Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-02-22 @ 7:05 AM
Study NCT ID:
NCT03281304
Status:
TERMINATED
Last Update Posted:
2023-03-21
First Post:
2017-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C479163', 'term': 'tofacitinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From baseline up to 4 weeks after last dose (maximum up to 43 months)', 'description': 'Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.', 'eventGroups': [{'id': 'EG000', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 47, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed-up to 4 weeks after the last dose.', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 47, 'seriousNumAtRisk': 70, 'deathsNumAffected': 1, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Faecal calprotectin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'SARS-CoV-2 test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Colon adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Respiratory disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Squamous cell carcinoma of the vulva', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Breast disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Endometrial hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Colon dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Herpes zoster oticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Diffuse large B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Remission Based on Modified Mayo Score at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}, {'id': 'OG001', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.9', 'ciLowerLimit': '0.5', 'ciUpperLimit': '25.0', 'groupDescription': 'Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 6', 'description': 'Remission as per modified mayo score was defined as an endoscopic subscore of 0 or 1, stool frequency subscore of 0 or 1, and rectal bleeding subscore of 0 at Month 6. Modified mayo score consisted of 3 components: stool frequency subscore, rectal bleeding subscore and endoscopic subscore: higher scores for each score = more severe disease. These scores were summed up to give a total modified mayo score range of 0 to 9; where higher scores indicating more severe disease.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.'}, {'type': 'SECONDARY', 'title': 'Time to Loss of Remission Based on Modified Mayo Score Using Kaplan-Meier Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}, {'id': 'OG001', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median was not estimated due to insufficient number of participants with the event.', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '1268'}, {'value': '1270', 'groupId': 'OG001', 'lowerLimit': '28', 'upperLimit': '1270'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Month 42', 'description': 'Time to loss of remission(flare): time from first drug administration until time of meeting loss of remission criteria based on modified mayo score. Loss of remission: meeting at least (\\>=)1 criteria: increase from Baseline in rectal bleeding subscore by \\>=1 point and increase in endoscopic subscore by \\>=1 point; increase from Baseline in rectal bleeding subscore by \\>=2 points and endoscopic subscore \\>0; increase in stool frequency subscore by \\>=2 points and increase in endoscopic subscore by \\>=1 point; increase in endoscopic subscore by \\>=2 points. Modified mayo score included 3 components: stool frequency, rectal bleeding and endoscopic subscores: Modified mayo score included 3 components: stool frequency, rectal bleeding and endoscopic subscores, each subscore graded from 0 to 3 with higher scores for each score=more severe disease. All scores summed up to give total modified mayo score range from 0 to 9; higher scores=more severe disease.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}, {'id': 'OG001', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}], 'classes': [{'title': 'Month 1', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': 'Month 9', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Month 15', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}, {'title': 'Month 18', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Month 21', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Month 24', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Month 27', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Month 30', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Month 33', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Month 36', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Month 39', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Month 42', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.9', 'ciLowerLimit': '-7.5', 'ciUpperLimit': '13.4', 'groupDescription': 'Month 1: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.4', 'ciLowerLimit': '0.1', 'ciUpperLimit': '22.8', 'groupDescription': 'Month 3: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.3', 'ciLowerLimit': '2.9', 'ciUpperLimit': '25.2', 'groupDescription': 'Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.0', 'ciLowerLimit': '8.0', 'ciUpperLimit': '31.8', 'groupDescription': 'Month 9: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.7', 'ciLowerLimit': '2.2', 'ciUpperLimit': '28.7', 'groupDescription': 'Month 12: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.3', 'ciLowerLimit': '0.0', 'ciUpperLimit': '27.9', 'groupDescription': 'Month 15: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.3', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '28.5', 'groupDescription': 'Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.1', 'ciLowerLimit': '-8.0', 'ciUpperLimit': '21.9', 'groupDescription': 'Month 21: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.7', 'ciLowerLimit': '-9.3', 'ciUpperLimit': '20.4', 'groupDescription': 'Month 24: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.6', 'ciLowerLimit': '-7.0', 'ciUpperLimit': '23.6', 'groupDescription': 