Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2026-02-25 @ 4:16 AM
Study NCT ID:
NCT01090492
Status:
COMPLETED
Last Update Posted:
2018-05-16
First Post:
2010-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PF-00489791 For The Treatment Of Raynaud's
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011928', 'term': 'Raynaud Disease'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D045743', 'term': 'Scleroderma, Diffuse'}, {'id': 'D012595', 'term': 'Scleroderma, Systemic'}], 'ancestors': [{'id': 'D000090122', 'term': 'Livedoid Vasculopathy'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000619499', 'term': 'PF-00489791'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Plasma concentration of PF-00489791 metabolites was not intended as secondary endpoint in the protocol and was considered as an exploratory endpoint.'}}, 'adverseEventsModule': {'description': 'Safety analysis population included all participants who received at least 1 dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'PF-00489791 4 mg (PRP)', 'description': 'PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 27, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PF-00489791 20 mg (PRP)', 'description': 'PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 34, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo (PRP)', 'description': 'Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.', 'otherNumAtRisk': 102, 'deathsNumAtRisk': 102, 'otherNumAffected': 43, 'seriousNumAtRisk': 102, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'PF-00489791 4 mg (SRP)', 'description': 'PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 34, 'seriousNumAtRisk': 61, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'PF-00489791 20 mg (SRP)', 'description': 'PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 51, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Placebo (SRP)', 'description': 'Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.', 'otherNumAtRisk': 122, 'deathsNumAtRisk': 122, 'otherNumAffected': 60, 'seriousNumAtRisk': 122, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Cystic fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Eye oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, 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{'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 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'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, 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55, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 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[{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 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'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Vasomotor rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Acne cystic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Increased tendency to bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Nail bed inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Pain of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Rash erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Skin burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Skin disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Phlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': "Raynaud's phenomenon", 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}], 'seriousEvents': [{'term': 'Oesophageal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Change From Baseline in Mean Raynaud's Condition Score (RCS) at Week 4", 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '83', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00489791 4 mg (PRP)', 'description': 'PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.'}, {'id': 'OG001', 'title': 'PF-00489791 20 mg (PRP)', 'description': 'PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.'}, {'id': 'OG002', 'title': 'Placebo (PRP)', 'description': 'Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.'}, {'id': 'OG003', 'title': 'PF-00489791 4 mg (SRP)', 'description': 'PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.'}, {'id': 'OG004', 'title': 'PF-00489791 20 mg (SRP)', 'description': 'PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.'}, {'id': 'OG005', 'title': 'Placebo (SRP)', 'description': 'Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.04', 'spread': '1.899', 'groupId': 'OG000'}, {'value': '2.90', 'spread': '2.160', 'groupId': 'OG001'}, {'value': '2.98', 'spread': '1.958', 'groupId': 'OG002'}, {'value': '3.14', 'spread': '2.431', 'groupId': 'OG003'}, {'value': '2.53', 'spread': '1.833', 'groupId': 'OG004'}, {'value': '2.97', 'spread': '2.492', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-0.76', 'spread': '1.901', 'groupId': 'OG000'}, {'value': '-1.05', 'spread': '1.771', 'groupId': 'OG001'}, {'value': '-0.61', 'spread': '1.404', 'groupId': 'OG002'}, {'value': '-0.82', 'spread': '1.624', 'groupId': 'OG003'}, {'value': '-0.15', 'spread': '1.090', 'groupId': 'OG004'}, {'value': '-0.24', 'spread': '1.437', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.6513', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.11', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.44', 'groupDescription': 'PRP: Adjusted mean difference analysis was based on Analysis of Covariance (ANCOVA) model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0057', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.69', 'ciLowerLimit': '-0.99', 'ciUpperLimit': '-0.38', 'groupDescription': 'PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.1157', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.44', 'ciLowerLimit': '-0.80', 'ciUpperLimit': '-0.08', 'groupDescription': 'SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.6286', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.15', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '0.25', 