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Table 3 Summary of clinical AEs and hypoglycemia (treated set)

From: Efficacy and safety of linagliptin in type 2 diabetes subjects at high risk for renal and cardiovascular disease: a pooled analysis of six phase III clinical trials

% Subjects Linagliptin 5 mg (n = 366) Placebo (n = 146)
Clinical AEs   
Any AE 62.6 62.3
Investigator-defined drug-related AE 10.4 8.2
Any AEs classified by system organ class*   
  Gastrointestinal disorders 11.5 15.8
  Infections and infestations 21.6 22.6
  Nasopharyngitis 5.7 4.8
  Injury, poisoning and procedural complications 7.4 8.2
  Metabolism and nutrition disorders 21.0 20.5
  Musculoskeletal and connective tissue disorders 11.2 11.0
  Nervous system disorders 8.2 12.3
  Respiratory, thoracic and mediastinal disorders 4.6 5.5
  Vascular disorders 7.1 4.8
  AEs leading to study drug discontinuation 1.4 3.4
  Serious AEs 4.1 6.2
Deaths 0.0 0.0
Hypoglycemia   
Subjects with hypoglycemia 9.3 2.1
Subjects with hypoglycemia by study   
  Studies without sulfonylurea 0.5 0.0
  Studies with sulfonylurea§ 19.8 5.9
Severe hypoglycemia 0.3 0.0
  1. *Medical Dictionary for Regulatory Activities, version 14.0.
  2. Individual AEs (preferred terms; %) were accelerated hypertension (linagliptin 0.0, placebo 0.7), arteriosclerosis (linagliptin 0.5, placebo 0.0), hypertension (linagliptin 5.2, placebo 4.1), hypertensive crisis (linagliptin 1.1, placebo 0.0), temporal arteritis (linagliptin 0.3, placebo 0.0). 2 of these events were considered drug-related (2 cases of hypertension; 1 with linagliptin and 1 with placebo).
  3. Linagliptin, n = 199; placebo, n = 95.
  4. §Linagliptin, n = 167; placebo, n = 51.
  5. Event requiring assistance of another person to actively administer carbohydrate, glucagon or other resuscitation.