TABLE 2

Adverse Events

Adverse eventGrade 1–2Possible, probable, or definite attributionGrade 3Possible, probable, or definite attribution
Highest toxicity grade*6 (60%)6/6 (100%)3 (30%)0/3 (0%)
Fatigue8 (80%)8/8 (100%)0 (0%)NA
Anorexia2 (20%)2/2 (100%)0 (0%)NA
Vomiting2 (20%)2/2 (100%)0 (0%)NA
Alkaline phosphatase increased2 (20%)2/2 (100%)0 (0%)NA
Hypoalbuminemia2 (20%)2/2 (100%)0 (0%)NA
Upper respiratory tract infection2 (20%)0/2 (0%)0 (0%)NA
Cholangitis0 (0%)NA1 (10%)0/1 (0%)
Hyponatremia0 (0%)NA1 (10%)0/1 (0%)
Pulmonary embolism0 (0%)NA1 (10%)0/1 (0%)
Urinary tract infection0 (0%)NA1 (10%)0/1 (0%)
Abdominal pain1 (10%)1/1 (100%)0 (0%)NA
Anemia (hemoglobin)1 (10%)1/1 (10%)0 (0%)NA
Blood total bilirubin increased1 (10%)1/1 (10%)0 (0%)NA
Diarrhea1 (10%)0/1 (0%)0 (0%)NA
Dysuria1 (10%)0/1 (0%)0 (0%)NA
Nausea1 (10%)1/1 (100%)0 (0%)NA
Platelet count decreased1 (10%)1/1 (100%)0 (0%)NA
Supraventricular tachycardia1 (10%)0/1 (0%)0 (0%)NA
  • * Two of 10 patients died during study. Both deaths were deemed possibly attributable to treatment.

  • NA = not applicable.

  • Adverse events are according to CTCAE 4.0. Highest toxicity grade is highest toxicity grade each patient experienced during study. One patient did not experience any significant toxicity. There were no grade 4 adverse events. Data are numbers followed by percentages in parentheses.