', 'upperLimit': '73.22'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.4', 'groupId': 'OG000', 'lowerLimit': '62.73', 'upperLimit': '75.98'}, {'value': '70.5', 'groupId': 'OG001', 'lowerLimit': '65.14', 'upperLimit': '75.86'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Months 1, 3, 6, 12, 18, 24 and 36', 'description': 'ELA is a numeric rating scale developed to characterize eyelash hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal), where 0=no eyelash, 1=minimal eyelash, 2=moderate eyelash and 3=normal eyelash. Higher scores represent lesser loss of eyelash hair.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was defined as all participants regardless of whether they received study intervention. All participants reported under "Overall Number of Participants Analyzed" included all participants from FAS without normal ELA score at baseline who contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': "Main Study: Percentage of Participants Achieving Patient's Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Months 1, 3, 6, 9, 12, 18, 24 and 36", 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '603', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants)', 'description': 'Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.'}, {'id': 'OG001', 'title': 'Main Study: Ritlecitinib 50 mg QD (Roll-over Participants)', 'description': 'Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'OG000'}, {'value': '587', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000', 'lowerLimit': '12.97', 'upperLimit': '19.91'}, {'value': '55.2', 'groupId': 'OG001', 'lowerLimit': '51.17', 'upperLimit': '59.22'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '426', 'groupId': 'OG000'}, {'value': '580', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.0', 'groupId': 'OG000', 'lowerLimit': '52.34', 'upperLimit': '61.74'}, {'value': '59.3', 'groupId': 'OG001', 'lowerLimit': '55.31', 'upperLimit': '63.31'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}, {'value': '542', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.8', 'groupId': 'OG000', 'lowerLimit': '64.38', 'upperLimit': '73.21'}, {'value': '66.4', 'groupId': 'OG001', 'lowerLimit': '62.44', 'upperLimit': '70.40'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '396', 'groupId': 'OG000'}, {'value': '509', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.5', 'groupId': 'OG000', 'lowerLimit': '72.34', 'upperLimit': '80.69'}, {'value': '69.5', 'groupId': 'OG001', 'lowerLimit': '65.55', 'upperLimit': '73.55'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '384', 'groupId': 'OG000'}, {'value': '474', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.6', 'groupId': 'OG000', 'lowerLimit': '74.55', 'upperLimit': '82.74'}, {'value': '72.6', 'groupId': 'OG001', 'lowerLimit': '68.56', 'upperLimit': '76.59'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '436', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.0', 'groupId': 'OG000', 'lowerLimit': '76.88', 'upperLimit': '85.03'}, {'value': '74.8', 'groupId': 'OG001', 'lowerLimit': '70.69', 'upperLimit': '78.85'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '420', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.4', 'groupId': 'OG000', 'lowerLimit': '78.31', 'upperLimit': '86.47'}, {'value': '78.6', 'groupId': 'OG001', 'lowerLimit': '74.65', 'upperLimit': '82.50'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '372', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.1', 'groupId': 'OG000', 'lowerLimit': '78.77', 'upperLimit': '87.33'}, {'value': '79.0', 'groupId': 'OG001', 'lowerLimit': '74.90', 'upperLimit': '83.17'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Months 1, 3, 6, 9, 12, 18, 24 and 36', 'description': "PGI-C is a self-administered single item questionnaire to evaluate the improvement or worsening of participant's AA as compared to the start of the study. Participants were required to select their response on a 7-point scale ranging from 1 (greatly worsened), 2=moderately worsened, 3=slightly worsened, 4=not changed, 5= slightly improved, 6=moderately improved, 7 (greatly improved). 95% CI was based on normal approximation.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was defined as all participants regardless of whether they received study intervention. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Main Study: Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36: Emotional Symptoms and Activity Limitations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '603', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants)', 'description': 'Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.'}, {'id': 'OG001', 'title': 'Main Study: Ritlecitinib 50 mg QD (Roll-over Participants)', 'description': 'Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.'}], 'classes': [{'title': 'Month 1: Emotional Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '584', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.683', 'groupId': 'OG000'}, {'value': '-0.84', 'spread': '1.036', 'groupId': 'OG001'}]}]}, {'title': 'Month 3: Emotional Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '576', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.61', 'spread': '0.867', 'groupId': 'OG000'}, {'value': '-0.86', 'spread': '1.055', 'groupId': 'OG001'}]}]}, {'title': 'Month 6: Emotional Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.77', 'spread': '1.012', 'groupId': 'OG000'}, {'value': '-0.95', 'spread': '1.087', 'groupId': 'OG001'}]}]}, {'title': 'Month 9: Emotional Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '505', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.95', 'spread': '1.091', 'groupId': 'OG000'}, {'value': '-0.95', 'spread': '1.123', 'groupId': 'OG001'}]}]}, {'title': 'Month 12: Emotional Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '385', 'groupId': 'OG000'}, {'value': '471', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.00', 'spread': '1.161', 'groupId': 'OG000'}, {'value': '-1.04', 'spread': '1.128', 'groupId': 'OG001'}]}]}, {'title': 'Month 18: Emotional Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.07', 'spread': '1.174', 'groupId': 'OG000'}, {'value': '-1.11', 'spread': '1.129', 'groupId': 'OG001'}]}]}, {'title': 'Month 24: Emotional Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '417', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.12', 'spread': '1.232', 'groupId': 'OG000'}, {'value': '-1.07', 'spread': '1.172', 'groupId': 'OG001'}]}]}, {'title': 'Month 36: Emotional Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '368', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.20', 'spread': '1.246', 'groupId': 'OG000'}, {'value': '-1.11', 'spread': '1.204', 'groupId': 'OG001'}]}]}, {'title': 'Month 1: Activity Limitations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '584', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.641', 'groupId': 'OG000'}, {'value': '-0.36', 'spread': '0.789', 'groupId': 'OG001'}]}]}, {'title': 'Month 3: Activity Limitations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '576', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.667', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '0.811', 'groupId': 'OG001'}]}]}, {'title': 'Month 6: Activity Limitations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.719', 'groupId': 'OG000'}, {'value': '-0.44', 'spread': '0.829', 'groupId': 'OG001'}]}]}, {'title': 'Month 9: Activity Limitations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.781', 'groupId': 'OG000'}, {'value': '-0.45', 'spread': '0.857', 'groupId': 'OG001'}]}]}, {'title': 'Month 12: Activity Limitations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '385', 'groupId': 'OG000'}, {'value': '471', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.36', 'spread': '0.793', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '0.871', 'groupId': 'OG001'}]}]}, {'title': 'Month 18: Activity Limitations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.40', 'spread': '0.830', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '0.869', 'groupId': 'OG001'}]}]}, {'title': 'Month 24: Activity Limitations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.43', 'spread': '0.824', 'groupId': 'OG000'}, {'value': '-0.52', 'spread': '0.890', 'groupId': 'OG001'}]}]}, {'title': 'Month 36: Activity Limitations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '368', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.43', 'spread': '0.858', 'groupId': 'OG000'}, {'value': '-0.53', 'spread': '0.859', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, At Months 1, 3, 6, 9, 12, 18, 24 and 36', 'description': "AAPPO scale is a 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 5-8 assessed emotional symptoms with responses scored from 0 ='never' to 4='always'. Items 9-11 assessed activity limitations with responses scored from 0='not at all' to 4='completely'. AAPPO emotional symptoms sub score was calculated as mean of items 5-8 and ranged from 0 (never) to 4 (always), where higher scores indicated more emotional symptoms. AAPPO activity limitations sub score was calculated as mean of items 9-11 and ranged from 0(not at all) to 4(completely), where higher scores indicated more activity limitations. For roll-over participants originating from Study B7931005 or B7981015, baseline is day 1 from Study B7931005 or B7981015. For de novo participants, baseline is day 1 from Study B7981032.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was defined as all participants regardless of whether they received study intervention. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '603', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants)', 'description': 'Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.'}, {'id': 'OG001', 'title': 'Main Study: Ritlecitinib 50 mg QD (Roll-over Participants)', 'description': 'Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.'