EMA 发布 EudraVigilance 疑似不良反应数据库 adrreports.eu 门户在线访问用户手册第 2.2 版
EudraVigilance - European database of suspected adverse reactions related to medicines: user manual for online access via the adrreports.eu portal
EMA 发布第 2.2 版 EudraVigilance 疑似药品不良反应数据库用户手册，编号 EMA/198270/2026，说明如何通过 adrreports.eu 门户在线访问相关报告。
手册说明了 adrreports.eu 门户各页签的数据口径与筛选方式，可用于区分个案总数与不良反应数。
PDF 文字版；图形和原始排版请参阅官方 PDF。
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31 August 2026
EMA/198270/2026
Data Analytics and Methods Taskforce
EudraVigilance - European database of suspected adverse
reactions related to medicines: User Manual for online
access via the adrreports.eu portal
Version 2.2
Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us
Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union
© European Medicines Agency, 2026. Reproduction is authorised provided the source is acknowledged.
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Contents
Overview ..................................................................................................... 3
1. Background Information .................................................................... 4
2. Disclaimer .......................................................................................... 4
3. Data elements for the a ggregated web (dashboard) reports ............. 5
4. Additional details on data elements for the aggregated web
(dashboard) reports .................................................................................... 7
4.1. Rules for when an individual case has more than one reporter ................................7
4.2. Rules for when an individual case has more than one suspected adverse reaction with
different outcome .......................................................................................................7
5. Layout ................................................................................................ 8
5.1. Tab 1 - Number of individual cases ......................................................................8
5.2. Tab 2 - Number of individual cases received over time ...........................................8
5.3. Tab 3 - Number of individual cases by EEA countries .............................................9
5.4. Tab 4 - Number of individual cases by Reaction Group ...........................................9
5.5. Tab 5 - Number of individual cases for a selected Reaction Group ......................... 10
5.6. Tab 6 - Number of individual cases for a selected Reaction ................................... 11
5.7. Tab 7 – Line Listing ......................................................................................... 11
6. Interpretation of web reports .......................................................... 14
7. Web report functionalities ................................................................ 15
7.1. General Navigation .......................................................................................... 15
7.1.1. Graph/Grid view .......................................................................................... 16
7.1.2. Legend ....................................................................................................... 17
7.2. Navigation in Tab 2 – Number of individual cases received over time ..................... 17
7.3. Navigation in Tab 4 – Number of individual cases by reaction groups ..................... 18
7.4. Navigation in Tab 5 – Number of individual cases for a selected reaction group ....... 18
7.5. Navigation in Tab 6 – Number of individual cases for a selected adverse reaction .... 18
7.6. Navigation in Tab 7 – Line Listing ...................................................................... 19
7.6.1. Filtering the Line Listing ............................................................................... 19
7.6.2. Line Listing and ICSR Form functionality ......................................................... 21
8. List of acronyms used in the document ............................................ 23
9. Supporting documents ..................................................................... 23
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Overview
This manual provides instructions on how to use the adrreports.eu portal to obtain access in
EudraVigilance to reports of suspected adverse reactions (also referred to as undesirable effects or side
effects) related to medicines. The access to information on suspected adverse reactions related to
medicines is defined in the EudraVigilance Access Policy.
By means of the adrreports.eu portal, web reports can be generated that provide information on
suspected adverse reactions related to medicines authorised in the European Economic Area (EEA).
Details of the web reports are described in this manual. This includes explanations on the available
browsing/query functionalities, the layout of the reports and the data elements presented for Individual
Case Safety Reports (ICSRs). Guidance on the interpretation of spontaneous case reports of suspected
adverse reactions to medicines is provided here.
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1. Background Information
The adrreports.eu portal provides public access to reports of suspected side effects submitted to the
EudraVigilance system by national medicines regulatory authorities and pharmaceutical companies that
hold marketing authorisations for medicines in the European Economic Area (EEA).
The European Medicines Agency (EMA) plays a key role in the safety monitoring of medicines in the
European Union (EU) - this is known as pharmacovigilance. The Agency’s main role in this area is to
support the coordination of the European pharmacovigilance system and to provide advice on the safe
and effective use of medicines. As part of this responsibility, the Agency is responsible for the
development, maintenance and co-ordination of EudraVigilance, a system for reporting suspected cases
of adverse reactions to a medicine. For more information please visit the EMA website.
