Table 3 Safety profile (according to NCI/CTC criteria)
Side effects | Number of patients with toxicity (%) | ||||
|---|---|---|---|---|---|
Grade 1 | Grade 2 | Grade 3 | Grade 4 | All grades | |
Hematological | |||||
Anemia | 4 (9.5%) | 0 | 0 | 0 | 4 (9.6) |
Leucopenia | 4 (9.5%) | 2 (4.8%) | 0 | 0 | 6 (14.2%) |
Neutropenia | 1 (2.4%) | 1 (2.4%) | 2 (4.8%) | 0 | 4 (9.6%) |
Thrombocytopenia | 2(4.8%) | 2 (4.8%) | 0 | 0 | 4 (9.6%) |
Non-hematological | |||||
Nausea/Vomiting | 5 (11.9%) | 11 (26.2%) | 0 | 0 | 16 (38.1%) |
Mucositis | 7 (16.7%) | 5 (11.9%) | 1 (2.4%) | 0 | 13 (31.0%) |
Neurotoxicity | 8 (19.0%) | 5 (11.9%) | 1 (2.4%) | 0 | 14 (33.3%) |
Diarrhoea | 8 (19.0%) | 7 (16.6%) | 2 (4.8%) | 0 | 17 (40.4%) |
Asthenia | 15 (35.7%) | 11 (26.2%) | 3 (7.1%) | 0 | 29 (69.0%) |
Hyperbilirubinemia | 1 (2.4%) | 3 (7.1%) | 0 | 0 | 4 (9.5%) |
Anorexia | 5 (11.9%) | 3 (7.1%) | 0 | 0 | 8 (19.0%) |