{"description":"Adverse events were captured collectively for the study, not by arm, because both arms received the same drugs.","eventGroups":[{"description":"Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.","id":"EG000","otherNumAffected":24,"otherNumAtRisk":74,"seriousNumAffected":3,"seriousNumAtRisk":74,"title":"Combination Drug Therapy"}],"frequencyThreshold":"5","otherEvents":[{"organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":74,"numEvents":22}],"term":"Anemia"},{"organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":74,"numEvents":11}],"term":"Leukocytes (total WBC)"},{"organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":74,"numEvents":12}],"term":"Lymphopenia"},{"organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":74,"numEvents":5}],"term":"Neutrophils/granulocytes (ANC/AGC)"},{"organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":74,"numEvents":12}],"term":"Platelets"},{"organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":74,"numEvents":32}],"term":"Fatigue (asthenia, lethargy, malaise)"},{"organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":74,"numEvents":5}],"term":"Rash/desquamation"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":74,"numEvents":14}],"term":"Constipation"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":74,"numEvents":12}],"term":"Diarrhea"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":74,"numEvents":11}],"term":"Nausea"},{"organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":74,"numEvents":6}],"term":"Taste alteration (dysgeusia)"},{"organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":74,"numEvents":6}],"term":"Edema: limb"},{"organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":74,"numEvents":9}],"term":"ALT, SGPT (serum glutamic pyruvic transaminase)"},{"organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":74,"numEvents":9}],"term":"Albumin, serum-low (hypoalbuminemia)"},{"organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":74,"numEvents":12}],"term":"Calcium, serum-low (hypocalcemia)"},{"organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":74,"numEvents":8}],"term":"Glucose, serum-high (hyperglycemia)"},{"organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":74,"numEvents":9}],"term":"Phosphate, serum-low (hypophosphatemia)"},{"organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":74,"numEvents":6}],"term":"Potassium, serum-low (hypokalemia)"},{"organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":74,"numEvents":5}],"term":"Sodium, serum-low (hyponatremia)"},{"organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":74,"numEvents":7}],"term":"Dizziness"},{"organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":74,"numEvents":5}],"term":"Mood alteration"},{"organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":74,"numEvents":15}],"term":"Neuropathy: sensory"},{"organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":74,"numEvents":5}],"term":"Pain"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":74,"numEvents":9}],"term":"Cough"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":74,"numEvents":7}],"term":"Dyspnea (shortness of breath)"}],"seriousEvents":[{"organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1}],"term":"Lung Hemorrhage"},{"organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1}],"term":"Pneumonia with Grade 3 or 4 Neutropenia"},{"organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1}],"term":"Pneumonia with Normal Absolute Neutrophil Count"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1}],"term":"Pneumonitis"}]}