{"eventGroups":[{"deathsNumAffected":1,"deathsNumAtRisk":28,"description":"Melphalan is administered at a dose of 200mg/m2 by rapid intravenous infusion via a central or peripheral vein over 30 minutes to one hour.\n\nMelphalan will be given as a single dose (not split over 2 or more days) and given on day-1.\n\nDosing will be based on body surface area calculated using actual body weight","id":"EG000","otherNumAffected":0,"otherNumAtRisk":28,"seriousNumAffected":13,"seriousNumAtRisk":28,"title":"Auto Transplant High Dose Melphalan"},{"deathsNumAffected":4,"deathsNumAtRisk":31,"description":"Bortezomib:\n\nBortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line. Bortezomib will be administered any time on day -4 and at least 20 hrs after the start of the melphalan infusion on day -1.\n\nBortezomib: Bortezomib:\n\nBortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line. Bortezomib will be administered any time on day -4 and at least 20 hrs after the start of the melphalan infusion on day -1.","id":"EG001","otherNumAffected":0,"otherNumAtRisk":31,"seriousNumAffected":18,"seriousNumAtRisk":31,"title":"Auto Transplant High Dose Melphalan+Bortezomib"}],"frequencyThreshold":"0","seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":28,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0}],"term":"Atrial Fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0}],"term":"C Diff Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Cervical Fusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Death (Disease Progression)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Death (Fall)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":28,"numEvents":3},{"groupId":"EG001","numAffected":11,"numAtRisk":31,"numEvents":11}],"term":"Disease Progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0}],"term":"Fall/Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":28,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0}],"term":"Fractured Right Arm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Hemolytic Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0}],"term":"Heparin-induced Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0}],"term":"Kidney Stone"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Knee Surgery"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0}],"term":"Laminectomy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Lower Extremity Weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Neutropenic Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Shingles Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Urinary Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":28,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0}],"term":"Chest Pain"}],"timeFrame":"3 Years Post Transplant"}