Table 3.

Cumulative incidence of major adverse events

	Group A (N=3395)	Group B (N=1755)	P value
	n (%)	n (%)	Group A vs B
Symptomatic hypoglycemia	104 (3.9)	45 (3.2)	0.317
Pancreatitis acute	5 (0.2)	3 (0.9)	0.861
Pancreatitis chronic	2 (0.1)	0 (0.0)	0.310
Skin disorders of non-extrinsic origin	201 (7.9)	90 (6.2)	0.240
Severe infections	71 (2.7)	28 (2.0)	0.222
Cancer	162 (7.4)	62 (4.8)	0.040*

Cumulative incidence (%) of major AEs was calculated per observation period by the Kaplan-Meier method (see figure 2). P values were by log-rank test. Potential factors contributing to cancer development were detailed by Cox regression analysis as shown in online supplemental table 3.

*p value with significance level smaller than 0.05.