Table 3.
CTCAE* | CTCAE | CTCAE | CTCAE | ||
---|---|---|---|---|---|
No toxicity | grade 1 | grade 2 | grade 3 | grade 4 | |
Alanine aminotransferase | ≤ULN† | >ULN −2.5 × ULN | >2.5–5.0 × ULN | >5.0 −20 × ULN | >20 × ULN |
Cycles (%) | 2 | 14 | 25 | 42 | 17 |
Patients | 0 | 7 | 6 | 26 | 26 |
Alkaline phosphatase | ≤ULN | >ULN −2.5 × ULN | >2.5–5.0 × ULN | >5.0 −20 × ULN | >20 × ULN |
Cycles (%) | 97 | 3 | 0 | 0 | 0 |
Patients | 58 | 7 | 0 | 0 | 0 |
Gamma-glutamyl transferase | ≤ULN | >ULN −2.5 × ULN | >2.5–5 × ULN | >5.0 −20 × ULN | >20 × ULN |
Cycles (%) | 27 | 43 | 23 | 7 | 0 |
Patients | 12 | 18 | 23 | 12 | 0 |
Bilirubin | ≤ULN | >ULN −1.5 × ULN | >1.5–3.0 × ULN | >3.0–10 × ULN | >10 × ULN |
Cycles (%) | 41 | 35 | 24 | 0 | 0 |
Patients | 13 | 21 | 31 | 0 | 0 |
Creatinine | ≤ULN | >ULN −1.5 × ULN | >1.5–3.0 × ULN | >3.0–6.0 × ULN | >6.0 × ULN |
Cycles (%) | 95 | 3 | 2 | 0 | 0 |
Patients | 54 | 8 | 3 | 0 | 0 |
Leucocyte nadir | ≥3.0 × 109 l−1 | <LLN‡−3.0 × 109 l−1 | <3.0–2.0 × 109l−1 | <2.0–1.0 × 109l−1 | <1.0 × 109l−1 |
Cycles (%) | 32 | 5 | 30 | 27 | 6 |
Patients | 6 | 1 | 14 | 30 | 14 |
Thrombocyte nadir | ≥75 × 109l−1 | <LLN (75 × 109l−1 | <75–50 × 109l−1 | <50–25 × 109l−1 | <1.0 × 109l−1 |
Cycles (%) | 53 | 20 | 7 | 10 | 10 |
Patients | 9 | 14 | 5 | 15 | 22 |
Mucositis | |||||
Cycles (%) | 64 | 13 | 8 | 15 | 0 |
Patients | 18 | 9 | 8 | 30 | 0 |
Common Terminology Criteria Adverse Events v 3.0.
Upper level of normal.
Lower level of normal.