Table 4.
Adverse events
| Child–Pugh | Grade 3/4 | All grades | ||||||
|---|---|---|---|---|---|---|---|---|
| 200 mg bid | 400 mg bid | 200 mg bid | 400 mg bid | |||||
| A (n = 7) | B (n = 6) | A (n = 6) | B (n = 8) | A (n = 7) | B (n = 6) | A (n = 6) | B (n = 8) | |
| Hematological | ||||||||
| Leukocytopenia | 0 | 0 | 0 | 0 | 2 (29%) | 0 | 1 (17%) | 0 |
| Lymphopenia | 2 (29%) | 1 (17%) | 1 (17%) | 1 (13%) | 2 (29%) | 1 (17%) | 1 (17%) | 2 (25%) |
| Platelets | 0 | 0 | 1 (17%) | 1 (13%) | 0 | 1 (17%) | 2 (33%) | 3 (38%) |
| Non‐hematological | ||||||||
| Hypertension | 0 | 1 (17%) | 1 (17%) | 3 (38%) | 0 | 1 (17%) | 1 (17%) | 3 (38%) |
| Fatigue | 0 | 0 | 0 | 0 | 0 | 1 (17%) | 0 | 0 |
| Fever | 0 | 0 | 0 | 0 | 1 (14%) | 2 (33%) | 0 | 1 (13%) |
| Weight loss | 0 | 0 | 0 | 0 | 2 (29%) | 1 (17%) | 1 (17%) | 4 (50%) |
| Hand–foot skin reaction | 0 | 0 | 0 | 2 (27%) | 2 (29%) | 2 (33%) | 5 (83%) | 3 (38%) |
| Rash | 0 | 0 | 0 | 2 (27%) | 2 (29%) | 3 (50%) | 4 (67%) | 6 (75%) |
| Alopecia | 0 | 0 | 0 | 0 | 2 (29%) | 1 (17%) | 2 (33%) | 0 |
| Dry skin | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 (38%) |
| Pruritus | 0 | 0 | 0 | 0 | 0 | 1 (17%) | 4 (67%) | 3 (38%) |
| Anorexia | 0 | 0 | 0 | 0 | 2 (29%) | 1 (17%) | 1 (17%) | 2 (25%) |
| Diarrhea | 0 | 0 | 1 (17%) | 0 | 4 (57%) | 4 (67%) | 2 (33%) | 5 (63%) |
| Stomatitis | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17%) | 2 (25%) |
| Lipase | 3 (43%) | 4 (67%) | 4 (67%) | 6 (75%) | 6 (86%) | 6 (100%) | 6 (100%) | 6 (75%) |
| Amylase | 1 (14%) | 1 (17%) | 1 (17%) | 1 (13%) | 4 (57%) | 3 (50%) | 4 (67%) | 5 (63%) |