Skip to main content

Advertisement

Table 3 Adverse events in MAD cohorts. Those TEAEs that occurred in more than one cohort in the MAD study are listed

From: Safety and tolerability of BAN2401 - a clinical study in Alzheimer’s disease with a protofibril selective Aβ antibody

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)
  1. 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.
  2. 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