What is an Adverse Event?
An Adverse Event is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. An adverse event can be any unfavorable or unintended abnormality, symptom or illness associated with the use of the drug. Thus, the suspicion that an observed physical or psychological reaction is due to prior medication use is sufficient for reporting. A Serious Adverse Event is an adverse event that results in death, in hospitalisation or prolongs an existing hospitalisation, would have resulted in hospitalization or death without emergency intervention, results in permanent disability or in malformation of an unborn child.
Why report Adverse Events?
Reporting Adverse Events is helpful because pharmaceutical companies and regulatory authorities learn from these reports how to use drugs more safely. For TopAlliance, patient safety is paramount. By reporting Adverse Events, you help us improve the safety of our patients. Your information also enables us to meet our reporting obligations to regulatory authorities.
Adverse Events that occur as part of a clinical trial must be reported to the appropriate study site.
If you or the person on whose behalf you are reporting is currently suffering from a Serious Adverse Event, you should immediately contact your doctor or other healthcare professional.