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).