{"description":"Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).","eventGroups":[{"deathsNumAffected":17,"deathsNumAtRisk":40,"description":"Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment","id":"EG000","otherNumAffected":40,"otherNumAtRisk":40,"seriousNumAffected":23,"seriousNumAtRisk":40,"title":"Non-small Cell Lung Cancer"},{"deathsNumAffected":3,"deathsNumAtRisk":8,"description":"Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic","id":"EG001","otherNumAffected":8,"otherNumAtRisk":8,"seriousNumAffected":3,"seriousNumAtRisk":8,"title":"Colorectal Cancer"},{"deathsNumAffected":4,"deathsNumAtRisk":12,"description":"Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible","id":"EG002","otherNumAffected":12,"otherNumAtRisk":12,"seriousNumAffected":3,"seriousNumAtRisk":12,"title":"Cutaneous Squamous Cell Carcinoma"},{"deathsNumAffected":5,"deathsNumAtRisk":12,"description":"Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)","id":"EG003","otherNumAffected":12,"otherNumAtRisk":12,"seriousNumAffected":3,"seriousNumAtRisk":12,"title":"Hepatocellular Carcinoma"},{"deathsNumAffected":24,"deathsNumAtRisk":55,"description":"Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent","id":"EG004","otherNumAffected":54,"otherNumAtRisk":54,"seriousNumAffected":28,"seriousNumAtRisk":54,"title":"Metastatic Castration-resistant Prostate Cancer"},{"deathsNumAffected":21,"deathsNumAtRisk":39,"description":"Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months","id":"EG005","otherNumAffected":39,"otherNumAtRisk":39,"seriousNumAffected":28,"seriousNumAtRisk":39,"title":"Ovarian Cancer"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":40,"numEvents":26},{"groupId":"EG001","numAffected":5,"numAtRisk":8,"numEvents":10},{"groupId":"EG002","numAffected":4,"numAtRisk":12,"numEvents":10},{"groupId":"EG003","numAffected":8,"numAtRisk":12,"numEvents":14},{"groupId":"EG004","numAffected":21,"numAtRisk":54,"numEvents":42},{"groupId":"EG005","numAffected":7,"numAtRisk":39,"numEvents":9}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":40,"numEvents":23},{"groupId":"EG001","numAffected":3,"numAtRisk":8,"numEvents":4},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":5},{"groupId":"EG004","numAffected":16,"numAtRisk":54,"numEvents":30},{"groupId":"EG005","numAffected":9,"numAtRisk":39,"numEvents":10}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":40,"numEvents":22},{"groupId":"EG001","numAffected":2,"numAtRisk":8,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":12,"numEvents":2},{"groupId":"EG004","numAffected":14,"numAtRisk":54,"numEvents":17},{"groupId":"EG005","numAffected":9,"numAtRisk":39,"numEvents":11}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":40,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":3,"numAtRisk":12,"numEvents":4},{"groupId":"EG004","numAffected":8,"numAtRisk":54,"numEvents":9},{"groupId":"EG005","numAffected":3,"numAtRisk":39,"numEvents":5}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":8,"numEvents":7},{"groupId":"EG002","numAffected":2,"numAtRisk":12,"numEvents":5},{"groupId":"EG003","numAffected":2,"numAtRisk":12,"numEvents":3},{"groupId":"EG004","numAffected":10,"numAtRisk":54,"numEvents":24},{"groupId":"EG005","numAffected":3,"numAtRisk":39,"numEvents":10}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":3,"numAtRisk":12,"numEvents":6},{"groupId":"EG004","numAffected":11,"numAtRisk":54,"numEvents":32},{"groupId":"EG005","numAffected":1,"numAtRisk":39,"numEvents":1}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40,"numEvents":5},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":12,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":4},{"groupId":"EG004","numAffected":6,"numAtRisk":54,"numEvents":17},{"groupId":"EG005","numAffected":2,"numAtRisk":39,"numEvents":6}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":40,"numEvents":11},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":2,"numAtRisk":54,"numEvents":2},{"groupId":"EG005","numAffected":1,"numAtRisk":39,"numEvents":1}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":4,"numAtRisk":54,"numEvents":13},{"groupId":"EG005","numAffected":4,"numAtRisk":39,"numEvents":4}],"term":"Amylase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":40,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":54,"numEvents":3},{"groupId":"EG005","numAffected":2,"numAtRisk":39,"numEvents":2}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40,"numEvents":5},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":54,"numEvents":4},{"groupId":"EG005","numAffected":1,"numAtRisk":39,"numEvents":1}],"term":"Lipase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":40,"numEvents":11},{"groupId":"EG001","numAffected":2,"numAtRisk":8,"numEvents":4},{"groupId":"EG002","numAffected":2,"numAtRisk":12,"numEvents":7},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":14,"numAtRisk":54,"numEvents":43},{"groupId":"EG005","numAffected":5,"numAtRisk":39,"numEvents":5}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":12,"numEvents":2},{"groupId":"EG003","numAffected":3,"numAtRisk":12,"numEvents":4},{"groupId":"EG004","numAffected":3,"numAtRisk":54,"numEvents":4},{"groupId":"EG005","numAffected":4,"numAtRisk":39,"numEvents":4}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":4,"numAtRisk":54,"numEvents":5},{"groupId":"EG005","numAffected":4,"numAtRisk":39,"numEvents":4}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":40,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":5},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":5,"numAtRisk":54,"numEvents":8},{"groupId":"EG005","numAffected":5,"numAtRisk":39,"numEvents":8}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40,"numEvents":5},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":8,"numAtRisk":54,"numEvents":14},{"groupId":"EG005","numAffected":2,"numAtRisk":39,"numEvents":3}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":40,"numEvents":114},{"groupId":"EG001","numAffected":4,"numAtRisk":8,"numEvents":40},{"groupId":"EG002","numAffected":10,"numAtRisk":12,"numEvents":30},{"groupId":"EG003","numAffected":7,"numAtRisk":