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/non-serious spontaneous cases reported up to the end of the previous week. The figures are updated online every Monday.
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 7 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 week. It presents information on the number of individual cases by age group, sex and geographic origin.

Tab 2 - Number of individual cases received over time

  • This tab displays the number of individual cases received over the last 12 months by geographic origin.
  • A trend line is also displayed to indicate the total number of individual cases.

Tab 3 - Number of individual cases by EEA countries

  • This tab displays the number of individual cases by EEA countries.
  • The map displays the relative frequency distribution of the total number of individual cases in each country.
  • The graph displays the total number of individual cases in each country.

Tab 4 - 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.
  • Five views presenting the number of individual cases by reaction groups are available: by age group, sex, seriousness, reporter group and geographic origin.

Tab 5 - 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 6 - 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.

Tab 7 – Line Listing

  • This tab displays the line listing of individual cases, including the ICSR form, based on the selection of filtering conditions.


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 3, Tab 4, Tab 5 and Tab 6 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.

The information available in Tab 2 and Tab 7 provides the number of individual cases reported over a period of time.

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EudraVigilance