Table 2.
Safety outcomes up to week 12
| Incidence, n (%) | Placebo N = 21 | Licogliflozin 30 mg N = 43 |
Licogliflozin 150 mg N = 43 |
|---|---|---|---|
| Number of patients with at least 1 AE | 18 (85.7) | 31 (72.1) | 36 (83.7) |
| Number of patients with at least 1 SAE | 1 (4.8)a | 0 | 0 |
| AEs leading to discontinuation of study treatment | 1 (4.8) | 1 (2.3) | 1 (2.3) |
| Study-drug-related AEs leading to discontinuation of study treatment | 0 | 1 (2.3) | 1 (2.3) |
| Most frequent AEs with incidence ≥5% in any arm | |||
| Diarrhea | 9 (42.9) | 21 (48.8) | 33 (76.7) |
| Flatulence | 2 (9.5) | 2 (4.7) | 8 (18.6) |
| Headache | 3 (14.3) | 2 (4.7) | 5 (11.6) |
| Nausea | 3 (14.3) | 4 (9.3) | 3 (7.0) |
| Vomiting | 2 (9.5) | 5 (11.6) | 2 (4.7) |
| Abdominal pain | 2 (9.5) | 1 (2.3) | 5 (11.6) |
| Abdominal distension | 0 | 2 (4.7) | 6 (14.0) |
| Dizziness | 3 (14.3) | 0 | 4 (9.3) |
| Constipation | 1 (4.8) | 2 (4.7) | 3 (7.0) |
| Upper abdominal pain | 2 (9.5) | 0 | 3 (7.0) |
| Fatigue | 0 | 2 (4.7) | 3 (7.0) |
| Influenza | 0 | 4 (9.3) | 0 |
| Nasopharyngitis | 1 (4.8) | 0 | 3 (7.0) |
| Upper respiratory-tract infection | 1 (4.8) | 3 (7.0) | 0 |
| Muscle spasm | 2 (9.5) | 0 | 1 (2.3) |
a
One event of viral gastroenteritis.
SAEs, serious adverse events.