Treatment-emergent AEs reported in >3% of all LX4211-treated patients, regardless of causality, and AEs of special interest
System organ class | LX4211 | Placebo (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 TEAE | 38 (66.7) | 36 (60.0) | 37 (61.7) | 34 (57.6) | 40 (66.7) | 185 (62.5) |
Infections and infestations | ||||||
Upper respiratory tract infection | 2 (3.5) | 2 (3.3) | 3 (5.0) | 1 (1.7) | 3 (5.0) | 11 (3.7) |
Nasopharyngitis | 4 (7.0) | 2 (3.3) | 1 (1.7) | 2 (3.4) | 1 (1.7) | 10 (3.4) |
Sinusitis | 3 (5.3) | 3 (5.0) | 0 | 1 (1.7) | 1 (1.7) | 8 (2.7) |
GI disorders | ||||||
Diarrhea | 2 (3.5) | 6 (10.0) | 4 (6.7) | 5 (8.5) | 4 (6.7) | 21 (7.1) |
Nausea | 5 (8.8) | 3 (5.0) | 2 (3.3) | 6 (10.2) | 3 (5.0) | 19 (6.4) |
Constipation | 1 (1.8) | 5 (8.3) | 1 (1.7) | 1 (1.7) | 4 (6.7) | 12 (4.1) |
Nervous system disorders | ||||||
Headache | 6 (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 infection | 0 | 1 (1.7) | 1 (1.7) | 1 (1.7) | 0 | 3 (1.0) |
Vaginal infection | 0 | 1 (1.7) | 0 | 1 (1.7) | 0 | 2 (0.7) |
Vaginitis bacterial | 0 | 0 | 1 (1.7) | 0 | 0 | 1 (0.3) |
Vulvovaginal candidiasis | 0 | 0 | 0 | 1 (1.7) | 0 | 1 (0.3) |
Vulvovaginitis | 0 | 1 (1.7) | 0 | 0 | 0 | 1 (0.3) |
Urinary tract infection | 1 (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] |
Hypoglycemia | 0 | 0 | 0 | 0 | 0 | 0 |
Data are n (%) unless otherwise noted.
↵* Each incidence of vaginal infection represents one patient each (n = 8).