Table 2.

Treatment-emergent adverse events reported in ≥10% of patients by dose and severity

Treatment-emergent adverse event	30 mg (n = 3)		60 mg (n = 3)		90 mg (n = 8)		120 mg (n = 61)		180 mg (n = 61)		240 mg (n = 13)		300 mg (n = 3)		Total (n = 152)
	Grade 1–2	≥Grade 3	Grade 1–2	≥Grade 3	Grade 1–2	≥Grade 3	Grade 1–2	≥Grade 3	Grade 1–2	≥Grade 3	Grade 1–2	≥Grade 3	Grade 1–2	≥Grade 3	All grade	Grade 1–2	≥Grade 3
Vomiting	1 (33%)	0	1 (33%)	0	2 (25%)	0	11 (18%)	0	18 (30%)	0	7 (54%)	0	2 (67%)	0	52 (34%)	52 (34%)	0
Nausea	0	0	2 (67%)	0	4 (50%)	0	12 (20%)	0	21 (34%)	0	8 (62%)	0	1 (33%)	0	48 (32%)	48 (32%)	0
Hypercholesterolemia	0	0	0	0	2 (25%)	0	16 (26%)	3 (5%)	12 (20%)	2 (3%)	10 (77%)	0	2 (67%)	0	47 (31%)	42 (28%)	5 (3%)
AST elevated	0	0	0	0	3 (38%)	0	15 (26%)	2 (3%)	18 (30%)	3 (5%)	5 (38%)	1 (1%)	0	0	47 (31%)	41 (27%)	6 (4%)
ALT elevated	0	0	0	0	3 (38%)	0	15 (26%)	3 (5%)	17 (28%)	2 (3%)	4 (31%)	1 (1%)	0	0	45 (30%)	39 (26%)	6 (4%)
Hypertriglyceridemia	0	0	0	0	2 (25%)	0	14 (23%)	3 (5%)	9 (15%)	2 (3%)	6 (46%)	0	1 (33%)	0	37 (24%)	32 (21%)	5 (3%)
Hypertension	0	0	1 (33%)	0	0	2 (1%)	8 (13%)	1 (2%)	9 (15%)	3 (5%)	5 (38%)	3 (2%)	1 (33%)	0	33 (22%)	24 (16%)	9 (6%)
CPK elevated	0	0	1 (33%)	0	2 (25%)	0	8 (13%)	0	18 (30%)	0	1 (8%)	0	1 (33%)	0	31 (20%)	31 (20%)	0
Diarrhea	0	0	0	0	0	0	3 (5%)	0	10 (16%)	1 (2%)	6 (46%)	0	2 (67%)	0	22 (14%)	21 (14%)	1 (1%)
Hyperlipidemia	1 (33%)	0	0	1 (33%)	3 (38%)	0	5 (8%)	0	11 (18%)	0	0	0	1 (33%)	0	22 (14%)	21 (14%)	1 (1%)
Rash	0	0	0	0	1 (13%)	0	5 (8%)	0	10 (16%)	1 (2%)	3 (23%)	0	0	0	20 (13%)	19 (13%)	1 (1%)
Dizziness	0	0	0	0	1 (13%)	0	5 (8%)	0	10 (16%)	0	2 (15%)	0	1 (33%)	0	16 (11%)	16 (11%)	0
γ-GGT elevated	0	0	0	0	1 (13%)	0	3 (5%)	3 (5%)	8 (13%)	1 (2%)	0	1 (1%)	0	0	17 (11%)	12 (8%)	5 (3%)
Upper respiratory infection	0	0	0	0	1 (13%)	0	8 (13%)	0	7 (11%)	1 (2%)	0	0	0	0	17 (11%)	16 (11%)	1 (1%)
Headache	0	0	0	0	2 (25%)	0	7 (11%)	0	3 (5%)	0	2 (15%)	0	0	0	14 (9%)	14 (9%)	0

AST aspartate transaminase, ALT alanine aminotransferase, CPK creatine phosphokinase, γ-GGT γ-glutamyl transpeptidase