'groupDescription': 'SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': "The Raynaud's Condition score (RCS) is participant's rating of difficulty considering number of attacks, duration, amount of pain, numbness, or other symptoms caused in the fingers (including painful sores) due to the Raynaud's phenomenon every day and impact of Raynaud's alone on use of hands every day. An 11 point Likert scale is used to rate the difficulty caused by the condition each day with 0 = no difficulty and 10 = extreme difficulty. Participants were asked to select the number that best describes their difficulty, with higher score indicating worse condition. Average daily score was considered for participants completing more than 1 Raynaud's pain score scale on a day. Baseline value was calculated as mean of the scores over 7 days prior to treatment start. Week 4 value was calculated as mean of the scores over the 7-day period prior to Week 4.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol analysis set (PPAS) included all randomized participants compliant with diary completion and were not amongst serious protocol violators, receiving study medication till the study completion.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in the Number of Raynaud's Attacks at Week 1, 2, 3 and 4", 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '83', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00489791 4 mg (PRP)', 'description': 'PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.'}, {'id': 'OG001', 'title': 'PF-00489791 20 mg (PRP)', 'description': 'PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.'}, {'id': 'OG002', 'title': 'Placebo (PRP)', 'description': 'Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.'}, {'id': 'OG003', 'title': 'PF-00489791 4 mg (SRP)', 'description': 'PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.'}, {'id': 'OG004', 'title': 'PF-00489791 20 mg (SRP)', 'description': 'PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.'}, {'id': 'OG005', 'title': 'Placebo (SRP)', 'description': 'Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '83', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '22.06', 'spread': '20.587', 'groupId': 'OG000'}, {'value': '16.31', 'spread': '10.885', 'groupId': 'OG001'}, {'value': '20.19', 'spread': '17.802', 'groupId': 'OG002'}, {'value': '22.80', 'spread': '16.270', 'groupId': 'OG003'}, {'value': '23.70', 'spread': '20.909', 'groupId': 'OG004'}, {'value': '23.08', 'spread': '20.698', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '83', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-3.75', 'spread': '7.494', 'groupId': 'OG000'}, {'value': '-2.47', 'spread': '6.477', 'groupId': 'OG001'}, {'value': '-1.41', 'spread': '7.934', 'groupId': 'OG002'}, {'value': '-3.17', 'spread': '7.994', 'groupId': 'OG003'}, {'value': '-4.49', 'spread': '14.692', 'groupId': 'OG004'}, {'value': '-2.36', 'spread': '11.850', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '83', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-5.30', 'spread': '9.487', 'groupId': 'OG000'}, {'value': '-2.36', 'spread': '8.371', 'groupId': 'OG001'}, {'value': '-2.45', 'spread': '11.107', 'groupId': 'OG002'}, {'value': '-3.76', 'spread': '9.028', 'groupId': 'OG003'}, {'value': '-4.43', 'spread': '17.312', 'groupId': 'OG004'}, {'value': '-1.87', 'spread': '11.051', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '83', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-4.66', 'spread': '10.559', 'groupId': 'OG000'}, {'value': '-4.86', 'spread': '5.681', 'groupId': 'OG001'}, {'value': '-4.03', 'spread': '10.396', 'groupId': 'OG002'}, {'value': '-4.25', 'spread': '11.408', 'groupId': 'OG003'}, {'value': '-3.75', 'spread': '8.601', 'groupId': 'OG004'}, {'value': '-1.93', 'spread': '9.487', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '82', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-4.85', 'spread': '13.008', 'groupId': 'OG000'}, {'value': '-3.07', 'spread': '7.118', 'groupId': 'OG001'}, {'value': '-3.65', 'spread': '10.460', 'groupId': 'OG002'}, {'value': '-3.89', 'spread': '8.326', 'groupId': 'OG003'}, {'value': '-2.68', 'spread': '10.002', 'groupId': 'OG004'}, {'value': '-2.25', 'spread': '10.624', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.9504', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.12', 'ciLowerLimit': '-2.43', 'ciUpperLimit': '2.68', 'groupDescription': 'At Week 4 - PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.4651', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.35', 'ciLowerLimit': '-3.74', 'ciUpperLimit': '1.03', 'groupDescription': 'At Week 4 - PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.7423', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.59', 'ciLowerLimit': '-2.92', 'ciUpperLimit': '1.73', 'groupDescription': 'At Week 4 - SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3524', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.91', 'ciLowerLimit': '-4.55', 'ciUpperLimit': '0.73', 'groupDescription': 'At Week 4 - SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3, Week 4', 'description': "Change from baseline in the number of Raynaud's attacks at Week 1, Week 2, Week 3 and Week 4 was calculated from the number of attacks reported over the 7-day period prior to each week from the patient diary, respectively.", 'unitOfMeasure': "Raynaud's attacks", 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PPAS included all randomized participants compliant with diary completion and were not amongst serious protocol violators, receiving study medication till the study completion. Here, number analyzed signifies those participants who were evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Mean Duration of Raynaud's Attacks at Week 4", 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '83', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00489791 4 mg (PRP)', 'description': 'PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.'}, {'id': 'OG001', 'title': 'PF-00489791 20 mg (PRP)', 'description': 'PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.'}, {'id': 'OG002', 'title': 'Placebo (PRP)', 'description': 'Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.'}, {'id': 'OG003', 'title': 'PF-00489791 4 mg (SRP)', 'description': 'PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.'}, {'id': 'OG004', 'title': 'PF-00489791 20 mg (SRP)', 'description': 'PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.'}, {'id': 'OG005', 'title': 'Placebo (SRP)', 'description': 'Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '83', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '17.69', 'spread': '13.184', 'groupId': 'OG000'}, {'value': '22.23', 'spread': '36.562', 'groupId': 'OG001'}, {'value': '19.61', 'spread': '40.603', 'groupId': 'OG002'}, {'value': '19.37', 'spread': '18.929', 'groupId': 'OG003'}, {'value': '19.07', 'spread': '18.196', 'groupId': 'OG004'}, {'value': '19.91', 'spread': '19.886', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '82', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-2.89', 'spread': '7.480', 'groupId': 'OG000'}, {'value': '-5.63', 'spread': '43.067', 'groupId': 'OG001'}, {'value': '-1.41', 'spread': '12.348', 'groupId': 'OG002'}, {'value': '-3.92', 'spread': '11.336', 'groupId': 'OG003'}, {'value': '-2.61', 'spread': '9.593', 'groupId': 'OG004'}, {'value': '-1.65', 'spread': '10.609', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.7900', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.21', 'ciLowerLimit': '-4.61', 'ciUpperLimit': '7.03', 'groupDescription': 'PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.1463', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-6.17', 'ciLowerLimit': '-11.61', 'ciUpperLimit': '-0.73', 'groupDescription': 'PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.1446', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-2.37', 'ciLowerLimit': '-4.44', 'ciUpperLimit': '-0.29', 'groupDescription': 'SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.5497', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.09', 'ciLowerLimit': '-3.45', 'ciUpperLimit': '1.26', 'groupDescription': 'SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': "Mean duration of Raynaud's attacks for a time period was calculated as sum of recorded durations of attacks in the time period divided by total number of attacks in the time period where duration was recorded.", 'unitOfMeasure': 'minutes per attack', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PPAS included all randomized participants compliant with diary completion and were not amongst serious protocol violators, receiving study medication till the study completion. Here, number analyzed signifies those participants who were evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in the Mean Raynaud's Pain Score at Week 1, 2, 3 and 4", 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '83', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00489791 4 mg (PRP)', 'description': 'PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.'}, {'id': 'OG001', 'title': 'PF-00489791 20 mg (PRP)', 'description': 'PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.'}, {'id': 'OG002', 'title': 'Placebo (PRP)', 'description': 'Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.'}, {'id': 'OG003', 'title': 'PF-00489791 4 mg (SRP)', 'description': 'PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.'}, {'id': 'OG004', 'title': 'PF-00489791 20 mg (SRP)', 'description': 'PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.'}, {'id': 'OG005', 'title': 'Placebo (SRP)', 'description': 'Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '83', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.84', 'spread': '2.074', 'groupId': 'OG000'}, {'value': '2.78', 'spread': '2.348', 'groupId': 'OG001'}, {'value': '2.80', 'spread': '2.064', 'groupId': 'OG002'}, {'value': '3.33', 'spread': '2.614', 'groupId': 'OG003'}, {'value': '2.54', 'spread': '1.895', 'groupId': 'OG004'}, {'value': '3.10', 'spread': '2.753', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '83', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.72', 'spread': '1.525', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '1.266', 'groupId': 'OG001'}, {'value': '-0.26', 'spread': '1.205', 'groupId': 'OG002'}, {'value': '-0.53', 'spread': '1.440', 'groupId': 'OG003'}, {'value': '-0.32', 'spread': '1.276', 'groupId': 'OG004'}, {'value': '-0.17', 'spread': '1.272', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '83', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.94', 'spread': '1.745', 'groupId': 'OG000'}, {'value': '-0.61', 'spread': '1.524', 'groupId': 'OG001'}, {'value': '-0.48', 'spread': '1.337', 'groupId': 'OG002'}, {'value': '-0.68', 'spread': '1.740', 'groupId': 'OG003'}, {'value': '-0.33', 'spread': '1.321', 'groupId': 'OG004'}, {'value': '-0.24', 'spread': '1.306', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '83', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.82', 'spread': '1.720', 'groupId': 'OG000'}, {'value': '-1.12', 'spread': '1.664', 'groupId': 'OG001'}, {'value': '-0.62', 'spread': '1.262', 'groupId': 'OG002'}, {'value': '-0.80', 'spread': '1.836', 'groupId': 'OG003'}, {'value': '-0.55', 'spread': '1.081', 'groupId': 'OG004'}, {'value': '-0.33', 'spread': '1.269', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '82', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.80', 'spread': '1.842', 'groupId': 'OG000'}, {'value': '-1.14', 'spread': '1.820', 'groupId': 'OG001'}, {'value': '-0.63', 'spread': '1.423', 'groupId': 'OG002'}, {'value': '-0.77', 'spread': '1.922', 'groupId': 'OG003'}, {'value': '-0.35', 'spread': '1.115', 'groupId': 