'Month 27: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.9', 'ciLowerLimit': '-12.8', 'ciUpperLimit': '18.3', 'groupDescription': 'Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-14.4', 'ciUpperLimit': '17.2', 'groupDescription': 'Month 33: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.9', 'ciLowerLimit': '-13.0', 'ciUpperLimit': '18.5', 'groupDescription': 'Month 36: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.3', 'ciLowerLimit': '-20.2', 'ciUpperLimit': '11.9', 'groupDescription': 'Month 39: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.3', 'ciLowerLimit': '-11.7', 'ciUpperLimit': '19.9', 'groupDescription': 'Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42', 'description': 'Remission as per modified partial mayo score was defined as stool frequency subscore of 0 or 1, and rectal bleeding sub score of 0 at the specified time points. Modified partial mayo scores consisted of 2 components: stool frequency and rectal bleeding: each subscore graded from 0 to 3 with higher scores for each score = more severe disease. These scores were summed up to give a total modified partial mayo score range of 0 to 6; where higher scores indicating more severe disease.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Remission Based on Total Mayo Score at Months 6, 18, 30 and 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}, {'id': 'OG001', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}], 'classes': [{'title': 'Month 6', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Month 18', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Month 30', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Month 42', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.4', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '24.1', 'groupDescription': 'Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.0', 'ciLowerLimit': '3.6', 'ciUpperLimit': '35.0', 'groupDescription': 'Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.9', 'ciLowerLimit': '-3.5', 'ciUpperLimit': '28.3', 'groupDescription': 'Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.9', 'ciLowerLimit': '-12.5', 'ciUpperLimit': '18.0', 'groupDescription': 'Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Months 6, 18, 30 and 42', 'description': "Remission as per total mayo score was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and physician global assessment (PGA), each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}, {'id': 'OG001', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}], 'classes': [{'title': 'Month 1', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}, {'title': 'Month 9', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Month 15', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}, {'title': 'Month 18', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Month 21', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Month 24', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Month 27', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Month 30', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Month 33', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Month 36', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Month 39', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Month 42', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.9', 'ciLowerLimit': '-7.5', 'ciUpperLimit': '13.4', 'groupDescription': 'Month 1: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.4', 'ciLowerLimit': '0.1', 'ciUpperLimit': '22.8', 'groupDescription': 'Month 3: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.3', 'ciLowerLimit': '2.4', 'ciUpperLimit': '25.6', 'groupDescription': 'Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.0', 'ciLowerLimit': '8.0', 'ciUpperLimit': '31.8', 'groupDescription': 'Month 9: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.7', 'ciLowerLimit': '2.2', 'ciUpperLimit': '28.7', 'groupDescription': 'Month 12: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.3', 'ciLowerLimit': '0.0', 'ciUpperLimit': '27.9', 'groupDescription': 'Month 15: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.7', 'ciLowerLimit': '0.7', 'ciUpperLimit': '29.9', 'groupDescription': 'Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.7', 'ciLowerLimit': '-9.5', 'ciUpperLimit': '20.6', 'groupDescription': 'Month 21: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.1', 'ciLowerLimit': '-8.0', 'ciUpperLimit': '21.9', 'groupDescription': 'Month 24: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.0', 'ciLowerLimit': '-5.7', 'ciUpperLimit': '25.1', 'groupDescription': 'Month 27: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.3', 'ciLowerLimit': '-11.4', 'ciUpperLimit': '19.7', 'groupDescription': 'Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-14.4', 'ciUpperLimit': '17.2', 'groupDescription': 'Month 33: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.9', 'ciLowerLimit': '-13.0', 'ciUpperLimit': '18.5', 'groupDescription': 'Month 36: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.9', 'ciLowerLimit': '-18.8', 'ciUpperLimit': '13.3', 'groupDescription': 'Month 39: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.9', 'ciLowerLimit': '-13.0', 'ciUpperLimit': '18.5', 'groupDescription': 'Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42', 'description': "Remission as per partial mayo score was defined as partial mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score range from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Remission Based on Modified Mayo Score at Months 18, 30 and 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}, {'id': 'OG001', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}], 'classes': [{'title': 'Month 18', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Month 30', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Month 42', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.7', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '30.8', 'groupDescription': 'Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.9', 'ciLowerLimit': '-3.5', 'ciUpperLimit': '28.3', 'groupDescription': 'Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-14.0', 'ciUpperLimit': '16.7', 'groupDescription': 'Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Months 18, 30 and 42', 'description': 'Remission as per modified mayo score was defined as an endoscopic subscore of 0 or 1, stool frequency subscore of 0 or 1, and rectal bleeding subscore of 0. Modified mayo score consisted of 3 components: stool frequency subscore, rectal bleeding subscore and endoscopic subscore: higher scores for each score = more severe disease. These scores were summed up to give a total modified mayo score range of 0 to 9; where higher scores indicating more severe disease.