Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-01 @ 10:13 PM
Study NCT ID:
NCT01973569
Status:
COMPLETED
Last Update Posted:
2020-02-12
First Post:
2013-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
AMG 162 (Denosumab) Phase 3 Study (DESIRABLE Study) in Participants With Rheumatoid Arthritis on Disease-modifying Antirheumatic Drugs (DMARDs) Treatment
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': 'D000069448', 'term': 'Denosumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dsclinicaltrial@daiichisankyo.co.jp', 'phone': '+81 362251111 (M-F 9-5 JST)', 'title': 'Daiichi Sanyko', 'organization': 'Contact for Clinical Trial Information'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected from the first dose to the last dose of study drug, up to 12 months.', 'description': 'Adverse events that emerge (or worsen) from the first dose of study drug to the last dose of study drug were reported in the Safety Analysis Set. The Safety Analysis Set was defined as all enrolled participants who received at least one dose of the investigational product. One participant of the Denosumab 6 months group was administered the placebo mistakenly, and was thus included in the placebo group for the safety analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'Denosumab 6 Months', 'description': 'denosumab administered subcutaneously every 6 months\n\ndenosumab: denosumab administered subcutaneously', 'otherNumAtRisk': 221, 'deathsNumAtRisk': 221, 'otherNumAffected': 127, 'seriousNumAtRisk': 221, 'deathsNumAffected': 0, 'seriousNumAffected': 19}, {'id': 'EG001', 'title': 'Denosumab 3 Months', 'description': 'denosumab administered subcutaneously every 3 months\n\ndenosumab: denosumab administered subcutaneously', 'otherNumAtRisk': 222, 'deathsNumAtRisk': 222, 'otherNumAffected': 122, 'seriousNumAtRisk': 222, 'deathsNumAffected': 1, 'seriousNumAffected': 19}, {'id': 'EG002', 'title': 'Placebo', 'description': 'placebo administered subcutaneously to match denosumab\n\nplacebo: placebo administered subcutaneously to match denosumab', 'otherNumAtRisk': 224, 'deathsNumAtRisk': 224, 'otherNumAffected': 125, 'seriousNumAtRisk': 224, 'deathsNumAffected': 0, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 20}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 69}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 73}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Immune thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Paroxysmal arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Spinal muscular atrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sudden hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abscess jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Atypical mycobacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Muscle rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Spondylolisthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Synovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diffuse large B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Intraductal proliferative breast lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lymphoproliferative disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Squamous cell carcinoma of lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Brain stem infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Calculus bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Prerenal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Total Sharp Score (TSS) From Baseline to Month 12 Following Subcutaneous Administration of Denosumab or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 6 Months', 'description': 'denosumab administered subcutaneously every 6 months\n\ndenosumab: denosumab administered subcutaneously'}, {'id': 'OG001', 'title': 'Denosumab 3 Months', 'description': 'denosumab administered subcutaneously every 3 months\n\ndenosumab: denosumab administered subcutaneously'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'placebo administered subcutaneously to match denosumab\n\nplacebo: placebo administered subcutaneously to match denosumab'}], 'classes': [{'categories': [{'measurements': [{'value': '0.99', 'groupId': 'OG000', 'lowerLimit': '0.49', 'upperLimit': '1.49'}, {'value': '0.72', 'groupId': 'OG001', 'lowerLimit': '0.41', 'upperLimit': '1.03'}, {'value': '1.49', 'groupId': 'OG002', 'lowerLimit': '0.99', 'upperLimit': '1.99'}]}]}], 'analyses': [{'pValue': '0.0235', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'The hierarchical testing procedure was applied for multiple comparisons of the primary endpoint. First, comparison between AMG 162 60mg Q3M vs placebo is tested. Only if it is rejected, comparison of AMG 162 60mg Q6M vs placebo is formally tested.', 'statisticalMethod': 'van Elteren stratified rank test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to month 12', 'description': 'Change from baseline in Total Sharp Score (TSS) from baseline to month 12 was assessed. The TSS was defined as the sum of the erosion score and the joint space narrowing scores from radiographic assessments. The maximum radiographic TSS from the both hands/wrists and both feet is 448. Higher values represented greater damage.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'TSS was assessed in Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change in Total Sharp Score (TSS) From Baseline to Month 6 Following Subcutaneous Administration of Denosumab or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 6 Months', 'description': 'denosumab administered subcutaneously every 6 months\n\ndenosumab: denosumab administered subcutaneously'}, {'id': 'OG001', 'title': 'Denosumab 3 Months', 'description': 'denosumab administered subcutaneously every 3 months\n\ndenosumab: denosumab administered subcutaneously'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'placebo administered subcutaneously to match denosumab\n\nplacebo: placebo administered subcutaneously to match denosumab'}], 'classes': [{'categories': [{'measurements': [{'value': '0.62', 'groupId': 'OG000', 'lowerLimit': '0.27', 'upperLimit': '0.98'}, {'value': '0.48', 'groupId': 'OG001', 'lowerLimit': '0.24', 'upperLimit': '0.72'}, {'value': '0.92', 'groupId': 'OG002', 'lowerLimit': '0.60', 'upperLimit': '1.23'}]}]}], 'analyses': [{'pValue': '0.0360', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'van Elteren stratified rank test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to month 6', 'description': 'Change from baseline in Total Sharp Score (TSS) from baseline to month 6 was assessed. The TSS was defined as the sum of the erosion score and the joint space narrowing scores from radiographic assessments. The maximum radiographic TSS from the both hands/wrists and both feet is 448. Higher values represented greater damage.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'TSS was assessed in the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change in Erosion Score From Baseline to Month 6 Following Subcutaneous Administration of Denosumab or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 6 Months', 'description': 'denosumab administered subcutaneously every 6 months\n\ndenosumab: denosumab administered subcutaneously'}, {'id': 'OG001', 'title': 'Denosumab 3 Months', 'description': 'denosumab administered subcutaneously every 3 months\n\ndenosumab: denosumab administered subcutaneously'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'placebo administered subcutaneously to match denosumab\n\nplacebo: placebo administered subcutaneously to match denosumab'}], 'classes': [{'categories': [{'measurements': [{'value': '0.34', 'groupId': 'OG000', 'lowerLimit': '0.16', 'upperLimit': '0.53'}, {'value': '0.13', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '0.24'}, {'value': '0.58', 'groupId': 'OG002', 'lowerLimit': '0.39', 'upperLimit': '0.78'}]}]}], 'analyses': [{'pValue': '0.1323', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'van Elteren stratified rank test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to month 6', 'description': 'Change from baseline in Erosion Score from baseline to month 6 was assessed. The Erosion Score was defined for the sum of the joint level erosion scores among the 44 joints in both hands/wrist and both feet from radiographic assessments using the van der Heijde modified Sharp scoring method. The maximum radiographic Erosion Score from both hands/wrist and both feet is 280. Higher values represented greater damage.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Erosion Score was assessed in the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change in Joint Space Narrowing From Baseline to Month 6 Following Subcutaneous Administration of Denosumab or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 6 Months', 'description': 'denosumab administered subcutaneously every 6 months\n\ndenosumab: denosumab administered subcutaneously'}, {'id': 'OG001', 'title': 'Denosumab 3 Months', 'description': 'denosumab administered subcutaneously every 3 months\n\ndenosumab: denosumab administered subcutaneously'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'placebo administered subcutaneously to match denosumab\n\nplacebo: placebo administered subcutaneously to match denosumab'}], 'classes': [{'categories': [{'measurements': [{'value': '0.28', 'groupId': 'OG000', 'lowerLimit': '0.07', 'upperLimit': '0.50'}, {'value': '0.35', 'groupId': 'OG001', 'lowerLimit': '0.17', 'upperLimit': '0.53'}, {'value': '0.33', 'groupId': 'OG002', 'lowerLimit': '0.18', 'upperLimit': '0.48'}]}]}], 'analyses': [{'pValue': '0.0448', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'van Elteren stratified rank test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to month 6', 'description': 'Change from baseline in Joint Space Narrowing from baseline to month 6 was assessed. Joint Space Narrowing was defined for the sum of the joint level joint space narrowing scores among the 42 joints in both hands/wrist and both feet from radiographic assessments using the van der Heijde modified Sharp scoring method. The maximum radiographic Joint Space Narrowing from both hands/wrists and both feet is 168. Higher values represented greater damage.