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) |