Ignite Creation Date:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2026-03-09 @ 8:37 AM
Study NCT ID:
NCT03981900
Status:
COMPLETED
Last Update Posted:
2024-10-01
First Post:
2019-06-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
IDentification of Factors Predictive of Tofacitinib's Survival in Patient With Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C479163', 'term': 'tofacitinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer Inc.', 'organization': 'Pfizer ClinicalTrials.gov Call Center'}, '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': 'Baseline up to 24 months after Tofacitinib treatment initiation (for a maximum of 48 months)', 'description': 'Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.', 'eventGroups': [{'id': 'EG000', 'title': 'Tofacitinib', 'description': 'Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).', 'otherNumAtRisk': 309, 'deathsNumAtRisk': 309, 'otherNumAffected': 197, 'seriousNumAtRisk': 309, 'deathsNumAffected': 3, 'seriousNumAffected': 64}], 'otherEvents': [{'term': 'LYMPHOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'PALPITATIONS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'VERTIGO', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 4}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'TINNITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'THYROID MASS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'GLARE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'GASTROINTESTINAL DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'ABDOMINAL DISCOMFORT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'ABDOMINAL DISTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'APHTHOUS ULCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'EPIPLOIC APPENDAGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'GASTROOESOPHAGEAL REFLUX DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'HIATUS HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'TREATMENT FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 44}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'DRUG INEFFECTIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'CHEST DISCOMFORT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'THERAPEUTIC RESPONSE SHORTENED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'DRUG INTOLERANCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'FACE OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'FEELING DRUNK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'FEELING OF BODY TEMPERATURE CHANGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'INFLAMMATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'INFLUENZA LIKE ILLNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'INJECTION SITE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'MALAISE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'SWELLING FACE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'HEPATIC CYTOLYSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'HEPATIC FUNCTION ABNORMAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'DRUG-INDUCED LIVER INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'HERPES ZOSTER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'TOOTH INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'GINGIVITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'HORDEOLUM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'ORAL HERPES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'PARONYCHIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'TOOTH ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'ARTHRITIS INFECTIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'CHRONIC SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'CONJUNCTIVITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'CYSTITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'DERMATITIS INFECTED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'DIVERTICULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'GENITAL HERPES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'GENITAL INFECTION FUNGAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'HERPES DERMATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'HERPES VIRUS INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'LARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'PYELONEPHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'RECTAL ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'RHINITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'RHINOTRACHEITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'SINUSITIS BACTERIAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'SKIN INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'STAPHYLOCOCCAL SKIN INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'SUBCUTANEOUS ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'TINEA MANUUM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'TONSILLITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'TRACHEITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'VULVOVAGINAL CANDIDIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'FOOT FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'ANKLE FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'ARTHROPOD BITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'BURN ORAL CAVITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'BURSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'EYELID INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'PRODUCT DOSE OMISSION IN ERROR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'SPINAL FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'WEIGHT INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'LABORATORY TEST ABNORMAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'TRANSAMINASES INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'BLOOD PRESSURE ABNORMAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'BLOOD UREA INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'CORONAVIRUS TEST POSITIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'GAMMA-GLUTAMYLTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'NEUTROPHIL COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'PREGNANCY TEST POSITIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'WEIGHT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'HYPERCHOLESTEROLAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'DYSLIPIDAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'HYPERTRIGLYCERIDAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'RHEUMATOID ARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'JOINT EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'ARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'BURSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'OSTEOARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'TENDON DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'INTERVERTEBRAL DISC DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'OSTEOPOROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'SYNOVIAL CYST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'SYNOVITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'SEBORRHOEIC KERATOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'SKIN PAPILLOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'SCIATICA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'MIGRAINE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'NEURALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'NEUROPATHY PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'CARPAL TUNNEL SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'CERVICOBRACHIAL SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'DISTURBANCE IN ATTENTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'NIGHTMARE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'GLOMERULONEPHRITIS MEMBRANOUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'RENAL IMPAIRMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'PROSTATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'LUNG DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'DYSPNOEA EXERTIONAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'EMPHYSEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'LUNG OPACITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'OROPHARYNGEAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'PULMONARY MASS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'RHINITIS ALLERGIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'ALOPECIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'DERMATITIS ACNEIFORM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'ECCHYMOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'ECZEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'RASH PRURITIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'HYPERHIDROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'NIGHT SWEATS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'ONYCHOLYSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'PRURIGO', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'SKIN BURNING SENSATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'SKIN EXFOLIATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'SKIN HYPERPIGMENTATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'URTICARIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'DENTAL IMPLANTATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'THERAPY CESSATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'FLUSHING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'HAEMATOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'HOT FLUSH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'PHLEBITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'SUPERFICIAL VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}], 'seriousEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'LYMPHOPROLIFERATIVE DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'ACUTE CORONARY SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'CARDIAC FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'CARDIAC TAMPONADE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'PERICARDITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'OESOPHAGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'DEATH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'DRUG INEFFECTIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'DRUG THERAPEUTIC INCOMPATIBILITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'INFLAMMATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'MALAISE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'TREATMENT FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'TUMOUR OF AMPULLA OF