{"eventGroups":[{"description":"Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.","id":"EG000","otherNumAffected":150,"otherNumAtRisk":164,"seriousNumAffected":5,"seriousNumAtRisk":164,"title":"DA + IV Iron"},{"description":"Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.","id":"EG001","otherNumAffected":147,"otherNumAtRisk":163,"seriousNumAffected":3,"seriousNumAtRisk":163,"title":"DA + Oral Iron"},{"description":"Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.","id":"EG002","otherNumAffected":141,"otherNumAtRisk":163,"seriousNumAffected":2,"seriousNumAtRisk":163,"title":"DA + Placebo"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":164,"numEvents":9},{"groupId":"EG001","numAffected":13,"numAtRisk":163,"numEvents":14},{"groupId":"EG002","numAffected":8,"numAtRisk":163,"numEvents":9}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":164,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":163,"numEvents":4}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Ischemia/Infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Pericardial effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Restrictive cardiomyopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Right ventricular dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":164,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Supraventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Valvular heart disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Extraocular muscle disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Ocular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Vision-Blurred"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Anus Mucositis/stomatitis (clinical exam)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Colonic hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Colonic perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":76,"numAtRisk":164,"numEvents":163},{"groupId":"EG001","numAffected":72,"numAtRisk":163,"numEvents":166},{"groupId":"EG002","numAffected":79,"numAtRisk":163,"numEvents":182}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":64,"numAtRisk":164,"numEvents":131},{"groupId":"EG001","numAffected":64,"numAtRisk":163,"numEvents":129},{"groupId":"EG002","numAffected":68,"numAtRisk":163,"numEvents":131}],"term":"Diarrhea-No Colostom"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":164,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Flatulence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Gastrointestinal disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Ileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":76,"numAtRisk":164,"numEvents":165},{"groupId":"EG001","numAffected":83,"numAtRisk":163,"numEvents":164},{"groupId":"EG002","numAffected":82,"numAtRisk":163,"numEvents":171}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":2}],"term":"Oral cavity Mucositis/stomatitis (functional/symptomatic)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":164,"numEvents":3},{"groupId":"EG001","numAffected":5,"numAtRisk":163,"numEvents":5},{"groupId":"EG002","numAffected":6,"numAtRisk":163,"numEvents":6}],"term":"Pain-Abdominal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":2}],"term":"Pain-Stomach"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Rectal hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":164,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Small intestinal stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":41,"numAtRisk":164,"numEvents":69},{"groupId":"EG001","numAffected":37,"numAtRisk":163,"numEvents":70},{"groupId":"EG002","numAffected":36,"numAtRisk":163,"numEvents":57}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":164,"numEvents":5},{"groupId":"EG001","numAffected":4,"numAtRisk":163,"numEvents":4},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Disease Progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Edema: Limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Edema: Viscera"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":164,"numEvents":32},{"groupId":"EG001","numAffected":17,"numAtRisk":163,"numEvents":26},{"groupId":"EG002","numAffected":18,"numAtRisk":163,"numEvents":27}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Multi-organ failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":164,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Cytokine release syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":164,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Abdominal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Anal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Bladder (urinary) infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":164,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Bladder infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":164,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":163,"numEvents":2}],"term":"Blood Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Bronchus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Colon infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":163,"numEvents":2}],"term":"Lung (pneumonia) infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Pharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":164,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":163,"numEvents":3},{"groupId":"EG002","numAffected":3,"numAtRisk":163,"numEvents":3}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Rectum infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Salivary gland infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Skin (cellulites) infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":164,"numEvents":5},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":163,"numEvents":4}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Upper airway infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":164,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Vaginal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Vascular access complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":2}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":163,"numEvents":2}],"term":"Alkaline phosphatase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":163,"numEvents":2}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":164,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":163,"numEvents":3}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"CPK (creatine phosphokinase)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":163,"numEvents":4},{"groupId":"EG002","numAffected":2,"numAtRisk":163,"numEvents":2}],"term":"Creatinine"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":164,"numEvents":19},{"groupId":"EG001","numAffected":17,"numAtRisk":163,"numEvents":25},{"groupId":"EG002","numAffected":28,"numAtRisk":163,"numEvents":52}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":164,"numEvents":16},{"groupId":"EG001","numAffected":11,"numAtRisk":163,"numEvents":22},{"groupId":"EG002","numAffected":10,"numAtRisk":163,"numEvents":22}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":164,"numEvents":24},{"groupId":"EG001","numAffected":17,"numAtRisk":163,"numEvents":21},{"groupId":"EG002","numAffected":21,"numAtRisk":163,"numEvents":37}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":164,"numEvents":13},{"groupId":"EG001","numAffected":15,"numAtRisk":163,"numEvents":23},{"groupId":"EG002","numAffected":14,"numAtRisk":163,"numEvents":24}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":164,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":163,"numEvents":2}],"term":"Prothrombin