Table 4.
Grade 3-4 Adverse events occurring in > 5% of all patients1, N=61
| Event | % All Patients (n = 61) | % Patients ≥ 65 years (n=15) |
|---|---|---|
| Anaemia | 31 | 13 |
| Febrile neutropenia | 36 | 27 |
| Leucopenia | 41 | 27 |
| Lymphopenia | 10 | 20 |
| Neutropenia | 30 | 20 |
| Thrombocytopenia | 43 | 53 |
| Diarrhoea | 7 | 7 |
| Nausea | 7 | 0 |
| Fatigue | 13 | 0 |
| Pyrexia | 11 | 13 |
| Alanine aminotransferase increased | 7 | 7 |
| Aspartate aminotransferase increased | 10 | 7 |
| Hyperbilirubinaemia | 10 | 13 |
| Cellulitis | 5 | 13 |
| Pneumonia | 10 | 0 |
| Sepsis | 10 | 13 |
| Staphylococcal sepsis* | 3 | 13 |
| Hypoalbuminaemia | 7 | 0 |
| Hypokalaemia | 26 | 7 |
| Hyponatraemia | 13 | 7 |
| Hypophosphataemia | 8 | 0 |
| Dyspnea | 15 | 7 |
| Hypoxia | 10 | 0 |
| Hypotension | 7 | 7 |
1
In addition Grade 3-4 adverse events occurring more than once in patients ≥ 65 years