VATER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'APPENDICITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'ABSCESS LIMB', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'ARTHRITIS BACTERIAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'CAMPYLOBACTER SEPSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'ENDOCARDITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'HELICOBACTER INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'HEPATITIS E', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'HERPES ZOSTER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'LATENT TUBERCULOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'PAROTITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'SEPSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'TUBERCULOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'SHOULDER FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'ANKLE FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'FIBULA FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'HUMERUS FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'MEDICATION ERROR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'OVERDOSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'PELVIC FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'RIB FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'NEUTROPHIL COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'PLATELET COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'RHEUMATOID ARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'MUSCULOSKELETAL CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'OSTEOARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'OSTEOPOROTIC FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'POLYARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'BENIGN NEOPLASM OF THYROID GLAND', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'BREAST CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': "KAPOSI'S SARCOMA", 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'LYMPHOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'SMALL CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'TRANSITIONAL CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'TRANSIENT ISCHAEMIC ATTACK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'INTRACRANIAL MASS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'ISCHAEMIC STROKE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'PREGNANCY, PUERPERIUM AND PERINATAL CONDITIONS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'COMPLETED SUICIDE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'NEPHROPATHY TOXIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'LUNG DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'ACUTE PULMONARY OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'EPISTAXIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'PLEURAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'PLEURISY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'PULMONARY MASS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'PULMONARY OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'MITRAL VALVE REPLACEMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'SPINAL FUSION SURGERY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}, {'term': 'PERIPHERAL ARTERY THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Version 26.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Duration of Tofacitinib Drug Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).'}], 'classes': [{'categories': [{'measurements': [{'value': '26.4', 'comment': 'Data for the upper limit of 95% CI was not estimable due to insufficient follow-up in this study.', 'groupId': 'OG000', 'lowerLimit': '24.1', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Date of initiation of study drug treatment up to date of permanent drug discontinuation or date of censoring (up to a maximum of 48 months)', 'description': 'The duration of tofacitinib drug survival was calculated as: date of permanent drug discontinuation minus date of first taking the drug + 1. If a participant did not present with the event of interest, that is they did not have a permanent drug discontinuation record during the study, then they were censored at the time of their last visit. Kaplan-Meier method was used for estimation.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included participants who met the eligibility criteria, received at least one dose of Tofacitinib and had at least one set of post-baseline measurements.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Pain Catastrophising Scale (PCS) Score at Month 1, 3, 6, 12, 18 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.4', 'spread': '14.0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.2', 'spread': '10.4', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.6', 'spread': '11.1', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.4', 'spread': '11.4', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.2', 'spread': '11.6', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.8', 'spread': '11.2', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.7', 'spread': '10.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, 3, 6, 12, 18 and 24', 'description': 'PCS is a 13 item questionnaire around thoughts and emotions experienced during pain, with each question scored on a 5-point scale ranging from 0 (not at all) to 4 (all the time), where higher scores indicated worse condition. There are three subscales of PCS: rumination (thinking deeply) \\[4 items\\], exaggeration \\[3 items\\] and helplessness \\[6 items\\]. Total scores and domain scores are derived by summing the scores of the individual items. Overall possible Total PCS score range is 0 to 52, where higher scores signifies worse condition. A total score of greater than or equal to (\\>=) 20 indicates a clinically relevant level of catastrophising. Mean change from baseline in total PCS score is reported in this outcome measure.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number of participants analyzed" signifies number of participants evaluable and contributed to data for this outcome measure. Here, "Number Analyzed" signifies number of participants evaluable at specified time points. No imputation used for missing values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).'}], 'classes': [{'title': 'Distraction at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.2', 'spread': '3.8', 'groupId': 'OG000'}]}]}, {'title': 'Catastrophising at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.4', 'spread': '3.0', 'groupId': 'OG000'}]}]}, {'title': 'Distancing from Pain at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.3', 'spread': '3.2', 'groupId': 'OG000'}]}]}, {'title': 'Ignoring Pain Sensations at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.3', 'spread': '3.6', 'groupId': 'OG000'}]}]}, {'title': 'Praying at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.6', 'spread': '2.9', 'groupId': 'OG000'}]}]}, {'title': 'Distraction, Change at month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '3.3', 'groupId': 'OG000'}]}]}, {'title': 'Catastrophising, Change at month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '2.8', 'groupId': 'OG000'}]}]}, {'title': 'Distancing from Pain, Change at month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'spread': '2.9', 'groupId': 'OG000'}]}]}, {'title': 'Ignoring Pain Sensations, Change at month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '3.7', 'groupId': 'OG000'}]}]}, {'title': 'Praying, Change at month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '2.2', 'groupId': 'OG000'}]}]}, {'title': 'Distraction, Change at month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '4.5', 'groupId': 'OG000'}]}]}, {'title': 'Catastrophising, Change at month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '3.3', 'groupId': 'OG000'}]}]}, {'title': 'Distancing from Pain, Change at month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '3.9', 'groupId': 'OG000'}]}]}, {'title': 'Ignoring Pain Sensations, Change at month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '4.1', 'groupId': 'OG000'}]}]}, {'title': 'Praying, Change at month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '2.0', 'groupId': 'OG000'}]}]}, {'title': 'Distraction, Change at month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '4.2', 'groupId': 'OG000'}]}]}, {'title': 'Catastrophising, Change at month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'Distancing from Pain, Change at month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '4.1', 'groupId': 'OG000'}]}]}, {'title': 'Ignoring Pain Sensations, Change at month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '4.4', 'groupId': 'OG000'}]}]}, {'title': 'Praying, Change at month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Distraction, Change at month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '4.3', 'groupId': 'OG000'}]}]}, {'title': 'Catastrophising, Change at month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'Distancing from Pain, Change at month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '3.9', 'groupId': 'OG000'}]}]}, {'title': 'Ignoring Pain Sensations, Change at month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '4.5', 'groupId': 'OG000'}]}]}, {'title': 'Praying, Change at month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '2.2', 'groupId': 'OG000'}]}]}, {'title': 'Distraction, Change at month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '4.5', 'groupId': 'OG000'}]}]}, {'title': 'Catastrophising, Change at month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '2.7', 'groupId': 'OG000'}]}]}, {'title': 'Distancing from Pain, Change at month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '3.3', 'groupId': 'OG000'}]}]}, {'title': 'Ignoring Pain Sensations, Change at month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '4.4', 'groupId': 'OG000'}]}]}, {'title': 'Praying, Change at month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '2.2', 'groupId': 'OG000'}]}]}, {'title': 'Distraction, Change at month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '5.4', 'groupId': 'OG000'}]}]}, {'title': 'Catastrophising, Change at month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'Distancing from Pain, Change at month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '2.8', 'groupId': 'OG000'}]}]}, {'title': 'Ignoring Pain Sensations, Change at month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '4.4', 'groupId': 'OG000'}]}]}, {'title': 'Praying, Change at month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '2.