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Table 2 Safety summary (pool of DM-INSULIN and DM-DYSLIPIDEMIA; safety population)

From: Alirocumab therapy in individuals with type 2 diabetes mellitus and atherosclerotic cardiovascular disease: analysis of the ODYSSEY DM-DYSLIPIDEMIA and DM-INSULIN studies

n (%)Alirocumab (n = 213)Control (n = 104)
TEAEs142 (66.7)70 (67.3)
Treatment-emergent SAEs28 (13.1)10 (9.6)
TEAEs leading to death1 (0.5)1 (1.0)
TEAEs occurring in ≥ 2% of individuals by preferred term
 Urinary tract infection8 (3.8)6 (5.8)
 Diarrhea8 (3.8)6 (5.8)
 Hypertension8 (3.8)4 (3.8)
 Influenza7 (3.3)4 (3.8)
 Headache7 (3.3)1 (1.0)
 Musculoskeletal pain7 (3.3)3 (2.9)
 Nasopharyngitis6 (2.8)5 (4.8)
 Back pain6 (2.8)2 (1.9)
 Dizziness6 (2.8)3 (2.9)
 Fatigue5 (2.3)3 (2.9)
 Cataract5 (2.3)1 (1.0)
 Myalgia5 (2.3)1 (1.0)
 Nausea4 (1.9)3 (2.9)
 Pain in extremity4 (1.9)3 (2.9)
 Arthralgia3 (1.4)3 (2.9)
 Bronchitis3 (1.4)3 (2.9)
 Hypotension2 (0.9)3 (2.9)
 Cough1 (0.5)3 (2.9)
 Hyperglycemia0 (0.0)3 (2.9)
  1. SAE serious adverse event, TEAE treatment-emergent adverse event