Table 3

Overall summary of AEs (treated set)

Treated set, n (%)478 (100)267 (100)
Any AE (%)67.668.9
Drug-related AE (%)15.118.7
AE leading to discontinuation of trial medication (%)2.13.0
Serious AE (%)3.63.0
 Drug-related serious AE†0.40.4
  • *One fatal event in the linagliptin group was a cardiorespiratory arrest and it was considered to be unrelated to the study drug by the investigator.

  • †The drug-related serious AEs by preferred term were hypoglycemia (placebo) and bronchial hyperactivity and pancreatitis (linagliptin).

  • AE, adverse event.