Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2026-04-13 @ 11:44 PM
Study NCT ID:
NCT03181893
Status:
COMPLETED
Last Update Posted:
2023-09-14
First Post:
2017-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study In Adults With Moderate To Severe Dermatomyositis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Italy'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003882', 'term': 'Dermatomyositis'}], 'ancestors': [{'id': 'D017285', 'term': 'Polymyositis'}, {'id': 'D009220', 'term': 'Myositis'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Week 40', 'description': 'The safety analysis set includes all participants who received at least one dose of randomized treatment in any stage. The AEs reported were treatment emergent.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants who received placebo in any stage.', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 22, 'seriousNumAtRisk': 45, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'PF-06823859 150 mg IV', 'description': 'Participants who received PF-06823859 150 mg IV in any stage.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 13, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'PF-06823859 600 mg IV', 'description': 'Participants who received PF-06823859 600 mg IV in any stage.', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 18, 'seriousNumAtRisk': 47, 'deathsNumAffected': 1, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Total', 'description': 'This arm included all participants (32, 9, 16 and 18 participants who were randomized and treated in Stage 1, Stage 2, Amended Stage 2, and Stage 3, respectively) in the safety analysis set', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 45, 'seriousNumAtRisk': 75, 'deathsNumAffected': 1, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Blood potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'SARS-CoV-2 test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Parathyroid tumour benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Mental impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Upper-airway cough syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Dermatomyositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Rosacea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}], 'seriousEvents': [{'term': 'Cytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Colitis microscopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Ocular icterus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Haemophagocytic lymphohistiocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Central nervous system lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 12 (Stage 1, Stage 2 and Amended Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': '(Stage 1) Placebo', 'description': 'Participants in this group were randomized to receive placebo on Day 1, Week 4, and Week 8. After week 12, participants went into a follow up period.'}, {'id': 'OG001', 'title': 'PF-06823859 600 mg IV (Stage 1)', 'description': 'Participants were randomized to receive PF-06823859 600 mg on Day 1, Week 4, and Week 8 in Stage 1.'}, {'id': 'OG002', 'title': '(Stage 2) Placebo', 'description': 'Participants in this group were randomized to receive placebo on Day 1, Week 4, and Week 8. After week 12, participants went into a follow up period.'}, {'id': 'OG003', 'title': '(Stage 2) PF-06823859 150 mg IV', 'description': 'Participants in this group were randomized to receive PF-06823859 150 mg on Day 1, Week 4, and Week 8 After week 12, participants went into a follow up period.'}, {'id': 'OG004', 'title': '(Stage 2) PF-06823859 600 mg IV', 'description': 'Dosing occurred Day 1, Week 4, and Week 8. After week 12, participants went into a follow-up period.'}, {'id': 'OG005', 'title': '(Amended Stage 2) Placebo Then Switched to PF-06823859 150 mg IV at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG006', 'title': '(Amended Stage 2) Placebo Then Switched to PF-06823859 600 mg IV at Week 12', 'description': 'Dosing occurred on Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG007', 'title': '(Amended Stage 2) PF-06823859 150 mg IV Then Switched to Placebo at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16 and 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG008', 'title': '(Amended Stage 2) PF-06823859 600 mg IV Then Switched to Placebo at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, and 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.44', 'spread': '5.270', 'groupId': 'OG000'}, {'value': '-19.62', 'spread': '9.140', 'groupId': 'OG001'}, {'value': '5.00', 'groupId': 'OG002'}, {'value': '-17.40', 'spread': '9.290', 'groupId': 'OG003'}, {'value': '-26.00', 'spread': '7.937', 'groupId': 'OG004'}, {'value': '-3.00', 'spread': '8.485', 'groupId': 'OG005'}, {'value': '3.00', 'groupId': 'OG006'}, {'value': '-16.40', 'spread': '5.835', 'groupId': 'OG007'}, {'value': '-15.33', 'spread': '6.028', 'groupId': 'OG008'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-14.82', 'ciLowerLimit': '-20.26', 'ciUpperLimit': '-9.37', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.183', 'statisticalMethod': 'LANCOVA-P model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': "The treatment effect was defined as the difference (mean chg from baseline at Week12 in the active treatment group minus that in the placebo group) in the mean change of CDASI activity score from baseline at Week 12. The score (range: 0-100) consists of the extent score (ES), Gottorn hands score (GHS), peringual score (PS) and allopecia score (AS). ES (range: 0-90) was obtained by summing up scores for the total erythema (ER \\[0-45\\], redness of the skin or mucous membranes), scaling (SC \\[0-30\\], peeling of the skin) and erosion/ulceration (EU \\[0-15\\], presence of the deeper wound). Total ER, SC and EU scores were calculated as a sum of the contributions from 15 individual areas of the body. GHS characterizes papules (swellings) on hand and is a sum of the papule's characterization score (0-6) and ulceration score (0-1). PS (0-2) characterizes abnormalities around nails. The AS (0-1) characterizes hair loss. Higher scores indicate greater disease severity.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) in Stage 1, Stage 2, and Amended Stage 2 included all participants who received at least 1 dose of randomized treatment in in Stage 1, Stage 2, or Amended Stage 2.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE) (Stage 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '(Stage 3) Placebo Then Switched to PF-06823859 600 mg IV at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG001', 'title': '(Stage 3) PF-06823859 600 mg IV Then Switched to Placebo at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, and 20. At Week 24, participants entered a 4-month follow-up period or rolled over to the long-term extension study.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 40', 'description': 'Adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was any untoward medical occurrence that at any dose resulted in any of following outcomes/deemed significant for any other reason: death; initial /prolonged inpatient hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect and suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. AEs included both serious (if occurred) and all non-serious adverse events. TEAEs are events between first dose of study drug and up to Week 40 that were absent before treatment or that worsened relative to pretreatment state.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set in Stage 3 (SAS3) included all participants who received at least 1 dose of randomized treatment in Stage 3.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Laboratory Abnormalities (Stage 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '(Stage 3) Placebo Then Switched to PF-06823859 600 mg IV at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG001', 'title': '(Stage 3) PF-06823859 600 mg IV Then Switched to Placebo at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, and 20. At Week 24, participants entered a 4-month follow-up period or rolled over to the long-term extension study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 40', 'description': 'Hemoglobin(HGB),hematocrit,erythrocytes(ery.),HDL cholesterol(chl.)\\<0.8\\*lower limit of normal(LLN);reticulocytes (ret.), ret./ery.(%)\\<0.5\\*LLN,\\>1.5\\*upper limit of normal (ULN);ery. mean corpuscular(EMC) volume,EMC HGB concentration,potassium,chloride,calcium,bicarbonate\\<0.9\\*LLN,\\>1.1\\*ULN;platelets\\<0.5\\*LLN,\\>1.75\\*ULN; leukocytes(leu.),glucose\\<0.6\\*LLN,\\>1.5\\*ULN;lymphocytes(lym.), lym./leu.(%),neutrophils (neu.), neu./leu.(%), protein,albumin\\<0.8\\*LLN,\\>1.2\\*ULN;basophils(bas.), bas./leu.(%), eosinophils(eos.), eos./leu., monocytes(mon.), mon./leu.(%), urate\\>1.2\\*ULN;bilirubin (total, direct,indirect)\\>1.5\\*ULN;aspartate/alanine aminotransferase,gamma glutamyl transferase,lactate dehydrogenase,alkaline phosphatase\\>3.0\\*ULN;urea nitrogen,creatinine,triglycerides, chl.\\>1.3\\*ULN; sodium \\<0.95\\*LLN,\\>1.05\\*ULN; creatine kinase \\>2.0\\*ULN;Urine: pH\\<4.5,\\>8;glucose, ketones,protein, HGB,urobilinogen,bilirubin,nitrite,leukocyte esterase\\>=1;ery., leu.\\>= 20;hyaline casts\\>1;bacteria\\>20.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set in Stage 3 (SAS3) included all participants who received at least 1 dose of randomized treatment in Stage 3.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Vital Sign Abnormalities (Stage 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '(Stage 3) Placebo Then Switched to PF-06823859 600 mg IV at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG001', 'title': '(Stage 3) PF-06823859 600 mg IV Then Switched to Placebo at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, and 20. At Week 24, participants entered a 4-month follow-up period or rolled over to the long-term extension study.'}], 'classes': [{'title': 'Sitting SBP Value <90 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sitting DBP Value <50 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sitting Pulse Rate Value <40 bpm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sitting Pulse Rate Value >120 bpm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 40', 'description': 'Abnormality in vital signs: Sitting pulse rate \\<40 beats per minute (bpm) to \\>120 bpm, sitting diastolic blood pressure (DBP) \\< 50 millimeter of mercury (mmHg), sitting systolic blood pressure (SBP) \\<90 mmHg.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The SAS3 included all participants who received at least 1 dose of randomized treatment in Stage 3.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Electrocardiogram (ECG) Abnormalities (Stage 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '(Stage 3) Placebo Then Switched to PF-06823859 600 mg IV at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG001', 'title': '(Stage 3) PF-06823859 600 mg IV Then Switched to Placebo at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, and 20. At Week 24, participants entered a 4-month follow-up period or rolled over to the long-term extension study.'