Table 3.
Adverse events (AEs) in all patients who received at least one dose of the study drug (TAS5315 or placebo) in part A
| AEs, n (%) | TAS5315 | Placebo (n=33) |
||
| 4 mg (n=29) | 2 mg (n=29) | Combined (n=58) | ||
| Any AE | 12 (41.4) | 13 (44.8) | 25 (43.1) | 19 (57.6) |
| AEs of special interest | 1 (3.4) | 2 (6.9) | 3 (5.2) | 1 (3.0) |
| Any drug-related AE | 1 (3.4) | 2 (6.9) | 3 (5.2) | 3 (9.1) |
| AE by severity category | ||||
| Mild AEs | 3 (10.3) | 4 (13.8) | 7 (12.1) | 6 (18.2) |
| Moderate AEs | 9 (31.0) | 9 (31.0) | 18 (31.0) | 12 (36.4) |
| Severe AEs | 0 | 0 | 0 | 1 (3.0) |
| Any serious AE | 0 | 0 | 0 | 1 (3.0) |
| Discontinuation due to AEs | 1 (3.4) | 0 | 1 (1.7) | 3 (9.1) |
| AEs leading to death | 0 | 0 | 0 | 0 |
| AEs occurring in ≥5% of patients in any group | ||||
| Bronchitis | 0 | 1 (3.4) | 1 (1.7) | 2 (6.1) |
| Cystitis | 1 (3.4) | 2 (6.9) | 3 (5.2) | 0 |
| Nasopharyngitis | 3 (10.3) | 3 (10.3) | 6 (10.3) | 4 (12.1) |
| Pruritus | 2 (6.9) | 2 (6.9) | 4 (6.9) | 0 |