Table 2.

Adverse events (A, all grades; B, grade 3–5 events) possibly related to study drug with an overall incidence of 5% or more overall

Adverse eventArm AArm BArm C
5 mg (n = 7)10 mg (n = 4)20 mg (n = 3)30 mg (n = 3)40 mg (n = 8)50 mg (n = 7)Total (n = 32) %20 mg (n = 4)40 mg (n = 6)Total (n = 10), %40 mg (n = 23)
n%
A. All grades
 Fatigue113565015601670
 Nausea2244384401148
 Vomiting11235382240835
 Diarrhea1242215601043
 Anorexia1114434220730
 Pyrexia115222460522
 ALT elevation14222220417
 AST elevation13219220522
 Abdominal pain2111222112029
 Dysgeusia11322222014
 Weight decreased116220626
 Influenza-like illness116134029
 Headache1119110313
 Stomatitis219110313
 Alkaline phosphatase elevation12911029
 Chills13522
 Dyspnea3216110
 Edema peripheral41329
 Dry skin11191120
 Night sweats111911014
 Rash3250
 Hyponatremia1121314
B. Grade 3–5 events
 Adverse event(n = 7)(n = 4)(n = 3)(n = 3)(n = 8)(n = 7)%(n = 4)(n = 6)%n%
 Fatigue1416220522
 ALT elevation116417
 AST elevation12911029
 Hyponatremia1121314
 Nausea13-
 Vomiting13-
 Anorexia110
 Pyrexia13110
 Alkaline phosphatase elevation13110
 Dyspnea2a6
 Edema peripheral13
  • aIncluding one grade 5 event.