Data in EudraVigilance is submitted electronically by national medicines regulatory authorities and by
pharmaceutical companies that hold the marketing authorisation for medicines. EudraVigilance data are
published in the European database of suspected adverse drug reaction reports, the adrreports.eu portal,
in 26 languages. This portal allows users to view the total number of individual suspected side effect
reports (also known as Individual Case Safety Reports, or ICSRs) submitted to EudraVigilance for
medicines authorised in the EEA. The EMA publishes the data available on the adrreports.eu portal so
that its stakeholders, including the general public, can access information that European regulatory
authorities can use to review the safety of a medicine or active substance.
The data available in the portal is based on adverse reactions reported spontaneously by patients,
healthcare professionals or other sources, which are then submitted electronically to EudraVigilance
in the form of an ICSR by national medicines regulatory authorities or pharmaceutical companies.
The adrreports.eu portal grants access to aggregated data outputs based on predefined queries. These
are made available in the form of web reports that consist of a number of tabs, each of which allows
users to query, filter and access the data in a different way. In addition, access to line listing of individual
cases and individual case report forms is provided in compliance with EU personal data protection law.
2. Disclaimer
The Information on suspected adverse reactions that can be accessed via the adrreports.eu portal should
not be interpreted as meaning that the medicine or the active substance causes the observed effect or
is unsafe to use. Information on the portal relates to suspected side effects, so medical events that have
been observed following the use of a medicine, but which are not necessarily related to or caused by the
medicine. The number of suspected adverse reactions in EudraVigilance should not serve as a basis for
determining the likelihood of an adverse reaction occurring.
The ICSRs in EudraVigilance do not represent all available information concerning the benefits and risks
of a medicine and should not be used in isolation by healthcare professionals to make decisions regarding
a patient's treatment regimen; other sources of information, including the product/prescribing
information, should also be consulted.
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3. Data elements for the a ggregated web (dashboard)
reports
Before an ICSR is submitted to EudraVigilance, the reporter completes the applicable data elements and
provides information on the suspected adverse reaction(s) (also known as side effect or undesirable
effect) that have been observed following the use of one or more medicines. These suspected side effects
are not necessarily related to or caused by the medicine (please see Guidance on the interpretation of
spontaneous case reports of suspected adverse reactions to medicines).
The web reports that can be accessed via the adrreports.eu portal provide different views of data on
ICSRs, which form part of each individual case submitted to EudraVigilance. The data elements available
to users of the portal are determined by the EudraVigilance Access Policy.
For the aggregated web (dashboard) reports the following applies:
• Age Group and Sex provide information on the individual, who experienced the suspected
undesirable effect.
• Report Type provides information on the classification of a report by the sender (e.g. spontaneous
report).
• Seriousness provides information on the suspected undesirable effect; it can be classified as
‘serious’ if it corresponds to a medical occurrence that results in death, is life-threatening, requires
inpatient hospitalisation, results in another medically important condition, or prolongation of existing
hospitalisation, results in persistent or significant disability or incapacity, or is a congenital
anomaly/birth defect. It can also refer to other important medical events that might not be
immediately life threatening or result in death or hospitalisation but might jeopardise the patient or
might require intervention (treatment) to prevent one of the other outcomes listed above. Examples
of such events are allergic bronchospasm (a serious problem with breathing) requiring treatment in
an emergency room or at home as well as seizures/convulsions and serious blood dyscrasias (blood
disorders) that do not result in hospitalisation.
• Geographic Origin provides information on the location of the reporter.
• Reporter Group provides information on the qualification of the reporter.
• Outcome provides information on the last reported status of the suspected undesirable effect.
• Reported suspected reaction provides information on the undesirable effect(s) experienced by a
patient according to the reporter.
The table below presents the data elements included in the web reports and possible values.