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Modified Mayo Score at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}, {'id': 'OG001', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.1', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Modified mayo score is an instrument designed to measure disease activity of UC. Modified mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 to 3 with higher scores indicating more severe disease. These individual scores were summed up to give a total modified mayo score range of 0 to 9, where higher scores indicated more severe disease.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Modified Mayo Score at Months 18, 30 and 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}, {'id': 'OG001', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}], 'classes': [{'title': 'Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 18, 30 and 42', 'description': 'Modified mayo score is an instrument designed to measure disease activity of UC. Modified mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 to 3 with higher scores indicating more severe disease. These individual scores were summed up to give a total modified mayo score range of 0 to 9, where higher scores indicated more severe disease.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and \'Number Analyzed\' = participants evaluable for this outcome measure at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Modified Partial Mayo Score at Months 1, 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}, {'id': 'OG001', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}], 'classes': [{'title': 'Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.3', 'groupDescription': 'Month 1', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.2', 'groupDescription': 'Month 3', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.3', 'groupDescription': 'Month 6', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Months 1, 3 and 6', 'description': 'Modified partial mayo scores consisted of 2 subscores: stool frequency and rectal bleeding with each subscore graded from 0 to 3 with higher scores indicating more severe disease. Individual subscores were summed up to give a total Modified partial mayo score ranges from 0 (normal or inactive disease) to 6 (severe disease) with higher scores indicating more severe disease.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and \'Number Analyzed\' = participants evaluable for this outcome measure at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}, {'id': 'OG001', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}], 'classes': [{'title': 'Change at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 33', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42', 'description': 'Modified partial mayo scores consisted of 2 subscores: stool frequency and rectal bleeding with each subscore graded from 0 to 3 with higher scores indicating more severe disease. Individual subscores were summed up to give a total modified partial mayo score range from 0 (normal or inactive disease) to 6 (severe disease) with higher scores indicating more severe disease.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and \'Number Analyzed\' = participants evaluable for this outcome measure at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Mayo Score at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}, {'id': 'OG001', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '0.1', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 6', 'description': "Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Mayo Score at Months 18, 30 and 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}, {'id': 'OG001', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}], 'classes': [{'title': 'Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 18, 30 and 42', 'description': "Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed"= participants evaluable for this outcome measure at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Partial Mayo Score at Months 1, 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}, {'id': 'OG001', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}], 'classes': [{'title': 'Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.3', 'groupDescription': 'Month 1', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.2', 'groupDescription': 'Month 3', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.3', 'groupDescription': 'Month 6', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Months 1, 3 and 6', 'description': "Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score range from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}, {'id': 'OG001', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}], 'classes': [{'title': 'Change at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 33', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42', 'description': "Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score ranges from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and \'Number Analyzed\' = participants evaluable for this outcome measure at specified time points.