}], 'classes': [{'title': 'Month 1: Current hair loss on Scalp', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '567', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000', 'lowerLimit': '6.96', 'upperLimit': '12.66'}, {'value': '37.2', 'groupId': 'OG001', 'lowerLimit': '33.23', 'upperLimit': '41.19'}]}]}, {'title': 'Month 3: Current hair loss on Scalp', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}, {'value': '559', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.5', 'groupId': 'OG000', 'lowerLimit': '23.18', 'upperLimit': '31.81'}, {'value': '38.5', 'groupId': 'OG001', 'lowerLimit': '34.43', 'upperLimit': '42.49'}]}]}, {'title': 'Month 6: Current hair loss on Scalp', 'denoms': [{'units': 'Participants', 'counts': [{'value': '409', 'groupId': 'OG000'}, {'value': '517', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.7', 'groupId': 'OG000', 'lowerLimit': '40.89', 'upperLimit': '50.55'}, {'value': '46.4', 'groupId': 'OG001', 'lowerLimit': '42.12', 'upperLimit': '50.72'}]}]}, {'title': 'Month 9: Current hair loss on Scalp', 'denoms': [{'units': 'Participants', 'counts': [{'value': '383', 'groupId': 'OG000'}, {'value': '490', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000', 'lowerLimit': '50.64', 'upperLimit': '60.59'}, {'value': '49.8', 'groupId': 'OG001', 'lowerLimit': '45.37', 'upperLimit': '54.22'}]}]}, {'title': 'Month 12: Current hair loss on Scalp', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '459', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.9', 'groupId': 'OG000', 'lowerLimit': '53.91', 'upperLimit': '63.93'}, {'value': '52.7', 'groupId': 'OG001', 'lowerLimit': '48.16', 'upperLimit': '57.29'}]}]}, {'title': 'Month 18: Current hair loss on Scalp', 'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'OG000'}, {'value': '421', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.2', 'groupId': 'OG000', 'lowerLimit': '57.15', 'upperLimit': '67.35'}, {'value': '57.2', 'groupId': 'OG001', 'lowerLimit': '52.52', 'upperLimit': '61.97'}]}]}, {'title': 'Month 24: Current hair loss on Scalp', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.8', 'groupId': 'OG000', 'lowerLimit': '62.72', 'upperLimit': '72.86'}, {'value': '60.7', 'groupId': 'OG001', 'lowerLimit': '55.92', 'upperLimit': '65.47'}]}]}, {'title': 'Month 36: Current hair loss on Scalp', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.3', 'groupId': 'OG000', 'lowerLimit': '64.00', 'upperLimit': '74.67'}, {'value': '58.5', 'groupId': 'OG001', 'lowerLimit': '53.34', 'upperLimit': '63.61'}]}]}, {'title': 'Month 1: Current hair loss on Eyebrows', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '441', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000', 'lowerLimit': '6.33', 'upperLimit': '13.38'}, {'value': '42.9', 'groupId': 'OG001', 'lowerLimit': '38.24', 'upperLimit': '47.48'}]}]}, {'title': 'Month 3: Current hair loss on Eyebrows', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.4', 'groupId': 'OG000', 'lowerLimit': '26.79', 'upperLimit': '37.91'}, {'value': '44.1', 'groupId': 'OG001', 'lowerLimit': '39.43', 'upperLimit': '48.79'}]}]}, {'title': 'Month 6: Current hair loss on Eyebrows', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '398', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.9', 'groupId': 'OG000', 'lowerLimit': '37.94', 'upperLimit': '49.80'}, {'value': '49.5', 'groupId': 'OG001', 'lowerLimit': '44.59', 'upperLimit': '54.41'}]}]}, {'title': 'Month 9: Current hair loss on Eyebrows', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.0', 'groupId': 'OG000', 'lowerLimit': '42.75', 'upperLimit': '55.22'}, {'value': '52.9', 'groupId': 'OG001', 'lowerLimit': '47.88', 'upperLimit': '57.97'}]}]}, {'title': 'Month 12: Current hair loss on Eyebrows', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.5', 'groupId': 'OG000', 'lowerLimit': '49.17', 'upperLimit': '61.85'}, {'value': '55.0', 'groupId': 'OG001', 'lowerLimit': '49.81', 'upperLimit': '60.28'}]}]}, {'title': 'Month 18: Current hair loss on Eyebrows', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.9', 'groupId': 'OG000', 'lowerLimit': '54.46', 'upperLimit': '67.36'}, {'value': '60.1', 'groupId': 'OG001', 'lowerLimit': '54.77', 'upperLimit': '65.48'}]}]}, {'title': 'Month 24: Current hair loss on Eyebrows', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.7', 'groupId': 'OG000', 'lowerLimit': '53.94', 'upperLimit': '67.45'}, {'value': '64.4', 'groupId': 'OG001', 'lowerLimit': '59.06', 'upperLimit': '69.74'}]}]}, {'title': 'Month 36: Current hair loss on Eyebrows', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63.8', 'groupId': 'OG000', 'lowerLimit': '56.65', 'upperLimit': '70.93'}, {'value': '64.7', 'groupId': 'OG001', 'lowerLimit': '59.08', 'upperLimit': '70.37'}]}]}, {'title': 'Month 1: Current hair loss on Eyelashes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '386', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000', 'lowerLimit': '4.60', 'upperLimit': '11.57'}, {'value': '40.9', 'groupId': 'OG001', 'lowerLimit': '36.03', 'upperLimit': '45.84'}]}]}, {'title': 'Month 3: Current hair loss on Eyelashes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.8', 'groupId': 'OG000', 'lowerLimit': '29.61', 'upperLimit': '41.94'}, {'value': '44.2', 'groupId': 'OG001', 'lowerLimit': '39.22', 'upperLimit': '49.20'}]}]}, {'title': 'Month 6: Current hair loss on Eyelashes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '350', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.7', 'groupId': 'OG000', 'lowerLimit': '39.21', 'upperLimit': '52.09'}, {'value': '46.6', 'groupId': 'OG001', 'lowerLimit': '41.35', 'upperLimit': '51.80'}]}]}, {'title': 'Month 9: Current hair loss on Eyelashes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '328', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.2', 'groupId': 'OG000', 'lowerLimit': '47.54', 'upperLimit': '60.95'}, {'value': '54.0', 'groupId': 'OG001', 'lowerLimit': '48.57', 'upperLimit': '59.36'}]}]}, {'title': 'Month 12: Current hair loss on Eyelashes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.2', 'groupId': 'OG000', 'lowerLimit': '49.36', 'upperLimit': '63.08'}, {'value': '55.3', 'groupId': 'OG001', 'lowerLimit': '49.80', 'upperLimit': '60.88'}]}]}, {'title': 'Month 18: Current hair loss on Eyelashes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61.9', 'groupId': 'OG000', 'lowerLimit': '54.98', 'upperLimit': '68.83'}, {'value': '62.3', 'groupId': 'OG001', 'lowerLimit': '56.61', 'upperLimit': '67.94'}]}]}, {'title': 'Month 24: Current hair loss on Eyelashes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.3', 'groupId': 'OG000', 'lowerLimit': '57.15', 'upperLimit': '71.51'}, {'value': '65.0', 'groupId': 'OG001', 'lowerLimit': '59.31', 'upperLimit': '70.77'}]}]}, {'title': 'Month 36: Current hair loss on Eyelashes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.8', 'groupId': 'OG000', 'lowerLimit': '62.43', 'upperLimit': '77.17'}, {'value': '67.5', 'groupId': 'OG001', 'lowerLimit': '61.55', 'upperLimit': '73.47'}]}]}, {'title': 'Month 1: Current hair loss on body', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '436', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000', 'lowerLimit': '10.54', 'upperLimit': '18.85'}, {'value': '31.9', 'groupId': 'OG001', 'lowerLimit': '27.51', 'upperLimit': '36.25'}]}]}, {'title': 'Month 3: Current hair loss on body', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.3', 'groupId': 'OG000', 'lowerLimit': '19.22', 'upperLimit': '29.33'}, {'value': '36.5', 'groupId': 'OG001', 'lowerLimit': '31.96', 'upperLimit': '41.06'}]}]}, {'title': 'Month 6: Current hair loss on body', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.6', 'groupId': 'OG000', 'lowerLimit': '28.91', 'upperLimit': '40.21'}, {'value': '41.9', 'groupId': 'OG001', 'lowerLimit': '37.06', 'upperLimit': '46.78'}]}]}, {'title': 'Month 9: Current hair loss on body', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '371', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.7', 'groupId': 'OG000', 'lowerLimit': '37.53', 'upperLimit': '49.77'}, {'value': '46.9', 'groupId': 'OG001', 'lowerLimit': '41.82', 'upperLimit': '51.98'}]}]}, {'title': 'Month 12: Current hair loss on body', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.3', 'groupId': 'OG000', 'lowerLimit': '45.98', 'upperLimit': '58.54'}, {'value': '49.9', 'groupId': 'OG001', 'lowerLimit': '44.60', 'upperLimit': '55.12'}]}]}, {'title': 'Month 18: Current hair loss on body', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.9', 'groupId': 'OG000', 'lowerLimit': '49.49', 'upperLimit': '62.41'}, {'value': '56.0', 'groupId': 'OG001', 'lowerLimit': '50.52', 'upperLimit': '61.43'}]}]}, {'title': 'Month 24: Current hair loss on body', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '302', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59.1', 'groupId': 'OG000', 'lowerLimit': '52.45', 'upperLimit': '65.82'}, {'value': '60.3', 'groupId': 'OG001', 'lowerLimit': '54.75', 'upperLimit': '65.78'}]}]}, {'title': 'Month 36: Current hair loss on body', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.2', 'groupId': 'OG000', 'lowerLimit': '58.25', 'upperLimit': '72.13'}, {'value': '62.2', 'groupId': 'OG001', 'lowerLimit': '56.44', 'upperLimit': '68.01'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, At Months 1, 3, 6, 9, 12, 18, 24 and 36', 'description': "AAPPO scale is a 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 1-4 assessed current hair loss from the scalp, eyebrows, eyelashes and body using a 5 point scale that ranged from 0 ='no hair loss' and 4='complete hair loss'. In this outcome measure, percentage of participants with AAPPO domain scores of 0 = no hair loss or 1 = a little hair loss, among participants with score \\>=2 at baseline are reported.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was defined as all participants regardless of whether they received study intervention. Participants reported under "Overall Number of Participants Analyzed" included all participants from FAS who had an AAPPO baseline score \\>=2 who contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Main Study: Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Months 1, 3, 6, 9, 12, 18, 24 and 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '603', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants)', 'description': 'Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.'}, {'id': 'OG001', 'title': 'Main Study: Ritlecitinib 50 mg QD (Roll-over Participants)', 'description': 'Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '431', 'groupId': 'OG000'}, {'value': '587', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '2.27', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '2.87', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '426', 'groupId': 'OG000'}, {'value': '578', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '2.47', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '2.80', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '422', 'groupId': 'OG000'}, {'value': '540', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '2.60', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '2.97', 'groupId': 'OG001'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}, {'value': '508', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '2.64', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '2.94', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '385', 'groupId': 'OG000'}, {'value': '471', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '2.66', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '3.16', 'groupId': 'OG001'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '436', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '2.72', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '3.08', 'groupId': 'OG001'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '420', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '2.75', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '3.11', 'groupId': 'OG001'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '366', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '2.92', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '2.