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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.