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, 3, 6 12, 18 and 24', 'description': 'CSQ evaluates cognitive coping, has 21 items and 5 domains in its French version. For each item, participants rate the frequency of their use of each coping strategy on a 4- point Likert-type scale (0= Never, 1= sometimes, 2= often and 3= very often). Domain scores are derived by summing the individual items scores that make-up the domain. Five domains with score range: distraction (5 items, score range: 0 to 15), catastrophising (4 items, score range: 0 to 12), distancing from pain (4 items, score range: 0 to 12), ignoring pain sensations (5 items, score range: 0 to 15) and praying (3 items, score range: 0 to 9). For each domain, higher scores indicated worse condition. Mean change from baseline in CSQ domain scores are reported in this outcome measure.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number Analyzed" signifies number of participants evaluable at specified time points. No imputation used for missing values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Low Disease Activity (LDA) According to Disease Activity Index 28 (DAS28)-4 Erythrocyte Sedimentation Rate (ESR) (<=3.2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '34.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '52.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '57.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 1, 3, 6, 12 18, and 24', 'description': "DAS28-4 ESR is a composite endpoint, calculated using 4 variables (represented by '4' in the name). Components includes: Tender Joint Count (TJC) with 28 joints assessed, Swollen Joint Count (SJC) with 28 joints assessed, ESR (millimeter per hours \\[mm/h\\]) and Patient Global Assessment (PtGA) recorded on 100 mm VAS (scores ranging 0 \\[no disease activity\\] to 100 mm \\[maximum disease activity\\], higher scores=more disease activity). The calculation of DAS28-4 ESR is as follows: 0.56 \\* square root (sqrt) (TJC) + 0.28 \\* sqrt (SJC) + 0.70\\* In (ESR) + 0.014\\* (PtGA); where ln = natural logarithm. Total DAS28-4 score range: 0 to 9.4, higher score=more disease activity. DAS28(ESR) score of \\<=3.2 indicates LDA. Percentage of participants with DAS28-4 ESR \\<=3.2 is presented in this outcome measure.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number Analyzed" signifies number of participants evaluable at specified time points. No imputation used for missing values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With LDA According to DAS28-4 C Reactive Protein (CRP) (<=3.2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '69.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '73.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 1, 3, 6, 12 18, and 24', 'description': "DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC with 28 joints assessed, SJC with 28 joints assessed, CRP (mg/L) and PtGA recorded on 100 mm VAS (scores ranging 0 \\[no disease activity\\] to 100 mm \\[maximum disease activity\\], higher scores=more disease activity). The calculation of DAS28-4 CRP is as follows: 0.56 \\* sqrt (TJC) + 0.28 \\* sqrt (SJC) + 0.36 \\* ln (CRP+l) + 0.014\\*PtGA + 0.96; where ln = natural logarithm. Total DAS28-4 score range: 0 to 9.4, higher score=more disease activity. DAS28(CRP) score of \\<=3.2 indicates LDA. Percentage of participants with DAS28-4 CRP \\<=3.2 is presented in this outcome measure.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number Analyzed" signifies number of participants evaluable at specified time points. No imputation used for missing values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With LDA According to Simplified Disease Activity Index (SDAI) <=11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '39.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '68.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '74.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 1, 3, 6, 12 18, and 24', 'description': 'SDAI is a composite end point, calculated as TJC + SJC (both using 28 joints) + PtGA (0-10 cm scale, higher score=more disease activity) + Physician Global Assessment (PhGA) (0-10 cm scale, higher score=more disease activity) + CRP (milligrams per deciliter \\[mg/dL\\]). The SDAI score is classified into four categories: remission (\\<=3.3), low (\\>3.3-11), moderate (\\>11-26), and high (\\>26) disease activity. The SDAI score ranges from 0 to 86 where higher scores indicates high disease activity. SDAI score of \\<=11 indicates LDA. Percentage of participants with SDAI \\<=11 is presented in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number Analyzed" signifies number of participants evaluable at specified time points. No imputation used for missing values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With LDA According to Clinical Disease Activity Index (CDAI) <=10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41.8', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '56.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '68.8', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 1, 3, 6, 12 18, and 24', 'description': 'CDAI is a composite end point, calculated as TJC + SJC (both using 28 joints) + PtGA (0-10 cm scale, higher score=more disease activity) + PhGA (0-10 cm scale, higher score=more disease activity). The CDAI score is classified into four categories: remission (\\<=2.8), low (\\>2.8-10), moderate (\\>10-22), and high (\\>22) disease activity. The CDAI score ranges from 0 to 76, where higher scores indicates high disease activity. CDAI score of \\<=10 indicates LDA. Percentage of participants with CDAI \\<=10 is presented in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number Analyzed" signifies number of participants evaluable at specified time points. No imputation used for missing values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Remission According to DAS28-4 ESR<2.6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.8', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '34.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 1, 3, 6, 12 18, and 24', 'description': "DAS28-4 ESR is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (mm/h) and PtGA recorded on 100 mm VAS (scores ranging 0 \\[no disease activity\\] to 100 mm \\[maximum disease activity\\], higher scores=more disease activity). The calculation of DAS28-4 ESR is as follows: 0.56 \\* sqrt (TJC) + 0.28 \\* sqrt (SJC) + 0.70\\* In(ESR) + 0.014\\* (PtGA); where ln = natural logarithm. Total DAS28-4 score range: 0 to 9.4, higher score=more disease activity. DAS28(ESR) score of \\<2.6 indicates LDA. Percentage of participants with DAS28-4 ESR \\<2.6 is presented in this outcome measure.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number Analyzed" signifies number of participants evaluable at specified time points. No imputation used for missing values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Remission According to DAS28-4 CRP <2.6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '59.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 1, 3, 6, 12 18, and 24', 'description': "DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC with 28 joints assessed, SJC with 28 joints assessed, CRP (mg/L) and PtGA recorded on 100 mm VAS (scores ranging 0 \\[no disease activity\\] to 100 mm \\[maximum disease activity\\], higher scores=more disease activity). The calculation of DAS28-4 CRP is as follows: 0.56 \\* sqrt (TJC) + 0.28 \\* sqrt (SJC) + 0.36 \\* ln (CRP+l) + 0.014\\*PtGA + 0.96; where ln = natural logarithm. Total DAS28-4 score range: 0 to 9.4, higher score=more disease activity. DAS28(CRP) score of \\<2.6 indicates LDA. Percentage of participants with DAS28-4 CRP \\<2.6 is presented in this outcome measure.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number Analyzed" signifies number of participants evaluable at specified time points. No imputation used for missing values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants in Remission According to SDAI <=3.3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 1, 3, 6, 12 18, and 24', 'description': 'SDAI is a composite end point, calculated as TJC + SJC (both using 28 joints) + PtGA (0-10 cm scale, higher score=more disease activity) + PhGA (0-10 cm scale, higher score=more disease activity) + CRP (mg/dL). The SDAI score is classified into four categories: remission (\\<=3.3), low (\\>3.3-11), moderate (\\>11-26), and high (\\>26) disease activity. The SDAI score ranges from 0 to 86 where higher scores indicates high disease activity. SDAI score of \\<=3.3 indicates LDA. Percentage of participants with SDAI \\<=3.3 is presented in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number Analyzed" signifies number of participants evaluable at specified time points. No imputation used for missing values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants in Remission According to CDAI<=2.8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 1, 3, 6, 12 18, and 24', 'description': 'CDAI is a composite end point, calculated as TJC + SJC (both using 28 joints) + PtGA (0-10 cm scale) + PhGA (0-10 cm scale). The CDAI score is classified into four categories: remission (\\<=2.8), low (\\>2.8-10), moderate (\\>10-22), and high (\\>22) disease activity. The CDAI score ranges from 0 to 76, where higher scores indicates high disease activity. CDAI score of \\<=2.8 indicates LDA. Percentage of participants with CDAI \\<=2.8 is presented in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number Analyzed" signifies number of participants evaluable at specified time points. No imputation used for missing values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Remission According to American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) 2011 Boolean Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 1, 3, 6, 12 18, and 24', 'description': 'ACREULAR 2011 Boolean criteria is derived as: ACR Remission = 1, if SJC (using 28 joints) \\<=1, TJC (using 28 joints) \\<=1, CRP \\<=1 mg/dL, and PtGA (0 to 10 cm scale, higher score=more disease activity) \\<=1 centimeter (cm) otherwise ACR remission =0. Higher scores indicated greater affection due to disease activity. Percentage of participants with remission according to ACR-EULAR 2011 Boolean criteria is reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number Analyzed" signifies number of participants evaluable at specified time points. No imputation used for missing values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in DAS28-4 ESR Score at Month 1, 3, 6, 12, 18 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.850', 'spread': '1.180', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.129', 'spread': '1.187', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.419', 'spread': '1.487', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.941', 'spread': '1.367', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.764', 'spread': '1.347', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.954', 'spread': '1.487', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.008', 'spread': '1.363', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, 3, 6, 12, 18, and 24', 'description': "DAS28-4 ESR is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (mm/h) and PtGA recorded on 100 mm VAS (scores ranging 0 \\[no disease activity\\] to 100 mm \\[maximum disease activity\\], higher scores=more disease activity). The calculation of DAS28-4 ESR is as follows: 0.56 \\* sqrt (TJC) + 0.28 \\* sqrt (SJC) + 0.70\\* In(ESR) + 0.014\\* (PtGA); where ln = natural logarithm. Total DAS28-4 score range: 0 to 9.4, higher score=more disease activity. Mean change from baseline in DAS28-4 ESR score at months 3, 6, 12, 18 and 24 is presented in this outcome measure.