Table 2.
Adverse events in SAD cohorts. Those TEAEs that occurred in more than one cohort in the SAD study are listed
| MedDRA Preferred Term | Placebo | BAN2401 (mg/kg) | ||||||
|---|---|---|---|---|---|---|---|---|
| (N = 12) (%) | 0.1 (N = 6) (%) | 0.3 (N = 6) (%) | 1 (N = 6) (%) | 3 (N = 6) (%) | 10 (N = 6) (%) | 15 (N = 6) (%) | Total (N = 36) (%) | |
| Subjects with any TEAE | 8 (66.7) | 6 (100.0) | 1 (16.7) | 3 (50.0) | 3 (50.0) | 2 (33.3) | 5 (83.3) | 20 (55.6) |
| Dizziness | 1 (8.3) | 2 (33.3) | 0 | 1 (16.7) | 0 | 0 | 0 | 3 (8.3) |
| Fatigue | 1 (8.3) | 0 | 0 | 0 | 0 | 0 | 2 (33.3) | 2 (5.6) |
| Sinusitis | 0 | 1 (16.7) | 0 | 0 | 1 (16.7) | 0 | 0 | 2 (5.6) |
| Asymptomatic ARIA-H | 0 | 0 | 1 (16.7) | 1 (16.7) | 0 | 0 | 0 | 2 (5.6) |
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