{"description":"For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.","eventGroups":[{"description":"Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.","id":"EG000","otherNumAffected":32,"otherNumAtRisk":46,"seriousNumAffected":2,"seriousNumAtRisk":46,"title":"Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)"},{"description":"Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.","id":"EG001","otherNumAffected":35,"otherNumAtRisk":42,"seriousNumAffected":6,"seriousNumAtRisk":42,"title":"Group C (Chemotherapy, Monoclonal Antibody Therapy)"}],"frequencyThreshold":"0","otherEvents":[{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":46,"numEvents":32},{"groupId":"EG001","numAffected":32,"numAtRisk":42,"numEvents":32}],"term":"Anemia"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Blood and lymphatic system disorders - Other, specify"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Bone marrow hypocellular"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Disseminated intravascular coagulation"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":46,"numEvents":18},{"groupId":"EG001","numAffected":22,"numAtRisk":42,"numEvents":22}],"term":"Febrile neutropenia"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Asystole"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Cardiac disorders - Other, specify"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Mobitz type I"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Sinus bradycardia"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Sinus tachycardia"},{"organSystem":"Ear and labyrinth disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"External ear inflammation"},{"organSystem":"Ear and labyrinth disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Hearing impaired"},{"organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Blurred vision"},{"organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Conjunctivitis"},{"organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":46,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0}],"term":"Dry eye"},{"organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Extraocular muscle paresis"},{"organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Eye disorders - Other, specify"},{"organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Eye pain"},{"organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Photophobia"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Abdominal distension"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":46,"numEvents":8},{"groupId":"EG001","numAffected":11,"numAtRisk":42,"numEvents":11}],"term":"Abdominal pain"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":46,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0}],"term":"Anal mucositis"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Colitis"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":46,"numEvents":5},{"groupId":"EG001","numAffected":6,"numAtRisk":42,"numEvents":6}],"term":"Constipation"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":46,"numEvents":6},{"groupId":"EG001","numAffected":13,"numAtRisk":42,"numEvents":13}],"term":"Diarrhea"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Dry mouth"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":46,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Dyspepsia"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Dysphagia"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0}],"term":"Esophageal pain"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Esophagitis"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0}],"term":"Gastric hemorrhage"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Gastritis"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":46,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":42,"numEvents":3}],"term":"Gastrointestinal disorders - Other, specify"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0}],"term":"Gingival pain"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0}],"term":"Hemorrhoids"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Ileus"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":46,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0}],"term":"Lower gastrointestinal hemorrhage"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":46,"numEvents":19},{"groupId":"EG001","numAffected":18,"numAtRisk":42,"numEvents":18}],"term":"Mucositis oral"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":46,"numEvents":10},{"groupId":"EG001","numAffected":15,"numAtRisk":42,"numEvents":15}],"term":"Nausea"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":42,"numEvents":3}],"term":"Oral hemorrhage"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":46,"numEvents":3},{"groupId":"EG001","numAffected":7,"numAtRisk":42,"numEvents":7}],"term":"Oral pain"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0}],"term":"Rectal hemorrhage"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0}],"term":"Rectal mucositis"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":46,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Rectal pain"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Stomach pain"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":46,"numEvents":8},{"groupId":"EG001","numAffected":13,"numAtRisk":42,"numEvents":13}],"term":"Vomiting"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":46,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Chills"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":42,"numEvents":4}],"term":"Edema limbs"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":7,"numAtRisk":42,"numEvents":7}],"term":"Fatigue"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":46,"numEvents":4},{"groupId":"EG001","numAffected":11,"numAtRisk":42,"numEvents":11}],"term":"Fever"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Flu like symptoms"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Gait disturbance"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"General disorders and administration site conditions - Other, specify"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":46,"numEvents":7},{"groupId":"EG001","numAffected":5,"numAtRisk":42,"numEvents":5}],"term":"Pain"},{"organSystem":"Hepatobiliary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Hepatic pain"},{"organSystem":"Immune system disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":46,"numEvents":5},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Allergic reaction"},{"organSystem":"Immune system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Anaphylaxis"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":5,"numAtRisk":42,"numEvents":5}],"term":"Catheter related infection"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":46,"numEvents":5},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Enterocolitis infectious"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":46,"numEvents":16},{"groupId":"EG001","numAffected":23,"numAtRisk":42,"numEvents":23}],"term":"Infections and infestations - Other, specify"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Lip infection"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Lung infection"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0}],"term":"Mucosal infection"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Otitis externa"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Otitis media"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0}],"term":"Pharyngitis"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":42,"numEvents":3}],"term":"Sinusitis"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Skin infection"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0}],"term":"Small intestine infection"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Tooth infection"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Urinary