Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-01-04 @ 3:04 AM
Study NCT ID:
NCT02585258
Status:
COMPLETED
Last Update Posted:
2023-07-18
First Post:
2015-10-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Finland']}, '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': 'D011239', 'term': 'Prednisolone'}, {'id': 'D005938', 'term': 'Glucocorticoids'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eb@amsterdamumc.nl', 'phone': '+3120-4444474', 'title': 'Prof Maarten Boers', 'organization': 'Amsterdam UMC, Vrije Universiteit'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Initially slow recruitment, initiatives to enhance recruitment and retention hampered or prohibited by strict and varying ethical guidelines across countries.\n\nThe covid-19 pandemic compromised collection of important endpoint data. The pragmatic design caused confounding by treatment changes, most likely reducing the difference in benefit between the groups.\n\nPost-hoc specification of adverse event frequencies done outside of statistical analysis plan.\n\nSee reference list (trial results).'}}, 'adverseEventsModule': {'timeFrame': '2 years', 'description': "At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list).\n\nSpecifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report:\n\n* SAE per specific term,\n* all non-serious AE reported \\>5%. This table includes both AESI and non-AESI.", 'eventGroups': [{'id': 'EG000', 'title': 'Prednisolone', 'description': 'prednisolone 5 mg per day\n\nPrednisolone: capsules 5 mg / day', 'otherNumAtRisk': 224, 'deathsNumAtRisk': 224, 'otherNumAffected': 169, 'seriousNumAtRisk': 224, 'deathsNumAffected': 3, 'seriousNumAffected': 55}, {'id': 'EG001', 'title': 'Placebo', 'description': 'placebo capsules once per day\n\nPlacebo: capsules 1 / day', 'otherNumAtRisk': 225, 'deathsNumAtRisk': 225, 'otherNumAffected': 164, 'seriousNumAtRisk': 225, 'deathsNumAffected': 2, 'seriousNumAffected': 46}], 'otherEvents': [{'term': 'all nonserious events', 'notes': 'total. placed under general disorders because system requires an organ system specification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 989, 'numAffected': 169}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 732, 'numAffected': 164}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'bronchitis, nasopharyngitis, respiratory tract infection', 'notes': 'combination of 3 terms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 53, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 50, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'urinary tract infection, cystitis', 'notes': 'combination of terms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 52, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 30, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'influenza, influenza-like illness', 'notes': 'combination of terms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 26, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 25, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 17, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}], 'seriousEvents': [{'term': 'myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'myocardial ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'atrial fibrillation/flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'AV block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'diverticular perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'lower gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'chesst discomfort/pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'abcess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'bursitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'covid-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'fungal infection', 'notes': 'oropharyngeal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'infectious pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'parainfluenzae infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'gastroenteritis, parasitic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'salmonellosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'epidydimitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'Postoperative abscess Hematoma infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'contusion', 'notes': 'chest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'spine fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'multiple fractures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'synovial rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'tendon rupture', 'notes': 'supraspinatus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'prostate specific antigen increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'weight decrease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'arthritis', 'notes': 'pseudoseptic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'intravertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'lung carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'basal cell carinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'epenymoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'gastrointestinal stromal tumor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'pancreas carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'urothelium transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'carotid atherosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'complex regional pain syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'facial paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'neuralgia, intercostal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'radicular syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'transient ischemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'intracranial hemorrhage, traumatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'Vertebrobasilar insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'dementia, neuropsychiatric symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'hyperventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'cough, productive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'total hip replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'thyroidectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'prostatectomy, transurethral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}, {'term': 'hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Signs and Symptoms: Mean DAS28 Post Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisolone', 'description': 'prednisolone 5 mg per day\n\nPrednisolone: capsules 5 mg / day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo capsules once per day\n\nPlacebo: capsules 1 / day'}], 'classes': [{'title': '3 months', 'categories': [{'measurements': [{'value': '3.26', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '3.62', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '3.06', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '3.42', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '2.89', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '3.25', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '3.02', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '3.89', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '2.97', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '3.33', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'mean difference over 2-years', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '-0.37', 'ciUpperLimit': '-0.23', 'pValueComment': 'one-sided.', 'estimateComment': 'placebo is reference. Negative difference is beneficial, means lower disease activity in prednisolone group.', 'groupDescription': 'mixed model reports the effect of treatment, adjusted for stratification factors', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '0,3,6,12,18,24 months', 'description': 'mean of the DAS28 (disease activity score-28 joints) post baseline. Range 0-8, higher scores mean more disease activity. See link in reference list.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'modified Intention-to-treat includes all patients who took study medication and attended at least one follow up visit'}, {'type': 'PRIMARY', 'title': 'The Total Number of Patients Experiencing at Least One Adverse Event (AE) of Special Interest (AESI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisolone', 'description': 'prednisolone 5 mg per day\n\nPrednisolone: capsules 5 mg / day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo capsules once per day\n\nPlacebo: capsules 1 / day'}], 'classes': [{'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '1.24', 'ciLowerLimit': '1.04', 'pValueComment': 'one-sided', 'estimateComment': 'prednisolone/placebo', 'groupDescription': 'mixed model reports the effect of treatment, adjusted for stratification factors', 'statisticalMethod': 'GEE', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months', 'description': 'AESI: (a serious adverse event \\[SAE\\], or an AE on a prespecified list of clinically relevant AEs commonly associated with the disease and glucocorticoid use', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Joint Damage Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisolone', 'description': 'prednisolone 5 mg per day\n\nPrednisolone: capsules 5 mg / day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo capsules once per day\n\nPlacebo: capsules 1 / day'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '6.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'mean differences over 2 years', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '-1.67', 'ciUpperLimit': '-0.68', 'pValueComment': 'one-sided', 'estimateComment': 'placebo is reference. Negative difference means less damage progression in prednisolone group.', 'groupDescription': 'mixed model reports the effect of treatment, adjusted for stratification factors', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '0, 24 months', 'description': '2-year change in total Sharp/van der Heijde damage score of hands and forefeet radiographs. Range of damage score: 0-448.