REXULTI Drug General Use-results Survey (Excessive Motor Activity or Physically/Verbally Aggressive Behavior Due to Rapid Changes in Mood, Irritability, and/or Outbursts Associated With Dementia Due to Alzheimer's Disease)

Safety Information (Adverse Event)

时间窗: 24 weeks from the initiation of brexpiprazole treatment

Any untoward medicinal occurrence in a patient or clinical study subject administered a Medicinal Product and which does not necessarily have a causal relationship with this treatment (ICH-E2A Guideline). An Adverse Event can therefore be any unfavorable and unintended sign (e.g. abnormal laboratory finding), symptom, or disease temporally associated with the use of a Medicinal Product (brexpiprazole), whether or not it is considered causally related to the Medicinal Product.

Safety Information (Special Situations)

时间窗: 24 weeks from the initiation of brexpiprazole treatment

Situations related to the use of an Otsuka product which may or may not be associated with an adverse event: -Maternal (pregnancy and breastfeeding) or paternal (via semen) exposure; -Exposure during breastfeeding; -Overdose/Incorrect dosage, misuse, abuse (e.g. patient sharing products); -Medication errors (e.g. patient took wrong dose); -Lack of therapeutic efficacy (e.g. the product doesn't work); -Occupational exposure (e.g.: nurse administering the product is exposed); -Cases of suspected transmission of infectious agents; -Use of suspected or confirmed falsified product(s) or quality defect of the product(s); -Withdrawal reactions; -Accidental exposure (e.g.: child takes parent's product); -Drug-drug/drug-food interactions; -Unintentional use of product in a non-approved population (e.g.: pediatric or geriatric population); -Disease progression/exacerbation of existing disease

Safety Information (Serious Adverse Event)

时间窗: 24 weeks from the initiation of brexpiprazole treatment

Any adverse drug experience/event occurring at any dose which -results in death -is life-threatening -requires inpatient hospitalization or prolonged of existing hospitalization -results in persistent or significant disability or incapacity -is a congenital anomaly/birth defect -is medically significant.

Safety Information (Number of off-Label Use)

时间窗: 24 weeks from the initiation of brexpiprazole treatment

Collecting any type of off-Label Use that refers to situations where a product is intentionally used for a medical purpose not in accordance with the authorized product information. Off-label use also includes the intentional use in non-authorized population categories not indicated in the label.

Safety Information (Non-serious Adverse Events)

时间窗: 24 weeks from the initiation of brexpiprazole treatment

All Adverse Events that do not meet the definition of a serious Adverse Event are considered non-serious Adverse Events.