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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:

  1. Death
  2. Life-threatening (immediately)
  3. Overnight hospitalisation (initial or prolonged)
  4. Requires an intravenous antibiotic/anti-viral/fungal drug
  5. Significant loss of function or disability
  6. Congenital malformation/birth defect
  7. 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*
  • Diagnosis
  • Biologic/targeted therapy details at time of event (these should be recorded on pg. 1 of the clinical follow up and noted with the event where discontinued due to the event)
  • Was the event serious & why? (SAE criteria e.g. required IV antibiotics)
  • Is the event related to the biologic/targeted therapy

*Where the patient was hospitalised admission/discharge are also very useful if available.

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 serious events are also classed as an Event of Special Interest if the event is one we would appreciate receiving the ESI form at the same time as the follow up form.  You could also include a discharge summary or clinic letter that you feel has relevant additional information to the serious event.

We may write to you to ask for further information on some events so if you have no further information regarding an SAE please let us know by writing this on the FUP as we will not bother you with repeated requests for information we know you do not have.

Help with adverse events and ESIs

If you have any queries related to adverse events of ESIs, our pharmacovigilance team will be happy help you. 

Tel: +44 (0)161 275 1613