{"eventGroups":[{"deathsNumAffected":3,"deathsNumAtRisk":27,"description":"Patients receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity. Patients may cross over to Group II at the time of disease progression.","id":"EG000","otherNumAffected":24,"otherNumAtRisk":27,"seriousNumAffected":10,"seriousNumAtRisk":27,"title":"Group I (Nivolumab)"},{"deathsNumAffected":5,"deathsNumAtRisk":27,"description":"Patients receive varlilumab IV over 90 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity.","id":"EG001","otherNumAffected":24,"otherNumAtRisk":27,"seriousNumAffected":12,"seriousNumAtRisk":27,"title":"Group II (Varlilumab, Nivolumab)"},{"deathsNumAffected":0,"deathsNumAtRisk":7,"description":"Pre cross over patients receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity. Patients may cross over to Group II at the time of disease progression.\n\nPost cross over patients receive varlilumab IV over 90 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity.","id":"EG002","otherNumAffected":7,"otherNumAtRisk":7,"seriousNumAffected":3,"seriousNumAtRisk":7,"title":"Cross Over to Group II Treatment (Varlilumab, Nivolumab)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":27,"numEvents":8},{"groupId":"EG001","numAffected":13,"numAtRisk":27,"numEvents":18},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":27,"numEvents":3},{"groupId":"EG001","numAffected":5,"numAtRisk":27,"numEvents":5},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Blood and lymph sys disorders - Oth Spec"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Leukocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Atrioventricular block complete"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Palpitations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Pericardial effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Sinus bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":27,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Hearing impaired"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":27,"numEvents":4},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Eye disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Floaters"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":27,"numEvents":6},{"groupId":"EG001","numAffected":6,"numAtRisk":27,"numEvents":7},{"groupId":"EG002","numAffected":2,"numAtRisk":7,"numEvents":2}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":27,"numEvents":6},{"groupId":"EG001","numAffected":5,"numAtRisk":27,"numEvents":5},{"groupId":"EG002","numAffected":2,"numAtRisk":7,"numEvents":2}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":27,"numEvents":3},{"groupId":"EG001","numAffected":6,"numAtRisk":27,"numEvents":6},{"groupId":"EG002","numAffected":2,"numAtRisk":7,"numEvents":2}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Esophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Gastroesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Gastrointestinal disorders - Oth spec"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":27,"numEvents":3},{"groupId":"EG001","numAffected":9,"numAtRisk":27,"numEvents":11},{"groupId":"EG002","numAffected":3,"numAtRisk":7,"numEvents":3}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Oral pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Rectal hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":5,"numAtRisk":27,"numEvents":5},{"groupId":"EG002","numAffected":3,"numAtRisk":7,"numEvents":3}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":27,"numEvents":3},{"groupId":"EG001","numAffected":4,"numAtRisk":27,"numEvents":4},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Edema limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":27,"numEvents":11},{"groupId":"EG001","numAffected":14,"numAtRisk":27,"numEvents":18},{"groupId":"EG002","numAffected":2,"numAtRisk":7,"numEvents":2}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Gait disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Gen disord and admin site conds-Oth spec"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":27,"numEvents":5},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Hepatobiliary disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Immune system disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Enterocolitis infectious"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":27,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":27,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Infections and infestations - Oth spec"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Rhinitis infective"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Upper respiratory infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":27,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":7,"numEvents":2}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Vascular access complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Wound complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":27,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":27,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Cardiac troponin I increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":6,"numAtRisk":27,"numEvents":6},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Investigations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Lipase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":27,"numEvents":11},{"groupId":"EG001","numAffected":12,"numAtRisk":27,"numEvents":16},{"groupId":"EG002","numAffected":6,"numAtRisk":7,"numEvents":9}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":5},{"groupId":"EG001","numAffected":4,"numAtRisk":27,"numEvents":8},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":27,"numEvents":5},{"groupId":"EG001","numAffected":8,"numAtRisk":27,"numEvents":14},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":2}],"term":"Serum amylase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Weight