\n\nscore at 24 months minus score at baseline: positive result means increasing/worsening of damage.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prednisolone', 'description': 'prednisolone 5 mg per day\n\nPrednisolone: capsules 5 mg / day'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'placebo capsules once per day\n\nPlacebo: capsules 1 / day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '226'}, {'groupId': 'FG001', 'numSubjects': '225'}]}, {'type': 'Started Study Meds: Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '224'}, {'groupId': 'FG001', 'numSubjects': '225'}]}, {'type': 'Returned for Follow up: Modified Intention-to-treat (ITT) Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '221'}, {'groupId': 'FG001', 'numSubjects': '223'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}, {'groupId': 'FG001', 'numSubjects': '137'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '88'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'includes covid-related access problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'BG000'}, {'value': '225', 'groupId': 'BG001'}, {'value': '449', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Prednisolone', 'description': 'prednisolone 5 mg per day\n\nPrednisolone: capsules 5 mg / day'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'placebo capsules once per day\n\nPlacebo: capsules 1 / day'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'BG000'}, {'value': '225', 'groupId': 'BG001'}, {'value': '449', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '224', 'groupId': 'BG000'}, {'value': '225', 'groupId': 'BG001'}, {'value': '449', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'BG000'}, {'value': '225', 'groupId': 'BG001'}, {'value': '449', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '72.5', 'spread': '5.3', 'groupId': 'BG000'}, {'value': '72.6', 'spread': '5.4', 'groupId': 'BG001'}, {'value': '72.6', 'spread': '5.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'BG000'}, {'value': '225', 'groupId': 'BG001'}, {'value': '449', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '316', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'BG000'}, {'value': '225', 'groupId': 'BG001'}, {'value': '449', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}]}]}, {'title': 'Romania', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'BG000'}, {'value': '225', 'groupId': 'BG001'}, {'value': '449', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'BG000'}, {'value': '225', 'groupId': 'BG001'}, {'value': '449', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}, {'title': 'Europe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'BG000'}, {'value': '225', 'groupId': 'BG001'}, {'value': '449', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'BG000'}, {'value': '225', 'groupId': 'BG001'}, {'value': '449', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27.2', 'spread': '4.5', 'groupId': 'BG000'}, {'value': '27.2', 'spread': '4.4', 'groupId': 'BG001'}, {'value': '27.2', 'spread': '4.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'disease duration', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'BG000'}, {'value': '225', 'groupId': 'BG001'}, {'value': '449', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10.8', 'spread': '10.4', 'groupId': 'BG000'}, {'value': '10.2', 'spread': '10.2', 'groupId': 'BG001'}, {'value': '10.6', 'spread': '10.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'DAS28 (Disease activity scale-28 joints)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'BG000'}, {'value': '225', 'groupId': 'BG001'}, {'value': '449', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4.43', 'spread': '1.04', 'groupId': 'BG000'}, {'value': '4.60', 'spread': '1.05', 'groupId': 'BG001'}, {'value': '4.51', 'spread': '1.05', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'DAS28 is an index that calculates a score based on 4 measures:\n\npainful joint count (28 joints), swollen joint count (28 joints), patient global assessment (0-10), and erythrocyte sedimentation rate. The range is from 0-8, with higher scores indicating more disease activity.\n\nsee: link in reference list.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sharp-van der Heijde damage score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '406', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20.0', 'spread': '34.6', 'groupId': 'BG000'}, {'value': '17.2', 'spread': '33.4', 'groupId': 'BG001'}, {'value': '18.6', 'spread': '34.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Sharp van der Heijde joint damage score is a score based on assessment of joint space narrowing and extent of erosions on a semi-quantitative scale, in selected joints of hands and forefeet. Theoretical range is from 0-448. A higher score means more damage.\n\nSee reference list.