Other terms
- Adverse Event Grading
- Age-Related Macular Degeneration (AMD)
- Aging Hands
- Alopecia Areata
- Alzheimer’s Disease
- Angina Pectoris
- Anterior Segment
- Antibody-Drug Conjugates
- Anticoagulation
- Arm
- Arrhythmia
- Arterial Closure
Adverse event
An adverse event refers to an unfavorable medical occurrence in a clinical trial subject who has been administered a pharmaceutical substance, whether or not it is considered drug related. An adverse event may be a physical event (sign, symptom), a psychological event (eg: change in mood), a laboratory event, or an increase in the severity or frequency of a preexisting symptom or condition.
Adverse events can be further classified as:
- Life threatening adverse events- occurrence places subject at immediate risk of death.
- Serious adverse events-occurrence leads to any of the following
- Death.
- Life-threatening adverse effect.
- Inpatient hospitalization or prolongation of existing hospitalization.
- Persistent or significant disability or incapacity.
- Birth defect.
- Requires medical intervention to prevent any of the above.
- Suspected adverse events- adverse events for which there is a reasonable possibility that the drug caused the event and there may be evidence to suggest a causal relationship.
- Unexpected adverse events- adverse events that are not listed under known risks in the investigator’s brochure or drug’s current labeling, or adverse events that are more severe or more specific than indicated.
Source: Investigational New Drug Application, 21 C.F.R. § 312.32 (2010).
