Trigger items | Explanation |
---|---|
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 |