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Mucosal Healing at Months 6, 18, 30 and 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}, {'id': 'OG001', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}], 'classes': [{'title': 'Month 6', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'Month 18', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}, {'title': 'Month 30', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Month 42', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.4', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '23.1', 'groupDescription': 'Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.6', 'ciLowerLimit': '3.5', 'ciUpperLimit': '32.6', 'groupDescription': 'Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.9', 'ciLowerLimit': '-3.3', 'ciUpperLimit': '28.1', 'groupDescription': 'Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-16.1', 'ciUpperLimit': '16.1', 'groupDescription': 'Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Months 6, 18, 30 and 42', 'description': 'Mucosal healing in participants was defined as the mayo endoscopic subscore of 0 or 1. The Mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicated more severe disease.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Response Based on Mayo Score at Months 6, 18, 30 and 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}, {'id': 'OG001', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}], 'classes': [{'title': 'Month 6', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': 'Month 18', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Month 30', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Month 42', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.4', 'ciLowerLimit': '1.3', 'ciUpperLimit': '22.0', 'groupDescription': 'Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.4', 'ciLowerLimit': '-4.2', 'ciUpperLimit': '26.4', 'groupDescription': 'Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.0', 'ciLowerLimit': '-5.8', 'ciUpperLimit': '25.2', 'groupDescription': 'Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted (weighted) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.9', 'ciLowerLimit': '-13.0', 'ciUpperLimit': '18.5', 'groupDescription': 'Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Months 6, 18, 30 and 42', 'description': "Clinical response was defined as a decrease from baseline in mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a mayo score range of 0 to 12, where higher scores indicating more severe disease.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}, {'id': 'OG001', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}], 'classes': [{'title': 'Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-137.5', 'spread': '980.6', 'groupId': 'OG000'}, {'value': '-21.9', 'spread': '304.7', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-45.3', 'spread': '1075.8', 'groupId': 'OG000'}, {'value': '-38.5', 'spread': '313.6', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-24.1', 'spread': '1444.6', 'groupId': 'OG000'}, {'value': '-47.3', 'spread': '331.4', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-173.5', 'spread': '1106.5', 'groupId': 'OG000'}, {'value': '-59.3', 'spread': '380.8', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-28.8', 'spread': '1113.4', 'groupId': 'OG000'}, {'value': '-45.0', 'spread': '350.7', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-104.8', 'spread': '1210.2', 'groupId': 'OG000'}, {'value': '69.3', 'spread': '480.5', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-51.0', 'spread': '1114.6', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '565.4', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-71.0', 'spread': '1254.6', 'groupId': 'OG000'}, {'value': '-29.3', 'spread': '462.7', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '118.3', 'spread': '1591.4', 'groupId': 'OG000'}, {'value': '-69.8', 'spread': '407.0', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.3', 'spread': '478.8', 'groupId': 'OG000'}, {'value': '-49.1', 'spread': '366.3', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.5', 'spread': '458.5', 'groupId': 'OG000'}, {'value': '-8.9', 'spread': '518.5', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 33', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84.4', 'spread': '434.5', 'groupId': 'OG000'}, {'value': '-4.9', 'spread': '484.8', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '230.7', 'spread': '1162.5', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '449.4', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-116.2', 'spread': '472.8', 'groupId': 'OG000'}, {'value': '-98.3', 'spread': '532.9', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-44.7', 'spread': '278.9', 'groupId': 'OG000'}, {'value': '-101.0', 'spread': '452.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42', 'description': 'Change from baseline in fecal calprotectin (in micrograms per gram \\[mcg/g\\]) was reported.', 'unitOfMeasure': 'Micrograms per gram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and \'Number Analyzed\' = participants evaluable for this outcome measure at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}, {'id': 'OG001', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}], 'classes': [{'title': 'Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '3.7', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '4.0', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '8.4', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '6.1', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 33', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '3.9', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '3.9', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '8.6', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '28.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42', 'description': 'Change From baseline in hs-CRP level (in milligrams per liter \\[mg/L\\]) is reported.', 'unitOfMeasure': 'Milligrams per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and \'Number Analyzed\' = participants evaluable for this outcome measure at specified time points.