Table 3 Treatment-emergent adverse events
From: Impact of race on dose selection of molecular-targeted agents in early-phase oncology trials
Adverse event | 4–32 mg Japanese cohort (n = 12) | 2–28 mg US cohort (n = 10) | 56–96 mg Japanese cohort (n = 6) | 48–80 mg US cohort (n = 11) | 160 mg Japanese cohort (n = 3) | 160 mg US cohort (n = 4) | 240 mg Japanese cohort (n = 6) | 240 mg US cohort (n = 9) | 320 mg US cohort (n = 8) | All (n = 69) |
|---|---|---|---|---|---|---|---|---|---|---|
Diarrhoea | 6 | 5 | 4 (96 mg 1 G3) | 4 | 2 (1 G3) | 4 | 5 | 5 | 4 | 39 (56.5%) |
Nausea | 6 | 6 | 1 | 6 | 3 | 2 | 6 | 4 | 5 | 39 (56.5%) |
Fatigue | 5 | 7 (2, ≥G3) | 3 | 5 (1, ≥G3) | 1 | 4 | 2 | 5 (1, ≥G3) | 6 (1, G3) | 38 (55.1%) |
Decreased appetite | 7 | 3 | 2 | 2 | 3 (1 G3) | 3 | 4 | 5 (1, ≥G3) | 5 | 34 (49.3%) |
Vomiting | 4 | 4 | 1 | 3 | 2 | 2 | 3 | 3 | 4 | 26 (37.7%) |
Rash | 3 | 2 | 4 | 4 (1, G3) | 2 | 0 | 5 | 0 | 3 | 23 (33.3%) |
Stomatitis | 3 | 1 | 1 | 3 | 2 | 1 | 6 | 5 (1, G3) | 1 | 23 (33.3%) |
Dysgeusia | 3 | 0 | 1 | 2 | 2 | 1 | 3 | 2 | 5 | 19 (27.5%) |
Constipation | 3 | 3 | 1 | 0 | 1 | 2 | 1 | 1 | 1 | 13 (18.8%) |
Dry mouth | 0 | 3 | 1 | 3 | 0 | 0 | 1 | 3 | 2 | 13 (18.8%) |
Edema | 2 | 2 | 1 | 1 | 1 | 0 | 3 | 1 | 1 | 12 (17.4%) |
Dyspnea | 2 | 2 | 0 | 1 | 1 | 0 | 0 | 3 | 2 | 12 (17.4%) |
Hyperglycaemia | 0 | 0 | 2 (56 mg 1 G3, 96 mg 1 G3) | 2 | 1 (1 G3) | 1 | 1 (1 G4) | 2 | 3 | 12 (17.4%) |
Cough | 1 | 2 | 1 | 3 | 2 | 0 | 1 | 0 | 1 | 11 (15.9%) |
Back pain | 1 | 5 | 0 | 1 | 0 | 0 | 1 | 3 | 0 | 11 (15.9%) |
Pyrexia | 0 | 1 | 0 | 2 | 1 | 0 | 2 | 2 | 2 | 10 (14.5%) |
Abdominal pain | 1 | 0 | 1 | 1 | 1 | 1 | 1 | 4 | 0 | 10 (14.5%) |
Blood creatinine increased | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 2 | 2 | 7 (10.1%) |
AST increased | 0 | 3 (1, ≥G3) | 1 | 1 | 0 | 0 | 0 | 2, ≥G3 | 0 | 7 (10.1%) |
Dehydration | 0 | 0 | 0 | 1, G3 | 0 | 1 | 0 | 1 | 3 (1, G3) | 6 (8.7%) |
Lung infection/ pneumonia | 0 | 1, G3 | 0 | 0 | 0 | 0 | 1 (1 G3) | 1 | 1, G3 | 4 (5.8%) |