'OG004'}, {'value': '-0.27', 'spread': '1.466', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.5909', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.15', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.52', 'groupDescription': 'Week 4 (PRP): Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0053', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.77', 'ciLowerLimit': '-1.12', 'ciUpperLimit': '-0.43', 'groupDescription': 'Week 4 (PRP): Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3462', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.28', 'ciLowerLimit': '-0.67', 'ciUpperLimit': '0.10', 'groupDescription': 'Week 4 (SRP): Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.1940', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.44', 'ciLowerLimit': '-0.88', 'ciUpperLimit': '-0.01', 'groupDescription': 'Week 4 (SRP): Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, 2, 3, 4', 'description': "Participants were asked to rate their worst Raynaud's pain in the past 24 hours using an 11 point Likert scale, with 0 = no Raynaud's pain and 10 = the worst possible pain. Highest (most severe) response was considered for participants responding at more than 1 point on the scale. Average daily score was considered for participants completing more than 1 Raynaud's pain score scale on a day. Baseline value was calculated as mean of the scores over 7 days prior to treatment start. Post-baseline value was calculated as mean of the scores over the 7-day period prior to the visit.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PPAS included all randomized participants compliant with diary completion and were not amongst serious protocol violators, receiving study medication till the study completion. Here, number analyzed signifies those participants who were evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': "Number of Participants With Decrease From Baseline in Digital Ulcers at Day 14 and 28: Secondary Raynaud's Phenomenon Cohort", 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00489791 4 mg (SRP)', 'description': 'PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.'}, {'id': 'OG001', 'title': 'PF-00489791 20 mg (SRP)', 'description': 'PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.'}, {'id': 'OG002', 'title': 'Placebo (SRP)', 'description': 'Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'With Decrease at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'With Decrease at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Day 14, 28', 'description': 'Presence of ulcer was assessed at baseline. At post-baseline visits, each ulcer was measured and scored: 1= smaller or improved compared to previous visit, 2= same as previous visit, 3= bigger or worse than previous visit, and 4= new. If a new digital ulcer develops during the course of the study, the measurement and scoring were initiated on this additional ulcer. Healed ulcers were not counted into the number of ulcers. Participants with SRP in the per-protocol population with at least 1 digital ulcer present at any assessment were evaluable for this measure. Results are reported for participants with presence of ulcer at baseline and decrease from baseline in ulcers at post-baseline visits.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPAS included all randomized participants compliant with diary completion and were not amongst serious protocol violators, receiving study medication till the study completion. Here, number analyzed signifies those participants who were evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of PF-00489791 and Its Metabolites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00489791 4 mg (PRP)', 'description': 'PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.'}, {'id': 'OG001', 'title': 'PF-00489791 20 mg (PRP)', 'description': 'PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.'}, {'id': 'OG002', 'title': 'PF-00489791 4 mg (SRP)', 'description': 'PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.'}, {'id': 'OG003', 'title': 'PF-00489791 20 mg (SRP)', 'description': 'PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0058', 'spread': '0.0314', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Number of observations above lower limit of quantification (NALQ) was 0, hence data could not be analyzed.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Number of observations above lower limit of quantification (NALQ) was 0, hence data was not summarized.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Number of observations above lower limit of quantification (NALQ) was 0, hence data was not summarized.', 'groupId': 'OG003'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.1523', 'spread': '0.0855', 'groupId': 'OG000'}, {'value': '0.5907', 'spread': '0.3736', 'groupId': 'OG001'}, {'value': '0.1756', 'spread': '0.09038', 'groupId': 'OG002'}, {'value': '0.7718', 'spread': '0.4991', 'groupId': 'OG003'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.1489', 'spread': '0.0854', 'groupId': 'OG000'}, {'value': '0.6525', 'spread': '0.3822', 'groupId': 'OG001'}, {'value': '0.1776', 'spread': '0.08508', 'groupId': 'OG002'}, {'value': '0.7577', 'spread': '0.4137', 'groupId': 'OG003'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Number of observations above lower limit of quantification (NALQ) was 0, hence data could not be analyzed.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Number of observations above lower limit of quantification (NALQ) was 0, hence data could not be analyzed.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Number of observations above lower limit of quantification (NALQ) was 0, hence data was not summarized.