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, At Months 1, 3, 6, 9, 12, 18, 24 and 36', 'description': 'HADS is a validated 14-item questionnaire used to assess states of anxiety and depression over the past week. The HADS consisted of 2 subscales, one for anxiety (HADS-A) and one for depression (HADS-D). The depression subscale comprised of 7 items with score ranging from 0 (no presence of depression) to 3 (severe feeling of depression). Total depression subscale score was calculated as the sum of 7 items and ranged from 0 to 21; higher score indicating greater severity of depression symptoms. For roll-over participants originating from Study B7931005 or B7981015, baseline is day 1 from Study B7931005 or B7981015. For de novo participants, baseline is day 1 from Study B7981032.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was defined as all participants regardless of whether they received study intervention. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Main Study: Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Months 1, 3, 6, 9, 12, 18, 24 and 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '603', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants)', 'description': 'Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.'}, {'id': 'OG001', 'title': 'Main Study: Ritlecitinib 50 mg QD (Roll-over Participants)', 'description': 'Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '430', 'groupId': 'OG000'}, {'value': '586', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '2.57', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '3.38', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '425', 'groupId': 'OG000'}, {'value': '575', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '2.65', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '3.46', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '2.79', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '3.33', 'groupId': 'OG001'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '3.02', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '3.46', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '384', 'groupId': 'OG000'}, {'value': '471', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '3.14', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '3.52', 'groupId': 'OG001'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '435', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '3.01', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '3.45', 'groupId': 'OG001'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '3.21', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '3.48', 'groupId': 'OG001'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '3.35', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '3.46', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, At Months 1, 3, 6, 9, 12, 18, 24 and 36', 'description': 'HADS is a validated 14-item questionnaire used to assess states of anxiety and depression over the past week. The HADS consisted of 2 subscales, one for anxiety (HADS-A) and one for depression (HADS-D). The anxiety subscale comprised of 7 items with score ranging from 0 (no anxiety) to 3 (severe anxiety). Total anxiety subscale score was calculated as the sum of 7 items and ranged from 0 to 21; higher score indicating greater severity of anxiety symptoms. For roll-over participants originating from Study B7931005 or B7981015, baseline is day 1 from Study B7931005 or B7981015. For de novo participants, baseline is day 1 from Study B7981032.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was defined as all participants regardless of whether they received study intervention. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants With Improvement on HADS Depression Score at Months 1, 3, 6, 9, 12, 18, 24 and 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants)', 'description': 'Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.'}, {'id': 'OG001', 'title': 'Main Study: Ritlecitinib 50 mg QD (Roll-over Participants)', 'description': 'Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.1', 'groupId': 'OG000', 'lowerLimit': '35.84', 'upperLimit': '70.41'}, {'value': '56.9', 'groupId': 'OG001', 'lowerLimit': '44.15', 'upperLimit': '69.64'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63.3', 'groupId': 'OG000', 'lowerLimit': '46.09', 'upperLimit': '80.58'}, {'value': '52.6', 'groupId': 'OG001', 'lowerLimit': '39.67', 'upperLimit': '65.59'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000', 'lowerLimit': '53.60', 'upperLimit': '86.40'}, {'value': '70.4', 'groupId': 'OG001', 'lowerLimit': '58.19', 'upperLimit': '82.55'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.5', 'groupId': 'OG000', 'lowerLimit': '48.22', 'upperLimit': '82.82'}, {'value': '69.4', 'groupId': 'OG001', 'lowerLimit': '56.48', 'upperLimit': '82.29'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.6', 'groupId': 'OG000', 'lowerLimit': '40.70', 'upperLimit': '76.55'}, {'value': '72.7', 'groupId': 'OG001', 'lowerLimit': '59.57', 'upperLimit': '85.89'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84.6', 'groupId': 'OG000', 'lowerLimit': '70.75', 'upperLimit': '98.48'}, {'value': '63.6', 'groupId': 'OG001', 'lowerLimit': '49.42', 'upperLimit': '77.85'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '68.42', 'upperLimit': '98.24'}, {'value': '62.8', 'groupId': 'OG001', 'lowerLimit': '48.34', 'upperLimit': '77.24'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000', 'lowerLimit': '62.47', 'upperLimit': '97.53'}, {'value': '75.7', 'groupId': 'OG001', 'lowerLimit': '61.85', 'upperLimit': '89.50'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Months 1, 3, 6, 9, 12, 18, 24 and 36', 'description': 'HADS is a validated 14-item questionnaire used to assess states of anxiety and depression over the past week. The HADS consisted of 2 subscales, one for anxiety (HADS-A) and one for depression (HADS-D). The depression subscale comprised of 7 items with score ranging from 0 (no presence of depression) to 3 (severe feeling of depression). Total depression subscale score was calculated as the sum of 7 items and ranged from 0 to 21; higher score indicating greater severity of depression symptoms. Improvement on HADS depression score was considered as achieving a "normal" depression subscale score indicative of an absence of depression. Among adults, a HADS-D score of 0-7 was considered "normal"; for adolescents, a HADS-D score of 0-6 was considered "normal". 95% CI was calculated based on normal approximation.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included was defined as all participants regardless of whether they received study intervention. All participants reported under "Overall Number of Participants Analyzed" included all participants from the FAS with a score indicative of depression at baseline who contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants With Improvement on HADS Anxiety Score At Months 1, 3, 6, 9, 12, 18, 24 and 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants)', 'description': 'Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.'}, {'id': 'OG001', 'title': 'Main Study: Ritlecitinib 50 mg QD (Roll-over Participants)', 'description': 'Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.1', 'groupId': 'OG000', 'lowerLimit': '40.69', 'upperLimit': '61.58'}, {'value': '54.2', 'groupId': 'OG001', 'lowerLimit': '45.25', 'upperLimit': '63.23'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.5', 'groupId': 'OG000', 'lowerLimit': '35.97', 'upperLimit': '57.05'}, {'value': '59.6', 'groupId': 'OG001', 'lowerLimit': '50.64', 'upperLimit': '68.65'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.6', 'groupId': 'OG000', 'lowerLimit': '42.91', 'upperLimit': '64.24'}, {'value': '62.5', 'groupId': 'OG001', 'lowerLimit': '53.53', 'upperLimit': '71.47'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '38.90', 'upperLimit': '61.10'}, {'value': '57.8', 'groupId': 'OG001', 'lowerLimit': '48.53', 'upperLimit': '67.07'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.4', 'groupId': 'OG000', 'lowerLimit': '43.45', 'upperLimit': '65.41'}, {'value': '64.4', 'groupId': 'OG001', 'lowerLimit': '55.22', 'upperLimit': '73.62'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.9', 'groupId': 'OG000', 'lowerLimit': '59.34', 'upperLimit': '80.39'}, {'value': '62.9', 'groupId': 'OG001', 'lowerLimit': '53.27', 'upperLimit': '72.50'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.1', 'groupId': 'OG000', 'lowerLimit': '62.52', 'upperLimit': '83.75'}, {'value': '61.1', 'groupId': 'OG001', 'lowerLimit': '51.25', 'upperLimit': '70.86'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.1', 'groupId': 'OG000', 'lowerLimit': '49.58', 'upperLimit': '74.56'}, {'value': '63.9', 'groupId': 'OG001', 'lowerLimit': '53.52', 'upperLimit': '74.19'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Months 1, 3, 6, 9, 12, 18, 24 and 36', 'description': 'HADS is a validated 14-item questionnaire used to assess states of anxiety and depression over the past week. The HADS consisted of 2 subscales, one for anxiety (HADS-A) and one for depression (HADS-D). The anxiety subscale comprised of 7 items with score ranging from 0 (no anxiety) to 3 (severe anxiety). Total anxiety subscale score was calculated as the sum of 7 items and ranged from 0 to 21; higher score indicating greater severity of anxiety symptoms. Improvement on HADS anxiety score was considered as achieving a "normal" anxiety subscale score indicative of an absence of anxiety. Among adults, a HADS-A score of 0-7 was considered "normal"; for adolescents, a HADS-A score of 0-8 was considered "normal". 95% CI was calculated based on normal approximation.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was defined as all participants regardless of whether they received study intervention. All participants reported under "Overall Number of Participants Analyzed" included all participants from the FAS with a score indicative of anxiety at baseline who contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Vaccine Sub-study: Percentage of Participants With Anti-tetanus Antibody Level >=1.0 International Units Per Milliliter (IU/mL) at Month 1-Tdap Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccine Sub-study: Tdap Vaccination', 'description': 'Participants who have received atleast 6 months of treatment with PF-06651600 50mg QD in the study B7981032 were continued to receive the study intervention while participating in this vaccine sub-study. Eligible participants who received the Tdap vaccine with or without the meningococcal ACWY vaccine were enrolled in this sub-study.