Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:42 AM
Study NCT ID:
NCT04784533
Status:
COMPLETED
Last Update Posted:
2024-10-09
First Post:
2021-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Durability of Response of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000506', 'term': 'Alopecia Areata'}], 'ancestors': [{'id': 'D000505', 'term': 'Alopecia'}, {'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'AAclinicaltrial_inquiries@concertpharma.com', 'phone': '781-860-0045', 'title': 'Colleen E. Hamilton', 'organization': 'Concert Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': 'If an Investigator wants to publish study data or results, the publication or presentation must be provided to Concert for review at least 60 days in advance. If Concert needs to file a patent application prior to publication, the publication can be delayed up to 90 days from Sponsor providing notice to the investigator of such need.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug up to last follow up visit (Week 76)', 'description': 'All-cause mortality: All randomized participants included all participants who were randomized in the study.\n\nAdverse events: Safety population included all participants who received study drug during the treatment period.', 'eventGroups': [{'id': 'EG000', 'title': 'Part A: Period 1 - CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.', 'otherNumAtRisk': 180, 'deathsNumAtRisk': 180, 'otherNumAffected': 91, 'seriousNumAtRisk': 180, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Part A: Period 1 - CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.', 'otherNumAtRisk': 137, 'deathsNumAtRisk': 137, 'otherNumAffected': 82, 'seriousNumAtRisk': 137, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID', 'description': 'Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute severity of alopecia tool (SALT) score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 9, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID', 'description': 'Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 10, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part A: Period 2 - CTP-543 8 mg BID to Placebo', 'description': 'Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 7, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'Part A: Period 2 - CTP-543 12 mg BID to Placebo', 'description': 'Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 9, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID', 'description': 'Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \\> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID', 'description': 'Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \\> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 5, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Part B: CTP-543 8 mg BID to Placebo to 8 mg BID', 'description': 'Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \\> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 12, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Part B: CTP-543 12 mg BID to Placebo to 12 mg BID', 'description': 'Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \\> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 14, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Asymptomatic COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Candida infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Costochondritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Joint stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Dysaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 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'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Endometrial hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Uterine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Seborrhoeic dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}], 'seriousEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Malignant Melanoma in Situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Pancreatic Carcinoma Metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Ankle Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Electrocardiogram T Wave Inversion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': "Crohn's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}, {'term': 'Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part A, Period 2: Percentage of Participants Achieving Loss of Regrowth Maintenance (LOM) Criteria Defined by Severity of Alopecia Tool (SALT) Score > 20 Following Dose Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID', 'description': 'Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID', 'description': 'Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.8', 'groupId': 'OG000', 'lowerLimit': '7.1', 'upperLimit': '48.5'}, {'value': '32.0', 'groupId': 'OG001', 'lowerLimit': '13.7', 'upperLimit': '50.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 24 to Week 48', 'description': 'SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score \\>20. The percentage of participants achieving LOM criteria (SALT \\>20) was compared to the percentage of participants maintaining treatment success (SALT ≤ 20) for each of the following dose reduction conditions. Due to the variable time on study for each participant within Part A Period 2, the primary analysis visit was the end of Part A Period 2, where the last observed non-missing SALT value was selected for each participant.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.'}, {'type': 'PRIMARY', 'title': 'Part A, Period 2: Percentage of Participants Achieving LOM Criteria Defined by SALT Score > 20 Following Drug Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Period 2 - CTP-543 8 mg BID to Placebo', 'description': 'Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part A: Period 2 - CTP-543 12 mg BID to Placebo', 'description': 'Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '66.1', 'upperLimit': '100.0'}, {'value': '80.0', 'groupId': 'OG001', 'lowerLimit': '64.3', 'upperLimit': '95.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 24 to Week 48', 'description': 'SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score \\>20. The percentage of participants achieving LOM criteria (SALT \\>20) was compared to the percentage of participants maintaining treatment success (SALT ≤ 20) for each of the following dose discontinuation conditions. Due to the variable time on study for each participant within Part A Period 2, the primary analysis visit was at the end of Part A Period 2, where the last observed non-missing SALT value was selected for each participant.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.'}, {'type': 'PRIMARY', 'title': 'Part B: Percentage of Participants by Dose Group Who Achieved Restoration of Regrowth (ROR) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID', 'description': 'Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \\> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID', 'description': 'Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \\> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.'}, {'id': 'OG002', 'title': 'Part B: CTP-543 8 mg BID to Placebo to 8 mg BID', 'description': 'Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \\> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.'}, {'id': 'OG003', 'title': 'Part B: CTP-543 12 mg BID to Placebo to 12 mg BID', 'description': 'Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \\> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000', 'lowerLimit': '17.1', 'upperLimit': '100.0'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '15.4', 'upperLimit': '84.6'}, {'value': '66.7', 'groupId': 'OG002', 'lowerLimit': '54.0', 'upperLimit': '99.8'}, {'value': '73.7', 'groupId': 'OG003', 'lowerLimit': '58.6', 'upperLimit': '97.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24 of re-treatment', 'description': "SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). ROR is defined as the participant's attainment of an absolute SALT score of ≤20 at Week 24 of re-treatment.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.'}, {'type': 'SECONDARY', 'title': 'Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT Score > 20 Following Dose Reduction Conditions at Weeks 28, 32, 36, 40, 44, and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID', 'description': 'Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute severity of alopecia tool (SALT) score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID', 'description': 'Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.'}], 'classes': [{'title': 'Week 28', 'categories': [{'measurements': [{'value': '0', 'comment': 'Not estimable as 0 participants achieved LOM criteria of SALT Score \\> 20', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '31.2'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '30.2'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '22.8'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '0', 'comment': 'Not estimable as 0 participants achieved LOM criteria of SALT Score \\> 20', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '23.8'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '38.3'}, {'value': '10.5', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '33.1'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '36.0'}, {'value': '0', 'comment': 'Not estimable as 0 participants achieved LOM criteria of SALT Score \\> 20', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '36.0'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '27.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 28, 32, 36, 40, 44, and 48', 'description': 'SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score \\>20.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.'}, {'type': 'SECONDARY', 'title': 'Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT > 20 Following Drug Discontinuation Conditions at Weeks 28, 32, 36, 40, 44, and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Period 2 - CTP-543 8 mg to Placebo', 'description': 'Participants who responded with an absolute SALT score of ≤20 at week 24 of the treatment period with 8 mg in Period 1, received CTP-543-matched placebo tablets, orally, for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part A, Period 2 - CTP-543 12 mg to CTP-543 Matched Placebo', 'description': 'Participants who responded with an absolute SALT score of ≤20 at week 24 of the treatment period with 12 mg in Period 1, received CTP-543 matched placebo tablets, orally, for up to 24 weeks'}], 'classes': [{'title': 'Week 28', 'categories': [{'measurements': [{'value': '0', 'comment': 'Not estimable as 0 participants achieved LOM criteria of SALT Score \\> 20', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '16.7', 'groupId': 'OG001', 'lowerLimit': '4.7', 'upperLimit': '37.4'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '3.6', 'upperLimit': '41.4'}, {'value': '14.3', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '36.3'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000', 'lowerLimit': '7.8', 'upperLimit': '55.1'}, {'value': '43.8', 'groupId': 'OG001', 'lowerLimit': '19.8', 'upperLimit': '70.1'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000', 'lowerLimit': '10.9', 'upperLimit': '69.2'}, {'value': '22.2', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '60.0'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '71.0'}, {'value': '0', 'comment': 'Not estimable as 0 participants achieved LOM criteria of SALT Score \\> 20', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '85.3'}, {'value': '28.6', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '71.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 28, 32, 36, 40, 44, and 48', 'description': 'SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score \\>20.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.'}, {'type': 'SECONDARY', 'title': 'Part A, Period 1: Percentage of Responders as Assessed on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Period 1 - CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part A: Period 1 - CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000', 'lowerLimit': '17.6', 'upperLimit': '30.4'}, {'value': '40.2', 'groupId': 'OG001', 'lowerLimit': '31.6', 'upperLimit': '48.7'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '26.9', 'groupId': 'OG000', 'lowerLimit': '20.2', 'upperLimit': '33.7'}, {'value': '39.1', 'groupId': 'OG001', 'lowerLimit': '30.6', 'upperLimit': '47.5'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '25.6', 'groupId': 'OG000', 'lowerLimit': '18.9', 'upperLimit': '32.3'}, {'value': '52.0', 'groupId': 'OG001', 'lowerLimit': '43.2', 'upperLimit': '60.9'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '28.8', 'groupId': 'OG000', 'lowerLimit': '21.9', 'upperLimit': '35.8'}, {'value': '48.7', 'groupId': 'OG001', 'lowerLimit': '39.8', 'upperLimit': '57.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.2', 'ciLowerLimit': '5.5', 'ciUpperLimit': '26.8', 'estimateComment': 'Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.', 'groupDescription': 'Week 12', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.1', 'ciLowerLimit': '1.3', 'ciUpperLimit': '22.9', 'estimateComment': 'Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.', 'groupDescription': 'Week 16', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.4', 'ciLowerLimit': '15.4', 'ciUpperLimit': '37.5', 'estimateComment': 'Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.', 'groupDescription': 'Week 20', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.9', 'ciLowerLimit': '8.5', 'ciUpperLimit': '31.3', 'estimateComment': 'Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.', 'groupDescription': 'Week 24', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 12, 16, 20, and 24', 'description': "SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied. SPRO responder is defined as a post-baseline response of 'very satisfied' or 'satisfied'.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.'}, {'type': 'SECONDARY', 'title': 'Part A, Period 1: Percentage of Participants Who Achieved an Absolute SALT Score ≤20 at Weeks 4, 8, 12, 16, 20, and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Period 1 - CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part A: Period 1 - CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '0', 'comment': 'Not estimable as 0 participants achieved SALT score criteria of ≤20', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'Not estimable as 0 participants achieved SALT score criteria of ≤20', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.7'}, {'value': '2.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '5.0'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '9.3'}, {'value': '16.4', 'groupId': 'OG001', 'lowerLimit': '10.0', 'upperLimit': '22.8'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '14.8'}, {'value': '24.2', 'groupId': 'OG001', 'lowerLimit': '16.8', 'upperLimit': '31.6'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000', 'lowerLimit': '10.3', 'upperLimit': '21.4'}, {'value': '35.2', 'groupId': 'OG001', 'lowerLimit': '26.8', 'upperLimit': '43.7'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '22.1', 'groupId': 'OG000', 'lowerLimit': '15.7', 'upperLimit': '28.5'}, {'value': '42.9', 'groupId': 'OG001', 'lowerLimit': '34.0', 'upperLimit': '51.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '3.9', 'estimateComment': 'Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.', 'groupDescription': 'Week 8', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.6', 'ciLowerLimit': '3.3', 'ciUpperLimit': '17.9', 'estimateComment': 'Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.', 'groupDescription': 'Week 12', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.0', 'ciLowerLimit': '5.3', 'ciUpperLimit': '22.8', 'estimateComment': 'Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.', 'groupDescription': 'Week 16', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.4', 'ciLowerLimit': '9.2', 'ciUpperLimit': '29.5', 'estimateComment': 'Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.', 'groupDescription': 'Week 20', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.8', 'ciLowerLimit': '9.8', 'ciUpperLimit': '31.7', 'estimateComment': 'Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.', 'groupDescription': 'Week 24', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4, 8, 12, 16, 20, and 24', 'description': 'SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period.'