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An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. It is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Adverse events can be classified into several categories such as serious adverse events (SAEs), non-serious adverse events (NSAEs), and unexpected adverse events. SAEs are defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. NSAEs are defined as any untoward medical occurrence that does not meet the criteria for an SAE. Unexpected adverse events are those that are not listed in the Investigator’s Brochure (IB) or the product information.
Adverse events can occur due to various reasons such as medication errors, drug interactions, allergic reactions, overdose, misuse of medication, and others. It is important to report adverse events to regulatory authorities such as the Food and Drug Administration (FDA) so that they can monitor the safety of drugs and take appropriate actions if necessary.
In summary, an adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. Adverse events can be classified into several categories such as serious adverse events (SAEs), non-serious adverse events (NSAEs), and unexpected adverse events. Adverse events can occur due to various reasons such as medication errors, drug interactions, allergic reactions, overdose, misuse of medication, and others. It is important to report adverse events to regulatory authorities such as the Food and Drug Administration (FDA) so that they can monitor the safety of drugs and take appropriate actions if necessary.
Here are some websites that discuss What Is An Adverse Event:
– [Wikipedia](https://en.wikipedia.org/wiki/Adverse_event)
– [JAMA Pediatrics](https://jamanetwork.com/journals/jamapediatrics/fullarticle/2771983)
– [Common Terminology Criteria for Adverse Events (CTCAE)](https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcae_v5_quick_reference_5x7.pdf)
– [MedDRA](https://www.meddra.org/patient-friendly-term-list)
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