{"description":"Four participants did not receive any study treatment and were excluded from the safety analyses.\n\nIn the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.","eventGroups":[{"description":"Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6\\*10\\^6 CD34+ cells/kg were collected.","id":"EG000","otherNumAffected":140,"otherNumAtRisk":147,"seriousNumAffected":4,"seriousNumAtRisk":147,"title":"G-CSF Plus Plerixafor"},{"description":"Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6\\*10\\^6 CD34+ cells/kg were collected.","id":"EG001","otherNumAffected":140,"otherNumAtRisk":151,"seriousNumAffected":6,"seriousNumAtRisk":151,"title":"G-CSF Plus Placebo"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":147},{"groupId":"EG001","numAffected":4,"numAtRisk":151}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Lymphadenopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Splenomegaly"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":147},{"groupId":"EG001","numAffected":4,"numAtRisk":151}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Angina pectoris"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Atrioventricular block first degree"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Extrasystoles"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Myocardial ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":147},{"groupId":"EG001","numAffected":4,"numAtRisk":151}],"term":"Palpitations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Supraventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":147},{"groupId":"EG001","numAffected":4,"numAtRisk":151}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Ventricular extrasystoles"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Congenital, familial and genetic disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Atrial septal defect"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Deafness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":2,"numAtRisk":151}],"term":"Ear pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Tinnitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Eye irritation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Eye pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Ocular hyperaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Vision blurred"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":147},{"groupId":"EG001","numAffected":5,"numAtRisk":151}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Abdominal mass"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":147},{"groupId":"EG001","numAffected":3,"numAtRisk":151}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":4,"numAtRisk":151}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":147},{"groupId":"EG001","numAffected":5,"numAtRisk":151}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Dental discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":47,"numAtRisk":147},{"groupId":"EG001","numAffected":29,"numAtRisk":151}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":147},{"groupId":"EG001","numAffected":6,"numAtRisk":151}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Duodenogastric reflux"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Eructation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Faeces discoloured"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":147},{"groupId":"EG001","numAffected":4,"numAtRisk":151}],"term":"Flatulence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":147},{"groupId":"EG001","numAffected":5,"numAtRisk":151}],"term":"Frequent bowel movements"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Haemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Hypoaesthesia oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Localised intraabdominal fluid collection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Mouth ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":51,"numAtRisk":147},{"groupId":"EG001","numAffected":39,"numAtRisk":151}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Oral soft tissue disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":147},{"groupId":"EG001","numAffected":13,"numAtRisk":151}],"term":"Paraesthesia oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Retching"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Stomach discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Tongue haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Toothache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":147},{"groupId":"EG001","numAffected":9,"numAtRisk":151}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":147},{"groupId":"EG001","numAffected":3,"numAtRisk":151}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":5,"numAtRisk":151}],"term":"Catheter related complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Catheter site discharge"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":4,"numAtRisk":151}],"term":"Catheter site erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Catheter site haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":147},{"groupId":"EG001","numAffected":6,"numAtRisk":151}],"term":"Catheter site haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Catheter site inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Catheter site oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":147},{"groupId":"EG001","numAffected":19,"numAtRisk":151}],"term":"Catheter site pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Catheter site pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":147},{"groupId":"EG001","numAffected":4,"numAtRisk":151}],"term":"Catheter site related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":147},{"groupId":"EG001","numAffected":2,"numAtRisk":151}],"term":"Chest discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":147},{"groupId":"EG001","numAffected":2,"numAtRisk":151}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":147},{"groupId":"EG001","numAffected":4,"numAtRisk":151}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":40,"numAtRisk":147},{"groupId":"EG001","numAffected":41,"numAtRisk":151}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Feeling abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":147},{"groupId":"EG001","numAffected":2,"numAtRisk":151}],"term":"Feeling cold"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Feeling hot"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Gait disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Influenza like illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Infusion site mass"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Infusion site thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":147},{"groupId":"EG001","numAffected":2,"numAtRisk":151}],"term":"Injection site bruising"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Injection site discharge"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":147},{"groupId":"EG001","numAffected":5,"numAtRisk":151}],"term":"Injection site erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Injection site haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Injection site induration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":147},{"groupId":"EG001","numAffected":3,"numAtRisk":151}],"term":"Injection site irritation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Injection site pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Injection site paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Injection site pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Injection site rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Injection site reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Injection site swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Irritability"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":147},{"groupId":"EG001","numAffected":10,"numAtRisk":151}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":147},{"groupId":"EG001","numAffected":11,"numAtRisk":151}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Peripheral coldness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Pitting oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":147},{"groupId":"EG001","numAffected":11,"numAtRisk":151}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Sensation of pressure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Vessel puncture site haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Bronchopneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Bronchopulmonary aspergillosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Catheter site infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Oral candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Pneumonia fungal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Tinea manuum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Tinea pedis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Tooth abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":147},{"groupId":"EG001","numAffected":4,"numAtRisk":151}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":2,"numAtRisk":151}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Arthropod bite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":147},{"groupId":"EG001","numAffected":4,"numAtRisk":151}],"term":"Citrate toxicity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":147},{"groupId":"EG001","numAffected":5,"numAtRisk":151}],"term":"Contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Post procedural discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Procedural hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Procedural nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Procedural pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Skin laceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Tooth fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Tooth injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":147},{"groupId":"EG001","numAffected":3,"numAtRisk":151}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Blood calcium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Blood glucose decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Blood magnesium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Blood potassium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Blood pressure increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":147},{"groupId":"EG001","numAffected":6,"numAtRisk":151}],"term":"Blood uric acid increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Body temperature increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"C-reactive protein increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Cardiac murmur"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Culture positive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Haemoglobin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Heart rate increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":4,"numAtRisk":151}],"term":"Heart rate irregular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Lymph node palpable"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":2,"numAtRisk":151}],"term":"Oxygen saturation decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Weight increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":147},{"groupId":"EG001","numAffected":6,"numAtRisk":151}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":147},{"groupId":"EG001","numAffected":5,"numAtRisk":151}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":3,"numAtRisk":151}],"term":"Hyperuricaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":147},{"groupId":"EG001","numAffected":6,"numAtRisk":151}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":147},{"groupId":"EG001","numAffected":29,"numAtRisk":151}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":147},{"groupId":"EG001","numAffected":16,"numAtRisk":151}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Tetany"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":147},{"groupId":"EG001","numAffected":17,"numAtRisk":151}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":147},{"groupId":"EG001","numAffected":34,"numAtRisk":151}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":53,"numAtRisk":147},{"groupId":"EG001","numAffected":64,"numAtRisk":151}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Flank pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Jaw disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Joint swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Muscle disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":147},{"groupId":"EG001","numAffected":8,"numAtRisk":151}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Muscle twitching"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":147},{"groupId":"EG001","numAffected":5,"numAtRisk":151}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Musculoskeletal discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":147},{"groupId":"EG001","numAffected":5,"numAtRisk":151}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":147},{"groupId":"EG001","numAffected":2,"numAtRisk":151}],"term":"Musculoskeletal stiffness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":147},{"groupId":"EG001","numAffected":11,"numAtRisk":151}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Pain in jaw"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Bone neoplasm malignant"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Lentigo"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Prostate cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Balance disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Burning sensation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Coordination abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":147},{"groupId":"EG001","numAffected":10,"numAtRisk":151}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":147},{"groupId":"EG001","numAffected":2,"numAtRisk":151}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Dyskinesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":147},{"groupId":"EG001","numAffected":35,"numAtRisk":151}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":147},{"groupId":"EG001","numAffected":7,"numAtRisk":151}],"term":"Hypoaesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Lethargy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":147},{"groupId":"EG001","numAffected":34,"numAtRisk":151}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Parosmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":147},{"groupId":"EG001","numAffected":2,"numAtRisk":151}],"term":"Restless legs syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Sensory disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Sinus headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":147},{"groupId":"EG001","numAffected":3,"numAtRisk":151}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Abnormal dreams"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Anticipatory anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":147},{"groupId":"EG001","numAffected":6,"numAtRisk":151}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Emotional distress"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":147},{"groupId":"EG001","numAffected":11,"numAtRisk":151}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Restlessness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":2,"numAtRisk":151}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Nocturia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Pollakiuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Proteinuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Pelvic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Vaginal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":3,"numAtRisk":151}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":147},{"groupId":"EG001","numAffected":4,"numAtRisk":151}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":147},{"groupId":"EG001","numAffected":4,"numAtRisk":151}],"term":"Dyspnoea exertional"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Nasal congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Nasal mucosal disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":3,"numAtRisk":151}],"term":"Paranasal sinus hypersecretion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":147},{"groupId":"EG001","numAffected":6,"numAtRisk":151}],"term":"Pharyngolaryngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Postnasal drip"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":2,"numAtRisk":151}],"term":"Rhinorrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Rhonchi"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Sinus congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Wheezing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Actinic keratosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Cold sweat"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Dermatitis contact"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":2,"numAtRisk":151}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":147},{"groupId":"EG001","numAffected":2,"numAtRisk":151}],"term":"Ecchymosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Eczema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Ephelides"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Erythema nodosum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":147},{"groupId":"EG001","numAffected":5,"numAtRisk":151}],"term":"Hyperhidrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Hypoaesthesia facial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Ingrowing nail"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":147},{"groupId":"EG001","numAffected":2,"numAtRisk":151}],"term":"Night sweats"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":147},{"groupId":"EG001","numAffected":2,"numAtRisk":151}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":147},{"groupId":"EG001","numAffected":2,"numAtRisk":151}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Rash generalised"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Scar"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Skin irritation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Skin lesion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Flushing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Hot flush"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":147},{"groupId":"EG001","numAffected":5,"numAtRisk":151}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":147},{"groupId":"EG001","numAffected":5,"numAtRisk":151}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Orthostatic hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Pallor"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":2,"numAtRisk":151}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Enterobacter bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Hemiparesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Muscle spasticity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Agitation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":147},{"groupId":"EG001","numAffected":0,"numAtRisk":151}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":147},{"groupId":"EG001","numAffected":1,"numAtRisk":151}],"term":"Jugular vein thrombosis"}],"timeFrame":"Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8)."}