12,"numEvents":19},{"groupId":"EG004","numAffected":38,"numAtRisk":54,"numEvents":161},{"groupId":"EG005","numAffected":36,"numAtRisk":39,"numEvents":154}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":40,"numEvents":20},{"groupId":"EG001","numAffected":3,"numAtRisk":8,"numEvents":12},{"groupId":"EG002","numAffected":3,"numAtRisk":12,"numEvents":11},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":21,"numAtRisk":54,"numEvents":32},{"groupId":"EG005","numAffected":15,"numAtRisk":39,"numEvents":54}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":40,"numEvents":16},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":12,"numEvents":4},{"groupId":"EG003","numAffected":6,"numAtRisk":12,"numEvents":6},{"groupId":"EG004","numAffected":13,"numAtRisk":54,"numEvents":20},{"groupId":"EG005","numAffected":14,"numAtRisk":39,"numEvents":18}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":40,"numEvents":48},{"groupId":"EG001","numAffected":3,"numAtRisk":8,"numEvents":9},{"groupId":"EG002","numAffected":2,"numAtRisk":12,"numEvents":3},{"groupId":"EG003","numAffected":4,"numAtRisk":12,"numEvents":7},{"groupId":"EG004","numAffected":13,"numAtRisk":54,"numEvents":25},{"groupId":"EG005","numAffected":19,"numAtRisk":39,"numEvents":92}],"term":"Injection site reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":40,"numEvents":12},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":4,"numAtRisk":12,"numEvents":6},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":2},{"groupId":"EG004","numAffected":20,"numAtRisk":54,"numEvents":25},{"groupId":"EG005","numAffected":13,"numAtRisk":39,"numEvents":17}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":12,"numEvents":2},{"groupId":"EG004","numAffected":4,"numAtRisk":54,"numEvents":4},{"groupId":"EG005","numAffected":4,"numAtRisk":39,"numEvents":4}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":40,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":54,"numEvents":3},{"groupId":"EG005","numAffected":1,"numAtRisk":39,"numEvents":1}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":40,"numEvents":23},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":3},{"groupId":"EG003","numAffected":3,"numAtRisk":12,"numEvents":4},{"groupId":"EG004","numAffected":31,"numAtRisk":54,"numEvents":52},{"groupId":"EG005","numAffected":8,"numAtRisk":39,"numEvents":9}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":40,"numEvents":23},{"groupId":"EG001","numAffected":2,"numAtRisk":8,"numEvents":10},{"groupId":"EG002","numAffected":2,"numAtRisk":12,"numEvents":4},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":3},{"groupId":"EG004","numAffected":12,"numAtRisk":54,"numEvents":38},{"groupId":"EG005","numAffected":2,"numAtRisk":39,"numEvents":7}],"term":"Cytokine release syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":40,"numEvents":14},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG003","numAffected":4,"numAtRisk":12,"numEvents":7},{"groupId":"EG004","numAffected":17,"numAtRisk":54,"numEvents":33},{"groupId":"EG005","numAffected":22,"numAtRisk":39,"numEvents":43}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":40,"numEvents":18},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":19},{"groupId":"EG002","numAffected":2,"numAtRisk":12,"numEvents":2},{"groupId":"EG003","numAffected":2,"numAtRisk":12,"numEvents":5},{"groupId":"EG004","numAffected":13,"numAtRisk":54,"numEvents":20},{"groupId":"EG005","numAffected":24,"numAtRisk":39,"numEvents":36}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":40,"numEvents":8},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":8},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG003","numAffected":3,"numAtRisk":12,"numEvents":3},{"groupId":"EG004","numAffected":4,"numAtRisk":54,"numEvents":5},{"groupId":"EG005","numAffected":12,"numAtRisk":39,"numEvents":15}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":12,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":4,"numAtRisk":54,"numEvents":4},{"groupId":"EG005","numAffected":7,"numAtRisk":39,"numEvents":8}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":10,"numAtRisk":39,"numEvents":10}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":40,"numEvents":7},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":3,"numAtRisk":12,"numEvents":3},{"groupId":"EG004","numAffected":1,"numAtRisk":54,"numEvents":1},{"groupId":"EG005","numAffected":6,"numAtRisk":39,"numEvents":8}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":40,"numEvents":8},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":2,"numAtRisk":54,"numEvents":2},{"groupId":"EG005","numAffected":3,"numAtRisk":39,"numEvents":3}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":2},{"groupId":"EG004","numAffected":6,"numAtRisk":54,"numEvents":6},{"groupId":"EG005","numAffected":3,"numAtRisk":39,"numEvents":3}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":40,"numEvents":5},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":3},{"groupId":"EG003","numAffected":2,"numAtRisk":12,"numEvents":2},{"groupId":"EG004","numAffected":4,"numAtRisk":54,"numEvents":6},{"groupId":"EG005","numAffected":1,"numAtRisk":39,"numEvents":1}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":4,"numAtRisk":54,"numEvents":4},{"groupId":"EG005","numAffected":2,"numAtRisk":39,"numEvents":2}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":6},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":3,"numAtRisk":54,"numEvents":3},{"groupId":"EG005","numAffected":2,"numAtRisk":39,"numEvents":2}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":40,"numEvents":12},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":12,"numEvents":2},{"groupId":"EG004","numAffected":11,"numAtRisk":54,"numEvents":13},{"groupId":"EG005","numAffected":10,"numAtRisk":39,"numEvents":11}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":40,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":12,"numEvents":3},{"groupId":"EG004","numAffected":6,"numAtRisk":54,"numEvents":9},{"groupId":"EG005","numAffected":3,"numAtRisk":39,"numEvents":3}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":12,"numAtRisk":54,"numEvents":19},{"groupId":"EG005","numAffected":1,"numAtRisk":39,"numEvents":1}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":40,"numEvents":7},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":54,"numEvents":4},{"groupId":"EG005","numAffected":2,"numAtRisk":39,"numEvents":2}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":40,"numEvents":11},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":4,"numAtRisk":54,"numEvents":7},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":54,"numEvents":3},{"groupId":"EG005","numAffected":3,"numAtRisk":39,"numEvents":4}],"term":"Hypomagnesaemia"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":40,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":7,"numAtRisk":54,"numEvents":7},{"groupId":"EG005","numAffected":6,"numAtRisk":39,"numEvents":6}],"term":"Malignant