What is a rare adverse event?
An adverse reaction[1] is considered rare when it has an incidence rate of less than 0.001[2]. In this sense, applying algorithms to evaluate causality between drug and adverse reaction is a tool that can help detect this possible association.
How does FDA define adverse event?
Adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Suspected adverse reaction means any adverse event for which there is a reasonable possibility that the drug caused the adverse event.
What percentage is rare?
Answer
| Term | Numerical rate | Percentage rate |
|---|---|---|
| Common | 1 in 10 – 1 in 100 | 10% – 1% |
| Uncommon | 1 in 100 – 1 in 1000 | 0.1% to 1% |
| Rare | 1 in 1000 – 1 in 10,000 | 0.01% to 0.1% |
| Very rare | Less than 1 in 10,000 | Less than 0.01% |
What is a common adverse reaction?
The ten most common ADRs were constipation, nausea +/- vomiting, fatigue, alopecia, drowsiness, myelosuppression, skin reactions, anorexia, mucositis and diarrhoea.
What is a serious ADR?
An adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect.
What is a Grade 1 adverse drug reaction?
GRADE 1 (Mild) Transient (goes away after a short time) or mild discomfort; no limitation in activity; no medical intervention/therapy required.
What is a Grade 5 AE?
Grades 5 are fatal adverse event resulting in death. Serious Adverse Events (SAE’s) Clarification should be made between a serious AE (SAE) and an AE that is considered severe in intensity (Grade 3 or 4), because the terms serious and severe are NOT synonymous.