}], 'classes': [{'title': 'PR Interval Aggregate Value >=300 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'QRS Duration Aggregate Value >=200 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'QT Interval Aggregate Value >=500 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'QTcF Interval Aggregate 450<=Value<480 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'QTcF Interval Aggregate 480<=Value<500 msec', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'QTcF Interval Aggregate Value >=500 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'PR %Chg >=25% or >=50%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'QRS Duration %Chg >=25% or >=50%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '30<=QTcF Chg (msec)<60', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'QTcF Chg (msec) >=60', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 40', 'description': 'ECG abnormalities criteria included: 1) QTc interval adjusted according to Fridericia formula (QTcF) (msec): \\>450, \\>480, \\>500, increase from baseline \\>=30, increase from baseline \\>=60; 2) Pulse rate (PR) (msec): \\>=300, change from baseline (Chg) \\>=25% or 50%; 3) QT (msec): \\>=500; 4) QRS (msec): \\>=200, Chg \\>=25% or 50%. Categories, with at least 1 participant having ECG abnormality in any of the reporting arms, were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The SAS3 included all participants who received at least 1 dose of randomized treatment in Stage 3.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With TEAEs and SAEs (Stage 1 and Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '(Stage 1) Placebo', 'description': 'Participants in this group were randomized to receive placebo on Day 1, Week 4, and Week 8. After week 12, participants went into a follow up period.'}, {'id': 'OG001', 'title': 'PF-06823859 600 mg IV (Stage 1)', 'description': 'Participants were randomized to receive PF-06823859 600 mg on Day 1, Week 4, and Week 8 in Stage 1.'}, {'id': 'OG002', 'title': '(Stage 2) Placebo', 'description': 'Participants in this group were randomized to receive placebo on Day 1, Week 4, and Week 8. After week 12, participants went into a follow up period.'}, {'id': 'OG003', 'title': '(Stage 2) PF-06823859 150 mg IV', 'description': 'Participants in this group were randomized to receive PF-06823859 150 mg on Day 1, Week 4, and Week 8 After week 12, participants went into a follow up period.'}, {'id': 'OG004', 'title': '(Stage 2) PF-06823859 600 mg IV', 'description': 'Dosing occurred Day 1, Week 4, and Week 8. After week 12, participants went into a follow-up period.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 28', 'description': 'AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was any untoward medical occurrence that at any dose resulted in any of following outcomes/deemed significant for any other reason: death; initial /prolonged inpatient hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect and suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. AEs included both serious (if occurred) and all non-serious adverse events. TEAEs are events between first dose of study drug and up to Week 28 that were absent before treatment or that worsened relative to pretreatment state.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set in Stage 1 (SAS1) and safety analysis set in Stage 2 (SAS2) included all participants who received at least 1 dose of randomized treatment in Stage 1 and Stage 2, respectively.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With TEAEs and SAEs (Amended Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '(Amended Stage 2) Placebo Then Switched to PF-06823859 150 mg IV at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG001', 'title': '(Amended Stage 2) Placebo Then Switched to PF-06823859 600 mg IV at Week 12', 'description': 'Dosing occurred on Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG002', 'title': '(Amended Stage 2) PF-06823859 150 mg IV Then Switched to Placebo at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16 and 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG003', 'title': '(Amended Stage 2) PF-06823859 600 mg IV Then Switched to Placebo at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, and 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 40', 'description': 'AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was any untoward medical occurrence that at any dose resulted in any of following outcomes/deemed significant for any other reason: death; initial /prolonged inpatient hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect and suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. AEs included both serious (if occurred) and all non-serious adverse events. TEAEs are events between first dose of study drug and up to Week 40 that were absent before treatment or that worsened relative to pretreatment state.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set in Amended Stage 2 (SASA2) includes all participants who received at least one dose of randomized treatment in Amended Stage 2.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Laboratory Abnormalities (Stage 1 and Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '(Stage 1) Placebo', 'description': 'Participants in this group were randomized to receive placebo on Day 1, Week 4, and Week 8. After week 12, participants went into a follow up period.'}, {'id': 'OG001', 'title': 'PF-06823859 600 mg IV (Stage 1)', 'description': 'Participants were randomized to receive PF-06823859 600 mg on Day 1, Week 4, and Week 8 in Stage 1.'}, {'id': 'OG002', 'title': '(Stage 2) Placebo', 'description': 'Participants in this group were randomized to receive placebo on Day 1, Week 4, and Week 8. After week 12, participants went into a follow up period.'}, {'id': 'OG003', 'title': '(Stage 2) PF-06823859 150 mg IV', 'description': 'Participants in this group were randomized to receive PF-06823859 150 mg on Day 1, Week 4, and Week 8 After week 12, participants went into a follow up period.'}, {'id': 'OG004', 'title': '(Stage 2) PF-06823859 600 mg IV', 'description': 'Dosing occurred Day 1, Week 4, and Week 8. After week 12, participants went into a follow-up period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 28', 'description': "HGB,hematocrit,ery.,HDL chl.\\<0.8\\*LLN;ret., ret./ery. (%)\\<0.5\\*LLN,\\>1.5\\*ULN;EMC volume,EMC HGB,EMC HGB concentration,potassium,chloride,calcium,bicarbonate\\<0.9\\*LLN,\\>1.1\\*ULN;platelets\\<0.5\\*LLN,\\>1.75\\*ULN;leu.,glucose\\<0.6\\*LLN,\\>1.5\\*ULN;lym., lym./leu.(%), neu., neu./leu. (%), protein,albumin \\<0.8\\*LLN,\\>1.2\\*ULN;bas., bas./leu.(%), eos., eos./leu., mon., mon./leu.(%), urate \\>1.2\\*ULN;bilirubin (total, direct, indirect)\\>1.5\\*ULN;aspartate/alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase\\>3.0\\*ULN;urea nitrogen, creatinine, triglycerides, chl.\\>1.3\\*ULN; sodium \\<0.95\\*LLN,\\>1.05\\*ULN; creatine kinase \\>2.0\\*ULN;Urine: pH\\<4.5,\\>8;glucose, ketones, protein, HGB, urobilinogen,bilirubin,nitrite,leukocyte esterase\\>=1;ery., leu.\\>= 20;hyaline casts\\>1;bacteria\\>20. Clinical significance of laboratory parameters was determined at the investigator's discretion.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The SAS1 and SAS2 included all participants who received at least 1 dose of randomized treatment in Stage 1 and Stage 2, respectively.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Laboratory Abnormalities (Amended Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '(Amended Stage 2) Placebo Then Switched to PF-06823859 150 mg IV at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG001', 'title': '(Amended Stage 2) Placebo Then Switched to PF-06823859 600 mg IV at Week 12', 'description': 'Dosing occurred on Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG002', 'title': '(Amended Stage 2) PF-06823859 150 mg IV Then Switched to Placebo at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16 and 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG003', 'title': '(Amended Stage 2) PF-06823859 600 mg IV Then Switched to Placebo at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, and 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 40', 'description': "HGB,hematocrit,ery.,HDL chl.\\<0.8\\*LLN;ret., ret./ery. (%)\\<0.5\\*LLN,\\>1.5\\*ULN;EMC volume,EMC HGB,EMC HGB concentration,potassium,chloride,calcium,bicarbonate\\<0.9\\*LLN,\\>1.1\\*ULN;platelets\\<0.5\\*LLN,\\>1.75\\*ULN;leu.,glucose\\<0.6\\*LLN,\\>1.5\\*ULN;lym., lym./leu.(%), neu., neu./leu. (%), protein,albumin \\<0.8\\*LLN,\\>1.2\\*ULN;bas., bas./leu.(%), eos., eos./leu., mon., mon./leu.(%), urate \\>1.2\\*ULN;bilirubin (total, direct, indirect)\\>1.5\\*ULN;aspartate/alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase\\>3.0\\*ULN;urea nitrogen, creatinine, triglycerides, chl.\\>1.3\\*ULN; sodium \\<0.95\\*LLN,\\>1.05\\*ULN; creatine kinase \\>2.0\\*ULN;Urine: pH\\<4.5,\\>8;glucose, ketones, protein, HGB, urobilinogen,bilirubin,nitrite,leukocyte esterase\\>=1;ery., leu.\\>= 20;hyaline casts\\>1;bacteria\\>20. Clinical significance of laboratory parameters was determined at the investigator's discretion.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The SASA2 includes all participants who received at least one dose of randomized treatment in Amended Stage 2.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Vital Sign Abnormalities (Stage 1 and Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '(Stage 1) Placebo', 'description': 'Participants in this group were randomized to receive placebo on Day 1, Week 4, and Week 8. After week 12, participants went into a follow up period.'}, {'id': 'OG001', 'title': 'PF-06823859 600 mg IV (Stage 1)', 'description': 'Participants were randomized to receive PF-06823859 600 mg on Day 1, Week 4, and Week 8 in Stage 1.'}, {'id': 'OG002', 'title': '(Stage 2) Placebo', 'description': 'Participants in this group were randomized to receive placebo on Day 1, Week 4, and Week 8. After week 12, participants went into a follow up period.'}, {'id': 'OG003', 'title': '(Stage 2) PF-06823859 150 mg IV', 'description': 'Participants in this group were randomized to receive PF-06823859 150 mg on Day 1, Week 4, and Week 8 After week 12, participants went into a follow up period.'}, {'id': 'OG004', 'title': '(Stage 2) PF-06823859 600 mg IV', 'description': 'Dosing occurred Day 1, Week 4, and Week 8. After week 12, participants went into a follow-up period.'}], 'classes': [{'title': 'Sitting SBP Value <90 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Sitting DBP Value <50 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Sitting Pulse Rate Value <40 bpm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Sitting Pulse Rate Value >120 bpm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 28', 'description': 'Abnormality in vital signs: Sitting pulse rate \\<40 bpm to \\>120 bpm, sitting DBP \\< 50 mmHg, sitting SBP \\<90 mmHg.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The SAS1 and SAS2 included all participants who received at least 1 dose of randomized treatment in Stage 1 and Stage 2, respectively.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Vital Sign Abnormalities (Amended Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '(Amended Stage 2) Placebo Then Switched to PF-06823859 150 mg IV at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG001', 'title': '(Amended Stage 2) Placebo Then Switched to PF-06823859 600 mg IV at Week 12', 'description': 'Dosing occurred on Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG002', 'title': '(Amended Stage 2) PF-06823859 150 mg IV Then Switched to Placebo at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16 and 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG003', 'title': '(Amended Stage 2) PF-06823859 600 mg IV Then Switched to Placebo at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, and 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}], 'classes': [{'title': 'Sitting SBP Value <90 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Sitting DBP Value <50 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Sitting Pulse Rate Value <40 bpm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Sitting Pulse Rate Value >120 bpm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 40', 'description': 'Abnormality in vital signs: Sitting pulse rate \\<40 bpm to \\>120 bpm, sitting DBP \\< 50 mmHg, sitting SBP \\<90 mmHg.