Table 3.
Treatment-related adverse events
Adverse event | Dose-level | Total | |||||
---|---|---|---|---|---|---|---|
1 | 2 | 3 | 7 | 5 | |||
No. of patients | 3 | 4 | 8 | 10 | 8 | 33 | |
Fatigue | All grades | 2 (67) | 3 (75) | 7 (88) | 7 (70) | 5 (63) | 24 (73) |
Grade ≥3 | 0 | 0 | 1 (13) | 0 | 0 | 1 (3) | |
Nausea | All grades | 1 (33) | 4 (100) | 7 (88) | 4 (40) | 7 (88) | 23 (70) |
Grade ≥3 | 0 | 0 | 1 (13) | 0 | 0 | 1 (3) | |
Diarrhea | All grades | 2 (67) | 2 (50) | 4 (50) | 5 (50) | 6 (75) | 19 (58) |
Grade ≥3 | 0 | 0 | 1 (13) | 1 (10) | 1 (13) | 3 (9) | |
Elevated ALAT | All grades | 1 (33) | 3 (75) | 5 (63) | 5 (50) | 4 (50) | 18 (55) |
Grade ≥3 | 0 | 1 (25) | 2 (25) | 1 (10) | 2 (25) | 6 (18) | |
Elevated ASAT | All grades | 1 (33) | 3 (75) | 5 (63) | 4 (40) | 4 (50) | 17 (52) |
Grade ≥3 | 0 | 1 (25) | 3 (38) | 1 (13) | 5 (15) | ||
Rash* | All grades | 0 | 2 (50) | 4 (50) | 5 (50) | 4 (50) | 15 (46) |
Grade ≥3 | 0 | 0 | 0 | 0 | 0 | 0 | |
Neutropenia | All grades | 2 (67) | 2 (50) | 1 (13) | 5 (50) | 3 (38) | 13 (39) |
Grade ≥3 | 2 (67) | 2 (50) | 1 (13) | 5 (50) | 3 (38) | 13 (39) | |
Vomiting | All grades | 0 | 2 (50) | 5 (63) | 2 (20) | 2 (25) | 11 (33) |
Grade ≥3 | 0 | 0 | 1 (13) | 0 | 0 | 1 (3) | |
Fever | All grades | 1 (33) | 1 (25) | 2 (25) | 2 (20) | 2 (25) | 8 (24) |
Grade ≥3 | 0 | 0 | 0 | 0 | 0 | 0 | |
Mucositis# | All grades | 0 | 1 (25) | 1 (13) | 2 (20) | 3 (38) | 7 (21) |
Grade ≥3 | 0 | 0 | 0 | 0 | 0 | 0 |
Treatment-related adverse events per dose-level. *includes desquamation, acneiform, erythema. # both clinical examination and symptomatic