}, {'type': 'SECONDARY', 'title': 'Part A, Period 1: Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Period 1 - CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part A: Period 1 - CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.'}], 'classes': [{'title': 'Relative Change From Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '11.17', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '8.73', 'groupId': 'OG001'}]}]}, {'title': 'Relative Change From Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.4', 'spread': '18.41', 'groupId': 'OG000'}, {'value': '-14.8', 'spread': '21.67', 'groupId': 'OG001'}]}]}, {'title': 'Relative Change From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-18.1', 'spread': '27.42', 'groupId': 'OG000'}, {'value': '-30.9', 'spread': '33.69', 'groupId': 'OG001'}]}]}, {'title': 'Relative Change From Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-26.3', 'spread': '31.68', 'groupId': 'OG000'}, {'value': '-39.9', 'spread': '36.24', 'groupId': 'OG001'}]}]}, {'title': 'Relative Change From Baseline at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-32.1', 'spread': '34.26', 'groupId': 'OG000'}, {'value': '-49.0', 'spread': '37.44', 'groupId': 'OG001'}]}]}, {'title': 'Relative Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-38.2', 'spread': '36.85', 'groupId': 'OG000'}, {'value': '-55.3', 'spread': '38.01', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '1.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.18', 'estimateComment': 'LS means,standard error(SE),and confidence intervals(CIs) are based on mixed model repeated measures(MMRM)analysis with effects for treatment,visit,treatment-by-visit interaction,and baseline value.The Model uses an unstructured covariance structure.', 'groupDescription': 'Week 4', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.3', 'ciLowerLimit': '-11.9', 'ciUpperLimit': '-2.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.32', 'estimateComment': 'LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.', 'groupDescription': 'Week 8', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.4', 'ciLowerLimit': '-19.3', 'ciUpperLimit': '-5.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.50', 'estimateComment': 'LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.', 'groupDescription': 'Week 12', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.6', 'ciLowerLimit': '-22.2', 'ciUpperLimit': '-6.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.90', 'estimateComment': 'LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.', 'groupDescription': 'Week 16', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.4', 'ciLowerLimit': '-23.7', 'ciUpperLimit': '-7.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.20', 'estimateComment': 'LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.', 'groupDescription': 'Week 20', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.4', 'ciLowerLimit': '-24.0', 'ciUpperLimit': '-6.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.36', 'estimateComment': 'LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.', 'groupDescription': 'Week 24', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss). Relative change (percent change) to baseline is calculated as: 100 x (\\[post-baseline SALT score - baseline SALT score\\]/baseline SALT score). Negative change indicates no hair loss.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number analyzed indicates the number of participants with data available for analysis at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Part A, Period 1: Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Period 1 - CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part A: Period 1 - CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000', 'lowerLimit': '20.1', 'upperLimit': '33.4'}, {'value': '47.6', 'groupId': 'OG001', 'lowerLimit': '38.9', 'upperLimit': '56.3'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '37.7', 'groupId': 'OG000', 'lowerLimit': '30.4', 'upperLimit': '45.1'}, {'value': '51.6', 'groupId': 'OG001', 'lowerLimit': '42.9', 'upperLimit': '60.2'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '47.6', 'groupId': 'OG000', 'lowerLimit': '39.2', 'upperLimit': '55.2'}, {'value': '63.1', 'groupId': 'OG001', 'lowerLimit': '54.6', 'upperLimit': '71.7'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '50.3', 'groupId': 'OG000', 'lowerLimit': '42.6', 'upperLimit': '58.0'}, {'value': '64.7', 'groupId': 'OG001', 'lowerLimit': '56.1', 'upperLimit': '73.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.9', 'ciLowerLimit': '9.9', 'ciUpperLimit': '31.8', 'estimateComment': 'Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.', 'groupDescription': 'Week 12', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.8', 'ciLowerLimit': '2.5', 'ciUpperLimit': '25.2', 'estimateComment': 'Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.', 'groupDescription': 'Week 16', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.6', 'ciLowerLimit': '4.1', 'ciUpperLimit': '27.0', 'estimateComment': 'Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.', 'groupDescription': 'Week 20', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.4', 'ciLowerLimit': '2.9', 'ciUpperLimit': '25.9', 'estimateComment': 'Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.', 'groupDescription': 'Week 24', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 12, 16, 20, and 24', 'description': "The CGI-I is a questionnaire that asks the clinician to evaluate the improvement or worsening of the participant's alopecia areata as compared to the start of the study on a 7-point scale. Responses range from 1 (very much worse) to 7 (very much improved). Responders were defined as participants with responses of 6 (much improved) or 7 (very much improved).", 'unitOfMeasure': 'Percentage of responders', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.'}, {'type': 'SECONDARY', 'title': 'Part A, Period 1: Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Period 1 - CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part A: Period 1 - CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '29.8', 'groupId': 'OG000', 'lowerLimit': '23.0', 'upperLimit': '36.7'}, {'value': '52.8', 'groupId': 'OG001', 'lowerLimit': '44.1', 'upperLimit': '61.4'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '33.5', 'groupId': 'OG000', 'lowerLimit': '26.4', 'upperLimit': '40.7'}, {'value': '55.5', 'groupId': 'OG001', 'lowerLimit': '46.9', 'upperLimit': '64.1'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '40.9', 'groupId': 'OG000', 'lowerLimit': '33.3', 'upperLimit': '48.4'}, {'value': '63.4', 'groupId': 'OG001', 'lowerLimit': '54.9', 'upperLimit': '71.9'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '46.0', 'groupId': 'OG000', 'lowerLimit': '38.4', 'upperLimit': '53.7'}, {'value': '65.5', 'groupId': 'OG001', 'lowerLimit': '57.0', 'upperLimit': '74.