Definitions
death, disability/incapacity, SAR, ’
ADVERSE EVENT, DISEASE, EVENT, ADVERSE EVENT, ADVERSE REACTION, EVENTS
Adverse event (AE): Any untoward medical occurrence in a participant to whom a medicinal product has been administered including occurrences which are not necessarily caused by or related to that product. An AE can, therefore, be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP.Adverse reaction (AR): Any untoward and unintended response in a participant to an IMP which is related to any dose administered to that participant. The phrase ‘response to an investigational medicinal product’ means that a causal relationship between a trial medication and an AE is at least a reasonable possibility, i.e. the relationship cannot be ruled out.Serious adverse event (SAE): A SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, and results in persistent or significant disability/incapacity; other ‘important medical events’ may also be considered serious if they jeopardise the participant or require an intervention to prevent one of the above consequences.Serious adverse reaction (SAR): An AE that is both serious and, in the opinion of the reporting investigator, believed with reasonable probability to be due to the trial treatments, based on the information provided.Suspected unexpected serious adverse reaction (SUSAR): A serious adverse reaction, the nature and severity of which is not consistent with the information about the medicinal product in question set out in the in the Investigator’s Brochure (IB).When completing the adverse event reporting form, the site PI or medical delegate will assign a causality using the definitions below:Suspected to be related—There is evidence to suggest a causal relationship with the administration of the trial treatment and the influence of other factors is unlikely.Not suspected to be—There is little or no evidence to suggest there is a causal relationship (e.g. the event did not occur within a reasonable time after administration of the trial treatment). There is another reasonable explanation for the event (e.g. the participant’s clinical condition, other concomitant treatment).If there is any doubt about the causality, the site PI or medical delegate will inform the LSHTM CTU Global Health Trials Group. In the case of discrepant views on causality between the investigator and others, all parties will discuss the case. If no agreement is made, both points of view will be recorded and reported onwards as required.