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '79.4', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 1', 'description': 'Percentage of participants with anti-tetanus antibody level \\>=1.0 IU/mL at Month 1 were reported in this outcome measure. Two-sided 95% CI was based on Clopper-Pearson exact method.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS-Tdap was defined as all participants who received the Tdap vaccine (with or without the meningococcal ACWY vaccine). Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Vaccine Sub-study: Percentage of Participants With Anti-tetanus Antibody Level >=0.1 IU/mL at Month 1-Tdap Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccine Sub-study: Tdap Vaccination', 'description': 'Participants who have received atleast 6 months of treatment with PF-06651600 50mg QD in the study B7981032 were continued to receive the study intervention while participating in this vaccine sub-study. Eligible participants who received the Tdap vaccine with or without the meningococcal ACWY vaccine were enrolled in this sub-study.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '79.4', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 1', 'description': 'Percentage of participants with anti-tetanus antibody level \\>=0.1 IU/mL at Month 1 were reported in this outcome measure. Two-sided 95% CI was based on Clopper-Pearson exact method.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS-Tdap was defined as all participants who received the Tdap vaccine (with or without the meningococcal ACWY vaccine). Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Vaccine Sub-study: Percentage of Participants With >=4 Times Increase in Anti-tetanus Antibody Level From Baseline at Month 1-Tdap Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccine Sub-study: Tdap Vaccination', 'description': 'Participants who have received atleast 6 months of treatment with PF-06651600 50mg QD in the study B7981032 were continued to receive the study intervention while participating in this vaccine sub-study. Eligible participants who received the Tdap vaccine with or without the meningococcal ACWY vaccine were enrolled in this sub-study.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '24.7', 'upperLimit': '75.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 1', 'description': 'Percentage of participants with \\>=4 times increase in anti-tetanus antibody level from baseline were reported in this outcome measure. Two-sided 95% CI was based on Clopper-Pearson exact method.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS-Tdap was defined as all participants who received the Tdap vaccine (with or without the meningococcal ACWY vaccine). Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Vaccine Sub-study: Geometric Mean Fold Change in Anti-tetanus Levels Above Baseline Values at Month 1-Tdap Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccine Sub-study: Tdap Vaccination', 'description': 'Participants who have received atleast 6 months of treatment with PF-06651600 50mg QD in the study B7981032 were continued to receive the study intervention while participating in this vaccine sub-study. Eligible participants who received the Tdap vaccine with or without the meningococcal ACWY vaccine were enrolled in this sub-study.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '10.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From Baseline (pre-vaccination on Day 1) to Month 1', 'description': 'Geometric mean and 95% CI were calculated by exponentiating the mean logarithm of the observed data and the corresponding CIs. Fold change was defined as the ratio of the post-baseline result to the baseline result. The assay results below the LLOQ were set to 0.5 \\* LLOQ except when pre-vaccination assay results is \\< LLOQ while postvaccination result is \\>= LLOQ, in which case the pre-vaccination value will be set to LLOQ.', 'unitOfMeasure': 'Fold change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS-Tdap was defined as all participants who received the Tdap vaccine (with or without the meningococcal ACWY vaccine). Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Vaccine Sub-study: Geometric Mean Concentrations (GMCs) of Anti-tetanus Antibody Levels at Month 1-Tdap Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccine Sub-study: Tdap Vaccination', 'description': 'Participants who have received atleast 6 months of treatment with PF-06651600 50mg QD in the study B7981032 were continued to receive the study intervention while participating in this vaccine sub-study. Eligible participants who received the Tdap vaccine with or without the meningococcal ACWY vaccine were enrolled in this sub-study.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '12.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Month 1', 'description': 'Geometric mean and 95% CI were calculated by exponentiating the mean logarithm of the observed data and the corresponding CIs. Assay results below the LLOQ were set to 0.5\\* LLOQ.', 'unitOfMeasure': 'milli-international units (mIU)/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS-Tdap was defined as all participants who received the Tdap vaccine (with or without the meningococcal ACWY vaccine). Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Vaccine Sub-study: Percentage of Participants With Human Serum Bactericidal Activity (hSBA) Titer >=1:8 at Month 1 Post-vaccination for Serogroup C-Meningococcal ACWY Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccine Sub-study: Meningococcal ACWY Vaccination', 'description': 'Participants who have received atleast 6 months of treatment with PF-06651600 50mg QD in the study B7981032 were continued to receive the study intervention while participating in this vaccine sub-study. Eligible participants who received the meningococcal ACWY vaccine with or without the Tdap vaccine were enrolled in this sub-study.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '71.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 1', 'description': 'Percentage of participants with hSBA titer \\>=1.8 at 1 month post vaccination for serogroup C were reported in this outcome measure. Two-sided 95% CI was based on Clopper-Pearson exact method.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS-ACWY was defined as all participants who received the meningococcal ACWY vaccine (with or without the Tdap vaccine). Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Vaccine Sub-study: Percentage of Participants With hSBA Titer >=1:4 at Month 1 Post-vaccination for Serogroup C-Meningococcal ACWY Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccine Sub-study: Meningococcal ACWY Vaccination', 'description': 'Participants who have received atleast 6 months of treatment with PF-06651600 50mg QD in the study B7981032 were continued to receive the study intervention while participating in this vaccine sub-study. Eligible participants who received the meningococcal ACWY vaccine with or without the Tdap vaccine were enrolled in this sub-study.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '85.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 1', 'description': 'Percentage of participants with hSBA titer \\>=1.4 at 1 month post vaccination for serogroup C were reported in this outcome measure. Two-sided 95% CI was based on Clopper-Pearson exact method.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS-ACWY was defined as all participants who received the meningococcal ACWY vaccine (with or without the Tdap vaccine). Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Vaccine Sub-study: Geometric Mean Titers (GMT) of Antibodies for Serogroup C at Baseline and Month 1-Meningococcal ACWY Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccine Sub-study: Meningococcal ACWY Vaccination', 'description': 'Participants who have received atleast 6 months of treatment with PF-06651600 50mg QD in the study B7981032 were continued to receive the study intervention while participating in this vaccine sub-study. Eligible participants who received the meningococcal ACWY vaccine with or without the Tdap vaccine were enrolled in this sub-study.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '3.6', 'upperLimit': '8.8'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.1', 'groupId': 'OG000', 'lowerLimit': '4.4', 'upperLimit': '44.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (pre-vaccination on Day 1) and Month 1', 'description': 'Geometric mean and 95% CI were calculated by exponentiating the mean logarithm of the observed data and the corresponding CIs. Assay results below the LLOQ were set to 0.5\\* LLOQ.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS-ACWY was defined as all participants who received the meningococcal ACWY vaccine (with or without the Tdap vaccine). Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Vaccine Sub-study: Number of Participants With SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccine Sub-study: Tdap Vaccination', 'description': 'Participants who have received atleast 6 months of treatment with PF-06651600 50mg QD in the study B7981032 were continued to receive the study intervention while participating in this vaccine sub-study. Eligible participants who received the Tdap vaccine with or without the meningococcal ACWY vaccine were enrolled in this sub-study.'}, {'id': 'OG001', 'title': 'Vaccine Sub-study: Meningococcal ACWY Vaccination', 'description': 'Participants who have received atleast 6 months of treatment with PF-06651600 50mg QD in the study B7981032 were continued to receive the study intervention while participating in this vaccine sub-study. Eligible participants who received the meningococcal ACWY vaccine with or without the Tdap vaccine were enrolled in this sub-study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From day of vaccination (Day 1) up to 35 days post last dose of vaccine (up to Day 36)', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; other important medical events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS was defined as all participants from the vaccine sub study who received at least 1 vaccine (Tdap or meningococcal ACWY).'}, {'type': 'SECONDARY', 'title': 'Vaccine Sub-study: Number of Participants With AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccine Sub-study: Tdap Vaccination', 'description': 'Participants who have received atleast 6 months of treatment with PF-06651600 50mg QD in the study B7981032 were continued to receive the study intervention while participating in this vaccine sub-study. Eligible participants who received the Tdap vaccine with or without the meningococcal ACWY vaccine were enrolled in this sub-study.'