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number of participants analyzed" signifies number of participants evaluable and contributed to data for this outcome measure. Here, "Number Analyzed" signifies number of participants evaluable at specified time points. No imputation used for missing values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in DAS28-4 CRP Score at Month 1, 3, 6, 12, 18 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.526', 'spread': '1.088', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.295', 'spread': '1.135', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.498', 'spread': '1.363', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.902', 'spread': '1.198', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.909', 'spread': '1.269', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.971', 'spread': '1.275', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.077', 'spread': '1.215', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, 3, 6, 12, 18, and 24', 'description': "DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC with 28 joints assessed, SJC with 28 joints assessed, CRP (mg/L) and PtGA recorded on 100 mm VAS (scores ranging 0 \\[no disease activity\\] to 100 mm \\[maximum disease activity\\], higher scores=more disease activity). The calculation of DAS28-4 CRP is as follows: 0.56 \\* sqrt (TJC) + 0.28 \\* sqrt (SJC) + 0.36 \\* ln (CRP+l) + 0.014\\*PtGA + 0.96; where ln = natural logarithm. Total DAS28-4 score range: 0 to 9.4, higher score=more disease activity. Mean change from baseline in DAS28-4 CRP score at months 3, 6, 12, 18 and 24 is presented in this outcome measure.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number of participants analyzed" signifies number of participants evaluable and contributed to data for this outcome measure. Here, "Number Analyzed" signifies number of participants evaluable at specified time points. No imputation used for missing values.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).'}], 'classes': [{'title': 'CRP, good responder, month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'CRP, moderate responder, month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}, {'title': 'CRP, non-responder, month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': 'CRP, good responder, month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}]}]}, {'title': 'CRP, moderate responder, month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}]}]}, {'title': 'CRP, non-responder, month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'CRP, good responder, month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}]}]}, {'title': 'CRP, moderate responder, month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}, {'title': 'CRP, non-responder, month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'CRP, good responder, month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}]}]}, {'title': 'CRP, moderate responder, month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}, {'title': 'CRP, non-responder, month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'CRP, good responder, month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}]}]}, {'title': 'CRP, moderate responder, month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'CRP, non-responder, month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'CRP, good responder, month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}, {'title': 'CRP, moderate responder, month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'CRP, non-responder, month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'ESR, good responder, month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}, {'title': 'ESR, moderate responder, month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'ESR, non-responder, month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}, {'title': 'ESR, good responder, month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}]}]}, {'title': 'ESR, moderate responder, month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}, {'title': 'ESR, non-responder, month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}]}]}, {'title': 'ESR, good responder, month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}]}]}, {'title': 'ESR, moderate responder, month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}]}]}, {'title': 'ESR, non-responder, month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'ESR, good responder, month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}]}]}, {'title': 'ESR, moderate responder, month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'ESR, non-responder, month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'ESR, good responder, month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'ESR, moderate responder, month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'ESR, non-responder, month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'ESR, good responder, month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}, {'title': 'ESR, moderate responder, month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'ESR, non-responder, month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 1, 3, 6, 12, 18, and 24', 'description': "28 EULAR criteria to evaluate participant's response to treatment is categorised as good responder, moderate responder and non-responder based on participants DAS28-4 CRP score and decrease in DAS28-4 CRP compared to initial pre-treatment visit (Visit 0 \\[V0\\]). Good response: DAS28 at treatment visit \\<= 3.2 and decrease in DAS 28 compared to V0 \\>1.2. Moderate responder: DAS28 at treatment visit \\> 3.2 to \\<= 5.1 or \\> 5.1 and decrease in DAS 28 compared to V0 \\>1.2 DAS28 at treatment visit \\<= 3.2 or \\> 3.2 to \\<= 5.1 and decrease in DAS 28 compared to V0 \\>0.6 and \\<=1.2. Non-responder: DAS28 at treatment visit \\> 5.1 and decrease in DAS 28 compared to V0 \\>0.6 to \\<=1.2 DAS28 at treatment visit \\<= 3.2 or \\> 3.2 to \\<= 5.1 or \\> 5.1 and decrease in DAS 28 compared to V0 \\<=0.6. Number of participants responding to treatment by considering DAS28 (EULAR criterion) is reported in this outcome measure.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number Analyzed" signifies number of participants evaluable at specified time points. No imputation used for missing values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in TJC at Month 1, 3, 6, 12, 18 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.4', 'spread': '6.0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.2', 'spread': '5.8', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.3', 'spread': '6.5', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.9', 'spread': '6.3', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.0', 'spread': '7.0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.1', 'spread': '5.9', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.1', 'spread': '6.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, 3, 6, 12, 18, and 24', 'description': 'TJC (28) is the count of the total number of tender joints out of a possible 28 joints which are checked at the visit. TJC was used to measure the pain and inflammation in the joints. Mean change from baseline in TJC is reported in this outcome measure.', 'unitOfMeasure': 'Tender Joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number of participants analyzed" signifies number of participants evaluable and contributed to data for this outcome measure. Here, "Number Analyzed" signifies number of participants evaluable at specified time points. No imputation used for missing values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in SJC at Month 1, 3, 6, 12, 18 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.3', 'spread': '5.1', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '4.5', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'spread': '4.9', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.9', 'spread': '5.1', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.3', 'spread': '5.1', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.4', 'spread': '5.2', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.3', 'spread': '5.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, 3, 6, 12, 18, and 24', 'description': 'SJC (28) is the count of the total number of swollen joints out of a possible 28 joints which are checked at the visit. SJC was used to measure the pain and inflammation in the joints. Mean change from baseline in TJC is reported in this outcome measure.', 'unitOfMeasure': 'Swollen Joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number of participants analyzed" signifies number of participants evaluable and contributed to data for this outcome measure. Here, "Number Analyzed" signifies number of participants evaluable at specified time points. No imputation used for missing values.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).'