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. 2015 Sep 11;33(6):1197–1205. doi: 10.1007/s10637-015-0281-z

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