Table 3. Selected drug-related adverse events.
| Grades 1–2, N (%) | N=54 Grades >2, N (%) | Total, N (%) | |
|---|---|---|---|
| Haematologic | |||
| Leukopenia | 16 (29.6) | 0 (0.0) | 16 (29.6) |
| Neutropenia | 22 (40.7) | 1 (1.9) | 23 (42.6) |
| Anaemia | 46 (85.2) | 5 (9.3) | 51 (94.4) |
| Thrombocytopenia | 42 (77.8) | 5 (9.3) | 47 (87.0) |
| Non-haematologic | |||
| Hypercholesterolaemia | 24 (44.4) | 0 (0.0) | 24 (44.4) |
| Triacylglyceridemia | 13 (24.1) | 0 (0.0) | 13 (24.1) |
| Hyperglycaemia | 36 (66.7) | 11 (20.4) | 47 (87.0) |
| Bilirubin | 11 (20.4) | 3 (5.6) | 14 (25.9) |
| ALP | 15 (27.8) | 3 (5.6) | 18 (33.3) |
| AST | 29 (53.7) | 3 (5.6) | 32 (59.3) |
| ALT | 18 (33.3) | 2 (3.7) | 20 (37.0) |
| γ-glutamyl transpeptidase | 7 (13.0) | 10 (18.5) | 17 (31.5) |
| Hypophosphatemia | 5 (9.3) | 9 (16.7) | 14 (25.9) |
| Hyponatremia | 15 (27.8) | 9 (16.7) | 24 (44.4) |
| Asthenia | 51 (94.4) | 1 (1.9) | 52 (96.3) |
| Myalgia | 20 (37.0) | 0 (0.0) | 20 (37.0) |
| Diarrhoea | 19 (35.2) | 0 (0.0) | 19 (35.2) |
| Constipation | 15 (27.8) | 0 (0.0) | 15 (27.8) |
| Anorexia | 43 (79.6) | 0 (0.0) | 43 (79.6) |
| Nausea | 21 (38.9) | 0 (0.0) | 21 (38.9) |
| Vomiting | 11 (20.4) | 0 (0.0) | 11 (20.4) |
| Abdominal pain | 27 (50.0) | 1 (1.9) | 28 (51.9) |
| Stomatitis | 41 (75.9) | 0 (0.0) | 41 (75.9) |
| Skin rash | 35 (64.8) | 0 (0.0) | 35 (64.8) |
| HFSR | 13 (24.1) | 0 (0.0) | 13 (24.1) |
| Haemorrhage | 17 (31.5) | 1 (1.9) | 18 (33.3) |
| Pneumonitisa | 5 (9.3) | 3 (5.6) | 8 (14.8) |
Abbreviations: ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; HFSR=hand-foot skin reaction.
a
Includes interstitial lung disease, lung infiltration, pneumonitis, pulmonary alveolar haemorrhage and other pulmonary toxicities.