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'not all patients had available radiographs for scoring'}], 'populationDescription': 'safety population: excludes 2 patients who did not start study medication'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-12', 'size': 1699956, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-01-20T04:21', 'hasProtocol': True}, {'date': '2021-03-02', 'size': 1750874, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-12-09T09:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 451}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-15', 'studyFirstSubmitDate': '2015-10-20', 'resultsFirstSubmitDate': '2021-12-20', 'studyFirstSubmitQcDate': '2015-10-22', 'lastUpdatePostDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-15', 'studyFirstPostDateStruct': {'date': '2015-10-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Signs and Symptoms: Mean DAS28 Post Baseline', 'timeFrame': '0,3,6,12,18,24 months', 'description': 'mean of the DAS28 (disease activity score-28 joints) post baseline. Range 0-8, higher scores mean more disease activity. See link in reference list.'}, {'measure': 'The Total Number of Patients Experiencing at Least One Adverse Event (AE) of Special Interest (AESI)', 'timeFrame': '24 months', 'description': 'AESI: (a serious adverse event \\[SAE\\], or an AE on a prespecified list of clinically relevant AEs commonly associated with the disease and glucocorticoid use'}], 'secondaryOutcomes': [{'measure': 'Joint Damage Progression', 'timeFrame': '0, 24 months', 'description': '2-year change in total Sharp/van der Heijde damage score of hands and forefeet radiographs. Range of damage score: 0-448.\n\nscore at 24 months minus score at baseline: positive result means increasing/worsening of damage.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['RheumatoId Arthritis']}, 'referencesModule': {'references': [{'pmid': '28029750', 'type': 'BACKGROUND', 'citation': 'Palmowski Y, Buttgereit T, Dejaco C, Bijlsma JW, Matteson EL, Voshaar M, Boers M, Buttgereit F. "Official View" on Glucocorticoids in Rheumatoid Arthritis: A Systematic Review of International Guidelines and Consensus Statements. Arthritis Care Res (Hoboken). 2017 Aug;69(8):1134-1141. doi: 10.1002/acr.23185. Epub 2017 Jul 10.'}, {'pmid': '29073333', 'type': 'BACKGROUND', 'citation': 'Palmowski Y, Buttgereit F, Boers M. Reply. Arthritis Care Res (Hoboken). 2019 Apr;71(4):577-578. doi: 10.1002/acr.23452. No abstract available.'}, {'pmid': '29370811', 'type': 'BACKGROUND', 'citation': 'Hartman L, Rasch LA, Klausch T, Bijlsma HWJ, Christensen R, Smulders YM, Ralston SH, Buttgereit F, Cutolo M, Da Silva JAP, Opris D, Rovensky J, Szamosi S, Middelink LM, Lems WF, Boers M. Harm, benefit and costs associated with low-dose glucocorticoids added to the treatment strategies for rheumatoid arthritis in elderly patients (GLORIA trial): study protocol for a randomised controlled trial. Trials. 2018 Jan 25;19(1):67. doi: 10.1186/s13063-017-2396-3.'}, {'pmid': '30171815', 'type': 'BACKGROUND', 'citation': 'Hartman L, Lems WF, Boers M. Outcome measures for adherence data from a medication event monitoring system: A literature review. J Clin Pharm Ther. 2019 Feb;44(1):1-5. doi: 10.1111/jcpt.12757. Epub 2018 Sep 1.'}, {'pmid': '33682887', 'type': 'BACKGROUND', 'citation': 'Hartman L, Cutolo M, Bos R, Opris-Belinski D, Kok MR, Griep-Wentink HJRM, Klaasen R, Allaart CF, Bruyn GAW, Raterman HG, Voshaar MJH, Gomes N, Pinto RMA, Klausch LT, Lems WF, Boers M. Medication adherence in older people with rheumatoid arthritis is lower according to electronic monitoring than according to pill count. Rheumatology (Oxford). 2021 Nov 3;60(11):5239-5246. doi: 10.1093/rheumatology/keab207.'}, {'pmid': '31421022', 'type': 'BACKGROUND', 'citation': 'Palmowski A, Nielsen SM, Buttgereit T, Palmowski Y, Boers M, Christensen R, Buttgereit F. Association Between Participant Retention and the Proportion of Included Elderly People in Rheumatology Trials: Results From a Series of Exploratory Meta-Regression Analyses. Arthritis Care Res (Hoboken). 2020 Oct;72(10):1490-1496. doi: 10.1002/acr.24051.'}, {'pmid': '30466715', 'type': 'BACKGROUND', 'citation': 'Palmowski A, Buttgereit T, Palmowski Y, Nielsen SM, Boers M, Christensen R, Buttgereit F. Applicability of trials in rheumatoid arthritis and osteoarthritis: A systematic review and meta-analysis of trial populations showing adequate proportion of women, but underrepresentation of elderly people. Semin Arthritis Rheum. 2019 Jun;48(6):983-989. doi: 10.1016/j.semarthrit.2018.10.017. Epub 2018 Nov 2.'}, {'pmid': '32222381', 'type': 'BACKGROUND', 'citation': 'Palmowski A, Nielsen SM, Buttgereit T, Palmowski Y, Boers M, Christensen R, Buttgereit F. Glucocorticoid-trials in rheumatoid arthritis mostly study representative real-world patients: A systematic review and meta-analysis. Semin Arthritis Rheum. 2020 Dec;50(6):1400-1405. doi: 10.1016/j.semarthrit.2020.02.016. Epub 2020 Mar 2.'}, {'pmid': '33075140', 'type': 'BACKGROUND', 'citation': 'Forsat ND, Palmowski A, Palmowski Y, Boers M, Buttgereit F. Recruitment and Retention of Older People in Clinical Research: A Systematic Literature Review. J Am Geriatr Soc. 2020 Dec;68(12):2955-2963. doi: 10.1111/jgs.16875. Epub 2020 Oct 19.'