Table 2

Summary of AEs

Placebo
(n = 188)Empagliflozin
10 mg
(n = 186)25 mg
(n = 189)
One or more AEs169 (89.9)160 (86.0)160 (84.7)
One or more drug-related* AEs64 (34.0)56 (30.1)76 (40.2)
AEs leading to discontinuation9 (4.8)10 (5.4)9 (4.8)
One or more serious AEs22 (11.7)20 (10.8)22 (11.6)
Deaths0 (0)0 (0)1 (0.5)
AEs with frequency ≥5% in any group (by preferred term)
 Hypoglycemia111 (59.0)97 (52.2)110 (58.2)
 Nasopharyngitis40 (21.3)34 (18.3)27 (14.3)
 Urinary tract infection23 (12.2)24 (12.9)24 (12.7)
 Diarrhea17 (9.0)12 (6.5)18 (9.5)
 Back pain14 (7.4)12 (6.5)15 (7.9)
 Arthralgia10 (5.3)18 (9.7)11 (5.8)
 Influenza12 (6.4)7 (3.8)14 (7.4)
 Bronchitis12 (6.4)10 (5.4)8 (4.2)
 Headache9 (4.8)8 (4.3)11 (5.8)
 Hyperglycemia14 (7.4)6 (3.2)8 (4.2)
 Hypertension10 (5.3)9 (4.8)7 (3.7)
 Dizziness2 (1.1)5 (2.7)13 (6.9)
 Gastroenteritis10 (5.3)8 (4.3)1 (0.5)
Special interest categories
 Confirmed hypoglycemic AEs109 (58.0)95 (51.1)109 (57.7)
  Severe hypoglycemic AEs3 (1.6)3 (1.6)1 (0.5)
 Events consistent with urinary tract infection§29 (15.4)29 (15.6)29 (15.3)
  Male0 (0)5 (5.2)3 (3.6)
  Female29 (25.7)24 (27.0)26 (24.8)
  Acute pyelonephritis or urosepsis0 (0)0 (0)0 (0)
 Events consistent with genital infectionΠ3 (1.6)8 (4.3)18 (9.5)
  Male1 (1.3)1 (1.0)7 (8.3)
  Female2 (1.8)7 (7.9)11 (10.5)
  • Data are n (%) for patients treated with ≥1 dose of trial medication.

  • *As assessed by the investigator.

  • †AEs consistent with hypoglycemia and with plasma glucose ≤70 mg/dL and/or requiring assistance.

  • ‡AEs consistent with hypoglycemia and with plasma glucose ≤70 mg/dL and requiring assistance.

  • §Reports of urinary tract infection were based on 70 preferred terms.

  • ΠReports of genital infection were based on 89 preferred terms.