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}, {'id': 'OG001', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 43 months', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment or worsened during the treatment period relative to the pretreatment state. AEs included both serious and all non-serious adverse events (irrespective of frequency threshold used to report other AEs in safety section).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of investigational product.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}, {'id': 'OG001', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 43 months', 'description': 'Serious infections were defined as any infections (viral, bacterial, and fungal) requiring parenteral antimicrobial therapy, hospitalization for treatment, or meeting other criteria that require the infection to be classified as serious adverse event. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of investigational product.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}, {'id': 'OG001', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 27 months', 'description': 'Abnormality criteria: Hematology: hemoglobin(Hg): \\<0.8\\* lower limit of normal (LLN); hematocrit: \\<0.8\\*LLN; lymphocytes: \\<0.8\\* LLN; lymphocytes/leukocytes: \\<0.8\\*LLN; erythrocytes: \\<0.8\\*LLN; erythrocytes mean corpuscular volume: \\<0.9\\*LLN; erythrocytes mean corpuscular Hg: \\<0.9\\*LLN; reticulocytes, reticulocytes/erythrocytes:\\>1.5\\* upper limit of normal (ULN); neutrophils, neutrophils/leukocytes: \\>1.2\\*ULN; basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes/leukocytes: \\>1.2\\*ULN; leukocyte esterase: \\>=1; Clinical chemistry: bicarbonate:\\<0.9\\*LLN, bilirubin: \\>1.5\\*ULN; indirect bilirubin: \\>1.5\\* ULN; aspartate aminotransferase(AT): \\>3.0\\*ULN; alanine AT: \\>3.0\\*ULN; gamma glutamyl transferase: \\>3.0\\* ULN; creatine kinase: \\>2.0\\*ULN; potassium: \\>1.1\\*ULN; blood urea nitrogen: \\>1.3\\*ULN; creatinine: \\>1.3\\*ULN; urate: \\>1.2\\*ULN; cholesterol: \\>1.3\\*ULN; HDL-cholesterol: \\<0.8\\* LLN; LDL-cholesterol: \\>1.2\\*ULN; triglycerides: \\>1.3\\*ULN; glucose: \\>1.5\\*ULN; and urine Hg \\>=1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of investigational product.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Laboratory Abnormalities Leading to Study Treatment Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}, {'id': 'OG001', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 43 months', 'description': 'Laboratory abnormalities leading to study treatment discontinuation: 2 sequential neutrophil counts \\<750 neutrophils per cubic millimeter (mm\\^3); 2 sequential lymphocyte counts \\<500 lymphocytes/mm\\^3; 2 sequential hemoglobin \\<8.0 grams per deciliter; 2 sequential platelet counts \\<75000 platelets/mm\\^3; 2 sequential AST or ALT elevations \\>=3\\*ULN with at least one total bilirubin value \\>=2\\*ULN; 2 sequential AST or ALT elevations \\>=3\\*ULN accompanied by signs or symptoms consistent with hepatic injury; 2 sequential AST or ALT elevations \\>=5\\*ULN; 2 sequential increases in creatinine \\>50% and \\>0.5 milligrams per deciliter over A3921139 baseline; 2 sequential CK elevations \\>10\\*ULN unless the causality is known not to be medically serious (eg, exercise induced).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of investigational product.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Vital Sign Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}, {'id': 'OG001', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}], 'classes': [{'title': 'DBP: <50 mmHg', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'DBP: Change >= 20mmHg increase', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'DBP: Change >= 20mmHg decrease', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'SBP: <90mmHg', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'SBP: Change >= 30mmHg increase', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'SBP: Change >= 30mmHg decrease', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 43 months', 'description': 'Vital signs abnormality criteria included: 1) a) diastolic blood pressure (DBP) of (less than) \\<50 millimeter of mercury (mmHg), b) change greater than equal to (\\>=) 20 mmHg increase, c) change \\>=20 mmHg decrease; 2) a) systolic blood pressure (SBP) of \\<90 mmHg, b) change \\>=30 mmHg increase, c) change \\>=30 mmHg decrease; 3) a) pulse rate value of \\<40 beats per minute (bpm), b) pulse rate \\>120 bpm. Only those categories in which at least 1 participant had data were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of investigational product.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Physical Examinations Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}, {'id': 'OG001', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 43 months', 'description': 'Physical examination included assessment of the weight, general appearance, eyes, mouth, lungs, heart, abdomen, musculoskeletal, extremities, skin and lymph nodes. Clinical significance was assessed by the Investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of investigational product.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Opportunistic Infections, All Malignancy, Gastrointestinal Perforation and Cardiovascular Events Adjudicated by Adjudication Committee', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}, {'id': 'OG001', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}], 'classes': [{'title': 'Opportunistic Infections', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'All Malignancy', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Gastrointestinal Perforation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cardiovascular Events', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 43 months', 'description': 'Number of participants with adjudicated opportunistic infections including herpes zoster (non-adjacent or \\>2 adjacent dermatomes); all malignancies including non-melanoma skin cancer; gastrointestinal perforation and cardiovascular events including pulmonary embolism and cerebrovascular accident, adjudicated by adjudication committee were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of investigational product.