neoplasm progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":54,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Cancer pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":39,"numEvents":1}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Jugular vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":54,"numEvents":7},{"groupId":"EG005","numAffected":8,"numAtRisk":39,"numEvents":14}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":3,"numAtRisk":54,"numEvents":3},{"groupId":"EG005","numAffected":3,"numAtRisk":39,"numEvents":3}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":39,"numEvents":3}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"2 SAEs were classified by the investigator as Unknown cause of death. Both were coded per MedDRA as General disorders and administration site conditions/Death.","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":39,"numEvents":2}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":39,"numEvents":1}],"term":"Discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Multiple organ dysfunction syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":54,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":39,"numEvents":2}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":39,"numEvents":1}],"term":"Systemic inflammatory response syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":12,"numEvents":4},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":3},{"groupId":"EG004","numAffected":7,"numAtRisk":54,"numEvents":9},{"groupId":"EG005","numAffected":7,"numAtRisk":39,"numEvents":7}],"term":"Cytokine release syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":39,"numEvents":1}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":54,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Interstitial lung disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":39,"numEvents":1}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Pulmonary haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":39,"numEvents":3}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":39,"numEvents":2}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":54,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":39,"numEvents":1}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":39,"numEvents":1}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":54,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":39,"numEvents":1}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":39,"numEvents":1}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":39,"numEvents":1}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":54,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Cardiac failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Cardiogenic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Cardiopulmonary failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":54,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Myocarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":54,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Right ventricular failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Cerebral haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Epilepsy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":54,"numEvents":3},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":39,"numEvents":2}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":54,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":39,"numEvents":1}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":39,"numEvents":2}],"term":"Intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":39,"numEvents":6}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":54,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Haematemesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":39,"numEvents":1}],"term":"Biliary dilatation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Cholecystitis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":54,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Psoriasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":54,"numEvents":2},{"groupId":"EG005","numAffected":1,"numAtRisk":39,"numEvents":1}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":54,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":54,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":54,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":54,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":54,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":54,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":54,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":39,"numEvents":1}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":54,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Staphylococcal sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":54,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Urosepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":54,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Cachexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Diabetic ketoacidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":54,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":39,"numEvents":0}],"term":"Hyperkalaemia"}],"timeFrame":"Day 1 up to approximately 2 years and 2 months"}