Data element Possible Values
Not Specified
0-1 Month
Age group (mapped against “Age at Time 2 Months - 2 Years
of Onset of Reaction/Event”, based on the
reported patient age or calculated based 3-11 Years
on difference between “Date of Birth” and 12-17 Years
“First Reaction Start Date” (if available in a
18-64 Years
valid date format dd/mm/yyyy)
65-85 Years
More than 85 Years
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Female
Sex Male
Not Specified
Report Type Spontaneous
Not Specified
Seriousness Serious
Non-Serious
European Economic Area (EEA)
Geographic Origin Non-European Economic Area (Non-EEA)
Not Specified
Healthcare Professional
(Physician, Pharmacist or Other Health Professional)
Reporter Group Non-Healthcare Professional
(Lawyer, Consumer or Other non-Health Professional)
Not Specified
Recovered/resolved
Recovering/resolving
Not recovered/not resolved
Outcome Recovered/resolved with sequelae
Fatal
Unknown
Not specified
Any undesirable effect (suspected adverse reaction)
reported by the reporter
Reported Suspected Reaction Undesirable effect terms are coded in line with a
dictionary of medical terms used to classify clinical
information
Any undesirable effect group based on the
classification reported by the reporter
Undesirable effect terms come from the dictionary of
Reaction Groups
medical terms used to classify clinical information and
are categorised into groups based on the clinical
signification
Running total count of individual cases submitted to
Number of individual cases
EudraVigilance
The Reported Suspected Reaction and Reaction Groups for a report are derived from the dictionary
of medical terms used to classify clinical information. The dictionary used is the Medical Dictionary for
Regulatory Activities (MedDRA ).
The Reported Suspected Reaction corresponds to the MedDRA reaction ‘Preferred Term (PT)’ and the
Reaction Groups correspond to the MedDRA Reaction ‘System Organ Class (SOC)’.
The table provides examples of the MedDRA classification:
Suspected Reported Reaction Reaction Group
(Preferred Term in MedDRA) (System Organ Class in MedDRA)
Headache Nervous system disorders
Ear infection Infections and infestations
For further information about the dictionary, please consult the adrreports.eu FAQ page ‘What is the
Medical Dictionary for Regulatory Activities (MedDRA )?’.
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4. Additional details on data elements for the aggregated
web (dashboard) reports
An individual case can only have one value for the data elements Age Group, Sex, Report Type and
Geographic Origin; for the data elements Reporter Group, Seriousness and Outcome, more than
one value can be available.
This is because an individual case concerns one individual patient, therefore the Age Group, Sex and
Geographic Origin can only be characterised by one value.
However, an individual case may have been reported by a Consumer and a Physician, which belong to
different Reporter Groups; the Outcome of a suspected undesirable effect might have been reported
as ‘recovering’ at the time of the initial report and following an update it is now reported as ‘unknown’.
To address these eventualities and prevent an over-counting of the number of individual cases in the
web reports, the following rules are applied:
4.1. Rules for when an individual case has more than one reporter
If at least one of the reporters is indicated as being a ‘Physician’, ‘Pharmacist’ or ‘Other Health
Professional’, the Reporter Group is defined as ‘Healthcare Professional’. Otherwise, if the reporters are
indicated as being a ‘Lawyer’ or ‘Consumer or other non-Health Professional’, the Reporter Group is
defined as ‘Non-Healthcare Professional’.
Reporter(s) Reporter Group
Individual case #1 Pharmacist Healthcare Professional
Individual case #2 Physician; Lawyer or Consumer Healthcare Professional
Individual case #3 Other non Health Professional Non-Healthcare Professional
4.2. Rules for when an individual case has more than one suspected
adverse reaction with different outcome
If at least one of the outcomes is fatal, the outcome for the individual case for the reported reaction is
defined as ‘Fatal’; if none of the outcomes is fatal, the outcome for the individual case for the reported
reaction is defined as ‘Unknown’.
Reported Suspected Adverse Outcome in web report
Reactions and Outcome(s)
The same reaction is not reported twice:
Reaction A -> Recovered/resolved Reaction A -> Recovered/resolved
Individual case #4
Reaction B -> Not Specified Reaction B -> Not Specified
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Reported Suspected Adverse Outcome in web report
Reactions and Outcome(s)
Individual case #5 The same reaction is reported twice: Reaction C -> Fatal
Reaction C -> Recovering/resolving
Reaction C -> Fatal
The same reaction is reported twice:
Reaction D -> Recovered/resolved Reaction D -> Unknown
Individual case #6
Reaction D -> Recovered/resolved with
sequelae
5. Layout
The web report is composed of 7 tabs.
