Table 1.
Hepatotoxicity grade by liver function test
| Liver function test | Hepatotoxicity gradea | ||||
|---|---|---|---|---|---|
| Grade 0 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
| Aspartate transaminase | AST ≤ ULN | AST > ULN and AST ≤ 2.5 x ULN | AST > 2.5 x ULN and AST ≤ 5 x ULN | AST > 5 x ULN and AST < 20 x ULN | AST ≥ 20 x ULN |
| Alanine aminotransferase | ALT ≤ ULN | ALT > ULN and ALT ≤2.5 x ULN | ALT > 2.5 x ULN and ALT ≤5 x ULN | ALT > 5 x ULN and ALT < 20 x ULN | ALT ≥20 x ULN |
| Total bilirubin | Bilirubin ≤ ULN | Bilirubin > ULN and bilirubin ≤1.5 x ULN | Bilirubin > 1.5 x ULN and bilirubin ≤3 x ULN | Bilirubin > 3 x ULN and bilirubin ≤10 x ULN | Bilirubin > 10 x ULN |
Abbreviations: ALT alanine aminotransferase, AST aspartate transaminase, ULN upper limit of the normal
aHepatotoxicity cut-offs were adapted from the Clinical Islet Transplantation study–Terminology Criteria for Adverse Events in trials of adult pancreatic islet transplantation (CIT-TCAE) Version 5.0 [13], which are modified standards of those set forth in the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) [14]