MedDRA Preferred Term | Placebo | BAN2401 (mg/kg) | ||||
---|---|---|---|---|---|---|
(N = 12) (%) | 0.3 (N = 6) (%) | 1 (N = 6) (%) | 3 (N = 6) (%) | 10 (N = 6) (%) | Total (N = 36) (%) | |
Subjects with any TEAE | 6 (75.0) | 4 (66.7) | 3 (50.0) | 4 (66.7) | 4 (66.7) | 15 (62.5) |
Upper respiratory tract infection | 1 (12.5) | 2 (33.3) | 0 | 0 | 2 (33.3) | 4 (16.7) |
Headache | 2 (25.0) | 1 (16.7) | 0 | 1 (16.7) | 1 (16.7) | 3 (12.5) |
Orthostatic hypotension | 0 | 1 (16.7) | 0 | 2 (33.3) | 0 | 3 (12.5) |
Nausea | 0 | 0 | 0 | 1 (16.7) | 1 (16.7) | 2 (8.3) |
Procedural pain | 0 | 1 (16.7) | 0 | 0 | 1 (16.7) | 2 (8.3) |
Sinusitis | 0 | 0 | 1 (16.7) | 1 (16.7) | 0 | 2 (8.3) |
Somnolence | 0 | 1 (16.7) | 0 | 0 | 1 (16.7) | 2 (8.3) |
Urinary tract infection | 0 | 0 | 0 | 1 (16.7) | 1 (16.7) | 2 (8.3) |
Vomiting | 0 | 0 | 0 | 0 | 2 (33.3) | 2 (8.3) |