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.9', 'ciLowerLimit': '11.9', 'ciUpperLimit': '34.0', 'estimateComment': 'Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.', 'groupDescription': 'Week 12', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.9', 'ciLowerLimit': '10.7', 'ciUpperLimit': '33.1', 'estimateComment': 'Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.', 'groupDescription': 'Week 16', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.6', 'ciLowerLimit': '11.2', 'ciUpperLimit': '33.9', 'estimateComment': 'Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.', 'groupDescription': 'Week 20', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.5', 'ciLowerLimit': '8.1', 'ciUpperLimit': '31.0', 'estimateComment': 'Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.', 'groupDescription': 'Week 24', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 12, 16, 20, and 24', 'description': "The PGI-I is a self-administered questionnaire that asks the participant to evaluate the improvement or worsening of their alopecia areata as compared to the start of the study on a 7-point scale. Responses range from 1 (very much worse) to 7 (very much improved). Responders were defined as participants with responses of 6 (much improved) or 7 (very much improved). PGI responder is a response of 'very much improved' or 'much improved'.", 'unitOfMeasure': 'Percentage of responders', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.'}, {'type': 'SECONDARY', 'title': 'Part A, Period 1: Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Period 1 - CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part A: Period 1 - CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.4', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '0.95', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '1.63', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.37', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '1.74', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '1.84', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '1.64', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '1.92', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '-0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.16', 'estimateComment': 'LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.', 'groupDescription': 'Week 12', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '-0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.18', 'estimateComment': 'LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.', 'groupDescription': 'Week 16', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.19', 'estimateComment': 'LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.', 'groupDescription': 'Week 20', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.20', 'estimateComment': 'LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.', 'groupDescription': 'Week 24', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 12, 16, 20, and 24', 'description': "The CGI-S is a questionnaire that asks the clinician to evaluate the symptom severity of the participant's alopecia areata at the time of assessment. The symptom severity was rated on a scale ranging from 1 to 7, where 1=normal, no hair loss; 2=borderline hair loss; 3=mild hair loss; 4=moderate hair loss; 5=marked hair loss; 6=severe hair loss; 7=among the most extreme hair loss. Higher scores indicate more hair loss. A negative change from baseline indicates less hair loss.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number analyzed indicates the number of participants with data available for analysis at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Part A, Period 1: Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Period 1 - CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part A: Period 1 - CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.4', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '1.56', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '1.74', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '1.78', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '1.66', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '1.95', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '-0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.16', 'estimateComment': 'LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.', 'groupDescription': 'Week 12', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '-0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.18', 'estimateComment': 'LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.', 'groupDescription': 'Week 16', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.18', 'estimateComment': 'LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.', 'groupDescription': 'Week 20', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.21', 'estimateComment': 'LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.', 'groupDescription': 'Week 24', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 12, 16, 20, and 24', 'description': 'The PGI-S is a self-administered questionnaire that asks the participant to evaluate the symptom severity of their alopecia areata at the time of assessment. Symptom severity was rated on a scale ranging from 1 to 7, where 1=normal, no hair loss; 2=borderline hair loss; 3=mild hair loss; 4=moderate hair loss; 5=marked hair loss; 6=severe hair loss; 7=among the most extreme hair loss. Higher scores indicate more hair loss. A negative change from baseline indicates less hair loss.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number analyzed indicates the number of participants with data available for analysis at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Part A, Period 1: Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Period 1 - CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part A: Period 1 - CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.'}], 'classes': [{'title': 'Satisfied Thickness Hair Coverage: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '0.67', 'groupId': 'OG001'}]}]}, {'title': 'Satisfied Thickness Hair Coverage: Change From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '1.15', 'groupId': 'OG001'}]}]}, {'title': 'Satisfied Thickness Hair Coverage: Change From Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '1.14', 'groupId': 'OG001'}]}]}, {'title': 'Satisfied Thickness Hair Coverage: Change From Baseline at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '1.16', 'groupId': 'OG001'}]}]}, {'title': 'Satisfied Thickness Hair Coverage: Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '1.25', 'groupId': 'OG001'}]}]}, {'title': 'Satisfied Evenness Hair Coverage: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '0.64', 'groupId': 'OG001'}]}]}, {'title': 'Satisfied Evenness Hair Coverage: Change From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '1.09', 'groupId': 'OG001'}]}]}, {'title': 'Satisfied Evenness Hair Coverage: Change From Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '1.14', 'groupId': 'OG001'}]}]}, {'title': 'Satisfied Evenness Hair Coverage: Change From Baseline at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '1.19', 'groupId': 'OG001'}]}]}, {'title': 'Satisfied Evenness Hair Coverage: Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '1.18', 'groupId': 'OG001'}]}]}, {'title': 'How Satisfied With Your Eyebrows: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '1.35', 'groupId': 'OG001'}]}]}, {'title': 'How Satisfied With Your Eyebrows: Change From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '1.43', 'groupId': 'OG001'}]}]}, {'title': 'How Satisfied With Your Eyebrows: Change From Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '1.44', 'groupId': 'OG001'}]}]}, {'title': 'How Satisfied With Your Eyebrows: Change From Baseline at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '1.32', 'groupId': 'OG001'}]}]}, {'title': 'How Satisfied With Your Eyebrows: Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '1.42', 'groupId': 'OG001'}]}]}, {'title': 'How Satisfied With Your Eyelashes: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '1.40', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '1.44', 'groupId': 'OG001'}]}]}, {'title': 'How Satisfied With Your Eyelashes: Change From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '1.42', 'groupId': 'OG001'}]}]}, {'title': 'How Satisfied With Your Eyelashes: Change From Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '1.42', 'groupId': 'OG001'}]}]}, {'title': 'How Satisfied With