Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2025-12-29 @ 9:59 PM
Study NCT ID:
NCT01568866
Status:
COMPLETED
Last Update Posted:
2022-11-14
First Post:
2012-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 3 Study With Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone for Relapsed Multiple Myeloma Patients
Sponsor:
Organization:
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': 'C524865', 'term': 'carfilzomib'}, {'id': 'D000069286', 'term': 'Bortezomib'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D001897', 'term': 'Boronic Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D001896', 'term': 'Boron Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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'}]}}, '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 after completion. 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': 'From the first dose of study drug up to 30 days after the last dose of study drug as of the data cut-off date of 03 January 2017; median duration of treatment was 27 weeks in the bortezomib group and 48 weeks in the carfilzomib treatment group.', 'description': 'Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.', 'eventGroups': [{'id': 'EG000', 'title': 'Bortezomib', 'otherNumAtRisk': 456, 'otherNumAffected': 435, 'seriousNumAtRisk': 456, 'seriousNumAffected': 182}, {'id': 'EG001', 'title': 'Carfilzomib', 'otherNumAtRisk': 463, 'otherNumAffected': 446, 'seriousNumAtRisk': 463, 'seriousNumAffected': 272}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 129}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 196}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'LYMPHOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 31}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 27}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 100}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'CATARACT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 32}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'CONJUNCTIVITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 22}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ABDOMINAL DISTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 126}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 75}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 184}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 167}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 89}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 108}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 75}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 107}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'CHILLS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 140}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 149}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'INFLUENZA LIKE ILLNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'MALAISE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 116}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 144}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 103}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 81}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 47}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'RHINITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 29}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 116}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 34}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'CONTUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 19}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'FALL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 18}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'BLOOD CREATININE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 52}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'CREATININE RENAL CLEARANCE DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 29}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'LYMPHOCYTE COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 42}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'PLATELET COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 57}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 50}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HYPERGLYCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 53}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HYPERURICAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 31}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HYPOCALCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 27}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HYPOKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 60}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HYPOPHOSPHATAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 32}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 60}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 105}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'BONE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 55}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'MUSCLE SPASMS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 92}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'MUSCULAR WEAKNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 44}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'MUSCULOSKELETAL CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 39}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'MUSCULOSKELETAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 24}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 28}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 55}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 42}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'DYSGEUSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 95}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HYPOAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'NEURALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'NEUROPATHY PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 130}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 49}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'PARAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 43}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'PERIPHERAL SENSORY NEUROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 29}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'POLYNEUROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'TREMOR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 19}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 122}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 125}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 128}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 144}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'EPISTAXIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 24}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'OROPHARYNGEAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 28}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'PRODUCTIVE COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 