}, {'id': 'OG001', 'title': 'Vaccine Sub-study: Meningococcal ACWY Vaccination', 'description': 'Participants who have received atleast 6 months of treatment with PF-06651600 50mg QD in the study B7981032 were continued to receive the study intervention while participating in this vaccine sub-study. Eligible participants who received the meningococcal ACWY vaccine with or without the Tdap vaccine were enrolled in this sub-study.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From day of vaccination (Day 1) up to 35 days post last dose of vaccine (up to Day 36)', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS was defined as all participants from the vaccine sub study who received at least 1 vaccine (Tdap or meningococcal ACWY).'}, {'type': 'SECONDARY', 'title': 'Vaccine Sub-study: Number of Participants With AEs Leading to Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccine Sub-study: Tdap Vaccination', 'description': 'Participants who have received atleast 6 months of treatment with PF-06651600 50mg QD in the study B7981032 were continued to receive the study intervention while participating in this vaccine sub-study. Eligible participants who received the Tdap vaccine with or without the meningococcal ACWY vaccine were enrolled in this sub-study.'}, {'id': 'OG001', 'title': 'Vaccine Sub-study: Meningococcal ACWY Vaccination', 'description': 'Participants who have received atleast 6 months of treatment with PF-06651600 50mg QD in the study B7981032 were continued to receive the study intervention while participating in this vaccine sub-study. Eligible participants who received the meningococcal ACWY vaccine with or without the Tdap vaccine were enrolled in this sub-study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From day of vaccination (Day 1) up to 35 days post last dose of vaccine (up to Day 36)', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs leading to discontinuation included participants who had an AE record that indicated that the AE caused the participant to be discontinued from the study or that action taken with study treatment was drug withdrawn.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS was defined as all participants from the vaccine sub study who received at least 1 vaccine (Tdap or meningococcal ACWY).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants)', 'description': 'Participants with a clinical diagnosis of alopecia areata (AA) received ritlecitinib (PF-06651600) 200 milligrams (mg) once daily (QD) for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.'}, {'id': 'FG001', 'title': 'Main Study: Ritlecitinib 50 mg QD (Roll-over Participants)', 'description': 'Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.'}, {'id': 'FG002', 'title': 'Vaccine Sub-study: Tdap With or Without Meningococcal ACWY Vaccine', 'description': 'Participants who received at least 6 months of treatment with ritlecitinib 50 mg QD in the Main study continued to receive the study treatment in the main study while participating in vaccine sub-study. Participants were administered a single dose of Tetanus and Diphtheria Toxoids and Acellular Pertussis (Tdap) vaccine with or without a single dose of meningococcal ACWY vaccine intramuscularly on Day 1 of the sub-study.'}], 'periods': [{'title': 'Main Study: Treatment Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '449'}, {'groupId': 'FG001', 'numSubjects': '603'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '447'}, {'groupId': 'FG001', 'numSubjects': '603'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '289'}, {'groupId': 'FG001', 'numSubjects': '332'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '160'}, {'groupId': 'FG001', 'numSubjects': '271'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '79'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Non-Compliance with Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'No Longer Met Eligibility Criteria (for adolescents)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'No Longer Met Eligibility Criteria (for adults)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Approved Drug Available For Indication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Main Study: Treatment Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '289'}, {'groupId': 'FG001', 'numSubjects': '332'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '289'}, {'groupId': 'FG001', 'numSubjects': '332'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Approved Drug Available For Indication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '179'}, {'groupId': 'FG001', 'numSubjects': '222'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Ongoing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '96'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Main Study Observation Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Approved Drug Available For Indication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Ongoing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Vaccine Sub Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'Tdap Vaccination With or Without ACWY Vaccination', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'ACWY Vaccination With Tdap Vaccination', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'comment': 'Participants who completed the 1-Month follow up visit of the vaccine sub-study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'This study consisted of Main study and vaccine sub-study. A total of 1052 participants were enrolled in the Main study and a total of 17 participants who received at least 6 months of study treatment in the main study were enrolled in the vaccine sub-study. Results are reported at primary completion date (PCD).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'BG000'}, {'value': '603', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '1069', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants)', 'description': 'Participants with a clinical diagnosis of alopecia areata (AA) received ritlecitinib (PF-06651600) 200 milligrams (mg) once daily (QD) for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.'}, {'id': 'BG001', 'title': 'Main Study: Ritlecitinib 50 mg QD (Roll-over Participants)', 'description': 'Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.'}, {'id': 'BG002', 'title': 'Vaccine Sub-study: Tdap With or Without Meningococcal ACWY Vaccine', 'description': 'Participants who received at least 6 months of treatment with ritlecitinib 50 mg QD in the Main study continued to receive the study treatment in the main study while participating in vaccine sub-study. Participants were administered a single dose of Tetanus and Diphtheria Toxoids and Acellular Pertussis (Tdap) vaccine with or without a single dose of meningococcal ACWY vaccine intramuscularly on Day 1 of the sub-study.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Main Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'BG000'}, {'value': '603', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1052', 'groupId': 'BG003'}]}], 'categories': [{'title': 'From 12 to <18 Years', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG003'}]}, {'title': 'From 18 to <45 Years', 'measurements': [{'value': '271', 'groupId': 'BG000'}, {'value': '360', 'groupId': 'BG001'}, {'value': '631', 'groupId': 'BG003'}]}, {'title': 'From 45 to <64 Years', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG003'}]}, {'title': '>=65 Years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG003'}]}]}, {'title': 'Vaccine Substudy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}], 'categories': [{'title': 'From 12 to <18 Years', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'From 18 to <45 Years', 'measurements': [{'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'From 45 to <64 Years', 'measurements': [{'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': '>=65 Years', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Main Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'BG000'}, {'value': '603', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1052', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '289', 'groupId': 'BG000'}, {'value': '375', 'groupId': 'BG001'}, {'value': '664', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '228', 'groupId': 'BG001'}, {'value': '388', 'groupId': 'BG003'}]}]}, {'title': 'Vaccine Substudy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Main Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'BG000'}, {'value': '603', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1052', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '383', 'groupId': 'BG000'}, {'value': '523', 'groupId': 'BG001'}, {'value': '906', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG003'}]}]}, {'title': 'Vaccine Substudy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Main Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'BG000'}, {'value': '603', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1052', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '310', 'groupId': 'BG000'}, {'value': '423', 'groupId': 'BG001'}, {'value': '733', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG003'}]}]}, {'title': 'Vaccine Substudy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.'}], 'populationDescription': 'Full Analysis set comprised of all participants regardless of whether they received study intervention. Participants of main study and vaccine sub-study were not exclusive.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-28', 'size': 3245773, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_003.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-14T15:50', 'hasProtocol': True}, {'date': '2024-04-12', 'size': 606887, 'label': 'Statistical Analysis Plan: Main study', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_004.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-14T15:45', 'hasProtocol': False}, {'date': '2023-06-20', 'size': 203173, 'label': 'Statistical Analysis Plan: sub study SAP', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_005.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-14T15:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1052}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-01-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2019-07-01', 'resultsFirstSubmitDate': '2025-06-24', 'studyFirstSubmitQcDate': '2019-07-01', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-28', 'studyFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Main Study: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Until Follow-up Visit', 'timeFrame': 'From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered treatment emergent if the event had start date on or after the first dosing date of this study.'