Your Eyelashes: Change From Baseline at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '1.37', 'groupId': 'OG001'}]}]}, {'title': 'How Satisfied With Your Eyelashes: Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '1.41', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 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The model is fit using an unstructured covariance structure.', 'groupDescription': 'Satisfied Thickness Hair Coverage: Week 12', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '-0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'estimateComment': 'LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.', 'groupDescription': 'Satisfied Thickness Hair Coverage: Week 16', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '-0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'estimateComment': 'LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.', 'groupDescription': 'Satisfied Thickness Hair Coverage: Week 20', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '-0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'estimateComment': 'LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.', 'groupDescription': 'Satisfied Thickness Hair Coverage: Week 24', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '-0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'estimateComment': 'LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.', 'groupDescription': 'Satisfied Evenness Hair Coverage: Week 12', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '-0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'estimateComment': 'LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.', 'groupDescription': 'Satisfied Evenness Hair Coverage: Week 16', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '-0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'estimateComment': 'LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.', 'groupDescription': 'Satisfied Evenness Hair Coverage: Week 20', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '-0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'estimateComment': 'LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.', 'groupDescription': 'Satisfied Evenness Hair Coverage: Week 24', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '-0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'estimateComment': 'LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.', 'groupDescription': 'How Satisfied With Your Eyebrows: Week 12', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '-0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'estimateComment': 'LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.', 'groupDescription': 'How Satisfied With Your Eyebrows: Week 16', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '-0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'estimateComment': 'LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.', 'groupDescription': 'How Satisfied With Your Eyebrows: Week 20', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '-0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'estimateComment': 'LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.', 'groupDescription': 'How Satisfied With Your Eyebrows: Week 24', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '-0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'estimateComment': 'LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.', 'groupDescription': 'How Satisfied With Your Eyelashes: Week 12', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '-0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'estimateComment': 'LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.', 'groupDescription': 'How Satisfied With Your Eyelashes: Week 16', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '-0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'estimateComment': 'LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.', 'groupDescription': 'How Satisfied With Your Eyelashes: Week 20', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '-0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'estimateComment': 'LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.', 'groupDescription': 'How Satisfied With Your Eyelashes: Week 24', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 12, 16, 20, and 24', 'description': 'The QPRO questionnaire provides additional details on key attributes of hair and helps provide context to the SPRO response. The individual items of QPRO are: Satisfied thickness hair coverage; Satisfied evenness hair coverage; How satisfied with your eyebrows; How satisfied with your eyelashes, scored on a scale ranging from 1 to 5 where 1=very satisfied, 2=satisfied, 3=neither satisfied nor dissatisfied, 4=dissatisfied, 5=very dissatisfied. Higher scores indicates the greater dissatisfaction on hair quality. A negative change from baseline indicate the greater satisfaction on hair quality.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number analyzed indicates the number of participants with data available for analysis at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: CTP-543 8 mg to 4 mg BID to 8 mg BID', 'description': 'Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \\> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID', 'description': 'Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \\> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.'}, {'id': 'OG002', 'title': 'Part B: CTP-543 8 mg BID to Placebo to 8 mg BID', 'description': 'Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \\> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.'}, {'id': 'OG003', 'title': 'Part B: CTP-543 12 mg BID to Placebo to 12 mg BID', 'description': 'Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \\> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000', 'lowerLimit': '17.1', 'upperLimit': '100.0'}, {'value': '62.5', 'groupId': 'OG001', 'lowerLimit': '29.0', 'upperLimit': '96.0'}, {'value': '26.7', 'groupId': 'OG002', 'lowerLimit': '4.3', 'upperLimit': '49.0'}, {'value': '15.8', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '32.2'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '100.0', 'upperLimit': '100.0'}, {'value': '62.5', 'groupId': 'OG001', 'lowerLimit': '29.0', 'upperLimit': '96.0'}, {'value': '23.1', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '46.0'}, {'value': '16.7', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '33.9'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000', 'lowerLimit': '44.9', 'upperLimit': '100.0'}, {'value': '62.5', 'groupId': 'OG001', 'lowerLimit': '29.0', 'upperLimit': '96.0'}, {'value': '30.8', 'groupId': 'OG002', 'lowerLimit': '5.7', 'upperLimit': '55.9'}, {'value': '43.8', 'groupId': 'OG003', 'lowerLimit': '19.4', 'upperLimit': '68.1'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000', 'lowerLimit': '17.1', 'upperLimit': '100.0'}, {'value': '62.5', 'groupId': 'OG001', 'lowerLimit': '29.0', 'upperLimit': '96.0'}, {'value': '50.0', 'groupId': 'OG002', 'lowerLimit': '21.7', 'upperLimit': '78.3'}, {'value': '61.1', 'groupId': 'OG003', 'lowerLimit': '38.6', 'upperLimit': '83.6'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000', 'lowerLimit': '17.1', 'upperLimit': '100.0'}, {'value': '62.5', 'groupId': 'OG001', 'lowerLimit': '29.0', 'upperLimit': '96.0'}, {'value': '69.2', 'groupId': 'OG002', 'lowerLimit': '44.1', 'upperLimit': '94.3'}, {'value': '70.6', 'groupId': 'OG003', 'lowerLimit': '48.9', 'upperLimit': '92.2'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000', 'lowerLimit': '17.1', 'upperLimit': '100.0'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '15.4', 'upperLimit': '84.6'}, {'value': '76.9', 'groupId': 'OG002', 'lowerLimit': '54.0', 'upperLimit': '99.8'}, {'value': '77.8', 'groupId': 'OG003', 'lowerLimit': '58.6', 'upperLimit': '97.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4, 8, 12, 16, 20, and 24 of re-treatment', 'description': "SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). ROR is defined as the participant's attainment of an absolute SALT score of ≤20 during re-treatment.