Appendix 4Adverse event definitions
TABLE 63
Adverse event definitions
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| Event | Definition |
|---|
| AE |
Any untoward medical occurrence in a patient or clinical trial participant that does not necessarily have a causal relationship with this product
AEs include an exacerbation of a pre-existing illness, an increase in the frequency or intensity of a pre-existing episodic event or condition, a condition (regardless of whether or not present prior to the start of the trial) that is detected after trial intervention administration (this does not include pre-existing conditions recorded as such at baseline), and continuous persistent disease or a symptom present at baseline that worsens following administration of the trial treatment
AEs do not include medical or surgical procedures, pre-existing disease or a condition present before treatment that does not worsen, hospitalisation where no untoward or unintended response has occurred (e.g. elective cosmetic surgery), and overdose of medication without signs or symptoms
|
| Adverse reaction | Any untoward and unintended response to an investigational medicinal product related to any dose administered |
| Unexpected adverse reaction | An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g. investigator’s brochure for an unauthorised product or summary of product characteristics for an authorised product) |
| SAE or serious adverse reaction | Any AE or adverse reaction that at any dose: |
- a
The term life-threatening refers to an event in which the patient is at risk of death at the time of the event; it does not refer to an event that might hypothetically cause death if it was more severe (e.g. a silent myocardial infarction).
- b
Hospitalisation is defined as an inpatient admission of any length of stay, even if the hospitalisation is a precautionary measure for continued observation. Hospitalisation for pre-existing conditions (including elective procedures that have not worsened) do not constitute a SAE.
- c
Medical judgement should be exercised in deciding whether an AE or adverse reaction is serious in other situations. Important AEs or adverse reactions may not be immediately life-threatening or result in death or hospitalisation, but may seriously jeopardise the participant by requiring intervention to prevent one of the other outcomes listed in the table (e.g. a secondary malignancy, an allergic bronchospasm requiring intensive emergency treatment, seizures or blood dyscrasias that do not require hospitalisation, or development of drug dependency).
