Table 4.

Nonhematologic toxicity occurring at any grade in three or more patients (>10%)

Adverse event, no. patients (cycles)Dose level (mg/m2)
10 (3 patients, 10 cycles)
15 (6 patients, 25 cycles)
20 (9 patients, 48 cycles)
25 (7 patients, 19 cycles)
All (25 patients, 102 cycles)
Grade 1-2Grade 3Grade 1-2Grade 3Grade 1-2Grade 3Grade 1-2Grade 3Grade 1-2Grade 3All
Diarrhea1 (1)4 (7)1 (1)4 (13)4 (7)13 (28)1 (1)14 = 56% (29 = 28%)
Fatigue1 (5)1 (4)3 (15)4 (5)9 (29)9 = 36% (29 = 28%)
Nausea1 (2)1 (1)3 (13)5 (3)10 (19)10 = 40% (19 = 19%)
Neuropathy (sensory)1 (1)1 (6)3 (8)4 (4)9 (19)9 = 36% (19 = 19%)
Vomiting1 (1)2 (8)1 (1)4 (10)4 = 16% (10 = 10%)
Anorexia4 (6)4 (6)4 = 16% (6 = 6%)
Arthralgia02 (3)1 (1)3 (4)3 = 12% (4 = 4%)
Stomatitis/pharyngitis1 (1)1 (3)1 (1)3 (5)3 = 12% (5 = 5%)