{"eventGroups":[{"deathsNumAffected":17,"deathsNumAtRisk":31,"description":"Participants with non-NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.","id":"EG000","otherNumAffected":31,"otherNumAtRisk":31,"seriousNumAffected":21,"seriousNumAtRisk":31,"title":"Cohort 1 Non-NK PTCL"},{"deathsNumAffected":1,"deathsNumAtRisk":2,"description":"Participants with NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.","id":"EG001","otherNumAffected":2,"otherNumAtRisk":2,"seriousNumAffected":2,"seriousNumAtRisk":2,"title":"Cohort 2 NK PTCL"},{"deathsNumAffected":2,"deathsNumAtRisk":19,"description":"Participants with cHL received 12 mg dose of AZD4573 once weekly until disease progression.","id":"EG002","otherNumAffected":18,"otherNumAtRisk":19,"seriousNumAffected":11,"seriousNumAtRisk":19,"title":"Cohort 3 cHL"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Bacteraemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"COVID-19"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Catheter site infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Enterobacter bacteraemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Enterococcal infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Herpes zoster"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Influenza"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Streptococcal infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":19,"numEvents":3}],"term":"Upper respiratory tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Urinary tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Vascular device infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Cancer pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":31,"numEvents":21},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":10,"numAtRisk":19,"numEvents":15}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"Febrile neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":7}],"term":"Leukopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Lymph node pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":31,"numEvents":126},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAffected":13,"numAtRisk":19,"numEvents":54}],"term":"Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":31,"numEvents":43},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAffected":4,"numAtRisk":19,"numEvents":9}],"term":"Thrombocytopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"Cytokine release syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":19,"numEvents":2}],"term":"Serum sickness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":19,"numEvents":2}],"term":"Decreased appetite"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"Hyperglycaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":19,"numEvents":5}],"term":"Hyperkalaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":31,"numEvents":9},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Hyperphosphataemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Hypertriglyceridaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Hypervolaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":31,"numEvents":16},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Hypocalcaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":31,"numEvents":14},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAffected":4,"numAtRisk":19,"numEvents":6}],"term":"Hypokalaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"Hypomagnesaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"Hyponatraemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":8},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":19,"numEvents":3}],"term":"Hypophosphataemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Tumour lysis syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Anxiety"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":19,"numEvents":3}],"term":"Dizziness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":19,"numEvents":6}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Dry eye"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Eye pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Vision blurred"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Palpitations"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":19,"numEvents":2}],"term":"Hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":19,"numEvents":4}],"term":"Cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":19,"numEvents":3}],"term":"Dyspnoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Hiccups"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Tachypnoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"Abdominal pain upper"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":31,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":5,"numAtRisk":19,"numEvents":5}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":31,"numEvents":18},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":7,"numAtRisk":19,"numEvents":8}],"term":"Diarrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Mouth ulceration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":31,"numEvents":14},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAffected":9,"numAtRisk":19,"numEvents":14}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":2}],"term":"Stomatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":31,"numEvents":10},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":19,"numEvents":2}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Cholestasis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":19,"numEvents":2}],"term":"Alopecia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Erythema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":19,"numEvents":3}],"term":"Pruritus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":19,"numEvents":3}],"term":"Rash"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Rash maculo-papular"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Skin weeping"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Arthralgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":19,"numEvents":2}],"term":"Back pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Muscle spasms"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Pain in extremity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Acute kidney injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Pelvic pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Vulvovaginal dryness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"Catheter site thrombosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Chills"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":6,"numAtRisk":19,"numEvents":6}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Influenza like illness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Mucosal inflammation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"Non-cardiac chest pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Oedema peripheral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":31,"numEvents":16},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":19,"numEvents":5}],"term":"Pyrexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Activated partial thromboplastin time prolonged"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":31,"numEvents":90},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAffected":11,"numAtRisk":19,"numEvents":35}],"term":"Alanine aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":19,"numEvents":2}],"term":"Amylase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":31,"numEvents":101},{"groupId":"EG001","numAffected":2,"numAtRisk":2,"numEvents":3},{"groupId":"EG002","numAffected":11,"numAtRisk":19,"numEvents":42}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"Bilirubin conjugated increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":19,"numEvents":5}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":31,"numEvents":46},{"groupId":"EG001","numAffected":2,"numAtRisk":2,"numEvents":2},{"groupId":"EG002","numAffected":5,"numAtRisk":19,"numEvents":18}],"term":"Blood bilirubin increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Blood calcium decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Blood cholesterol increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Blood creatinine increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Blood fibrinogen increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Blood lactate dehydrogenase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"Blood phosphorus decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":19,"numEvents":5}],"term":"Blood phosphorus increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"Blood potassium decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"Blood potassium increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"Blood triglycerides increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Blood urea increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":19,"numEvents":2}],"term":"Fibrin D dimer increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":31,"numEvents":18},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":19,"numEvents":7}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"International normalised ratio increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Lipase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"Lymphocyte count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"Prothrombin time prolonged"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Serum ferritin increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":19,"numEvents":3}],"term":"Transaminases increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"Troponin increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":31,"numEvents":34},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":2}],"term":"White blood cell count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Tendon rupture"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"COVID-19"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"Escherichia sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Herpes zoster disseminated"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"Pneumonia viral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"Staphylococcal bacteraemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"Staphylococcal sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Streptococcal sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":19,"numEvents":3}],"term":"Febrile neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Leukopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":2}],"term":"Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Hyponatraemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"Tumour lysis syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"Haemorrhage intracranial"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Syncope"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"Sinus tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Pulmonary embolism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Diarrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"Liver injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"Acute kidney injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"Fanconi syndrome acquired"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"Chills"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Pyrexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Alanine aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":19,"numEvents":2}],"term":"Blood bilirubin increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"C-reactive protein increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":9},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Liver function test increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":3}],"term":"Transaminases increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"White blood cell count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"Fall"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Vascular access complication"}],"timeFrame":"From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months)."}