27}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 34}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 41}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'FLUSHING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 24}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 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'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'UROSEPSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'VIRAL 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'FOOT FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HEAD INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HIP FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HUMERUS FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'INFUSION RELATED REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'LIGAMENT SPRAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ULNA FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'UPPER LIMB FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ASPARTATE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'BLOOD CORTISOL DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'BLOOD CREATININE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'INFLUENZA B VIRUS TEST POSITIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'LYMPHOCYTE COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'PLATELET COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'TROPONIN T INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 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'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HYPERCALCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HYPERGLYCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HYPERKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HYPOGLYCAEMIA', 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'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'BONE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'FLANK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'INTERVERTEBRAL DISC PROTRUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'LUMBAR SPINAL STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'MOBILITY DECREASED', 'stats': [{'groupId': 'EG000', 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'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'OSTEOARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'OSTEONECROSIS OF JAW', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'PATHOLOGICAL FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'RHABDOMYOLYSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ACUTE MYELOID LEUKAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'BASAL CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'BLADDER TRANSITIONAL CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'CANCER PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'CARCINOMA IN SITU', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'COLON CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'MENINGEAL NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'METASTASES TO SPINE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'MULTIPLE MYELOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'OESOPHAGEAL SQUAMOUS CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'PLASMACYTOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'PLEURAL MESOTHELIOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'RECTAL CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'SQUAMOUS CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ACQUIRED EPILEPTIC APHASIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'CENTRAL NERVOUS SYSTEM LESION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'CEREBROVASCULAR ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'COGNITIVE DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 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{'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HYPERCAPNIC COMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HYPERTENSIVE ENCEPHALOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ISCHAEMIC STROKE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'LETHARGY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'LOSS OF CONSCIOUSNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'METABOLIC ENCEPHALOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'NEURALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'NEUROPATHY PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'PARAPARESIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 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1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'RADICULOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'SCIATICA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'SPINAL CORD COMPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'DYSTHYMIC DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'MENTAL DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'PSYCHOTIC DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ALBUMINURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ANURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'NEPHROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, 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'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'RENAL IMPAIRMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'URINARY RETENTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'PROSTATOMEGALY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'UTERINE HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ACUTE PULMONARY OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ACUTE RESPIRATORY DISTRESS SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ACUTE RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 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'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'EPISTAXIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HYPOXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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463, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'PULMONARY OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'DRUG ERUPTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ECZEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ERYTHEMA MULTIFORME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'PRURITUS GENERALISED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'PURPURA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'COLOSTOMY CLOSURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HAEMORRHOID OPERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'REMOVAL OF INTERNAL FIXATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'AORTIC ANEURYSM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'AORTIC EMBOLUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'CIRCULATORY COLLAPSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'DEEP VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HAEMATOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HYPERTENSIVE CRISIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'MALIGNANT HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ORTHOSTATIC HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'PERIPHERAL ARTERIAL OCCLUSIVE DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'THROMBOPHLEBITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'VENA CAVA THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'VENOUS THROMBOSIS LIMB', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '465', 'groupId': 'OG000'}, {'value': '464', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bortezomib + DEX', 'description': 'Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'Carfilzomib + DEX', 'description': 'Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '8.4', 'upperLimit': '10.4'}, {'value': '18.7', 'comment': 'Could not be estimated due to the low number of events.', 'groupId': 'OG001', 'lowerLimit': '15.6', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.533', 'ciLowerLimit': '0.437', 'ciUpperLimit': '0.651', 'estimateComment': 'The hazard ratio (carfilzomib/bortezomib) was estimated using a Cox proportional hazards model stratified by prior proteasome inhibitor treatment, lines of prior treatment, ISS stage, and choice of route of bortezomib administration.', 'groupDescription': "The PFS interim analysis was to be performed using a group sequential monitoring plan.\n\nThe monitoring plan included an O'Brien-Fleming type of efficacy stopping boundary constructed using the Lan-DeMets alpha spending function to ensure a 1-sided Type I error rate ≤ 0.025.", 'statisticalMethod': 'Stratified Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Log rank test stratified by the randomization stratification factors.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization until the data cut-off date of 10 November 2014; median follow-up time for PFS was 11.1.and 11.9 months in the bortezomib and carfilzomib arms respectively', 'description': 'Progression-free survival (PFS) was defined as the time from randomization to the earlier of disease progression or death due to any cause. Participants were evaluated for disease response and progression according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) as assessed by an Independent Review Committee (IRC).\n\nMedian PFS was estimated using the Kaplan-Meier method. Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '465', 'groupId': 'OG000'}, {'value': '464', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bortezomib + DEX', 'description': 'Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'Carfilzomib + DEX', 'description': 'Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000', 'lowerLimit': '32.6', 'upperLimit': '42.3'}, {'value': '47.6', 'comment': 'Could not be estimated due to the low number of events', 'groupId': 'OG001', 'lowerLimit': '42.5', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0100', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.791', 'ciLowerLimit': '0.648', 'ciUpperLimit': '0.964', 'pValueComment': 'The multiplicity in testing secondary endpoints was adjusted per group using the sequential Holm procedure to preserve the family-wise error rate at 0.025.', 'estimateComment': 'The hazard ratio (carfilzomib/bortezomib) was estimated using a Cox proportional hazards model stratified by prior proteasome inhibitor treatment, lines of prior treatment, ISS stage, and choice of route of bortezomib administration.', 'groupDescription': "The second interim analysis of overall survival was to be conducted after 394 events had been reached. A one-sided significance level was determined using the O'Brien-Fleming-type α spending function based on the actual number of events (α=0.0123).", 'statisticalMethod': 'Stratified Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Log rank test stratified by the randomization stratification factors.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization until the data cut-off date of 03 January 2017; median follow-up time for OS was 36.9 and 37.5 months for each treatment group respectively.', 'description': "Overall survival (OS) is defined as the time from randomization to the date of death (whatever the cause). Participants who were alive or lost to follow-up as of the data analysis cut-off date were censored at the patient's date of last contact (last known to be alive).\n\nMedian overall survival was estimated using the Kaplan-Meier method.", 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population'}, {'type': 'SECONDARY', 'title': 'Overall Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '465', 'groupId': 'OG000'}, {'value': '464', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bortezomib + DEX', 'description': 'Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'Carfilzomib + DEX', 'description': 'Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.6', 'groupId': 'OG000', 'lowerLimit': '58.0', 'upperLimit': '67.0'}, {'value': '76.9', 'groupId': 'OG001', 'lowerLimit': '72.8', 'upperLimit': '80.7'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.032', 'ciLowerLimit': '1.519', 'ciUpperLimit': '2.718', 'pValueComment': 'The multiplicity in testing secondary endpoints was adjusted per group using the sequential Holm procedure to preserve the family-wise error rate at 0.025.', 'estimateComment': 'The odds ratio (carfilzomib/bortezomib) was calculated using the Cochran-Mantel-Haenszel method stratified by prior proteasome inhibitor treatment, lines of prior treatment, ISS stage, and choice of route of bortezomib administration.', 'statisticalMethod': 'Stratified Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Cochran-Mantel-Haenszel test stratified by the randomization stratification factors.'}], 'paramType': 'NUMBER', 'timeFrame': 'Disease response was assessed every 28 days until end of treatment or the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group.', 'description': 'Disease response was evaluated according to the IMWG-URC by the IRC. Overall response was defined as the percentage of participants with a best overall response of partial response (PR), very good PR (VGPR), complete response (CR) or stringent CR (sCR).\n\nsCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM).\n\nCR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and \\< 5% plasma cells in BM biopsy; VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-protein with urine M-protein \\<100 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline.\n\nPR: ≥ 50% reduction of serum M-protein and reduction in urine M-protein by ≥ 90% or to \\< 200 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bortezomib + DEX', 'description': 'Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'Carfilzomib + DEX', 'description': 'Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000', 'lowerLimit': '9.3', 'upperLimit': '13.8'}, {'value': '21.3', 'comment': 'Could not be estimated due to the low number of events', 'groupId': 'OG001', 'lowerLimit': '21.3', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization until the data cut-off date of 10 November 2014; median follow-up time for DOR was 9.4 and 10.4 months for each treatment group respectively.', 'description': 'Duration of response (DOR) was calculated for participants who achieved an sCR, CR, VGPR, or PR. Duration of response is defined as the time from first evidence of PR or better to confirmation of disease progression or death due to any cause. Median duration of response was estimated using the Kaplan-Meier method. Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population with an overall response'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '463', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bortezomib + DEX', 'description': 'Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'Carfilzomib + DEX', 'description': 'Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.0', 'groupId': 'OG000', 'lowerLimit': '27.7', 'upperLimit': '36.3'}, {'value': '6.0', 'groupId': 'OG001', 'lowerLimit': '3.9', 'upperLimit': '8.2'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.137', 'ciLowerLimit': '0.089', 'ciUpperLimit': '0.210', 'pValueComment': 'The multiplicity in testing secondary endpoints was adjusted per group using the sequential Holm procedure to preserve the family-wise error rate at 0.025.', 'estimateComment': 'The odds ratio (carfilzomib/bortezomib) was estimated using the unconditional Cochran-Mantel-Haenszel method.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'From the first dose of study drug up to 30 days after the last dose of study drug as of the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group.', 'description': 'Neuropathy events were defined as Grade 2 or higher peripheral neuropathy as specified by peripheral neuropathy Standardised Medical Dictionary for Regulatory Activities (MedDRA) Query, narrow (scope) (SMQN) terms.\n\nPeripheral neuropathy was assessed by neurologic exam and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03:\n\nGrade 1: Asymptomatic; Grade 2: Moderate symptoms, limiting instrumental activities of daily living (ADL) Grade 3: Severe symptoms; limiting self-care ADL; Grade 4: Life-threatening consequences, urgent intervention indicated; Grade 5: Death.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population (all participants who received at least 1 dose of study treatment)'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Significant Reduction in Left Ventricular Ejection Fraction (LVEF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bortezomib + DEX', 'description': 'Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'Carfilzomib + DEX', 'description': 'Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 24 weeks', 'description': 'A significant reduction in LVEF was defined as a ≥ 10% decrease (absolute change) from baseline in participants whose baseline LVEF is ≤ 55%.\n\nFor participants with LVEF \\> 55% at baseline, a significant change was defined as a decrease in LVEF to \\< 45%.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Cardiopulmonary Safety Evaluable subgroup (all randomized participants who enrolled in the cardiopulmonary substudy with evaluable baseline echocardiogram scans per the central laboratory) and with both baseline and at least one post-baseline LVEF measurement within 24 weeks.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Right Ventricular Fractional Area Change (FAC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bortezomib + DEX', 'description': 'Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'Carfilzomib + DEX', 'description': 'Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.'}], 'classes': [{'title': 'Week 12 (n=40, 40)', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '5.00', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '5.36', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (n=26, 31)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '6.10', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '5.03', 'groupId': 'OG001'}]}]}, {'title': 'Week 36 (n=15, 18)', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '7.27', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '6.38', 'groupId': 'OG001'}]}]}, {'title': 'End of Treatment (n=23, 18)', 'categories': [{'measurements': [{'value': '0.4', 'spread': '4.73', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '5.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group).', 'description': 'Right ventricular function was assessed by measuring fractional area change (FAC) on echocardiogram.', 'unitOfMeasure': 'percent fractional area change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Cardiopulmonary Safety Evaluable subgroup with available FAC data at baseline; "n" indicates participants whose results were available at both the baseline and the specified post-baseline visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pulmonary Artery Systolic Pressure (PASP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bortezomib + DEX', 'description': 'Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'Carfilzomib + DEX', 'description': 'Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.'}], 'classes': [{'title': 'Week 12 (n=34, 30)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '11.72', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '11.44', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (n=22, 20)', 'categories': [{'measurements': [{'value': '1.7', 'spread': '8.47', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '13.63', 'groupId': 'OG001'}]}]}, {'title': 'Week 36 (n=12, 14)', 'categories': [{'measurements': [{'value': '4.0', 'spread': '7.24', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '13.55', 'groupId': 'OG001'}]}]}, {'title': 'End of Treatment (n=21, 14)', 'categories': [{'measurements': [{'value': '3.4', 'spread': '8.14', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '11.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group).', 'description': 'Pulmonary artery pressure was measured using transthoracic echocardiogram.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Cardiopulmonary Safety Evaluable subgroup with available PASP data at baseline; "n" indicates participants whose results were available at both the baseline and the specified post-baseline visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bortezomib + DEX', 'description': 'Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.'}, {'id': 'FG001', 'title': 'Carfilzomib + DEX', 'description': 'Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '465'}, {'groupId': 'FG001', 'numSubjects': '464'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '456'}, {'groupId': 'FG001', 'numSubjects': '463'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Indicates participants still receiving treatment', 'groupId': 'FG000', 'numSubjects': '27'}, {'comment': 'Indicates participants still receiving treatment', 'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '438'}, {'groupId': 'FG001', 'numSubjects': '416'}]}], 'dropWithdraws': [{'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '208'}, {'groupId': 'FG001', 'numSubjects': '183'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '96'}]}, {'type': 'Patient Request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Protocol Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomized but Not Dosed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Adults with relapsed multiple myeloma were enrolled between 20 June 2012 and 30 June 2014 at 198 centers in 27 countries in Europe, North America, South America, and the Asia-Pacific region.