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The SASA2 includes all participants who received at least one dose of randomized treatment in Amended Stage 2.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '(Stage 1) Placebo', 'description': 'Participants in this group were randomized to receive placebo on Day 1, Week 4, and Week 8. After week 12, participants went into a follow up period.'}, {'id': 'OG001', 'title': 'PF-06823859 600 mg IV (Stage 1)', 'description': 'Participants were randomized to receive PF-06823859 600 mg on Day 1, Week 4, and Week 8 in Stage 1.'}, {'id': 'OG002', 'title': '(Stage 2) Placebo', 'description': 'Participants in this group were randomized to receive placebo on Day 1, Week 4, and Week 8. After week 12, participants went into a follow up period.'}, {'id': 'OG003', 'title': '(Stage 2) PF-06823859 150 mg IV', 'description': 'Participants in this group were randomized to receive PF-06823859 150 mg on Day 1, Week 4, and Week 8 After week 12, participants went into a follow up period.'}, {'id': 'OG004', 'title': '(Stage 2) PF-06823859 600 mg IV', 'description': 'Dosing occurred Day 1, Week 4, and Week 8. After week 12, participants went into a follow-up period.'}], 'classes': [{'title': 'PR Interval Aggregate Value >=300 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'QRS Duration Aggregate Value >=200 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'QT Interval Aggregate Value >=500 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'QTcF Interval Aggregate 450<=Value<480 msec', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'QTcF Interval Aggregate 480<=Value<500 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'QTcF Interval Aggregate Value >=500 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'PR %Chg >=25% or >=50%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'QRS Duration %Chg >=25% or >=50%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '30<=QTcF Chg (msec)<60', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'QTcF Chg (msec) >=60', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 28', 'description': 'ECG abnormalities criteria included: 1) QTc interval adjusted according to Fridericia formula (QTcF) (msec): \\>450, \\>480, \\>500, increase from baseline \\>=30, increase from baseline \\>=60; 2) Pulse rate (PR) (msec): \\>=300, change from baseline (Chg) \\>=25% or 50%; 3) QT (msec): \\>=500; 4) QRS (msec): \\>=200, Chg \\>=25% or 50%. Categories, with at least 1 participant having ECG abnormality in any of the reporting arms, were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The SAS1 and SAS2 included all participants who received at least 1 dose of randomized treatment in Stage 1 and Stage 2, respectively.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With ECG Abnormalities (Amended Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '(Amended Stage 2) Placebo Then Switched to PF-06823859 150 mg IV at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG001', 'title': '(Amended Stage 2) Placebo Then Switched to PF-06823859 600 mg IV at Week 12', 'description': 'Dosing occurred on Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG002', 'title': '(Amended Stage 2) PF-06823859 150 mg IV Then Switched to Placebo at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16 and 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG003', 'title': '(Amended Stage 2) PF-06823859 600 mg IV Then Switched to Placebo at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, and 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}], 'classes': [{'title': 'PR Interval Aggregate Value >=300 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'QRS Duration Aggregate Value >=200 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'QT Interval Aggregate Value >=500 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'QTcF Interval Aggregate 450<=Value<480 msec', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'QTcF Interval Aggregate 480<=Value<500 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'QTcF Interval Aggregate Value >=500 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'PR %Chg >=25% or >=50%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'QRS Duration %Chg >=25% or >=50%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '30<=QTcF Chg (msec)<60', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'QTcF Chg (msec) >=60', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 40', 'description': 'ECG abnormalities criteria included: 1) QTc interval adjusted according to Fridericia formula (QTcF) (msec): \\>450, \\>480, \\>500, increase from baseline \\>=30, increase from baseline \\>=60; 2) Pulse rate (PR) (msec): \\>=300, change from baseline (Chg) \\>=25% or 50%; 3) QT (msec): \\>=500; 4) QRS (msec): \\>=200, Chg \\>=25% or 50%. Categories, with at least 1 participant having ECG abnormality in any of the reporting arms, were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The SASA2 includes all participants who received at least one dose of randomized treatment in Amended Stage 2.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': '(Stage 1) Placebo', 'description': 'Participants in this group were randomized to receive placebo on Day 1, Week 4, and Week 8. After week 12, participants went into a follow up period.'}, {'id': 'OG001', 'title': 'PF-06823859 600 mg IV (Stage 1)', 'description': 'Participants were randomized to receive PF-06823859 600 mg on Day 1, Week 4, and Week 8 in Stage 1.'}, {'id': 'OG002', 'title': '(Stage 2) Placebo', 'description': 'Participants in this group were randomized to receive placebo on Day 1, Week 4, and Week 8. After week 12, participants went into a follow up period.'}, {'id': 'OG003', 'title': '(Stage 2) PF-06823859 150 mg IV', 'description': 'Participants in this group were randomized to receive PF-06823859 150 mg on Day 1, Week 4, and Week 8 After week 12, participants went into a follow up period.'}, {'id': 'OG004', 'title': '(Stage 2) PF-06823859 600 mg IV', 'description': 'Dosing occurred Day 1, Week 4, and Week 8. After week 12, participants went into a follow-up period.'}, {'id': 'OG005', 'title': '(Amended Stage 2) Placebo Then Switched to PF-06823859 150 mg IV at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG006', 'title': '(Amended Stage 2) Placebo Then Switched to PF-06823859 600 mg IV at Week 12', 'description': 'Dosing occurred on Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG007', 'title': '(Amended Stage 2) PF-06823859 150 mg IV Then Switched to Placebo at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16 and 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG008', 'title': '(Amended Stage 2) PF-06823859 600 mg IV Then Switched to Placebo at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, and 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '-2.60', 'spread': '4.326', 'groupId': 'OG000'}, {'value': '-19.62', 'spread': '9.140', 'groupId': 'OG001'}, {'value': '1.00', 'groupId': 'OG002'}, {'value': '-9.80', 'spread': '12.174', 'groupId': 'OG003'}, {'value': '-2.33', 'spread': '1.528', 'groupId': 'OG004'}, {'value': '-6.50', 'spread': '6.364', 'groupId': 'OG005'}, {'value': '0.00', 'groupId': 'OG006'}, {'value': '-8.70', 'spread': '5.638', 'groupId': 'OG007'}, {'value': '-6.67', 'spread': '2.517', 'groupId': 'OG008'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '-2.44', 'spread': '8.126', 'groupId': 'OG000'}, {'value': '-12.00', 'spread': '10.277', 'groupId': 'OG001'}, {'value': '3.00', 'groupId': 'OG002'}, {'value': '-11.20', 'spread': '10.986', 'groupId': 'OG003'}, {'value': '-15.00', 'spread': '7.550', 'groupId': 'OG004'}, {'value': '-3.00', 'spread': '7.071', 'groupId': 'OG005'}, {'value': '-1.00', 'groupId': 'OG006'}, {'value': '-14.40', 'spread': '7.648', 'groupId': 'OG007'}, {'value': '-14.00', 'spread': '2.000', 'groupId': 'OG008'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '-4.22', 'spread': '6.942', 'groupId': 'OG000'}, {'value': '-17.19', 'spread': '9.595', 'groupId': 'OG001'}, {'value': '4.00', 'groupId': 'OG002'}, {'value': '-14.20', 'spread': '5.020', 'groupId': 'OG003'}, {'value': '-18.67', 'spread': '10.066', 'groupId': 'OG004'}, {'value': '-2.50', 'spread': '7.778', 'groupId': 'OG005'}, {'value': '-2.00', 'groupId': 'OG006'}, {'value': '-17.80', 'spread': '7.540', 'groupId': 'OG007'}, {'value': '-14.00', 'spread': '4.000', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, Week 4, and Week 8 (except for Week 12 which is a primary outcome measure)', 'description': "The treatment effect was defined as the difference (mean change from baseline at Weeks 1, 4, 8 in the active treatment group minus the mean change from baseline at Weeks 1, 4, 8 in the placebo group) in the mean change of CDASI activity score from baseline at scheduled timepoints. The score (range: 0-100) consists of the ES, GHS, PS and AS. ES (range: 0-90) was obtained by summing up scores for the total erythema (ER \\[0-45\\], redness of the skin or mucous membranes), scaling (SC \\[0-30\\], peeling of the skin) and erosion/ulceration (EU \\[0-15\\], presence of the deeper wound). Total ER, SC and EU scores were calculated as a sum of the contributions from 15 individual areas of the body. GHS characterizes papules (swellings) on hand and is a sum of the papule's characterization score (0-6) and ulceration score (0-1). PS (0-2) characterizes abnormalities around nails. The AS (0-1) characterizes hair loss. Higher scores indicate greater disease severity.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS in Stage 1, Stage 2, and Amended Stage 2 included all participants who received at least 1 dose of randomized treatment in in Stage 1, Stage 2, or Amended Stage 2.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CDASI Activity Score at All Scheduled Timepoints Through Week 12 (Stage 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '(Stage 3) Placebo Then Switched to PF-06823859 600 mg IV at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG001', 'title': '(Stage 3) PF-06823859 600 mg IV Then Switched to Placebo at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, and 20. At Week 24, participants entered a 4-month follow-up period or rolled over to the long-term extension study.'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '-2.00', 'spread': '3.808', 'groupId': 'OG000'}, {'value': '-2.11', 'spread': '2.522', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-3.78', 'spread': '5.333', 'groupId': 'OG000'}, {'value': '-5.11', 'spread': '5.555', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-5.00', 'spread': '7.382', 'groupId': 'OG000'}, {'value': '-7.78', 'spread': '6.667', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-5.89', 'spread': '8.177', 'groupId': 'OG000'}, {'value': '-8.56', 'spread': '7.923', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, Week 4, Week 8 and Week 12', 'description': "The treatment effect was defined as the difference (mean change from baseline at Weeks 1, 4, 8,12 in the active treatment group minus the mean change from baseline at Weeks 1, 4, 8, 12 in the placebo group) in the mean change of CDASI activity score from baseline at scheduled timepoints. The score (range: 0-100) consists of the ES, GHS, PS and AS. ES (range: 0-90) was obtained by summing up scores for the total erythema (ER \\[0-45\\], redness of the skin or mucous membranes), scaling (SC \\[0-30\\], peeling of the skin) and erosion/ulceration (EU \\[0-15\\], presence of the deeper wound). Total ER, SC and EU scores were calculated as a sum of the contributions from 15 individual areas of the body. GHS characterizes papules (swellings) on hand and is a sum of the papule's characterization score (0-6) and ulceration score (0-1). PS (0-2) characterizes abnormalities around nails. The AS (0-1) characterizes hair loss. Higher scores indicate greater disease severity.