To investigate intends to evaluate the incidence of adverse drug reactions (ADRs) in individuals who receive Evusheld in clinical practice to determine its post-marketing safety profile in Japanese.
To investigate intends to evaluate the incidence of adverse drug reactions (ADRs) in individuals who receive Evusheld in clinical practice to determine its post-marketing safety profile in Japanese. The investigation will be conducted as the addtional pharmacovigilance activitiy specified in the Japan Risk Management Plan (J-RMP) of Evusheld in compliance with the Ministerial Ordinance on Good Post-marketing Study Practice (GPSP Ordinance) and for the purpose of application for re-examination under Article 14-4 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act).
Study Type
OBSERVATIONAL
Enrollment
366
Research Site
Aichi, Japan
Research Site
Chiba, Japan
Research Site
Fukuoka, Japan
Incidence of ADRs
The incidence of ADRs related to Evusheld Safety Specification; anaphylaxis and other serious allergic reactions, cardiovascular events
Time frame: 24weeks(6 months)
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Research Site
Fukushima, Japan
Research Site
Hiroshima, Japan
Research Site
Hokkaido, Japan
Research Site
Hyōgo, Japan
Research Site
Ibaraki, Japan
Research Site
Ishikawa, Japan
Research Site
Kagoshima, Japan
...and 8 more locations