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}, {'id': 'FG001', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}], 'periods': [{'title': 'Treatment Phase (up to 42 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '43'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Follow-up Phase (up to 4 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants could be followed up even if they did not complete treatment.', 'groupId': 'FG000', 'numSubjects': '63'}, {'comment': 'Participants could be followed up even if they did not complete treatment.', 'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study enrolled participants from A3921139 (NCT01470612) who were on tofacitinib 10 milligram (mg) twice daily (BID) for at least 2 consecutive years, who were in stable remission for at least 6 months prior to baseline of A3921288 and who were not receiving any corticosteroid treatment to treat their ulcerative colitis (UC) for at least 4 weeks prior to enrollment.', 'preAssignmentDetails': 'The Baseline visit of this study was the last visit in study A3921139. All procedures done at the last visit in A3921139 for participants enrolled into this study were used as the Baseline data for this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tofacitinib 5 mg BID', 'description': 'Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}, {'id': 'BG001', 'title': 'Tofacitinib 10 mg BID', 'description': 'Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-11', 'size': 2625552, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-02-05T15:41', 'hasProtocol': True}, {'date': '2020-03-11', 'size': 2207625, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-02-05T15:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'whyStopped': 'The study terminated early due to business reasons, with the study already meeting its primary objective. The decision to terminate the trial was not based on any safety and/or efficacy concerns.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-21', 'studyFirstSubmitDate': '2017-09-11', 'resultsFirstSubmitDate': '2021-02-05', 'studyFirstSubmitQcDate': '2017-09-11', 'lastUpdatePostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-18', 'studyFirstPostDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Remission Based on Modified Mayo Score at Month 6', 'timeFrame': 'Month 6', 'description': 'Remission as per modified mayo score was defined as an endoscopic subscore of 0 or 1, stool frequency subscore of 0 or 1, and rectal bleeding subscore of 0 at Month 6. Modified mayo score consisted of 3 components: stool frequency subscore, rectal bleeding subscore and endoscopic subscore: higher scores for each score = more severe disease. These scores were summed up to give a total modified mayo score range of 0 to 9; where higher scores indicating more severe disease.'}], 'secondaryOutcomes': [{'measure': 'Time to Loss of Remission Based on Modified Mayo Score Using Kaplan-Meier Method', 'timeFrame': 'Up to Month 42', 'description': 'Time to loss of remission(flare): time from first drug administration until time of meeting loss of remission criteria based on modified mayo score. Loss of remission: meeting at least (\\>=)1 criteria: increase from Baseline in rectal bleeding subscore by \\>=1 point and increase in endoscopic subscore by \\>=1 point; increase from Baseline in rectal bleeding subscore by \\>=2 points and endoscopic subscore \\>0; increase in stool frequency subscore by \\>=2 points and increase in endoscopic subscore by \\>=1 point; increase in endoscopic subscore by \\>=2 points. Modified mayo score included 3 components: stool frequency, rectal bleeding and endoscopic subscores: Modified mayo score included 3 components: stool frequency, rectal bleeding and endoscopic subscores, each subscore graded from 0 to 3 with higher scores for each score=more severe disease. All scores summed up to give total modified mayo score range from 0 to 9; higher scores=more severe disease.'}, {'measure': 'Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42', 'timeFrame': 'Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42', 'description': 'Remission as per modified partial mayo score was defined as stool frequency subscore of 0 or 1, and rectal bleeding sub score of 0 at the specified time points. Modified partial mayo scores consisted of 2 components: stool frequency and rectal bleeding: each subscore graded from 0 to 3 with higher scores for each score = more severe disease. These scores were summed up to give a total modified partial mayo score range of 0 to 6; where higher scores indicating more severe disease.'}, {'measure': 'Number of Participants With Remission Based on Total Mayo Score at Months 6, 18, 30 and 42', 'timeFrame': 'Months 6, 18, 30 and 42', 'description': "Remission as per total mayo score was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and physician global assessment (PGA), each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease."}, {'measure': 'Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42', 'timeFrame': 'Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42', 'description': "Remission as per partial mayo score was defined as partial mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score range from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease."}, {'measure': 'Number of Participants With Remission Based on Modified Mayo Score at Months 18, 30 and 42', 'timeFrame': 'Months 18, 30 and 42', 'description': 'Remission as per modified mayo score was defined as an endoscopic subscore of 0 or 1, stool frequency subscore of 0 or 1, and rectal bleeding subscore of 0. Modified mayo score consisted of 3 components: stool frequency subscore, rectal bleeding subscore and endoscopic subscore: higher scores for each score = more severe disease. These scores were summed up to give a total modified mayo score range of 0 to 9; where higher scores indicating more severe disease.'}, {'measure': 'Change From Baseline in Modified Mayo Score at Month 6', 'timeFrame': 'Baseline, Month 6', 'description': 'Modified mayo score is an instrument designed to measure disease activity of UC. Modified mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 to 3 with higher scores indicating more severe disease. These individual scores were summed up to give a total modified mayo score range of 0 to 9, where higher scores indicated more severe disease.'}, {'measure': 'Change From Baseline in Modified Mayo Score at Months 18, 30 and 42', 'timeFrame': 'Baseline, Months 18, 30 and 42', 'description': 'Modified mayo score is an instrument designed to measure disease activity of UC. Modified mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 to 3 with higher scores indicating more severe disease. These individual scores were summed up to give a total modified mayo score range of 0 to 9, where higher scores indicated more severe disease.'}, {'measure': 'Change From Baseline in Modified Partial Mayo Score at Months 1, 3 and 6', 'timeFrame': 'Baseline, Months 1, 3 and 6', 'description': 'Modified partial mayo scores consisted of 2 subscores: stool frequency and rectal bleeding with each subscore graded from 0 to 3 with higher scores indicating more severe disease. Individual subscores were summed up to give a total Modified partial mayo score ranges from 0 (normal or inactive disease) to 6 (severe disease) with higher scores indicating more severe disease.'}, {'measure': 'Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42', 'timeFrame': 'Baseline, Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42', 'description': 'Modified partial mayo scores consisted of 2 subscores: stool frequency and rectal bleeding with each subscore graded from 0 to 3 with higher scores indicating more severe disease. Individual subscores were summed up to give a total modified partial mayo score range from 0 (normal or inactive disease) to 6 (severe disease) with higher scores indicating more severe disease.'}, {'measure': 'Change From Baseline in Total Mayo Score at Month 6', 'timeFrame': 'Baseline, Month 6', 'description': "Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease."}, {'measure': 'Change From Baseline in Total Mayo Score at Months 18, 30 and 42', 'timeFrame': 'Baseline, Months 18, 30 and 42', 'description': "Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease."}, {'measure': 'Change From Baseline in Partial Mayo Score at Months 1, 3 and 6', 'timeFrame': 'Baseline, Months 1, 3 and 6', 'description': "Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score range from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease."}, {'measure': 'Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42', 'timeFrame': 'Baseline, Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42', 'description': "Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score ranges from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease."}, {'measure': 'Number of Participants With Mucosal Healing at Months 6, 18, 30 and 42', 'timeFrame': 'Months 6, 18, 30 and 42', 'description': 'Mucosal healing in participants was defined as the mayo endoscopic subscore of 0 or 1. The Mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicated more severe disease.'}, {'measure': 'Number of Participants With Clinical Response Based on Mayo Score at Months 6, 18, 30 and 42', 'timeFrame': 'Months 6, 18, 30 and 42', 'description': "Clinical response was defined as a decrease from baseline in mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a mayo score range of 0 to 12, where higher scores indicating more severe disease."}, {'measure': 'Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42', 'timeFrame': 'Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42', 'description': 'Change from baseline in fecal calprotectin (in micrograms per gram \\[mcg/g\\]) was reported.'}, {'measure': 'Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42', 'timeFrame': 'Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42', 'description': 'Change From baseline in hs-CRP level (in milligrams per liter \\[mg/L\\]) is reported.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline up to 43 months', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment or worsened during the treatment period relative to the pretreatment state. AEs included both serious and all non-serious adverse events (irrespective of frequency threshold used to report other AEs in safety section).'}, {'measure': 'Number of Participants With Serious Infections', 'timeFrame': 'Baseline up to 43 months', 'description': 'Serious infections were defined as any infections (viral, bacterial, and fungal) requiring parenteral antimicrobial therapy, hospitalization for treatment, or meeting other criteria that require the infection to be classified as serious adverse event. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events.'}, {'measure': 'Number of Participants With Clinical Laboratory Abnormalities', 'timeFrame': 'Baseline up to 27 months', 'description': 'Abnormality criteria: Hematology: hemoglobin(Hg): \\<0.8\\* lower limit of normal (LLN); hematocrit: \\<0.8\\*LLN; lymphocytes: \\<0.8\\* LLN; lymphocytes/leukocytes: \\<0.8\\*LLN; erythrocytes: \\<0.8\\*LLN; erythrocytes mean corpuscular volume: \\<0.9\\*LLN; erythrocytes mean corpuscular Hg: \\<0.9\\*LLN; reticulocytes, reticulocytes/erythrocytes:\\>1.5\\* upper limit of normal (ULN); neutrophils, neutrophils/leukocytes: \\>1.2\\*ULN; basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes/leukocytes: \\>1.2\\*ULN; leukocyte esterase: \\>=1; Clinical chemistry: bicarbonate:\\<0.9\\*LLN, bilirubin: \\>1.5\\*ULN; indirect bilirubin: \\>1.5\\* ULN; aspartate aminotransferase(AT): \\>3.0\\*ULN; alanine AT: \\>3.0\\*ULN; gamma glutamyl transferase: \\>3.0\\* ULN; creatine kinase: \\>2.0\\*ULN; potassium: \\>1.1\\*ULN; blood urea nitrogen: \\>1.3\\*ULN; creatinine: \\>1.3\\*ULN; urate: \\>1.2\\*ULN; cholesterol: \\>1.3\\*ULN; HDL-cholesterol: \\<0.8\\* LLN; LDL-cholesterol: \\>1.2\\*ULN; triglycerides: \\>1.3\\*ULN; glucose: \\>1.5\\*ULN; and urine Hg \\>=1.'