Table 3.
Laboratory measurements
| Normal ranges males (females) | Number (Grade) of subjects with toxicity* | Change to maximum median (range)† | Change to final median (range)‡ | |
|---|---|---|---|---|
| Alanine amino transferase (U l−1) | 0–50 (0–40) | 3 (I) | 2 (0–70) | −2.5 (−23 to 63) |
| Aspartate amino transferase (U l−1) | 0–40 | 2 (I) | 6.5 (0–28) | 1 (−8 to 27) |
| Alkaline phosphatase (U l−1) | 0–120 | – | 5 (0–34) | −6.5 (−26 to 34) |
| Gamma glutamyl transferase (U l−1) | 0–50 (0–35) | 1 (II) | 5 (0–69) | 3.5 (−14 to 52) |
| Amylase (U l−1) | 0–53 | 1 (I), 1 (II) | 5.5 (0–63) | −2 (−13 to 9) |
| Total cholesterol (mmol l−1) | 3.9–6.5 | 6 (II), 4 (III) | 0.95 (0.1–3.2) | 0.65 (−0.5 to 2.1) |
| HDL-cholesterol (mmol l−1) | 0.9–1.7 (1.2–2.3) | ND | 0.1 (0–0.3) | −0.2 (−0.6 to 0.2) |
| LDL-cholesterol (mmol l−1) | 3.5–4.5 | ND | 0.9 (0.1–3.2) | 0.55 (−0.2 to 2.5) |
| Triglycerides (mmol l−1) | 0.8–2.0 | 1 (II), 1 (III) | 1.05 (0–6.7) | 0.5 (−1.9 to 1.7) |
| Creatinine (µmol l−1) | 60–120 (53–100) | 2 (I) | 4.5 (0–26) | −4 (−18 to 8) |
| Total bilirubin (µmol l−1) | 3–17 | 1 (I) | 6 (2–10) | 1 (−4 to 5) |
| Glucose (mmol l−1) | 4.0–6.0 | 1 (I) | 0.1 (0–1.9) | −0.3 (−1.4 to 1.5) |
| Creatine phosphokinase (U l−1) | 0–200 (0–170) | 4 (I), 2 (II), 1 (III) | 21 (0–614) | −23 (−157 to 84) |
ND, Not determined.
*
Number of subjects with toxicity graded I, Grade 1; II, Grade 2; III, Grade 3.
†
Median and range of the individual changes of 24 subjects from baseline (day 1) to maximum values. If day 1 was the maximum the result was 0.
‡
Median and range of the individual changes of 24 subjects from baseline (day 1) to last observed values. If day 1 was the maximum the result was a negative value.