Table 1.

Person-time adjusted analysis of pancreatitis and pancreatitis acute adverse events including data after glycaemic rescue: sitagliptin 100 mg vs. non-exposed

Adverse event end-point	Treatment	n/Patient-years of exposure (100 patient-years event rate)*	Difference vs. non-exposed (95% CI)†
Pancreatitis/pancreatitis acute	Sitagliptin 100 mg	4/4708 (0.08)	−0.02 (−0.20, 0.14)
	Non-exposed	4/3942 (0.10)
Pancreatitis	Sitagliptin 100 mg	3/4708 (0.06)	0.06 (−0.04, 0.19)
	Non-exposed	0/3943 (0.00)
Pancreatitis acute	Sitagliptin 100 mg	1/4709 (0.02)	−0.08 (−0.25, 0.03)
	Non-exposed	4/3942 (0.10)

n = Number of patients with ≥ 1 occurrence of the end-point.

^*Patient-years of exposure were computed as the total time in the treatment period + 14 days for patients who did not have an event, and as the total time up to the time of the first event for patients who had an event.

^†95% CI computed using the Miettinen & Nurminen method stratified by study.