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.'}, {'type': 'SECONDARY', 'title': 'Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID', 'description': 'Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \\> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID', 'description': 'Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \\> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.'}, {'id': 'OG002', 'title': 'Part B: CTP-543 8 mg BID to Placebo to 8 mg BID', 'description': 'Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \\> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.'}, {'id': 'OG003', 'title': 'Part B: CTP-543 12 mg BID to Placebo to 12 mg BID', 'description': 'Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \\> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.'}], 'classes': [{'title': 'Relative Change From Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-20.8', 'spread': '15.27', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '69.43', 'groupId': 'OG001'}, {'value': '12.1', 'spread': '39.44', 'groupId': 'OG002'}, {'value': '47.8', 'spread': '71.19', 'groupId': 'OG003'}]}]}, {'title': 'Relative Change From Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-39.6', 'spread': '20.33', 'groupId': 'OG000'}, {'value': '26.2', 'spread': '109.97', 'groupId': 'OG001'}, {'value': '10.5', 'spread': '48.10', 'groupId': 'OG002'}, {'value': '47.1', 'spread': '94.35', 'groupId': 'OG003'}]}]}, {'title': 'Relative Change From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-42.6', 'spread': '27.06', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '78.81', 'groupId': 'OG001'}, {'value': '-7.2', 'spread': '84.41', 'groupId': 'OG002'}, {'value': '33.9', 'spread': '119.41', 'groupId': 'OG003'}]}]}, {'title': 'Relative Change From Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-48.8', 'spread': '52.66', 'groupId': 'OG000'}, {'value': '-11.4', 'spread': '78.88', 'groupId': 'OG001'}, {'value': '-13.4', 'spread': '95.31', 'groupId': 'OG002'}, {'value': '-15.2', 'spread': '116.20', 'groupId': 'OG003'}]}]}, {'title': 'Relative Change From Baseline at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-54.8', 'spread': '43.90', 'groupId': 'OG000'}, {'value': '-7.8', 'spread': '83.35', 'groupId': 'OG001'}, {'value': '-29.2', 'spread': '93.24', 'groupId': 'OG002'}, {'value': '-31.5', 'spread': '108.97', 'groupId': 'OG003'}]}]}, {'title': 'Relative Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-39.3', 'spread': '53.48', 'groupId': 'OG000'}, {'value': '-7.9', 'spread': '81.41', 'groupId': 'OG001'}, {'value': '-39.3', 'spread': '84.49', 'groupId': 'OG002'}, {'value': '-38.4', 'spread': '105.80', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24 of re-treatment', 'description': 'SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss). Relative change (percent change) to baseline is calculated as: 100 x (\\[post-baseline SALT score - baseline SALT score\\]/baseline SALT score).', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment. Number analyzed indicates the number of participants with data available for analysis at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing at Least One Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '19', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Period 1 - CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part A: Period 1 - CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.'}, {'id': 'OG002', 'title': 'Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID', 'description': 'Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute severity of alopecia tool (SALT) score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.'}, {'id': 'OG003', 'title': 'Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID', 'description': 'Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.'}, {'id': 'OG004', 'title': 'Part A: Period 2 - CTP-543 8 mg BID to Placebo', 'description': 'Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.'}, {'id': 'OG005', 'title': 'Part A: Period 2 - CTP-543 12 mg BID to Placebo', 'description': 'Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.'}, {'id': 'OG006', 'title': 'Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID', 'description': 'Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \\> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.'}, {'id': 'OG007', 'title': 'Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID', 'description': 'Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \\> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.'}, {'id': 'OG008', 'title': 'Part B: CTP-543 8 mg BID to Placebo to 8 mg BID', 'description': 'Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \\> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.'}, {'id': 'OG009', 'title': 'Part B: CTP-543 12 mg BID to Placebo to 12 mg BID', 'description': 'Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \\> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '14', 'groupId': 'OG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug up to last follow up visit (Week 76)', 'description': "An adverse event is any untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the patient's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an adverse event. TEAEs were defined as any adverse event that occurs after administration of the first dose of study drug in each Part/Period (ie, on or after the day of the first dose in each Part/Period). TEAEs included both serious and non-serious TEAEs.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received study drug during the treatment period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A: Period 1 - CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 milligrams (mg) tablets, orally, twice daily (BID) for up to 24 weeks.'}, {'id': 'FG001', 'title': 'Part A: Period 1 - CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.'}, {'id': 'FG002', 'title': 'Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID', 'description': 'Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute severity of alopecia tool (SALT) score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.'}, {'id': 'FG003', 'title': 'Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID', 'description': 'Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.'}, {'id': 'FG004', 'title': 'Part A: Period 2 - CTP-543 8 mg BID to Placebo', 'description': 'Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.'}, {'id': 'FG005', 'title': 'Part A: Period 2 - CTP-543 12 mg BID to Placebo', 'description': 'Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.'}, {'id': 'FG006', 'title': 'Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID', 'description': 'Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \\> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.'}, {'id': 'FG007', 'title': 'Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID', 'description': 'Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \\> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.'}, {'id': 'FG008', 'title': 'Part B: CTP-543 8 mg BID to Placebo to 8 mg BID', 'description': 'Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \\> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.'}, {'id': 'FG009', 'title': 'Part B: CTP-543 12 mg BID to Placebo to 12 mg BID', 'description': 'Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \\> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.'}], 'periods': [{'title': 'Part A: Period 1 (Day 1 to Week 24)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '180'}, {'groupId': 'FG001', 'numSubjects': '137'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Efficacy Population', 'comment': 'Efficacy population included all participants who were randomized in the study, dispensed study drug, and had at least 1 post treatment severity of alopecia tool (SALT) assessment.