Table 3.

Treatment-related adverse events occurring in ≥5% of patients

ToxicityGrade 1/2 n (%)Grade 3/4 n (%)Total n (%)
Mouth sores*17 (31%)8 (15%)25 (45%)
Nausea10 (18%)1 (2%)11 (20%)
Fatigue11 (20%)0 (0%)11 (20%)
Thrombocytopenia2 (4%)8 (15%)10 (18%)
Diarrhea6 (11%)2 (4%)8 (15%)
Hypokalemia2 (4%)3 (6%)5 (9%)
Hyponatremia1 (2%)4 (7%)5 (9%)
Hypertriglyceridemia3 (6%)2 (4%)5 (9%)
Neutropenia2 (4%)2 (4%)4 (7%)
Pruritus4 (7%)0 (0%)4 (7%)
Rash3 (6%)1 (2%)4 (7%)
Weight loss4 (7%)0 (0%)4 (7%)
Anorexia3 (6%)0 (0%)3 (6%)
Herpes simplex2 (4%)1 (2%)3 (6%)
Hypocalcemia1 (2%)2 (4%)3 (6%)
Fever3 (6%)0 (0%)3 (6%)
Headache3 (6%)0 (0%)3 (6%)
Vomiting1 (2%)2 (4%)3 (6%)
  • * Mouth sores included almost exclusively the verbatim terms “mucositis,” “lip ulcer,” and “mouth sores.”