What does the term "adverse events" refer to?

The term "adverse events" specifically refers to unwanted or harmful outcomes that occur as a result of using a product, such as a medication or medical device. This definition encompasses a wide range of negative effects, including those that are serious enough to require medical attention or those that may cause a change in the product's usage or indication.

Understanding this concept is crucial in the field of healthcare and product safety, where monitoring and reporting of adverse events play a significant role in ensuring patient safety and guiding regulatory decisions. The data collected from adverse events can lead to improved product labeling, risk communication, and even changes in clinical practice to mitigate risks.

The other options refer to outcomes that either have a positive connotation, are neutral, or are expected side effects that are part of the product's profile, which does not align with the definition of "adverse events." This distinction is important within regulatory frameworks, clinical trials, and pharmacovigilance efforts where clear definitions help in assessing the safety and efficacy of healthcare products.