Table 2.
Summary of safety and TEAEs by MedDRA, SOC and PT
| MEDI0382 (n = 6 per cohort) | Pooled MEDI0382 (n = 36) | Pooled placebo (n = 12) | ||||||
|---|---|---|---|---|---|---|---|---|
| 5 μg | 10 μg | 30 μg | 100 μg | 150 μg | 300 μg | |||
| TEAEs, n (%) | 2 (33.3) | 3 (50.0) | 4 (66.7) | 2 (33.3) | 5 (83.3) | 5 (83.3) | 21 (58.3) | 2 (16.7) |
| TEAEs by SOC and PT, n (%) | ||||||||
| Cardiac disorders | 0 | 1 (16.7) | 0 | 1 (16.7) | 0 | 1 (16.7) | 3 (8.3) | 0 |
| Arrhythmia | 0 | 0 | 0 | 1 (16.7) | 0 | 0 | 1 (2.8) | 0 |
| AV block, second degree | 0 | 1 (16.7) | 0 | 0 | 0 | 0 | 1 (2.8) | 0 |
| Ventricular extrasystoles | 0 | 0 | 0 | 0 | 0 | 1 (16.7) | 1 (2.8) | 0 |
| GI disorders | 0 | 1 (16.7) | 0 | 1 (16.7) | 5 (83.3) | 5 (83.3) | 12 (33.3) | 1 (8.3) |
| Abdominal distension | 0 | 0 | 0 | 0 | 2 (33.3) | 0 | 2 (5.6) | 0 |
| Abdominal pain | 0 | 1 (16.7) | 0 | 0 | 0 | 0 | 1 (2.8) | 0 |
| Diarrhoea | 0 | 1 (16.7) | 0 | 0 | 0 | 0 | 1 (2.8) | 0 |
| Nausea | 0 | 0 | 0 | 1 (16.7) | 4 (66.7) | 3 (50.0) | 8 (22.2) | 1 (8.3) |
| Vomiting | 0 | 0 | 0 | 1 (16.7) | 4 (66.7) | 5 (83.3) | 10 (27.8) | 0 |
| General disorders and administration site conditions | 0 | 0 | 1 (16.7) | 0 | 0 | 1 (16.7) | 2 (5.6) | 0 |
| Application site erosion | 0 | 0 | 1 (16.7) | 0 | 0 | 0 | 1 (2.8) | 0 |
| Device‐associated injury | 0 | 0 | 0 | 0 | 0 | 1 (16.7) | 1 (2.8) | 0 |
| Immune system disorders | 0 | 0 | 1 (16.7) | 0 | 0 | 0 | 1 (2.8) | 0 |
| Seasonal allergies | 0 | 0 | 1 (16.7) | 0 | 0 | 0 | 1 (2.8) | 0 |
| Infections and infestations | 1 (16.7) | 0 | 0 | 0 | 0 | 0 | 1 (2.8) | 1 (8.3) |
| Nasopharyngitis | 1 (16.7) | 0 | 0 | 0 | 0 | 0 | 1 (2.8) | 1 (8.3) |
| Injury, poisoning, and procedural complications | 0 | 0 | 0 | 1 (16.7) | 0 | 0 | 0 | 1 (2.8) |
| Procedural dizziness | 0 | 0 | 0 | 1 (16.7) | 0 | 0 | 0 | 1 (2.8) |
| Musculoskeletal and connective tissue disorders | 0 | 0 | 1 (16.7) | 0 | 0 | 0 | 1 (2.8) | 0 |
| Musculoskeletal chest pain | 0 | 0 | 1 (16.7) | 0 | 0 | 0 | 1 (2.8) | 0 |
| Nervous system disorders | 1 (16.7) | 1 (16.7) | 1 (16.7) | 1 (16.7) | 2 (33.3) | 1 (16.7) | 7 (19.4) | 0 |
| Dizziness | 0 | 1 (16.7) | 1 (16.7) | 0 | 2 (33.3) | 1 (16.7) | 5 (13.9) | 0 |
| Headache | 1 (16.7) | 0 | 1 (16.7) | 1 (16.7) | 1 (16.7) | 0 | 4 (11.1) | 0 |
| Respiratory, thoracic, and mediastinal disorders | 0 | 0 | 0 | 0 | 1 (16.7) | 0 | 1 (2.8) | 0 |
| Oropharyngeal pain | 0 | 0 | 0 | 0 | 1 (16.7) | 0 | 1 (2.8) | 0 |
AV, atrioventricular; GI, gastrointestinal; MedDRA, Medical Dictionary for Regulatory Activities; PT, preferred term; SOC, systems organ class; TEAE, treatment‐emergent adverse event