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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%)