5.1. Tab 1 - Number of individual cases
The tab provides the running total of individual cases identified in EudraVigilance up to the end of
the previous week.
The tab presents the information on the number of individual cases by Age Group, Sex and
Geographic Origin.
5.2. Tab 2 - Number of individual cases received over time
The tab displays the number of individual cases received over the last 12 months split by
geographic origin i.e. cases arising in EEA countries relative to those arising outside of the EEA.
The graph on this tab also contains a trend line to indicate the total number of individual cases
over time.
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Note that the legend for the total number of cases over time is express in K, i.e. 4K means 4000.
5.3. Tab 3 - Number of individual cases by EEA countries
The tab displays the number of individual cases in EEA countries for the selected medicinal
product/substance
The map view displays the percentage of total EEA cases in each country.
The graph view displays the total number of individual cases in each country.
For data privacy reasons and to avoid the risk of patient/reporter re-identification, a threshold is applied
if the number of individual cases available for a specific country is less or equal to 3. In this instance,
the distinct country is not displayed in the graph.
A colour coding has been applied according to the percentage of cases in a country.
5.4. Tab 4 - Number of individual cases by Reaction Group
The tab displays a graph that visualises the number of individual cases by Reaction Group.
Five distinct views are available, allowing users to split the Reaction Group data on this tab by Age Group,
Sex, Seriousness, Reporter Group and Geographic Origin.
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5.5. Tab 5 - Number of individual cases for a selected Reaction Group
The tab displays the number of individual cases for a selected Reaction Group defined by the user.
Three web reports for a selected Reaction Group are available; the first web report presents the data by
Age Group & Sex, the second by Reporter Group and the third by Geographic Origin.
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5.6. Tab 6 - Number of individual cases for a selected Reaction
This tab displays the number of individual cases for a selected Reaction which is defined by the user.
Three web reports for a selected Reaction are available: the first report presents the data by Age Group
& Sex, the second by Reporter Group and the third by Outcome.
5.7. Tab 7 – Line Listing
The tab displays the line listing of individual cases reported to EudraVigilance for a specified
product or substance. Data elements are displayed as per the level of access granted to the public in
the EudraVigilance Access Policy.
The data elements listed below can be used to filter the line listing:
• Seriousness
• Geographic Origin
• Reporter Group
• Sex
• Age Group
• Reaction Groups
• Reporter Suspected Reaction
• Gateway Date
See section 7.6. for detailed instructions on filtering the line listing.
Data elements reflected in the Line Listings are summarised in the table below:
ICH
Line Listing Data E2B(R3)
Element Description Example
Elements
References
EudraVigilance local number, which is an
EU local number N/A identifier assigned to the ICSR in EudraVigilance EU-EC-12345
EudraVigilance Gateway Date, which is the date
EV Gateway
N/A of receipt of the 01/01/2014
Receipt Date
ICSR in EudraVigilance
Report type C.1.3 Type of Report Spontaneous
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ICH
Line Listing Data E2B(R3)
Element Description Example
Elements
References
Primary source Qualification: grouped as
Primary source Healthcare
C.2.r.4 Healthcare Professional or Non-Healthcare
qualification Professional
Professional
Primary source Primary Source for Regulatory Purposes,
country for displayed as EEA/non EEA.
C.2.r.5 EEA
regulatory
purposes
Tolerable pain
reduces
gastric fundal
accommodation and
gastric motility in
healthy subjects: a
The literature reference(s) for suspected adverse crossover
Literature reactions described in the literature and the ultrasonographic
C.4.r.1
Reference(s) corresponding ICSRs in study. Hasuo H1,
EudraVigilance Kusunoki
H2, Kanbara K1,
Abe T1, Yunoki N3,
Haruma K2,
Fukunaga M1.
Biopsychosoc Med.
