{"description":"Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab","eventGroups":[{"deathsNumAffected":2,"deathsNumAtRisk":3,"description":"Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 60 mg/m2 .","id":"EG000","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":2,"seriousNumAtRisk":3,"title":"60/10"},{"deathsNumAffected":1,"deathsNumAtRisk":3,"description":"Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 100 mg/m2.","id":"EG001","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":0,"seriousNumAtRisk":3,"title":"100/10"},{"deathsNumAffected":2,"deathsNumAtRisk":3,"description":"Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 15 MBq/kg, single injection with lilotomab 100 mg/m2 .","id":"EG002","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":2,"seriousNumAtRisk":3,"title":"100/15"},{"deathsNumAffected":4,"deathsNumAtRisk":7,"description":"Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 20 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing on Day 0.","id":"EG003","otherNumAffected":5,"otherNumAtRisk":7,"seriousNumAffected":3,"seriousNumAtRisk":7,"title":"100/20"},{"deathsNumAffected":2,"deathsNumAtRisk":18,"description":"Rituximab pre-treatment on Day -14","id":"EG004","otherNumAffected":10,"otherNumAtRisk":18,"seriousNumAffected":4,"seriousNumAtRisk":18,"title":"Rituximab"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":2,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":2,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":2,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":2,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":2,"numAtRisk":18}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Extravasation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Jaundice"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Skin laceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Oral candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":2,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":2,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Blood lactate dehydrogenase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Blood calcium increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"C-reactive protein increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Gamma glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Heart rate increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Oxygen saturation decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":2,"numAtRisk":7},{"groupId":"EG004","numAffected":2,"numAtRisk":18}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":2,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Groin pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Tumour ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Amnesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Thoracic outlet syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Testicular pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":2,"numAtRisk":18}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Skin lesion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Agitation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":2,"numAtRisk":18}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Pollakiuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Hypoaesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Hyperhidrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Vascular compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Dysphonea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Lymphoedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Infusion site extravasation"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Neutropenic sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Traumatic haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Hypomagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":18}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":2,"numAtRisk":18}],"term":"Disease progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Renal impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":1,"numAtRisk":18}],"term":"Lower respiratory tract infection"}],"timeFrame":"All adverse events were collected from the time of rituximab infusion up to 12 weeks after Betalutin administration on Day 0. Treatment-related adverse events were collected up to 2 years"}