Viewing Study NCT02654132

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Ignite Creation Date: 2025-12-24 @ 9:38 PM
Ignite Modification Date: 2026-02-19 @ 11:46 AM
Study NCT ID: NCT02654132
Status: COMPLETED
Last Update Posted: 2022-11-01
First Post: 2015-12-31
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: An Investigational Immuno-therapy Trial of Pomalidomide and Low-dose Dexamethasone With or Without Elotuzumab to Treat Refractory and Relapsed and Refractory Multiple Myeloma (ELOQUENT-3)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C546027', 'term': 'elotuzumab'}, {'id': 'C467566', 'term': 'pomalidomide'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'phone': 'Please email', 'title': 'Bristol Myers-Squibb Study Director', 'organization': 'Bristol Myers-Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months)', 'description': 'All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants', 'eventGroups': [{'id': 'EG000', 'title': 'E-Pd Cohort', 'description': 'Elotuzumab + Pomalidomide + Dexamethasone', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 56, 'seriousNumAtRisk': 60, 'deathsNumAffected': 41, 'seriousNumAffected': 42}, {'id': 'EG001', 'title': 'Pd Cohort', 'description': 'Pomalidomide + Dexamethasone', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 57, 'otherNumAffected': 49, 'seriousNumAtRisk': 55, 'deathsNumAffected': 41, 'seriousNumAffected': 33}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Cataract subcapsular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Diverticular perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Primary amyloidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Adenovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Atypical pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Bacterial sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Escherichia sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'H1N1 influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Pneumococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Pneumocystis jirovecii pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Pneumonia influenzal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Progressive multifocal leukoencephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Pseudomonal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Streptococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Systemic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Thoracic vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Invasive breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 7}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Metastases to bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Plasma cell leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Prostate cancer stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Haemorrhagic transformation stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Bladder prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E-Pd Cohort', 'description': 'Elotuzumab + Pomalidomide + Dexamethasone'}, {'id': 'OG001', 'title': 'Pd Cohort', 'description': 'Pomalidomide + Dexamethasone'}], 'classes': [{'categories': [{'measurements': [{'value': '10.25', 'comment': 'Upper limit not reached', 'groupId': 'OG000', 'lowerLimit': '6.54', 'upperLimit': 'NA'}, {'value': '4.70', 'groupId': 'OG001', 'lowerLimit': '2.83', 'upperLimit': '7.62'}]}]}], 'analyses': [{'pValue': '0.0043', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.51', 'ciLowerLimit': '0.32', 'ciUpperLimit': '0.82', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to date of progression or death (up to approximately 21 months)', 'description': 'PFS is defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Progressive disease response criteria were defined as an increase of 25% from lowest response value in any one or more of the following:\n\n1\\. Serum M-component and/or 2. Urine M-component and/or 3. Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels 4. Bone marrow plasma cell percentage; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E-Pd Cohort', 'description': 'Elotuzumab + Pomalidomide + Dexamethasone'}, {'id': 'OG001', 'title': 'Pd Cohort', 'description': 'Pomalidomide + Dexamethasone'}], 'classes': [{'categories': [{'measurements': [{'value': '58.3', 'groupId': 'OG000', 'lowerLimit': '44.9', 'upperLimit': '70.9'}, {'value': '24.6', 'groupId': 'OG001', 'lowerLimit': '14.1', 'upperLimit': '37.8'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.62', 'ciLowerLimit': '2.05', 'ciUpperLimit': '10.43', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose to disease progression (up to approximately 21 months)', 'description': "ORR is defined as the percentage of participants who achieved a best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) using the modified International Myeloma Working Group (IMWG) criteria described as follows, as per investigator's assessment\n\n* CR: Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and \\< 5% plasma cells in bone marrow\n* sCR: CR, as defined above, plus the following: Normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence\n* VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \\>= 90% reduction in serum M-protein level plus urine M-protein level \\< 100 mg per 24 hour\n* PR: \\>= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \\>= 90% or to \\< 200 mg per 24 hour.", 'unitOfMeasure': 'Percent of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E-Pd Cohort', 'description': 'Elotuzumab + Pomalidomide + Dexamethasone'}, {'id': 'OG001', 'title': 'Pd Cohort', 'description': 'Pomalidomide + Dexamethasone'}], 'classes': [{'categories': [{'measurements': [{'value': '29.80', 'groupId': 'OG000', 'lowerLimit': '22.87', 'upperLimit': '45.67'}, {'value': '17.41', 'groupId': 'OG001', 'lowerLimit': '13.83', 'upperLimit': '27.70'}]}]}], 'analyses': [{'pValue': '0.0217', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.59', 'ciLowerLimit': '0.37', 'ciUpperLimit': '0.93', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to death (up to approximately 52 months)', 'description': 'OS is the time from randomization to the date of death from any cause. The survival time for participants who had not died was censored at the last known alive date. OS was censored at the date of randomization for subjects who were randomized but had no follow-up.