}], 'classes': [{'title': 'Baseline, Fibromyalgia: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '156', 'groupId': 'OG000'}]}]}, {'title': 'Baseline, Fibromyalgia: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}]}]}, {'title': 'Month 1, Fibromyalgia: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}]}]}, {'title': 'Month 1, Fibromyalgia: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': 'Month 3, Fibromyalgia: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000'}]}]}, {'title': 'Month 3, Fibromyalgia: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}, {'title': 'Month 6, Fibromyalgia: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}]}]}, {'title': 'Month 6, Fibromyalgia: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}, {'title': 'Month 12, Fibromyalgia: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}]}]}, {'title': 'Month 12, Fibromyalgia: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Month 18, Fibromyalgia: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}]}]}, {'title': 'Month 18, Fibromyalgia: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Month 24, Fibromyalgia: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}, {'title': 'Month 24, Fibromyalgia: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Month 1, 3, 6, 12, 18 and 24', 'description': 'FiRST is used to detect fibromyalgia in participants with diffuse rheumatic pain. It is a questionnaire which contains 6 items: diffuse pain, painful symptoms, fatigue, sleep and cognitive disorders, nonpainful abnormal sensations and functional somatic symptoms. Each of the 6 items contain yes or no response, and a positive answer to 5 out of the 6 answers can detect fibromyalgia. At each specified time points number of participants with "Yes" or "No" to fibromyalgia is reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number Analyzed" signifies number of participants evaluable at specified time points. No imputation used for missing values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Duration of Morning Stiffness at Month 1, 3, 6, 12, 18 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '51.5', 'spread': '53.3', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-24.3', 'spread': '43.0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-31.3', 'spread': '48.8', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-31.5', 'spread': '49.1', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-36.6', 'spread': '50.8', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-32.2', 'spread': '47.9', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-40.0', 'spread': '49.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, 3, 6, 12, 18 and 24', 'description': 'Morning stiffness is a common symptom of rheumatoid arthritis. The duration of morning stiffness is measured in minutes. Mean change from baseline in morning stiffness is reported in this outcome measure.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number of participants analyzed" signifies number of participants evaluable and contributed to data for this outcome measure. Here, "Number Analyzed" signifies number of participants evaluable at specified time points. No imputation used for missing values.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).'}], 'classes': [{'title': 'Good complier at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Minor complier at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}]}]}, {'title': 'No-complier at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Good complier at month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}]}]}, {'title': 'Minor complier at month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}]}]}, {'title': 'No-complier at month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Good complier at month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}]}]}, {'title': 'Minor complier at month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}]}]}, {'title': 'No-complier at month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Good complier at month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}, {'title': 'Minor complier at month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}]}]}, {'title': 'No-complier at month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Good complier at month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}, {'title': 'Minor complier at month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}]}]}, {'title': 'No-complier at month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Good complier at month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': 'Minor complier at month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}]}]}, {'title': 'No-complier at month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Good complier at month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': 'Minor complier at month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}]}]}, {'title': 'No-complier at month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 1, 3, 6, 12, 18 and 24', 'description': 'Girerd questionnaire is used to evaluate participant\'s treatment compliance and is made up of 6 yes or no questions. lf the participant responds "no" to all questions, it is considered as participant is a good complier. lf the participant responds "yes" once or twice, it is considered as participant is a minor complier. lf the participant responds "yes" three times or more, it is considered as participant is a no-complier.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in European Quality of Life (EuroQoL) 5-Dimension 3 Levels of Severity (EQ-5D-3L) Index Score at Month 1, 3, 6, 12, 18 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3987', 'spread': '0.3731', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1314', 'spread': '0.3185', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1767', 'spread': '0.4054', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1886', 'spread': '0.3638', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2362', 'spread': '0.4058', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2190', 'spread': '0.4020', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2123', 'spread': '0.3911', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, 3, 6, 12, 18 and 24', 'description': 'EQ-5D-3L is a standardized, participant administered measure of self-reported instrument used to evaluate health-related quality of life. It consists of two parts: EQ-5D index score (Part I) and the EQ-VAS (Part II). For Part I, i.e. EQ-5D-3L index score, participants rated their current health state on 5 single-item dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with each dimension having three levels of function:. 1=no problems, 2=some problems and 3=extreme problems. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score was transformed and results in a total index score range of 0 to 1.00; higher scores indicating a better health condition. Mean change from baseline in EQ-5D-3L index score is reported in this outcome measure.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number of participants analyzed" signifies number of participants evaluable and contributed to data for this outcome measure. Here, "Number Analyzed" signifies number of participants evaluable at specified time points. No imputation used for missing values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).'}], 'classes': [{'title': 'PCS at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.0', 'spread': '8.7', 'groupId': 'OG000'}]}]}, {'title': 'PCS at Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '7.6', 'groupId': 'OG000'}]}]}, {'title': 'PCS at Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.8', 'spread': '8.9', 'groupId': 'OG000'}]}]}, {'title': 'PCS at Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.9', 'spread': '8.7', 'groupId': 'OG000'}]}]}, {'title': 'PCS at Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.9', 'spread': '9.2', 'groupId': 'OG000'}]}]}, {'title': 'PCS at Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.9', 'spread': '9.1', 'groupId': 'OG000'}]}]}, {'title': 'PCS at Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.3', 'spread': '9.8', 'groupId': 'OG000'}]}]}, {'title': 'MCS at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.2', 'spread': '10.4', 'groupId': 'OG000'}]}]}, {'title': 'MCS at Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '9.1', 'groupId': 'OG000'}]}]}, {'title': 'MCS at Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '10.6', 'groupId': 'OG000'}]}]}, {'title': 'MCS at Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '9.5', 'groupId': 'OG000'}]}]}, {'title': 'MCS at Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '11.1', 'groupId': 'OG000'}]}]}, {'title': 'MCS at Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': '10.2', 'groupId': 'OG000'}]}]}, {'title': 'MCS at Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.9', 'spread': '10.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, 3, 6, 12, 18 and 24', 'description': 'SF-12 was a participant reported outcome survey that represented overall health status by measuring 8 health-related aspects of an individual: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE) and Mental Health (MH). The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Responses on the SF-12 were also used to calculate 2 summary scores: Physical component score (PCS) and mental component score (MCS). The score range for each of these 2 summary scores was from 0 (poor health) to 100 (better health), where 100 indicated good health condition. Mean change from baseline in PCS and MCS scores are reported in this outcome measure.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Month 1, 3, 6, 12, 18 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26.9', 'spread': '11.7', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '9.3', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.2', 'spread': '10.9', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.2', 'spread': '10.1', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.9', 'spread': '12.1', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.8', 'spread': '11.6', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.4', 'spread': '11.4', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 1, 3, 6, 12, 18 and 24', 'description': "FACIT-Fatigue questionnaire consists of 13 self-evaluated questions. Each question has a response of values 0 (not at all) to 4 (very much). Score for each question is calculated by first reversing negatively stated-items (subtracting the response from '4' except for the 2 positively stated-items) and then summing the raw (0-4) scores. The FACIT-Fatigue total score is derived by summing the response to each question which gives a value between 0 (worse score) and 52 (best score). Higher scores represent better participant's status (less fatigue). Mean change from baseline in FACIT-Fatigue total score is reported in this outcome measure.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number of participants analyzed" signifies number of participants evaluable and contributed to data for this outcome measure. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Tofacitinib Tolerance Issue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 24', 'description': 'Number of participants who discontinued tofacitinib due to tolerance issue.