Table 2.

Common adverse events (>10% of patients)

TAK-441 dose
50 mg (n = 3)100 mg (n = 5)200 mg (n = 6)400 mg (n = 6)800 mg (n = 5)1,600 mg (n = 9)Total (N = 34)
AE, n (%)All gradesGrade ≥3All gradesGrade ≥3All gradesGrade ≥3All gradesGrade ≥3All gradesGrade ≥3All gradesGrade ≥3All gradesGrade ≥3
Dysgeusia1 (33)04 (80)0004 (67)02 (40)05 (56)016 (47)0
Fatigue1 (33)01 (20)04 (67)1 (17)3 (50)02 (40)05 (56)2 (22)16 (47)3 (9)
Nausea2 (67)02 (40)04 (67)02 (33)03 (60)03 (33)1 (11)16 (47)1 (3)
Muscle spasms1 (33)04 (80)03 (50)03 (50)01 (20)03 (33)1 (11)15 (44)1 (3)
Constipation1 (33)01 (20)02 (33)02 (33)01 (20)03 (33)1 (11)10 (29)1 (3)
Alopecia002 (40)01 (17)02 (33)01 (20)03 (33)09 (26)0
Decreased appetite1 (33)01 (20)02 (33)0002 (40)03 (33)09 (26)0
Diarrhea1 (33)02 (40)0002 (33)02 (40)01 (11)08 (24)0
Vomiting00002 (33)02 (33)02 (40)02 (22)1 (11)8 (24)1 (3)
Chills002 (40)01 (17)1 (17)1 (17)01 (20)0005 (15)1 (3)
Headache001 (20)02 (33)01 (17)0001 (11)05 (15)0
Peripheral edema002 (40)0002 (33)0001 (11)05 (15)0
Weight loss00001 (17)01 (17)02 (40)01 (11)05 (15)0
Anemia00001 (17)1 (17)2 (33)0001 (11)04 (12)1 (3)
Cough001 (20)0001 (17)0002 (22)04 (12)0
Hyponatremia1 (33)1 (33)001 (17)1 (17)1 (17)1 (17)1 (20)1 (20)004 (12)4 (12)
Pyrexia002 (40)01 (17)01 (17)000004 (12)0