}, {'pmid': '34324628', 'type': 'BACKGROUND', 'citation': "Buttgereit T, Palmowski A, Forsat N, Boers M, Witham MD, Rodondi N, Moutzouri E, Navidad AJQ, Van't Hof AWJ, van der Worp B, Coll-Planas L, Voshaar M, de Wit M, da Silva J, Stegemann S, Bijlsma JW, Koeller M, Mooijaart S, Kearney PM, Buttgereit F. Barriers and potential solutions in the recruitment and retention of older patients in clinical trials-lessons learned from six large multicentre randomized controlled trials. Age Ageing. 2021 Nov 10;50(6):1988-1996. doi: 10.1093/ageing/afab147."}, {'pmid': '33394036', 'type': 'BACKGROUND', 'citation': "Santiago T, Voshaar M, de Wit M, Carvalho PD, Buttgereit F, Cutolo M, Paolino S, Castelar Pinheiro GR, Boers M, Da Silva JAP. Patients' and rheumatologists' perspectives on the efficacy and safety of low-dose glucocorticoids in rheumatoid arthritis-an international survey within the GLORIA study. Rheumatology (Oxford). 2021 Jul 1;60(7):3334-3342. doi: 10.1093/rheumatology/keaa785."}, {'pmid': '8523365', 'type': 'BACKGROUND', 'citation': "van der Heijde DM, van Leeuwen MA, van Riel PL, van de Putte LB. Radiographic progression on radiographs of hands and feet during the first 3 years of rheumatoid arthritis measured according to Sharp's method (van der Heijde modification). J Rheumatol. 1995 Sep;22(9):1792-6."}, {'pmid': '31132016', 'type': 'RESULT', 'citation': 'Hartman L, Bos R, Buttgereit F, Guler-Yuksel M, Ionescu R, Kok MR, Lems WF, Micaelo M, Opris-Belinski D, Pusztai A, Santos E, Da Silva J, Szekanecz Z, Zeiner K, Zhang D, Boers M. Remarkable international variability in reasons for ineligibility and non-participation in the GLORIA trial. Scand J Rheumatol. 2019 Jul;48(4):340-341. doi: 10.1080/03009742.2018.1559880. Epub 2019 May 27. No abstract available.'}, {'pmid': '35641125', 'type': 'RESULT', 'citation': 'Boers M, Hartman L, Opris-Belinski D, Bos R, Kok MR, Da Silva JA, Griep EN, Klaasen R, Allaart CF, Baudoin P, Raterman HG, Szekanecz Z, Buttgereit F, Masaryk P, Klausch LT, Paolino S, Schilder AM, Lems WF, Cutolo M; GLORIA Trial consortium. Low dose, add-on prednisolone in patients with rheumatoid arthritis aged 65+: the pragmatic randomised, double-blind placebo-controlled GLORIA trial. Ann Rheum Dis. 2022 Jul;81(7):925-936. doi: 10.1136/annrheumdis-2021-221957. Epub 2022 May 31.'}, {'pmid': '36165675', 'type': 'RESULT', 'citation': 'Hartman L, da Silva JAP, Buttgereit F, Cutolo M, Opris-Belinski D, Szekanecz Z, Masaryk P, Voshaar MJH, Heymans MW, Lems WF, van der Heijde DMFM, Boers M. Development of prediction models to select older RA patients with comorbidities for treatment with chronic low-dose glucocorticoids. Rheumatology (Oxford). 2023 May 2;62(5):1824-1833. doi: 10.1093/rheumatology/keac547.'}, {'pmid': '36335684', 'type': 'RESULT', 'citation': 'Hartman L, El Alili M, Cutolo M, Opris D, Da Silva J, Szekanecz Z, Buttgereit F, Masaryk P, Bos R, Kok MR, Paolino S, Coupe V, Lems WF, Boers M; GLORIA consortium. Cost-effectiveness and cost-utility of add-on, low-dose prednisolone in patients with rheumatoid arthritis aged 65+: The pragmatic, multicenter, placebo-controlled GLORIA trial. Semin Arthritis Rheum. 2022 Dec;57:152109. doi: 10.1016/j.semarthrit.2022.152109. Epub 2022 Oct 21.'}, {'pmid': '36810945', 'type': 'DERIVED', 'citation': 'Palmowski A, Nielsen SM, Boyadzhieva Z, Schneider A, Pankow A, Hartman L, Da Silva JAP, Kirwan J, Wassenberg S, Dejaco C, Christensen R, Boers M, Buttgereit F. Safety and efficacy associated with long-term low-dose glucocorticoids in rheumatoid arthritis: a systematic review and meta-analysis. Rheumatology (Oxford). 2023 Aug 1;62(8):2652-2660. doi: 10.1093/rheumatology/kead088.'}], 'seeAlsoLinks': [{'url': 'https://www.das-score.nl/en/', 'label': 'description of DAS28 score instrument'}]}, 'descriptionModule': {'briefSummary': 'Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis:\n\nThe Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study (GLORIA)', 'detailedDescription': "Rationale: Rheumatoid arthritis (RA) is a condition with high impact both on the individual and society. In the context of comparing the effectiveness of existing healthcare interventions in the elderly, RA is a condition highly relevant to the community since it has a strongly negative impact on the quality of life of the individual, is particularly frequent in the elderly, and is associated with significant costs. RA management remains challenging: there is an urgent unmet medical and societal need for improved treatment strategies that are effective, safe and affordable. Evidence based information on the glucocorticoid (GC) harm/benefit balance will have a high impact on RA treatment strategies and on treatment strategies for the many other inflammatory disorders for which GCs are considered. The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study (GLORIA) is a 5-year project funded by the European Commission under the Horizon 2020 Program, designed to address these needs.