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Number of observations above lower limit of quantification (NALQ) was 0, hence data was not summarized.', 'groupId': 'OG003'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.1088', 'spread': '0.0629', 'groupId': 'OG000'}, {'value': '0.6890', 'spread': '0.4318', 'groupId': 'OG001'}, {'value': '0.1167', 'spread': '0.05644', 'groupId': 'OG002'}, {'value': '0.7565', 'spread': '0.6224', 'groupId': 'OG003'}]}]}, {'title': 'Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.1178', 'spread': '0.0614', 'groupId': 'OG000'}, {'value': '0.6337', 'spread': '0.3745', 'groupId': 'OG001'}, {'value': '0.1224', 'spread': '0.0638', 'groupId': 'OG002'}, {'value': '0.6639', 'spread': '0.5834', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, 15, 29 (Day 1, 15, 29 for first intervention period), 43, 57, 71 (Day 1, 15, 29 for second intervention period)', 'description': 'Only participants receiving PF-00489791 were to be analyzed for this outcome. Data have been calculated by setting plasma concentration values below the lower limit of quantification to 0. The lower limit of quantification is 0.0100 microgram per milliliter (mcg/mL). Data for plasma concentration of PF-00489791 metabolites was not analyzed, as it was not intended to be a secondary endpoint and was deemed optional.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included participants who received 1 dose of study drug and were analyzed for pharmacokinetic parameters. Here, Overall number of participants signifies participants evaluable for either first or second intervention period and number analyzed signifies those participants who were evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Test Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}, {'value': '60', 'groupId': 'OG004'}, {'value': '114', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00489791 4 mg (PRP)', 'description': 'PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.'}, {'id': 'OG001', 'title': 'PF-00489791 20 mg (PRP)', 'description': 'PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.'}, {'id': 'OG002', 'title': 'Placebo (PRP)', 'description': 'Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.'}, {'id': 'OG003', 'title': 'PF-00489791 4 mg (SRP)', 'description': 'PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.'}, {'id': 'OG004', 'title': 'PF-00489791 20 mg (SRP)', 'description': 'PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.'}, {'id': 'OG005', 'title': 'Placebo (SRP)', 'description': 'Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening up to 28 days after last study dose (up to 98 days)', 'description': 'Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (less than \\[\\<\\] 0.8\\*lower limit of normal\\[LLN\\]); leukocytes (\\<0.6 LLN /greater than \\[\\>\\] 1.5\\*upper LN \\[ULN\\]; platelets (\\<0.5\\*LLN/\\>1.75\\*ULN); neutrophils, lymphocytes (\\<0.8\\* LLN/\\>1.2\\*ULN); eosinophils, basophils, monocytes (\\>1.2\\*ULN); bilirubin (\\>1.5\\*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), Gamma GT, alkaline phosphatase (\\>3\\*ULN); BUN, creatinine (\\>1.3\\*ULN); glucose (\\<0.6 LLN/\\>1.5\\*ULN); uric acid (\\>1.2\\*ULN); sodium (\\<0.95\\*LLN/\\>1.05\\*ULN); potassium, calcium, chloride, bicarbonate (\\<0.9\\*LLN/\\>1.1\\*ULN); albumin, total protein (\\<0.8\\*LLN/\\>1.2\\*ULN); creatine kinase (\\>2.0\\*ULN); Urine Specific Gravity, Urine pH, urine blood, urine glucose, urine protein, urine ketones, urine leukocytes esterase (\\>=1 high-powered field). Total number of participants with any laboratory abnormalities was reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all randomized participants who took at least 1 dose of study medication along with at least 1 on-treatment laboratory test result.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Changes in Vital Signs and Orthostatic Blood Pressure Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '64', 'groupId': 'OG004'}, {'value': '122', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00489791 4 mg (PRP)', 'description': 'PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.'}, {'id': 'OG001', 'title': 'PF-00489791 20 mg (PRP)', 'description': 'PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.'}, {'id': 'OG002', 'title': 'Placebo (PRP)', 'description': 'Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.'}, {'id': 'OG003', 'title': 'PF-00489791 4 mg (SRP)', 'description': 'PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.'}, {'id': 'OG004', 'title': 'PF-00489791 20 mg (SRP)', 'description': 'PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.'}, {'id': 'OG005', 'title': 'Placebo (SRP)', 'description': 'Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening up to 28 days after last study dose (up to 98 days)', 'description': "Vital signs assessment included measurement of supine and standing pulse rate, systolic and diastolic blood pressures. Criteria for clinically significant vital signs and orthostatic blood pressure measurements were based on investigator's judgement.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set consisted of all participants who took at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Electrocardiogram (ECG) Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '64', 'groupId': 'OG004'}, {'value': '122', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00489791 4 mg (PRP)', 'description': 'PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.'}, {'id': 'OG001', 'title': 'PF-00489791 20 mg (PRP)', 'description': 'PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.'}, {'id': 'OG002', 'title': 'Placebo (PRP)', 'description': 'Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.'}, {'id': 'OG003', 'title': 'PF-00489791 4 mg (SRP)', 'description': 'PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.'}, {'id': 'OG004', 'title': 'PF-00489791 20 mg (SRP)', 'description': 'PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.'