{"eventGroups":[{"description":"INDUCTION THERAPY:\n\nPatients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2.\n\nAUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.\n\nPatients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.\n\nPatients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy.","id":"EG000","otherNumAffected":14,"otherNumAtRisk":66,"seriousNumAffected":0,"seriousNumAtRisk":66,"title":"Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)"},{"description":"INDUCTION THERAPY:\n\nPatients receive amifostine as in arm I and melphalan as in arm I at a lower dose.\n\nAUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.\n\nPatients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.\n\nPatients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy.","id":"EG001","otherNumAffected":7,"otherNumAtRisk":64,"seriousNumAffected":0,"seriousNumAtRisk":64,"title":"Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)"}],"frequencyThreshold":"0","otherEvents":[{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":66,"numEvents":7},{"groupId":"EG001","numAffected":3,"numAtRisk":64,"numEvents":3}],"term":"Mucositis-Grade 3 or higher"},{"notes":"Mucositis recorded separately.","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":66,"numEvents":7},{"groupId":"EG001","numAffected":3,"numAtRisk":64,"numEvents":3}],"term":"Diarrhea"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":66,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":64,"numEvents":1}],"term":"Atrial fibrillation"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":64,"numEvents":0}],"term":"Pulmonary embolism"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":64,"numEvents":0}],"term":"Neutropenic fever"},{"notes":"Mucositis recorded separately","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":66,"numEvents":7},{"groupId":"EG001","numAffected":2,"numAtRisk":64,"numEvents":2}],"term":"Nausea/Vomiting"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":66,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":64,"numEvents":1}],"term":"Dehydration"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":64,"numEvents":0}],"term":"Anorexia"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":64,"numEvents":0}],"term":"Graft versus host disease of the gut"}]}