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set in Stage 3 (FAS3) included all participants who received at least 1 dose of randomized treatment in Stage 3.'}, {'type': 'SECONDARY', 'title': 'Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': '(Stage 1) Placebo', 'description': 'Participants in this group were randomized to receive placebo on Day 1, Week 4, and Week 8. After week 12, participants went into a follow up period.'}, {'id': 'OG001', 'title': 'PF-06823859 600 mg IV (Stage 1)', 'description': 'Participants were randomized to receive PF-06823859 600 mg on Day 1, Week 4, and Week 8 in Stage 1.'}, {'id': 'OG002', 'title': '(Stage 2) Placebo', 'description': 'Participants in this group were randomized to receive placebo on Day 1, Week 4, and Week 8. After week 12, participants went into a follow up period.'}, {'id': 'OG003', 'title': '(Stage 2) PF-06823859 150 mg IV', 'description': 'Participants in this group were randomized to receive PF-06823859 150 mg on Day 1, Week 4, and Week 8 After week 12, participants went into a follow up period.'}, {'id': 'OG004', 'title': '(Stage 2) PF-06823859 600 mg IV', 'description': 'Dosing occurred Day 1, Week 4, and Week 8. After week 12, participants went into a follow-up period.'}, {'id': 'OG005', 'title': '(Amended Stage 2) Placebo Then Switched to PF-06823859 150 mg IV at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG006', 'title': '(Amended Stage 2) Placebo Then Switched to PF-06823859 600 mg IV at Week 12', 'description': 'Dosing occurred on Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG007', 'title': '(Amended Stage 2) PF-06823859 150 mg IV Then Switched to Placebo at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16 and 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG008', 'title': '(Amended Stage 2) PF-06823859 600 mg IV Then Switched to Placebo at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, and 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG009', 'title': '(Stage 3) Placebo Then Switched to PF-06823859 600 mg IV at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG010', 'title': '(Stage 3) PF-06823859 600 mg IV Then Switched to Placebo at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, and 20. At Week 24, participants entered a 4-month follow-up period or rolled over to the long-term extension study.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '31.50', 'spread': '11.750', 'groupId': 'OG000'}, {'value': '33.23', 'spread': '10.323', 'groupId': 'OG001'}, {'value': '23.00', 'groupId': 'OG002'}, {'value': '28.60', 'spread': '9.017', 'groupId': 'OG003'}, {'value': '37.00', 'spread': '9.644', 'groupId': 'OG004'}, {'value': '26.00', 'spread': '5.657', 'groupId': 'OG005'}, {'value': '37.00', 'groupId': 'OG006'}, {'value': '35.40', 'spread': '13.226', 'groupId': 'OG007'}, {'value': '30.00', 'spread': '7.937', 'groupId': 'OG008'}, {'value': '17.22', 'spread': '11.595', 'groupId': 'OG009'}, {'value': '12.56', 'spread': '8.095', 'groupId': 'OG010'}]}]}, {'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '28.90', 'spread': '12.982', 'groupId': 'OG000'}, {'value': '27.68', 'spread': '8.962', 'groupId': 'OG001'}, {'value': '24.00', 'groupId': 'OG002'}, {'value': '18.80', 'spread': '6.535', 'groupId': 'OG003'}, {'value': '34.67', 'spread': '9.713', 'groupId': 'OG004'}, {'value': '19.50', 'spread': '0.707', 'groupId': 'OG005'}, {'value': '37.00', 'groupId': 'OG006'}, {'value': '26.70', 'spread': '12.667', 'groupId': 'OG007'}, {'value': '23.33', 'spread': '9.018', 'groupId': 'OG008'}, {'value': '15.22', 'spread': '9.846', 'groupId': 'OG009'}, {'value': '10.44', 'spread': '6.894', 'groupId': 'OG010'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '28.11', 'spread': '16.136', 'groupId': 'OG000'}, {'value': '21.23', 'spread': '11.182', 'groupId': 'OG001'}, {'value': '26.00', 'groupId': 'OG002'}, {'value': '17.40', 'spread': '2.408', 'groupId': 'OG003'}, {'value': '22.00', 'spread': '12.490', 'groupId': 'OG004'}, {'value': '23.00', 'spread': '1.414', 'groupId': 'OG005'}, {'value': '36.00', 'groupId': 'OG006'}, {'value': '21.00', 'spread': '10.677', 'groupId': 'OG007'}, {'value': '16.00', 'spread': '9.539', 'groupId': 'OG008'}, {'value': '13.44', 'spread': '8.819', 'groupId': 'OG009'}, {'value': '7.44', 'spread': '5.503', 'groupId': 'OG010'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '26.33', 'spread': '13.892', 'groupId': 'OG000'}, {'value': '15.29', 'spread': '6.157', 'groupId': 'OG001'}, {'value': '27.00', 'groupId': 'OG002'}, {'value': '14.40', 'spread': '5.857', 'groupId': 'OG003'}, {'value': '18.33', 'spread': '5.508', 'groupId': 'OG004'}, {'value': '23.50', 'spread': '2.121', 'groupId': 'OG005'}, {'value': '35.00', 'groupId': 'OG006'}, {'value': '17.60', 'spread': '10.895', 'groupId': 'OG007'}, {'value': '16.00', 'spread': '11.269', 'groupId': 'OG008'}, {'value': '12.22', 'spread': '10.883', 'groupId': 'OG009'}, {'value': '4.78', 'spread': '4.116', 'groupId': 'OG010'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '27.11', 'spread': '14.903', 'groupId': 'OG000'}, {'value': '12.86', 'spread': '5.876', 'groupId': 'OG001'}, {'value': '28.00', 'groupId': 'OG002'}, {'value': '11.20', 'spread': '4.817', 'groupId': 'OG003'}, {'value': '11.00', 'spread': '3.464', 'groupId': 'OG004'}, {'value': '23.00', 'spread': '2.828', 'groupId': 'OG005'}, {'value': '40.00', 'groupId': 'OG006'}, {'value': '19.00', 'spread': '14.087', 'groupId': 'OG007'}, {'value': '14.67', 'spread': '9.504', 'groupId': 'OG008'}, {'value': '11.33', 'spread': '9.206', 'groupId': 'OG009'}, {'value': '4.00', 'spread': '3.464', 'groupId': 'OG010'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, Week 4, Week 8 and Week 12', 'description': "The CDASI activity score (range: 0-100) consists of the ES, GHS, PS and AS. ES (range: 0-90) was obtained by summing up scores for the total erythema (ER \\[0-45\\], redness of the skin or mucous membranes), scaling (SC \\[0-30\\], peeling of the skin) and erosion/ulceration (EU \\[0-15\\], presence of the deeper wound). Total ER, SC and EU scores were calculated as a sum of the contributions from 15 individual areas of the body. GHS characterizes papules (swellings) on hand and is a sum of the papule's characterization score (0-6) and ulceration score (0-1). PS (0-2) characterizes abnormalities around nails. The AS (0-1) characterizes hair loss. Higher scores indicate greater disease severity.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who received at least 1 dose of randomized treatment in any study stage.'}, {'type': 'SECONDARY', 'title': 'Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': '(Stage 1) Placebo', 'description': 'Participants in this group were randomized to receive placebo on Day 1, Week 4, and Week 8. After week 12, participants went into a follow up period.'}, {'id': 'OG001', 'title': 'PF-06823859 600 mg IV (Stage 1)', 'description': 'Participants were randomized to receive PF-06823859 600 mg on Day 1, Week 4, and Week 8 in Stage 1.'}, {'id': 'OG002', 'title': '(Stage 2) Placebo', 'description': 'Participants in this group were randomized to receive placebo on Day 1, Week 4, and Week 8. After week 12, participants went into a follow up period.'}, {'id': 'OG003', 'title': '(Stage 2) PF-06823859 150 mg IV', 'description': 'Participants in this group were randomized to receive PF-06823859 150 mg on Day 1, Week 4, and Week 8 After week 12, participants went into a follow up period.'}, {'id': 'OG004', 'title': '(Stage 2) PF-06823859 600 mg IV', 'description': 'Dosing occurred Day 1, Week 4, and Week 8. After week 12, participants went into a follow-up period.'}, {'id': 'OG005', 'title': '(Amended Stage 2) Placebo Then Switched to PF-06823859 150 mg IV at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG006', 'title': '(Amended Stage 2) Placebo Then Switched to PF-06823859 600 mg IV at Week 12', 'description': 'Dosing occurred on Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG007', 'title': '(Amended Stage 2) PF-06823859 150 mg IV Then Switched to Placebo at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16 and 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG008', 'title': '(Amended Stage 2) PF-06823859 600 mg IV Then Switched to Placebo at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, and 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG009', 'title': '(Stage 3) Placebo Then Switched to PF-06823859 600 mg IV at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'OG010', 'title': '(Stage 3) PF-06823859 600 mg IV Then Switched to Placebo at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, and 20. At Week 24, participants entered a 4-month follow-up period or rolled over to the long-term extension study.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '4.30', 'spread': '5.397', 'groupId': 'OG000'}, {'value': '5.50', 'spread': '3.901', 'groupId': 'OG001'}, {'value': '3.00', 'groupId': 'OG002'}, {'value': '4.20', 'spread': '3.701', 'groupId': 'OG003'}, {'value': '7.00', 'spread': '1.732', 'groupId': 'OG004'}, {'value': '7.50', 'spread': '4.950', 'groupId': 'OG005'}, {'value': '7.00', 'groupId': 'OG006'}, {'value': '4.70', 'spread': '4.373', 'groupId': 'OG007'}, {'value': '7.00', 'spread': '3.000', 'groupId': 'OG008'}, {'value': '5.56', 'spread': '6.044', 'groupId': 'OG009'}, {'value': '2.00', 'spread': '1.871', 'groupId': 'OG010'}]}]}, {'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '4.90', 'spread': '5.021', 'groupId': 'OG000'}, {'value': '5.41', 'spread': '4.159', 'groupId': 'OG001'}, {'value': '4.00', 'groupId': 'OG002'}, {'value': '3.80', 'spread': '3.347', 'groupId': 'OG003'}, {'value': '6.33', 'spread': '3.215', 'groupId': 'OG004'}, {'value': '6.00', 'spread': '7.071', 'groupId': 'OG005'}, {'value': '7.00', 'groupId': 'OG006'}, {'value': '3.90', 'spread': '3.542', 'groupId': 'OG007'}, {'value': '4.67', 'spread': '2.887', 'groupId': 'OG008'}, {'value': '6.00', 'spread': '5.809', 'groupId': 'OG009'}, {'value': '1.89', 'spread': '1.764', 'groupId': 'OG010'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '5.11', 'spread': '5.278', 'groupId': 'OG000'}, {'value': '5.23', 'spread': '3.337', 'groupId': 'OG001'}, {'value': '4.00', 'groupId': 'OG002'}, {'value': '3.00', 'spread': '2.449', 'groupId': 'OG003'}, {'value': '9.00', 'spread': '1.732', 'groupId': 'OG004'}, {'value': '7.00', 'spread': '5.657', 'groupId': 'OG005'}, {'value': '7.00', 'groupId': 'OG006'}, {'value': '4.40', 'spread': '4.248', 'groupId': 'OG007'}, {'value': '6.33', 'spread': '1.528', 'groupId': 'OG008'}, {'value': '5.22', 'spread': '4.631', 'groupId': 'OG009'}, {'value': '1.56', 'spread': '2.297', 'groupId': 'OG010'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '5.89', 'spread': '5.231', 'groupId': 'OG000'}, {'value': '5.00', 'spread': '4.427', 'groupId': 'OG001'}, {'value': '5.00', 'groupId': 'OG002'}, {'value': '4.40', 'spread': '2.881', 'groupId': 'OG003'}, {'value': '8.33', 'spread': '0.577', 'groupId': 'OG004'}, {'value': '5.50', 'spread': '3.536', 'groupId': 'OG005'}, {'value': '7.00', 'groupId': 'OG006'}, {'value': '3.70', 'spread': '3.945', 'groupId': 'OG007'}, {'value': '4.67', 'spread': '3.215', 'groupId': 'OG008'}, {'value': '5.11', 'spread': '4.859', 'groupId': 'OG009'}, {'value': '1.00', 'spread': '1.118', 'groupId': 'OG010'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '6.33', 'spread': '5.679', 'groupId': 'OG000'}, {'value': '5.05', 'spread': '3.905', 'groupId': 'OG001'}, {'value': '6.00', 'groupId': 'OG002'}, {'value': '3.60', 'spread': '3.286', 'groupId': 'OG003'}, {'value': '6.33', 'spread': '1.528', 'groupId': 'OG004'}, {'value': '4.50', 'spread': '4.950', 'groupId': 'OG005'}, {'value': '7.00', 'groupId': 'OG006'}, {'value': '3.10', 'spread': '4.358', 'groupId': 'OG007'}, {'value': '5.00', 'spread': '1.000', 'groupId': 'OG008'}, {'value': '5.22', 'spread': '5.019', 'groupId': 'OG009'}, {'value': '1.33', 'spread': '1.581', 'groupId': 'OG010'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, Week 4, Week 8 and Week 12', 'description': "The Damage Score (DS) was calculated as a sum of the total poilkiloderma score (POLS), total calcinosis score (CALS) and Gotorn's hands damage score (GHDS). The POLS characterizes specific dispigmentation in the particulal area and calcinosis score characterizes calcification of the skin in the particular area. The POLS and the CALS are summed up over 15 individual areas in the body and each of them has range 0-15. The GHDS has the range 0-2 so that the DS has the range 0-32. Higher scores indicate greater disease severity.