{"description":"Treatment emergent","eventGroups":[{"description":"bortezomib, dexamethasone, and thalidomide","id":"EG000","otherNumAffected":48,"otherNumAtRisk":49,"seriousNumAffected":11,"seriousNumAtRisk":49,"title":"Three Drug Regimen (VDT)"},{"description":"bortezomib, dexamethasone, thalidomide, and cyclophosphamide","id":"EG001","otherNumAffected":47,"otherNumAtRisk":49,"seriousNumAffected":20,"seriousNumAtRisk":49,"title":"Four Drug Regimen (VDTC)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":49},{"groupId":"EG001","numAffected":32,"numAtRisk":49}],"term":"Gastrointestinal Disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":49},{"groupId":"EG001","numAffected":28,"numAtRisk":49}],"term":"General Disorders and Administration Site Conditions"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":49},{"groupId":"EG001","numAffected":27,"numAtRisk":49}],"term":"Nervous System Disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":49},{"groupId":"EG001","numAffected":22,"numAtRisk":49}],"term":"Blood and Lymphatic System Disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":49},{"groupId":"EG001","numAffected":13,"numAtRisk":49}],"term":"Musculoskeletal and Connective Tissue Disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":49},{"groupId":"EG001","numAffected":11,"numAtRisk":49}],"term":"Infections and Infestations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":49},{"groupId":"EG001","numAffected":15,"numAtRisk":49}],"term":"Metabolism and Nutrition Disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":49},{"groupId":"EG001","numAffected":12,"numAtRisk":49}],"term":"Skin and Subcutaneous Tissue Disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":49},{"groupId":"EG001","numAffected":9,"numAtRisk":49}],"term":"Respiratory, Thoracic and Mediastinal Disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":49},{"groupId":"EG001","numAffected":13,"numAtRisk":49}],"term":"Vascular Disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":49},{"groupId":"EG001","numAffected":8,"numAtRisk":49}],"term":"Psychiatric Disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":49},{"groupId":"EG001","numAffected":6,"numAtRisk":49}],"term":"Eye Disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":49},{"groupId":"EG001","numAffected":3,"numAtRisk":49}],"term":"Hepatobiliary Disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":49},{"groupId":"EG001","numAffected":3,"numAtRisk":49}],"term":"Cardiac Disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":49},{"groupId":"EG001","numAffected":5,"numAtRisk":49}],"term":"Investigations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":49},{"groupId":"EG001","numAffected":3,"numAtRisk":49}],"term":"Ear and labyrinth Disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":49},{"groupId":"EG001","numAffected":3,"numAtRisk":49}],"term":"Injury, Poisoning and Procedural Complications"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":49},{"groupId":"EG001","numAffected":2,"numAtRisk":49}],"term":"Renal and Urinary Disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":49},{"groupId":"EG001","numAffected":0,"numAtRisk":49}],"term":"Endocrine Disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":49},{"groupId":"EG001","numAffected":1,"numAtRisk":49}],"term":"Immune System Disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":49},{"groupId":"EG001","numAffected":1,"numAtRisk":49}],"term":"Neoplasms Benign, Malignant and Unspecified"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":49},{"groupId":"EG001","numAffected":1,"numAtRisk":49}],"term":"Reproductive System and Brest Disorders"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":49},{"groupId":"EG001","numAffected":7,"numAtRisk":49}],"term":"Infections and Infestations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":49},{"groupId":"EG001","numAffected":4,"numAtRisk":49}],"term":"Gastrointestinal Disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":49},{"groupId":"EG001","numAffected":4,"numAtRisk":49}],"term":"General Disorders and administration site Conditions"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":49},{"groupId":"EG001","numAffected":7,"numAtRisk":49}],"term":"Musculoskeletal and Connective Tissue Disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":49},{"groupId":"EG001","numAffected":4,"numAtRisk":49}],"term":"Respiratory, Thoracic and mediastinal Disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":49},{"groupId":"EG001","numAffected":2,"numAtRisk":49}],"term":"Nervous System Disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":49},{"groupId":"EG001","numAffected":2,"numAtRisk":49}],"term":"Blood and Lymphatic System Disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":49},{"groupId":"EG001","numAffected":2,"numAtRisk":49}],"term":"Cardiac Disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":49},{"groupId":"EG001","numAffected":2,"numAtRisk":49}],"term":"Injury, Poisoning and Procedural Complications"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":49},{"groupId":"EG001","numAffected":1,"numAtRisk":49}],"term":"Metabolism and Nutritional Disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":49},{"groupId":"EG001","numAffected":1,"numAtRisk":49}],"term":"Psychiatric Disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":49},{"groupId":"EG001","numAffected":0,"numAtRisk":49}],"term":"Renal and Urinary Disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":49},{"groupId":"EG001","numAffected":1,"numAtRisk":49}],"term":"Skin and Subcutaneous Tissue Disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":49},{"groupId":"EG001","numAffected":1,"numAtRisk":49}],"term":"Vascular Disorders"}],"timeFrame":"From first dose to 30 days post last dose"}