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Joint Space Narrowing was assessed in the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change in Erosion Score From Baseline to Month 12 Following Subcutaneous Administration of Denosumab or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 6 Months', 'description': 'denosumab administered subcutaneously every 6 months\n\ndenosumab: denosumab administered subcutaneously'}, {'id': 'OG001', 'title': 'Denosumab 3 Months', 'description': 'denosumab administered subcutaneously every 3 months\n\ndenosumab: denosumab administered subcutaneously'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'placebo administered subcutaneously to match denosumab\n\nplacebo: placebo administered subcutaneously to match denosumab'}], 'classes': [{'categories': [{'measurements': [{'value': '0.51', 'groupId': 'OG000', 'lowerLimit': '0.22', 'upperLimit': '0.80'}, {'value': '0.22', 'groupId': 'OG001', 'lowerLimit': '0.09', 'upperLimit': '0.34'}, {'value': '0.98', 'groupId': 'OG002', 'lowerLimit': '0.65', 'upperLimit': '1.31'}]}]}], 'analyses': [{'pValue': '0.0104', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'van Elteren stratified rank test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to month 12', 'description': 'Change from baseline in Erosion Score from baseline to month 12 was assessed. The Erosion Score was defined for the sum of the joint level erosion scores among the 44 joints in both hands/wrist and both feet from radiographic assessments using the van der Heijde modified Sharp scoring method. The maximum radiographic Erosion Score from both hands/wrist and both feet is 280. Higher values represented greater damage.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Erosion Score was assessed in the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change in Joint Space Narrowing From Baseline to Month 12 Following Subcutaneous Administration of Denosumab or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 6 Months', 'description': 'denosumab administered subcutaneously every 6 months\n\ndenosumab: denosumab administered subcutaneously'}, {'id': 'OG001', 'title': 'Denosumab 3 Months', 'description': 'denosumab administered subcutaneously every 3 months\n\ndenosumab: denosumab administered subcutaneously'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'placebo administered subcutaneously to match denosumab\n\nplacebo: placebo administered subcutaneously to match denosumab'}], 'classes': [{'categories': [{'measurements': [{'value': '0.48', 'groupId': 'OG000', 'lowerLimit': '0.20', 'upperLimit': '0.76'}, {'value': '0.50', 'groupId': 'OG001', 'lowerLimit': '0.27', 'upperLimit': '0.74'}, {'value': '0.51', 'groupId': 'OG002', 'lowerLimit': '0.28', 'upperLimit': '0.74'}]}]}], 'analyses': [{'pValue': '0.2570', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'van Elteren stratified rank test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to month 12', 'description': 'Change from baseline in Joint Space Narrowing from baseline to month 12 was assessed. Joint Space Narrowing was defined for the sum of the joint level joint space narrowing scores among the 42 joints in both hands/wrist and both feet from radiographic assessments using the van der Heijde modified Sharp scoring method. The maximum radiographic Joint Space Narrowing from both hands/wrists and both feet is 168. Higher values represented greater damage.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Joint Space Narrowing was assessed in the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Bone Mineral Density (BMD) From Baseline to Month 12 Following Subcutaneous Administration of Denosumab or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 6 Months', 'description': 'denosumab administered subcutaneously every 6 months\n\ndenosumab: denosumab administered subcutaneously'}, {'id': 'OG001', 'title': 'Denosumab 3 Months', 'description': 'denosumab administered subcutaneously every 3 months\n\ndenosumab: denosumab administered subcutaneously'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'placebo administered subcutaneously to match denosumab\n\nplacebo: placebo administered subcutaneously to match denosumab'}], 'classes': [{'categories': [{'measurements': [{'value': '3.99', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '4.88', 'spread': '0.24', 'groupId': 'OG001'}, {'value': '-1.03', 'spread': '0.25', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.02', 'ciLowerLimit': '4.41', 'ciUpperLimit': '5.63', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model adjusting for treatment, baseline (BL) value, machine type, BL value-by-machine type interaction, and BL use of glucocorticoid was used.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to month 12', 'description': 'The percent change from baseline in Bone Mineral Density (BMD) to month 12 was assessed. Bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Bone mineral density was assessed in the Full Analysis Set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Denosumab 6 Months', 'description': 'denosumab administered subcutaneously every 6 months\n\ndenosumab: denosumab administered subcutaneously'}, {'id': 'FG001', 'title': 'Denosumab 3 Months', 'description': 'denosumab administered subcutaneously every 3 months\n\ndenosumab: denosumab administered subcutaneously'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'placebo administered subcutaneously to match denosumab\n\nplacebo: placebo administered subcutaneously to match denosumab'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '228'}, {'groupId': 'FG001', 'numSubjects': '225'}, {'groupId': 'FG002', 'numSubjects': '226'}]}, {'type': 'Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '222'}, {'groupId': 'FG001', 'numSubjects': '222'}, {'groupId': 'FG002', 'numSubjects': '223'}]}, {'type': 'Did Not Receive Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Discontinued Study Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'Discontinued Study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '199'}, {'groupId': 'FG001', 'numSubjects': '200'}, {'groupId': 'FG002', 'numSubjects': '208'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Invasive dental treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Prohibited concomitant d', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Did not receive study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'A total of 679 participants who met all inclusion and none of the exclusion criteria were included in the study; efficacy outcomes were assessed in the Full Analysis Set (n=654).