{"eventGroups":[{"description":"Induction:\n\nBortezomib (Velcade) 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days\n\nConditioning:\n\nBortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1\n\nBortezomib (Velcade) and Dexamethasone: Induction:\n\nVelcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days\n\nDexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days\n\nConditioning:\n\nBortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4\n\nMelphalan 70-100 mg/m2/day IV on days -2 and -1","id":"EG000","otherNumAffected":35,"otherNumAtRisk":35,"seriousNumAffected":35,"seriousNumAtRisk":35,"title":"Bortezomib and Dexamethasone"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":35,"numEvents":4}],"term":"alkaline phosphatase elevated"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":35,"numEvents":3}],"term":"drug rash"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"tinnitus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":35,"numEvents":15}],"term":"nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":35,"numEvents":14}],"term":"diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":35,"numEvents":4}],"term":"adrenal insufficiency"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":35,"numEvents":13}],"term":"constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":35,"numEvents":5}],"term":"anorexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":35,"numEvents":4}],"term":"abdominal distension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":35,"numEvents":8}],"term":"hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":35,"numEvents":14}],"term":"alopecia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":35,"numEvents":7}],"term":"rash"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":35,"numEvents":10}],"term":"dyspnea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":35,"numEvents":16}],"term":"sinus tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":35,"numEvents":5}],"term":"muscle weakness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":35,"numEvents":6}],"term":"dizziness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":35,"numEvents":12}],"term":"anxiety"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":35,"numEvents":7}],"term":"Blurred vision"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":35,"numEvents":3}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":35,"numEvents":14}],"term":"Bone pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":35,"numEvents":7}],"term":"cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":35,"numEvents":5}],"term":"peripheral edema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":35,"numEvents":4}],"term":"petechiae"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":35,"numEvents":3}],"term":"oral mucositis"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"autograft versus host disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":35,"numEvents":7}],"term":"neutropenic fever"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":35}],"term":"fever"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":35,"numEvents":3}],"term":"Acute kidney failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Adult Respiratory Distress Syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"cardiac arrest"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"creatinine increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":35,"numEvents":15}],"term":"diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"Epstein Barr Virus-related Polymorphous Post Transplant Lymphoproliferative disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"epistaxis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":35,"numEvents":18}],"term":"fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"gastrointestinal bleed"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"hemorrhoidal hemmorhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"invasive aspirgillosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"multiorgan failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":35,"numEvents":6}],"term":"nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":35,"numEvents":4}],"term":"sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":35,"numEvents":9}],"term":"syncope"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"thrombocytopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"stomatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":35,"numEvents":3}],"term":"skin rash"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":35,"numEvents":11}],"term":"hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"Dizziness"}],"timeFrame":"100 days"}