Time"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Weight gain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":164,"numEvents":6},{"groupId":"EG001","numAffected":3,"numAtRisk":163,"numEvents":8},{"groupId":"EG002","numAffected":3,"numAtRisk":163,"numEvents":3}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":164,"numEvents":12},{"groupId":"EG001","numAffected":8,"numAtRisk":163,"numEvents":9},{"groupId":"EG002","numAffected":7,"numAtRisk":163,"numEvents":7}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Hypercalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":164,"numEvents":3},{"groupId":"EG001","numAffected":10,"numAtRisk":163,"numEvents":16},{"groupId":"EG002","numAffected":6,"numAtRisk":163,"numEvents":7}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":163,"numEvents":2}],"term":"Hyperkalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Hyperuricemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":163,"numEvents":3}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":164,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":163,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Hypoglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":164,"numEvents":8},{"groupId":"EG001","numAffected":4,"numAtRisk":163,"numEvents":4},{"groupId":"EG002","numAffected":5,"numAtRisk":163,"numEvents":7}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Hypomagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":164,"numEvents":5},{"groupId":"EG001","numAffected":3,"numAtRisk":163,"numEvents":4},{"groupId":"EG002","numAffected":4,"numAtRisk":163,"numEvents":6}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Iron increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":164,"numEvents":5},{"groupId":"EG001","numAffected":2,"numAtRisk":163,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":164,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":163,"numEvents":5},{"groupId":"EG002","numAffected":2,"numAtRisk":163,"numEvents":2}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Chest wall pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Extremity-lower weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":164,"numEvents":5},{"groupId":"EG001","numAffected":2,"numAtRisk":163,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":163,"numEvents":2}],"term":"Muscle Weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Musculoskeletal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":2}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Trunk weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Pain-Anal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Depressed level of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":163,"numEvents":3},{"groupId":"EG002","numAffected":2,"numAtRisk":163,"numEvents":2}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Ischemia-Cerebral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Mental status changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":164,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Neuralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Neuro"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":163,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Peripheral motor neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":164,"numEvents":8},{"groupId":"EG001","numAffected":2,"numAtRisk":163,"numEvents":2},{"groupId":"EG002","numAffected":4,"numAtRisk":163,"numEvents":6}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":164,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":163,"numEvents":3}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Syncope Vasovagal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":163,"numEvents":2}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Glomerular filtration rate"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Renal Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Pelvic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Vaginal fistula"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Adult respiratory distress syndrome (ARDS)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Atelectasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":163,"numEvents":2}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":164,"numEvents":21},{"groupId":"EG001","numAffected":8,"numAtRisk":163,"numEvents":9},{"groupId":"EG002","numAffected":16,"numAtRisk":163,"numEvents":19}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":164,"numEvents":5},{"groupId":"EG001","numAffected":2,"numAtRisk":163,"numEvents":2},{"groupId":"EG002","numAffected":3,"numAtRisk":163,"numEvents":3}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":163,"numEvents":2}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Pulmonary"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Pulmonary hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Acne"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":163,"numEvents":4}],"term":"Hand-foot skin reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Pain of skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":44,"numAtRisk":164,"numEvents":77},{"groupId":"EG001","numAffected":48,"numAtRisk":163,"numEvents":91},{"groupId":"EG002","numAffected":46,"numAtRisk":163,"numEvents":77}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Rash/Desquamation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Sweating"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Urticaria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":164,"numEvents":66},{"groupId":"EG001","numAffected":30,"numAtRisk":163,"numEvents":55},{"groupId":"EG002","numAffected":33,"numAtRisk":163,"numEvents":58}],"term":"Flushing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":164,"numEvents":28},{"groupId":"EG001","numAffected":20,"numAtRisk":163,"numEvents":29},{"groupId":"EG002","numAffected":14,"numAtRisk":163,"numEvents":16}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":164,"numEvents":34},{"groupId":"EG001","numAffected":13,"numAtRisk":163,"numEvents":19},{"groupId":"EG002","numAffected":24,"numAtRisk":163,"numEvents":31}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Phlebitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":164,"numEvents":7},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":8,"numAtRisk":163,"numEvents":8}],"term":"Thrombosis"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Fistula-intestinal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":163,"numEvents":1}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Syndromes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Activated partial thromboplastin time prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":164,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":163,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":163,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":164,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":163,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":163,"numEvents":0}],"term":"Thrombosis"}]}