{"description":"Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population.\n\nOut of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)","eventGroups":[{"deathsNumAffected":261,"deathsNumAtRisk":335,"description":"Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m2. Dose was capped at body surface area (BSA) of 2.0 m2 (i.e., dose did not exceed 6.4 mg).\n\nPatients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle).","id":"EG000","otherNumAffected":330,"otherNumAtRisk":335,"seriousNumAffected":136,"seriousNumAtRisk":335,"title":"Lurbinectedin (PM01183)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":59,"numAtRisk":335,"numEvents":100}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":89,"numAtRisk":335,"numEvents":174}],"term":"Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":54,"numAtRisk":335,"numEvents":83}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":335,"numEvents":21}],"term":"Abdominal pain upper"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":116,"numAtRisk":335,"numEvents":189}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":62,"numAtRisk":335,"numEvents":104}],"term":"Diarrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":167,"numAtRisk":335,"numEvents":276}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":76,"numAtRisk":335,"numEvents":126}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":129,"numAtRisk":335,"numEvents":335}],"term":"Asthenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":335,"numEvents":28}],"term":"Chest pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":122,"numAtRisk":335,"numEvents":242}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":335,"numEvents":23}],"term":"Mucosal inflammation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":335,"numEvents":35}],"term":"Oedema peripheral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":48,"numAtRisk":335,"numEvents":56}],"term":"Pyrexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":335,"numEvents":33}],"term":"Weight decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":102,"numAtRisk":335,"numEvents":144}],"term":"Decreased appetite"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":335,"numEvents":31}],"term":"Hypoalbuminaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":335,"numEvents":28}],"term":"Arthralgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":51,"numAtRisk":335,"numEvents":71}],"term":"Back pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":335,"numEvents":25}],"term":"Musculoskeletal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":335,"numEvents":32}],"term":"Pain in extremity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":335,"numEvents":34}],"term":"Tumour pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":335,"numEvents":28}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":335,"numEvents":27}],"term":"Neuropathy peripheral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":335,"numEvents":37}],"term":"Insomnia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":58,"numAtRisk":335,"numEvents":71}],"term":"Cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":77,"numAtRisk":335,"numEvents":99}],"term":"Dyspnoea"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":335,"numEvents":18}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":335,"numEvents":21}],"term":"Febrile neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335,"numEvents":4}],"term":"Leukopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Lymphopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":335,"numEvents":22}],"term":"Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":335,"numEvents":36}],"term":"Thrombocytopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Cushing's syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":335,"numEvents":12}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Colitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335,"numEvents":2}],"term":"Diarrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335,"numEvents":2}],"term":"Dysphagia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335,"numEvents":2}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":335,"numEvents":5}],"term":"Intestinal obstruction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Intra-abdominal haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":335,"numEvents":4}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335,"numEvents":2}],"term":"Small intestinal obstruction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335,"numEvents":3}],"term":"Upper gastrointestinal haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":335,"numEvents":9}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335,"numEvents":2}],"term":"Asthenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335,"numEvents":2}],"term":"Gait disturbance"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":335,"numEvents":21}],"term":"General physical health deterioration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Non-cardiac chest pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Oedema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Oedema peripheral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":335,"numEvents":8}],"term":"Pyrexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":335,"numEvents":4}],"term":"Cholangitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Hyperbilirubinaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Jaundice cholestatic"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Bacteraemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Biliary tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Bronchitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Device related infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Escherichia urinary tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":335,"numEvents":3}],"term":"Lung infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Peritonitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":335,"numEvents":10}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Pseudomonal bacteraemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Respiratory tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":335,"numEvents":3}],"term":"Sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335,"numEvents":2}],"term":"Septic shock"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335,"numEvents":2}],"term":"Skin infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":335,"numEvents":4}],"term":"Upper respiratory tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":335,"numEvents":4}],"term":"Urinary tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Compression fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Spinal fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Vascular access complication"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Alanine aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":2}],"term":"Blood calcium decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335,"numEvents":2}],"term":"Blood creatinine increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Blood phosphorus decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335,"numEvents":3}],"term":"Neutrophil count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335,"numEvents":5}],"term":"Platelet count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Decreased appetite"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":335,"numEvents":4}],"term":"Dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335,"numEvents":2}],"term":"Hypoalbuminaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":335,"numEvents":11}],"term":"Hyponatraemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":335,"numEvents":5}],"term":"Back pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Bone pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Intervertebral disc compression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335,"numEvents":2}],"term":"Muscular weakness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Musculoskeletal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Pain in extremity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335,"numEvents":3}],"term":"Tumour pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Aphasia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Cerebrovascular accident"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Cognitive disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335,"numEvents":2}],"term":"Dizziness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Facial paralysis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335,"numEvents":2}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335,"numEvents":2}],"term":"Hemiplegia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335,"numEvents":2}],"term":"Neuralgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Seizure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335,"numEvents":2}],"term":"Spinal cord compression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Subacute combined cord degeneration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Syncope"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Product Issues","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Device malfunction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335,"numEvents":2}],"term":"Confusional state"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Mental status changes"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":335,"numEvents":5}],"term":"Haematuria"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Hydronephrosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335,"numEvents":2}],"term":"Renal failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Acute respiratory failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Aspiration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":2}],"term":"Chronic obstructive pulmonary disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":335,"numEvents":13}],"term":"Dyspnoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Haemoptysis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Lung infiltration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Pleural effusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":335,"numEvents":3}],"term":"Pneumonitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335,"numEvents":2}],"term":"Pneumothorax"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Pulmonary arterial hypertension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":335,"numEvents":4}],"term":"Pulmonary embolism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335,"numEvents":2}],"term":"Respiratory failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Cementoplasty"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Deep vein thrombosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335,"numEvents":2}],"term":"Embolism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335,"numEvents":1}],"term":"Superior vena cava occlusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335,"numEvents":2}],"term":"Superior vena cava syndrome"}],"timeFrame":"From the date of first infusion to the date of death or last contact, up to an average of 5 years"}