Table III.
Dose level 1 (n = 3) |
Dose level 2 (n = 10) |
Dose level 3 (n = 7) |
All (n = 20) |
|||||
---|---|---|---|---|---|---|---|---|
Adverse effect | All grades, no. (%) | Grade 3/4, no. (%) | All grades, no. (%) | Grade 3/4, no. (%) | All grades, no. (%) | Grade 3/4, no. (%) | All grades, no. (%) | Grade 3/4, no. (%) |
Fatigue | 1 (33) | 0 | 7 (70) | 3 (30) | 5 (71) | 1 (14) | 13 (65) | 4 (20) |
Nausea | 1 (33) | 0 | 7 (70) | 0 | 5 (71) | 0 | 13 (65) | 0 |
Diarrhea | 1 (33) | 0 | 6 (60) | 0 | 4 (57) | 1 (14) | 11 (55) | 1 (5) |
Vomiting | 0 | 0 | 7 (70) | 0 | 2 (28) | 0 | 9 (45) | 0 |
Anorexia | 0 | 0 | 6 (60) | 0 | 2 (28) | 0 | 8 (40) | 0 |
Abdominal pain | 0 | 0 | 2 (20) | 0 | 1 (14) | 0 | 3 (15) | 0 |
Constipation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Dehydration | 0 | 0 | 2 (20) | 0 | 0 | 0 | 2 (10) | 0 |
Dizziness | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Dyspepsia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Hyperglycemia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Hyponatremia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Generalized muscle weakness | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |