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Table 3 Clinical adverse experience summary

From: Safety and tolerability of sitagliptin in patients with type 2 diabetes: a pooled analysis

 

Sitagliptin 100 mg

n (%)

(N = 3415)

Non-Exposed

n (%)

(N = 2724)

Difference in Sitagliptin

and Non-Exposed

% (95% CI)*

With one or more adverse experiences

2150 (63.0)

1711 (62.8)

0.1 (-2.3, 2.6)

With drug-related adverse experiences†

440 (12.9)

483 (17.7)

-4.8 (-6.7, -3.0)

With serious adverse experiences

230 (6.7)

184 (6.8)

-0.0 (-1.3, 1.2)

With serious drug-related adverse experiences†

8 (0.2)

8 (0.3)

-0.1 (-0.4, 0.2)

Who died

11 (0.3)

16 (0.6)

-0.3 (-0.7, 0.1)

Discontinued due to adverse experiences

106 (3.1)

101 (3.7)

-0.6 (-1.5, 0.3)

Discontinued due to drug-related adverse experiences

30 (0.9)

40 (1.5)

-0.6 (-1.2, -0.1)

Discontinued due to serious adverse experiences

51 (1.5)

47 (1.7)

-0.2 (-0.9, 0.4)

Discontinued due to serious drug-related adverse experiences

4 (0.1)

4 (0.1)

-0.0 (-0.3, 0.2)

  1. CI = confidence interval
  2. *Positive differences indicate that the incidence rate for the sitagliptin group is higher than the incidence rate for the non-exposed group. "0.0" and "-0.0" represent rounding for values that are slightly greater and slightly less than zero, respectively.
  3. †Determined by the investigator to be possibly, probably, or definitely drug-related.