An adverse event (AE) is a medical occurrence in a patient or clinical research subject who has received a pharmaceutical product that is not always related to the treatment.
Any unfavorable or unexpected sign, symptom, or disease associated with the use of a medicinal product, whether or not related to the medicinal product, is referred to as an adverse event (AE).
Adverse events in clinical trials must be reported to the study sponsor and, if necessary, the local ethics committee. Non-serious adverse events are simply documented in the annual summary sent to the regulatory authority, whereas serious adverse events must be reported to regulatory authorities immediately.
The sponsor collects AE reports from local researchers and alerts all participating sites to AEs at other sites, as well as the local investigators' and sponsors' assessments of the severity of the AEs.While the study is still ongoing, this process gives the sponsor and all local investigators access to a set of data that could indicate potential problems with the study treatment.
Adverse event reporting
All adverse events in clinical trials must be reported to the drug regulatory authority of the country in which the drug or device is to be registered. Minor adverse events are 'bundled' by the sponsor and reported later; serious adverse events must be reported right away.
The scope and nature of data collected are determined by the method used to elicit AEs reported by individuals in order to provide evidence on likely adverse drug reactions (ADRs). There is concern that the types of questions and how they are phrased may lead to measurement error, making comparisons between studies and pooled analysis difficult.
Adverse event grade levels
The number of grade 3 and grade 4 adverse events is frequently reported in clinical trial results. Grades have been established.
Mild AE
Moderate AE
Severe AE
Life-threatening or disabling AE
Death from AE