Table 3.
Treatment-related adverse events that occurred in ≥20% of participants in the safety population.
All patients (n = 30) |
200 mg cohort (n = 15) |
300 mg cohort (n = 15) |
||||
---|---|---|---|---|---|---|
All grades | Grade 3–4 | All grades | Grade 3–4 | All grades | Grade 3–4 | |
Any events | 29 (97%) | 22 (73%) | 14 (93%) | 9 (60%) | 15 (100%) | 13 (87%) |
Rash | 25 (83%) | 15 (50%) | 11 (73%) | 6 (40%) | 14 (93%) | 9 (60%) |
Diarrhea | 21 (70%) | 4 (13%) | 9 (60%) | 1 (7%) | 12 (80%) | 3 (20%) |
Increased alanine aminotransferas | 20 (67%) | 2 (7%) | 9 (60%) | 1 (7%) | 11 (73%) | 1 (7%) |
Increased aspartate aminotransferase | 19 (63%) | 1 (3%) | 10 (67%) | 1 (7%) | 9 (60%) | 0 |
Itch | 18 (60%) | 0 | 8 (53%) | 0 | 10 (67%) | 0 |
Increased conjugated bilirubin | 16 (53%) | 0 | 7 (47%) | 0 | 9 (60%) | 0 |
Xerosis cutis | 16 (53%) | 0 | 8 (53%) | 0 | 8 (53%) | 0 |
Paronychia | 15 (50%) | 1 (3%) | 5 (33%) | 0 | 10 (67%) | 1 (7%) |
Increased γ-glutamyltransferase | 11 (37%) | 3 (10%) | 6 (40%) | 2 (13%) | 5 (33%) | 1 (7%) |
Mouth ulcer | 10 (33%) | 2 (7%) | 2 (13%) | 0 | 8 (53%) | 2 (13%) |
Increased blood bilirubin | 10 (33%) | 0 | 4 (27%) | 0 | 6 (40%) | 0 |
Cutaneous fissure | 9 (30%) | 1 (3%) | 2 (13%) | 0 | 7 (47%) | 1 (7%) |
Anorexia | 9 (30%) | 0 | 3 (20%) | 0 | 6 (40%) | 0 |
Eyelash growth | 8 (27%) | 0 | 4 (27%) | 0 | 4 (27%) | 0 |
Increased alkaline phosphatase | 8 (27%) | 0 | 6 (40%) | 0 | 2 (13%) | 0 |
Increased serum creatinine | 7 (23%) | 0 | 5 (33%) | 0 | 2 (13%) | 0 |
Nausea | 6 (20%) | 1 (3%) | 1 (7%) | 0 | 5 (33%) | 1 (7%) |
Skin exfoliation | 6 (20%) | 0 | 3 (20%) | 0 | 3 (20%) | 0 |
Extended QT interval of electrocardiogram | 5 (17%) | 0 | 4 (27%) | 0 | 1 (7%) | 0 |
Abdominal discomfort | 4 (13%) | 0 | 1 (7%) | 0 | 3 (20%) | 0 |
Conjunctivitis | 4 (13%) | 0 | 0 | 0 | 4 (27%) | 0 |
Oral mucositis | 4 (13%) | 0 | 3 (20%) | 0 | 1 (7%) | 0 |
Alopecia | 4 (13%) | 0 | 1 (7%) | 0 | 3 (20%) | 0 |
Data are n (%). Treatment-related adverse events were assessed by investigators.
QT = time interval between the start of the Q wave and end of the T wave in the electrical cycle of the heart.