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '178'}, {'groupId': 'FG001', 'numSubjects': '135'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}, {'groupId': 'FG001', 'numSubjects': '118'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Treatment Emergent or Worsening Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Non-compliance With Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}, {'title': 'Part A: Period 2 (Week 24 to Week 48)', 'milestones': [{'type': 'STARTED', 'comment': 'The Part A Period 2 consists of participants from Part A Period 1 from each dose group who achieved an absolute SALT score of ≤20 at Week 24.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '25'}, {'groupId': 'FG004', 'numSubjects': '18'}, {'groupId': 'FG005', 'numSubjects': '25'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '25'}, {'groupId': 'FG004', 'numSubjects': '18'}, {'groupId': 'FG005', 'numSubjects': '25'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}, {'title': 'Part B (Day 1 to Week 24)', 'milestones': [{'type': 'STARTED', 'comment': 'The Part B consists of participants who achieved loss of regrowth maintenance (absolute SALT score of \\> 20) from Part A Period 2.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '8'}, {'groupId': 'FG008', 'numSubjects': '15'}, {'groupId': 'FG009', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '8'}, {'groupId': 'FG008', 'numSubjects': '13'}, {'groupId': 'FG009', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study centers in the United States from 26 February 2021 to 16 May 2023.', 'preAssignmentDetails': '429 participants were screened, out of which 317 participants who experienced moderate to severe hair loss due to alopecia areata were enrolled to receive CTP-543 or placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '317', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A: Period 1 - CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.'}, {'id': 'BG001', 'title': 'Part A: Period 1 - CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.0', 'spread': '14.05', 'groupId': 'BG000'}, {'value': '39.6', 'spread': '13.21', 'groupId': 'BG001'}, {'value': '39.8', 'spread': '13.68', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '167', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '293', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Asian', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants included all participants who were randomized in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-09', 'size': 13051742, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-08-22T12:14', 'hasProtocol': True}, {'date': '2023-02-14', 'size': 4022402, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-08-22T12:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 317}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'dispFirstSubmitDate': '2024-04-04', 'completionDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-03', 'studyFirstSubmitDate': '2021-03-03', 'resultsFirstSubmitDate': '2024-08-23', 'studyFirstSubmitQcDate': '2021-03-03', 'dispFirstPostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-03', 'studyFirstPostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A, Period 2: Percentage of Participants Achieving Loss of Regrowth Maintenance (LOM) Criteria Defined by Severity of Alopecia Tool (SALT) Score > 20 Following Dose Reduction', 'timeFrame': 'From Week 24 to Week 48', 'description': 'SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score \\>20. The percentage of participants achieving LOM criteria (SALT \\>20) was compared to the percentage of participants maintaining treatment success (SALT ≤ 20) for each of the following dose reduction conditions. Due to the variable time on study for each participant within Part A Period 2, the primary analysis visit was the end of Part A Period 2, where the last observed non-missing SALT value was selected for each participant.'}, {'measure': 'Part A, Period 2: Percentage of Participants Achieving LOM Criteria Defined by SALT Score > 20 Following Drug Discontinuation', 'timeFrame': 'From Week 24 to Week 48', 'description': 'SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score \\>20. The percentage of participants achieving LOM criteria (SALT \\>20) was compared to the percentage of participants maintaining treatment success (SALT ≤ 20) for each of the following dose discontinuation conditions. Due to the variable time on study for each participant within Part A Period 2, the primary analysis visit was at the end of Part A Period 2, where the last observed non-missing SALT value was selected for each participant.'}, {'measure': 'Part B: Percentage of Participants by Dose Group Who Achieved Restoration of Regrowth (ROR) at Week 24', 'timeFrame': 'Week 24 of re-treatment', 'description': "SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). ROR is defined as the participant's attainment of an absolute SALT score of ≤20 at Week 24 of re-treatment."}], 'secondaryOutcomes': [{'measure': 'Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT Score > 20 Following Dose Reduction Conditions at Weeks 28, 32, 36, 40, 44, and 48', 'timeFrame': 'Weeks 28, 32, 36, 40, 44, and 48', 'description': 'SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score \\>20.'}, {'measure': 'Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT > 20 Following Drug Discontinuation Conditions at Weeks 28, 32, 36, 40, 44, and 48', 'timeFrame': 'Weeks 28, 32, 36, 40, 44, and 48', 'description': 'SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score \\>20.'}, {'measure': 'Part A, Period 1: Percentage of Responders as Assessed on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24', 'timeFrame': 'Weeks 12, 16, 20, and 24', 'description': "SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied. SPRO responder is defined as a post-baseline response of 'very satisfied' or 'satisfied'."}, {'measure': 'Part A, Period 1: Percentage of Participants Who Achieved an Absolute SALT Score ≤20 at Weeks 4, 8, 12, 16, 20, and 24', 'timeFrame': 'Weeks 4, 8, 12, 16, 20, and 24', 'description': 'SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).'}, {'measure': 'Part A, Period 1: Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss). Relative change (percent change) to baseline is calculated as: 100 x (\\[post-baseline SALT score - baseline SALT score\\]/baseline SALT score). Negative change indicates no hair loss.'}, {'measure': 'Part A, Period 1: Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20 and 24', 'timeFrame': 'Weeks 12, 16, 20, and 24', 'description': "The CGI-I is a questionnaire that asks the clinician to evaluate the improvement or worsening of the participant's alopecia areata as compared to the start of the study on a 7-point scale. Responses range from 1 (very much worse) to 7 (very much improved). Responders were defined as participants with responses of 6 (much improved) or 7 (very much improved)."}, {'measure': 'Part A, Period 1: Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24', 'timeFrame': 'Weeks 12, 16, 20, and 24', 'description': "The PGI-I is a self-administered questionnaire that asks the participant to evaluate the improvement or worsening of their alopecia areata as compared to the start of the study on a 7-point scale. Responses range from 1 (very much worse) to 7 (very much improved). Responders were defined as participants with responses of 6 (much improved) or 7 (very much improved). PGI responder is a response of 'very much improved' or 'much improved'."}, {'measure': 'Part A, Period 1: Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24', 'timeFrame': 'Baseline, Weeks 12, 16, 20, and 24', 'description': "The CGI-S is a questionnaire that asks the clinician to evaluate the symptom severity of the participant's alopecia areata at the time of assessment. The symptom severity was rated on a scale ranging from 1 to 7, where 1=normal, no hair loss; 2=borderline hair loss; 3=mild hair loss; 4=moderate hair loss; 5=marked hair loss; 6=severe hair loss; 7=among the most extreme hair loss. Higher scores indicate more hair loss. A negative change from baseline indicates less hair loss."