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Table 3 Adverse event summary

From: Safety and tolerability of sitagliptin in clinical studies: a pooled analysis of data from 10,246 patients with type 2 diabetes

 

Incidence Rate per 100 Patient-years†

 

Sitagliptin 100 mg

Non-exposed

Difference between Sitagliptin and Non-exposed (95% CI)*

With one or more adverse events

153.5

162.6

-7.6 (-15.6, 0.3)

With drug-related‡ adverse events

20.0

26.8

-6.4 (-8.7, -4.1)

With serious adverse events

7.8

7.9

-0.1 (-1.3, 1.1)

With serious drug-related‡ adverse events

0.4

0.3

0.1 (-0.1, 0.4)

Who died

0.3

0.5

-0.2 (-0.5, 0.1)

Discontinued due to adverse events

4.8

5.2

-0.5 (-1.5, 0.4)

Discontinued due to drug-related‡ adverse events

1.7

2.3

-0.5 (-1.1, 0.1)

Discontinued due to serious adverse events

1.7

1.7

-0.0 (-0.6, 0.5)

Discontinued due to serious drug-related‡ adverse events

0.2

0.1

0.1 (-0.1, 0.3)

  1. CI = confidence interval
  2. †100 * (number of patients with ≥ 1 event/person years of follow-up time).
  3. * Between-group difference and 95% CI based on stratified analysis. 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.
  4. ‡As determined by the investigator.