{"eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":60,"description":"Melphalan 100mg/m2/day iv days -2 and -1\n\nMelphalan: High-dose chemotherapy regimen for conditioning treatment before autologous stem cell Transplantation. Patients will receive melphalan at a total dose of 200mg/m2, divided in two doses of 100mg/m2/day on days -2 and -1, with the ASCT at day 0.","id":"EG000","otherNumAffected":36,"otherNumAtRisk":60,"seriousNumAffected":9,"seriousNumAtRisk":60,"title":"Arm A (Mel)"},{"deathsNumAffected":1,"deathsNumAtRisk":60,"description":"Melphalan 100mg/m2/day iv days -2 and -1 Bendamustine 200mg/m2/day iv days -4 and -3\n\nMelphalan: High-dose chemotherapy regimen for conditioning treatment before autologous stem cell Transplantation. Patients will receive melphalan at a total dose of 200mg/m2, divided in two doses of 100mg/m2/day on days -2 and -1, with the ASCT at day 0.\n\nBendamustine: High-dose chemotherapy regimen for conditioning treatment before autologous stem cell Transplantation. Patients will receive bendamustine at a total dose of 400mg/m2, divided in two doses of 200mg/m2/day on days -4 and -3. Melphalan is given at a total dose of 200mg/m2, divided in two doses of 100mg/m2/day, each on days -2 and -1, with the ASCT at day 0.","id":"EG001","otherNumAffected":43,"otherNumAtRisk":60,"seriousNumAffected":12,"seriousNumAtRisk":60,"title":"Arm B (BenMel)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":60,"numEvents":31},{"groupId":"EG001","numAffected":30,"numAtRisk":60,"numEvents":30}],"term":"Gastrointestinal disordes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":60,"numEvents":10},{"groupId":"EG001","numAffected":20,"numAtRisk":60,"numEvents":20}],"term":"Metabolic and nutritional disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":60,"numEvents":5},{"groupId":"EG001","numAffected":3,"numAtRisk":60,"numEvents":3}],"term":"Cardiac and thromboembolic disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":60,"numEvents":0},{"groupId":"EG001","numAffected":5,"numAtRisk":60,"numEvents":5}],"term":"Weight loss >10%"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":60,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":60,"numEvents":2}],"term":"Engraftment syndrome"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"fever unkown origin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":60,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"respiratory failue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":60,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":60,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":60,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"respiratory infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":60,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"right ventricular disfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":60,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":60,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Respiratory insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"Esophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":60,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":60,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Pancolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":60,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"Panaritium"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":60,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Septic Schock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"Thromboembolic event"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":60,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"ARDS"}],"timeFrame":"Deaths were assessed up to 24 months. Adverse Events were assessed through 60 days"}