\n\nObjective: The primary objectives of the GLORIA project are twofold:\n\n1. To assess the effectiveness, safety and cost-effectiveness of low-dose GC therapy (5 mg/day) compared to placebo given for two years as co-treatment for elderly RA patients (≥ 65 years) in a pragmatic randomized trial;\n2. To assess study medication adherence through a medication packaging solution, and test the effectiveness of smart device technology to improve adherence.\n\nOther objectives of the GLORIA project are: to deliver an outcome prediction model for individual patient outcome, to tailor treatment strategies for elderly RA patients with comorbidities; and deliver data to support:\n\n1. better guidelines on RA treatment in the elderly;\n2. more accurate information for elderly RA patients, their physicians and researchers;\n3. improved strategies for trial design and conduct in the elderly.\n\nStudy design: The GLORIA study is a randomized, double-blind, placebo-controlled pragmatic multicenter clinical trial to assess the effectiveness and safety of a daily dose of 5 mg prednisolone or matching placebo in elderly RA patients. Patients will be randomized into two arms: the experimental arm (receiving prednisolone 5 mg/day) or the control arm (receiving placebo). The design emulates the routine care setting: eligibility criteria are very liberal, assessments and procedures are tailored to represent standard of care, and concurrent antirheumatic treatment is allowed next to the trial medication with minimal limitations. Furthermore, all patients will have an adherence monitoring device loaded into the cap of the drug bottle; adherence data will be monitored throughout the trial. In addition, to test the effect of adherence reminders, a substudy (another trial) will be nested in the main GLORIA trial.\n\nSubstudy design: The substudy is limited to patients with a smart device (smartphone, tablet, etc) who have completed at least 3 months of the main study on treatment. The experimental arm of the substudy will receive an application loaded onto their smart device that communicates with an adherence monitoring device loaded into the cap of the drug bottle and delivers reminders to improve adherence. The control arm of the substudy will not have this application and reminders. The substudy has a duration of three months.\n\nStudy population: Patients of 65 years of age and older with RA according to the 1987 or the 2010 classification criteria of the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR), requiring antirheumatic therapy because of inadequate disease control, as evidenced by a disease activity score of 28 joints calculated with erythrocyte sedimentation rate (DAS28) ≥2.60.\n\nSubstudy population: Patients in the main study who have completed at least 3 months on treatment, in possession of and familiar with a smart device.\n\nIntervention: In this two-armed clinical trial, patients will be randomized to either the experimental arm or the control arm. The experimental arm will receive prednisolone 5 mg/day added to existing antirheumatic treatment. The control arm will receive matching placebo added to existing antirheumatic treatment. Treatment duration is two years per patient. Subsequently, study drug is tapered in linear fashion to zero in 6 weeks by inserting increasing numbers of non-treatment days. Patients experiencing a flare at that time can restart open label prednisolone at the discretion of the treating rheumatologist.\n\nCo-interventions: As part of standard of care all patients will receive Calcium 500 mg/Vitamin D3 800 IU. Besides the study medication, almost all treatment is allowed; both treatment for comorbidities, as well as antirheumatic treatment. This includes biologic and nonbiologic disease-modifying antirheumatic drugs (DMARDs), non-steroidal anti-inflammatory drugs (NSAIDs), short term oral or parental GCs for comorbidities and acetaminophen. However, it is advised not to start other antirheumatic therapy (DMARD, biologic) or give intra-articular or intramuscular GC injections, especially not in the first 3 months, but it is allowed if clinically judged as unavoidable. In such cases, preferred administration is at baseline.\n\nSubstudy intervention: All patients will have an adherence monitoring device loaded into the cap of the drug bottle that will be equipped with a wireless transmitter, which not only tracks adherence but can also communicate real time with a smart device of the patient (smartphone, tablet, etc.), through special software to remind patients of the time of medication. In the substudy, patients with a smart device will receive an application loaded on their smart device that communicates with the adherence monitoring device loaded into the cap of the drug bottle. The app sends a reminder message to the patient when it's time to take the medication and in case of non-adherence the app also sends an alert message to inform the patient he or she has forgotten to take the medication. Eligible patients will be randomized to either the experimental arm that receive reminders on their smart device, or to the control arm that will not receive reminders, for a period of 3 months.