tract infection"},{"organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Bruising"},{"organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Fracture"},{"organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":46,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0}],"term":"Vascular access complication"},{"organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Venous injury"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":46,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":42,"numEvents":3}],"term":"Activated partial thromboplastin time prolonged"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":46,"numEvents":27},{"groupId":"EG001","numAffected":25,"numAtRisk":42,"numEvents":25}],"term":"Alanine aminotransferase increased"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":46,"numEvents":5},{"groupId":"EG001","numAffected":3,"numAtRisk":42,"numEvents":3}],"term":"Alkaline phosphatase increased"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":46,"numEvents":16},{"groupId":"EG001","numAffected":21,"numAtRisk":42,"numEvents":21}],"term":"Aspartate aminotransferase increased"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":13,"numAtRisk":42,"numEvents":13}],"term":"Blood bilirubin increased"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0}],"term":"CD4 lymphocytes decreased"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Cholesterol high"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":46,"numEvents":6},{"groupId":"EG001","numAffected":8,"numAtRisk":42,"numEvents":8}],"term":"Creatinine increased"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Fibrinogen decreased"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":8,"numAtRisk":42,"numEvents":8}],"term":"GGT increased"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"INR increased"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":5,"numAtRisk":42,"numEvents":5}],"term":"Investigations - Other, specify"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Lipase increased"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":46,"numEvents":9},{"groupId":"EG001","numAffected":9,"numAtRisk":42,"numEvents":9}],"term":"Lymphocyte count decreased"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":46,"numEvents":31},{"groupId":"EG001","numAffected":35,"numAtRisk":42,"numEvents":35}],"term":"Neutrophil count decreased"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":46,"numEvents":29},{"groupId":"EG001","numAffected":34,"numAtRisk":42,"numEvents":34}],"term":"Platelet count decreased"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":42,"numEvents":3}],"term":"Serum amylase increased"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Weight gain"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":46,"numEvents":3},{"groupId":"EG001","numAffected":6,"numAtRisk":42,"numEvents":6}],"term":"Weight loss"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":46,"numEvents":31},{"groupId":"EG001","numAffected":29,"numAtRisk":42,"numEvents":29}],"term":"White blood cell decreased"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Acidosis"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Alkalosis"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":46,"numEvents":3},{"groupId":"EG001","numAffected":12,"numAtRisk":42,"numEvents":12}],"term":"Anorexia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":46,"numEvents":3},{"groupId":"EG001","numAffected":5,"numAtRisk":42,"numEvents":5}],"term":"Dehydration"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":46,"numEvents":2},{"groupId":"EG001","numAffected":5,"numAtRisk":42,"numEvents":5}],"term":"Hypercalcemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":46,"numEvents":20},{"groupId":"EG001","numAffected":18,"numAtRisk":42,"numEvents":18}],"term":"Hyperglycemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":42,"numEvents":3}],"term":"Hyperkalemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":46,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Hypermagnesemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":42,"numEvents":4}],"term":"Hypernatremia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":46,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":42,"numEvents":3}],"term":"Hypertriglyceridemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":42,"numEvents":3}],"term":"Hyperuricemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":46,"numEvents":13},{"groupId":"EG001","numAffected":18,"numAtRisk":42,"numEvents":18}],"term":"Hypoalbuminemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":46,"numEvents":16},{"groupId":"EG001","numAffected":20,"numAtRisk":42,"numEvents":20}],"term":"Hypocalcemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":42,"numEvents":3}],"term":"Hypoglycemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":46,"numEvents":17},{"groupId":"EG001","numAffected":23,"numAtRisk":42,"numEvents":23}],"term":"Hypokalemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":46,"numEvents":10},{"groupId":"EG001","numAffected":9,"numAtRisk":42,"numEvents":9}],"term":"Hypomagnesemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":46,"numEvents":16},{"groupId":"EG001","numAffected":16,"numAtRisk":42,"numEvents":16}],"term":"Hyponatremia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":46,"numEvents":14},{"groupId":"EG001","numAffected":11,"numAtRisk":42,"numEvents":11}],"term":"Hypophosphatemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":46,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":42,"numEvents":4}],"term":"Tumor lysis syndrome"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Arthralgia"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":46,"numEvents":5},{"groupId":"EG001","numAffected":5,"numAtRisk":42,"numEvents":5}],"term":"Back pain"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":42,"numEvents":3}],"term":"Bone pain"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0}],"term":"Buttock pain"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":46,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0}],"term":"Myalgia"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Neck pain"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":46,"numEvents":2},{"groupId":"EG001","numAffected":5,"numAtRisk":42,"numEvents":5}],"term":"Pain in extremity"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Abducens nerve disorder"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Cognitive disturbance"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":46,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":42,"numEvents":3}],"term":"Dizziness"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0}],"term":"Dysgeusia"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0}],"term":"Extrapyramidal disorder"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Facial nerve disorder"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":46,"numEvents":9},{"groupId":"EG001","numAffected":8,"numAtRisk":42,"numEvents":8}],"term":"Headache"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Nervous system disorders - Other, specify"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Neuralgia"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Peripheral motor neuropathy"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":46,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Peripheral sensory neuropathy"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Seizure"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Tremor"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Trigeminal nerve