Table 2 Safety and tolerability: treatment-emergent AEs and summary of safety measures at post-treatment (day 1)
From: Psilocybin therapy for females with anorexia nervosa: a phase 1, open-label feasibility study
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%) |
