Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2025-12-25 @ 3:14 PM
Study NCT ID:
NCT00330759
Status:
COMPLETED
Last Update Posted:
2022-11-07
First Post:
2006-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Australia', 'Austria', 'Belgium', 'Brazil', 'Bulgaria', 'Canada', 'Chile', 'Czechia', 'France', 'Germany', 'Greece', 'Hungary', 'India', 'Israel', 'Italy', 'Latvia', 'Lithuania', 'Mexico', 'Netherlands', 'Peru', 'Poland', 'Portugal', 'Romania', 'Russia', 'Slovakia', 'South Africa', 'Spain', 'Sweden', 'Switzerland', 'Ukraine', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D013117', 'term': 'Spinal Cord Compression'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069448', 'term': 'Denosumab'}, {'id': 'D000077211', 'term': 'Zoledronic Acid'}], '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'}, {'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-572-6436', 'title': 'Study Director', 'organization': 'Amgen Inc.'}, 'certainAgreement': {'otherDetails': "The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'up to 2 years 9 months', 'description': 'The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Zoledronic Acid 4 mg Q4W', 'otherNumAtRisk': 878, 'otherNumAffected': 767, 'seriousNumAtRisk': 878, 'seriousNumAffected': 581}, {'id': 'EG001', 'title': 'Denosumab 120 mg Q4W', 'otherNumAtRisk': 878, 'otherNumAffected': 751, 'seriousNumAtRisk': 878, 'seriousNumAffected': 552}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 264}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 234}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 50}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 100}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 90}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 90}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 84}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 47}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 209}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 188}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 165}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 163}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 260}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 244}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 167}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 174}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 171}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 156}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 92}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 216}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 203}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 43}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 135}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 106}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 47}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 170}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 125}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 38}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 39}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Thoracic vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 35}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 105}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 99}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 190}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 163}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 42}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 88}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 53}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 137}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 124}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 183}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 169}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 149}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 137}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 53}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 92}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 128}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 121}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 67}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 93}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 99}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 46}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 45}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 73}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 62}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 93}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 89}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 151}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 172}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 171}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 193}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 48}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 67}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Agranulocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 25}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Anaemia of chronic disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Aplastic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bone marrow failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Erythropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Febrile bone marrow aplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Granulocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hyperviscosity syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Retroperitoneal lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Arrhythmia supraventricular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 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{'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pain in jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pathological fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Polyarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Acute myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bile duct cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cancer pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cervix cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Colon cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hepatic cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Malignant ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 100}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 103}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Malignant pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Metastases to abdominal cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Metastases to bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 9}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Metastases to bone marrow', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 43}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Metastases to gastrointestinal tract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Metastases to liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 16}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Metastases to lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Metastases to lymph nodes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Metastases to meninges', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Metastases to peritoneum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Metastases to pleura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Metastases to rectum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Metastases to spine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Metastasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 7}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Metastatic bronchial carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Metastatic carcinoma of the bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Metastatic malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Metastatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Metastatic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Metastatic renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Multiple myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Non-small cell lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Paraneoplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pericardial effusion malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pharyngeal neoplasm benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rectal cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Sarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Small cell lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Tumour associated fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cauda equina syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cerebral artery embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 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'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diplegia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Epiduritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Nervous system 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vena cava thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 878, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 878, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 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Median was estimated using the Kaplan-Meier method.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, composed of all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Time to First On-Study Skeletal-Related Event (Superiority)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '890', 'groupId': 'OG000'}, {'value': '886', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoledronic Acid', 'description': 'Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks'}, {'id': 'OG001', 'title': 'Denosumab', 'description': 'Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '496.0', 'groupId': 'OG000', 'lowerLimit': '371.00', 'upperLimit': '589.00'}, {'value': '625.0', 'comment': 'Upper limit could not be estimated due to the low number of events.', 'groupId': 'OG001', 'lowerLimit': '456.00', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.060', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.71', 'ciUpperLimit': '0.98', 'estimateComment': 'Stratified by tumor type, previous skeletal-related event, and systematic anti-cancer therapy', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure.'}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 33 months', 'description': 'Time to first on-study skeletal-related event (SRE) using a test for superiority. Median was estimated using the Kaplan-Meier method.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, composed of all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Time to the First-and-Subsequent On-Study Skeletal-Related Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '890', 'groupId': 'OG000'}, {'value': '886', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoledronic Acid', 'description': 'Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks'}, {'id': 'OG001', 'title': 'Denosumab', 'description': 'Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '436', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.145', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.04', 'estimateComment': 'Stratified by tumor type, previous skeletal-related event, and systematic anti-cancer therapy', 'statisticalMethod': 'Anderson-Gill model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure.'