}, {'id': 'OG005', 'title': 'Placebo (SRP)', 'description': 'Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening up to 28 days after last study dose (up to 98 days)', 'description': "ECG assessment included measurement of PR, QRS, QT,corrected QT interval (QTc)values. Criteria for clinically significant ECG values were based on investigator's judgement.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set consisted of all participants who took at least 1 dose of study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PRP Cohort: Placebo First, Then PF-00489791 4 mg', 'description': 'Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 4 milligram (mg) (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.'}, {'id': 'FG001', 'title': 'PRP Cohort: PF-00489791 4mg First, Then Placebo', 'description': 'PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.'}, {'id': 'FG002', 'title': 'PRP Cohort: Placebo First, Then PF-00489791 20 mg', 'description': 'Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.'}, {'id': 'FG003', 'title': 'PRP Cohort: PF-00489791 20 mg First, Then Placebo', 'description': 'PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.'}, {'id': 'FG004', 'title': 'SRP Cohort: Placebo First, Then PF-00489791 4 mg', 'description': 'Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 4 milligram (mg) (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.'}, {'id': 'FG005', 'title': 'SRP Cohort: PF-00489791 4 mg First, Then Placebo', 'description': 'PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.'}, {'id': 'FG006', 'title': 'SRP Cohort: Placebo First, Then PF-00489791 20 mg', 'description': 'Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.'}, {'id': 'FG007', 'title': 'SRP Cohort: PF-00489791 20 mg First, Then Placebo', 'description': 'PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.'}], 'periods': [{'title': 'First Intervention Period (4 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '28'}, {'groupId': 'FG004', 'numSubjects': '33'}, {'groupId': 'FG005', 'numSubjects': '32'}, {'groupId': 'FG006', 'numSubjects': '32'}, {'groupId': 'FG007', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '29'}, {'groupId': 'FG005', 'numSubjects': '30'}, {'groupId': 'FG006', 'numSubjects': '31'}, {'groupId': 'FG007', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Did not meet inclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '5'}]}]}, {'title': 'Placebo Washout Period ( 2 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '29'}, {'groupId': 'FG005', 'numSubjects': '30'}, {'groupId': 'FG006', 'numSubjects': '31'}, {'groupId': 'FG007', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '29'}, {'groupId': 'FG005', 'numSubjects': '30'}, {'groupId': 'FG006', 'numSubjects': '31'}, {'groupId': 'FG007', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention Period (4 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '29'}, {'groupId': 'FG005', 'numSubjects': '30'}, {'groupId': 'FG006', 'numSubjects': '31'}, {'groupId': 'FG007', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '27'}, {'groupId': 'FG005', 'numSubjects': '29'}, {'groupId': 'FG006', 'numSubjects': '22'}, {'groupId': 'FG007', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '9'}, {'groupId': 'FG007', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'Non-compliance', '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'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': "A total of 243 participants were stratified into 2 cohorts (Primary Raynaud's phenomenon\\[PRP\\] and secondary RP\\[SRP\\]), who entered a 2-week placebo run-in period (to establish baseline), followed by a cross-over period (first 4 week treatment period,then a 2 week placebo washout,then 4 week treatment period) and then a 2-week placebo run-out period."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}, {'value': '33', 'groupId': 'BG007'}, {'value': '243', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'PRP Cohort: Placebo First, Then PF-00489791 4 mg', 'description': 'Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 4 milligram (mg) (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.'}, {'id': 'BG001', 'title': 'PRP Cohort: PF-00489791 4mg First, Then Placebo', 'description': 'PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first intervention DB period and 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second DB intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.'}, {'id': 'BG002', 'title': 'PRP Cohort: Placebo First, Then PF-00489791 20 mg', 'description': 'Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in second DB intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.'}, {'id': 'BG003', 'title': 'PRP Cohort: PF-00489791 20 mg First, Then Placebo', 'description': 'PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.'}, {'id': 'BG004', 'title': 'SRP Cohort: Placebo First, Then PF-00489791 4 mg', 'description': 'Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 4 milligram (mg) (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.'}, {'id': 'BG005', 'title': 'SRP Cohort: PF-00489791 4 mg First, Then Placebo', 'description': 'PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.'}, {'id': 'BG006', 'title': 'SRP Cohort: Placebo First, Then PF-00489791 20 mg', 'description': 'Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.'