gain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":7,"numEvents":2}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":27,"numEvents":7},{"groupId":"EG001","numAffected":6,"numAtRisk":27,"numEvents":9},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Acidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":27,"numEvents":3},{"groupId":"EG001","numAffected":8,"numAtRisk":27,"numEvents":11},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":27,"numEvents":5},{"groupId":"EG001","numAffected":4,"numAtRisk":27,"numEvents":7},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Hypercalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":27,"numEvents":5},{"groupId":"EG001","numAffected":7,"numAtRisk":27,"numEvents":7},{"groupId":"EG002","numAffected":3,"numAtRisk":7,"numEvents":3}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":27,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Hyperkalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Hypermagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Hypernatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Hyperuricemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":5,"numAtRisk":27,"numEvents":7},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":27,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Hypoglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":3},{"groupId":"EG001","numAffected":4,"numAtRisk":27,"numEvents":5},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":27,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Hypomagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":27,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":27,"numEvents":3},{"groupId":"EG002","numAffected":2,"numAtRisk":7,"numEvents":2}],"term":"Hypophosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":27,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Metabolism, nutrition disord - Oth spec"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":27,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":6,"numAtRisk":27,"numEvents":7},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Flank pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Generalized muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Joint range of motion decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Muscle weakness lower limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Muscle weakness upper limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Musculoskeletal, conn tissue - Oth spec"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":27,"numEvents":5},{"groupId":"EG001","numAffected":3,"numAtRisk":27,"numEvents":3},{"groupId":"EG002","numAffected":2,"numAtRisk":7,"numEvents":2}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":27,"numEvents":4},{"groupId":"EG001","numAffected":4,"numAtRisk":27,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Neoplasms benign, mal, uncpec - Oth spec"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Tumor pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":7,"numEvents":3}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":27,"numEvents":4},{"groupId":"EG001","numAffected":4,"numAtRisk":27,"numEvents":4},{"groupId":"EG002","numAffected":2,"numAtRisk":7,"numEvents":2}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":27,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Lethargy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Nervous system disorders - Oth spec"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Neuralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Paresthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":27,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Presyncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Stroke"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Hallucinations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":27,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Irritability"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Restlessness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Urinary tract pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Urine discoloration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Genital edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Allergic rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":27,"numEvents":3},{"groupId":"EG001","numAffected":4,"numAtRisk":27,"numEvents":5},{"groupId":"EG002","numAffected":2,"numAtRisk":7,"numEvents":2}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":27,"numEvents":4},{"groupId":"EG001","numAffected":8,"numAtRisk":27,"numEvents":8},{"groupId":"EG002","numAffected":2,"numAtRisk":7,"numEvents":2}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":27,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Nasal congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":27,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Resp, thoracic, mediastinal - Oth spec"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Sleep apnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Voice alteration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Erythema multiforme"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Hyperhidrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Pain of skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Rash acneiform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":27,"numEvents":4},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":27,"numEvents":4},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Skin and subcut tissue disord - Oth spec"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Urticaria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Surgical and medical proced - Oth spec"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":7,"numEvents":3}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":27,"numEvents":6},{"groupId":"EG001","numAffected":5,"numAtRisk":27,"numEvents":5},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Thromboembolic event"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Vascular disorders - Other, specify"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Blurred vision"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":7,"numEvents":2}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Gastric hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Gastric ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Lower gastrointestinal hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Upper gastrointestinal hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Edema limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Gen disord and admin site conds-Oth spec"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Immune system disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Infections and infestations - Oth spec"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Hypercalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Tumor lysis syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Neoplasms benign, mal, uncpec - Oth spec"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Tumor pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Intracranial hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Renal calculi"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Hematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":7,"numEvents":0}],"term":"Thromboembolic event"}],"timeFrame":"25 months for adverse events and 37 months for mortality"}