}], 'paramType': 'NUMBER', 'timeFrame': 'up to 33 months', 'description': 'Time to the first-and-subsequent on-study skeletal-related event (SRE) using multiple event analysis. To be considered a subsequent SRE, the event must occur at least 21 days after the previous SRE.\n\nThis outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative mean number of events.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, composed of all randomized participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zoledronic Acid', 'description': 'Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks'}, {'id': 'FG001', 'title': 'Denosumab', 'description': 'Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '890'}, {'groupId': 'FG001', 'numSubjects': '886'}]}, {'type': 'Received Investigational Product', 'achievements': [{'groupId': 'FG000', 'numSubjects': '878'}, {'groupId': 'FG001', 'numSubjects': '878'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '178'}, {'groupId': 'FG001', 'numSubjects': '180'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '712'}, {'groupId': 'FG001', 'numSubjects': '706'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '316'}, {'groupId': 'FG001', 'numSubjects': '310'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '126'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '143'}, {'groupId': 'FG001', 'numSubjects': '124'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'Participant request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Ineligibility determined', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '44'}]}]}], 'recruitmentDetails': 'Participants were enrolled from 21 June 2006 through 16 May 2008', 'preAssignmentDetails': 'A total of 1779 participants were enrolled in the study. Three participants from one site were excluded from all analyses because Institutional Review Board (IRB) review activities and oversight were not ensured.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '890', 'groupId': 'BG000'}, {'value': '886', 'groupId': 'BG001'}, {'value': '1776', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Zoledronic Acid', 'description': 'Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks'}, {'id': 'BG001', 'title': 'Denosumab', 'description': 'Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.6', 'spread': '10.7', 'groupId': 'BG000'}, {'value': '59.3', 'spread': '11.4', 'groupId': 'BG001'}, {'value': '59.9', 'spread': '11.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '338', 'groupId': 'BG000'}, {'value': '298', 'groupId': 'BG001'}, {'value': '636', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '552', 'groupId': 'BG000'}, {'value': '588', 'groupId': 'BG001'}, {'value': '1140', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White or Caucasian', 'categories': [{'measurements': [{'value': '770', 'groupId': 'BG000'}, {'value': '770', 'groupId': 'BG001'}, {'value': '1540', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}, {'title': 'Japanese', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Tumor Type Stratification Factor', 'classes': [{'title': 'Multiple myeloma', 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '452', 'groupId': 'BG000'}, {'value': '457', 'groupId': 'BG001'}, {'value': '909', 'groupId': 'BG002'}]}]}, {'title': 'Non-small cell lung cancer', 'categories': [{'measurements': [{'value': '345', 'groupId': 'BG000'}, {'value': '343', 'groupId': 'BG001'}, {'value': '688', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Previous Skeletal-Related Event Stratification Factor', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '446', 'groupId': 'BG000'}, {'value': '440', 'groupId': 'BG001'}, {'value': '886', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '444', 'groupId': 'BG000'}, {'value': '446', 'groupId': 'BG001'}, {'value': '890', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Systematic Anti-Cancer Therapy Stratification Factor', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '747', 'groupId': 'BG000'}, {'value': '746', 'groupId': 'BG001'}, {'value': '1493', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1779}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'dispFirstSubmitDate': '2010-06-29', 'completionDateStruct': {'date': '2011-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-04', 'studyFirstSubmitDate': '2006-05-25', 'dispFirstSubmitQcDate': '2010-06-29', 'resultsFirstSubmitDate': '2010-12-09', 'studyFirstSubmitQcDate': '2006-05-25', 'dispFirstPostDateStruct': {'date': '2010-07-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-03-04', 'studyFirstPostDateStruct': {'date': '2006-05-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to the First On-Study Skeletal-Related Event (Non-Inferiority)', 'timeFrame': 'up to 33 months', 'description': 'Time to the first on-study skeletal-related event (SRE) using a non-inferiority analysis. Median was estimated using the Kaplan-Meier method.'}], 'secondaryOutcomes': [{'measure': 'Time to First On-Study Skeletal-Related Event (Superiority)', 'timeFrame': 'up to 33 months', 'description': 'Time to first on-study skeletal-related event (SRE) using a test for superiority. Median was estimated using the Kaplan-Meier method.'}, {'measure': 'Time to the First-and-Subsequent On-Study Skeletal-Related Event', 'timeFrame': 'up to 33 months', 'description': 'Time to the first-and-subsequent on-study skeletal-related event (SRE) using multiple event analysis. To be considered a subsequent SRE, the event must occur at least 21 days after the previous SRE.\n\nThis outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative mean number of events.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bone metastases', 'lytic bone lesions', 'advanced cancer', 'multiple myeloma', 'lymphoma', 'solid tumors', 'skeletal related events', 'skeletal fractures', 'spinal cord compressions, radiation to bone', 'surgery to bone, bisphosphonates', 'denosumab'], 'conditions': ['Bone Metastases']}, 'referencesModule': {'references': [{'pmid': '24162260', 'type': 'BACKGROUND', 'citation': 'Henry D, Vadhan-Raj S, Hirsh V, von Moos R, Hungria V, Costa L, Woll PJ, Scagliotti G, Smith G, Feng A, Jun S, Dansey R, Yeh H. Delaying skeletal-related events in a randomized phase 3 study of denosumab versus zoledronic acid in patients with advanced cancer: an analysis of data from patients with solid tumors. Support Care Cancer. 