\n\nMain study endpoints:\n\n* To measure benefit, primary endpoints are a) signs and symptoms: the time-averaged mean value (estimated from linear mixed models) of the DAS28; b) damage progression: change from baseline after 2-years in total Sharp/van der Heijde damage score of hands and forefeet radiographs.\n* To measure safety, the primary endpoint is the total number of patients experiencing at least one serious adverse event, or one clinical event related to the disease or its therapy.\n* Other major outcomes are cost-effectiveness, cost-utility, and medication adherence.\n\nAssessment takes place at varying intervals, and includes seven clinic visits and 3 assessments by telephone.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: GLORIA is a pragmatic trial, with measurements that are almost all part of standard of care, and therefore there are no additional risks associated with these measurements. However, the intervention in this trial is that patients are randomized to either standard of care with low-dose GCs or standard of care without low-dose GCs for a duration of two years. It is known that GCs have strong favorable effects on disease activity, of which patients randomised to the control arm (placebo) cannot benefit. However, side effects of GCs are known as well, and patients in the experimental arm (prednisone 5 mg/day) might suffer from them. Although side effects predominantly occur when GC are used in high doses for long periods of time, elderly are more likely to suffer from adverse effects of the disease and its therapy than younger patients. However, elderly are underrepresented or even excluded from many clinical trials, so it is difficult to estimate their risk: this forms the rationale for the trial. To reduce risks, participants are monitored and patients with a low probability of benefit and patients with a high probability of harm will be excluded from participation to this trial. For the substudy to measure adherence through an innovative application, no additional risks are expected: if the application appears to be successful, patients randomised to the intervention can only benefit from it since it improves their medication adherence; in case the application is not successful, for patients not randomised to the application or for patients without a smart device, no difference is expected with the 'normal' situation, in which patients do not have access to an adherence application."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Population (base) RA patients of 65 years of age and older requiring antirheumatic therapy.\n\nInclusion criteria\n\nIn order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n* RA according to the 1987 or the 2010 classification criteria of the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) (Aletaha D et al, Ann Rheum Dis 2010;69:1580);\n* inadequate disease control, as evidenced by a disease activity score of 28 joints calculated with erythrocyte sedimentation rate (DAS28) ≥2.60;\n* age ≥ 65 years.\n\nExclusion criteria\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\nLower probability of benefit:\n\n* Change, stop or start of antirheumatic treatment in the last month prior to eligibility assessment, including methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, azathioprine, intramuscular and oral gold, cyclosporine, biologic agents including anti-tumor necrosis factor (TNF), anakinra, abatacept, rituximab, tocilizumab (temporary exclusion);\n* Treatment with systemic GC: oral or parenteral GC with a cumulative prednisolone equivalent dose of 200 mg or higher in the last 3 months;\n* Treatment with any GC (oral, intra-articular, intravenous or intramuscular) in the last 30 days (temporary exclusion);\n* Note: as this is a pragmatic trial, patients who require start of (other) antirheumatic treatment at baseline or during the trial can still be eligible (see 7.1).\n\nHigher probability of harm:\n\n* Exposure to investigational therapy in the last three months;\n* Current participation in another clinical trial;\n* Major surgery, donation or loss of approximately 500 ml blood within 4 weeks prior to the screening visit (temporary exclusion)\n* Absolute contraindication to low-dose prednisolone, as determined by the treating physician, such as: uncontrolled chronic infections, diabetes mellitus, hypertension, osteoporosis. When these conditions are under control (e.g. with antiosteoporosis drugs, antihypertensive drugs) these patients can enter;\n* Absolute contraindication to Calcium and/or Vitamin D supplement as determined by the treating physician, such as: hyperparathyroidism (when insufficiently treated);\n* Uncontrolled comorbid conditions, short life span, etc. as determined by the treating physician.\n\nDifficulty to measure harm/benefit:\n\n* Absolute indication to start with oral or intravenous GC, according to the treating physician;\n* Inability to comply with medical instructions or inability to assess major outcomes at 6-monthly visits, in the assessment of the treating physician.\n\nSubjects/patients not capable or willing to provide informed consent.