disorder"},{"organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Agitation"},{"organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":46,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Anxiety"},{"organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Confusion"},{"organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":46,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Depression"},{"organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":46,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0}],"term":"Insomnia"},{"organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Psychosis"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Acute kidney injury"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Bladder spasm"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Cystitis noninfective"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Proteinuria"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0}],"term":"Renal and urinary disorders - Other, specify"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Urinary frequency"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Urinary tract obstruction"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":46,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Urinary tract pain"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Allergic rhinitis"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Bronchopulmonary hemorrhage"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Bronchospasm"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":42,"numEvents":4}],"term":"Cough"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Dyspnea"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Epistaxis"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":46,"numEvents":2},{"groupId":"EG001","numAffected":5,"numAtRisk":42,"numEvents":5}],"term":"Hypoxia"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":46,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":42,"numEvents":3}],"term":"Pharyngeal mucositis"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":46,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Pharyngolaryngeal pain"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Pleural effusion"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Pneumonitis"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Respiratory, thoracic and mediastinal disorders - Other, specify"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":46,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Alopecia"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Body odor"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Erythema multiforme"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Hyperhidrosis"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Nail loss"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Pain of skin"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":46,"numEvents":3},{"groupId":"EG001","numAffected":4,"numAtRisk":42,"numEvents":4}],"term":"Pruritus"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":42,"numEvents":3}],"term":"Purpura"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Rash acneiform"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":46,"numEvents":4},{"groupId":"EG001","numAffected":12,"numAtRisk":42,"numEvents":12}],"term":"Rash maculo-papular"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":42,"numEvents":4}],"term":"Skin and subcutaneous tissue disorders - Other, specify"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0}],"term":"Skin hyperpigmentation"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Skin ulceration"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Stevens-Johnson syndrome"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Urticaria"},{"organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Flushing"},{"organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":46,"numEvents":5},{"groupId":"EG001","numAffected":10,"numAtRisk":42,"numEvents":10}],"term":"Hypertension"},{"organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":46,"numEvents":2},{"groupId":"EG001","numAffected":9,"numAtRisk":42,"numEvents":9}],"term":"Hypotension"},{"organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Thromboembolic event"},{"organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0}],"term":"Vascular disorders - Other, specify"}],"seriousEvents":[{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0}],"term":"Anemia"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":46,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Febrile neutropenia"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Cardiac disorders - Other, specify"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Sinus tachycardia"},{"organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0}],"term":"Photophobia"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Abdominal pain"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Colitis"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0}],"term":"Esophageal pain"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0}],"term":"Esophagitis"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":6,"numAtRisk":42,"numEvents":6}],"term":"Mucositis oral"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Nausea"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Oral pain"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Typhlitis"},{"organSystem":"Immune system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Anaphylaxis"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Enterocolitis infectious"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":42,"numEvents":3}],"term":"Infections and infestations - Other, specify"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Lung infection"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":42,"numEvents":3}],"term":"Alanine aminotransferase increased"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":42,"numEvents":3}],"term":"Aspartate aminotransferase increased"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Blood bilirubin increased"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Creatinine increased"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0}],"term":"Neutrophil count decreased"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0}],"term":"Platelet count decreased"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Weight loss"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"White blood cell decreased"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Acidosis"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":42,"numEvents":3}],"term":"Anorexia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Dehydration"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Glucose intolerance"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Hyperglycemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Hyperkalemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Hypokalemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Hyponatremia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2}],"term":"Tumor lysis syndrome"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Musculoskeletal and connective tissue disorder - Other, specify"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0}],"term":"Dizziness"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0}],"term":"Headache"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Seizure"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Acute kidney injury"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Cystitis noninfective"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Urinary frequency"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Dyspnea"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Epistaxis"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Hypoxia"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0}],"term":"Pharyngeal mucositis"},{"organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0}],"term":"Hypertension"},{"organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1}],"term":"Hypotension"}]}