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Table 4 Summary of clinical adverse experiences by system organ class

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

System Organ Class

Sitagliptin 100 mg

n (%)

(N = 3415)

Non-Exposed

n (%)

(N = 2724)

Difference between Sitagliptin

and Non-Exposed

% (95% CI)*

Blood and Lymphatic System Disorders

33 (1.0)

11 (0.3)

0.6 (0.1, 1.0)

Cardiac Disorders

136 (4.0)

105 (3.9)

0.1 (-0.9, 1.1)

Congenital, Familial, and Genetic Disorders

7 (0.2)

4 (0.1)

0.1 (-0.2, 0.3)

Ear And Labyrinth Disorders

50 (1.5)

53 (1.9)

-0.5 (-1.2, 0.2)

Endocrine Disorders

9 (0.3)

15 (0.6)

-0.3 (-0.7, 0.0)

Eye Disorders

140 (4.1)

112 (4.1)

-0.0 (-1.0, 1.0)

Gastrointestinal Disorders

659 (19.3)

493 (18.1)

1.2 (-0.8, 3.1)

General Disorders And Administration Site Conditions

259 (7.6)

212 (7.8)

-0.2 (-1.6, 1.1)

Hepatobiliary Disorders

44 (1.3)

27 (1.0)

0.3 (-0.3, 0.8)

Immune System Disorders

32 (0.9)

25 (0.9)

0.0 (-0.5, 0.5)

Infections And Infestations

1179 (34.5)

897 (32.9)

1.6 (-0.8, 4.0)

Injury, Poisoning And Procedural Complications

290 (8.5)

222 (8.1)

0.3 (-1.1, 1.7)

Investigations

143 (4.2)

145 (5.3)

-1.1 (-2.2, -0.1)

Metabolism And Nutrition Disorders

219 (6.4)

373 (13.7)

-7.3 (-8.8, -5.8)

Musculoskeletal And Connective Tissue Disorders

576 (16.9)

434 (15.9)

0.9 (-0.9, 2.8)

Neoplasms Benign, Malignant And Unspecified

76 (2.2)

44 (1.6)

0.6 (-0.1, 1.3)

Nervous System Disorders

433 (12.7)

344 (12.6)

0.1 (-1.6, 1.7)

Pregnancy, Puerperium, and Perinatal Conditions

1 (0.0)

2 (0.1)

-0.0 (-0.2, 0.1)

Psychiatric Disorders

143 (4.2)

121 (4.4)

-0.3 (-1.3, 0.8)

Renal And Urinary Disorders

99 (2.9)

74 (2.7)

0.2 (-0.7, 1.0)

Reproductive System And Breast Disorders

90 (2.6)

84 (3.1)

-0.4 (-1.3, 0.4)

Respiratory, Thoracic And Mediastinal Disorders

279 (8.2)

208 (7.6)

0.5 (-0.8, 1.9)

Skin And Subcutaneous Tissue Disorders

248 (7.3)

169 (6.2)

1.1 (-0.2, 2.3)

Social Circumstances

2 (0.1)

1 (0.0)

0.0 (-0.2, 0.2)

Surgical and Medical Procedures

3 (0.1)

1 (0.0)

0.1 (-0.1, 0.2)

Vascular Disorders

181 (5.3)

141 (5.2)

0.1 (-1.0, 1.2)

  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. For malignant tumors n (%): 31 (0.9%) in the sitagliptin group and 26 (1.0%) in the non-exposed group.