}, {'measure': 'Number of Participants With Clinically Significant Laboratory Abnormalities Leading to Study Treatment Discontinuation', 'timeFrame': 'Baseline up to 43 months', 'description': 'Laboratory abnormalities leading to study treatment discontinuation: 2 sequential neutrophil counts \\<750 neutrophils per cubic millimeter (mm\\^3); 2 sequential lymphocyte counts \\<500 lymphocytes/mm\\^3; 2 sequential hemoglobin \\<8.0 grams per deciliter; 2 sequential platelet counts \\<75000 platelets/mm\\^3; 2 sequential AST or ALT elevations \\>=3\\*ULN with at least one total bilirubin value \\>=2\\*ULN; 2 sequential AST or ALT elevations \\>=3\\*ULN accompanied by signs or symptoms consistent with hepatic injury; 2 sequential AST or ALT elevations \\>=5\\*ULN; 2 sequential increases in creatinine \\>50% and \\>0.5 milligrams per deciliter over A3921139 baseline; 2 sequential CK elevations \\>10\\*ULN unless the causality is known not to be medically serious (eg, exercise induced).'}, {'measure': 'Number of Participants With Vital Sign Abnormalities', 'timeFrame': 'Baseline up to 43 months', 'description': 'Vital signs abnormality criteria included: 1) a) diastolic blood pressure (DBP) of (less than) \\<50 millimeter of mercury (mmHg), b) change greater than equal to (\\>=) 20 mmHg increase, c) change \\>=20 mmHg decrease; 2) a) systolic blood pressure (SBP) of \\<90 mmHg, b) change \\>=30 mmHg increase, c) change \\>=30 mmHg decrease; 3) a) pulse rate value of \\<40 beats per minute (bpm), b) pulse rate \\>120 bpm. Only those categories in which at least 1 participant had data were reported.'}, {'measure': 'Number of Participants With Clinically Significant Physical Examinations Abnormalities', 'timeFrame': 'Baseline up to 43 months', 'description': 'Physical examination included assessment of the weight, general appearance, eyes, mouth, lungs, heart, abdomen, musculoskeletal, extremities, skin and lymph nodes. Clinical significance was assessed by the Investigator.'}, {'measure': 'Number of Participants With Opportunistic Infections, All Malignancy, Gastrointestinal Perforation and Cardiovascular Events Adjudicated by Adjudication Committee', 'timeFrame': 'Baseline up to 43 months', 'description': 'Number of participants with adjudicated opportunistic infections including herpes zoster (non-adjacent or \\>2 adjacent dermatomes); all malignancies including non-melanoma skin cancer; gastrointestinal perforation and cardiovascular events including pulmonary embolism and cerebrovascular accident, adjudicated by adjudication committee were reported.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ulcerative colitis', 'inflammatory bowel disease'], 'conditions': ['Ulcerative Colitis']}, 'referencesModule': {'references': [{'pmid': '40028509', 'type': 'DERIVED', 'citation': "Torres J, D'Haens GR, Regueiro M, Santana G, Panes J, Vermeire S, Gardiner S, Kulisek N, Modesto I, Su C, Lawendy N, Mundayat R, Paulissen J, Dubinsky MC. Potential predictors of efficacy outcomes following tofacitinib dose reduction in patients with ulcerative colitis in stable remission: a post hoc analysis of outcomes from the RIVETING study. Therap Adv Gastroenterol. 2025 Feb 27;18:17562848251318849. doi: 10.1177/17562848251318849. eCollection 2025."}, {'pmid': '38778549', 'type': 'DERIVED', 'citation': "Panes J, D'Haens GR, Sands BE, Ng SC, Lawendy N, Kulisek N, Guo X, Wu J, Vranic I, Panaccione R, Vermeire S. Analysis of tofacitinib safety in ulcerative colitis from the completed global clinical developmental program up to 9.2 years of drug exposure. United European Gastroenterol J. 2024 Jul;12(6):793-801. doi: 10.1002/ueg2.12584. Epub 2024 May 22."}, {'pmid': '38425446', 'type': 'DERIVED', 'citation': 'Rubin DT, Torres J, Regueiro M, Reinisch W, Prideaux L, Kotze PG, Tan FH, Gardiner S, Mundayat R, Cadatal MJ, Ng SC. Association Between Smoking Status and the Efficacy and Safety of Tofacitinib in Patients with Ulcerative Colitis. Crohns Colitis 360. 2024 Jan 20;6(1):otae004. doi: 10.1093/crocol/otae004. eCollection 2024 Jan.'}, {'pmid': '36124702', 'type': 'DERIVED', 'citation': "Sandborn WJ, D'Haens GR, Sands BE, Panaccione R, Ng SC, Lawendy N, Kulisek N, Modesto I, Guo X, Mundayat R, Su C, Vranic I, Panes J. Tofacitinib for the Treatment of Ulcerative Colitis: An Integrated Summary of up to 7.8 Years of Safety Data from the Global Clinical Programme. J Crohns Colitis. 2023 Apr 3;17(3):338-351. doi: 10.1093/ecco-jcc/jjac141."}, {'pmid': '35648151', 'type': 'DERIVED', 'citation': 'Winthrop KL, Vermeire S, Long MD, Panes J, Ng SC, Kulisek N, Mundayat R, Lawendy N, Vranic I, Modesto I, Su C, Melmed GY. Long-term Risk of Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2023 Jan 5;29(1):85-96. doi: 10.1093/ibd/izac063.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=A3921288', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study is a follow up study for subjects with Ulcerative Colitis (UC) in stable remission designed to evaluate flexible dosing of CP-690,550.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Currently enrolled in Study A3921139 receiving CP-690,550 10 mg BID for at least 2 years consecutively.\n* In stable remission on CP-690,550 10 mg BID\n* Agree to use highly effective contraception\n* Negative pregnancy test\n* Comply with visits, treatments, lab tests, diary and other study procedures\n* Signed and dated informed consent document.\n\nExclusion Criteria:\n\n* 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