Table 3

Summary of AEs

Placebo10 mg empagliflozin25 mg empagliflozin
n272276276
≥1 AEs143 (52.6)135 (48.9)142 (51.4)
≥1 drug-related AEs*21 (7.7)55 (19.9)54 (19.6)
≥1 AEs leading to discontinuation5 (1.8)4 (1.4)6 (2.2)
≥1 serious AEs7 (2.6)3 (1.1)4 (1.4)
Deaths01 (0.4)0
AEs with frequency of ≥5% in any group (by preferred term)
 Nasopharyngitis26 (9.6)15 (5.4)20 (7.2)
 Hypoglycemia14 (5.1)19 (6.9)19 (6.9)
 Pollakiuria7 (2.6)11 (4.0)17 (6.2)
 Thirst1 (0.4)2 (0.7)15 (5.4)
Special interest categories
 Hypoglycemia13 (4.8)18 (6.5)17 (6.2)
  Events requiring assistance000
 Events consistent with UTI§10 (3.7)11 (4.0)13 (4.7)
  Male1 (0.6)1 (0.6)4 (2.6)
  Female9 (8.7)10 (9.5)9 (7.4)
 Events consistent with genital infection**1 (0.4)14 (5.1)15 (5.4)
  Male1 (0.6)8 (4.7)6 (3.9)
  Female06 (5.7)9 (7.4)
 Events consistent with volume depletion1 (0.4)1 (0.4)0
 Positive orthostatic BP test#
  At baseline42/254 (16.5)40/259 (15.4)51/259 (19.7)
  At week 1251/254 (20.1)67/259 (25.9)76/259 (29.3)
  • Data are n (%) or n/N (%) for patients receiving ≥1 dose of study drug.

  • * As assessed by the investigator.

  • Reported by investigators using MedDRA-preferred term “hypoglycemia.” 

  • Events consistent with hypoglycemia and plasma glucose ≤3.9 mmol/L and/or requiring assistance.

  • § Based on 70 preferred terms.

  • ** Based on 89 preferred terms.

  • Based on eight preferred terms.

  • # Patients with a positive orthostatic BP test/patients who had an orthostatic BP measurement at baseline and week 12 (%).