Table 3.

Treatment-related adverse events observed during entire study

CategoryGrade, # Events
Dose level 1Dose level 2Dose level 3Dose level 4
Auditory
 TinnitusGrade 1, 1
Blood/bone marrow
 HemoglobinGrade 2, 2Grade 2, 1Grade 2, 1Grade 2, 2
Grade 3, 1
Constitutional
 FatigueGrade 1, 2Grade 2, 1Grade 1, 1Grade 1, 1
Grade 2, 1Grade 3, 1
 Fever (nonneutropenic)Grade 1, 1Grade 2, 1
 Rigors/chillsGrade 1, 1Grade 1, 1
Gastrointestinal
 AnorexiaGrade 1, 1
 ConstipationGrade 1, 1
 NauseaGrade 1, 1Grade 1, 1Grade 1, 1
 VomitingGrade 1, 1
Metabolic/Laboratory
 HypoalbuminemiaGrade 2, 1
Musculoskeletal
 Muscle weaknessGrade 2, 1
Neurologic
 Neuropathy: sensoryGrade 1, 1Grade 3, 1Grade 1, 2
 Neuropathy: motorGrade 2, 1
 DizzinessGrade 1, 1
Pain
 LimbGrade 1, 1
 MyalgiasGrade 3, 1