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Database of Adverse Event Notifications: about the search results

29 November 2012

There are two types of search results:

• Medicine summary
• List of reports

Medicine summary

The total number of cases in the medicine summary is usually less than the sum of the number of MedDRA reaction terms because multiple adverse events have been reported for some patients.

• The medicine summary groups reported adverse events together.
• This report enables a quick assessment of the most commonly reported adverse events for a particular medicine.
• Although the medicine searched for is suspected of causing the adverse events reported, the link between the medicine and the adverse event is unlikely to be certain.
• Note that because patients can have more than one adverse event, the total of each of the columns is likely to be higher than the total numbers of cases.

Heading	Description
MedDRA system organ class	A description of what, in general terms, was affected by the adverse event, as described by the Medical Dictionary for Regulatory Activities MedDRA (for example 'cardiac disorders').
MedDRA reaction term	A description of the adverse event as defined by MedDRA. These adverse events are grouped by system organ class.
Number of cases	The number of cases for which each type of adverse event was reported.
Number of cases with a single suspected medicine	Results show where a medicine is the only medicine suspected to be related to the adverse event.
Number of cases where death was a reported outcome	These reports of death may or may not have been the result of taking a medicine.

List of reports

The list of reports lists the data case-by-case in chronological order. Thus, the details of each case (de-identified) are listed in the order of report entry date.

The list of reports contains more information than the medicine summary, but does not group the cases according to the reported adverse event.

Heading	Description
Case number	A unique number that provides a reference to a particular case.
Report entry date	The date that information from the original report was entered into the database. This date does not necessarily reflect the date of the adverse event. Although reports are often received soon after an adverse event occurred, there are occasions, often in response to the publicising of a particular adverse event, that the TGA receives reports of adverse events many years after they occurred.
Age (yrs)	Age of patient at time of adverse event ('-' if unknown).
Gender	Gender of patient ('-' if unknown).
Medicines reported as being taken	Medicines reported to have been taken by the patient. This can be the trade name or the name of the active ingredient. Please note that it is possible that not all medicines taken by the patient were reported to the TGA. There are three types of links between medicine and adverse event: Suspected - there is a possibility that the medicine caused the adverse event. Interaction - an interaction between two or more medicines is suspected to have caused the adverse event; this is usually based on a history in the literature of interactions between the medicines concerned Not suspected - this medicine was taken at the time of the adverse event, but it is not suspected to be related to the adverse event.
MedDRA reaction term	A description of the adverse event as defined by the Medical Dictionary for Regulatory Activities (MedDRA).

The Database of Adverse Event Notifications is updated monthly. Reports generated on different days may be different, even if the same date range is searched, because the TGA receives follow-up information from reporters that leads to cases being updated in the database.