\n\nResults are reported as of the data cut-off date of 03 January 2017, the pre-specified 2nd interim analysis of the secondary endpoint of overall survival.', 'preAssignmentDetails': 'Randomization was stratified by previous proteasome inhibitor therapy (yes vs no), previous lines of treatment (1 vs 2 or 3), International Staging System stage (I vs II-III), and planned route of bortezomib administration (intravenous vs subcutaneous) if randomly assigned to the bortezomib group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '465', 'groupId': 'BG000'}, {'value': '464', 'groupId': 'BG001'}, {'value': '929', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bortezomib + DEX', 'description': 'Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.'}, {'id': 'BG001', 'title': 'Carfilzomib + DEX', 'description': 'Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.0', 'groupId': 'BG000', 'lowerLimit': '30.0', 'upperLimit': '88.0'}, {'value': '65.0', 'groupId': 'BG001', 'lowerLimit': '35.0', 'upperLimit': '89.0'}, {'value': '65.0', 'groupId': 'BG002', 'lowerLimit': '30.0', 'upperLimit': '89.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'title': '< 65 years', 'measurements': [{'value': '210', 'groupId': 'BG000'}, {'value': '223', 'groupId': 'BG001'}, {'value': '433', 'groupId': 'BG002'}]}, {'title': '65 -74 years', 'measurements': [{'value': '189', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '353', 'groupId': 'BG002'}]}, {'title': '≥ 75 years', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '236', 'groupId': 'BG000'}, {'value': '224', 'groupId': 'BG001'}, {'value': '460', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '229', 'groupId': 'BG000'}, {'value': '240', 'groupId': 'BG001'}, {'value': '469', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '353', 'groupId': 'BG000'}, {'value': '348', 'groupId': 'BG001'}, {'value': '701', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian/Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Reported', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}, {'title': 'Multiple', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) Performance Status', 'classes': [{'categories': [{'title': '0 (Fully active)', 'measurements': [{'value': '232', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '453', 'groupId': 'BG002'}]}, {'title': '1 (Restrictive but ambulatory)', 'measurements': [{'value': '203', 'groupId': 'BG000'}, {'value': '211', 'groupId': 'BG001'}, {'value': '414', 'groupId': 'BG002'}]}, {'title': '2 (Ambulatory but unable to work)', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Eastern Cooperative Oncology Group (ECOG) Performance Status is used by doctors and researchers to assess how a participants disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. 0 = Fully Active; 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, no self-care, confined to bed or chair; 5 = Dead.', 'unitOfMeasure': 'Participants'}, {'title': 'Stratification Factor: Prior Proteasome Inhibitor Treatment', 'classes': [{'categories': [{'title': 'Carfilzomib or bortezomib', 'measurements': [{'value': '253', 'groupId': 'BG000'}, {'value': '252', 'groupId': 'BG001'}, {'value': '505', 'groupId': 'BG002'}]}, {'title': 'No prior carfilzomib or bortezomib', 'measurements': [{'value': '212', 'groupId': 'BG000'}, {'value': '212', 'groupId': 'BG001'}, {'value': '424', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Stratification Factor: Lines of Prior Treatment', 'classes': [{'categories': [{'title': '1 line', 'measurements': [{'value': '229', 'groupId': 'BG000'}, {'value': '231', 'groupId': 'BG001'}, {'value': '460', 'groupId': 'BG002'}]}, {'title': '2 or 3 lines', 'measurements': [{'value': '236', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '469', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Stratification Factor: International Staging System (ISS) Stage', 'classes': [{'categories': [{'title': 'Stage I', 'measurements': [{'value': '204', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '409', 'groupId': 'BG002'}]}, {'title': 'Stage II or III', 'measurements': [{'value': '261', 'groupId': 'BG000'}, {'value': '259', 'groupId': 'BG001'}, {'value': '520', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The International Staging System (ISS) for myeloma was published by the International Myeloma Working Group:\n\n* Stage I: β2-microglobulin (β2M) \\< 3.5 mg/L, albumin \\>= 3.5 g/dL\n* Stage II: β2M \\< 3.5 mg/L and albumin \\< 3.5 g/dL; or β2M 3.5 mg/L - 5.5 mg/L irrespective of the serum albumin\n* Stage III: β2M ≥ 5.5 mg/L', 'unitOfMeasure': 'Participants'}, {'title': 'Stratification Factor: Route of Bortezomib Administration', 'classes': [{'categories': [{'title': 'Intravenous', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}]}, {'title': 'Subcutaneous', 'measurements': [{'value': '357', 'groupId': 'BG000'}, {'value': '356', 'groupId': 'BG001'}, {'value': '713', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The route of bortezomib administration (IV versus SC) was made in accordance with local regulatory approved route of administration. The value for this variable was selected for all participants prior to randomization to treatment group in order to balance the baseline characteristics that led to the choice of the particular route of bortezomib administration between the 2 arms.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat population (all randomized participants)'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 929}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-10', 'studyFirstSubmitDate': '2012-03-28', 'resultsFirstSubmitDate': '2015-11-06', 'studyFirstSubmitQcDate': '2012-03-30', 'lastUpdatePostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-11-06', 'studyFirstPostDateStruct': {'date': '2012-04-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival', 'timeFrame': 'From randomization until the data cut-off date of 10 November 2014; median follow-up time for PFS was 11.1.and 11.9 months in the bortezomib and carfilzomib arms respectively', 'description': 'Progression-free survival (PFS) was defined as the time from randomization to the earlier of disease progression or death due to any cause. Participants were evaluated for disease response and progression according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) as assessed by an Independent Review Committee (IRC).\n\nMedian PFS was estimated using the Kaplan-Meier method. Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'From randomization until the data cut-off date of 03 January 2017; median follow-up time for OS was 36.9 and 37.5 months for each treatment group respectively.', 'description': "Overall survival (OS) is defined as the time from randomization to the date of death (whatever the cause). Participants who were alive or lost to follow-up as of the data analysis cut-off date were censored at the patient's date of last contact (last known to be alive).\n\nMedian overall survival was estimated using the Kaplan-Meier method."