Table 3

Treatment-emergent AEs reported in >3% of all LX4211-treated patients, regardless of causality, and AEs of special interest

System organ classLX4211Placebo (N = 60)Total (N = 296)
75 mg once daily (N = 57)200 mg once daily (N = 60)200 mg twice daily (N = 60)400 mg once daily (N = 59)
Number of patients with at least one TEAE38 (66.7)36 (60.0)37 (61.7)34 (57.6)40 (66.7)185 (62.5)
Infections and infestations
 Upper respiratory tract infection2 (3.5)2 (3.3)3 (5.0)1 (1.7)3 (5.0)11 (3.7)
 Nasopharyngitis4 (7.0)2 (3.3)1 (1.7)2 (3.4)1 (1.7)10 (3.4)
 Sinusitis3 (5.3)3 (5.0)01 (1.7)1 (1.7)8 (2.7)
GI disorders
 Diarrhea2 (3.5)6 (10.0)4 (6.7)5 (8.5)4 (6.7)21 (7.1)
 Nausea5 (8.8)3 (5.0)2 (3.3)6 (10.2)3 (5.0)19 (6.4)
 Constipation1 (1.8)5 (8.3)1 (1.7)1 (1.7)4 (6.7)12 (4.1)
Nervous system disorders
 Headache6 (10.5)6 (10.0)2 (3.3)3 (5.1)1 (1.7)18 (6.1)
AEs of special interest
 GU events*
  Vulvovaginal mycotic infection01 (1.7)1 (1.7)1 (1.7)03 (1.0)
  Vaginal infection01 (1.7)01 (1.7)02 (0.7)
  Vaginitis bacterial001 (1.7)001 (0.3)
  Vulvovaginal candidiasis0001 (1.7)01 (0.3)
  Vulvovaginitis01 (1.7)0001 (0.3)
  Urinary tract infection1 (1.8)1 (1.7)1 (1.7)1 (1.7)1 (1.7)4 (1.4)
 GU events in female patients  [n = female patients]1 (4.0) [25]3 (7.0) [43]3 (9.7) [31]3 (9.7) [31]1 (2.9) [34]11 (6.5) [164]
 Hypoglycemia000000
  • Data are n (%) unless otherwise noted.

  • * Each incidence of vaginal infection represents one patient each (n = 8).