A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs with an onset date on or after the first dose of brexpiprazole. They are all adverse events that started after start of brexpiprazole; or if the event was continuous from baseline and was worsening, serious, study drug-related, or resulted in death, discontinuation, interruption, or reduction of study therapy. Adverse events were graded on a 3-point scale. The intensity of an adverse experience was defined as follows: 1 = Mild: Discomfort noticed, but no disruption to daily activity, 2 = Moderate: Discomfort sufficient to reduce or affect normal daily activity, and 3 = Severe: Inability to work or perform normal daily activity.

Time frame: From first dose through 30 days after last dose of study drug (Up to approximately Week 16)

Population: Safety Sample comprised of those participants who signed an informed consent form (ICF) for the trial and received at least one dose of brexpiprazole in Trial 331-201-00182. As prespecified in the SAP, data was analyzed based on the treatments (Brexpiprazole or Placebo) received in parent study 331-14-213. Participants received brexpiprazole 2 or 3 mg or placebo in the parent study, data for this study was analyzed and reported in a combined way for brexpiprazole 2 and 3 mg.