Table 3A. Adverse events occurring in at least 10% of patients.
|
Grade of adverse event |
|||||
|---|---|---|---|---|---|
| Adverse event | 1 | 2 | 3 | 4 | Total number (%) of patientsa |
| Nausea | 14 | 2 | 2 | 0 | 18 (40.9) |
| Fatigue | 12 | 5 | 1 | 0 | 18 (40.9) |
| Rash | 10 | 3 | 1 | 0 | 14 (31.8) |
| Pyrexia | 9 | 2 | 0 | 0 | 11 (25.0) |
| Chills | 9 | 0 | 1 | 0 | 10 (22.7) |
| Decreased appetite | 8 | 2 | 0 | 0 | 10 (22.7) |
| Vomiting | 8 | 2 | 0 | 0 | 10 (22.7) |
| Anaemia | 1 | 4 | 4 | 0 | 9 (20.5) |
| Infusion-related reaction | 2 | 4 | 2 | 0 | 8 (18.2) |
| Dyspnoea | 3 | 3 | 0 | 1 | 7 (15.9) |
| Constipation | 7 | 0 | 0 | 0 | 7 (15.9) |
| Abdominal pain | 4 | 0 | 3 | 0 | 7 (15.9) |
| Dyspepsia | 5 | 2 | 0 | 0 | 7 (15.9) |
| GGT increased | 0 | 1 | 5 | 0 | 6 (13.6) |
| Urinary tract infection | 2 | 2 | 2 | 0 | 6 (13.6) |
| Blood creatinine increased | 1 | 5 | 0 | 0 | 6 (13.6) |
| Pruritus | 5 | 1 | 0 | 0 | 6 (13.6) |
| AST increased | 0 | 1 | 4 | 0 | 5 (11.4) |
| Hyperglycaemia | 0 | 3 | 2 | 0 | 5 (11.4) |
| Arthralgia | 2 | 3 | 0 | 0 | 5 (11.4) |
| Cough | 5 | 0 | 0 | 0 | 5 (11.4) |
Abbreviations: AST=aspartate aminotransferase; GGT=γ-glutamyl transferase.
a
Number and percentage of patients experiencing at least one event during the course of the study are reported at the highest grade experienced.