Table 4.

Adverse events regardless of relationship to study drug reported in at 15% or more of subjects

Arm A (N = 37)Arm B (N = 20)
Any gradeGrade 3/4Any gradeGrade 3/4
Nonhematologic adverse event
 Nausea19 (51)1 (3)11 (55)1 (5)
 Fatigue14 (38)3 (8)13 (65)1 (5)
 Vomiting13 (35)1 (3)12 (32)0 (0)
 Constipation7 (19)1 (3)5 (25)1 (5)
 Stomatitis7 (19)1 (3)4 (20)0 (0)
 Arthralgia6 (16)0 (0)1 (5)0 (0)
 Back pain6 (16)1 (3)1 (5)0 (0)
 Dehydration6 (16)2 (5)4 (20)1 (5)
 Dyspnea6 (16)1 (3)2 (10)0 (0)
 Pyrexia5 (13)0 (0)4 (20)1 (5)
Hematologic adverse event
 Neutropenia4 (11)1 (3)4 (20)1 (5)
 Lymphopenia24 (65)12 (32)13 (65)5 (25)
 Thrombocytopenia11 (30)1 (3)4 (20)1 (5)
 Anemia35 (95)1 (3)15 (75)2 (10)

NOTE: All values in table are expressed as n (%).