{"eventGroups":[{"description":"Patients receive 150 mg/m\\^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m\\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m\\^2/day capecitabine PO BID on days 2-15","id":"EG000","otherNumAffected":16,"otherNumAtRisk":17,"seriousNumAffected":7,"seriousNumAtRisk":17,"title":"Group 1 (6/6 UGT1A1 Genotype)"},{"description":"Patients receive 150 mg/m\\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\\^2/day capecitabine PO BID on days 2-15","id":"EG001","otherNumAffected":10,"otherNumAtRisk":10,"seriousNumAffected":6,"seriousNumAtRisk":10,"title":"Group 2 (6/7 UGT1A1 Genotype)"},{"description":"Patients receive 75 mg/m\\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\\^2/day capecitabine PO BID on days 2-15","id":"EG002","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":1,"seriousNumAtRisk":6,"title":"Group 3 (7/7 UGT1A1 Genotype)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":17,"numEvents":120},{"groupId":"EG001","numAffected":10,"numAtRisk":10,"numEvents":58},{"groupId":"EG002","numAffected":6,"numAtRisk":6,"numEvents":57}],"term":"Hemoglobin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Cardiac disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":2}],"term":"Hearing loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Eye disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":10,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":17,"numEvents":66},{"groupId":"EG001","numAffected":7,"numAtRisk":10,"numEvents":25},{"groupId":"EG002","numAffected":4,"numAtRisk":6,"numEvents":19}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":10,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Ear, nose and throat examination abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Esophageal mucositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":17,"numEvents":4},{"groupId":"EG001","numAffected":4,"numAtRisk":10,"numEvents":7},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Mucositis oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":17,"numEvents":71},{"groupId":"EG001","numAffected":7,"numAtRisk":10,"numEvents":31},{"groupId":"EG002","numAffected":6,"numAtRisk":6,"numEvents":20}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Obstruction gastric"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Stomach pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":17,"numEvents":39},{"groupId":"EG001","numAffected":4,"numAtRisk":10,"numEvents":13},{"groupId":"EG002","numAffected":6,"numAtRisk":6,"numEvents":16}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":17,"numEvents":10},{"groupId":"EG001","numAffected":6,"numAtRisk":10,"numEvents":16},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Immune system disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Gastric infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Gingival infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":17,"numEvents":45},{"groupId":"EG001","numAffected":7,"numAtRisk":10,"numEvents":26},{"groupId":"EG002","numAffected":3,"numAtRisk":6,"numEvents":16}],"term":"Leukocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":17,"numEvents":39},{"groupId":"EG001","numAffected":7,"numAtRisk":10,"numEvents":26},{"groupId":"EG002","numAffected":3,"numAtRisk":6,"numEvents":13}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":17,"numEvents":48},{"groupId":"EG001","numAffected":5,"numAtRisk":10,"numEvents":9},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":17}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":3},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":6}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":10,"numEvents":6},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":17,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":2}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":7}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hyperkalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":17,"numEvents":9},{"groupId":"EG001","numAffected":2,"numAtRisk":10,"numEvents":9},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":5}],"term":"Laryngeal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Memory impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":17,"numEvents":98},{"groupId":"EG001","numAffected":7,"numAtRisk":10,"numEvents":41},{"groupId":"EG002","numAffected":5,"numAtRisk":6,"numEvents":33}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Taste alteration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Ureteric obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":17,"numEvents":13},{"groupId":"EG001","numAffected":5,"numAtRisk":10,"numEvents":13},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":10}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":17,"numEvents":13},{"groupId":"EG001","numAffected":2,"numAtRisk":10,"numEvents":6},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":9}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Hemorrhage nasal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":6}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":17,"numEvents":81},{"groupId":"EG001","numAffected":9,"numAtRisk":10,"numEvents":53},{"groupId":"EG002","numAffected":5,"numAtRisk":6,"numEvents":51}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":2}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":17,"numEvents":11},{"groupId":"EG001","numAffected":2,"numAtRisk":10,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hand-and-foot syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Peripheral ischemia"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":17,"numEvents":6},{"groupId":"EG001","numAffected":2,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hemoglobin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":17,"numEvents":5},{"groupId":"EG001","numAffected":2,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":17,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Catheter related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Colitis, infectious (e.g., Clostridium difficile)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":17,"numEvents":5},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Leukocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":17,"numEvents":6},{"groupId":"EG001","numAffected":3,"numAtRisk":10,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":17,"numEvents":5},{"groupId":"EG001","numAffected":2,"numAtRisk":10,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Thrombosis"}]}