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tofacitinib', 'description': 'Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '314'}]}, {'type': 'Safety Analysis Set (SAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '309'}]}, {'type': 'Full Analysis Set (FAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '306'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '227'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}]}], 'dropWithdraws': [{'type': 'Participant decision - Without withdrawal of consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '46'}]}, {'type': 'Decision of the researcher', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Participants diagnosed with moderate-to-severe active rheumatoid arthritis who initiated Tofacitinib in the real-world setting were observed in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Tofacitinib', 'description': 'Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '< 65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '194', 'groupId': 'BG000'}]}]}, {'title': '>= 65 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '112', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '241', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'Safety Analysis Set (SAS) included participants who received at least one dose of Tofacitinib.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-21', 'size': 2456091, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-06-05T16:53', 'hasProtocol': True}, {'date': '2021-04-26', 'size': 1227157, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-06-05T16:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 314}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-05', 'studyFirstSubmitDate': '2019-06-07', 'resultsFirstSubmitDate': '2024-06-05', 'studyFirstSubmitQcDate': '2019-06-07', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-05', 'studyFirstPostDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of Tofacitinib Drug Survival', 'timeFrame': 'Date of initiation of study drug treatment up to date of permanent drug discontinuation or date of censoring (up to a maximum of 48 months)', 'description': 'The duration of tofacitinib drug survival was calculated as: date of permanent drug discontinuation minus date of first taking the drug + 1. If a participant did not present with the event of interest, that is they did not have a permanent drug discontinuation record during the study, then they were censored at the time of their last visit. Kaplan-Meier method was used for estimation.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Total Pain Catastrophising Scale (PCS) Score at Month 1, 3, 6, 12, 18 and 24', 'timeFrame': 'Baseline, Month 1, 3, 6, 12, 18 and 24', 'description': 'PCS is a 13 item questionnaire around thoughts and emotions experienced during pain, with each question scored on a 5-point scale ranging from 0 (not at all) to 4 (all the time), where higher scores indicated worse condition. There are three subscales of PCS: rumination (thinking deeply) \\[4 items\\], exaggeration \\[3 items\\] and helplessness \\[6 items\\]. Total scores and domain scores are derived by summing the scores of the individual items. Overall possible Total PCS score range is 0 to 52, where higher scores signifies worse condition. A total score of greater than or equal to (\\>=) 20 indicates a clinically relevant level of catastrophising. Mean change from baseline in total PCS score is reported in this outcome measure.'}, {'measure': 'Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24', 'timeFrame': 'Baseline, Month 1, 3, 6 12, 18 and 24', 'description': 'CSQ evaluates cognitive coping, has 21 items and 5 domains in its French version. For each item, participants rate the frequency of their use of each coping strategy on a 4- point Likert-type scale (0= Never, 1= sometimes, 2= often and 3= very often). Domain scores are derived by summing the individual items scores that make-up the domain. Five domains with score range: distraction (5 items, score range: 0 to 15), catastrophising (4 items, score range: 0 to 12), distancing from pain (4 items, score range: 0 to 12), ignoring pain sensations (5 items, score range: 0 to 15) and praying (3 items, score range: 0 to 9). For each domain, higher scores indicated worse condition. Mean change from baseline in CSQ domain scores are reported in this outcome measure.'}, {'measure': 'Percentage of Participants With Low Disease Activity (LDA) According to Disease Activity Index 28 (DAS28)-4 Erythrocyte Sedimentation Rate (ESR) (<=3.2)', 'timeFrame': 'Baseline, Month 1, 3, 6, 12 18, and 24', 'description': "DAS28-4 ESR is a composite endpoint, calculated using 4 variables (represented by '4' in the name). Components includes: Tender Joint Count (TJC) with 28 joints assessed, Swollen Joint Count (SJC) with 28 joints assessed, ESR (millimeter per hours \\[mm/h\\]) and Patient Global Assessment (PtGA) recorded on 100 mm VAS (scores ranging 0 \\[no disease activity\\] to 100 mm \\[maximum disease activity\\], higher scores=more disease activity). The calculation of DAS28-4 ESR is as follows: 0.56 \\* square root (sqrt) (TJC) + 0.28 \\* sqrt (SJC) + 0.70\\* In (ESR) + 0.014\\* (PtGA); where ln = natural logarithm. Total DAS28-4 score range: 0 to 9.4, higher score=more disease activity. DAS28(ESR) score of \\<=3.2 indicates LDA. Percentage of participants with DAS28-4 ESR \\<=3.2 is presented in this outcome measure."}, {'measure': 'Percentage of Participants With LDA According to DAS28-4 C Reactive Protein (CRP) (<=3.2)', 'timeFrame': 'Baseline, Month 1, 3, 6, 12 18, and 24', 'description': "DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC with 28 joints assessed, SJC with 28 joints assessed, CRP (mg/L) and PtGA recorded on 100 mm VAS (scores ranging 0 \\[no disease activity\\] to 100 mm \\[maximum disease activity\\], higher scores=more disease activity). The calculation of DAS28-4 CRP is as follows: 0.56 \\* sqrt (TJC) + 0.28 \\* sqrt (SJC) + 0.36 \\* ln (CRP+l) + 0.014\\*PtGA + 0.96; where ln = natural logarithm. Total DAS28-4 score range: 0 to 9.4, higher score=more disease activity. DAS28(CRP) score of \\<=3.2 indicates LDA. Percentage of participants with DAS28-4 CRP \\<=3.2 is presented in this outcome measure."}, {'measure': 'Percentage of Participants With LDA According to Simplified Disease Activity Index (SDAI) <=11', 'timeFrame': 'Baseline, Month 1, 3, 6, 12 18, and 24', 'description': 'SDAI is a composite end point, calculated as TJC + SJC (both using 28 joints) + PtGA (0-10 cm scale, higher score=more disease activity) + Physician Global Assessment (PhGA) (0-10 cm scale, higher score=more disease activity) + CRP (milligrams per deciliter \\[mg/dL\\]). The SDAI score is classified into four categories: remission (\\<=3.3), low (\\>3.3-11), moderate (\\>11-26), and high (\\>26) disease activity. The SDAI score ranges from 0 to 86 where higher scores indicates high disease activity. SDAI score of \\<=11 indicates LDA. Percentage of participants with SDAI \\<=11 is presented in this outcome measure.'}, {'measure': 'Percentage of Participants With LDA According to Clinical Disease Activity Index (CDAI) <=10', 'timeFrame': 'Baseline, Month 1, 3, 6, 12 18, and 24', 'description': 'CDAI is a composite end point, calculated as TJC + SJC (both using 28 joints) + PtGA (0-10 cm scale, higher score=more disease activity) + PhGA (0-10 cm scale, higher score=more disease activity). The CDAI score is classified into four categories: remission (\\<=2.8), low (\\>2.8-10), moderate (\\>10-22), and high (\\>22) disease activity. The CDAI score ranges from 0 to 76, where higher scores indicates high disease activity. CDAI score of \\<=10 indicates LDA. Percentage of participants with CDAI \\<=10 is presented in this outcome measure.'}, {'measure': 'Percentage of Participants With Remission According to DAS28-4 ESR<2.6', 'timeFrame': 'Baseline, Month 1, 3, 6, 12 18, and 24', 'description': "DAS28-4 ESR is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (mm/h) and PtGA recorded on 100 mm VAS (scores ranging 0 \\[no disease activity\\] to 100 mm \\[maximum disease activity\\], higher scores=more disease activity). The calculation of DAS28-4 ESR is as follows: 0.56 \\* sqrt (TJC) + 0.28 \\* sqrt (SJC) + 0.70\\* In(ESR) + 0.014\\* (PtGA); where ln = natural logarithm. Total DAS28-4 score range: 0 to 9.4, higher score=more disease activity. DAS28(ESR) score of \\<2.6 indicates LDA. Percentage of participants with DAS28-4 ESR \\<2.6 is presented in this outcome measure."}, {'measure': 'Percentage of Participants With Remission According to DAS28-4 CRP <2.6', 'timeFrame': 'Baseline, Month 1, 3, 6, 12 18, and 24', 'description': "DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC with 28 joints assessed, SJC with 28 joints assessed, CRP (mg/L) and PtGA recorded on 100 mm VAS (scores ranging 0 \\[no disease activity\\] to 100 mm \\[maximum disease activity\\], higher scores=more disease activity). The calculation of DAS28-4 CRP is as follows: 0.56 \\* sqrt (TJC) + 0.28 \\* sqrt (SJC) + 0.36 \\* ln (CRP+l) + 0.014\\*PtGA + 0.96; where ln = natural logarithm. Total DAS28-4 score range: 0 to 9.4, higher score=more disease activity. DAS28(CRP) score of \\<2.6 indicates LDA. Percentage of participants with DAS28-4 CRP \\<2.6 is presented in this outcome measure."}, {'measure': 'Percentage of Participants in Remission According to SDAI <=3.3', 'timeFrame': 'Baseline, Month 1, 3, 6, 12 18, and 24', 'description': 'SDAI is a composite end point, calculated as TJC + SJC (both using 28 joints) + PtGA (0-10 cm scale, higher score=more disease activity) + PhGA (0-10 cm scale, higher score=more disease activity) + CRP (mg/dL). The SDAI score is classified into four categories: remission (\\<=3.3), low (\\>3.3-11), moderate (\\>11-26), and high (\\>26) disease activity. The SDAI score ranges from 0 to 86 where higher scores indicates high disease activity. SDAI score of \\<=3.3 indicates LDA. Percentage of participants with SDAI \\<=3.3 is presented in this outcome measure.'}, {'measure': 'Percentage of Participants in Remission According to CDAI<=2.8', 'timeFrame': 'Baseline, Month 1, 3, 6, 12 18, and 24', 'description': 'CDAI is a composite end point, calculated as TJC + SJC (both using 28 joints) + PtGA (0-10 cm scale) + PhGA (0-10 cm scale). The CDAI score is classified into four categories: remission (\\<=2.8), low (\\>2.8-10), moderate (\\>10-22), and high (\\>22) disease activity. The CDAI score ranges from 0 to 76, where higher scores indicates high disease activity. CDAI score of \\<=2.8 indicates LDA. Percentage of participants with CDAI \\<=2.8 is presented in this outcome measure.'