Table 1.
Adverse event | Trifluridine/tipiracil (n=533) | Placebo (n=265) | ||||
Overall incidence, % | Highest grade | Incidence at highest grade, n (%) | Overall incidence, % | Highest grade | Incidence at highest grade, n (%) | |
Nausea | 48.4 | 3 | 10 (1.9) | 23.8 | 3 | 3 (1.1) |
Vomiting | 27.8 | 3 | 11 (2.1) | 14.3 | 3 | 1 (0.4) |
Diarrhoea | 31.9 | 4 | 16 (3.0)* | 12.5 | 3 | 1 (0.4) |
Dysgeusia | 6.8 | 2 | 3 (0.6) | 2.3 | 2 | 1 (0.4) |
Fatigue | 35.3 | 3 | 21 (3.9) | 23.4 | 3 | 15 (5.7) |
Asthenia | 18.2 | 3 | 18 (3.4) | 11.3 | 3 | 8 (3.0) |
*One incidence of grade 4 diarrhoea was observed in trifluridine/tipiracil patients. This number indicates the total number of grade 3 and 4 diarrhoea events.