Table 3.

Adverse events (regardless of relationship to drug) in ≥15% of patients and all grade 3 and 4 adverse events in two or more patients

Adverse eventNo. of ptsDose 10-90 mg (n = 14)Dose 130 mg (n = 5)Dose 180 mg (n = 3)Dose 240 mg* (n = 14)Dose 320 mg (n = 4)
G1-2G3G1-2G3G1-2G3G1-2G3G1-2G3
Fatigue203112129010
Diarrhea184010216130
Peripheral edema185010208020
Nausea141020305030
Dizziness132010206020
Constipation122010205020
Anemia111100106020
Vomiting100010105030
Abdominal pain101010115010
Headache93020002020
AST increase82000101400
Rash81000006010
Dyspnea72001201000
Thrombocytopenia62000002010
Anorexia62010011010
Hot flushes61000202010
ALT increase62010100200
Visual disturbance53000000020
Insomnia51000102010
Hyponatremia40100000300
LRTI40111100000

Abbreviations: pts, patients; LRTI, lower respiratory tract infection.

  • *Grade 4 dyspnea in one patient and grade 4 thrombocytopenia in one patient at 240-mg dose.