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Table 7 Adverse drug reactions in the safety analysis set

From: Effects of bezafibrate on lipid and glucose metabolism in dyslipidemic patients with diabetes: the J-BENEFIT study

Adverse drug reactions

Cases

Cases without diabetes drug

Cases with diabetes drug

Number

5978

2382

3596

ADRs

306 (5.1%)

103 (4.3%)

203 (5.6%)

Blood creatine phosphokinase increased

48 (0.8%)

17 (0.7%)

31 (0.9%)

Blood creatinine increased

46 (0.8%)

18 (0.8%)

28 (0.8%)

Blood urea increased

29 (0.5%)

10 (0.4%)

19 (0.5%)

Renal impairment

19 (0.3%)

8 (0.3%)

11 (0.3%)

Aspartate aminotransferase increased

18 (0.3%)

7 (0.3%)

11 (0.3%)

Myalgia

17 (0.3%)

6 (0.3%)

11 (0.3%)

Hepatic function abnormal

15 (0.3%)

2 (0.1%)

13 (0.4%)

Pruritus

13 (0.2%)

6 (0.3%)

7 (0.2%)

Alanine aminotransferase increased

13 (0.2%)

5 (0.2%)

8 (0.2%)

Rash

12 (0.2%)

6 (0.3%)

6 (0.2%)

Dyspepsia

7 (0.1%)

1 (0.0%)

6 (0.2%)

Others

72 (1.2%)

19 (0.8%)

53 (1.5%)