Table 4.
Grades 3 and 4 adverse drug reactions
| Adverse Reaction (MedDRA/J Ver9.0) | Number of patients (n = 74) |
|||
|---|---|---|---|---|
| Grade 1 (%) | Grade 2 (%) | Grade 3 (%) | Grade 4 (%) | |
| Neutropenia | 8 (10.8) | 11 (14.9) | 23 (31.1) | 27 (36.5) |
| Lymphocytopenia | 15 (20.3) | 16 (21.6) | 29 (39.2) | 6 (8.1) |
| Leukopenia | 5 (6.8) | 20 (27.0) | 39 (52.7) | 5 (6.8) |
| Haemoglobin decreased | 23 (31.1) | 27 (36.5) | 11 (14.9) | 2 (2.7) |
| Thrombocytopenia | 27 (36.5) | 13 (17.6) | 4 (5.4) | 1 (1.4) |
| Deep vein thrombosis | 0 (0) | 0 (0) | 0 (0) | 1 (1.4) |
| Hand-foot syndrome | 20 (27.0) | 26 (35.1) | 12 (16.2) | 0 (0) |
| Stomatitis | 29 (39.2) | 22 (29.7) | 6 (8.1) | 0 (0) |
| Erythropenia | 42 (56.8) | 11 (14.9) | 3 (4.1) | 0 (0) |
| Nausea | 37 (50.0) | 6 (8.1) | 2 (2.7) | 0 (0) |
| ALT (GPT) increased | 16 (21.6) | 1 (1.4) | 2 (2.7) | 0 (0) |
| Blood potassium decreased | 10 (13.5) | 0 (0) | 2 (2.7) | 0 (0) |
| Febrile neutropenia | 0 (0) | 0 (0) | 2 (2.7) | 0 (0) |
| Rash | 17 (23.0) | 19 (25.7) | 1 (1.4) | 0 (0) |
| Fatigue | 28 (37.8) | 5 (6.8) | 1 (1.4) | 0 (0) |
| Vomiting | 11 (14.9) | 5 (6.8) | 1 (1.4) | 0 (0) |
| γ-GTP increased | 13 (17.6) | 4 (5.4) | 1 (1.4) | 0 (0) |
| Diarrhoea | 12 (16.2) | 4 (5.4) | 1 (1.4) | 0 (0) |
| AST (GOT) increased | 18 (24.3) | 2 (2.7) | 1 (1.4) | 0 (0) |
| Upper respiratory tract infection | 0 (0) | 2 (2.7) | 1 (1.4) | 0 (0) |
| Blood sodium decreased | 15 (20.3) | 0 (0) | 1 (1.4) | 0 (0) |
| Small intestinal obstruction | 0 (0) | 0 (0) | 1 (1.4) | 0 (0) |
| Herpes zoster | 0 (0) | 0 (0) | 1 (1.4) | 0 (0) |
| Infection | 0 (0) | 0 (0) | 1 (1.4) | 0 (0) |
| Glucose tolerance impaired | 0 (0) | 0 (0) | 1 (1.4) | 0 (0) |