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Table 3 Adverse events

From: Safety, tolerability and effects on cardiometabolic risk factors of empagliflozin monotherapy in drug-naïve patients with type 2 diabetes: a double-blind extension of a Phase III randomized controlled trial

  Placebo
(n = 229)
Empagliflozin
10 mg
(n = 224)
Empagliflozin
25 mg
(n = 223)
Sitagliptin
100 mg
(n = 223)
Any adverse event n (%) 175 (76.4) 172 (76.8) 174 (78.0) 161 (72.2)
Drug-relateda
adverse events n (%)
36 (15.7) 49 (21.9) 52 (23.3) 31 (13.9)
Discontinuation due to adverse events n (%) 15 (6.6) 11 (4.9) 9 (4.0) 11 (4.9)
Severe adverse events n (%) 14 (6.1) 17 (7.6) 15 (6.7) 17 (7.6)
Serious adverse events n (%) 23 (10.0) 25 (11.2) 16 (7.2) 18 (8.1)
 Deaths 1 (0.4) 0 (0.0) 0 (0.0) 1 (0.4)
Adverse events with frequency of ≥5 % in any group (by preferred term) n (%)
 Hyperglycaemia 63 (27.5) 20 (8.9) 11 (4.9) 28 (12.6)
 Nasopharyngitis 27 (11.8) 32 (14.3) 25 (11.2) 27 (12.1)
 Urinary tract infection 21 (9.2) 20 (8.9) 14 (6.3) 18 (8.1)
 Upper respiratory tract infection 12 (5.2) 17 (7.6) 16 (7.2) 19 (8.5)
 Dyslipidaemia 15 (6.6) 16 (7.1) 14 (6.3) 14 (6.3)
 Back pain 12 (5.2) 7 (3.1) 7 (3.1) 19 (8.5)
 Hypertension 13 (5.7) 11 (4.9) 5 (2.2) 14 (6.3)
 Bronchitis 10 (4.4) 11 (4.9) 6 (2.7) 12 (5.4)
 Diarrhoea 9 (3.9) 12 (5.4) 6 (2.7) 8 (3.6)
Special interest categories n (%)
 Confirmed hypoglycaemiab 2 (0.9) 2 (0.9) 2 (0.9) 2 (0.9)
  Events requiring assistance 0 (0.0) 1 (0.4) 0 (0.0) 0 (0.0)
 Events consistent with urinary tract infectionc 25 (10.9) 21 (9.4) 20 (9.0) 20 (9.0)
  Male 4 (3.2) 4 (2.8) 4 (2.8) 6 (4.3)
  Female 21 (20.0) 17 (20.7) 16 (20.3) 14 (17.1)
 Events consistent with genital infectiond 4 (1.7) 13 (5.8) 14 (6.3) 2 (0.9)
  Male 2 (1.6) 4 (2.8) 4 (2.8) 1 (0.7)
  Female 2 (1.9) 9 (11.0) 10 (12.7) 1 (1.2)
 Events consistent with volume depletione 1 (0.4) 6 (2.7) 2 (0.9) 3 (1.3)
  1. Data from the treated set
  2. aAs reported by the investigator
  3. bPlasma glucose ≤3.9 mmol/l and/or requiring assistance
  4. cBased on 77 preferred terms
  5. dBased on 89 preferred terms
  6. eBased on eight preferred terms