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infestations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":235},{"groupId":"EG001","numAffected":39,"numAtRisk":238}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":235},{"groupId":"EG001","numAffected":14,"numAtRisk":238}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":235},{"groupId":"EG001","numAffected":12,"numAtRisk":238}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":235},{"groupId":"EG001","numAffected":27,"numAtRisk":238}],"term":"Platelet count 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deficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":235},{"groupId":"EG001","numAffected":0,"numAtRisk":238}],"term":"Anaemia vitamin B12 deficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":235},{"groupId":"EG001","numAffected":1,"numAtRisk":238}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":235},{"groupId":"EG001","numAffected":1,"numAtRisk":238}],"term":"Haemolytic uraemic syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 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21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":235},{"groupId":"EG001","numAffected":0,"numAtRisk":238}],"term":"General physical condition abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":235},{"groupId":"EG001","numAffected":1,"numAtRisk":238}],"term":"Monoclonal immunoglobulin present"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":235},{"groupId":"EG001","numAffected":1,"numAtRisk":238}],"term":"Bone lesion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":235},{"groupId":"EG001","numAffected":1,"numAtRisk":238}],"term":"Bladder transitional cell carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":235},{"groupId":"EG001","numAffected":1,"numAtRisk":238}],"term":"Haemorrhage intracranial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":235},{"groupId":"EG001","numAffected":1,"numAtRisk":238}],"term":"Chronic kidney disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":235},{"groupId":"EG001","numAffected":1,"numAtRisk":238}],"term":"Urinary bladder polyp"}],"timeFrame":"All-cause mortality includes deaths that occurred from randomization until the end of study; median (minimum, maximum) follow-up time was 30.7 (0, 39) and 31.2 (0, 38) months in each treatment group respectively. Adverse events are reported from the first dose of study drug up to 30 days after last dose, as of the end of study; median (minimum, maximum) duration of treatment was 29.1 (0.1, 156.3) weeks and 38.0 (0.1, 158.3) weeks in each treatment group respectively."}