Table 3.
Grades | ||||
---|---|---|---|---|
Parameter | Origin | 1 | 2 | 3 |
ALT (ULNR) | CPI | 1.2 (or # 70 IU l−1) to 3 ULNR | 3 to 5* | 5 to 10 |
FDA | 1.1 to 2.5 ULNR | 2.6 to 5 | 5 to 10 | |
NIH | 1.25 to 2.5 ULNR | 2.5 to 5 | 5 to 10 | |
AST (ULNR) | CPI | 1.2 (or # 70 IU l−1) to 3 ULNR | 3 to 5* | 5 to 10 |
FDA | 1.1 to 2.5 ULNR | 2.6 to 5 | 5 to 10 | |
NIH | 1.25 to 2.5 ULNR | 2.5 to 5 | 5 to 10 | |
Bilirubin (ULNR) | CPI | 1.3 (or # 35 IU l−1) to 2 ULNR if change from baseline >10 µmol l−1 | 2 to 2.5* | 2.5 to 3 |
FDA, if LFT normal† | 1.1 to 1.5 ULNR | 1.6 to 2 | 2 to 3 | |
FDA, if increase of LFT† | 1.1 to 1.25 | 1.26 to 1.5 | 1.51 to 1.75 | |
NIH | 1.25 to 2.5 ULNR | 2.5 to 5 | 5 to 10 | |
Alkaline Phosphatases (ULNR) | CPI | 1.1 (or # 132 IU l−1) to 2 ULNR | 2.1 to 3 | 3.1 to 10 |
FDA | 1.1 to 2 ULNR | 2.1 to 3 | 3.1 to 10 | |
NIH | 1.25 to 2.5 ULNR | 2.6 to 5 | 5 to 10 |
Use Hy's law: ALT >3 ULNR and bilirubin >2 ULNR induces upgrading to level 3 [9.]
The appearance of worsening of fatigue, nausea, vomiting, fever, rash eosinophilia or right upper quadrant pain or tenderness or the association to INR superior to 1.5 induces an upgrading [17]. ULNR, Upper limit of normal range; LLNR, Lower limit of normal range; CPI, Club phase I task force.