Table 8.
Drug-related treatment-emergent adverse events experienced by >5% of patients (safety analysis set).
| Drug-related TEAE occurring in >5% of patients, n (%) | ASP0113 (n = 246) |
Placebo (n = 255) |
||||||
|---|---|---|---|---|---|---|---|---|
| Total | Mild | Moderate | Severe | Total | Mild | Moderate | Severe | |
| Injection-site pain | 183 (74.4) | 120 (48.8) | 62 (25.2) | 1 (0.4) | 39 (15.3) | 38 (14.9) | 1 (0.4) | 0 |
| Injection-site erythema | 45 (18.3) | 39 (15.9) | 6 (2.4) | 0 | 4 (1.6) | 4 (1.6) | 0 | 0 |
| Injection-site induration | 36 (14.6) | 32 (13.0) | 4 (1.6) | 0 | 2 (0.8) | 2 (0.8) | 0 | 0 |
| Injection-site swelling | 24 (9.8) | 20 (8.1) | 4 (1.6) | 0 | 4 (1.6) | 4 (1.6) | 0 | 0 |
TEAE severity grading was according to MedDRA version 16.0, mild: grade 0–1; moderate: grade 2; and severe: grade 3. MedDRA=Medical Dictionary for Regulatory Activities; TEAE=treatment-emergent adverse event.