Table 4.

Overall summary of adverse events (treated set)

	Linagliptin	Placebo
Patients*, n	183	89
Any adverse event, n (%)	114 (62.3)	43 (48.3)
Severe adverse events, n (%)	4 (2.2)	1 (1.1)
Drug-related adverse events, n (%)	21 (11.5)	12 (13.5)
Adverse events leading to discontinuation of trial medication, n (%)	5 (2.7)	2 (2.2)
Serious adverse events, n (%)	4 (2.2)	3 (3.4)
Fatal, n (%)	0 (0.0)	1 (1.1)
Increase in amylase, n (%)	2 (1.1)	1 (1.1)
Pancreatitis, n (%)	0 (0.0)	0 (0.0)
Pancreatic cancer, n (%)	0 (0.0)	0 (0.0)
Colon cancer, n (%)	1 (0.5)	0 (0.0)
Patients with cardiovascular death, myocardial infarction, stroke or unstable angina, n (%)	0 (0.0)	1 (1.1)

^*All patients who were treated with ≥ 1 dose of study medication.