Exceeds 500 ms or there has been an increase of ≥ 60 ms compared with the pre-drug baseline value [12]
|
Drug-induced QT prolongation
|
Alanine aminotransferase (ALT) ≥ 5× or alkaline phosphatase (ALP) ≥ 2× and total bilirubin (TBL) ≥ 2× upper limit of normal (ULN) [13]
|
Drug-induced liver injury
|
Baseline < 180 umol/L: 50% increment from baseline or minimum increment by 40 umol/L; baseline > 180 umol/L: Minimum increment by 90 umol/L. Note: Drug exposure must be 24 h preceding the event [14]
|
Drug-induced acute kidney injury
|
< 50 × 109 platelets/L [15]
|
Thrombocytopenia
|
< 1.5 × 109 neutrophils/L [16]
|
Neutropenia
|
> 6.8 mg/dL (404 µmol/L) [17]
|
Hyperuricaemia
|
< 10 g/dL haemoglobin [18]
|
Drug-induced anaemia
|