{"description":"Serious adverse events and other adverse events (i.e. granulocyte transfusion related events) data were collected. The number of participants at risk for other adverse events corresponds to the number of participants who received granulocyte transfusions (6 control arm subjects and 51 granulocyte arm subjects).","eventGroups":[{"description":"Received antimicrobial therapy alone.","id":"EG000","otherNumAffected":1,"otherNumAtRisk":6,"seriousNumAffected":25,"seriousNumAtRisk":58,"title":"Control Arm"},{"description":"Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.","id":"EG001","otherNumAffected":32,"otherNumAtRisk":51,"seriousNumAffected":26,"seriousNumAtRisk":56,"title":"Granulocyte Arm"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":5,"numAtRisk":51,"numEvents":5}],"term":"Allergic reaction/ hypersensitivity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0}],"term":"Sinus bradycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":3},{"groupId":"EG001","numAffected":17,"numAtRisk":51,"numEvents":36}],"term":"Sinus tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":9,"numAtRisk":51,"numEvents":15}],"term":"Hypertension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":10,"numAtRisk":51,"numEvents":14}],"term":"Hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":51,"numEvents":3}],"term":"Dyspnea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":8,"numAtRisk":51,"numEvents":16}],"term":"Hypoxia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":51,"numEvents":1}],"term":"Wheezing"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0}],"term":"Cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":51,"numEvents":0}],"term":"Hemolysis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":15,"numAtRisk":51,"numEvents":42}],"term":"Rigors and Chills"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG001","numAffected":28,"numAtRisk":51,"numEvents":81}],"term":"Fever"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58},{"groupId":"EG001","numAffected":0,"numAtRisk":56}],"term":"Abdominal infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58},{"groupId":"EG001","numAffected":2,"numAtRisk":56}],"term":"Abdominal sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Nausea, vomiting and abdominal pain.","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":58},{"groupId":"EG001","numAffected":1,"numAtRisk":56}],"term":"Abdominal symptom"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"PTT (Grade 2)","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58},{"groupId":"EG001","numAffected":0,"numAtRisk":56}],"term":"Activated partial thromboplastin time shortened"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":58},{"groupId":"EG001","numAffected":1,"numAtRisk":56}],"term":"Acute lung injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58},{"groupId":"EG001","numAffected":0,"numAtRisk":56}],"term":"Acute respiratory distress syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58},{"groupId":"EG001","numAffected":0,"numAtRisk":56}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":58},{"groupId":"EG001","numAffected":1,"numAtRisk":56}],"term":"Ataxia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58},{"groupId":"EG001","numAffected":0,"numAtRisk":56}],"term":"Atrial fibrillation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58},{"groupId":"EG001","numAffected":0,"numAtRisk":56}],"term":"Increased blast cell count"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58},{"groupId":"EG001","numAffected":0,"numAtRisk":56}],"term":"Increased blood creatinine"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":58},{"groupId":"EG001","numAffected":1,"numAtRisk":56}],"term":"Bronchopneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac 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infestations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":58},{"groupId":"EG001","numAffected":1,"numAtRisk":56}],"term":"Fungaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58},{"groupId":"EG001","numAffected":0,"numAtRisk":56}],"term":"Gastric haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":58},{"groupId":"EG001","numAffected":1,"numAtRisk":56}],"term":"Graft versus host disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58},{"groupId":"EG001","numAffected":0,"numAtRisk":56}],"term":"Hallucination"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":58},{"groupId":"EG001","numAffected":1,"numAtRisk":56}],"term":"Hydraemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58},{"groupId":"EG001","numAffected":0,"numAtRisk":56}],"term":"Hyperbilirubinaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58},{"groupId":"EG001","numAffected":0,"numAtRisk":56}],"term":"Hypoalbuminaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58},{"groupId":"EG001","numAffected":0,"numAtRisk":56}],"term":"Hypocalcaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58},{"groupId":"EG001","numAffected":0,"numAtRisk":56}],"term":"Hypokalaemic syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":58},{"groupId":"EG001","numAffected":2,"numAtRisk":56}],"term":"Hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58},{"groupId":"EG001","numAffected":0,"numAtRisk":56}],"term":"Infection in an immunocompromised host"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58},{"groupId":"EG001","numAffected":1,"numAtRisk":56}],"term":"Mental status changes"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58},{"groupId":"EG001","numAffected":0,"numAtRisk":56}],"term":"Metabolic disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":58},{"groupId":"EG001","numAffected":3,"numAtRisk":56}],"term":"Multi-organ failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":58},{"groupId":"EG001","numAffected":1,"numAtRisk":56}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":58},{"groupId":"EG001","numAffected":1,"numAtRisk":56}],"term":"Pelvic abscess"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":58},{"groupId":"EG001","numAffected":1,"numAtRisk":56}],"term":"Pericardial effusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":58},{"groupId":"EG001","numAffected":1,"numAtRisk":56}],"term":"Pneumothorax"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58},{"groupId":"EG001","numAffected":0,"numAtRisk":56}],"term":"Increased prothrombin level"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":58},{"groupId":"EG001","numAffected":1,"numAtRisk":56}],"term":"Respiratory distress"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58},{"groupId":"EG001","numAffected":2,"numAtRisk":56}],"term":"Respiratory failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58},{"groupId":"EG001","numAffected":1,"numAtRisk":56}],"term":"Sepsis neonatal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58},{"groupId":"EG001","numAffected":3,"numAtRisk":56}],"term":"Septic shock"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":58},{"groupId":"EG001","numAffected":1,"numAtRisk":56}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58},{"groupId":"EG001","numAffected":2,"numAtRisk":56}],"term":"Sepsis syndrome"}],"timeFrame":"Serious adverse events were reported up to 42 days after randomization."}