{"eventGroups":[{"deathsNumAffected":1,"deathsNumAtRisk":29,"description":"Subjects with AL will receive Bendamustine and Dexamethasone\n\nBendamustine: Patients will start bendamustine at dose level 0 and according to CrCl on day 1 and 2 of each cycle:\n\n* CrCl ≥ 60 mL/min: 100 mg/m2 IV on day 1 and 2 of each cycle\n* CrCl 59 - 30 mL/min: 90 mg/m2 IV on day 1 and 2 of each cycle\n\nAvailable to qualifying subjects is the option to dose escalate to dose level (+)1:\n\n* 120 mg/m2 (if CrCl ≥ 60 mL/min at the time of inclusion into the study)\n* 100 mg/m2 (if CrCl 59-30 mL/min at the time of inclusion into the study)\n\nDexamethasone: 40 mg orally on days 1, 8, 15, 22 of each cycle","id":"EG000","otherNumAffected":20,"otherNumAtRisk":29,"seriousNumAffected":10,"seriousNumAtRisk":29,"title":"Treatment Arm"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":29,"numEvents":8}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":29,"numEvents":6}],"term":"Decreased lymphocyte count"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":29,"numEvents":4}],"term":"Chronic kidney disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":29,"numEvents":3}],"term":"Hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":29,"numEvents":3}],"term":"Hypertension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":29,"numEvents":3}],"term":"Decreased neutrophil count"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":29,"numEvents":3}],"term":"Syncope"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":29,"numEvents":2}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":29,"numEvents":2}],"term":"Decreased white blood cell count"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":29,"numEvents":2}],"term":"Anemia"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29,"numEvents":1}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29,"numEvents":1}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":29,"numEvents":2}],"term":"Renal dysfunction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29,"numEvents":1}],"term":"Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29,"numEvents":1}],"term":"Rash"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29,"numEvents":1}],"term":"Infusion-related reaction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":29,"numEvents":2}],"term":"Fever and chills"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29,"numEvents":1}],"term":"Atrial fibrillation"}],"timeFrame":"2 years"}