}, {'measure': 'Percentage of Participants With Remission According to American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) 2011 Boolean Criteria', 'timeFrame': 'Baseline, Month 1, 3, 6, 12 18, and 24', 'description': 'ACREULAR 2011 Boolean criteria is derived as: ACR Remission = 1, if SJC (using 28 joints) \\<=1, TJC (using 28 joints) \\<=1, CRP \\<=1 mg/dL, and PtGA (0 to 10 cm scale, higher score=more disease activity) \\<=1 centimeter (cm) otherwise ACR remission =0. Higher scores indicated greater affection due to disease activity. Percentage of participants with remission according to ACR-EULAR 2011 Boolean criteria is reported in this outcome measure.'}, {'measure': 'Change From Baseline in DAS28-4 ESR Score at Month 1, 3, 6, 12, 18 and 24', 'timeFrame': 'Baseline, Month 1, 3, 6, 12, 18, and 24', 'description': "DAS28-4 ESR is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (mm/h) and PtGA recorded on 100 mm VAS (scores ranging 0 \\[no disease activity\\] to 100 mm \\[maximum disease activity\\], higher scores=more disease activity). The calculation of DAS28-4 ESR is as follows: 0.56 \\* sqrt (TJC) + 0.28 \\* sqrt (SJC) + 0.70\\* In(ESR) + 0.014\\* (PtGA); where ln = natural logarithm. Total DAS28-4 score range: 0 to 9.4, higher score=more disease activity. Mean change from baseline in DAS28-4 ESR score at months 3, 6, 12, 18 and 24 is presented in this outcome measure."}, {'measure': 'Change From Baseline in DAS28-4 CRP Score at Month 1, 3, 6, 12, 18 and 24', 'timeFrame': 'Baseline, Month 1, 3, 6, 12, 18, and 24', 'description': "DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC with 28 joints assessed, SJC with 28 joints assessed, CRP (mg/L) and PtGA recorded on 100 mm VAS (scores ranging 0 \\[no disease activity\\] to 100 mm \\[maximum disease activity\\], higher scores=more disease activity). The calculation of DAS28-4 CRP is as follows: 0.56 \\* sqrt (TJC) + 0.28 \\* sqrt (SJC) + 0.36 \\* ln (CRP+l) + 0.014\\*PtGA + 0.96; where ln = natural logarithm. Total DAS28-4 score range: 0 to 9.4, higher score=more disease activity. Mean change from baseline in DAS28-4 CRP score at months 3, 6, 12, 18 and 24 is presented in this outcome measure."}, {'measure': 'Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)', 'timeFrame': 'Month 1, 3, 6, 12, 18, and 24', 'description': "28 EULAR criteria to evaluate participant's response to treatment is categorised as good responder, moderate responder and non-responder based on participants DAS28-4 CRP score and decrease in DAS28-4 CRP compared to initial pre-treatment visit (Visit 0 \\[V0\\]). Good response: DAS28 at treatment visit \\<= 3.2 and decrease in DAS 28 compared to V0 \\>1.2. Moderate responder: DAS28 at treatment visit \\> 3.2 to \\<= 5.1 or \\> 5.1 and decrease in DAS 28 compared to V0 \\>1.2 DAS28 at treatment visit \\<= 3.2 or \\> 3.2 to \\<= 5.1 and decrease in DAS 28 compared to V0 \\>0.6 and \\<=1.2. Non-responder: DAS28 at treatment visit \\> 5.1 and decrease in DAS 28 compared to V0 \\>0.6 to \\<=1.2 DAS28 at treatment visit \\<= 3.2 or \\> 3.2 to \\<= 5.1 or \\> 5.1 and decrease in DAS 28 compared to V0 \\<=0.6. Number of participants responding to treatment by considering DAS28 (EULAR criterion) is reported in this outcome measure."}, {'measure': 'Change From Baseline in TJC at Month 1, 3, 6, 12, 18 and 24', 'timeFrame': 'Baseline, Month 1, 3, 6, 12, 18, and 24', 'description': 'TJC (28) is the count of the total number of tender joints out of a possible 28 joints which are checked at the visit. TJC was used to measure the pain and inflammation in the joints. Mean change from baseline in TJC is reported in this outcome measure.'}, {'measure': 'Change From Baseline in SJC at Month 1, 3, 6, 12, 18 and 24', 'timeFrame': 'Baseline, Month 1, 3, 6, 12, 18, and 24', 'description': 'SJC (28) is the count of the total number of swollen joints out of a possible 28 joints which are checked at the visit. SJC was used to measure the pain and inflammation in the joints. Mean change from baseline in TJC is reported in this outcome measure.'}, {'measure': 'Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response', 'timeFrame': 'Baseline, Month 1, 3, 6, 12, 18 and 24', 'description': 'FiRST is used to detect fibromyalgia in participants with diffuse rheumatic pain. It is a questionnaire which contains 6 items: diffuse pain, painful symptoms, fatigue, sleep and cognitive disorders, nonpainful abnormal sensations and functional somatic symptoms. Each of the 6 items contain yes or no response, and a positive answer to 5 out of the 6 answers can detect fibromyalgia. At each specified time points number of participants with "Yes" or "No" to fibromyalgia is reported in this outcome measure.'}, {'measure': 'Change From Baseline in Duration of Morning Stiffness at Month 1, 3, 6, 12, 18 and 24', 'timeFrame': 'Baseline, Month 1, 3, 6, 12, 18 and 24', 'description': 'Morning stiffness is a common symptom of rheumatoid arthritis. The duration of morning stiffness is measured in minutes. Mean change from baseline in morning stiffness is reported in this outcome measure.'}, {'measure': 'Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24', 'timeFrame': 'Month 1, 3, 6, 12, 18 and 24', 'description': 'Girerd questionnaire is used to evaluate participant\'s treatment compliance and is made up of 6 yes or no questions. lf the participant responds "no" to all questions, it is considered as participant is a good complier. lf the participant responds "yes" once or twice, it is considered as participant is a minor complier. lf the participant responds "yes" three times or more, it is considered as participant is a no-complier.'}, {'measure': 'Change From Baseline in European Quality of Life (EuroQoL) 5-Dimension 3 Levels of Severity (EQ-5D-3L) Index Score at Month 1, 3, 6, 12, 18 and 24', 'timeFrame': 'Baseline, Month 1, 3, 6, 12, 18 and 24', 'description': 'EQ-5D-3L is a standardized, participant administered measure of self-reported instrument used to evaluate health-related quality of life. It consists of two parts: EQ-5D index score (Part I) and the EQ-VAS (Part II). For Part I, i.e. EQ-5D-3L index score, participants rated their current health state on 5 single-item dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with each dimension having three levels of function:. 1=no problems, 2=some problems and 3=extreme problems. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score was transformed and results in a total index score range of 0 to 1.00; higher scores indicating a better health condition. Mean change from baseline in EQ-5D-3L index score is reported in this outcome measure.'}, {'measure': 'Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24', 'timeFrame': 'Baseline, Month 1, 3, 6, 12, 18 and 24', 'description': 'SF-12 was a participant reported outcome survey that represented overall health status by measuring 8 health-related aspects of an individual: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE) and Mental Health (MH). The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Responses on the SF-12 were also used to calculate 2 summary scores: Physical component score (PCS) and mental component score (MCS). The score range for each of these 2 summary scores was from 0 (poor health) to 100 (better health), where 100 indicated good health condition. Mean change from baseline in PCS and MCS scores are reported in this outcome measure.'}, {'measure': 'Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Month 1, 3, 6, 12, 18 and 24', 'timeFrame': 'Baseline, Month 1, 3, 6, 12, 18 and 24', 'description': "FACIT-Fatigue questionnaire consists of 13 self-evaluated questions. Each question has a response of values 0 (not at all) to 4 (very much). Score for each question is calculated by first reversing negatively stated-items (subtracting the response from '4' except for the 2 positively stated-items) and then summing the raw (0-4) scores. The FACIT-Fatigue total score is derived by summing the response to each question which gives a value between 0 (worse score) and 52 (best score). Higher scores represent better participant's status (less fatigue). Mean change from baseline in FACIT-Fatigue total score is reported in this outcome measure."}, {'measure': 'Number of Participants With Tofacitinib Tolerance Issue', 'timeFrame': 'Month 24', 'description': 'Number of participants who discontinued tofacitinib due to tolerance issue.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthritis, Rheumatoid']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=A3921313', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Regarding Tofacitinib, newly introduced on the market, few data on drug retention and no data on the factors predictive of Tofacitinib drug survival in patients with RA are available.\n\nTherefore, the primary objective of the DeFacTo study will be to identify the factors predictive of Tofacitinib drug survival in patients with RA.\n\nAs secondary objectives, the impact of behavioural strategies on drug survival and other clinical parameters as well as Tofacitinib effectiveness and tolerability will be studied under real-life conditions of use in French patients with RA.', 'detailedDescription': "This is an observational, open-label, prospective, multi-centre, national study designed to evaluate the factors predictive of Tofacitinib's survival in patients with rheumatoid arthritis\n\nIf catastrophisation is described as a distortion of the perception of pain involving a both emotional and cognitive component, pushing the patient to see only the worst, coping involves adaptive strategies by which the patient attempts to find solutions in order to better cope with his/her disease. It has been demonstrated that such behavioural strategies can influence directly or indirectly the intensity of symptoms in patients suffering from chronic disease.\n\nTherefore, as secondary objectives, the impact of behavioural strategies on drug survival and other clinical parameters as well as Tofacitinib effectiveness and tolerability will be studied under real-life conditions of use in French patients with RA.\n\nThe duration of this study will be approximately 48 months including a 24-month recruitment period and a 24-month patient follow-up period.\n\nPatients will be followed prospectively and follow-up visits will be conducted after the initial consultations. No visit or additional test is required by the protocol, since the study is observational"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a diagnosis of moderate to severe active rheumatoid arthritis for whom the rheumatologist has decided to initiate a treatment with Tofacitinib', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient 18 years of age or older\n* Patient in whom the diagnosis of moderate to severe active rheumatoid arthritis has been confirmed by a rheumatologist\n* Patient for whom the rheumatologist decides to initiate treatment with Tofacitinib\n* Patient informed of the study\n\nExclusion Criteria:\n\n* Patient participating in a randomised clinical trial.