Specified Drug Use Survey on AJOVY Subcutaneous Injection for Long-term Use

Study Overview
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Brief Summary
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To evaluate the long-term safety of AJOVY in patients under actual use conditions and to specifically evaluate cardiovascular events. In addition, information on efficacy will be collected.

Official Title
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AJOVY Subcutaneous Injection Long-term Specified Use-results Survey

Conditions
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Migraine Disorders

Intervention / Treatment
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* Drug: Fremanezumab 225 Mg/1.5 mL Subcutaneous Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Exclusion Criteria: patients with a known hypersensitivity to components of AJOVY

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Drug<br>Ajovy syringe for SC injection 225 mg. | Drug: Fremanezumab 225 Mg/1.5 mL Subcutaneous Solution<br>* The usual adult dose is 225 mg of fremanezumab (genetical recombination) administered subcutaneously as a single dose once every 4 weeks or 675 mg administered subcutaneously as a single dose once every 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety information (Adverse Event) | 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 (see Annex Ⅳ, 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, whether or not it is considered causally related to the Medicinal Product. | 2 years from the start date of treatment | 
| Number of Special Situations | Collecting any 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 | 2 years from the start date of treatment | 
| Number of off-Label Use | 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. | 2 years from the start date of treatment | 
| Incidence of Serious Adverse Event (e.g. resulting in death or life-threatening) | Collecting the number of 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. | 2 years from the start date of treatment | 
| Incidence of Non-serious Adverse Events (i.e. all Adverse Events that do not meet the definition of a serious Adverse Event) | Collecting the number of non-serious Adverse Events | 2 years from the start date of treatment |