{"eventGroups":[{"description":"40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.","id":"EG000","otherNumAffected":23,"otherNumAtRisk":40,"seriousNumAffected":10,"seriousNumAtRisk":40,"title":"DVD-R Single Arm"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NCI CTCAE V3.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":40,"numEvents":16}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"NCI CTCAE V3.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":40,"numEvents":14}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"NCI CTCAE V3.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":40,"numEvents":14}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"NCI CTCAE V3.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":40,"numEvents":12}],"term":"Anemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"NCI CTCAE V3.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":40,"numEvents":12}],"term":"Edema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"NCI CTCAE V3.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":40,"numEvents":12}],"term":"Upper respiratory infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"NCI CTCAE V3.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":40,"numEvents":10}],"term":"Periphenal neurophaty"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI CTCAE V3.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":40,"numEvents":10}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI CTCAE V3.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":40,"numEvents":10}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"NCI CTCAE V3.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":40,"numEvents":9}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"NCI CTCAE V3.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":40,"numEvents":8}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"NCI CTCAE V3.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":40,"numEvents":7}],"term":"Leukopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"NCI CTCAE V3.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":40,"numEvents":7}],"term":"Pelvic pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"NCI CTCAE V3.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":40,"numEvents":6}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"NCI CTCAE V3.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":40,"numEvents":6}],"term":"Hypokalemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"NCI CTCAE V3.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":40,"numEvents":6}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI CTCAE V3.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":40,"numEvents":5}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NCI CTCAE V3.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":40,"numEvents":5}],"term":"Generalized pain"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"NCI CTCAE V3.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":40,"numEvents":5}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"NCI CTCAE V3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Upper respiratory infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NCI CTCAE V3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"NCI CTCAE V3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Dyspnea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI CTCAE V3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"NCI CTCAE V3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Cellulitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI CTCAE V3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Disphagia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"NCI CTCAE V3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Allergic reaction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NCI CTCAE V3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Loss of balance"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"NCI CTCAE V3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Pulmonary emboli"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"NCI CTCAE V3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Septic thrombophlebitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"NCI CTCAE V3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Syncopal episode"}],"timeFrame":"Severity and frequency of adverse events (AEs) were evaluated at each visit. Serious adverse events (SAEs) were followed until resolution or until clearly determined be unrelated to study treatment."}