Overall summary of AEs (treated set)
| Linagliptin | Placebo | |
|---|---|---|
| Treated set, n (%) | 478 (100) | 267 (100) |
| Any AE (%) | 67.6 | 68.9 |
| Drug-related AE (%) | 15.1 | 18.7 |
| AE leading to discontinuation of trial medication (%) | 2.1 | 3.0 |
| Serious AE (%) | 3.6 | 3.0 |
| Fatal* | 0.2 | 0.0 |
| Drug-related serious AE† | 0.4 | 0.4 |
*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.