Table 4. Grade 3 & 4 toxicities in the safety population (CTCAE version 4.03).
| Adverse event | CED-only (N = 19) No. (%) | CED+GEF (N = 18) No. (%) |
|---|---|---|
| Fatigue | 4 (21) | 6 (33) |
| Hypertension | 1 (5) | 5 (28) |
| Lymphopenia | 2 (11) | 3 (17) |
| Anorexia | 1 (5) | 3 (17) |
| Ataxia | - | 4 (22) |
| Dysphasia | 2 (11) | 1 (6) |
| Headache | 1 (5) | 2 (11) |
| Rash Pustular | 1 (5) | 2 (11) |
| Alanine aminotransferase increased | 2 (11) | - |
| Pain | 1 (5) | 1 (6) |
| Fall | 2 (11) | - |
| Thromboembolic event | 1 (5) | 1 (6) |
| Eye disorder | - | 2 (11) |
| Hyperglycemia | 1 (5) | 1 (6) |
| Cognitive Disturbance | - | 2 (11) |
| Muscle weakness right-sided | 1 (5) | 1 (6) |
| Sepsis | - | 2 (11) |
| Aspartate aminotransferase increased | 1 (5) | - |
| Blurred vision | - | 1 (6) |
| Diarrhoea | - | 1 (6) |
| Generalised muscle weakness | - | 1 (6) |
| Haemorrhage | 1 (5) | - |
| Infection | - | 1 (6) |
| Mucositis Oral | - | 1 (6) |
| Seizure | - | 1 (6) |
| Stomatitis | 1 (5) | - |
| Confusion | - | 1 (6) |
| Skin ulceration | - | 1 (6) |
| Musculoskeletal and connective tissue disorder | - | 1 (6) |
| Cholesterol High | 1 (5) | - |
| Nervous system disorders | - | 1 (6) |
| Hypertrigylceridomia | 1 (5) | - |
| Movements involuntary | - | 1 (6) |
| Paresthesia | - | 1 (6) |
| GGT increased | 1 (5) | - |
| Cushingoid | 1 (5) | - |