Table 4.

Number of patients with nonhematologic drug-related toxicity occurring in three or more patients (safety population, Q3W N = 28, Q1W N = 27)

Q3W Dose level (mg/m2)Q1W Dose level (mg/m2)
Toxicity3.5 (N = 1)7 (N = 1)15 (N = 2)30 (N = 3)60 (N = 14)75 (N = 7)All (N = 28)15 (N = 3)25 (N = 3)30 (N = 6)35 (N = 4)40 (N = 7)45 (N = 4)All (N = 27)
Fatigue001234*10 (36%)015253a16 (59%)
Diarrhea0001427 (25%)0003126 (22%)
Alopecia0000347 (25%)1011216 (22%)
Nausea0010315 (18%)1022229 (33%)
Stomatitis0000224 (14%)0000224 (15%)
Hypersensitivity0000123 (11%)0000000 (0%)
Nail Disorder0000314 (14%)0010001 (4%)
Vomiting0000123 (11%)0001214 (15%)
Dysgeusia0001203 (11%)0001124 (15%)
Rash0000033 (11%)001011a3 (11%)
Lacrimation increased0000213 (11%)0000022 (7%)
Dehydration0101013 (11%)0000000 (0%)
Decreased appetite0001102 (7%)0101114 (15%)
Dry mouth0000101 (4%)1101003 (11%)
Mucosal inflammation0000000 (0%)00001a2a3 (11%)
  • NOTE: See Supplementary Section for full detailed listing of above toxicities with grades.

  • aDenotes presence of a grade III or higher event; in the Q3W group, there was one grade III event of fatigue at 75 mg/m2. In the Q1W group, there was one patient with grade III mucosal inflammation at 40 mg/m2 and one patient with grade III fatigue, one patient with grade III rash, and two patients with grade III mucosal inflammation at 45 mg/m2.