}, {'measure': 'Part A, Period 1: Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24', 'timeFrame': 'Baseline, Weeks 12, 16, 20, and 24', 'description': 'The PGI-S is a self-administered questionnaire that asks the participant to evaluate the symptom severity of their alopecia areata at the time of assessment. Symptom severity was rated on a scale ranging from 1 to 7, where 1=normal, no hair loss; 2=borderline hair loss; 3=mild hair loss; 4=moderate hair loss; 5=marked hair loss; 6=severe hair loss; 7=among the most extreme hair loss. Higher scores indicate more hair loss. A negative change from baseline indicates less hair loss.'}, {'measure': 'Part A, Period 1: Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24', 'timeFrame': 'Baseline, Weeks 12, 16, 20, and 24', 'description': 'The QPRO questionnaire provides additional details on key attributes of hair and helps provide context to the SPRO response. The individual items of QPRO are: Satisfied thickness hair coverage; Satisfied evenness hair coverage; How satisfied with your eyebrows; How satisfied with your eyelashes, scored on a scale ranging from 1 to 5 where 1=very satisfied, 2=satisfied, 3=neither satisfied nor dissatisfied, 4=dissatisfied, 5=very dissatisfied. Higher scores indicates the greater dissatisfaction on hair quality. A negative change from baseline indicate the greater satisfaction on hair quality.'}, {'measure': 'Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24', 'timeFrame': 'Weeks 4, 8, 12, 16, 20, and 24 of re-treatment', 'description': "SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). ROR is defined as the participant's attainment of an absolute SALT score of ≤20 during re-treatment."}, {'measure': 'Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24 of re-treatment', 'description': 'SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss). Relative change (percent change) to baseline is calculated as: 100 x (\\[post-baseline SALT score - baseline SALT score\\]/baseline SALT score).'}, {'measure': 'Number of Participants Experiencing at Least One Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'From first dose of study drug up to last follow up visit (Week 76)', 'description': "An adverse event is any untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the patient's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an adverse event. TEAEs were defined as any adverse event that occurs after administration of the first dose of study drug in each Part/Period (ie, on or after the day of the first dose in each Part/Period). TEAEs included both serious and non-serious TEAEs."}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CTP-543'], 'conditions': ['Alopecia Areata']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the regrowth of hair with CTP-543 and subsequent durability of that regrowth following dose reduction in adult patients with moderate to severe alopecia areata.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Definitive diagnosis of alopecia areata with a current episode of scalp hair loss lasting at least 6 months and not exceeding 10 years at the time of Screening. Total disease duration greater than 10 years is permitted.\n* At least 50% scalp hair loss, as defined by a severity of alopecia tool (SALT) score ≥50, at Screening and Baseline.\n* Willing to comply with the study visits and requirements of the study protocol.\n\nExclusion Criteria:\n\n* Treatment with other medications or agents within 1 month of Baseline or during the study that may affect hair regrowth or immune response.\n* Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or other scalp condition that may interfere with the SALT assessment, or untreated actinic keratosis anywhere on the body at Screening and/or Baseline.\n* Treatment with systemic immunosuppressive medications within 3 months of Screening or during the study, or biologics within 6 months of Screening or during the study.\n* Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug.\n* Clinically significant medical condition, psychiatric disease, or social condition, as determined by the Investigator, that may unfavorably alter the risk-benefit of study participation, adversely affect study compliance, or confound interpretation of study results.'}, 'identificationModule': {'nctId': 'NCT04784533', 'briefTitle': 'A Study to Evaluate the Durability of Response of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata', 'organization': {'class': 'INDUSTRY', 'fullName': 'Concert Pharmaceuticals'}, 'officialTitle': 'A Study to Evaluate Maintenance of Hair Regrowth Following Dose Reduction of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata', 'orgStudyIdInfo': {'id': 'CP543.2004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: Period 1 - CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 milligrams (mg) tablets, orally, twice daily (BID) for up to 24 weeks.', 'interventionNames': ['Drug: CTP-543']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: Period 1 - CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.', 'interventionNames': ['Drug: CTP-543']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID', 'description': 'Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute severity of alopecia tool (SALT) score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.', 'interventionNames': ['Drug: CTP-543']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID', 'description': 'Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.', 'interventionNames': ['Drug: CTP-543']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part A: Period 2 - CTP-543 8 mg BID to Placebo', 'description': 'Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part A: Period 2 - CTP-543 12 mg BID to Placebo', 'description': 'Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID', 'description': 'Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \\> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.', 'interventionNames': ['Drug: CTP-543']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID', 'description': 'Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \\> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.', 'interventionNames': ['Drug: CTP-543']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: CTP-543 8 mg BID to Placebo to 8 mg BID', 'description': 'Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \\> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.', 'interventionNames': ['Drug: CTP-543']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: CTP-543 12 mg BID to Placebo to 12 mg BID', 'description': 'Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \\> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.', 'interventionNames': ['Drug: CTP-543']}], 'interventions': [{'name': 'CTP-543', 'type': 'DRUG', 'description': 'Oral dosing', 'armGroupLabels': ['Part A: Period 1 - CTP-543 12 mg BID', 'Part A: Period 1 - CTP-543 8 mg BID', 'Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID', 'Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID', 'Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID', 'Part B: CTP-543 12 mg BID to Placebo to 12 mg BID', 'Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID', 'Part B: CTP-543 8 mg BID to Placebo to 8 mg BID']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral dosing', 'armGroupLabels': ['Part A: Period 2 - CTP-543 12 mg BID to Placebo', 'Part A: Period 2 - CTP-543 8 mg BID to Placebo']}]}, 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'Springville', 'state': 'Utah', 'country': 'United States', 'facility': 'Springville Dermatology/CCT Research', 'geoPoint': {'lat': 40.16523, 'lon': -111.61075}}, {'zip': '23233', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'West End Dermatology Associates', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Concert Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}