Table 3

Summary of adverse events over 24 weeks

Placebo
(N = 109)Dapagliflozin
10 mg/day
(N = 109)
≥1 Adverse event56 (51.4)53 (48.6)
Adverse events leading to discontinuation3 (2.8)2 (1.8)
≥1 Serious adverse event6 (5.5)1 (0.9)
Deaths00
Treatment-related adverse events8 (7.3)18 (16.5)
Hypoglycemia*4 (3.7)14 (12.8)
Adverse events with frequency ≥3% in any group (by MedDRA preferred term)
 Bronchitis1 (0.9)5 (4.6)
 Urinary tract infection**7 (6.4)5 (4.6)
 Hypertension4 (3.7)1 (0.9)
Adverse events of special interest
 Patients experiencing events of genital infection06 (5.5)
  Men0/601/46 (2.2)
  Women0/495/63 (7.9)
 Patients experiencing events of urinary tract infection7 (6.4)7 (6.4)
  Men1/60 (1.7)3/46 (6.5)
  Women6/49 (12.2)4/63 (6.3)
 Renal impairment/failure02 (1.8)
 Orthostatic hypotension01 (0.9)
 Elevated liver tests01 (0.9)
  Elevated bilirubin >2× upper limit of normal01 (0.9)
  • Data are n (%). N is the number of patients in the safety analysis set.

  • * No major episodes of hypoglycemia were reported.

  • ** Events based on most common MedDRA preferred terms.

  • Reports were based on a predefined list of MedDRA terms.

  • All events of renal impairment/failure were decreased renal creatinine clearance.