Specified Drug Use Survey on AJOVY Subcutaneous Injection for Long-term Use
- Conditions
- Migraine Disorders
- Interventions
- Registration Number
- NCT05342493
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- patients with a known hypersensitivity to components of AJOVY
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Drug Fremanezumab 225 Mg/1.5 mL Subcutaneous Solution Ajovy syringe for SC injection 225 mg.
- Primary Outcome Measures
Name Time Method Safety information (Adverse Event) 2 years from the start date of 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 (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.Number of Special Situations 2 years from the start date of treatment 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 diseaseNumber of off-Label Use 2 years from the start date of 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.
Incidence of Serious Adverse Event (e.g. resulting in death or life-threatening) 2 years from the start date of treatment 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.Incidence of Non-serious Adverse Events (i.e. all Adverse Events that do not meet the definition of a serious Adverse Event) 2 years from the start date of treatment Collecting the number of non-serious Adverse Events
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pharmacovigilance Department
🇯🇵Osaka, Japan