{"description":"Routine reporting includes all toxicities reported via AdEERs and all grade 4 \\& higher non-hematologic Adverse Events","eventGroups":[{"deathsNumAffected":69,"deathsNumAtRisk":306,"description":"Patients receive levofloxacin PO or IV over 60-90 minutes once or twice daily beginning on day 3 during 2 consecutive courses of chemotherapy or beginning on day -2 during HSCT and continuing until blood counts recover.\n\nlevofloxacin: Given PO or IV","id":"EG000","otherNumAffected":36,"otherNumAtRisk":306,"seriousNumAffected":4,"seriousNumAtRisk":306,"title":"Arm I (Levofloxacin)"},{"deathsNumAffected":67,"deathsNumAtRisk":307,"description":"Patients receive established standard of care and receive chemotherapy or HSCT as patients in Arm I.","id":"EG001","otherNumAffected":37,"otherNumAtRisk":307,"seriousNumAffected":3,"seriousNumAtRisk":307,"title":"Arm II (Standard of Care)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":306},{"groupId":"EG001","numAffected":2,"numAtRisk":307}],"term":"Acidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":306},{"groupId":"EG001","numAffected":2,"numAtRisk":307}],"term":"Adult respiratory distress syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":306},{"groupId":"EG001","numAffected":4,"numAtRisk":307}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Alkalosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":306},{"groupId":"EG001","numAffected":0,"numAtRisk":307}],"term":"Anaphylaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":306},{"groupId":"EG001","numAffected":2,"numAtRisk":307}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Asystole"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Atelectasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":306},{"groupId":"EG001","numAffected":2,"numAtRisk":307}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":306},{"groupId":"EG001","numAffected":0,"numAtRisk":307}],"term":"Bronchopulmonary hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":306},{"groupId":"EG001","numAffected":0,"numAtRisk":307}],"term":"Capillary leak syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":306},{"groupId":"EG001","numAffected":2,"numAtRisk":307}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Catheter related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Depressed level of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":306},{"groupId":"EG001","numAffected":0,"numAtRisk":307}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Disseminated intravascular coagulation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":306},{"groupId":"EG001","numAffected":2,"numAtRisk":307}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Enterocolitis infectious"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":306},{"groupId":"EG001","numAffected":0,"numAtRisk":307}],"term":"Fibrinogen decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":306},{"groupId":"EG001","numAffected":3,"numAtRisk":307}],"term":"GGT increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Hepatic failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Hepatobiliary disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":306},{"groupId":"EG001","numAffected":2,"numAtRisk":307}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Hyperkalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Hypernatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":306},{"groupId":"EG001","numAffected":0,"numAtRisk":307}],"term":"Hypertriglyceridemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":306},{"groupId":"EG001","numAffected":3,"numAtRisk":307}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":306},{"groupId":"EG001","numAffected":5,"numAtRisk":307}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Hypomagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":306},{"groupId":"EG001","numAffected":2,"numAtRisk":307}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":306},{"groupId":"EG001","numAffected":4,"numAtRisk":307}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":306},{"groupId":"EG001","numAffected":3,"numAtRisk":307}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Ileal hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":306},{"groupId":"EG001","numAffected":4,"numAtRisk":307}],"term":"Infections and infestations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Intracranial hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Left ventricular systolic dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":306},{"groupId":"EG001","numAffected":4,"numAtRisk":307}],"term":"Mucositis oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Multi-organ failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Nervous system disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":306},{"groupId":"EG001","numAffected":0,"numAtRisk":307}],"term":"Pericardial effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":306},{"groupId":"EG001","numAffected":0,"numAtRisk":307}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":306},{"groupId":"EG001","numAffected":0,"numAtRisk":307}],"term":"Portal hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Portal vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Pulmonary edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Renal and urinary disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":306},{"groupId":"EG001","numAffected":5,"numAtRisk":307}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":306},{"groupId":"EG001","numAffected":2,"numAtRisk":307}],"term":"Respiratory, thoracic and mediastinal disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":306},{"groupId":"EG001","numAffected":0,"numAtRisk":307}],"term":"Reversible posterior leukoencephalopathy syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":306},{"groupId":"EG001","numAffected":11,"numAtRisk":307}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Sinus bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Small intestine infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Stridor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Ventricular fibrillation"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":306},{"groupId":"EG001","numAffected":0,"numAtRisk":307}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":306},{"groupId":"EG001","numAffected":0,"numAtRisk":307}],"term":"Capillary leak syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Death NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Heart failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":306},{"groupId":"EG001","numAffected":0,"numAtRisk":307}],"term":"Infections and infestations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":306},{"groupId":"EG001","numAffected":0,"numAtRisk":307}],"term":"Multi-organ failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":306},{"groupId":"EG001","numAffected":0,"numAtRisk":307}],"term":"Pulmonary edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":306},{"groupId":"EG001","numAffected":1,"numAtRisk":307}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":306},{"groupId":"EG001","numAffected":0,"numAtRisk":307}],"term":"Sepsis"}],"timeFrame":"Up to 60 days after enrollment or receiving of levofloxacin"}