Table 2.
Haematological and non-haematological toxicity.
| Any grade |
Grade 3–4 |
Grade 1–2 |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| Type of adverse event (n = 14) | Any grade N (%) |
Dose level 0 (1.3 mg/m2) |
Dose level 1 (1.5 mg/m2) |
Grade 3–4 N (%) |
Dose level 0 (1.3 mg/m2) |
Dose level 1 (1.5 mg/m2) |
Grade 1–2 N (%) |
Dose level 0 (1.3 mg/m2) |
Dose level 1 (1.5 mg/m2) |
| Haematological | |||||||||
| Anemia | 11 (78.5) | 6 (42.8) | 5 (35.7) | 1 (7.1) | 1 (7.1) | 0 (0) | 10 (71.4) | 5 (35.7) | 5 (35.7) |
| Neutropenia | 8 (57.1) | 2 (14.3) | 6 (42.8) | 2 (14.3) | 0 (0) | 2 (14.3) | 6 (42.8) | 2 (14.3) | 4 (28.5) |
| Lymphopenia | 8 (57.1) | 4 (28.5) | 4 (28.5) | 1 (7.1) | 1 (7.1) | 0 (0) | 7 (50.0) | 3 (21.4) | 4 (28.5) |
| Leukopenia | 6 (42.8) | 1 (7.1) | 5 (35.7) | 0 (0) | 0 (0) | 0 (0) | 6 (42.8) | 1 (7.1) | 5 (35.7) |
| Thrombocytopenia | 3 (21.4) | 1 (7.1) | 2 (14.3) | 0 (0) | 0 (0) | 0 (0) | 3 (21) | 1 (7.1) | 2 (14.3) |
| Non-haematological | |||||||||
| ALT/GPT increased | 12 (85.7) | 7 (50.0) | 5 (35.7) | 7 (50) | 6 (42.8) | 1 (7.1) | 5 (35.7) | 1 (7.1) | 4 (28.5) |
| AST/GOT increased | 12 (85.7) | 7 (50.0) | 5 (35.7) | 0 (0) | 0 (0) | 0 (0) | 12 (85.7) | 7 (50.0) | 5 (35.7) |
| Nausea | 7 (50.0) | 4 (28.5) | 3 (21.4) | 0 (0) | 0 (0) | 0 (0) | 7(50.0) | 4 (28.5) | 3 (21.4) |
| Fatigue | 6 (42.8) | 3 (21.4) | 3 (21.4) | 0 (0) | 0 (0) | 0 (0) | 6 (42.8) | 3 (21.4) | 3 (21.4) |
| Skin disorders (dermatitis, epitelitis, erythema) | 5 (35.7) | 2 (14.3) | 3 (21.4) | 1 (7.1) | 1 (7.1) | 0 (0) | 4 (28.5) | 1 (7.1) | 3 (21.4) |
| GGT increased | 10 (71.4) | 6 (42.8) | 4 (28.5) | 1 (7.1) | 1 (7.1) | 0 (0) | 9 (64.2) | 5 (35.7) | 4 (28.5) |
| Anorexia | 4 (28.5) | 2 (14.3) | 2 (14.3) | 0 (0) | 0 (0) | 0 (0) | 4 (28.5) | 2 (14.3) | 2 (14.3) |
| CPK increased | 4 (28.5) | 2 (14.3) | 2 (14.3) | 0 (0) | 0 (0) | 0 (0) | 4 (28.5) | 2 (14.3) | 2 (14.3) |
| Vomiting | 3 (21.4) | 1 (7.1) | 2 (14.3) | 0 (0) | 0 (0) | 0 (0) | 3 (21.4) | 1 (7.1) | 2 (14.3) |
| Diarrhea | 2 (14.3) | 1 (7.1) | 1 (7.1) | 0 (0) | 0 (0) | 0 (0) | 2 (14.3) | 1 (7.1) | 1 (7.1) |
| Dyspepsia | 2 (14.3) | 1 (7.1) | 1 (7.1) | 0 (0) | 0 (0) | 0 (0) | 2 (14.3) | 1 (7.1) | 1 (7.1) |
| Epigastralgia | 2 (14.3) | 2 (14.3) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 2 (14.3) | 2 (14.3) | 0 (0) |
| Alkaline phosphatase increased | 2 (14.3) | 0 (0) | 2 (14.3) | 0 (0) | 0 (0) | 0 (0) | 2 (14.3) | 0 (0) | 2 (14.3) |
| Sepsis | 1 (7.1) | 0 (0) | 1 (7.1) | 1 (7.1) | 0 (0) | 1 (7.1) | 0 (0) | 0 (0) | 0 (0) |
| Catheter related infection | 1 (7.1) | 0 (0) | 1 (7.1) | 1 (7.1) | 0 (0) | 1 (7.1) | 0 (0) | 0 (0) | 0 (0) |
| Abdominal pain | 1 (7.1) | 0 (0) | 1 (7.1) | 0 (0) | 0 (0) | 0 (0) | 1 (7.1) | 0 (0) | 1 (7.1) |
| Dizziness | 1 (7.1) | 1 (7.1) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (7.1) | 1 (7.1) | 0 (0) |
| Headache | 1 (7.1) | 0 (0) | 1 (7.1) | 0 (0) | 0 (0) | 0 (0) | 1 (7.1) | 0 (0) | 1 (7.1) |
| Myalgia | 1 (7.1) | 1 (7.1) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (7.1) | 1 (7.1) | 0 (0) |
| Haemoglobinuria | 1 (7.1) | 0 (0) | 1 (7.1) | 0 (0) | 0 (0) | 0 (0) | 1 (7.1) | 0 (0) | 1 (7.1) |
| Limb cramps | 1 (7.1) | 1 (7.1) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (7.1) | 1 (7.1) | 0 (0) |
| Hypersialorrea | 1 (7.1) | 1 (7.1) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (7.1) | 1 (7.1) | 0 (0) |
| Venous injury | 1 (7.1) | 1 (7.1) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (7.1) | 1 (7.1) | 0 (0) |