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'BG000'}, {'value': '219', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}, {'value': '654', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Denosumab 6 Months', 'description': 'denosumab administered subcutaneously every 6 months\n\ndenosumab: denosumab administered subcutaneously'}, {'id': 'BG001', 'title': 'Denosumab 3 Months', 'description': 'denosumab administered subcutaneously every 3 months\n\ndenosumab: denosumab administered subcutaneously'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'placebo administered subcutaneously to match denosumab\n\nplacebo: placebo administered subcutaneously to match denosumab'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}, {'value': '453', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '201', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.1', 'spread': '12.3', 'groupId': 'BG000'}, {'value': '58.2', 'spread': '12.04', 'groupId': 'BG001'}, {'value': '55.8', 'spread': '11.7', 'groupId': 'BG002'}, {'value': '57.4', 'spread': '12.04', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}, {'value': '489', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '165', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '217', 'groupId': 'BG000'}, {'value': '219', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}, {'value': '654', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '22.38', 'spread': '3.68', 'groupId': 'BG000'}, {'value': '22.64', 'spread': '3.62', 'groupId': 'BG001'}, {'value': '22.65', 'spread': '3.49', 'groupId': 'BG002'}, {'value': '22.56', 'spread': '3.59', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The Baseline Analysis Population included participants in the Full Analysis Set (FAS). The FAS was defined as all randomized participants excluding those who met any of the following criteria:\n\n* Received no investigational product\n* Had no baseline TSS or no available TSS after the first administration of the investigational product'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 679}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-03', 'studyFirstSubmitDate': '2013-10-25', 'resultsFirstSubmitDate': '2019-09-17', 'studyFirstSubmitQcDate': '2013-10-25', 'lastUpdatePostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-21', 'studyFirstPostDateStruct': {'date': '2013-10-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Total Sharp Score (TSS) From Baseline to Month 12 Following Subcutaneous Administration of Denosumab or Placebo', 'timeFrame': 'baseline to month 12', 'description': 'Change from baseline in Total Sharp Score (TSS) from baseline to month 12 was assessed. The TSS was defined as the sum of the erosion score and the joint space narrowing scores from radiographic assessments. The maximum radiographic TSS from the both hands/wrists and both feet is 448. Higher values represented greater damage.'}], 'secondaryOutcomes': [{'measure': 'Change in Total Sharp Score (TSS) From Baseline to Month 6 Following Subcutaneous Administration of Denosumab or Placebo', 'timeFrame': 'baseline to month 6', 'description': 'Change from baseline in Total Sharp Score (TSS) from baseline to month 6 was assessed. The TSS was defined as the sum of the erosion score and the joint space narrowing scores from radiographic assessments. The maximum radiographic TSS from the both hands/wrists and both feet is 448. Higher values represented greater damage.'}, {'measure': 'Change in Erosion Score From Baseline to Month 6 Following Subcutaneous Administration of Denosumab or Placebo', 'timeFrame': 'baseline to month 6', 'description': 'Change from baseline in Erosion Score from baseline to month 6 was assessed. The Erosion Score was defined for the sum of the joint level erosion scores among the 44 joints in both hands/wrist and both feet from radiographic assessments using the van der Heijde modified Sharp scoring method. The maximum radiographic Erosion Score from both hands/wrist and both feet is 280. Higher values represented greater damage.'}, {'measure': 'Change in Joint Space Narrowing From Baseline to Month 6 Following Subcutaneous Administration of Denosumab or Placebo', 'timeFrame': 'baseline to month 6', 'description': 'Change from baseline in Joint Space Narrowing from baseline to month 6 was assessed. Joint Space Narrowing was defined for the sum of the joint level joint space narrowing scores among the 42 joints in both hands/wrist and both feet from radiographic assessments using the van der Heijde modified Sharp scoring method. The maximum radiographic Joint Space Narrowing from both hands/wrists and both feet is 168. Higher values represented greater damage.'