Table 2.

AEs occurring in 10% or more of patients, regardless of the study drug relationship

AEs, n (%)Total (N = 47)
All gradesGrade 3Grade 4
Any47 (100)29 (61.7)6 (12.8)
Diarrhea36 (76.6)5 (10.6)0
Fatigue36 (76.6)12 (25.5)1 (2.1)
Nausea36 (76.6)4 (8.5)0
Vomiting22 (46.8)2 (4.3)0
Weight decrease17 (36.2)00
Anorexia16 (34.0)2 (4.3)0
Abdominal pain, upper12 (25.5)4 (8.5)0
Dysgeusia12 (25.5)00
Rash12 (25.5)1 (2.1)0
Dyspnea11 (23.4)00
Dehydration10 (21.3)4 (8.5)0
Back pain9 (19.1)2 (4.3)0
Dizziness9 (19.1)00
Dry mouth8 (17.0)00
Urinary tract infection8 (17.0)00
Constipation7 (14.9)00
Dyspepsia7 (14.9)00
Pyrexia7 (14.9)00
Cough6 (12.8)1 (2.1)0
Headache6 (12.8)00
Abdominal pain5 (10.6)00
Hypertriglyceridemia5 (10.6)3 (6.4)1 (2.1)
Myalgia5 (10.6)00
Tachycardia5 (10.6)00