}, {'measure': 'Overall Response', 'timeFrame': 'Disease response was assessed every 28 days until end of treatment or the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group.', 'description': 'Disease response was evaluated according to the IMWG-URC by the IRC. Overall response was defined as the percentage of participants with a best overall response of partial response (PR), very good PR (VGPR), complete response (CR) or stringent CR (sCR).\n\nsCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM).\n\nCR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and \\< 5% plasma cells in BM biopsy; VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-protein with urine M-protein \\<100 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline.\n\nPR: ≥ 50% reduction of serum M-protein and reduction in urine M-protein by ≥ 90% or to \\< 200 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline.'}, {'measure': 'Duration of Response', 'timeFrame': 'From randomization until the data cut-off date of 10 November 2014; median follow-up time for DOR was 9.4 and 10.4 months for each treatment group respectively.', 'description': 'Duration of response (DOR) was calculated for participants who achieved an sCR, CR, VGPR, or PR. Duration of response is defined as the time from first evidence of PR or better to confirmation of disease progression or death due to any cause. Median duration of response was estimated using the Kaplan-Meier method. Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored.'}, {'measure': 'Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy', 'timeFrame': 'From the first dose of study drug up to 30 days after the last dose of study drug as of the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group.', 'description': 'Neuropathy events were defined as Grade 2 or higher peripheral neuropathy as specified by peripheral neuropathy Standardised Medical Dictionary for Regulatory Activities (MedDRA) Query, narrow (scope) (SMQN) terms.\n\nPeripheral neuropathy was assessed by neurologic exam and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03:\n\nGrade 1: Asymptomatic; Grade 2: Moderate symptoms, limiting instrumental activities of daily living (ADL) Grade 3: Severe symptoms; limiting self-care ADL; Grade 4: Life-threatening consequences, urgent intervention indicated; Grade 5: Death.'}, {'measure': 'Percentage of Participants With a Significant Reduction in Left Ventricular Ejection Fraction (LVEF)', 'timeFrame': 'Baseline and 24 weeks', 'description': 'A significant reduction in LVEF was defined as a ≥ 10% decrease (absolute change) from baseline in participants whose baseline LVEF is ≤ 55%.\n\nFor participants with LVEF \\> 55% at baseline, a significant change was defined as a decrease in LVEF to \\< 45%.'}, {'measure': 'Change From Baseline in Right Ventricular Fractional Area Change (FAC)', 'timeFrame': 'Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group).', 'description': 'Right ventricular function was assessed by measuring fractional area change (FAC) on echocardiogram.'}, {'measure': 'Change From Baseline in Pulmonary Artery Systolic Pressure (PASP)', 'timeFrame': 'Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group).', 'description': 'Pulmonary artery pressure was measured using transthoracic echocardiogram.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['multiple myeloma', 'relapsed multiple myeloma'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '27491641', 'type': 'BACKGROUND', 'citation': 'Moreau P, Joshua D, Chng WJ, Palumbo A, Goldschmidt H, Hajek R, Facon T, Ludwig H, Pour L, Niesvizky R, Oriol A, Rosinol L, Suvorov A, Gaidano G, Pika T, Weisel K, Goranova-Marinova V, Gillenwater HH, Mohamed N, Aggarwal S, Feng S, Dimopoulos MA. Impact of prior treatment on patients with relapsed multiple myeloma treated with carfilzomib and dexamethasone vs bortezomib and dexamethasone in the phase 3 ENDEAVOR study. Leukemia. 2017 Jan;31(1):115-122. doi: 10.1038/leu.2016.186. Epub 2016 Jul 4.'}, {'pmid': '28025582', 'type': 'BACKGROUND', 'citation': 'Chng WJ, Goldschmidt H, Dimopoulos MA, Moreau P, Joshua D, Palumbo A, Facon T, Ludwig H, Pour L, Niesvizky R, Oriol A, Rosinol L, Suvorov A, Gaidano G, Pika T, Weisel K, Goranova-Marinova V, Gillenwater HH, Mohamed N, Feng S, Aggarwal S, Hajek R. Carfilzomib-dexamethasone vs bortezomib-dexamethasone in relapsed or refractory multiple myeloma by cytogenetic risk in the phase 3 study ENDEAVOR. Leukemia. 2017 Jun;31(6):1368-1374. doi: 10.1038/leu.2016.390. Epub 2016 Dec 27.'}, {'pmid': '28843768', 'type': 'BACKGROUND', 'citation': 'Dimopoulos MA, Goldschmidt H, Niesvizky R, Joshua D, Chng WJ, Oriol A, Orlowski RZ, Ludwig H, Facon T, Hajek R, Weisel K, Hungria V, Minuk L, Feng S, Zahlten-Kumeli A, Kimball AS, Moreau P. Carfilzomib or bortezomib in relapsed or refractory multiple myeloma (ENDEAVOR): an interim overall survival analysis of an open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Oct;18(10):1327-1337. doi: 10.1016/S1470-2045(17)30578-8. Epub 2017 Aug 23.'}, {'pmid': '28306371', 'type': 'BACKGROUND', 'citation': 'Ludwig H, Dimopoulos MA, Moreau P, Chng WJ, Goldschmidt H, Hajek R, Facon T, Pour L, Niesvizky R, Oriol A, Rosinol L, Suvorov A, Gaidano G, Pika T, Weisel K, Goranova-Marinova V, Palumbo A, Gillenwater HH, Mohamed N, Aggarwal S, Feng S, Joshua D. Carfilzomib and dexamethasone vs bortezomib and dexamethasone in patients with relapsed multiple myeloma: results of the phase 3 study ENDEAVOR (NCT01568866) according to age subgroup. Leuk Lymphoma. 2017 Oct;58(10):2501-2504. doi: 10.1080/10428194.2017.1298755. Epub 2017 Mar 17. No abstract available.'}, {'pmid': '29991494', 'type': 'BACKGROUND', 'citation': 'Chari A, Stewart AK, Russell SD, Moreau P, Herrmann J, Banchs J, Hajek R, Groarke J, Lyon AR, Batty GN, Ro S, Huang M, Iskander KS, Lenihan D. Analysis of carfilzomib cardiovascular safety profile across relapsed and/or refractory multiple myeloma clinical trials. Blood Adv. 2018 Jul 10;2(13):1633-1644. doi: 10.1182/bloodadvances.2017015545.'}, {'pmid': '30478094', 'type': 'BACKGROUND', 'citation': 'Dimopoulos M, Siegel D, White DJ, Boccia R, Iskander KS, Yang Z, Kimball AS, Mezzi K, Ludwig H, Niesvizky R. Carfilzomib vs bortezomib in patients with multiple myeloma and renal failure: a subgroup analysis of ENDEAVOR. Blood. 2019 Jan 10;133(2):147-155. doi: 10.1182/blood-2018-06-860015. Epub 2018 Nov 26.'}, {'pmid': '33166401', 'type': 'BACKGROUND', 'citation': 'Facon T, Niesvizky R, Mateos MV, Siegel D, Rosenbaum C, Bringhen S, Weisel K, Ho PJ, Ludwig H, Kumar S, Wang K, Obreja M, Yang Z, Klippel Z, Mezzi K, Goldrick A, Tekle C, Dimopoulos MA. Efficacy and safety of carfilzomib-based regimens in frail patients with relapsed and/or refractory multiple myeloma. Blood Adv. 2020 Nov 10;4(21):5449-5459. doi: 10.1182/bloodadvances.2020001965.'}, {'pmid': '28439109', 'type': 'BACKGROUND', 'citation': 'Hari P, Mateos MV, Abonour R, Knop S, Bensinger W, Ludwig H, Song K, Hajek R, Moreau P, Siegel DS, Feng S, Obreja M, Aggarwal SK, Iskander K, Goldschmidt H. Efficacy and safety of carfilzomib regimens in multiple myeloma patients relapsing after autologous stem cell transplant: ASPIRE and ENDEAVOR outcomes. Leukemia. 