Table 2

Summary of AEs and ADRs

Placebo (n = 57)Pemafibrate 0.2 mg/day (n = 54)Pemafibrate 0.4 mg/day (n = 55)
Total AEs41 (71.9)36 (66.7)33 (60.0)
 vs. placeboP = 0.681P = 0.232
Serious AEs3 (5.3)3 (5.6)2 (3.6)
AEs leading to discontinuation004 (7.3)
Total ADRs7 (12.3)6 (11.1)9 (16.4)
 vs. placeboP = 1.000P = 0.597
Serious ADRs000
ADRs leading to discontinuation002 (3.6)
Laboratory tests
 AST >3× ULN000
 AST >5× ULN000
 ALT >3× ULN1 (1.8)00
 ALT >5× ULN000
 GGT >3× ULN4 (7.0)2 (3.7)0
 GGT >5× ULN4 (7.0)00
 CK >4× ULN01 (1.9)0
 CK >5× ULN01 (1.9)0
 CK >10× ULN000
 Serum creatinine >1.5 mg/dL2 (3.5)1 (1.9)2 (3.6)
 Serum creatinine >2.0 mg/dL01 (1.9)1 (1.8)
  • Data are presented as the number of patients (%). GGT, γ-glutamyl transferase. P values were estimated by Fisher exact test.