Table 3. Selected laboratory data at and following DILI onset (N=32, presented as mean± s.d).
| N=32 | |
|---|---|
| At protocol defined date of onset: | |
| - ALT (U/L) | 499 ± 585 |
| - AST (U/L) | 414 ± 499 |
| - AlkP (U/L) | 365 ± 345 |
| - Total Bilirubin (mg/Dl) | 4.8 ± 6.5 |
| - INR | 1.1 ± 0.2 |
| Pattern of Liver Injury | |
| - Cholestatic | 11/30 (36.7%) |
| - Mixed | 10/30 (33.3%) |
| - Hepatocellular | 9/30 (30.0%) |
| Peak values: | |
| - ALT (U/L) | 686 ± 915 |
| - AST (U/L) | 491 ± 488 |
| - AlkP (U/L) | 623 ± 563 |
| - Total Bilirubin (mg/dL) | 8.7 ± 10.3 |
| - INR | 1.4 ± 0.6 |
| Times to Peak and Recovery (in days) | |
| ALT: | |
| - Onset to Peak | 11 ± 26 |
| - Peak to 50% Reduction | 25± 37 |
| - Peak to below ULN | 106 ± 152 |
| AST: | |
| - Onset to Peak | 4 ± 6 |
| - Peak to a 50% Reduction from Peak | 8 ± 13 |
| - Peak to below ULN | 101 ± 163 |
| AlkP: | |
| - Onset to Peak | 31 ± 45 |
| - Peak to a 50% Reduction from Peak | 56 ± 69 |
| - Peak to below ULN | 123 ± 195 |
| Total Bilirubin: | |
| - Onset to Peak | 40 ± 88 |
| - Peak to a 50% Reduction from Peak | 20 ± 28 |
| - Peak to < 2.5 mg/dL | 41 ± 44 |
| Eosinophils * | |
| - Absolute eosinophil (count/μL) | 286 ± 407 |
| - Eosinophil > 500/μL | 4/17 (23.5%) |
*
Only 17 patients had a complete blood count within 2 weeks of onset to calculate eosinophil counts.
AST: Aspartate aminotransferase; ALT: Alanine aminotransferase; AlkP: Alkaline Phosphatase; INR: International Normalized Ratio; ULN: Upper limit of normal