Data collection
Clinical data were extracted from electronic medical record system of
the HUG, anonymized using a study-specific patient identifier and
collected in electronic certified clinical database management system
software (REDCap™), an application compliant with the requirements of
the Swiss clinical trial requirements. De-identified data were analyzed
and stored following Swiss legal requirements for data protection using
ISO 9001/2008 standards. Health related personal data were accessible
only by investigators. We used Cairo and Bishop criteria to define
laboratory TLS (LTLS) or clinical TLS (CTLS). LTLS involved 25% changes
with baseline or upper normal value at two separate occasions (between
three days before and seven days after treatment onset) of uric acid,
potassium, phosphorous and calcium. CTLS was defined as serum creatinine
increasing 1.5 times the upper normal values and/or seizure and/or
cardiac arrhythmia [18]. The Swiss Group for Clinical Cancer
Research (SAKK) provided data from the Swiss BL cohort. Comparative
clinical dataset from CALGB 50303 study were available through the NCI
platform.