{"eventGroups":[{"description":"Pomalidomide: Only enough CC-4047 for 1 cycle of therapy may be provided to the patient each cycle. Participants will receive CC-4047 4 mg/day for 21 days, every 28 days. Treatment will continue until disease recurrence or untoward toxicity.","id":"EG000","otherNumAffected":71,"otherNumAtRisk":71,"seriousNumAffected":6,"seriousNumAtRisk":71,"title":"Pomalidomide"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":71,"numAtRisk":71}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":71,"numAtRisk":71}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":71,"numAtRisk":71}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"For some \"Other\" (non-serious) adverse events, only the affected organ system was recorded/reported.","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":71,"numAtRisk":71}],"term":"Blood/Bone Marrow"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":71}],"term":"Cardiac Arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"For some \"Other\" (non-serious) adverse events, only the affected organ system was recorded/reported.","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":71}],"term":"Cardiac General"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":55,"numAtRisk":71}],"term":"Constitutional Symptoms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"For some \"Other\" (non-serious) adverse events, only the affected organ system was recorded/reported.","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":71}],"term":"Dermatology / Skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"For some \"Other\" (non-serious) adverse events, only the affected organ system was recorded/reported.","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":44,"numAtRisk":71}],"term":"Gastrointestinal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":71}],"term":"Hemorrhage / Bleeding"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"For some \"Other\" (non-serious) adverse events, only the affected organ system was recorded/reported.","organSystem":"Hepatobiliary disorders","stats":[{"groupId":"EG000","numAffected":70,"numAtRisk":71}],"term":"Hepatobiliary / Pancreas"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":71}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"For some \"Other\" (non-serious) adverse events, only the affected organ system was recorded/reported.","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":71}],"term":"Lymphatics"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"For some \"Other\" (non-serious) adverse events, only the affected organ system was recorded/reported.","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":66,"numAtRisk":71}],"term":"Metabolic/Laboratory"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"For some \"Other\" (non-serious) adverse events, only the affected organ system was recorded/reported.","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":71}],"term":"Musculoskeletal / Soft Tissue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"For some \"Other\" (non-serious) adverse events, only the affected organ system was recorded/reported.","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":55,"numAtRisk":71}],"term":"Neurology"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"For some \"Other\" (non-serious) adverse events, only the affected organ system was recorded/reported.","organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":71}],"term":"Ocular / Vision"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":40,"numAtRisk":71}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"For some \"Other\" (non-serious) adverse events, only the affected organ system was recorded/reported.","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":40,"numAtRisk":71}],"term":"Pulmonary / Upper Respiratory"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"For some \"Other\" (non-serious) adverse events, only the affected organ system was recorded/reported.","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":45,"numAtRisk":71}],"term":"Renal / Genitourinary"}],"seriousEvents":[{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":71,"numEvents":2}],"term":"Acute renal failure"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Hospitalization for sinus infection"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":71,"numEvents":3}],"term":"Hospialization for progressive disease, sepsis and pneumonia"},{"organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Hospitalization for removal of port"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Hospitalization for fever"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":71,"numEvents":2}],"term":"RSV Pneumonia"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Fever neutropenia dehydration"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":71,"numEvents":4}],"term":"Hospitalization for neutropenic fever"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Hospitalization due to acute liver failure hepatitis B flare"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Hospitalization for pneumonia"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":71,"numEvents":2}],"term":"Atrial Fibrilation"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Pancytopenia"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Hypoxia"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Hospitalization dyspnea due to congestive heart failure"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Hospitalization for shortness of breath"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Dyspnea"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Dyspnea on exertion"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Hospitalization for bronchitis"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Epistaxis"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":71,"numEvents":2}],"term":"Hospitalization for hypotension"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Respiratory failure secondary to opioid overdose"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Hospitalization for intractable pain, low fever"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Hospitalization for acute respiratory distress syndrome, encephalopathy, fatigue"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":71,"numEvents":4}],"term":"Pneumonia"},{"organSystem":"Surgical and medical procedures","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Intrahepatic chemotherapy"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Paraparesis, spinal cord compression"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Small bowel obstruction"},{"organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Fracture of T7 with possible cord compression"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Deep vein thrombosis and cerebrovascular accident"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Blood transfusion"},{"organSystem":"Surgical and medical procedures","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Wrong dosage dispensed"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Hospitalization with fever and low blood pressure"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Acute diarrhea"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Hospitalization for Pneumonia and gastrointestinal bleeding"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Hospitalization for diarrhea and dizziness"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Elevated liver function test"},{"organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Deep vein thrombosis diagnosis"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Hospitalization for sepsis"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Worsening renal failure"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Tachycardia"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Pneumonia, fever and altered mental status"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Severe cough, shortness of breath and hypoxemia"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Shortness of breath fever chills"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Hospitalization for parainfluenza type 2"},{"organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Mental status changes and bacteremia"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Recurrent multifocal pneumonia"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Upper respiratory infection and fever"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Acute onset diarrhea and acute renal insufficiency"},{"organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Hospitalization due to transient ischemic attack"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Shortness of breath with wheezing"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Recurrent bilateral pneumonia"}]}