\n\nSubstudy\n\nAdditional exclusion criteria for subjects participating in the substudy to measure the effect of a reminder via smart device on adherence:\n\nInability/difficulty to measure benefit:\n\n* Not in the possession of a smart device;\n* Premature discontinuation of study medication within or at 3 months of the main trial.'}, 'identificationModule': {'nctId': 'NCT02585258', 'acronym': 'Gloria', 'briefTitle': 'The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study', 'organization': {'class': 'OTHER', 'fullName': 'Amsterdam UMC, location VUmc'}, 'officialTitle': 'The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the Cost-effectiveness and Safety of Additional Low-dose Glucocorticoid in Treatment Strategies for Elderly Patients With Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'VUMC-ARC-GLORIA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'prednisolone', 'description': 'prednisolone 5 mg per day', 'interventionNames': ['Drug: Prednisolone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo capsules once per day', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Prednisolone', 'type': 'DRUG', 'otherNames': ['glucocorticoid'], 'description': '1 capsule containing a tablet of 5 mg prednisolone/ day', 'armGroupLabels': ['prednisolone']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['matching placebo'], 'description': '1 capsule containing a placebo tablet / day', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Magdeburg', 'country': 'Germany', 'facility': 'Facharztpraxis', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'city': 'Püttlingen', 'country': 'Germany', 'facility': 'Knappschaftsklinikum Saar', 'geoPoint': {'lat': 49.2855, 'lon': 6.88723}}, {'city': 'Debrecen', 'country': 'Hungary', 'facility': 'University of Debrecen', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'city': 'Genova', 'country': 'Italy', 'facility': 'University of Genova', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Alkmaar', 'country': 'Netherlands', 'facility': 'Noordwest Ziekenhuis', 'geoPoint': {'lat': 52.63167, 'lon': 4.74861}}, {'city': 'Amersfoort', 'country': 'Netherlands', 'facility': 'Meander', 'geoPoint': {'lat': 52.155, 'lon': 5.3875}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'VUmc', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Apeldoorn', 'country': 'Netherlands', 'facility': 'Gelre', 'geoPoint': {'lat': 52.21, 'lon': 5.96944}}, {'city': 'Gouda', 'country': 'Netherlands', 'facility': 'Groene Hart Ziekenhuis', 'geoPoint': {'lat': 52.01667, 'lon': 4.70833}}, {'city': 'Groningen', 'country': 'Netherlands', 'facility': 'UMCG', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Leeuwarden', 'country': 'Netherlands', 'facility': 'MCL', 'geoPoint': {'lat': 53.20271, 'lon': 5.80973}}, {'city': 'Leiden', 'country': 'Netherlands', 'facility': 'LUMC', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'city': 'Lelystad', 'country': 'Netherlands', 'facility': 'MC Zuiderzee', 'geoPoint': {'lat': 52.50833, 'lon': 5.475}}, {'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'MUMC', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Maasstad', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Sneek', 'country': 'Netherlands', 'facility': 'Antonius Ziekenhuis', 'geoPoint': {'lat': 53.03297, 'lon': 5.6589}}, {'city': 'The Hague', 'country': 'Netherlands', 'facility': 'HAGA', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'UMC Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'city': 'Venlo', 'country': 'Netherlands', 'facility': 'VieCurie MC', 'geoPoint': {'lat': 51.37, 'lon': 6.16806}}, {'city': 'Coimbra', 'country': 'Portugal', 'facility': 'CHU Coimbra', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Hospital de Egas Moniz', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Hospital de Santa Maria', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Instituto Portugues de Reumatologia', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'city': 'Ponte de Lima', 'country': 'Portugal', 'facility': 'Hospital de Ponte Lima', 'geoPoint': {'lat': 41.76719, 'lon': -8.58393}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Carol Davila University of Medicine and Pharmacy', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Carol Davila', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'NURCH', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}], 'overallOfficials': [{'name': 'Maarten Boers, Prof. dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Amsterdam UMC, location VUmc'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'expected active from 2022', 'ipdSharing': 'YES', 'description': '(meta) data will be shared after signing a data sharing agreement, at reasonable cost', 'accessCriteria': 'scientific use'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amsterdam UMC, location VUmc', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Commission', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Prof. dr. M. Boers', 'investigatorAffiliation': 'Amsterdam UMC, location VUmc'}}}}