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who received at least 1 dose of randomized treatment in any study stage.'}, {'type': 'SECONDARY', 'title': 'Absolute Values for Total Improvement Score (TIS) at Week 12 and Intermediate Scheduled Time Points (Stage 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Stage 3)', 'description': 'Participants who were randomized to placebo then PF-06823859 600 mg with a treatment switch at Week 12 in Stage 3.'}, {'id': 'OG001', 'title': 'PF-06823859 600 mg IV (Stage 3)', 'description': 'Participants who were randomized to 600 mg PF-06823859 then placebo with a treatment switch at Week 12 in Stage 3.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '25.83', 'groupId': 'OG000', 'lowerLimit': '13.15', 'upperLimit': '38.52'}, {'value': '36.67', 'groupId': 'OG001', 'lowerLimit': '23.98', 'upperLimit': '49.35'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '36.67', 'groupId': 'OG000', 'lowerLimit': '23.38', 'upperLimit': '49.95'}, {'value': '49.17', 'groupId': 'OG001', 'lowerLimit': '35.88', 'upperLimit': '62.45'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '36.94', 'groupId': 'OG000', 'lowerLimit': '21.93', 'upperLimit': '51.96'}, {'value': '56.39', 'groupId': 'OG001', 'lowerLimit': '41.38', 'upperLimit': '71.40'}]}]}], 'analyses': [{'pValue': '0.1537', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '10.83', 'ciLowerLimit': '-7.10', 'ciUpperLimit': '28.77', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.274', 'groupDescription': 'Difference of the active treatment from Placebo at Week 4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.1312', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '12.50', 'ciLowerLimit': '-6.29', 'ciUpperLimit': '31.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.761', 'groupDescription': 'Difference of the active treatment from Placebo at Week 8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0647', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '19.44', 'ciLowerLimit': '-1.79', 'ciUpperLimit': '40.68', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.161', 'groupDescription': 'Difference of the active treatment from Placebo at Week 12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 4, Week 8 and Week 12', 'description': 'The TIS was the sum of all 6 improvement scores where higher score indicates worse status (PhGA \\[from the MDAAT, 0-20 scale\\], PtGA \\[0-10 scale\\], MMT \\[0-35 scale\\], HAQ-DI \\[0-10 scale\\], muscle enzymes \\[0-7.5 scale\\], and extramuscular global assessment \\[0-20 scale\\]) associated with the change in each core set measure. A total improvement score between 0 and 100 corresponded to the degree of improvement, with higher scores corresponding to a greater degree of improvement: of ≥20 represented minimal improvement, a score of ≥40 represented moderate improvement, and a score of ≥60 represented major improvement.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS3 included all participants who received at least 1 dose of randomized treatment in Stage 3.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Core Set Measures (CSM) of the TIS (Global Disease Activity [PhGA] and Extramuscular Global Assessment [EmGA]) (Stage 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Stage 3)', 'description': 'Participants who were randomized to placebo then PF-06823859 600 mg with a treatment switch at Week 12 in Stage 3.'}, {'id': 'OG001', 'title': 'PF-06823859 600 mg IV (Stage 3)', 'description': 'Participants who were randomized to 600 mg PF-06823859 then placebo with a treatment switch at Week 12 in Stage 3.'}], 'classes': [{'title': 'PhGA Week 4', 'categories': [{'measurements': [{'value': '-1.00', 'groupId': 'OG000', 'lowerLimit': '-1.89', 'upperLimit': '-0.11'}, {'value': '-1.68', 'groupId': 'OG001', 'lowerLimit': '-2.57', 'upperLimit': '-0.79'}]}]}, {'title': 'PhGA Week 8', 'categories': [{'measurements': [{'value': '-1.65', 'groupId': 'OG000', 'lowerLimit': '-2.80', 'upperLimit': '-0.51'}, {'value': '-2.76', 'groupId': 'OG001', 'lowerLimit': '-3.90', 'upperLimit': '-1.61'}]}]}, {'title': 'PhGA Week 12', 'categories': [{'measurements': [{'value': '-2.05', 'groupId': 'OG000', 'lowerLimit': '-3.56', 'upperLimit': '-0.55'}, {'value': '-3.40', 'groupId': 'OG001', 'lowerLimit': '-4.90', 'upperLimit': '-1.90'}]}]}, {'title': 'Extramuscular Global Assessment Week 4', 'categories': [{'measurements': [{'value': '-1.02', 'groupId': 'OG000', 'lowerLimit': '-2.07', 'upperLimit': '0.03'}, {'value': '-1.55', 'groupId': 'OG001', 'lowerLimit': '-2.60', 'upperLimit': '-0.49'}]}]}, {'title': 'Extramuscular Global Assessment Week 8', 'categories': [{'measurements': [{'value': '-1.91', 'groupId': 'OG000', 'lowerLimit': '-2.80', 'upperLimit': '-1.01'}, {'value': '-2.48', 'groupId': 'OG001', 'lowerLimit': '-3.38', 'upperLimit': '-1.58'}]}]}, {'title': 'Extramuscular Global Assessment Week 12', 'categories': [{'measurements': [{'value': '-1.59', 'groupId': 'OG000', 'lowerLimit': '-2.64', 'upperLimit': '-0.53'}, {'value': '-2.81', 'groupId': 'OG001', 'lowerLimit': '-3.87', 'upperLimit': '-1.76'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 4, Week 8 and Week 12', 'description': 'PhGA: assessment of the severity of disease by the physician. The physician used the visual analog scale and put a mark on 0 cm (best) -10 cm (worst) scale where higher score indicated worse status.\n\nEmGA: overall evaluation of disease activity in all extramuscular systems using visual analog scale 0 cm (best) -10 cm (worst) scale where higher score indicated worse status.', 'unitOfMeasure': 'Centimeter (cm)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set in Stage 3 (FAS3) included all participants who received at least 1 dose of randomized treatment in Stage 3.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the CSM of the TIS (PtGA) (Stage 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Stage 3)', 'description': 'Participants who were randomized to placebo then PF-06823859 600 mg with a treatment switch at Week 12 in Stage 3.'}, {'id': 'OG001', 'title': 'PF-06823859 600 mg IV (Stage 3)', 'description': 'Participants who were randomized to 600 mg PF-06823859 then placebo with a treatment switch at Week 12 in Stage 3.'}], 'classes': [{'title': 'PtGA Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-18.29', 'groupId': 'OG000', 'lowerLimit': '-31.78', 'upperLimit': '-4.79'}, {'value': '-17.88', 'groupId': 'OG001', 'lowerLimit': '-30.75', 'upperLimit': '-5.00'}]}]}, {'title': 'PtGA Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.81', 'groupId': 'OG000', 'lowerLimit': '-29.88', 'upperLimit': '-3.73'}, {'value': '-32.60', 'groupId': 'OG001', 'lowerLimit': '-45.85', 'upperLimit': '-19.35'}]}]}, {'title': 'PtGA Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-14.04', 'groupId': 'OG000', 'lowerLimit': '-25.91', 'upperLimit': '-2.17'}, {'value': '-43.81', 'groupId': 'OG001', 'lowerLimit': '-55.68', 'upperLimit': '-31.95'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 4, Week 8 and Week 12', 'description': "PtGA: assessment of the severity of disease by the participant/participant's guardian, using a visual analog scale from 0 mm (no evidence of disease activity) to 100 mm (extremely active or severe disease activity). Higher score indicated worse status.", 'unitOfMeasure': 'Millimeter (mm)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS3 included all participants who received at least 1 dose of randomized treatment in Stage 3.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the CSM of the TIS (MMT8 and HAQ01-HAQ-DI) (Stage 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Stage 3)', 'description': 'Participants who were randomized to placebo then PF-06823859 600 mg with a treatment switch at Week 12 in Stage 3.'}, {'id': 'OG001', 'title': 'PF-06823859 600 mg IV (Stage 3)', 'description': 'Participants who were randomized to 600 mg PF-06823859 then placebo with a treatment switch at Week 12 in Stage 3.'}], 'classes': [{'title': 'MMT8 - Derived Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.76', 'groupId': 'OG000', 'lowerLimit': '1.37', 'upperLimit': '14.16'}, {'value': '8.24', 'groupId': 'OG001', 'lowerLimit': '1.84', 'upperLimit': '14.63'}]}]}, {'title': 'MMT8 - Derived Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.14', 'groupId': 'OG000', 'lowerLimit': '4.60', 'upperLimit': '19.68'}, {'value': '15.24', 'groupId': 'OG001', 'lowerLimit': '7.70', 'upperLimit': '22.78'}]}]}, {'title': 'MMT8 - Derived Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.65', 'groupId': 'OG000', 'lowerLimit': '2.29', 'upperLimit': '21.01'}, {'value': '21.24', 'groupId': 'OG001', 'lowerLimit': '11.87', 'upperLimit': '30.60'}]}]}, {'title': 'HAQ01-HAQ-DI Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'groupId': 'OG000', 'lowerLimit': '-0.24', 'upperLimit': '0.18'}, {'value': '-0.20', 'groupId': 'OG001', 'lowerLimit': '-0.39', 'upperLimit': '0.00'}]}]}, {'title': 'HAQ01-HAQ-DI Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.28', 'upperLimit': '0.28'}, {'value': '-0.38', 'groupId': 'OG001', 'lowerLimit': '-0.64', 'upperLimit': '-0.11'}]}]}, {'title': 'HAQ01-HAQ-DI Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'groupId': 'OG000', 'lowerLimit': '-0.40', 'upperLimit': '0.28'}, {'value': '-0.52', 'groupId': 'OG001', 'lowerLimit': '-0.84', 'upperLimit': '-0.19'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 4, Week 8 and Week 12', 'description': 'Manual Muscle Testing-8 designated muscle groups (MMT-8): was a set of 8 designated muscles tested unilaterally generally on right side (left side used unless right side cannot be used). Potential score range was from 0 to 80, where higher scores denoted better health status.