\n* Patient presenting with a contraindication to prescription of Tofacitinib\n* Patients who are investigational site staff members or patients who are Pfizer employees directly involved in the conduct of the trial.'}, 'identificationModule': {'nctId': 'NCT03981900', 'briefTitle': "IDentification of Factors Predictive of Tofacitinib's Survival in Patient With Rheumatoid Arthritis", 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': "IDentification of Predictive Factors of Continuation of Treatment With Tofacitinib in Patients With Rheumatoid Arthritis in Common Practice and the Impact of the Patient's Behavioural Strategies on Clinical Parameters: The DeFacTo Study.", 'orgStudyIdInfo': {'id': 'A3921313'}, 'secondaryIdInfos': [{'id': 'DeFacTo', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rheumatoid arthritis', 'description': 'All participants with a diagnosis of moderate to severe active rheumatoid arthritis and treated with Tofacitinib', 'interventionNames': ['Drug: Tofacitinib']}], 'interventions': [{'name': 'Tofacitinib', 'type': 'DRUG', 'otherNames': ['Xeljanz'], 'description': '5 mg BID, oral administrtaion', 'armGroupLabels': ['Rheumatoid arthritis']}, {'name': 'Tofacitinib', 'type': 'DRUG', 'otherNames': ['Xeljanz'], 'description': 'tablet form 11mg once daily oral', 'armGroupLabels': ['Rheumatoid arthritis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62022', 'city': 'Arras', 'country': 'France', 'facility': "Centre Hospitalier D'arras", 'geoPoint': {'lat': 50.29301, 'lon': 2.78186}}, {'zip': '93602', 'city': 'Aulnay-sous-Bois', 'country': 'France', 'facility': 'Hopital Robert Ballanger', 'geoPoint': {'lat': 48.93814, 'lon': 2.49402}}, {'zip': '15000', 'city': 'Aurillac', 'country': 'France', 'facility': 'Cabinet Medical', 'geoPoint': {'lat': 44.92539, 'lon': 2.43983}}, {'zip': '89011', 'city': 'Auxerre', 'country': 'France', 'facility': 'Centre Hospitalier D Auxerre', 'geoPoint': {'lat': 47.7996, 'lon': 3.57033}}, {'zip': '62600', 'city': 'Berck', 'country': 'France', 'facility': 'Institut Calot Helio Marin', 'geoPoint': {'lat': 50.4, 'lon': 1.6}}, {'zip': '93009', 'city': 'Bobigny', 'country': 'France', 'facility': 'hopital Avicenne', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'zip': '01012', 'city': 'Bourg-en-Bresse', 'country': 'France', 'facility': 'Centre Hospitalier de Fleyriat', 'geoPoint': {'lat': 46.20574, 'lon': 5.2258}}, {'zip': '18020', 'city': 'Bourges', 'country': 'France', 'facility': 'Hopital Jacques Cœur', 'geoPoint': {'lat': 47.08333, 'lon': 2.4}}, {'zip': '29200', 'city': 'Brest', 'country': 'France', 'facility': 'Cabinet Medical', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '19100', 'city': 'Brive-la-Gaillarde', 'country': 'France', 'facility': 'Cabinet Medical', 'geoPoint': {'lat': 45.1589, 'lon': 1.53326}}, {'zip': '33520', 'city': 'Bruges', 'country': 'France', 'facility': 'Cabinet Medical', 'geoPoint': {'lat': 44.88287, 'lon': -0.61222}}, {'zip': '46005', 'city': 'Cahors', 'country': 'France', 'facility': 'Centre Hospitalier Jean Rougier', 'geoPoint': {'lat': 44.4491, 'lon': 1.43663}}, {'zip': '69641', 'city': 'Caluire-et-Cuire', 'country': 'France', 'facility': 'Infirmerie Protestante de Lyon', 'geoPoint': {'lat': 45.79462, 'lon': 4.8464}}, {'zip': '06414', 'city': 'Cannes', 'country': 'France', 'facility': 'Hopital Pierre Nouveau', 'geoPoint': {'lat': 43.55135, 'lon': 7.01275}}, {'zip': '11010', 'city': 'Carcassonne', 'country': 'France', 'facility': 'Centre Hospitalier de Carcassonne', 'geoPoint': {'lat': 43.21649, 'lon': 2.34863}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Hopital Gabriel Montpied', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '60321', 'city': 'Compiègne', 'country': 'France', 'facility': 'Centre Hospitalier de Compiegne', 'geoPoint': {'lat': 49.41794, 'lon': 2.82606}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Hopital Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '28102', 'city': 'Dreux', 'country': 'France', 'facility': 'Hopital Victor Jousselin', 'geoPoint': {'lat': 48.73649, 'lon': 1.36566}}, {'zip': '91265', 'city': 'Juvisy-sur-Orge', 'country': 'France', 'facility': 'Centre Hospitalier des Deux Vallees Juvisy', 'geoPoint': {'lat': 48.68333, 'lon': 2.38333}}, {'zip': '05000', 'city': 'La Battie Vieille', 'country': 'France', 'facility': 'Cabinet Medical'}, {'zip': '83260', 'city': 'La Moutonne', 'country': 'France', 'facility': 'Cabinet Medical', 'geoPoint': {'lat': 43.1179, 'lon': 6.07515}}, {'zip': '85925', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'Centre Hospitalier Departemental Vendee Les Oudairies', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '33110', 'city': 'Le Bouscat', 'country': 'France', 'facility': 'Hopital Suburbain Du Bouscat', 'geoPoint': {'lat': 44.86488, 'lon': -0.59864}}, {'zip': '33491', 'city': 'Le Bouscat', 'country': 'France', 'facility': 'Hopital Suburbain', 'geoPoint': {'lat': 44.86488, 'lon': -0.59864}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Lille - Hopital B Roger Salengro', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Hopital B Roger Salengro-chu De Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'Hopital Dupuytren', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '87100', 'city': 'Limoges', 'country': 'France', 'facility': 'Cabinet Medical', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '69009', 'city': 'Lyon', 'country': 'France', 'facility': 'Clinique de La Sauvegarde / Cabinet Le Trait D Union', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69337', 'city': 'Lyon', 'country': 'France', 'facility': 'Clinique de la Sauvegarde', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '82000', 'city': 'Montauban', 'country': 'France', 'facility': 'Clinique du Pont de Chaume', 'geoPoint': {'lat': 44.01759, 'lon': 1.3542}}, {'zip': '82013', 'city': 'Montauban', 'country': 'France', 'facility': 'Centre Hospitalier de Montauban', 'geoPoint': {'lat': 44.01759, 'lon': 1.3542}}, {'zip': '71307', 'city': 'Montceau-les-Mines', 'country': 'France', 'facility': 'Centre Hospitalier Montceau Les Mines-Hopital Jean Bouveri', 'geoPoint': {'lat': 46.66667, 'lon': 4.36667}}, {'zip': '76290', 'city': 'Montivilliers', 'country': 'France', 'facility': 'Hopital Jacques Monod', 'geoPoint': {'lat': 49.54518, 'lon': 0.18769}}, {'zip': '34000', 'city': 'Montpellier', 'country': 'France', 'facility': 'Cabinet Medical', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '34070', 'city': 'Montpellier', 'country': 'France', 'facility': 'Cabinet Medical Saint Roch', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '34070', 'city': 'Montpellier', 'country': 'France', 'facility': 'Clinique Beau Soleil', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Hopital Lapeyronie', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'Hopital Caremeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '45067', 'city': 'Orléans', 'country': 'France', 'facility': 'Centre Hospitalier Orleans-Hopital La Source', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '75008', 'city': 'Paris', 'country': 'France', 'facility': 'Cabinet Medical', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75651', 'city': 'Paris', 'country': 'France', 'facility': 'Centre Hospitalier Pitie Salpetriere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75679', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75877', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Bichat Claude Bernard', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '24019', 'city': 'Périgueux', 'country': 'France', 'facility': 'Centre Hospitalier de Perigueux', 'geoPoint': {'lat': 45.18691, 'lon': 0.71439}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Hospices Civils de Lyon - Hopital Lyon Sud- Hematologie', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'Cabinet Medical', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'Centre Hospitalier La Miletrie', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '74374', 'city': 'Pringy', 'country': 'France', 'facility': 'Centre Hospitalier Annecy Genevois Site Annecy', 'geoPoint': {'lat': 45.94622, 'lon': 6.12608}}, {'zip': '76031', 'city': 'Rouen', 'country': 'France', 'facility': 'Hopital Charles Nicolle', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '50000', 'city': 'Saint-Lô', 'country': 'France', 'facility': 'Cabinet Medical', 'geoPoint': {'lat': 49.11624, 'lon': -1.09031}}, {'zip': '94163', 'city': 'Saint-Mandé', 'country': 'France', 'facility': 'Hopital Inter-armees Begin', 'geoPoint': {'lat': 48.83864, 'lon': 2.41579}}, {'zip': '97410', 'city': 'Saint-Pierre', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire Saint Pierre', 'geoPoint': {'lat': 43.29282, 'lon': 5.40682}}, {'zip': '42277', 'city': 'Saint-Priest-en-Jarez', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire Saint Etienne Hopital Nord', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}, {'zip': '42277', 'city': 'Saint-Priest-en-Jarez', 'country': 'France', 'facility': 'Hopital Nord', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}, {'zip': '65013', 'city': 'Tarbes', 'country': 'France', 'facility': 'Centre Hospitalier de Bigorre Site La Gespe', 'geoPoint': {'lat': 43.23407, 'lon': 0.07139}}, {'zip': '31036', 'city': 'Toulouse', 'country': 'France', 'facility': 'Clinique Medipole Garonne', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Hopital Purpan', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '31400', 'city': 'Toulouse', 'country': 'France', 'facility': 'Cabinet Medical', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37000', 'city': 'Tours', 'country': 'France', 'facility': 'Cabinet de Rhumatologie', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '37000', 'city': 'Tours', 'country': 'France', 'facility': 'Cabinet Medical', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '10003', 'city': 'Troyes', 'country': 'France', 'facility': 'Hopital des Hauts Clos', 'geoPoint': {'lat': 48.30073, 'lon': 4.08524}}, {'zip': '59322', 'city': 'Valenciennes', 'country': 'France', 'facility': 'Cabinet Medical', 'geoPoint': {'lat': 50.35909, 'lon': 3.52506}}, {'zip': '47305', 'city': 'Villeneuve-sur-Lot', 'country': 'France', 'facility': 'Hopital Psv', 'geoPoint': {'lat': 44.40854, 'lon': 0.70415}}, {'zip': '94300', 'city': 'Vincennes', 'country': 'France', 'facility': 'Cabinet Medical', 'geoPoint': {'lat': 48.8486, 'lon': 2.43769}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}