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Table 4 Summary of adverse events by system organ class

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†

System Organ Class

Sitagliptin

100 mg

Non-exposed

Difference between Sitagliptin

and Non-exposed (95% CI)*

Blood and Lymphatic System Disorders

1.1

0.6

0.4 (0.0, 0.8)

Cardiac Disorders

4.2

4.3

-0.2 (-1.1, 0.7)

Congenital, Familial, and Genetic Disorders

0.2

0.3

-0.0 (-0.3, 0.2)

Ear And Labyrinth Disorders

1.7

2.0

-0.4 (-1.0, 0.2)

Endocrine Disorders

0.3

0.5

-0.2 (-0.5, 0.1)

Eye Disorders

4.0

4.3

-0.2 (-1.1, 0.6)

Gastrointestinal Disorders

26.0

27.7

-1.2 (-3.7, 1.2)

General Disorders And Administration Site Conditions

8.8

9.3

-0.6 (-1.9, 0.8)

Hepatobiliary Disorders

1.3

1.1

0.2 (-0.3, 0.7)

Immune System Disorders

1.0

1.1

-0.1 (-0.6, 0.3)

Infections And Infestations

49.2

48.1

1.8 (-1.7, 5.3)

Injury, Poisoning And Procedural Complications

9.7

9.4

0.7 (-0.7, 2.1)

Investigations

15.1

15.7

-1.2 (-3.0, 0.6)

Metabolism And Nutrition Disorders

9.3

16.3

-6.8 (-8.5, -5.2)

Musculoskeletal And Connective Tissue Disorders

20.3

19.4

1.0 (-1.1, 3.0)

Neoplasms Benign, Malignant And Unspecified

2.2

1.7

0.6 (-0.0, 1.2)

Nervous System Disorders

15.4

15.5

-0.2 (-2.0, 1.6)

Pregnancy, Puerperium, and Perinatal Conditions

0.0

0.1

-0.0**

Psychiatric Disorders

4.6

4.7

0.0 (-0.9, 1.0)

Renal And Urinary Disorders

3.0

3.0

-0.1 (-0.8, 0.7)

Reproductive System And Breast Disorders

2.8

3.2

-0.3 (-1.1, 0.5)

Respiratory, Thoracic And Mediastinal Disorders

8.8

8.6

0.2 (-1.2, 1.4)

Skin And Subcutaneous Tissue Disorders

8.6

7.3

1.3 (0.1, 2.5)

Social Circumstances

0.0

0.1

-0.0**

Surgical and Medical Procedures

0.1

0.1

0.0**

Vascular Disorders

5.8

5.8

-0.2 (-1.2, 0.9)

  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. ** 95% CIs were not computed for events that occurred in fewer than 4 patients in both groups, because the CIs would necessarily have included 0.