Table 3 Adverse events related to study drugs reported in at least 5% of patients according to NCI-CTC criteria
By patient ( n =56) | By cycle ( n =307) | |||
|---|---|---|---|---|
Toxicity, n (%) | All grades | Grade 3/4 | All grades | Grade 3/4 |
Haematological | ||||
Leucopoenia | 36 (64) | 6 (11) | 111 (36) | 13 (4) |
Neutropenia | 35 (63) | 14 (25) | 121 (39) | 26 (8) |
Anaemia | 37 (66) | 6 (11) | 124 (40) | 7 (2) |
Thrombocytopenia | 5 (9) | 2 (4) | 5 (2) | 2 (1) |
Non-haematological | ||||
Nausea | 44 (79) | 4 (7) | 136 (44) | 7 (2) |
Diarrhoea | 42 (75) | 13 (23) | 141 (46) | 15 (5) |
Fatigue | 33 (59) | 4 (7) | 86 (28) | 7 (2) |
Alopecia | 33 (59) | NA | 202 (66) | NA |
Vomiting | 30 (54) | 6 (11) | 94 (31) | 9 (3) |
Abdominal pain | 19 (34) | 1 (2) | 40 (13) | 1 (<0.5) |
Anorexia | 10 (18) | 1 (2) | 13 (4) | 1 (<0.5) |
Constipation | 6 (11) | 1 (2) | 7 (2) | 1 (<0.5) |
Pyrexia | 6 (11) | 0 | 7 (2) | 0 |
Headache | 6 (11) | 0 | 14 (4) | 0 |
Asthenia | 4 (7) | 2 (4) | 15 (5) | 4 (1) |
Cholinergic syndrome | 4 (7) | 1 (2) | 5 (2) | 2 (1) |
Weight decreased | 5 (9) | 0 | 17 (6) | 0 |
Paraesthesia | 3 (5) | 0 | 4 (1) | 0 |
Vertigo | 3 (5) | 0 | 4 (1) | 0 |
