Table 2.
Summary of treatment-emergent adverse events
| Fasiglifam, n (%) | |||
|---|---|---|---|
| Placebo, n (%) | 25 mg | 50 mg | |
| Number of participants | 67 | 63 | 62 |
| Patients with any TEAEs | 40 (59.7) | 37 (58.7) | 35 (56.5) |
| Patients with any TEAEs: mild | 35 (52.2) | 31 (49.2) | 35 (56.5) |
| Patients with any TEAEs: moderate | 5 (7.5) | 6 (9.5) | 0 |
| Patients with any TEAEs: severe | 0 | 0 | 0 |
| Patients with any treatment-related TEAEs | 4 (6.0) | 4 (6.3) | 9 (14.5) |
| Patients with any TEAEs leading to drug discontinuation | 3 (4.5) | 2 (3.2) | 1 (1.6) |
| Patients with any treatment-emergent serious AEs | 1 (1.5) | 2 (3.2) | 0 |
| Deaths | 0 | 0 | 0 |
| Patients with any TEAEs and a frequency of at least 5% in any group | |||
| Nasopharyngitis | 11 (16.4) | 11 (17.5) | 9 (14.5) |
| Upper respiratory tract inflammation | 1 (1.5) | 5 (7.9) | 5 (8.1) |
| Patients with any treatment-related TEAEs | |||
| Lymphadenopathy | 1 (1.5) | 0 | 0 |
| Constipation | 1 (1.5) | 0 | 0 |
| Feeling abnormal | 0 | 0 | 1 (1.6) |
| Hepatic function abnormal | 0 | 1 (1.6) | 1 (1.6) |
| Cholelithiasis | 0 | 0 | 1 (1.6) |
| Bronchitis | 0 | 0 | 1 (1.6) |
| Increased alanine aminotransferase | 0 | 1 (1.6) | 3 (4.8) |
| Increased aspartate aminotransferase | 0 | 1 (1.6) | 0 |
| Blood creatine phosphokinase increased | 0 | 1 (1.6) | 0 |
TEAEs are listed in order of severity. Each participant was counted only once by maximum severity of Preferred Term or System Organ Class. AE, adverse event; TEAE, treatment-emergent AE.