Table 7.
300 mg (N = 76) | ||
---|---|---|
All grades, n (%) | Grade ≥3, n (%) | |
Overall | 71 (93) | 29 (38) |
Constipation | 9 (12) | 0 (0) |
Diarrhea | 43 (57) | 0 (0) |
Nausea | 20 (26) | 0 (0) |
Vomiting | 21 (28) | 0 (0) |
Malaise | 10 (13) | 0 (0) |
Alanine aminotransferase increased | 22 (29) | 3 (4) |
Aspartate aminotransferase increased | 13 (17) | 2 (3) |
Platelet count decreased | 13 (17) | 0 (0) |
Decreased appetite | 12 (16) | 3 (4) |
Hyponatremia | 22 (29) | 15 (20) |
Dysgeusia | 9 (12) | 0 (0) |
Hypoesthesia | 8 (11) | 0 (0) |
Peripheral sensory neuropathy | 18 (24) | 0 (0) |
TRAEs of special interest | ||
Rash | 5 (7) | 0 (0) |
QTc prolongation | 5 (7) | 0 (0) |
Interstitial lung disease | 0 (0) | 0 (0) |