Adverse Events Quiz

Test your knowledge with the BADBIR Adverse Events Quiz. Read a series of statements and then decide whether this would classify as an adverse event, a serious adverse event and/or an event of special interest. Click here to begin the quiz.

Adverse Events Presentation

Please click here for a powerpoint version of the latest BADBIR adverse events presentation and here for a pdf version.

How Do We Define Adverse Events?

The information we collect at BADBIR relates to Adverse Events (AE) and Serious Adverse Events (SAE). We define AE as follows - "Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have to have a causal relationship with the product."

For example, for someone registered with BADBIR (either in the biologic or conventional cohorts) we would like information about medical treatment that they have whilst on the Register, even if the treatment occurs not as a result of being on the biologic therapy. Details of adverse events can be recorded on page 3 of the routine follow-up questionnaire. There is no obligation to inform BADBIR of adverse events as they occur - instead they can always be reported as part of normal follow-up.

Is this Event an SAE?

When giving details of an AE on the BADBIR database, you will be asked to decide if the event you are reporting is serious (that is, an SAE). The following may help you in making that decision:

• Was the event life threatening?
• Did the person get admitted to hospital overnight?
• Did the event prolong hospitalisation (if the person was already in hospital at the time of the event)?
• Did the event cause a congenital anomaly (if the person was pregnant at the time of the event)?
• Did the event cause the person to have IV antibiotics?

Events of Special Interest

As well as making a decision on whether an event is an SAE, we will also ask if the event classifies as one of our 'Events of Special Interest (ESI)'. These 13 events are ones that we have an interest in and therefore we collect a little extra information on them. Please click on the ESI below to bring up a pdf version of the form:

• Aplastic Anaemia Click here
• Cancer (not including skin) Click here
• Central Demylination Click here
• Congestive Heart Failure Click here
• Hepatic Dysfunction Click here
• Lymphoproliferative Disease Click here
• Myocardial Infarction Click here
• Pregnancy Outcome Click here
• Psoriasis Flare Click here
• Serious Infection (excl.TB) Click here
• Skin Cancer (inc. Bowen's Disease Click here
• Surgery Click here
• Tuberculosis Click here

The data for these ESI forms can be entered directly on to the BADBIR database in the relevant follow-up Adverse Event section.