Table 1 ODWG hepatic function criteria and dose escalation schema for each cohort as defined by hepatic function
Group Norm | Group Mild | Group Mod | Group Sev | |
|---|---|---|---|---|
Normal hepatic function | Mild hepatic dysfunction | Moderate hepatic dysfunction | Severe Hepatic dysfunction | |
ODWG hepatic function criteria | Bil ≤ ULN AST ≤ ULN | B1: bil ≤ULN and AST > ULN B2: ULN <bil ≤ 1.5x ULN and any AST | 1.5x ULN < bil ≤ 3x ULN and any AST | 3x ULN < bil ≤ 10x ULN and any AST |
Dose Level | mg | mg | mg | mg |
Level - 2 | - | 1 | 0.5 | - |
Level - 1 | - | 1.5 | 1 | 0.5 |
Level 1 | 2 | 2 | 1.5 | 1 |
Level +1 | no escalation | no escalation | 2 | 1.5 |
Level +2 | no escalation | no escalation | no escalation | 2 |
Abbreviation: AST Aspartate aminotransferase; Bil bilirubin; ODWG Organ Dysfunction Working Group | ||||