Primary objective
DLTs
TUMOUR LYSIS SYNDROME
Safety was assessed by clinical review of all relevant parameters, including AEs, clinical laboratory evaluations (chemistry, haematology, coagulation analysis, urinalysis and detection of tumour lysis syndrome), vital signs, physical examination (including ECOG performance status), cardiac monitoring and neurological assessments. The number of patients with DLTs was summarised by severity, relatedness and preferred term/system organ class.