\n\nHAQ-DI: contained eight sections (including dressing \\& grooming, arising, eating, walking, hygiene, grip, reach, and activities). Each section had multiple questions that the participant used to rank their functionality and ranged from 0 to 3 where 0 = without any difficulty and 3 = unable to do. For each participant, the average ranking was calculated for each of the eight sections. HAQ-DI had a score range of 0 to 3, where higher score reflected worse status.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS3 included all participants who received at least 1 dose of randomized treatment in Stage 3.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the CSM of the TIS (Aldolase and Creatine Kinase) (Stage 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Stage 3)', 'description': 'Participants who were randomized to placebo then PF-06823859 600 mg with a treatment switch at Week 12 in Stage 3.'}, {'id': 'OG001', 'title': 'PF-06823859 600 mg IV (Stage 3)', 'description': 'Participants who were randomized to 600 mg PF-06823859 then placebo with a treatment switch at Week 12 in Stage 3.'}], 'classes': [{'title': 'Aldolase Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.19', 'groupId': 'OG000', 'lowerLimit': '-1.34', 'upperLimit': '0.96'}, {'value': '-3.09', 'groupId': 'OG001', 'lowerLimit': '-4.25', 'upperLimit': '-1.92'}]}]}, {'title': 'Aldolase Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.31', 'groupId': 'OG000', 'lowerLimit': '-2.45', 'upperLimit': '-0.16'}, {'value': '-3.57', 'groupId': 'OG001', 'lowerLimit': '-4.74', 'upperLimit': '-2.40'}]}]}, {'title': 'Aldolase Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.66', 'groupId': 'OG000', 'lowerLimit': '-2.18', 'upperLimit': '0.86'}, {'value': '-3.20', 'groupId': 'OG001', 'lowerLimit': '-4.76', 'upperLimit': '-1.64'}]}]}, {'title': 'Creatine Kinase Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-37.96', 'groupId': 'OG000', 'lowerLimit': '-119.16', 'upperLimit': '43.24'}, {'value': '-157.48', 'groupId': 'OG001', 'lowerLimit': '-238.68', 'upperLimit': '-76.28'}]}]}, {'title': 'Creatine Kinase Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-70.96', 'groupId': 'OG000', 'lowerLimit': '-137.03', 'upperLimit': '-4.90'}, {'value': '-175.93', 'groupId': 'OG001', 'lowerLimit': '-241.99', 'upperLimit': '-109.86'}]}]}, {'title': 'Creatine Kinase ) Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-39.85', 'groupId': 'OG000', 'lowerLimit': '-125.71', 'upperLimit': '46.01'}, {'value': '-185.77', 'groupId': 'OG001', 'lowerLimit': '-273.92', 'upperLimit': '-97.62'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 4, Week 8 and Week 12', 'description': 'The LS mean (with 90% CI) of CSM of the TIS (aldolase and creatine kinase) at weeks 4, 8, 12 were presented.', 'unitOfMeasure': 'Units per litre (U/L)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS3 included all participants who received at least 1 dose of randomized treatment in Stage 3.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '(Stage 1) Placebo', 'description': 'Participants in this group were randomized to receive placebo on Day 1, Week 4, and Week 8 in Stage 1 After week 12, participants went into a follow up period.'}, {'id': 'FG001', 'title': '(Stage 1) PF-06823859 600 mg Intravenous (IV)', 'description': 'Participants in this group were randomized to receive PF-06823859 600 mg on Day 1, Week 4, and Week 8 in Stage 1. After week 12, participants went into a follow up period.'}, {'id': 'FG002', 'title': '(Stage 2) Placebo', 'description': 'Participants in this group were randomized to receive placebo on Day 1, Week 4, and Week 8 in Stage 2. After week 12, participants went into a follow up period.'}, {'id': 'FG003', 'title': '(Stage 2) PF-06823859 150 mg IV', 'description': 'Participants in this group were randomized to receive PF-06823859 150 mg on Day 1, Week 4, and Week 8. After week 12, participants went into a follow up period.'}, {'id': 'FG004', 'title': '(Stage 2) PF-06823859 600 mg IV', 'description': 'Dosing occurred Day 1, Week 4, and Week 8. After week 12, participants went into a follow-up period.'}, {'id': 'FG005', 'title': '(Amended Stage 2) Placebo Then Switched to PF-06823859 150 mg IV at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'FG006', 'title': '(Amended Stage 2) Placebo Then Switched to PF-06823859 600 mg IV at Week 12', 'description': 'Dosing occurred on Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'FG007', 'title': '(Amended Stage 2) PF-06823859 150 mg IV Then Switched to Placebo at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16 and 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'FG008', 'title': '(Amended Stage 2) PF-06823859 600 mg IV Then Switched to Placebo at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, and 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'FG009', 'title': '(Stage 3) Placebo Then Switched to PF-06823859 600 mg IV at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'FG010', 'title': '(Stage 3) PF-06823859 600 mg IV Then Switched to Placebo at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, and 20. At Week 24, participants entered a 4-month follow-up period or rolled over to the long-term extension study.'}], 'periods': [{'title': 'Baseline to Week 12 (All Stages)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '10'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '9'}, {'groupId': 'FG010', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '10'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '9'}, {'groupId': 'FG010', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'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'}, {'groupId': 'FG010', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'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'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Adverse Event', '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'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}, {'title': 'Weeks 12-24 (Amended Stage 2, Stage 3)', 'milestones': [{'type': 'STARTED', 'comment': 'Participants from Stage 1 or Stage 2 did not participate in the treatment switch from Week 12 to 24. Therefore, not applicable for this period.', 'achievements': [{'comment': 'Not applicable for this period.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Not applicable for this period.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Not applicable for this period.', 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'Not applicable for this period.', 'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'Not applicable for this period.', 'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '10'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '9'}, {'groupId': 'FG010', 'numSubjects': '9'}]}, {'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': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '8'}, {'groupId': 'FG010', 'numSubjects': '8'}]}, {'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': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Other', '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': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', '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': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Adverse Event', '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': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'A total of 75 participants were randomized at 19 centers in 5 countries: 32, 9, 16 and 18 participants were treated in Stage 1, Stage 2, Amended Stage 2 and Stage 3, respectively.\n\nA fixed sequence design with crossover at Week 12 was employed in Amended Stage 2 and Stage 3 to provide all participants with the opportunity to receive active drug during the treatment period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '9', 'groupId': 'BG009'}, {'value': '9', 'groupId': 'BG010'}, {'value': '75', 'groupId': 'BG011'}]}], 'groups': [{'id': 'BG000', 'title': '(Stage 1) Placebo', 'description': 'Participants in this group were randomized to receive placebo on Day 1, Week 4, and Week 8. After week 12, participants went into a follow up period.'}, {'id': 'BG001', 'title': '(Stage 1) PF-06823859 600 mg Intravenous (IV)', 'description': 'Participants in this group were randomized to receive PF-06823859 600 mg on Day 1, Week 4, and Week 8.\n\nAfter week 12, participants went into a follow up period.'}, {'id': 'BG002', 'title': '(Stage 2) Placebo', 'description': 'Participants in this group were randomized to receive placebo on Day 1, Week 4, and Week 8. After week 12, participants went into a follow up period.'}, {'id': 'BG003', 'title': '(Stage 2) PF-06823859 150 mg IV', 'description': 'Participants in this group were randomized to receive PF-06823859 150 mg on Day 1, Week 4, and Week 8 After week 12, participants went into a follow up period.'}, {'id': 'BG004', 'title': '(Stage 2) PF-06823859 600 mg IV', 'description': 'Dosing occurred Day 1, Week 4, and Week 8. After week 12, participants went into a follow-up period.'}, {'id': 'BG005', 'title': '(Amended Stage 2) Placebo Then Switched to PF-06823859 150 mg IV at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'BG006', 'title': '(Amended Stage 2) Placebo Then Switched to PF-06823859 600 mg IV at Week 12', 'description': 'Dosing occurred on Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'BG007', 'title': '(Amended Stage 2) PF-06823859 150 mg IV Then Switched to Placebo at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16 and 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'BG008', 'title': '(Amended Stage 2) PF-06823859 600 mg IV Then Switched to Placebo at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, and 20. At Week 24, participants then entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'BG009', 'title': '(Stage 3) Placebo Then Switched to PF-06823859 600 mg IV at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, 20. At Week 24, participants entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'BG010', 'title': '(Stage 3) PF-06823859 600 mg IV Then Switched to Placebo at Week 12', 'description': 'Dosing occurred Day 1, Weeks 4, 8, 12, 16, and 20. At Week 24, participants entered a 4-month follow-up period or rolled over to the long-term extension study.'}, {'id': 'BG011', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.20', 'spread': '14.054', 'groupId': 'BG000'}, {'value': '54.41', 'spread': '13.154', 'groupId': 'BG001'}, {'value': '42.00', 'groupId': 'BG002'}, {'value': '51.60', 'spread': '15.726', 'groupId': 'BG003'}, {'value': '45.67', 'spread': '23.714', 'groupId': 'BG004'}, {'value': '64.00', 'spread': '1.414', 'groupId': 'BG005'}, {'value': '44', 'groupId': 'BG006'}, {'value': '53.90', 'spread': '10.999', 'groupId': 'BG007'}, {'value': '47.00', 'spread': '13.115', 'groupId': 'BG008'}, {'value': '47.44', 'spread': '12.126', 'groupId': 'BG009'}, {'value': '42.44', 'spread': '16.697', 'groupId': 'BG010'}, {'value': '50.63', 'spread': '13.793', 'groupId': 'BG011'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '18-64 Years', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}, {'value': '8', 'groupId': 'BG010'}, {'value': '62', 'groupId': 'BG011'}]}]}, {'title': '65-84 Years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '13', 'groupId': 'BG011'}]}]}, {'title': '>=85 Years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '7', 'groupId': 'BG010'}, {'value': '66', 'groupId': 'BG011'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '9', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '13', 'groupId': 'BG011'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '7', 'groupId': 'BG010'}, {'value': '62', 'groupId': 'BG011'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}, {'value': '8', 'groupId': 'BG010'}, {'value': '69', 'groupId': 'BG011'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}]}, {'title': 'Multiracial', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}]}]}, {'title': 'Not reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The safety analysis population included all participants who had received at least 1 dose of study drug or placebo.