Table 3.

Most common (≧ 10% in nonhematologic) toxicities summary (maximum grade shown), in cycle 1.

Dose level and toxicity grade, n (%)
All dose levels (n = 27)Dose level 1 (n = 3)Dose level 2 (n = 3)Dose level 3 (n = 3)Dose level 4 (n = 12)Dose level 5 (n = 6)
Toxicity typeAll grades≧Grade 3All grades≧Grade 3All grades≧Grade 3All grades≧Grade 3All grades≧Grade 3All grades≧Grade 3
GI Toxicity
 Diarrhea24 (89)3 (11)3 (100)1 (33)3 (100)3 (100)9 (75)6 (100)2 (33)
 Vomiting13 (48)1 (4)1 (33)2 (67)2 (67)4 (33)4 (67)1 (17)
 Nausea12 (44)1 (4)1 (33)2 (67)2 (67)4 (33)3 (50)1 (17)
Bone marrow toxicity
 Lymphocyte count decreased18 (67)6 (22)2 (67)1 (33)3 (100)1 (33)9 (75)5 (42)3 (50)
 Anemia15 (56)1 (4)1 (33)1 (33)2 (67)8 (67)1 (8)3 (50)
 White blood cell decreased12 (44)3 (11)2 (67)2 (67)1 (33)5 (42)2 (17)3 (50)
 Neutrophil count decreased9 (33)6 (22)2 (67)2 (67)5 (42)2 (17)2 (33)2 (33)
Other
 Hypotension1 (4)1 (4)1 (17)1 (17)
Investigations
 Hypophosphatemia7 (26)1 (4)2 (67)4 (33)1 (17)1 (17)
 Hypokalemia6 (22)2 (7)3 (25)1 (8)3 (50)1 (17)