Table 3. Adverse events.
Grade 1–2 | Grade 3 | Grade 4 | |
---|---|---|---|
Haematological toxic effects | |||
| |||
Anaemia | 12 (23%) | 1 (2%) | 0 |
Neutrophil count decreased | 7 (13%) | 3 (6%) | 0 |
Platelet count decreased | 11 (21%) | 0 | 0 |
White blood cell decreased | 9 (17%) | 1 (2%) | 0 |
| |||
Non-haematological toxic effects | |||
| |||
Abdominal pain | 6 (12%) | 1 (2%) | 0 |
Alanine aminotransferase increased | 14 (27%) | 3 (6%) | 0 |
Alkaline phosphatase increased | 4 (8%) | 1 (2%) | 0 |
Aspartate aminotransferase increased | 20 (38%) | 3 (6%) | 0 |
Blood bilirubin increased | 11 (21%) | 0 | 0 |
Confusion | 0 | 1 (2%) | 0 |
Constipation | 8 (15%) | 0 | 0 |
Dehydration | 0 | 1 (2%) | 0 |
Diarrhoea | 30 (58%) | 3 (6%) | 0 |
Fatigue | 35 (67%) | 4 (8%) | 0 |
Headache | 9 (17%) | 0 | 0 |
Hyperglycaemia | 6 (12%) | 0 | 0 |
Hypertension | 22 (42%) | 6 (12%) | 0 |
Hypertriglyceridaemia | 0 | 1 (2%) | 1 (2%) |
Hypocalcaemia | 7 (13%) | 0 | 0 |
Hypomagnesaemia | 9 (17%) | 0 | 0 |
Hypophosphataemia | 5 (10%) | 0 | 0 |
INR increased | 7 (13%) | 0 | 0 |
Mucositis oral | 9 (17%) | 0 | 0 |
Nausea | 32 (62%) | 1 (2%) | 0 |
Hand–foot syndrome | 2 (4%) | 1 (2%) | 0 |
Pancreatitis | 0 | 1 (2%) | 0 |
Skin and subcutaneous tissue disorders (other) | 6 (12%) | 0 | 0 |
Skin hypopigmentation | 7 (13%) | 0 | 0 |
Thromboembolic event | 0 | 0 | 1 (2%) |
Urinary tract infection | 0 | 1 (2%) | 0 |
Vomiting | 11 (21%) | 0 | 0 |
Adverse events according to Common Terminology Criteria for Adverse Events 4.0, excluding grade 1–2 toxic effects that occurred in less than 10% of patients.