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-20', 'size': 16906639, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-05-26T08:58', 'hasProtocol': True}, {'date': '2022-06-09', 'size': 4950715, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-05-26T08:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-11-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-08', 'studyFirstSubmitDate': '2017-06-05', 'resultsFirstSubmitDate': '2023-05-26', 'studyFirstSubmitQcDate': '2017-06-07', 'lastUpdatePostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-08', 'studyFirstPostDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 12 (Stage 1, Stage 2 and Amended Stage 2)', 'timeFrame': 'Baseline and Week 12', 'description': "The treatment effect was defined as the difference (mean chg from baseline at Week12 in the active treatment group minus that in the placebo group) in the mean change of CDASI activity score from baseline at Week 12. The score (range: 0-100) consists of the extent score (ES), Gottorn hands score (GHS), peringual score (PS) and allopecia score (AS). ES (range: 0-90) was obtained by summing up scores for the total erythema (ER \\[0-45\\], redness of the skin or mucous membranes), scaling (SC \\[0-30\\], peeling of the skin) and erosion/ulceration (EU \\[0-15\\], presence of the deeper wound). Total ER, SC and EU scores were calculated as a sum of the contributions from 15 individual areas of the body. GHS characterizes papules (swellings) on hand and is a sum of the papule's characterization score (0-6) and ulceration score (0-1). PS (0-2) characterizes abnormalities around nails. The AS (0-1) characterizes hair loss. Higher scores indicate greater disease severity."}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE) (Stage 3)', 'timeFrame': 'Up to Week 40', 'description': 'Adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was any untoward medical occurrence that at any dose resulted in any of following outcomes/deemed significant for any other reason: death; initial /prolonged inpatient hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect and suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. AEs included both serious (if occurred) and all non-serious adverse events. TEAEs are events between first dose of study drug and up to Week 40 that were absent before treatment or that worsened relative to pretreatment state.'}, {'measure': 'Number of Participants With Clinically Significant Laboratory Abnormalities (Stage 3)', 'timeFrame': 'Up to Week 40', 'description': 'Hemoglobin(HGB),hematocrit,erythrocytes(ery.),HDL cholesterol(chl.)\\<0.8\\*lower limit of normal(LLN);reticulocytes (ret.), ret./ery.(%)\\<0.5\\*LLN,\\>1.5\\*upper limit of normal (ULN);ery. mean corpuscular(EMC) volume,EMC HGB concentration,potassium,chloride,calcium,bicarbonate\\<0.9\\*LLN,\\>1.1\\*ULN;platelets\\<0.5\\*LLN,\\>1.75\\*ULN; leukocytes(leu.),glucose\\<0.6\\*LLN,\\>1.5\\*ULN;lymphocytes(lym.), lym./leu.(%),neutrophils (neu.), neu./leu.(%), protein,albumin\\<0.8\\*LLN,\\>1.2\\*ULN;basophils(bas.), bas./leu.(%), eosinophils(eos.), eos./leu., monocytes(mon.), mon./leu.(%), urate\\>1.2\\*ULN;bilirubin (total, direct,indirect)\\>1.5\\*ULN;aspartate/alanine aminotransferase,gamma glutamyl transferase,lactate dehydrogenase,alkaline phosphatase\\>3.0\\*ULN;urea nitrogen,creatinine,triglycerides, chl.\\>1.3\\*ULN; sodium \\<0.95\\*LLN,\\>1.05\\*ULN; creatine kinase \\>2.0\\*ULN;Urine: pH\\<4.5,\\>8;glucose, ketones,protein, HGB,urobilinogen,bilirubin,nitrite,leukocyte esterase\\>=1;ery., leu.\\>= 20;hyaline casts\\>1;bacteria\\>20.'}, {'measure': 'Number of Participants With Vital Sign Abnormalities (Stage 3)', 'timeFrame': 'Baseline up to Week 40', 'description': 'Abnormality in vital signs: Sitting pulse rate \\<40 beats per minute (bpm) to \\>120 bpm, sitting diastolic blood pressure (DBP) \\< 50 millimeter of mercury (mmHg), sitting systolic blood pressure (SBP) \\<90 mmHg.'}, {'measure': 'Number of Participants With Electrocardiogram (ECG) Abnormalities (Stage 3)', 'timeFrame': 'Baseline up to Week 40', 'description': 'ECG abnormalities criteria included: 1) QTc interval adjusted according to Fridericia formula (QTcF) (msec): \\>450, \\>480, \\>500, increase from baseline \\>=30, increase from baseline \\>=60; 2) Pulse rate (PR) (msec): \\>=300, change from baseline (Chg) \\>=25% or 50%; 3) QT (msec): \\>=500; 4) QRS (msec): \\>=200, Chg \\>=25% or 50%. Categories, with at least 1 participant having ECG abnormality in any of the reporting arms, were reported in this outcome measure.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With TEAEs and SAEs (Stage 1 and Stage 2)', 'timeFrame': 'Up to Week 28', 'description': 'AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was any untoward medical occurrence that at any dose resulted in any of following outcomes/deemed significant for any other reason: death; initial /prolonged inpatient hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect and suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. AEs included both serious (if occurred) and all non-serious adverse events. TEAEs are events between first dose of study drug and up to Week 28 that were absent before treatment or that worsened relative to pretreatment state.'}, {'measure': 'Number of Participants With TEAEs and SAEs (Amended Stage 2)', 'timeFrame': 'Up to Week 40', 'description': 'AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was any untoward medical occurrence that at any dose resulted in any of following outcomes/deemed significant for any other reason: death; initial /prolonged inpatient hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect and suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. AEs included both serious (if occurred) and all non-serious adverse events. TEAEs are events between first dose of study drug and up to Week 40 that were absent before treatment or that worsened relative to pretreatment state.'}, {'measure': 'Number of Participants With Clinically Significant Laboratory Abnormalities (Stage 1 and Stage 2)', 'timeFrame': 'Up to Week 28', 'description': "HGB,hematocrit,ery.,HDL chl.\\<0.8\\*LLN;ret., ret./ery. (%)\\<0.5\\*LLN,\\>1.5\\*ULN;EMC volume,EMC HGB,EMC HGB concentration,potassium,chloride,calcium,bicarbonate\\<0.9\\*LLN,\\>1.1\\*ULN;platelets\\<0.5\\*LLN,\\>1.75\\*ULN;leu.,glucose\\<0.6\\*LLN,\\>1.5\\*ULN;lym., lym./leu.(%), neu., neu./leu. (%), protein,albumin \\<0.8\\*LLN,\\>1.2\\*ULN;bas., bas./leu.(%), eos., eos./leu., mon., mon./leu.(%), urate \\>1.2\\*ULN;bilirubin (total, direct, indirect)\\>1.5\\*ULN;aspartate/alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase\\>3.0\\*ULN;urea nitrogen, creatinine, triglycerides, chl.\\>1.3\\*ULN; sodium \\<0.95\\*LLN,\\>1.05\\*ULN; creatine kinase \\>2.0\\*ULN;Urine: pH\\<4.5,\\>8;glucose, ketones, protein, HGB, urobilinogen,bilirubin,nitrite,leukocyte esterase\\>=1;ery., leu.\\>= 20;hyaline casts\\>1;bacteria\\>20. Clinical significance of laboratory parameters was determined at the investigator's discretion."}, {'measure': 'Number of Participants With Clinically Significant Laboratory Abnormalities (Amended Stage 2)', 'timeFrame': 'Up to Week 40', 'description': "HGB,hematocrit,ery.,HDL chl.\\<0.8\\*LLN;ret., ret./ery. (%)\\<0.5\\*LLN,\\>1.5\\*ULN;EMC volume,EMC HGB,EMC HGB concentration,potassium,chloride,calcium,bicarbonate\\<0.9\\*LLN,\\>1.1\\*ULN;platelets\\<0.5\\*LLN,\\>1.75\\*ULN;leu.,glucose\\<0.6\\*LLN,\\>1.5\\*ULN;lym., lym./leu.(%), neu., neu./leu. (%), protein,albumin \\<0.8\\*LLN,\\>1.2\\*ULN;bas., bas./leu.(%), eos., eos./leu., mon., mon./leu.(%), urate \\>1.2\\*ULN;bilirubin (total, direct, indirect)\\>1.5\\*ULN;aspartate/alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase\\>3.0\\*ULN;urea nitrogen, creatinine, triglycerides, chl.\\>1.3\\*ULN; sodium \\<0.95\\*LLN,\\>1.05\\*ULN; creatine kinase \\>2.0\\*ULN;Urine: pH\\<4.5,\\>8;glucose, ketones, protein, HGB, urobilinogen,bilirubin,nitrite,leukocyte esterase\\>=1;ery., leu.\\>= 20;hyaline casts\\>1;bacteria\\>20. Clinical significance of laboratory parameters was determined at the investigator's discretion."}, {'measure': 'Number of Participants With Vital Sign Abnormalities (Stage 1 and Stage 2)', 'timeFrame': 'Up to Week 28', 'description': 'Abnormality in vital signs: Sitting pulse rate \\<40 bpm to \\>120 bpm, sitting DBP \\< 50 mmHg, sitting SBP \\<90 mmHg.'}, {'measure': 'Number of Participants With Vital Sign Abnormalities (Amended Stage 2)', 'timeFrame': 'Up to Week 40', 'description': 'Abnormality in vital signs: Sitting pulse rate \\<40 bpm to \\>120 bpm, sitting DBP \\< 50 mmHg, sitting SBP \\<90 mmHg.'}, {'measure': 'Number of Participants With ECG Abnormalities (Stage 1 and Stage 2)', 'timeFrame': 'Up to Week 28', 'description': 'ECG abnormalities criteria included: 1) QTc interval adjusted according to Fridericia formula (QTcF) (msec): \\>450, \\>480, \\>500, increase from baseline \\>=30, increase from baseline \\>=60; 2) Pulse rate (PR) (msec): \\>=300, change from baseline (Chg) \\>=25% or 50%; 3) QT (msec): \\>=500; 4) QRS (msec): \\>=200, Chg \\>=25% or 50%. Categories, with at least 1 participant having ECG abnormality in any of the reporting arms, were reported in this outcome measure.'}, {'measure': 'Number of Participants With ECG Abnormalities (Amended Stage 2)', 'timeFrame': 'Up to Week 40', 'description': 'ECG abnormalities criteria included: 1) QTc interval adjusted according to Fridericia formula (QTcF) (msec): \\>450, \\>480, \\>500, increase from baseline \\>=30, increase from baseline \\>=60; 2) Pulse rate (PR) (msec): \\>=300, change from baseline (Chg) \\>=25% or 50%; 3) QT (msec): \\>=500; 4) QRS (msec): \\>=200, Chg \\>=25% or 50%. Categories, with at least 1 participant having ECG abnormality in any of the reporting arms, were reported in this outcome measure.'}, {'measure': 'Change From Baseline in CDASI Activity Score at at All Scheduled Timepoints Through Week 12 (Stage 1, Stage 2 and Amended Stage 2)', 'timeFrame': 'Baseline, Week 1, Week 4, and Week 8 (except for Week 12 which is a primary outcome measure)', 'description': "The treatment effect was defined as the difference (mean change from baseline at Weeks 1, 4, 8 in the active treatment group minus the mean change from baseline at Weeks 1, 4, 8 in the placebo group) in the mean change of CDASI activity score from baseline at scheduled timepoints. The score (range: 0-100) consists of the ES, GHS, PS and AS. ES (range: 0-90) was obtained by summing up scores for the total erythema (ER \\[0-45\\], redness of the skin or mucous membranes), scaling (SC \\[0-30\\], peeling of the skin) and erosion/ulceration (EU \\[0-15\\], presence of the deeper wound). Total ER, SC and EU scores were calculated as a sum of the contributions from 15 individual areas of the body. GHS characterizes papules (swellings) on hand and is a sum of the papule's characterization score (0-6) and ulceration score (0-1). PS (0-2) characterizes abnormalities around nails. The AS (0-1) characterizes hair loss. Higher scores indicate greater disease severity."