Table 3.
Adverse events in MAD cohorts. Those TEAEs that occurred in more than one cohort in the MAD study are listed
| 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) |
For each row category, a subject with 2 or more TEAEs with the same PT in that category was counted only once. A TEAE is defined as an AE which started after first dose and within 90 days of last dose.
AE adverse event, MAD multiple ascending dose, MedDRA Medical Dictionary for Regulatory Activities, PT preferred term, SAD single ascending dose, TEAE treatment emergent adverse event