Table 5.
Most Common Adverse Events (>3%)
| TEAE | ADR | |||
|---|---|---|---|---|
| Adverse Event | ONO‐4474 | Placebo | ONO‐4474 | Placebo |
| SOC, Preferred Terma | (n = 55) | (n = 55) | (n = 55) | (n = 55) |
| Gastrointestinal disorders | ||||
| Constipation | 2 (3.6) | – | 2 (3.6) | – |
| Dyspepsia | – | 2 (3.6) | – | 2 (3.6) |
| Infections and infestations | ||||
| Viral upper respiratory tract infection | 3 (5.5) | 1 (1.8) | – | – |
| Investigations | ||||
| Blood urine present | 1 (1.8) | 2 (3.6) | 1 (1.8) | 2 (3.6) |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 3 (5.5) | 1 (1.8) | 2 (3.6) | 1 (1.8) |
| Myalgia | 4 (7.3) | – | 4 (7.3) | – |
| Nervous system disorders | ||||
| Dizziness | 2 (3.6) | – | 2 (3.6) | – |
| Hypoesthesia | 2 (3.6) | 1 (1.8) | 2 (3.6) | 1 (1.8) |
| Skin and subcutaneous tissue disorders | ||||
| Rash | 2 (3.6) | – | 2 (3.6) | – |
ADR, adverse drug reaction; SOC, system organ class; TEAE, treatment‐emergent adverse event.
a
Medical Dictionary for Regulatory Activities, Japanese Translation, version 20.0.