}, {'measure': 'Main Study: Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation Until Follow-up Visit', 'timeFrame': 'From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; other important medical events. AEs leading to discontinuation included participants who had an AE record that indicated that the AE caused the participant to be discontinued from the study or that action taken with study treatment was drug withdrawn.'}, {'measure': 'Main Study: Number of Participants According to Categorization of Vital Signs Data Until Follow-up Visit', 'timeFrame': 'From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)', 'description': 'Vital signs including blood pressure included systolic blood pressure (SBP) \\[Millimeters of mercury, mmHg\\]) and diastolic blood pressure (DBP) and pulse rate \\[beats per minute (bpm)\\] were measured using an automated device in a sitting position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Criteria for vital sign abnormalities included: SBP\\<90mmHg, DBP\\<50 mmHg and pulse rate\\<40mmHg.'}, {'measure': 'Main Study: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values Until Follow-up Visit', 'timeFrame': 'From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)', 'description': 'Criteria for laboratory abnormalities included:Hemoglobin, Hematocrit, Erythrocytes (\\<0.8\\*LLN); Ery. Volume, Hemoglobin,Mean Corpuscular HGB Concentration \\<0.8\\*LLN or \\>1.5\\*LLN;Reticulocytes, Leukocytes, Lymphocytes, Neutrophils, Neutrophils, Basophils, Eosinophils, Monocytes (\\>1.2\\*ULN), Prothrombin Time(\\>1.1\\*ULN).Clinical Chemistry: Bilirubin, Direct Bilirubin, Indirect Bilirubin (1.5\\*ULN), Aspartate Aminotransferase, Alanine Aminotransferase, Gamma Glutamyl Transferase, Alkaline Phosphatase (\\>3.0\\*ULN); Albumin, Urate (\\<0.8\\*LLN and \\>1.2\\*ULN; Urea Nitrogen,Creatinine Cholesterol \\>1.3\\*ULN; Cholesterol \\<0.8\\*LLN or \\>1.2\\*LLN, Triglycerides,Potassium,Calcium \\< 0.9x LLN \\& \\> 1.1x ULN; Bicarbonate, Glucose, Creatine Kinase. Urinalysis: Glucose, Ketones, Protein, Hemoglobin, Urobilinogen, Bilirubin, Nitrite \\>=1; Leukocyte Erythrocytes, Leukocytes \\>=20; Epithelial Cells\\>=6, Hyaline Cast\\>1; Bacteria\\>20. Number of participants with any laboratory abnormality meeting specified criteria is included.'}, {'measure': 'Vaccine Sub-study: Percentage of Participants With Tetanus Booster Response', 'timeFrame': 'Month 1', 'description': 'Booster response to tetanus toxoid was defined as: \\>=4-fold rise in anti-tetanus toxoid immunoglobulin G (IgG) antibody concentration at Month 1 if the pre-vaccination concentration was \\<=2.7 International Units per milliliter (IU/mL); OR \\>=2-fold rise in anti-tetanus toxoid IgG antibody concentration if the pre-vaccination concentration was \\>2.7 IU/mL. Two-sided 95% confidence interval (CI) was based on Clopper-Pearson exact method.'}], 'secondaryOutcomes': [{'measure': 'Main Study: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Until End of Study', 'timeFrame': 'From start of study intervention (Day 1) until end of study', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered treatment emergent if the event had start date on or after the first dosing date of this study.'}, {'measure': 'Main Study: Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation Until End of Study', 'timeFrame': 'From start of study intervention (Day 1) until end of study', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; other important medical events. AEs leading to discontinuation included participants who had an AE record that indicated that the AE caused the participant to be discontinued from the study or that action taken with study treatment was drug withdrawn.'}, {'measure': 'Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs Until End of Study', 'timeFrame': 'From start of study intervention (Day 1) until end of study', 'description': 'Vital signs including blood pressure (systolic and diastolic blood pressure \\[Millimeters of mercury, mmHg\\]) and pulse rate (beats per minute \\[bpm\\]) were measured using an automated device in a sitting position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Clinically significant abnormalities will be determined by investigator.'}, {'measure': 'Main Study: Number of Participants With Clinically Significant Laboratory Abnormalities Until End of Study', 'timeFrame': 'From start of study intervention (Day 1) until end of study', 'description': 'Following laboratory parameters were assessed: Hemoglobin, Hematocrit, Erythrocytes Erythrocyte (ery.) corpuscular volume, Ery. Mean Corpuscular hemoglobin concentration, Reticulocytes, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils, Monocytes, Prothrombin Time, Bilirubin, Direct Bilirubin, Indirect Bilirubin, Aspartate Aminotransferase, Alanine Aminotransferase, Gamma Glutamyl Transferase, Alkaline Phosphatase; Albumin, Urate; Urea Nitrogen, Creatinine, Cholesterol, Triglycerides, Potassium, Calcium, Bicarbonate, Glucose, Creatine Kinase. Urinalysis: Glucose, Ketones, Protein, Hemoglobin, Urobilinogen, Bilirubin, Nitrite, Leukocyte Erythrocytes, Leukocytes; Epithelial Cells, Hyaline Cast, Bacteria. Clinically significant abnormalities will be determined by investigator.'}, {'measure': 'Main Study: Percentage of Participants Achieving Response Based on Severity of Alopecia Tool (SALT) Overall Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36', 'timeFrame': 'At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36', 'description': 'SALT is a quantitative assessment of AA severity based on the scalp terminal hair loss. A visual aid was utilized showing the division of the scalp hair into four quadrants (back, top of scalp, right side and left side), with each of the four quadrants given an accurate determination of the percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. The SALT overall score included any hair loss regardless of etiology (e.g., including scalp hair loss due to both androgenetic alopecia and AA). In this outcome measure, percentage of participants with SALT overall score \\<= 10 were reported. 95% CI was calculated based on normal approximation.'}, {'measure': 'Main Study: Percentage of Participants Achieving Response Based on Alopecia Areata (AA) SALT Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36', 'timeFrame': 'At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36', 'description': 'SALT is a quantitative assessment of AA severity based on scalp terminal hair loss. Scalp hair was divided into four quadrants (back, top of scalp, right side and left side), with each given an accurate determination of the percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of scalp in that area. SALT score=sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. SALT AA Score = SALT overall score minus SALT AGA score, where SALT overall score included any hair loss regardless of etiology and SALT AGA score included scalp hair loss only due to androgenetic alopecia. SALT AA score ranged from 0 (no hair loss) to 100 (complete scalp hair loss), with lower score indicating less hair loss. 95% CI was calculated based on normal approximation.'}, {'measure': 'Main Study: Percentage of Participants Achieving Response Based on SALT Overall Score <= 20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36', 'timeFrame': 'At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36', 'description': 'SALT is a quantitative assessment of AA severity based on the scalp terminal hair loss. A visual aid was utilized showing the division of the scalp hair into four quadrants (back, top of scalp, right side and left side), with each of the four quadrants given an accurate determination of the percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. The SALT overall score included any hair loss regardless of etiology (e.g., including scalp hair loss due to both androgenetic alopecia and AA). In this outcome measure, percentage of participants with SALT overall score \\<=20 were reported. 95% CI was calculated based on normal approximation.'}, {'measure': 'Main Study: Percentage of Participants Achieving Response Based on AA SALT Score <=20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36', 'timeFrame': 'At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36', 'description': 'SALT is a quantitative assessment of AA severity based on scalp terminal hair loss. Scalp hair was divided into four quadrants (back, top of scalp, right side and left side), with each given an accurate determination of the percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of scalp in that area. SALT score=sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. SALT AA Score = SALT overall score minus SALT AGA score, where SALT overall score included any hair loss regardless of etiology and SALT AGA score included scalp hair loss only due to androgenetic alopecia. SALT AA score ranged from 0 (no hair loss) to 100 (complete scalp hair loss), with lower score indicating less hair loss. 95% CI was calculated based on normal approximation.'}, {'measure': 'Main Study: Change From Baseline in SALT Overall Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36', 'timeFrame': 'Baseline, At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36', 'description': 'SALT is a quantitative assessment of AA severity based on the scalp terminal hair loss. A visual aid was utilized showing division of scalp hair into four quadrants (back, top of scalp, right side and left side), with each of four quadrants given an accurate determination of the percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of scalp in that area. SALT score is sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. SALT overall score included any hair loss regardless of etiology (e.g., including scalp hair loss due to both androgenetic alopecia and AA). For roll-over participants originating from Study B7931005 or B7981015, baseline is day 1 from Study B7931005 or B7981015. For de novo participants, baseline is day 1 from Study B7981032.'}, {'measure': 'Main Study: Change From Baseline in AA SALT Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36', 'timeFrame': 'Baseline, At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36', 'description': 'SALT=quantitative assessment of AA severity based on scalp terminal hair loss. Scalp hair was divided into 4 quadrants (back, top of scalp, right side and left side), with each given an accurate determination of percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of scalp in that area. SALT score=sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss). SALT AA Score = SALT overall score minus SALT AGA score, where SALT overall score included any hair loss regardless of etiology and SALT AGA score included scalp hair loss only due to androgenetic alopecia. SALT AA score ranged from 0 (no hair loss) to 100 (complete scalp hair loss), lower score= less hair loss. Baseline (Roll-over participants: Day 1 from Study B7931005 or B7981015; De novo participants: Day 1 from Study B7981032).'