}, {'measure': 'Change From Baseline in CDASI Activity Score at All Scheduled Timepoints Through Week 12 (Stage 3)', 'timeFrame': 'Baseline, Week 1, Week 4, Week 8 and Week 12', 'description': "The treatment effect was defined as the difference (mean change from baseline at Weeks 1, 4, 8,12 in the active treatment group minus the mean change from baseline at Weeks 1, 4, 8, 12 in the placebo group) in the mean change of CDASI activity score from baseline at scheduled timepoints. The score (range: 0-100) consists of the ES, GHS, PS and AS. ES (range: 0-90) was obtained by summing up scores for the total erythema (ER \\[0-45\\], redness of the skin or mucous membranes), scaling (SC \\[0-30\\], peeling of the skin) and erosion/ulceration (EU \\[0-15\\], presence of the deeper wound). Total ER, SC and EU scores were calculated as a sum of the contributions from 15 individual areas of the body. GHS characterizes papules (swellings) on hand and is a sum of the papule's characterization score (0-6) and ulceration score (0-1). PS (0-2) characterizes abnormalities around nails. The AS (0-1) characterizes hair loss. Higher scores indicate greater disease severity."}, {'measure': 'Absolute Values of CDASI Activity Score at All Scheduled Timepoints Through Week 12 (All Stages)', 'timeFrame': 'Baseline, Week 1, Week 4, Week 8 and Week 12', 'description': "The CDASI activity score (range: 0-100) consists of the ES, GHS, PS and AS. ES (range: 0-90) was obtained by summing up scores for the total erythema (ER \\[0-45\\], redness of the skin or mucous membranes), scaling (SC \\[0-30\\], peeling of the skin) and erosion/ulceration (EU \\[0-15\\], presence of the deeper wound). Total ER, SC and EU scores were calculated as a sum of the contributions from 15 individual areas of the body. GHS characterizes papules (swellings) on hand and is a sum of the papule's characterization score (0-6) and ulceration score (0-1). PS (0-2) characterizes abnormalities around nails. The AS (0-1) characterizes hair loss. Higher scores indicate greater disease severity."}, {'measure': 'Absolute Values of CDASI Damage Score at All Scheduled Timepoints Through Week 12 (All Stages)', 'timeFrame': 'Baseline, Week 1, Week 4, Week 8 and Week 12', 'description': "The Damage Score (DS) was calculated as a sum of the total poilkiloderma score (POLS), total calcinosis score (CALS) and Gotorn's hands damage score (GHDS). The POLS characterizes specific dispigmentation in the particulal area and calcinosis score characterizes calcification of the skin in the particular area. The POLS and the CALS are summed up over 15 individual areas in the body and each of them has range 0-15. The GHDS has the range 0-2 so that the DS has the range 0-32. Higher scores indicate greater disease severity."}, {'measure': 'Absolute Values for Total Improvement Score (TIS) at Week 12 and Intermediate Scheduled Time Points (Stage 3)', 'timeFrame': 'Week 4, Week 8 and Week 12', 'description': 'The TIS was the sum of all 6 improvement scores where higher score indicates worse status (PhGA \\[from the MDAAT, 0-20 scale\\], PtGA \\[0-10 scale\\], MMT \\[0-35 scale\\], HAQ-DI \\[0-10 scale\\], muscle enzymes \\[0-7.5 scale\\], and extramuscular global assessment \\[0-20 scale\\]) associated with the change in each core set measure. A total improvement score between 0 and 100 corresponded to the degree of improvement, with higher scores corresponding to a greater degree of improvement: of ≥20 represented minimal improvement, a score of ≥40 represented moderate improvement, and a score of ≥60 represented major improvement.'}, {'measure': 'Change From Baseline in the Core Set Measures (CSM) of the TIS (Global Disease Activity [PhGA] and Extramuscular Global Assessment [EmGA]) (Stage 3)', 'timeFrame': 'Baseline, Week 4, Week 8 and Week 12', 'description': 'PhGA: assessment of the severity of disease by the physician. The physician used the visual analog scale and put a mark on 0 cm (best) -10 cm (worst) scale where higher score indicated worse status.\n\nEmGA: overall evaluation of disease activity in all extramuscular systems using visual analog scale 0 cm (best) -10 cm (worst) scale where higher score indicated worse status.'}, {'measure': 'Change From Baseline in the CSM of the TIS (PtGA) (Stage 3)', 'timeFrame': 'Baseline, Week 4, Week 8 and Week 12', 'description': "PtGA: assessment of the severity of disease by the participant/participant's guardian, using a visual analog scale from 0 mm (no evidence of disease activity) to 100 mm (extremely active or severe disease activity). Higher score indicated worse status."}, {'measure': 'Change From Baseline in the CSM of the TIS (MMT8 and HAQ01-HAQ-DI) (Stage 3)', 'timeFrame': 'Week 4, Week 8 and Week 12', 'description': 'Manual Muscle Testing-8 designated muscle groups (MMT-8): was a set of 8 designated muscles tested unilaterally generally on right side (left side used unless right side cannot be used). Potential score range was from 0 to 80, where higher scores denoted better health status.\n\nHAQ-DI: contained eight sections (including dressing \\& grooming, arising, eating, walking, hygiene, grip, reach, and activities). Each section had multiple questions that the participant used to rank their functionality and ranged from 0 to 3 where 0 = without any difficulty and 3 = unable to do. For each participant, the average ranking was calculated for each of the eight sections. HAQ-DI had a score range of 0 to 3, where higher score reflected worse status.'}, {'measure': 'Change From Baseline in the CSM of the TIS (Aldolase and Creatine Kinase) (Stage 3)', 'timeFrame': 'Baseline, Week 4, Week 8 and Week 12', 'description': 'The LS mean (with 90% CI) of CSM of the TIS (aldolase and creatine kinase) at weeks 4, 8, 12 were presented.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dermatomyositis']}, 'referencesModule': {'references': [{'pmid': '39798982', 'type': 'DERIVED', 'citation': 'Fiorentino D, Mangold AR, Werth VP, Christopher-Stine L, Femia A, Chu M, Musiek ACM, Sluzevich JC, Graham LV, Fernandez AP, Aggarwal R, Rieger K, Page KM, Li X, Hyde C, Rath N, Sloan A, Oemar B, Banerjee A, Salganik M, Banfield C, Neelakantan S, Beebe JS, Vincent MS, Peeva E, Vleugels RA. Efficacy, safety, and target engagement of dazukibart, an IFNbeta specific monoclonal antibody, in adults with dermatomyositis: a multicentre, double-blind, randomised, placebo-controlled, phase 2 trial. Lancet. 2025 Jan 11;405(10473):137-146. doi: 10.1016/S0140-6736(24)02071-3.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C0251002', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'A Study looking at Investigational drug and Placebo administered to adult Patients with moderate to severe Dermatomyositis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria for Patients with Skin Predominant Activity:\n\n* Must have CDASI Activity score of greater than or equal to 14, and have failed at least 1 standard of care systemic treatment, (eg, corticosteroids).\n* Confirmation of DM by the investigator and two of the following:\n\n 1. Gottron's papules;\n 2. Gottron's sign;\n 3. Heliotrope eruption;\n 4. Nailfold changes, (dilated capillary loops, capillary dropout, cuticular hypertrophy and/or rugged cuticles;\n 5. Photodistributed violaceous erythema, (skin that is exposed to sunlight and appears purplish/reddish, and patchy in appearance;\n 6. Positive DM serology -\n* Post DM diagnosis; standard of care workup for DM must have been completed prior to entry into this research study.\n* Willing to provide 8 biopsies during the course of the research study\n\nInclusion Criteria for Patients with Muscle Predominant Activity:\n\n* MMT-8 ≤136/150 and PhGA, VAS ≥3 cm (0-10 cm) by visual analog scale (VAS)\n* Sum of PhGA, VAS, PtGA, and extramuscular global assessment VAS scores is ≥10 cm (0-10 cm) VAS for each.\n\n * Participant has failed at least two or more adequate courses of an immunosuppressive agent or immunomodulatory agent, including IVIG, at a dose known to be effective for rheumatologic diseases.\n\nExclusion Criteria for Patients with Skin Predominant Activity:\n\n* Investigator site staff or members of their family.\n* Acute and Chronic present medical conditions\n* Intake of greater than 15 mg of prednisone or equivalent per day\n* Pregnant or breastfeeding females. Fertile men and women who will not comply with the use of 2 effective birth control methods as per the research protocol\n* Have required management of acute or chronic infections\n* Have pre existing demyelinating disorder such as multiple sclerosis, or other severe neurological deficits.\n* Clinically significant lab abnormalities\n* Any health condition that may be worsened by immunosuppression\n\nExclusion Criteria for Patients with Muscle Predominant Activity:\n\nSimilar to patients with skin predominant activity; Intake of \\>20 mg oral prednisone/day, or equivalent"}, 'identificationModule': {'nctId': 'NCT03181893', 'briefTitle': 'A Study In Adults With Moderate To Severe Dermatomyositis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 2 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PF-06823859 IN ADULT SUBJECTS WITH DERMATOMYOSITIS', 'orgStudyIdInfo': {'id': 'C0251002'}, 'secondaryIdInfos': [{'id': '2020-004228-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo ARM', 'interventionNames': ['Drug: Placebo Arm']}, {'type': 'EXPERIMENTAL', 'label': 'PF-06823859 ARM high', 'interventionNames': ['Drug: PF-06823859 high']}, {'type': 'EXPERIMENTAL', 'label': 'PF-06823859 ARM low', 'interventionNames': ['Drug: PF-06823859 low']}], 'interventions': [{'name': 'PF-06823859 low', 'type': 'DRUG', 'description': 'A humanized immunoglobulin neutralizing antibody', 'armGroupLabels': ['PF-06823859 ARM low']}, {'name': 'Placebo Arm', 'type': 'DRUG', 'description': 'Placebo contains histidine, sucrose, PS80, ethylene diamine, and triacetic acid', 'armGroupLabels': ['Placebo ARM']}, {'name': 'PF-06823859 high', 'type': 'DRUG', 'description': 'A humanized immunoglobulin neutralizing antibody', 'armGroupLabels': ['PF-06823859 ARM high']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'The University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'The University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Arizona Research Pharmacy', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Attune Health Research Inc.', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Freidenrich Center for Translational Research at Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University Of Miami Hospital', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Hospital Clinical Translational Research Site (Infusion site)', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '66205', 'city': 'Fairway', 'state': 'Kansas', 'country': 'United States', 'facility': 'KU Clinical Research Center - Clinical and Translational Science Unit (CTSU)', 'geoPoint': {'lat': 39.02223, 'lon': -94.6319}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'The University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '21224-6821', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Bayview Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital - ACC", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital - CTC", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital - CTH", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Clinical Research Unit (CRU)', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Department of Medicine Division of Rheumatic and Autoimmune Disease', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Lillehei Clinical Research Unit (LCRU)', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota Health 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