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'E-Pd Cohort', 'description': 'Elotuzumab + Pomalidomide + Dexamethasone'}, {'id': 'FG001', 'title': 'Pd Cohort', 'description': 'Pomalidomide + Dexamethasone'}], 'periods': [{'title': 'Pre-Treatment Period', 'milestones': [{'type': 'STARTED', 'comment': 'Started = Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'comment': 'Completed = Continued into Treatment Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Participant Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '55'}]}], 'dropWithdraws': [{'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'Adverse Event unrelated to study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Study drug toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Maximum Clinical Benefit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Participant request to discontinue', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Administrative reasons by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '117 participants were randomized, and 115 participants were treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'E-Pd Cohort', 'description': 'Elotuzumab + Pomalidomide + Dexamethasone'}, {'id': 'BG001', 'title': 'Pd Cohort', 'description': 'Pomalidomide + Dexamethasone'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.2', 'spread': '9.92', 'groupId': 'BG000'}, {'value': '65.5', 'spread': '9.95', 'groupId': 'BG001'}, {'value': '65.9', 'spread': '9.90', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'All treated participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '9', 'groupId': 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'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-05', 'studyFirstSubmitDate': '2015-12-31', 'resultsFirstSubmitDate': '2019-01-17', 'studyFirstSubmitQcDate': '2016-01-12', 'lastUpdatePostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-31', 'studyFirstPostDateStruct': {'date': '2016-01-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'From randomization to date of progression or death (up to approximately 21 months)', 'description': 'PFS is defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Progressive disease response criteria were defined as an increase of 25% from lowest response value in any one or more of the following:\n\n1\\. Serum M-component and/or 2. Urine M-component and/or 3. Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels 4. Bone marrow plasma cell percentage; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'From first dose to disease progression (up to approximately 21 months)', 'description': "ORR is defined as the percentage of participants who achieved a best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) using the modified International Myeloma Working Group (IMWG) criteria described as follows, as per investigator's assessment\n\n* CR: Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and \\< 5% plasma cells in bone marrow\n* sCR: CR, as defined above, plus the following: Normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence\n* VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \\>= 90% reduction in serum M-protein level plus urine M-protein level \\< 100 mg per 24 hour\n* PR: \\>= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \\>= 90% or to \\< 200 mg per 24 hour."}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From randomization to death (up to approximately 52 months)', 'description': 'OS is the time from randomization to the date of death from any cause. The survival time for participants who had not died was censored at the last known alive date. OS was censored at the date of randomization for subjects who were randomized but had no follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '35960908', 'type': 'DERIVED', 'citation': 'Dimopoulos MA, Dytfeld D, Grosicki S, Moreau P, Takezako N, Hori M, Leleu X, LeBlanc R, Suzuki K, Raab MS, Richardson PG, Popa McKiver M, Jou YM, Yao D, Das P, San-Miguel J. Elotuzumab Plus Pomalidomide and Dexamethasone for Relapsed/Refractory Multiple Myeloma: Final Overall Survival Analysis From the Randomized Phase II ELOQUENT-3 Trial. J Clin Oncol. 2023 Jan 20;41(3):568-578. doi: 10.1200/JCO.21.02815. Epub 2022 Aug 12.'}, {'pmid': '30403938', 'type': 'DERIVED', 'citation': 'Dimopoulos MA, Dytfeld D, Grosicki S, Moreau P, Takezako N, Hori M, Leleu X, LeBlanc R, Suzuki K, Raab MS, Richardson PG, Popa McKiver M, Jou YM, Shelat SG, Robbins M, Rafferty B, San-Miguel J. Elotuzumab plus Pomalidomide and Dexamethasone for Multiple Myeloma. N Engl J Med. 2018 Nov 8;379(19):1811-1822. doi: 10.1056/NEJMoa1805762.'}], 'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'http://www.BMSStudyConnect.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if adding Elotuzumab to Pomalidomide and low-dose dexamethasone is a more effective treatment of relapsed and refractory multiple myeloma compared to pomalidomide and low-dose dexamethasone by itself.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* ≥ 2 prior lines of therapy which must have included at least 2 consecutive cycles of lenalidomide and a proteosome inhibitor alone or in combination\n* Documented refractory or relapsed and refractory multiple myeloma\n* Refractory to proteosome inhibitor and lenalidomide, and to last treatment\n* Relapsed and refractory patients must have achieved at least a partial response to previous treatment with proteosome inhibitor or lenalidomide, or both, but progressed within 6 months, and were refractory to their last treatment\n* Measurable disease at screening\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n\nExclusion Criteria:\n\n* Active plasma cell leukemia\n* Prior treatment with pomalidomide\n* Unable to tolerate thromboembolic prophylaxis while on the study\n* Prior autologous stem cell transplant within 12 weeks\n* Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C'}, 'identificationModule': {'nctId': 'NCT02654132', 'briefTitle': 'An Investigational Immuno-therapy Trial of Pomalidomide and Low-dose Dexamethasone With or Without 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