Serious adverse events
The BSRBR-RA collects details of adverse events from both clinicians and participants. Not all adverse events are considered as ‘serious'. Below is the definition that the BSRBR-RA uses to determine how to categorise an event.
A serious adverse event or reaction is an untoward medical occurrence that is considered to represent a significant hazard to the patient. This definition is derived from regulatory authorities, including the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), and includes events that result in:
- Life-threatening (immediately)
- Overnight hospitalisation (initial or prolonged)
- Requires an intravenous antibiotic/anti-viral/fungal drug
- Significant loss of function or disability
- Congenital malformation/birth defect
- Other medically important event*
* Certain adverse events may not necessarily belong to any of these classifications but are still considered medically significant/important and should be considered serious (ie all malignancies and pregnancy).
Adverse event data is a key element of our research so it’s important that we make sure that the data we use is correct.
The most essential pieces of information when recording an event are:
- Date of event*
- Biologic/targeted therapy details at time of event (these should be recorded in the Biologic Targeted Therapy section of the follow up record)
- Was the event serious & why? (SAE criteria e.g. required IV antibiotics)
- Is the event related to the biologic/targeted therapy?
* Please provide admission/discharge dates if available. If unavailable, please estimate these dates and select the ‘This is an estimated date’ box.
Where this information is not available, particularly in the case of a death, it is really important that you report the event as a SAE in the current follow up record and add that you have no further details around the event in the Detailed Event Description box, so that we don’t request further information from you.
Elective procedures (e.g. joint replacements) that include overnight hospitalisation are not automatically considered as a serious event unless the hospital stay is prolonged due to complications (e.g. infection). However we would still like to know about planned surgeries, and in particular why they were performed, as it will be the indication for the surgery that is an event rather than the procedure itself.
Some adverse events are classed as an Event of Special Interest (ESI). The way we capture this information has changed. For these events, we will use the query system in the database if we need further information from you, with the exception of serious infections, where you can complete the serious infection ESI form when the event is entered in the follow-up record.
We may contact you to ask for additional information regarding an event. If you have no further details, please let us know, in order to prevent repeated requests.
Yellow Card Scheme
In addition to reporting all suspected side effects and adverse drug reactions on the BSRBR-RA database, please remember to also report these directly to the MHRA using the Yellow Card Scheme.
Help with adverse events and ESIs
If you have any queries related to adverse events or ESIs, our pharmacovigilance team will be happy help you.
Tel: +44 (0)161 275 1613