Table 1

Safety summary (safety analysis set)*

Dapagliflozin 5 mg (n = 277)Dapagliflozin 10 mg (n = 296)Placebo (n = 260)
AEs
 ≥1 AE215 (77.6)236 (79.7)189 (72.7)
 ≥1 AE related to study drug93 (33.6)97 (32.8)39 (15.0)
 AE leading to study discontinuation11 (4.0)13 (4.4)9 (3.5)
AE of special interest
 Genital infection43 (15.5)40 (13.5)8 (3.1)
 Urinary tract infection32 (11.6)16 (5.4)21 (8.1)
 Renal impairment/failure4 (1.4)2 (0.7)3 (1.2)
 Fractures4 (1.4)6 (2.0)8 (3.1)
 Hypotension/dehydration or hypovolemia03 (1.0)5 (1.9)
 Hypersensitivity15 (5.4)15 (5.1)6 (2.3)
 Cardiovascular events1 (0.4)2 (0.7)1 (0.4)
SAEs
 ≥1 SAE37 (13.4)40 (13.5)30 (11.5)
 ≥1 SAE related to study drug8 (2.9)13 (4.4)2 (0.8)
 SAE leading to study discontinuation5 (1.8)8 (2.7)3 (1.2)
Hypoglycemia
 ≥1 SAE of hypoglycemia3 (1.1)4 (1.4)3 (1.2)
 Hypoglycemia leading to study discontinuation1 (0.4)01 (0.4)
Ketone-related events
 ≥1 ketone-related SAE13 (4.7)13 (4.4)3 (1.2)
 Ketone-related SAE leading to study discontinuation2 (0.7)7 (2.4)0
Death001 (0.4)
  • Data are presented as n (%).

  • *Includes AE and SAE with onset on or after day 1 of the treatment period up to and 30 days after the last dose date in the treatment period.

  • †Includes urinary tract infections, cystitis, genitourinary tract infections, urogenital fungal infections, and pyelonephritis.