Viewing a web report

You can search for web reports on suspected side effects (also known as adverse drug reactions) for a medicine or active substances by using the A-Z browse tool.

All web reports have the same layout, data elements and functionalities. The figure displayed online is always a running total of serious spontaneous cases reported up to the end of the previous month. The figures are updated online on the 15th of the current month.
The information provided in the web reports is based on individual cases that meet the criteria described on the data source web page.

Each web report is composed of 4 tabs

Tab 1 - Number of individual cases

  • This tab provides the running total of individual cases identified in EudraVigilance up to the end of the previous month. It presents information on the number of individual cases by age group, sex and geographic origin.

Tab 2 - Number of individual cases by reaction groups

  • This tab displays the number of individual cases by reaction groups.
  • The reaction groups are based on a classification of the side effect (also known as adverse drug reaction), using the MedDRA dictionary of terms.
  • Four views presenting the number of individual cases by reaction groups are available: by age group, sex, reporter group and geographic origin.

Tab 3 - Number of individual cases for a selected reaction group

  • This tab displays the number of individual cases for a selected reaction group.
  • The reaction groups are based on a classification of the side effect (also known as adverse drug reaction), using the MedDRA dictionary of terms.
  • Three reports for a selected reaction group are available: the first report presents the data by age group and sex, the second by reporter group and the third by geographic origin.

Tab 4 - Number of individual cases for a selected reaction

  • This tab displays the number of individual cases for a selected reaction, defined by the user.
  • The reaction corresponds to the suspected reaction reported by the reporter; as such, this tab provides the most detailed level of information.
  • The reaction is based on the MedDRA dictionary of terms for side effects (also known as adverse drug reactions).
  • Three reports for a selected reaction are available: the first report presents the data by age group and sex, the second by reporter group and the third by outcome.


More information

Important

The running total of individual cases available in Tab 1 is the value that should be used to quantify the total number of individual cases that have been reported to EudraVigilance for a selected medicine or active substance.

The information available in Tab 2, Tab 3 and Tab 4 takes into account the suspected side effect(s) reported in an individual case; as an individual case may refer to more than one suspected side effect, the information does NOT represent the total number of individual cases that have been reported to EudraVigilance, but the number of related side effects.

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EudraVigilance