Table 2.
Safety and tolerability: treatment-emergent AEs and summary of safety measures at post-treatment (day 1)
| Treatment-emergent AEs | |
|---|---|
| MedDRA preferred term | COMP360 25 mg n = 10 (%) |
| Headache | 8 (80%) |
| Fatigue | 7 (70%) |
| Nausea | 3 (30%) |
| Feeling abnormal | 2 (20%) |
| Migraine | 2 (20%) |
| Dizziness | 2 (20%) |
| Illusion | 2 (20%) |
| Pain | 1 (10%) |
| Anxiety | 1 (10%) |
| Orthostatic heart rate response increased | 1 (10%) |
| Abdominal pain upper | 1 (10%) |
| Safety assessments | |
| Clinically significant changes in clinical laboratory tests | |
| Hypoglycemia | 2 (20%) |
| Clinically significant changes in ECG | 0 (0%) |
| Clinically significant changes in vital signs | 0 (0%) |
| Clinically significant increases in C-SSRS | 0 (0%) |
COMP360, psilocybin.