}, {'measure': 'Change in Erosion Score From Baseline to Month 12 Following Subcutaneous Administration of Denosumab or Placebo', 'timeFrame': 'baseline to month 12', 'description': 'Change from baseline in Erosion Score from baseline to month 12 was assessed. The Erosion Score was defined for the sum of the joint level erosion scores among the 44 joints in both hands/wrist and both feet from radiographic assessments using the van der Heijde modified Sharp scoring method. The maximum radiographic Erosion Score from both hands/wrist and both feet is 280. Higher values represented greater damage.'}, {'measure': 'Change in Joint Space Narrowing From Baseline to Month 12 Following Subcutaneous Administration of Denosumab or Placebo', 'timeFrame': 'baseline to month 12', 'description': 'Change from baseline in Joint Space Narrowing from baseline to month 12 was assessed. Joint Space Narrowing was defined for the sum of the joint level joint space narrowing scores among the 42 joints in both hands/wrist and both feet from radiographic assessments using the van der Heijde modified Sharp scoring method. The maximum radiographic Joint Space Narrowing from both hands/wrists and both feet is 168. Higher values represented greater damage.'}, {'measure': 'Percent Change in Bone Mineral Density (BMD) From Baseline to Month 12 Following Subcutaneous Administration of Denosumab or Placebo', 'timeFrame': 'baseline to month 12', 'description': 'The percent change from baseline in Bone Mineral Density (BMD) to month 12 was assessed. Bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis', 'Denosumab', 'RANKL', 'RANK', 'AMG 162', 'joint damage', 'Developmental Phase III'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '33858976', 'type': 'DERIVED', 'citation': 'Tanaka Y, Takeuchi T, Soen S, Yamanaka H, Yoneda T, Tanaka S, Nitta T, Okubo N, Genant HK, van der Heijde D. Effects of Denosumab in Japanese Patients With Rheumatoid Arthritis Treated With Conventional Antirheumatic Drugs: 36-month Extension of a Phase III Study. J Rheumatol. 2021 Nov;48(11):1663-1671. doi: 10.3899/jrheum.201376. Epub 2021 Apr 15.'}, {'pmid': '31826682', 'type': 'DERIVED', 'citation': 'Takeuchi T, Soen S, Ishiguro N, Yamanaka H, Tanaka S, Kobayashi M, Okubo N, Nitta T, Tanaka Y. Predictors of new bone erosion in rheumatoid arthritis patients receiving conventional synthetic disease-modifying antirheumatic drugs: Analysis of data from the DRIVE and DESIRABLE studies. Mod Rheumatol. 2021 Jan;31(1):34-41. doi: 10.1080/14397595.2019.1703484. Epub 2020 Jan 9.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the inhibitory effect of progression, compared with placebo, in joint destruction by AMG 162 administered subcutaneously to rheumatoid arthritis participants.', 'detailedDescription': 'To evaluate the inhibitory effect of progression, compared with placebo, in joint destruction by AMG 162 administered subcutaneously at a dose of 60 mg every 6 months or every 3 months for 12 months to rheumatoid arthritis participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with rheumatoid arthritis according to the American College of Rheumatology (ACR) criteria for rheumatoid arthritis classification (1987 revision) or the 2010 ACR-EULAR (The European League Against Rheumatism) classification criteria for rheumatoid arthritis\n\nExclusion Criteria:\n\n* Functional class IV according by the ACR revised classification (1991)'}, 'identificationModule': {'nctId': 'NCT01973569', 'acronym': 'DESIRABLE', 'briefTitle': 'AMG 162 (Denosumab) Phase 3 Study (DESIRABLE Study) in Participants With Rheumatoid Arthritis on Disease-modifying Antirheumatic Drugs (DMARDs) Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'A Confirmatory Study of AMG 162 (Denosumab) in Patients With Rheumatoid Arthritis on DMARDs Treatment (Phase III)', 'orgStudyIdInfo': {'id': 'AMG162-D-J301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Denosumab 6 months', 'description': 'denosumab administered subcutaneously every 6 months', 'interventionNames': ['Drug: denosumab']}, {'type': 'EXPERIMENTAL', 'label': 'Denosumab 3 months', 'description': 'denosumab administered subcutaneously every 3 months', 'interventionNames': ['Drug: denosumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo administered subcutaneously to match denosumab', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'denosumab', 'type': 'DRUG', 'otherNames': ['AMG 162'], 'description': 'denosumab administered subcutaneously', 'armGroupLabels': ['Denosumab 3 months', 'Denosumab 6 months']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo administered subcutaneously to match denosumab', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '162-0054', 'city': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Tsutomu Takeuchi, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Division of Rheumatology Department of Internal Medicine, Keio University'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/daiichi-sankyo/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https:// vivli.org/ourmember/daiichi-sankyo/', 'accessCriteria': "Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daiichi Sankyo', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}