Case Series Analysis (CSA) for Vigibase

This premium feature will only be available for organizations that have purchased Vigibase functionality. If your organization has purchased Vigibase, users will be able to access the Case Series Analysis for Vigibase by selecting the Vigibase tab under Case Series Analysis.

Once on the search tab of the Case Series Analysis for Vigibase users can enter in search criteria by selecting a field they would like to search on under the “Must have”:

Selecting or entering in the search parameter:

When searching for Products, users will have the choice of searching using the standard Evidex product names or the listing from the WHO Drug Dictionary.

When searching under WHO Product Name, users can search by the product name or the Drug Record Number for the desired product.

Please note: Search will begin once you have entered in at least three characters.

For more information about the WHO Drug Dictionary, users may reference this article published in Therapeutic Innovation & Regulatory Science:
​WHODrug: A Global, Validated and Updated Dictionary for Medicinal Information

When adding multiple values in a search criteria, each additional item within one selector will be treated as an “OR” criteria.

In this case, any match that has a product identifier of aspirin, warfarin, or heparin will appear in the results.

When adding multiple instances of a value, each additional instance will be treated as an “AND” condition.

In this case, the results returned require the case to have either acetylsalicylic acid OR warfarin AND must also have heparin.

As you create your query, you can reference the summary section to understand how your query will be constructed.

Continue adding fields until you are satisfied with the search parameters entered.

Note: Role can only be selected in the search criteria once. You can add additional values to the role criteria to create an OR condition for all products in your search.

Once you have supplied the search criteria you would like to use for the analysis you can navigate to the “Advanced Statistics” tab:

Once on this page, you can select the background source for your analysis:

Please note: We have limited the background calculation for Vigibase to cases with products flagged as either Medicinal Product or Vaccine in the WHO Dictionary. Cases with only Products identified as Herbal Remedies, Homeopathic Remedies, Blood Products, and others are excluded from background calculations. There are few case reports in the Vigibase database involving only these excluded product types.

Once you’ve selected your background rate, you can click “Submit Request” to queue a request for your analysis.

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Once requested the Result Requests grid will be updated with a new row reflecting your request with a status of “Requested”:

When your request has begun processing, the record will be updated to “In Progress”:

You will receive an email notification once your request has been completed or you can see the status updated to Complete once the analysis is available.

You will see the basic statistical data for your search in the grid; however, for the full analysis please download the Excel® workbook by clicking “download.”

Once you have downloaded the results and opened the document, you will see a workbook with two worksheets, Summary and Pt-Detail.
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The Summary worksheet shows the statistical analysis across all events and products selected. The following statistical data is available:

If you would like to learn more about how these values are calculated, please review the help article below:
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Advanced Statistics Methodology

The Pt-Detail worksheet shows the statistical values for each Drug and Adverse Event (MedDRA Preferred Term) so that you can better understand how the aggregated data on the Summary tab was produced.