{"eventGroups":[{"description":"Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.\n\nConcurrent therapeutic medications:\n\n* Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14\n* Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)\n\nOther drugs:\n\n* Aspirin: 81 or 325 mg daily oral\n* Pegfilgrastim subcutaneous on Day 2","id":"EG000","otherNumAffected":12,"otherNumAtRisk":14,"seriousNumAffected":3,"seriousNumAtRisk":14,"title":"Amrubicin + Lenalidomide + Dexamethasone"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":14}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":14}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":14}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14}],"term":"Deep venous thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":14}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":14}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":14}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":14}],"term":"Elevated AST/ALT"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":14}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":14}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":14}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":14}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14}],"term":"Osteonecrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14}],"term":"Muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14}],"term":"Muscle cramps"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14}],"term":"Graft vs host diseae (GvHD)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":14}],"term":"Skin disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":14}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14}],"term":"Hiccups"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":14}],"term":"Creatinine"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":14}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":14}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14}],"term":"Decreased ejection fraction (transient)"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14}],"term":"Cord compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Hospitalization for infusional chemotherapy","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14}],"term":"Progressive disease"}],"timeFrame":"Up to 12 weeks treatment, plus a minimum of 30 days follow-up"}