2017 Dec;31(12):2630-2641. doi: 10.1038/leu.2017.122. Epub 2017 Apr 25.'}, {'pmid': '30287200', 'type': 'BACKGROUND', 'citation': 'Leleu X, Martin TG, Einsele H, Lyons RM, Durie BGM, Iskander KS, Ailawadhi S. Role of Proteasome Inhibitors in Relapsed and/or Refractory Multiple Myeloma. Clin Lymphoma Myeloma Leuk. 2019 Jan;19(1):9-22. doi: 10.1016/j.clml.2018.08.016. Epub 2018 Sep 5.'}, {'pmid': '30796199', 'type': 'BACKGROUND', 'citation': 'Ludwig H, Moreau P, Dimopoulos MA, Mateos MV, Kaiser M, Hajek R, Feng S, Cocks K, Buchanan J, Weisel K. Health-related quality of life in the ENDEAVOR study: carfilzomib-dexamethasone vs bortezomib-dexamethasone in relapsed/refractory multiple myeloma. Blood Cancer J. 2019 Feb 22;9(3):23. doi: 10.1038/s41408-019-0181-0.'}, {'pmid': '29446103', 'type': 'BACKGROUND', 'citation': 'Mateos MV, Goldschmidt H, San-Miguel J, Mikhael J, DeCosta L, Zhou L, Obreja M, Blaedel J, Szabo Z, Leleu X. Carfilzomib in relapsed or refractory multiple myeloma patients with early or late relapse following prior therapy: A subgroup analysis of the randomized phase 3 ASPIRE and ENDEAVOR trials. Hematol Oncol. 2018 Apr;36(2):463-470. doi: 10.1002/hon.2499. Epub 2018 Feb 15.'}, {'pmid': '32108443', 'type': 'BACKGROUND', 'citation': 'Moreau P, Stewart KA, Dimopoulos M, Siegel D, Facon T, Berenson J, Raje N, Berdeja JG, Orlowski RZ, Yang H, Ma H, Klippel Z, Zahlten-Kumeli A, Mezzi K, Iskander K, Mateos MV. Once-weekly (70 mg/m2 ) vs twice-weekly (56 mg/m2 ) dosing of carfilzomib in patients with relapsed or refractory multiple myeloma: A post hoc analysis of the ENDEAVOR, A.R.R.O.W., and CHAMPION-1 trials. Cancer Med. 2020 May;9(9):2989-2996. doi: 10.1002/cam4.2945. Epub 2020 Feb 28.'}, {'pmid': '31388932', 'type': 'BACKGROUND', 'citation': 'Dimopoulos MA, Moreau P, Iida S, Huang SY, Takezako N, Chng WJ, Zahlten-Kumeli A, Sersch MA, Li J, Huang M, Lee JH. Outcomes for Asian patients with multiple myeloma receiving once- or twice-weekly carfilzomib-based therapy: a subgroup analysis of the randomized phase 3 ENDEAVOR and A.R.R.O.W. Trials. Int J Hematol. 2019 Oct;110(4):466-473. doi: 10.1007/s12185-019-02704-z. Epub 2019 Aug 6.'}, {'pmid': '28937327', 'type': 'BACKGROUND', 'citation': 'Goldschmidt H, Moreau P, Ludwig H, Niesvizky R, Chng WJ, Joshua D, Weisel K, Spencer A, Orlowski RZ, Feng S, Iskander KS, Dimopoulos MA. Carfilzomib-dexamethasone versus subcutaneous or intravenous bortezomib in relapsed or refractory multiple myeloma: secondary analysis of the phase 3 ENDEAVOR study. Leuk Lymphoma. 2018 Jun;59(6):1364-1374. doi: 10.1080/10428194.2017.1376743. Epub 2017 Sep 22.'}, {'pmid': '29027825', 'type': 'BACKGROUND', 'citation': 'Jakubowiak AJ, Houisse I, Majer I, Benedict A, Campioni M, Panjabi S, Ailawadhi S. Cost-effectiveness of carfilzomib plus dexamethasone compared with bortezomib plus dexamethasone for patients with relapsed or refractory multiple myeloma in the United States. Expert Rev Hematol. 2017 Dec;10(12):1107-1119. doi: 10.1080/17474086.2017.1391088.'}, {'pmid': '33067574', 'type': 'BACKGROUND', 'citation': 'Weisel K, Mateos MV, Gay F, Delforge M, Cook G, Szabo Z, Desgraz R, DeCosta L, Moreau P. Efficacy and safety profile of deep responders to carfilzomib-based therapy: a subgroup analysis from ASPIRE and ENDEAVOR. Leukemia. 2021 Jun;35(6):1732-1744. doi: 10.1038/s41375-020-01049-5. Epub 2020 Oct 16.'}, {'pmid': '31640435', 'type': 'BACKGROUND', 'citation': 'Weisel K, Majer I, DeCosta L, Oriol A, Goldschmidt H, Ludwig H, Campioni M, Szabo Z, Dimopoulos M. Carfilzomib and dexamethasone versus eight cycles of bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma: an indirect comparison using data from the phase 3 ENDEAVOR and CASTOR trials. Leuk Lymphoma. 2020 Jan;61(1):37-46. doi: 10.1080/10428194.2019.1648806. Epub 2019 Oct 22.'}, {'pmid': '31160237', 'type': 'BACKGROUND', 'citation': 'Orlowski RZ, Moreau P, Niesvizky R, Ludwig H, Oriol A, Chng WJ, Goldschmidt H, Yang Z, Kimball AS, Dimopoulos M. Carfilzomib-Dexamethasone Versus Bortezomib-Dexamethasone in Relapsed or Refractory Multiple Myeloma: Updated Overall Survival, Safety, and Subgroups. Clin Lymphoma Myeloma Leuk. 2019 Aug;19(8):522-530.e1. doi: 10.1016/j.clml.2019.04.018. Epub 2019 May 2.'}, {'pmid': '30610657', 'type': 'DERIVED', 'citation': 'Majer IM, Castaigne JG, Palmer S, DeCosta L, Campioni M. Modeling Covariate-Adjusted Survival for Economic Evaluations in Oncology. Pharmacoeconomics. 2019 May;37(5):727-737. doi: 10.1007/s40273-018-0759-6.'}, {'pmid': '26771810', 'type': 'DERIVED', 'citation': 'Rosenthal A, Luthi J, Belohlavek M, Kortum KM, Mookadam F, Mayo A, Fonseca R, Bergsagel PL, Reeder CB, Mikhael JR, Stewart AK. Carfilzomib and the cardiorenal system in myeloma: an endothelial effect? Blood Cancer J. 2016 Jan 15;6(1):e384. doi: 10.1038/bcj.2015.112.'}, {'pmid': '26671818', 'type': 'DERIVED', 'citation': 'Dimopoulos MA, Moreau P, Palumbo A, Joshua D, Pour L, Hajek R, Facon T, Ludwig H, Oriol A, Goldschmidt H, Rosinol L, Straub J, Suvorov A, Araujo C, Rimashevskaya E, Pika T, Gaidano G, Weisel K, Goranova-Marinova V, Schwarer A, Minuk L, Masszi T, Karamanesht I, Offidani M, Hungria V, Spencer A, Orlowski RZ, Gillenwater HH, Mohamed N, Feng S, Chng WJ; ENDEAVOR Investigators. Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): a randomised, phase 3, open-label, multicentre study. Lancet Oncol. 2016 Jan;17(1):27-38. doi: 10.1016/S1470-2045(15)00464-7. Epub 2015 Dec 5.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study was to compare progression-free survival in patients with multiple myeloma who relapsed after 1 to 3 prior therapies treated with carfilzomib plus dexamethasone or bortezomib plus dexamethasone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Multiple myeloma with relapsing or progressing disease at study entry.\n2. Patients must have evaluable multiple myeloma with, at least one of the following (assessed within 21 days prior to randomization):\n\n * Serum M-protein ≥ 0.5 g/dL, or\n * Urine M-protein ≥ 200 mg/24 hour, or\n * In patients without detectable serum or urine M-protein, serum free light chain (SFLC) \\> 100 mg/L (involved light chain) and an abnormal serum kappa/lamda ratio, or\n * For immunoglobulin (Ig) A patients whose disease can only be reliably measured by serum quantitative immunoglobulin (qIgA) ≥ 750 mg/dL (0.75 g/dL).\n3. Patients must have documented at least partial response (PR) to at least 1 line of prior therapy. PR documentation can be based on Investigator assessment.\n4. Received 1, but no more than 3 prior treatment regimens or lines of therapy for multiple myeloma. (Induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as one line of therapy).\n5. Prior therapy with Velcade is allowed as long as the patient had at least a PR to prior Velcade therapy, was not removed from Velcade therapy due to toxicity, and will have at least a 6 month Velcade treatment-free interval from last dose received until first study treatment. (Patients may receive maintenance therapy with drugs that are not in the proteasome inhibitor class during this 6 month Velcade treatment-free interval).