Table 2.

Treatment-emergent adverse events

50 mg50 mg100 mg300 mg400 mg500 mg600 mg700 mg
QDBIDBIDBIDBIDBIDBIDBIDTotal
AE, n (%)(n = 3)(n = 4)(n = 5)(n = 6)(n = 11)(n = 5)(n = 14)(n = 4)(N = 52)
All-grade AEs in ≥10% of patients
Fatigue2 (66.7)2 (50.0)4 (80.0)3 (50.0)10 (90.9)5 (100.0)8 (57.1)2 (50.0)36 (69.2)
Nausea3 (100.0)4 (100.0)3 (60.0)4 (66.7)5 (45.5)4 (80.0)8 (57.1)3 (75.0)34 (65.4)
Decreased appetite02 (50.0)1 (20.0)3 (50.0)7 (63.6)4 (80.0)8 (57.1)3 (75.0)28 (53.8)
Vomiting2 (66.7)2 (50.0)03 (50.0)3 (27.3)2 (40.0)8 (57.1)2 (50.0)22 (42.3)
Constipation1 (33.3)2 (50.0)1 (20.0)4 (66.7)2 (18.2)06 (42.9)3 (75.0)19 (36.5)
Abdominal pain1 (33.3)1 (25.0)02 (33.3)5 (45.5)1 (20.0)4 (28.6)1 (25.0)15 (28.8)
Diarrhea1 (33.3)2 (50.0)1 (20.0)1 (16.7)4 (36.4)1 (20.0)3 (21.4)1 (25.0)14 (26.9)
Back pain1 (33.3)003 (50.0)3 (27.3)04 (28.6)2 (50.0)13 (25.0)
Dyspnea1 (33.3)1 (25.0)1 (20.0)1 (16.7)2 (18.2)1 (20.0)5 (35.7)1 (25.0)13 (25.0)
Cough1 (33.3)02 (40.0)2 (33.3)1 (9.1)2 (40.0)3 (21.4)011 (21.2)
Hypokalemia02 (50.0)2 (40.0)1 (16.7)2 (18.2)02 (14.3)1 (25.0)10 (19.2)
Weight decreased2 (66.7)01 (20.0)1 (16.7)3 (27.3)02 (14.3)1 (25.0)10 (19.2)
Pain1 (33.3)1 (25.0)01 (16.7)1 (9.1)2 (40.0)1 (7.1)2 (50.0)9 (17.3)
Pyrexia1 (33.3)1 (25.0)01 (16.7)3 (27.3)02 (14.3)08 (15.4)
Dehydration01 (25.0)01 (16.7)3 (27.3)02 (14.3)07 (13.5)
Dizziness1 (33.3)0001 (9.1)02 (14.3)2 (50.0)6 (11.5)
Dysgeusia001 (20.0)1 (16.7)1 (9.1)02 (14.3)1 (25.0)6 (11.5)
Grade 3 or 4 AEs occurring in ≥2 patients
Fatigue00001 (9.1)1 (20.0)3 (21.4)1 (25.0)6 (11.5)
Abdominal pain01 (25.0)003 (27.3)01 (7.1)05 (9.6)
Hypokalemia01 (25.0)1 (20.0)01 (9.1)01 (7.1)1 (25.0)5 (9.6)
Nausea01 (25.0)01 (16.7)1 (9.1)02 (14.3)05 (9.6)
Dehydration01 (25.0)01 (16.7)1 (9.1)0003 (5.8)
Dyspnea00001 (9.1)02 (14.3)03 (5.8)
Hypotension001 (20.0)1 (16.7)1 (9.1)0003 (5.8)
Vomiting01 (25.0)001 (9.1)01 (7.1)03 (5.8)
ALT increased01 (25.0)00001 (7.1)02 (3.8)
Anemia001 (20.0)01 (9.1)0002 (3.8)
Back pain00001 (9.1)01 (7.1)02 (3.8)
Bacterial infection0000002 (14.3)02 (3.8)
Hyponatremia0000002 (14.3)02 (3.8)
Pneumonia0001 (16.7)001 (7.1)02 (3.8)
Small intestinal obstruction02 (50.0)0000002 (3.8)
  • Abbreviations: AE, adverse event; ALT, alanine aminotransferase; BID, twice daily; QD, once daily.