}, {'measure': 'Main Study: Percentage of Participants Achieving Atleast 75% Improvement in Overall SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36', 'timeFrame': 'At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36', 'description': 'SALT is a quantitative assessment of AA severity based on the scalp terminal hair loss. A visual aid was utilized showing the division of the scalp hair into four quadrants (back, top of scalp, right side and left side), with each of the four quadrants given an accurate determination of the percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. The SALT overall score included any hair loss regardless of etiology (e.g., including scalp hair loss due to both androgenetic alopecia and AA). An Overall SALT 75 response was a 75% or greater reduction from baseline in SALT score.'}, {'measure': 'Main Study: Percentage of Participants Achieving Atleast 75% Improvement in AA SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36', 'timeFrame': 'At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36', 'description': 'SALT=quantitative assessment of AA severity based on scalp terminal hair loss. Scalp hair was divided into four quadrants (back, top of scalp, right side and left side), with each given an accurate determination of percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of scalp in that area. SALT score=sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. SALT AA Score= SALT overall score minus SALT AGA score, where SALT overall score included any hair loss regardless of etiology and SALT AGA score included scalp hair loss only due to androgenetic alopecia. SALT AA score ranged from 0 (no hair loss) to 100 (complete scalp hair loss), where lower score=less hair loss. SALT 75 response= 75% or greater reduction from baseline in AA SALT score.'}, {'measure': 'Main Study: Percentage of Participants Achieving Atleast 2-Grade Improvement From Baseline or Absolute Score of 3 in the Eyebrow Assessment (EBA) at Months 1, 3, 6, 12, 18, 24 and 36 in Participants Without Normal EBA Score at Baseline', 'timeFrame': 'At Months 1, 3, 6, 12, 18, 24 and 36', 'description': 'EBA is a numeric rating scale developed to characterize eyebrow hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal), where 0= no eyebrow, 1=minimal eyebrow, 2=moderate eyebrow and 3= normal eyebrow. Higher scores represent lesser loss of eyebrow hair. 95% CI was based on normal approximation.'}, {'measure': 'Main Study: Percentage of Participants Achieving Atleast 2-Grade Improvement From Baseline or Absolute Score of 3 in the Eyelash Assessment (ELA) at Months 1, 3, 6, 12, 18, 24 and 36 in Participants Without Normal ELA Score at Baseline', 'timeFrame': 'At Months 1, 3, 6, 12, 18, 24 and 36', 'description': 'ELA is a numeric rating scale developed to characterize eyelash hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal), where 0=no eyelash, 1=minimal eyelash, 2=moderate eyelash and 3=normal eyelash. Higher scores represent lesser loss of eyelash hair.'}, {'measure': "Main Study: Percentage of Participants Achieving Patient's Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Months 1, 3, 6, 9, 12, 18, 24 and 36", 'timeFrame': 'At Months 1, 3, 6, 9, 12, 18, 24 and 36', 'description': "PGI-C is a self-administered single item questionnaire to evaluate the improvement or worsening of participant's AA as compared to the start of the study. Participants were required to select their response on a 7-point scale ranging from 1 (greatly worsened), 2=moderately worsened, 3=slightly worsened, 4=not changed, 5= slightly improved, 6=moderately improved, 7 (greatly improved). 95% CI was based on normal approximation."}, {'measure': 'Main Study: Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36: Emotional Symptoms and Activity Limitations', 'timeFrame': 'Baseline, At Months 1, 3, 6, 9, 12, 18, 24 and 36', 'description': "AAPPO scale is a 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 5-8 assessed emotional symptoms with responses scored from 0 ='never' to 4='always'. Items 9-11 assessed activity limitations with responses scored from 0='not at all' to 4='completely'. AAPPO emotional symptoms sub score was calculated as mean of items 5-8 and ranged from 0 (never) to 4 (always), where higher scores indicated more emotional symptoms. AAPPO activity limitations sub score was calculated as mean of items 9-11 and ranged from 0(not at all) to 4(completely), where higher scores indicated more activity limitations. For roll-over participants originating from Study B7931005 or B7981015, baseline is day 1 from Study B7931005 or B7981015. For de novo participants, baseline is day 1 from Study B7981032."}, {'measure': 'Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline', 'timeFrame': 'Baseline, At Months 1, 3, 6, 9, 12, 18, 24 and 36', 'description': "AAPPO scale is a 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 1-4 assessed current hair loss from the scalp, eyebrows, eyelashes and body using a 5 point scale that ranged from 0 ='no hair loss' and 4='complete hair loss'. In this outcome measure, percentage of participants with AAPPO domain scores of 0 = no hair loss or 1 = a little hair loss, among participants with score \\>=2 at baseline are reported."}, {'measure': 'Main Study: Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Months 1, 3, 6, 9, 12, 18, 24 and 36', 'timeFrame': 'Baseline, At Months 1, 3, 6, 9, 12, 18, 24 and 36', 'description': 'HADS is a validated 14-item questionnaire used to assess states of anxiety and depression over the past week. The HADS consisted of 2 subscales, one for anxiety (HADS-A) and one for depression (HADS-D). The depression subscale comprised of 7 items with score ranging from 0 (no presence of depression) to 3 (severe feeling of depression). Total depression subscale score was calculated as the sum of 7 items and ranged from 0 to 21; higher score indicating greater severity of depression symptoms. For roll-over participants originating from Study B7931005 or B7981015, baseline is day 1 from Study B7931005 or B7981015. For de novo participants, baseline is day 1 from Study B7981032.'}, {'measure': 'Main Study: Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Months 1, 3, 6, 9, 12, 18, 24 and 36', 'timeFrame': 'Baseline, At Months 1, 3, 6, 9, 12, 18, 24 and 36', 'description': 'HADS is a validated 14-item questionnaire used to assess states of anxiety and depression over the past week. The HADS consisted of 2 subscales, one for anxiety (HADS-A) and one for depression (HADS-D). The anxiety subscale comprised of 7 items with score ranging from 0 (no anxiety) to 3 (severe anxiety). Total anxiety subscale score was calculated as the sum of 7 items and ranged from 0 to 21; higher score indicating greater severity of anxiety symptoms. For roll-over participants originating from Study B7931005 or B7981015, baseline is day 1 from Study B7931005 or B7981015. For de novo participants, baseline is day 1 from Study B7981032.'}, {'measure': 'Main Study: Percentage of Participants With Improvement on HADS Depression Score at Months 1, 3, 6, 9, 12, 18, 24 and 36', 'timeFrame': 'At Months 1, 3, 6, 9, 12, 18, 24 and 36', 'description': 'HADS is a validated 14-item questionnaire used to assess states of anxiety and depression over the past week. The HADS consisted of 2 subscales, one for anxiety (HADS-A) and one for depression (HADS-D). The depression subscale comprised of 7 items with score ranging from 0 (no presence of depression) to 3 (severe feeling of depression). Total depression subscale score was calculated as the sum of 7 items and ranged from 0 to 21; higher score indicating greater severity of depression symptoms. Improvement on HADS depression score was considered as achieving a "normal" depression subscale score indicative of an absence of depression. Among adults, a HADS-D score of 0-7 was considered "normal"; for adolescents, a HADS-D score of 0-6 was considered "normal". 95% CI was calculated based on normal approximation.'}, {'measure': 'Main Study: Percentage of Participants With Improvement on HADS Anxiety Score At Months 1, 3, 6, 9, 12, 18, 24 and 36', 'timeFrame': 'At Months 1, 3, 6, 9, 12, 18, 24 and 36', 'description': 'HADS is a validated 14-item questionnaire used to assess states of anxiety and depression over the past week. The HADS consisted of 2 subscales, one for anxiety (HADS-A) and one for depression (HADS-D). The anxiety subscale comprised of 7 items with score ranging from 0 (no anxiety) to 3 (severe anxiety). Total anxiety subscale score was calculated as the sum of 7 items and ranged from 0 to 21; higher score indicating greater severity of anxiety symptoms. Improvement on HADS anxiety score was considered as achieving a "normal" anxiety subscale score indicative of an absence of anxiety. Among adults, a HADS-A score of 0-7 was considered "normal"; for adolescents, a HADS-A score of 0-8 was considered "normal". 95% CI was calculated based on normal approximation.'}, {'measure': 'Vaccine Sub-study: Percentage of Participants With Anti-tetanus Antibody Level >=1.0 International Units Per Milliliter (IU/mL) at Month 1-Tdap Vaccination', 'timeFrame': 'Month 1', 'description': 'Percentage of participants with anti-tetanus antibody level \\>=1.0 IU/mL at Month 1 were reported in this outcome measure. Two-sided 95% CI was based on Clopper-Pearson exact method.'}, {'measure': 'Vaccine Sub-study: Percentage of Participants With Anti-tetanus Antibody Level >=0.1 IU/mL at Month 1-Tdap Vaccination', 'timeFrame': 'Month 1', 'description': 'Percentage of participants with anti-tetanus antibody level \\>=0.1 IU/mL at Month 1 were reported in this outcome measure. Two-sided 95% CI was based on Clopper-Pearson exact method.'}, {'measure': 'Vaccine Sub-study: Percentage of Participants With >=4 Times Increase in Anti-tetanus Antibody Level From Baseline at Month 1-Tdap Vaccination', 'timeFrame': 'Month 1', 'description': 'Percentage of participants with \\>=4 times increase in anti-tetanus antibody level from baseline were reported in this outcome measure. Two-sided 95% CI was based on Clopper-Pearson exact method.'}, {'measure': 'Vaccine Sub-study: Geometric Mean Fold Change in Anti-tetanus Levels Above Baseline Values at Month 1-Tdap Vaccination', 'timeFrame': 'From Baseline (pre-vaccination on Day 1) to Month 1', 'description': 'Geometric mean and 95% CI were calculated by exponentiating the mean logarithm of the observed data and the corresponding CIs. Fold change was defined as the ratio of the post-baseline result to the baseline result. The assay results below the LLOQ were set to 0.5 \\* LLOQ except when pre-vaccination assay results is \\< LLOQ while postvaccination result is \\>= LLOQ, in which case the pre-vaccination value will be set to LLOQ.'