\n6. Prior therapy with carfilzomib is allowed as long as the patient had at least a PR to prior carfilzomib therapy, was not removed from carfilzomib therapy due to toxicity, and had at least a 6-month carfilzomib treatment-free interval from last dose received until first study treatment. (Patients may receive maintenance therapy with drugs that are not in the proteasome inhibitor class during this 6 month carfilzomib treatment-free interval). The exception to this is patients randomized or previously randomized in any other Onyx-Sponsored Phase 3 trial.\n7. Males and females ≥ 18 years of age.\n8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.\n9. Adequate hepatic function within 21 days prior to randomization, with bilirubin \\< 1.5 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\< 3 times the ULN.\n10. Left ventricular ejection fraction (LVEF) ≥ 40%.\n11. Absolute neutrophil count (ANC) ≥ 1000/mm³ within 21 days prior to randomization. Screening ANC should be independent of growth factor support for ≥ 1 week.\n12. Hemoglobin ≥ 8.0 g/dL within 21 days prior to randomization. Use of erythropoietic stimulating factors and red blood cell (RBC) transfusions per institutional guidelines is allowed, however most recent RBC transfusion may not have been done within 7 days prior to obtaining screening hemoglobin.\n13. Platelet count ≥ 50,000/mm³ (≥ 30,000/mm³ if myeloma involvement in the bone marrow is \\> 50%) within 21 days prior to randomization. Patients should not have received platelet transfusions for at least 1 week prior to obtaining the screening platelet count.\n14. Calculated or measured creatinine clearance (CrCl) of ≥ 15 mL/min within 21 days prior to randomization. Calculation should be based on standard formula such as the Cockcroft and Gault:\n\n \\[(140 - Age) x Mass (kg) / (72 x Creatinine mg/dL)\\]; multiply result by 0.85 if female.\n15. Written informed consent in accordance with federal, local, and institutional guidelines.\n16. Female patients of child-bearing potential (FCBP) must have a negative serum pregnancy test within 21 days prior to randomization and agree to use an effective method of contraception during and for 3 months following last dose of drug (more frequent pregnancy tests may be conducted if required per local regulations). FCBP is defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n17. Male patients must use an effective barrier method of contraception during study and for 3 months following the last dose if sexually active with a FCBP.\n\nExclusion Criteria:\n\n1. Multiple Myeloma of IgM subtype.\n2. Glucocorticoid therapy (prednisone \\> 30 mg/day or equivalent) within 14 days prior to randomization.\n3. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).\n4. Plasma cell leukemia or circulating plasma cells ≥ 2 × 10\\^9/L.\n5. Waldenstrom's Macroglobulinemia.\n6. Patients with known amyloidosis.\n7. Chemotherapy with approved or investigational anticancer therapeutics within 21 days prior to randomization.\n8. Patients randomized or previously randomized in any other Onyx-Sponsored Phase 3 trial.\n9. Focal radiation therapy within 7 days prior to randomization. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to randomization (i.e., prior radiation must have been to less than 30% of the bone marrow).\n10. Immunotherapy within 21 days prior to randomization.\n11. Major surgery (excluding kyphoplasty) within 28 days prior to randomization.\n12. Active congestive heart failure (New York Heart Association \\[NYHA\\] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within four months prior to randomization.\n13. Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at hepatitis B) or antifungal agents within 14 days prior to randomization.\n14. Known human immunodeficiency (HIV) seropositive, hepatitis C infection, and/or hepatitis B (except for patients with hepatitis B surface antigen \\[SAg\\] or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed).\n15. Patients with known cirrhosis.\n16. Second malignancy within the past 3 years except:\n\n * adequately treated basal cell or squamous cell skin cancer\n * carcinoma in situ of the cervix\n * prostate cancer \\< Gleason score 6 with stable prostate-specific antigen (PSA) over 12 months\n * breast carcinoma in situ with full surgical resection\n * treated medullary or papillary thyroid cancer\n17. Patients with myelodysplastic syndrome.\n18. Significant neuropathy (Grades 3 to 4, or Grade 2 with pain) within 14 days prior to randomization.\n19. Female patients who are pregnant or lactating.\n20. Known history of allergy to Captisol(a cyclodextrin derivative used to solubilize carfilzomib).\n21. Patients with hypersensitivity to carfilzomib, Velcade, boron, or mannitol.\n22. Patients with contraindication to dexamethasone.\n23. Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment.\n24. Ongoing graft-vs-host disease.\n25. Patients with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to randomization."}, 'identificationModule': {'nctId': 'NCT01568866', 'acronym': 'ENDEAVOR', 'briefTitle': 'Phase 3 Study With Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone for Relapsed Multiple Myeloma Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Randomized, Open-label, Phase 3 Study of Carfilzomib Plus Dexamethasone vs. Bortezomib Plus Dexamethasone in Patients With Relapsed Multiple Myeloma', 'orgStudyIdInfo': {'id': '2011-003'}, 'secondaryIdInfos': [{'id': '2012-000128-16', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Carfilzomib plus Dexamethasone', 'description': 'Participants received 20 mg/m² carfilzomib administered by intravenous (IV) infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.', 'interventionNames': ['Drug: Carfilzomib', 'Drug: Dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bortezomib plus Dexamethasone', 'description': 'Participants received bortezomib 1.3 mg/m² administered IV or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.', 'interventionNames': ['Drug: Bortezomib', 'Drug: Dexamethasone']}], 'interventions': [{'name': 'Carfilzomib', 'type': 'DRUG', 'otherNames': ['PR-171', 'Krypolis'], 'description': 'Carfilzomib is administered over 30 minutes as an infusion.', 'armGroupLabels': ['Carfilzomib plus Dexamethasone']}, {'name': 'Bortezomib', 'type': 'DRUG', 'otherNames': ['Velcade'], 'description': 'Bortezomib is administered as a 3-5 second bolus IV injection or SC injection (in accordance with regulatory approval)', 'armGroupLabels': ['Bortezomib plus Dexamethasone']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Tablet for oral administration; On days when carfilzomib or bortezomib was administered, the dexamethasone was to be given 30 minutes to 4 hours prior to the carfilzomib or bortezomib dose.', 'armGroupLabels': ['Bortezomib plus Dexamethasone', 'Carfilzomib plus Dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Providence St. Joseph Medical Center', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Moore Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Santa Maria', 'state': 'California', 'country': 'United 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