a medical event experienced by a patient after he/she receives a drug, therapeutic biologic, or devi ce.
In pharmacology, an adverse event is any unexpected or dangerous reaction to a drug. Aerosol: A fine mist or spray that contains tiny particles. A medication can be aerosolized by a nebulizer and inhaled as a form of treatment.
Less than desireable results of taking medication, also known as side effects
An undesirable health event that occurs in a participant during a clinical trial. It may or may not be related to the treatment itself.
An undesirable experience occurring to an individual during the course of a study or clinical trial.
a damage resulting from a medical intervention, or in other words, it is an unfavourable event which is not due to the patient condition, but caused by medical care and treatment
an occurrence during clinical care which results in physical or psychological injury or harm to a patient or harm to the mission of the organization
an occurrence that is not expected or is out of the ordinary
an unintended injury or complication that results in disability at the time of discharge, death or prolonged hospital stay and that is caused by health care management rather than by the patient's underlying disease process
a side effect that is may occur in a certain percentage of cases that are treated
Any unwanted, unpleasant, negative, or dangerous effect in response to a treatment or intervention (also referred to as an adverse effect, adverse reaction or side effect).
Any change from a subject's normal status, or a worsening of an existing condition. For example a cold or flu, or migraine headaches in a person with no previous diagnosis. Serious Adverse Event: Any adverse event that causes hospitalization, disability, incapacity, birth defects, medical or surgical intervention, or death.
Any effect caused by a medication or therapy other than the reason for which it was prescribed. It may or may not be expected.
"An unintended injury that was caused by medical management and that resulted in measurable disability" [Harvard Medical Practice Study].
An undesired effect caused by a drug.
Any untoward physical or psychological occurrence in a human subject participating in research. An AE can be any unfavorable or unintended event including abnormal laboratory finding, symptom or disease associated with the research or the use of a medical investigational test article. An AE does not necessarily have to have a causal relationship with the research, or any risk associated with the research or the research intervention, or the assessment.
An adverse event is any experience that has taken place during the course of a research project, which, in the opinion of the investigators, was harmful to a subject participating in the research, increased the risks of harm in the research, or had an unfavorable impact on the risk/benefit ratio. Adverse events may be expected/anticipated (such as a known possible drug side effect) or unexpected/unanticipated. Expected or possible adverse events should be listed in the Risk Assessment section of the protocol.
Term used to denote a side effect, or negative health consequence, reported after taking a certain substance. The event may or may not be linked to the substance.
A negative experience encountered by an individual during the course of a clinical trial, that is associated with the study drug.
Any undesirable event that occurs following vaccination. An adverse event could be a true vaccine reaction, or just a coincidental event, with further research needed to distinguish between them.
Any change in health that occurs in a person after he or she enrolls in a clinical trial. Not every adverse event is related to the treatment or test being studied, but researchers must report all adverse events to the Food and Drug Administration (FDA).
A side effect that results from the use of a treatment. Life-threatening side effects are called "serious adverse events."
an unwanted effect caused by the administration of a drug; onset may be sudden or develop over time; also known as a side effect
An untoward, undesirable, and usually unanticipated event, such as death of a patient, an employee, or a visitor in a health care organization. Incidents such as patient falls or improper administration of medications are also considered adverse events even if there is no permanent effect on the patient.
an undesired action or effect of an experimental treatment.
For safety's sake, any unwanted, negative medical occurrence during the time a patient participates in a clinical trial is called an adverse event. All adverse events are documented, whether or not they seem related to the experimental drug. The study physician then decides if the AE is related to the experimental drug and reports this information as well.
an untoward occurrence in a patient or subject who is receiving a pharmaceutical product; may or may not have a causal relationship with treatment
Any negative medical occurrence in a patient which does not necessarily relate to treatment.
(AD-verse uh-VENT) Unwanted side effect of treatment
in a clinical trial, an unwanted effect detected in participants. The term is used whether or not the effect can be attributed to the vaccine under study.
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. An adverse event (AE) can therefore be any unfavourable 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. (ICH) See also serious adverse event, serious adverse experience.
A toxic reaction to a medical therapy.
An Adverse Event is any unfavorable event that occurs in a patient who is participating in a clinical trial, whether or not related to the medicinal (investigational) product. Pre-existing conditions that worsen during a study are to be reported as Adverse Events.
Any undesirable side effect that may result from a vaccination.
An unwanted and unintended occurrence affecting a human participant during research. Adverse events may be unexpected or expected.
An injury caused by medical management, rather than by the underlying condition of the patient.
The development of an undesirable or harmful side effect during drug therapy. (see Side Effects)
An unwanted effect detected in participants in a trial. The term is used regardless of whether the effect can be attributed to the intervention under evaluation. See also Side effect.
Any untoward medical occurrence that may present during treatment with a pharmaceutical product, but which does not necessarily have a causal relationship with this treatment.
a toxic reaction to a medical treatment.
An unwanted side effect of treatment.
An unwanted medical problem that occurs during treatment. Adverse events may be unrelated to the treatment or they may be caused by the therapy or procedure. For example, an adverse event may be caused by the toxic effects of a particular drug or dietary supplement or by an interaction with another therapy. Also called adverse effect and side effect.
An adverse event (AE) is any adverse change in health or "side-effect" that occurs in a person during a clinical trial or within a pre-specified period after dosing is complete. Not every adverse event is causally related to the treatment or test being studied, but researchers must report all adverse events to the Food and Drug Administration (FDA)or the relevant regulatory authority in the country where the drug or device is to be registered. Adverse events categorized as "serious" [for example death, illness requiring hospitalization, events deemed life-threatening, or involving cancer or fetal exposure] must be reported to the regulatory authorities immediately, whereas minor adverse events are merely documented in the annual summary sent to the regulatory authority.