Table 3.
Summary of drug-related treatment emergent AEs stratified by worst grade (MedDRA/J)
| N | (Per cent) | Grade |
Grade ≥3 |
||||||
|---|---|---|---|---|---|---|---|---|---|
| AE PT | 1 | 2 | 3 | 4 | 5 | n | Per cent | ||
| At least one TEAE | 41 | 91.1 | 14 | 15 | 9 | 2 | 1 | 12 | 26.7 |
| Dermatitis acneiform | 24 | 53.3 | 15 | 9 | 0 | 0 | 0 | 0 | 0 |
| Decreased appetite | 14 | 31.1 | 8 | 5 | 1 | 0 | 0 | 1 | 2.2 |
| Stomatitis | 13 | 28.9 | 11 | 2 | 0 | 0 | 0 | 0 | 0 |
| Diarrhoea | 12 | 26.7 | 9 | 3 | 0 | 0 | 0 | 0 | 0 |
| Dry skin | 10 | 22.2 | 9 | 1 | 0 | 0 | 0 | 0 | 0 |
| Anaemia | 8 | 17.8 | 0 | 4 | 4 | 0 | 0 | 4 | 8.9 |
| Malaise | 8 | 17.8 | 4 | 3 | 1 | 0 | 0 | 1 | 2.2 |
| Paronychia | 7 | 15.6 | 5 | 2 | 0 | 0 | 0 | 0 | 0 |
| Fatigue | 6 | 13.3 | 4 | 1 | 1 | 0 | 0 | 1 | 2.2 |
| Alanine aminotransferase increased | 6 | 13.3 | 6 | 0 | 0 | 0 | 0 | 0 | 0 |
| Weight decreased | 6 | 13.3 | 1 | 5 | 0 | 0 | 0 | 0 | 0 |
| Dysgeusia | 6 | 13.3 | 4 | 2 | 0 | 0 | 0 | 0 | 0 |
| Nausea | 5 | 11.1 | 5 | 0 | 0 | 0 | 0 | 0 | 0 |
| Neutrophil count decreased | 5 | 11.1 | 0 | 2 | 1 | 2 | 0 | 3 | 6.7 |
| White cell count decreased | 5 | 11.1 | 0 | 2 | 2 | 1 | 0 | 3 | 6.7 |
| Pruritus | 5 | 11.1 | 5 | 0 | 0 | 0 | 0 | 0 | 0 |
| Aspartate aminotransferase increased | 4 | 8.9 | 4 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hypertension | 4 | 8.9 | 0 | 4 | 0 | 0 | 0 | 0 | 0 |
| Abdominal pain | 3 | 6.7 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Vomiting | 3 | 6.7 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Nasopharyngitis | 3 | 6.7 | 2 | 1 | 0 | 0 | 0 | 0 | 0 |
| Blood bilirubin increased | 3 | 6.7 | 1 | 2 | 0 | 0 | 0 | 0 | 0 |
| Lymphocyte count decreased | 3 | 6.7 | 0 | 1 | 2 | 0 | 0 | 2 | 4.4 |
AE, adverse event; MedDRA/J, Medical Dictionary for Regulatory Activities/Japanese version; PT, preferred term; TEAE, treatment emergent AE.