}, {'id': 'BG007', 'title': 'SRP Cohort: PF-00489791 20 mg First, Then Placebo', 'description': 'PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'title': 'Between 18 to 44 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '95', 'groupId': 'BG008'}]}, {'title': 'Between 45 to 64 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '26', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}, {'value': '24', 'groupId': 'BG007'}, {'value': '146', 'groupId': 'BG008'}]}, {'title': 'Greater than or equal to (>=) 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}, {'value': '31', 'groupId': 'BG006'}, {'value': '28', 'groupId': 'BG007'}, {'value': '220', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '23', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 243}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'dispFirstSubmitDate': '2012-11-09', 'completionDateStruct': {'date': '2011-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-16', 'studyFirstSubmitDate': '2010-03-18', 'dispFirstSubmitQcDate': '2012-11-09', 'resultsFirstSubmitDate': '2017-08-15', 'studyFirstSubmitQcDate': '2010-03-18', 'dispFirstPostDateStruct': {'date': '2012-11-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-16', 'studyFirstPostDateStruct': {'date': '2010-03-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change From Baseline in Mean Raynaud's Condition Score (RCS) at Week 4", 'timeFrame': 'Baseline, Week 4', 'description': "The Raynaud's Condition score (RCS) is participant's rating of difficulty considering number of attacks, duration, amount of pain, numbness, or other symptoms caused in the fingers (including painful sores) due to the Raynaud's phenomenon every day and impact of Raynaud's alone on use of hands every day. An 11 point Likert scale is used to rate the difficulty caused by the condition each day with 0 = no difficulty and 10 = extreme difficulty. Participants were asked to select the number that best describes their difficulty, with higher score indicating worse condition. Average daily score was considered for participants completing more than 1 Raynaud's pain score scale on a day. Baseline value was calculated as mean of the scores over 7 days prior to treatment start. Week 4 value was calculated as mean of the scores over the 7-day period prior to Week 4."}], 'secondaryOutcomes': [{'measure': "Change From Baseline in the Number of Raynaud's Attacks at Week 1, 2, 3 and 4", 'timeFrame': 'Baseline, Week 1, Week 2, Week 3, Week 4', 'description': "Change from baseline in the number of Raynaud's attacks at Week 1, Week 2, Week 3 and Week 4 was calculated from the number of attacks reported over the 7-day period prior to each week from the patient diary, respectively."}, {'measure': "Change From Baseline in Mean Duration of Raynaud's Attacks at Week 4", 'timeFrame': 'Baseline, Week 4', 'description': "Mean duration of Raynaud's attacks for a time period was calculated as sum of recorded durations of attacks in the time period divided by total number of attacks in the time period where duration was recorded."}, {'measure': "Change From Baseline in the Mean Raynaud's Pain Score at Week 1, 2, 3 and 4", 'timeFrame': 'Baseline, Week 1, 2, 3, 4', 'description': "Participants were asked to rate their worst Raynaud's pain in the past 24 hours using an 11 point Likert scale, with 0 = no Raynaud's pain and 10 = the worst possible pain. Highest (most severe) response was considered for participants responding at more than 1 point on the scale. Average daily score was considered for participants completing more than 1 Raynaud's pain score scale on a day. Baseline value was calculated as mean of the scores over 7 days prior to treatment start. Post-baseline value was calculated as mean of the scores over the 7-day period prior to the visit."}, {'measure': "Number of Participants With Decrease From Baseline in Digital Ulcers at Day 14 and 28: Secondary Raynaud's Phenomenon Cohort", 'timeFrame': 'Baseline, Day 14, 28', 'description': 'Presence of ulcer was assessed at baseline. At post-baseline visits, each ulcer was measured and scored: 1= smaller or improved compared to previous visit, 2= same as previous visit, 3= bigger or worse than previous visit, and 4= new. If a new digital ulcer develops during the course of the study, the measurement and scoring were initiated on this additional ulcer. Healed ulcers were not counted into the number of ulcers. Participants with SRP in the per-protocol population with at least 1 digital ulcer present at any assessment were evaluable for this measure. Results are reported for participants with presence of ulcer at baseline and decrease from baseline in ulcers at post-baseline visits.'}, {'measure': 'Plasma Concentration of PF-00489791 and Its Metabolites', 'timeFrame': 'Day 1, 15, 29 (Day 1, 15, 29 for first intervention period), 43, 57, 71 (Day 1, 15, 29 for second intervention period)', 'description': 'Only participants receiving PF-00489791 were to be analyzed for this outcome. Data have been calculated by setting plasma concentration values below the lower limit of quantification to 0. The lower limit of quantification is 0.0100 microgram per milliliter (mcg/mL). Data for plasma concentration of PF-00489791 metabolites was not analyzed, as it was not intended to be a secondary endpoint and was deemed optional.'}, {'measure': 'Number of Participants With Laboratory Test Abnormalities', 'timeFrame': 'Screening up to 28 days after last study dose (up to 98 days)', 'description': 'Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (less than \\[\\<\\] 0.8\\*lower limit of normal\\[LLN\\]); leukocytes (\\<0.6 LLN /greater than \\[\\>\\] 1.5\\*upper LN \\[ULN\\]; platelets (\\<0.5\\*LLN/\\>1.75\\*ULN); neutrophils, lymphocytes (\\<0.8\\* LLN/\\>1.2\\*ULN); eosinophils, basophils, monocytes (\\>1.2\\*ULN); bilirubin (\\>1.5\\*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), Gamma GT, alkaline phosphatase (\\>3\\*ULN); BUN, creatinine (\\>1.3\\*ULN); glucose (\\<0.6 LLN/\\>1.5\\*ULN); uric acid (\\>1.2\\*ULN); sodium (\\<0.95\\*LLN/\\>1.05\\*ULN); potassium, calcium, chloride, bicarbonate (\\<0.9\\*LLN/\\>1.1\\*ULN); albumin, total protein (\\<0.8\\*LLN/\\>1.2\\*ULN); creatine kinase (\\>2.0\\*ULN); Urine Specific Gravity, Urine pH, urine blood, urine glucose, urine protein, urine ketones, urine leukocytes esterase (\\>=1 high-powered field). Total number of participants with any laboratory abnormalities was reported.'