2014 Mar;22(3):679-87. doi: 10.1007/s00520-013-2022-1. Epub 2013 Oct 26.'}, {'pmid': '21343556', 'type': 'BACKGROUND', 'citation': 'Henry DH, Costa L, Goldwasser F, Hirsh V, Hungria V, Prausova J, Scagliotti GV, Sleeboom H, Spencer A, Vadhan-Raj S, von Moos R, Willenbacher W, Woll PJ, Wang J, Jiang Q, Jun S, Dansey R, Yeh H. Randomized, double-blind study of denosumab versus zoledronic acid in the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma. J Clin Oncol. 2011 Mar 20;29(9):1125-32. doi: 10.1200/JCO.2010.31.3304. Epub 2011 Feb 22.'}, {'pmid': '23154554', 'type': 'BACKGROUND', 'citation': 'Scagliotti GV, Hirsh V, Siena S, Henry DH, Woll PJ, Manegold C, Solal-Celigny P, Rodriguez G, Krzakowski M, Mehta ND, Lipton L, Garcia-Saenz JA, Pereira JR, Prabhash K, Ciuleanu TE, Kanarev V, Wang H, Balakumaran A, Jacobs I. Overall survival improvement in patients with lung cancer and bone metastases treated with denosumab versus zoledronic acid: subgroup analysis from a randomized phase 3 study. J Thorac Oncol. 2012 Dec;7(12):1823-1829. doi: 10.1097/JTO.0b013e31826aec2b.'}, {'pmid': '22851406', 'type': 'BACKGROUND', 'citation': 'Vadhan-Raj S, von Moos R, Fallowfield LJ, Patrick DL, Goldwasser F, Cleeland CS, Henry DH, Novello S, Hungria V, Qian Y, Feng A, Yeh H, Chung K. Clinical benefit in patients with metastatic bone disease: results of a phase 3 study of denosumab versus zoledronic acid. Ann Oncol. 2012 Dec;23(12):3045-3051. doi: 10.1093/annonc/mds175. Epub 2012 Jul 31.'}, {'pmid': '29972647', 'type': 'DERIVED', 'citation': 'Abdel-Rahman O. Predictors of skeletal-related events among cancer patients with bone metastases treated with zoledronic acid: a secondary analysis of a randomized study. Expert Opin Drug Saf. 2018 Aug;17(8):757-761. doi: 10.1080/14740338.2018.1497157. Epub 2018 Jul 11.'}, {'pmid': '26093811', 'type': 'DERIVED', 'citation': 'Body JJ, Bone HG, de Boer RH, Stopeck A, Van Poznak C, Damiao R, Fizazi K, Henry DH, Ibrahim T, Lipton A, Saad F, Shore N, Takano T, Shaywitz AJ, Wang H, Bracco OL, Braun A, Kostenuik PJ. Hypocalcaemia in patients with metastatic bone disease treated with denosumab. Eur J Cancer. 2015 Sep;51(13):1812-21. doi: 10.1016/j.ejca.2015.05.016. Epub 2015 Jun 17.'}, {'pmid': '25976743', 'type': 'DERIVED', 'citation': 'Diel IJ, Body JJ, Stopeck AT, Vadhan-Raj S, Spencer A, Steger G, von Moos R, Goldwasser F, Feng A, Braun A. The role of denosumab in the prevention of hypercalcaemia of malignancy in cancer patients with metastatic bone disease. Eur J Cancer. 2015 Jul;51(11):1467-75. doi: 10.1016/j.ejca.2015.04.017. Epub 2015 May 11.'}, {'pmid': '23975226', 'type': 'DERIVED', 'citation': 'von Moos R, Body JJ, Egerdie B, Stopeck A, Brown JE, Damyanov D, Fallowfield LJ, Marx G, Cleeland CS, Patrick DL, Palazzo FG, Qian Y, Braun A, Chung K. Pain and health-related quality of life in patients with advanced solid tumours and bone metastases: integrated results from three randomized, double-blind studies of denosumab and zoledronic acid. Support Care Cancer. 2013 Dec;21(12):3497-507. doi: 10.1007/s00520-013-1932-2. Epub 2013 Aug 22.'}, {'pmid': '22975218', 'type': 'DERIVED', 'citation': 'Lipton A, Fizazi K, Stopeck AT, Henry DH, Brown JE, Yardley DA, Richardson GE, Siena S, Maroto P, Clemens M, Bilynskyy B, Charu V, Beuzeboc P, Rader M, Viniegra M, Saad F, Ke C, Braun A, Jun S. Superiority of denosumab to zoledronic acid for prevention of skeletal-related events: a combined analysis of 3 pivotal, randomised, phase 3 trials. Eur J Cancer. 2012 Nov;48(16):3082-92. doi: 10.1016/j.ejca.2012.08.002. Epub 2012 Sep 10.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}, {'url': 'http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf', 'label': 'Notice regarding posted summaries of trial results'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases (lytic bone lesions from multiple myeloma) in subjects with advanced cancer and multiple myeloma (excluding breast and prostate cancer)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with histologically/cystologically confirmed advanced cancers including solid tumors, multiple myeloma, and lymphoma\n* Radiographic evidence of at least one bone metastasis (or lytic bone lesion from multiple myeloma); ECOG performance status 0, 1, or 2\n* Adequate organ function\n\nExclusion Criteria:\n\n* Diagnosis of breast or prostate cancer\n* Current or prior intravenous bisphosphonate administration\n* Current or prior oral bisphosphonates for bone metastases, life expectancy of less than 6 months\n* Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw'}, 'identificationModule': {'nctId': 'NCT00330759', 'briefTitle': 'Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa) in the Treatment of Bone Metastases in Subjects With Advanced Cancer (Excluding Breast and Prostate Cancer) or Multiple Myeloma.', 'orgStudyIdInfo': {'id': '20050244'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'zoledronic acid', 'description': 'denosumab placebo with active zoledronic acid', 'interventionNames': ['Drug: Zoledronic Acid']}, {'type': 'EXPERIMENTAL', 'label': 'denosumab', 'description': 'active denosumab with zoledronic acid placebo', 'interventionNames': ['Biological: Denosumab']}], 'interventions': [{'name': 'Denosumab', 'type': 'BIOLOGICAL', 'description': '120 milligrams by subcutaneous injection every 4 weeks', 'armGroupLabels': ['denosumab']}, {'name': 'Zoledronic Acid', 'type': 'DRUG', 'otherNames': ['Zometa'], 'description': '4 milligrams intravenous Zoledronic Acid over minimum 15 minutes every 4 weeks', 'armGroupLabels': ['zoledronic acid']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}