Table 4.

Summary of AEs and ADRs (SAS).

(A) With Statin
Parameter	Placebo		Pemafibrate
		0.1 mg/day	0.2 mg/day	0.4 mg/day
n	178	45	382	72
AE
Total	73 (41.0)	29 (64.4)	164 (42.9)	34 (47.2)
Serious	2 (1.1)	2 (4.4)	6 (1.6)	0
Leading to withdrawal	2 (1.1)	2 (4.4)	12 (3.1)	0
ADR
Total	17 (9.6)	3 (6.7)	36 (9.4)	2 (2.8)
Serious	1 (0.6)	0	2 (0.5)	0
Leading to withdrawal	2 (1.1)	1 (2.2)	11 (2.9)	0
n	178	45	382	72
AST ≥ ULN × 3	0 1	0	1 (0.3)	1 (1.4)
ALT ≥ ULN × 3	1 (0.6)	1 (2.2)	0	1 (1.4)
sCr ≥ ULN	37 (20.8)	8 (17.8)	61 (16.0)	11 (15.3)
CK ≥ 2.5 and < ULN × 5	4 (2.2)	2 (4.4)	7 (1.8)	2 (2.8)
CK ≥ 5 and < ULN × 10	0	0	3 (0.8)	0
CK ≥ ULN × 10	0	0	1 (0.3)	0
(B) Without Statin
Parameter	Placebo		Pemafibrate
		0.1 mg/day	0.2 mg/day	0.4 mg/day
n	120	82	202	174
AE
Total	55 (45.8)	27 (32.9)	78 (38.6)	60 (34.5)
Serious	0	1 (1.2)	4 (2.0)	2 (1.1)
Leading to withdrawal	0	2 (2.4)	3 (1.5)	6 (3.4)
ADR
Total	10 (8.3)	3 (3.7)	14 (6.9)	16 (9.2)
Serious	0	0	1 (0.5)	1 (0.6)
Leading to withdrawal	0	1 (1.2)	2 (1.0)	3 (1.7)
n	120	82	202	173
AST ≥ ULN × 3	0	0	0	1 (0.6)
ALT ≥ ULN × 3	0	0	0	0
sCr ≥ ULN	16 (13.3)	15 (18.3)	34 (16.8)	22 (12.7)
CK ≥ 2.5 and < ULN × 5	1 (0.8)	2 (2.4)	3 (1.5)	0
CK ≥ 5 and < ULN × 10	1 (0.8)	0	0	1 (0.6)
CK ≥ ULN × 10	0	0	0	1 (0.6)

Data are presented as the number of patients (percentage). ¹ n = 177. AE, adverse event; ADR, adverse drug reaction; SAS, safety analysis set; AST, aspartate aminotransferase; ULN, upper limit of normal; ALT, alanine aminotransferase; sCr, serum creatinine; CK, creatine kinase.