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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.