Table 2. Adverse events registered during the study, stratified by NCI class and grade.
| NCI class | Events (N) | Pts (N) | Pts (%) | n.a. | Gr I | Gr II | Gr III | Gr IV |
|---|---|---|---|---|---|---|---|---|
| Pain | 32 | 15 | 41.7 | 0 | 12 | 13 | 7 | 0 |
| Gastrointestinal | 26 | 14 | 38.9 | 0 | 14 | 12 | 0 | 0 |
| Pulmonary | 20 | 9 | 25.0 | 0 | 5 | 5 | 6 | 4 |
| Cardiovascular (general) | 17 | 12 | 33.3 | 0 | 8 | 4 | 5 | 0 |
| Constitutional symptoms | 15 | 9 | 25.0 | 0 | 10 | 4 | 1 | 0 |
| Neurology | 11 | 8 | 22.2 | 0 | 3 | 6 | 2 | 0 |
| Blood/bone marrow | 10 | 5 | 13.9 | 0 | 1 | 5 | 4 | 0 |
| Not to classify | 7 | 5 | 13.9 | 4 | 3 | 0 | 0 | 0 |
| Renal/genitourinary | 5 | 4 | 11.1 | 0 | 2 | 1 | 2 | 0 |
| Haemorrhage | 5 | 3 | 8.3 | 0 | 3 | 0 | 1 | 1 |
| Hepatic | 4 | 2 | 5.6 | 0 | 0 | 0 | 4 | 0 |
| Infection/febrile neutropenia | 3 | 3 | 8.3 | 1 | 1 | 1 | 0 | 0 |
| Metabolic/laboratory | 3 | 3 | 8.3 | 0 | 1 | 1 | 1 | 0 |
| Allergy/immunology | 1 | 1 | 2.8 | 0 | 0 | 1 | 0 | 0 |
| Ocular/visual | 1 | 1 | 2.8 | 0 | 0 | 1 | 0 | 0 |
| Total | 160 | 30 | 83.3 | 5 | 63 | 54 | 33 | 5 |
Pts=patients; Gr=grade; n.a.=grade not specified.