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Table 3 Summary of adverse events (treated set)

From: A randomised, active- and placebo-controlled, three-period crossover trial to investigate short-term effects of the dipeptidyl peptidase-4 inhibitor linagliptin on macro- and microvascular endothelial function in type 2 diabetes

 

Linagliptin 5 mg

Glimepiride 1–4 mg

Placebo

Patients (n)

40

41

40

Any adverse events (%)

27.5

61.0

35.0

Severe adverse events (%)

0.0

0.0

0.0

Drug-related adverse events (%)

17.5

43.9

10.0

Other significant adverse events (according to ICH E3) (%)

0.0

2.4

2.5

Adverse events leading to discontinuation of trial medication (%)

0.0

0.0

2.5

Adverse events of special interest* (%)

0.0

4.9

10.0

Serious adverse events (%)

0.0

0.0

0.0

  1. MedDRA version 16.1 used for reporting
  2. ICH International Conference on Harmonisation (E3 guideline)
  3. * Pre-specified adverse events of special interest: hepatic injury, hypersensitivity reactions, skin lesions, renal adverse events and pancreatitis