Table 2. Adverse events.
Data are expressed in number (and percentage) of patients with adverse events.
| Event number of patients (%) |
AZP-531 N = 23 |
Placebo N = 24 |
|---|---|---|
| Any event | 14 (60.9) | 14 (58.3) |
| Related event | 8 (34.8) | 10 (41.7) |
| Events reported in >5% of the patients | ||
| Injection site erythema | 1 (4.3) | 2 (8.3) |
| Injection site hematoma | 3 (13.0) | 6 (25.0) |
| Injection site pruritus | 0 (0) | 2 (8.3) |
| Oropharyngeal pain | 0 (0) | 2 (8.3) |
| Somnolencea | 2 (8.7) | 0 (0) |
| Events reported in <5% of the patients | ||
| Ear pain | 1 (4.3) | 0 (0) |
| Vision blurred | 1 (4.3) | 0 (0) |
| Abdominal pain | 1 (4.3) | 0 (0) |
| Diarrhoea | 1 (4.3) | 0 (0) |
| Asthenia | 1 (4.3) | 0 (0) |
| Fatigue | 0 (0) | 1 (4.2) |
| Feeling cold | 1 (4.3) | 0 (0) |
| Hunger | 1 (4.3) | 0 (0) |
| Injection site pain | 1 (4.3) | 0 (0) |
| Injection site paresthesia | 1 (4.3) | 0 (0) |
| Malaise | 1 (4.3) | 0 (0) |
| Erysipelas | 1 (4.3) | 0 (0) |
| Gastroenteritis | 1 (4.3) | 0 (0) |
| Nasopharyngitis | 1 (4.3) | 0 (0) |
| Otitis Media | 1 (4.3) | 0 (0) |
| Pharyngitis | 0 (0) | 1 (4.2) |
| Rhinitis | 0 (0) | 1 (4.2) |
| Fall | 0 (0) | 1 (4.2) |
| Ligament sprain | 1 (4.3) | 0 (0) |
| Scratch | 1 (4.3) | 0 (0) |
| Blood TSH decreased | 0 (0) | 1 (4.2) |
| Hyperglycaemia | 1 (4.3) | 0 (0) |
| PICA | 1 (4.3) | 0 (0) |
| Arthralgia | 0 (0) | 1 (4.2) |
| Back pain | 0 (0) | 1 (4.2) |
| Pain in extremity | 0 (0) | 1 (4.2) |
| Torticollis | 1 (4.3) | 0 (0) |
| Dizziness | 1 (4.3) | 0 (0) |
| Headache | 1 (4.3) | 0 (0) |
| Anxiety | 1 (4.3) | 1 (4.2) |
| Nightmare | 1 (4.3) | 0 (0) |
| Polyuria | 1 (4.3) | 0 (0) |
| Ecchymosis | 0 (0) | 1 (4.2) |
| Pruritus | 1 (4.3) | 0 (0) |
aPatients who reported somnolence were 23 and 30 years old respectively.