About the search results: DAEN - medicines
Try the new beta version of the DAEN - medicines for easier searching and better display of results.
There are two types of results shown in tables:
Quick tip: DAEN - medicines beta version
The new DAEN - medicines beta also shows your results in interactive graphs. You can also sort the information in the tables by clicking on the headings.
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 also includes vaccines.
- 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 or vaccine.
- Although the medicine or vaccine 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.
|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 or vaccine is the only product reported as 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 or vaccine.|
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.
|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 or vaccines 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/s and/or vaccine/s and adverse event:
The type of link reflects the view of the reporter.
|MedDRA reaction term||A description of the adverse event as defined by the Medical Dictionary for Regulatory Activities (MedDRA).|
Quick tip: DAEN - medicines beta version
Results are also shown in tables and interactive graphs. You can switch between viewing results in tables and graphs or in graphs only by using the Tables and graphs/Graphs buttons in the top right corner of the page.
Please note that to retain your selections when you switch between the two views (Tables and graphs or Graphs), you must select the medicines individually.
Hover over the table to view table functions, at the top right of each table:
displays the filters that have been applied to your search.
- displays the table in full screen mode.
- displays additional options for sorting results and exporting data, either in Comma Separated Values (.csv) or Microsoft Excel (.xlsx) format. There is a limit to how many rows of data can be exported in a single file:
- 30,000 rows for .csv and
- 150,000 rows for .xlsx.
You can also sort the information in the tables by clicking on the column headings.
Search results are displayed in interactive graphs by age, gender, adverse reaction and report date:
- Click on a graph segment to narrow your search results to that selection. All other tables and graphs will also update. To undo this action, click the selected area within the graph again. To make more than one selection, hold 'control' and click on the graph segments.
- Right click on a graph segment to show additional view options.
- For the Case data by report date graph (within the Graphs view) you can further drill down into the data by year, month and day. These drill down options display when you hover over the graph.
The Database of Adverse Event Notifications - medicines is updated daily. The reports in this database start from 1 January 1971 up to 14 days prior to the date of access. 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.