}, {'measure': 'Vaccine Sub-study: Geometric Mean Concentrations (GMCs) of Anti-tetanus Antibody Levels at Month 1-Tdap Vaccination', 'timeFrame': 'Month 1', 'description': 'Geometric mean and 95% CI were calculated by exponentiating the mean logarithm of the observed data and the corresponding CIs. Assay results below the LLOQ were set to 0.5\\* LLOQ.'}, {'measure': 'Vaccine Sub-study: Percentage of Participants With Human Serum Bactericidal Activity (hSBA) Titer >=1:8 at Month 1 Post-vaccination for Serogroup C-Meningococcal ACWY Vaccination', 'timeFrame': 'Month 1', 'description': 'Percentage of participants with hSBA titer \\>=1.8 at 1 month post vaccination for serogroup C were reported in this outcome measure. Two-sided 95% CI was based on Clopper-Pearson exact method.'}, {'measure': 'Vaccine Sub-study: Percentage of Participants With hSBA Titer >=1:4 at Month 1 Post-vaccination for Serogroup C-Meningococcal ACWY Vaccination', 'timeFrame': 'Month 1', 'description': 'Percentage of participants with hSBA titer \\>=1.4 at 1 month post vaccination for serogroup C were reported in this outcome measure. Two-sided 95% CI was based on Clopper-Pearson exact method.'}, {'measure': 'Vaccine Sub-study: Geometric Mean Titers (GMT) of Antibodies for Serogroup C at Baseline and Month 1-Meningococcal ACWY Vaccination', 'timeFrame': 'Baseline (pre-vaccination on Day 1) and Month 1', 'description': 'Geometric mean and 95% CI were calculated by exponentiating the mean logarithm of the observed data and the corresponding CIs. Assay results below the LLOQ were set to 0.5\\* LLOQ.'}, {'measure': 'Vaccine Sub-study: Number of Participants With SAEs', 'timeFrame': 'From day of vaccination (Day 1) up to 35 days post last dose of vaccine (up to Day 36)', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; other important medical events.'}, {'measure': 'Vaccine Sub-study: Number of Participants With AEs', 'timeFrame': 'From day of vaccination (Day 1) up to 35 days post last dose of vaccine (up to Day 36)', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.'}, {'measure': 'Vaccine Sub-study: Number of Participants With AEs Leading to Discontinuation', 'timeFrame': 'From day of vaccination (Day 1) up to 35 days post last dose of vaccine (up to Day 36)', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs leading to discontinuation included participants who had an AE record that indicated that the AE caused the participant to be discontinued from the study or that action taken with study treatment was drug withdrawn.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alopecia', 'Alopecia Areata', 'Alopecia totalis', 'Alopecia universalis', 'Hair loss', 'JAK inhibitor', 'PF-06651600', 'Ritlecitinib'], 'conditions': ['Alopecia Areata']}, 'referencesModule': {'references': [{'pmid': '39962358', 'type': 'DERIVED', 'citation': 'King B, Mirmirani P, Lo Sicco K, Ramot Y, Sinclair R, Asfour L, Ezzedine K, Paul C, Ohyama M, Edwards RA, Bonfanti G, Kerkmann U, Wajsbrot D, Ishowo-Adejumo R, Zwillich SH, Lejeune A. Patterns of clinical response in patients with alopecia areata treated with ritlecitinib in the ALLEGRO clinical development programme. J Eur Acad Dermatol Venereol. 2025 Jun;39(6):1163-1173. doi: 10.1111/jdv.20547. Epub 2025 Feb 17.'}, {'pmid': '39846397', 'type': 'DERIVED', 'citation': 'Tziotzios C, Sinclair R, Lesiak A, Mehlis S, Kinoshita-Ise M, Tsianakas A, Luo X, Law EH, Ishowo-Adejumo R, Wolk R, Sadrarhami M, Lejeune A. Long-term safety and efficacy of ritlecitinib in adults and adolescents with alopecia areata and at least 25% scalp hair loss: Results from the ALLEGRO-LT phase 3, open-label study. J Eur Acad Dermatol Venereol. 2025 Jun;39(6):1152-1162. doi: 10.1111/jdv.20526. Epub 2025 Jan 23.'}, {'pmid': '39432738', 'type': 'DERIVED', 'citation': 'Piliang M, Soung J, King B, Shapiro J, Rudnicka L, Farrant P, Magnolo N, Piraccini BM, Luo X, Wolk R, Woodworth D, Schaefer G, Lejeune A. Efficacy and safety of the oral Janus kinase 3/tyrosine kinase expressed in hepatocellular carcinoma family kinase inhibitor ritlecitinib over 24 months: integrated analysis of the ALLEGRO phase IIb/III and long-term phase III clinical studies in alopecia areata. Br J Dermatol. 2025 Jan 24;192(2):215-227. doi: 10.1093/bjd/ljae365.'}, {'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.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=B7981032', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is a global Phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have alopecia areata. Eligible patients from the prior studies B7931005 (NCT02974868) and B7981015 (NCT03732807) will have an opportunity to enroll as well as patients who have not previously participated in either of these studies. The study is open-label and all patients entering the study will receive active study drug.\n\nA sub-study of approximately 60 adult patients who are participating in the B7981032 study will be conducted at select sites in the US, Australia and Canada. The sub-study will evaluate the immune response to tetanus and meningococcal vaccines in patients who have received a minimum of 6 months of 50 mg PF-06651600.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria-\n\nFor de novo participants and participants from Study B7931005 and B7981015 with \\>30 days between first visit in B7981032 and last dose in the prior study:\n\n* Clinical diagnosis of alopecia areata (AA) with no other cause of hair loss. Androgenetic alopecia coexistent with AA is allowed.\n* De novo participants \\>=12 to \\<18 years of age: \\>=50% terminal hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis\n* De novo participants \\>=18 years of age and participants from Study B7931005 or B7981015 with \\>30 days between first visit in B7981032 and last dose in the prior study: \\>=25% terminal hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis\n* No evidence of terminal scalp hair regrowth within 6 months (de novo only)\n* Current episode of terminal scalp hair loss \\<=10 years (de novo only)\n\nExclusion Criteria-\n\nFor de novo participants and participants from Study B7931005 and B7981015 with \\>30 days between first visit in B7981032 and last dose in the prior study:\n\n* Hearing loss with progression over previous 5 years, or sudden hearing loss, or middle or inner ear disease, or other auditory condition that is considered acute, fluctuating or progressive\n* History of or current malignancies with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ\n* History of a single episode of disseminated herpes zoster or disseminated herpes simplex, or a history of more than one episode of localized, dermatomal herpes zoster\n* Infection requiring hospitalization, or parenteral antimicrobial therapy within 6 months prior to Day 1\n\nExclusion criteria for all participants:\n\n\\- Participants who have previously taken Janus kinase (JAK) inhibitors other than PF-06651600 must have received the last dose \\>12 weeks prior to the screening visit'}, 'identificationModule': {'nctId': 'NCT04006457', 'acronym': 'ALLEGRO-LT', 'briefTitle': 'Long-Term PF-06651600 for the Treatment of Alopecia Areata', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 3 OPEN-LABEL, MULTI-CENTER, LONG-TERM STUDY INVESTIGATING THE SAFETY AND EFFICACY OF PF-06651600 IN ADULT AND ADOLESCENT PARTICIPANTS WITH ALOPECIA AREATA', 'orgStudyIdInfo': {'id': 'B7981032'}, 'secondaryIdInfos': [{'id': '2023-509801-59-00', 'type': 'REGISTRY', 'domain': 'CTIS (EU)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment sequence 1', 'description': 'Participants who did not previously receive study intervention in either study B7931005 or B7981015 will receive 200 milligrams (mg) PF-06651600, given as four 50 mg tablets once daily (QD) for 1 month, followed by 50 mg PF-06651600 tablet or capsule given QD for 59 months.\n\nPatients participating in the vaccine sub-study will receive the 2 vaccines or one of the 2 vaccines at the vaccine sub-study Day 1, which will occur at a scheduled study visit on or after the Month 9 visit and prior to or on the Month 56 visit of the main B7981032 study.', 'interventionNames': ['Drug: PF-06651600', 'Biological: Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine', 'Biological: Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment sequence 2', 'description': 'Participants who previously received study intervention in either study B7931005 or B7981015 will receive 50 mg PF-06651600 tablet or capsule given QD for 59 months.\n\nPatients participating in the vaccine sub-study will receive the 2 vaccines or 1 of the 2 vaccines at the vaccine sub-study Day 1, which will occur at a scheduled study visit on or after the Month 6 visit and prior to or on the Month 56 visit of the main B7981032 study.', 'interventionNames': ['Drug: PF-06651600', 'Biological: Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine', 'Biological: Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine']}], 'interventions': [{'name': 'PF-06651600', 'type': 'DRUG', 'description': '50 mg oral tablets/capsules', 'armGroupLabels': ['Treatment sequence 1', 'Treatment sequence 2']}, {'name': 'Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine', 'type': 'BIOLOGICAL', 'description': 'Single intramuscular injection administered to patients participating in the vaccine sub-study', 'armGroupLabels': ['Treatment sequence 1', 'Treatment sequence 2']}, {'name': 'Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine', 'type': 'BIOLOGICAL', 'description': 'Single intramuscular injection administered to patients participating in the vaccine sub-study', 'armGroupLabels': ['Treatment sequence 1', 'Treatment sequence 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'The University of Alabama at Birmingham Hosptial Outreach Lab', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'The University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'The University of Alabama at Birmingham, Department of Dermatology', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Mosaic Dermatology', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92697', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Univ of California, Irvine, Dermatology Clinical Research Center', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '92562', 'city': 'Murrieta', 'state': 'California', 'country': 'United States', 'facility': 'Dermatology Specialists Inc.', 'geoPoint': {'lat': 33.55391, 'lon': -117.21392}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94118', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Clinical Trials Unit', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '92701', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Dermatology, Inc.', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital Clinical and Translational Research Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80045', 'city': 'Aurora', 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