}, {'measure': 'Number of Participants With Clinically Significant Changes in Vital Signs and Orthostatic Blood Pressure Measurements', 'timeFrame': 'Screening up to 28 days after last study dose (up to 98 days)', 'description': "Vital signs assessment included measurement of supine and standing pulse rate, systolic and diastolic blood pressures. Criteria for clinically significant vital signs and orthostatic blood pressure measurements were based on investigator's judgement."}, {'measure': 'Number of Participants With Abnormal Electrocardiogram (ECG) Values', 'timeFrame': 'Screening up to 28 days after last study dose (up to 98 days)', 'description': "ECG assessment included measurement of PR, QRS, QT,corrected QT interval (QTc)values. Criteria for clinically significant ECG values were based on investigator's judgement."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Raynaud's phenomenon", 'vasospasm', 'scleroderma', 'systemic sclerosis', 'CREST', 'phosphodiesterase inhibitor'], 'conditions': ["Raynaud's Disease", 'Peripheral Vascular Disease']}, 'referencesModule': {'references': [{'pmid': '33998674', 'type': 'DERIVED', 'citation': "Su KY, Sharma M, Kim HJ, Kaganov E, Hughes I, Abdeen MH, Ng JHK. Vasodilators for primary Raynaud's phenomenon. Cochrane Database Syst Rev. 2021 May 17;5(5):CD006687. doi: 10.1002/14651858.CD006687.pub4."}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7331010&StudyName=PF-00489791%20For%20The%20Treatment%20Of%20Raynaud%27s', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': "The investigators propose that once daily administration of PF-00489791, a phosphodiesterase inhibitor, will reduce vasospasm and improve symptoms and signs associated with Primary and Secondary Raynaud's Phenomenon."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Active Raynaud's Phenomenon\n* Stable disease and medication requirements over the previous two months\n* For Secondary Raynaud's Phenomenon subjects, a diagnosis of scleroderma using the American College of Rheumatology criteria or by the presence of at least 3/5 features of CREST syndrome\n* both sexes\n\nExclusion Criteria:\n\n* Uncontrolled hypertension, diabetes mellitus, angina, or using oral nitrates\n* Smoking within 3 months or smoking cessation using nicotine products\n* Subjects currently taking sildenafil, tadalafil or vardenafil\n* Subjects with ulnar arterial occlusive disease as shown by a modified Allen test\n* Pregnant or breast feeding or considering pregnancy in next 4 months\n* Participation in trial for investigational drug within 30 days"}, 'identificationModule': {'nctId': 'NCT01090492', 'briefTitle': "PF-00489791 For The Treatment Of Raynaud's", 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': "A Phase 2a Randomized Double-blinded, Placebo And Active Controlled Two Cohort Two Doses Cross-over Multi-center Clinical Study To Assess Efficacy Of A Once Daily Administration Of A Phosphodiesterase 5 Inhibitor (Pf-00489791) For The Treatment Of Vasospasm In Primary And Secondary Raynaud's Phenomenon", 'orgStudyIdInfo': {'id': 'A7331010'}, 'secondaryIdInfos': [{'id': 'EudraCT 2010-019009-40'}, {'id': '2010-019009-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Secondary Raynaud 4 mg dose (period 1)', 'interventionNames': ['Drug: PF-00489791']}, {'type': 'EXPERIMENTAL', 'label': 'Secondary Raynaud 4 mg dose (period 2)', 'interventionNames': ['Drug: PF-00489791']}, {'type': 'EXPERIMENTAL', 'label': 'Secondary Raynaud 20 mg dose (period 1)', 'interventionNames': ['Drug: PF-00489791']}, {'type': 'EXPERIMENTAL', 'label': 'Secondary Raynaud 20 mg dose (period 2)', 'interventionNames': ['Drug: PF-00489791']}, {'type': 'EXPERIMENTAL', 'label': 'Primary Raynaud 4 mg dose (period 1)', 'interventionNames': ['Drug: PF-00489791']}, {'type': 'EXPERIMENTAL', 'label': 'Primary Raynaud 4 mg dose (period 2)', 'interventionNames': ['Drug: PF-00489791']}, {'type': 'EXPERIMENTAL', 'label': 'Primary Raynaud 20 mg dose (period 1)', 'interventionNames': ['Drug: PF-00489791']}, {'type': 'EXPERIMENTAL', 'label': 'Primary Raynaud 20 mg dose (period 2)', 'interventionNames': ['Drug: PF-00489791']}], 'interventions': [{'name': 'PF-00489791', 'type': 'DRUG', 'description': "Subjects with Secondary Raynaud's Phenomenon will receive PF-00489791 4 mg once a day for the first 4 week cross over period and then placebo once a day for the second 4 week cross over period", 'armGroupLabels': ['Secondary Raynaud 4 mg dose (period 1)']}, {'name': 'PF-00489791', 'type': 'DRUG', 'description': "Subjects with Secondary Raynaud's Phenomenon will receive placebo once a day for the first 4 week cross over period and then PF-00489791 4 mg once a day for the second 4 week cross over period", 'armGroupLabels': ['Secondary Raynaud 4 mg dose (period 2)']}, {'name': 'PF-00489791', 'type': 'DRUG', 'description': "Subjects with Secondary Raynaud's Phenomenon will receive PF-00489791 20 mg once a day for the first 4 week cross over period and then placebo once a day for the second 4 week cross over period", 'armGroupLabels': ['Secondary Raynaud 20 mg dose (period 1)']}, {'name': 'PF-00489791', 'type': 'DRUG', 'description': "Subjects with Secondary Raynaud's Phenomenon will receive placebo once a day for the first 4 week cross over period and then PF-00489791 20 mg once a day for the second 4 week cross over period", 'armGroupLabels': ['Secondary Raynaud 20 mg dose (period 2)']}, {'name': 'PF-00489791', 'type': 'DRUG', 'description': "Subjects with Primary Raynaud's Phenomenon will receive PF-00489791 4 mg once a day for the first 4 week cross over period and then placebo once a day for the second 4 week cross over period", 'armGroupLabels': ['Primary Raynaud 4 mg dose (period 1)']}, {'name': 'PF-00489791', 'type': 'DRUG', 'description': "Subjects with Primary Raynaud's Phenomenon will receive placebo once a day for the first 4 week cross over period 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