Table 2.

Summary of AEs

Dose level (mg)1530456080100130180245330450330340400All
Schedule21/2821/2821/2821/2821/2821/2821/2821/2821/2821/2821/2828/2828/2828/2821 or 28/28
No. of patients43443533373107160
Toxicity gradeAllAllAllAllAllAll≥3AllAllAll≥3All≥3All≥3All≥3AllAll≥3All
Any AE21223311232723210261946
Gastrointestinal
 Nausea1002130001040209041028
 Diarrhea0021110012030017010119
 Vomiting0002100000030203040015
 Decreased appetite0000000011020106030014
 Dysgeusia1010100010010105020013
Skin and mucosa
 Rasha0000000010142324011514
 Stomatitisb000000000000000402107
 Xeroderma000000000102011400018
Constitutional
 Fatigue0000210011040206031021

NOTE: AEs possibly or likely treatment-related that occurred in ≥10% of patients according to maximum grade for each patient by dose level and grade. AEs grades ≥3 are presented in separate columns for each dose-schedule only when observed.

  • aIncluding preferred terms of rash, rash maculo-papular, rash macular, rash pruritic, rash erythematous, and rash papular.

  • bIncluding preferred terms of stomatitis, mucosal inflammation, mouth ulceration.