2015 Feb
Mapped against the ‘Age at Time of Onset of
Reaction / Event’, based on the reported patient
age or calculated based on difference between
D.2.2a ‘Date of Birth’ and ‘First Reaction Start Date’ (if
Patient age group available in a valid date format dd/mm/yyyy) 18-64 Years
‘Age at Time of Onset of Reaction /
D.2.2b
Event (unit)’
Patient Age Group ‘Patient Age Group’ (as per reporter)
D.2.3 Adult
(as per reporter)
Patient sex D.5 ‘Sex’ (gender of the patient) Female
To indicated if this is a report that relates to a
Parent/Child N/A Yes
parent and a child
‘Reaction / Event MedDRA
E.i.2.1b Rash (3d – Resolved
Preferred term’ description
E.i.6a/b ‘Duration of Reaction / Event’ -
‘Outcome of Reaction / Event at the Time of Last Life Threatening,
Reaction List PT E.i.7
Observation’ Caused / Prolonged
(Duration –
The seriousness criteria of the reported reaction, Hospitalisation)
Outcome -
E.i.3.2a, e.g. Results in Death, Life Threatening, Caused /
seriousness
E.i.3.2b, Prolonged Hospitalisation, Nausea (1d -
criteria)
E.i.3.2c, Disabling / Incapacitating, Resolved)
E.i.3.2d, Congenital Anomaly / Birth Defect,
E.i.3.2e, Other Medically Important Headache (3d – Not
E.i.3.2f Condition resolved)
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Drug List (Drug Characterisation of ‘Drug Role’, defined as PRODUCT
Char - suspect, interacting, concomitant or drug not [Substance]
Indication PT – administered. (S -Dental pain,
Action taken – G.k.1 Based on this data element, 2 different ‘Drug’ Headache – Drug
[Duration - Dose - (medicines) lists will be created: withdrawn – [1d –
Route]) - for suspect and interacting drugs 0.5mg – oral])
- for concomitant or drug not administered
Or Or
Reported medicinal product, displayed as
Drug List (Drug recoded against the Extended EudraVigilance PRODUCT
Char - G.k.2.2 Medicinal Product Dictionary for centrally [Substance]
Indication PT – authorised products (for non- centrally (S - Dental pain,
Action taken – authorised products, only the recoded substance Headache – Drug
[Duration - Dose - will be displayed where reported) withdrawn – [1d –
Substance / Specified Substance Name, 0.5mg – oral – More
Route– More in
displayed as recoded against the Extended in
ICSR]) G.k.2.3.r .1 EudraVigilance Medicinal Product Dictionary (if ICSR])
not, it will be displayed as reported)
Indication of the medicinal product described as
G.k.7.r.2 b MedDRA Preferred
Term
‘Duration of Drug Administration’, as reported or
based on ‘Drug Administration Start Date’ and
G.k.4.r.6 a ‘End Date’
G.k.4.r.1 a/b Dose of the medicine
G.k.4.r.1 Route of administration of the medicine
0.2
Missing data will be displayed ‘blank’ or ‘not available’.
By default the individual cases are sorted in descending order based on the ‘EV Gateway Receipt Date’
i.e. the most recently received case meeting the filtering conditions is the first one returned in the line
listing. Users wishing to sort the line listing differently should do so by exporting the data into an
appropriate application (See section 7.6. instructions on exporting the line listing).
As it is not possible to include all data elements for an ICSR in the line listing, an ICSR form is also
available for further review.
The ICSR form presents the data elements for an individual case as per the EudraVigilance Access Policy
(public access).
Data elements in the form are grouped into logical sections (e.g. drug, reaction, medical history) so that
the user can easily visualise the available information.
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6. Interpretation of web reports
The running total of individual cases available in Tab 1- Number of individual cases and Tab 2 –
Number of individual cases received over time is the value that should be used to quantify the total
number of spontaneous 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
undesirable effect(s) (adverse reactions) reported in an individual case; as an individual case may refer
to more than one suspected undesirable effect, the information shown in Tab 3, 4, 5 and 6 does NOT
represent the total number of individual cases that have been reported to EudraVigilance, but the number
of related undesirable effects.
The table provides an example of the number of running total of individual cases (Tab 1) and how this
information appears in Tab 3, 4, 5 and 6
Number of Reported Suspected Adverse Number of individual cases Number of individual
individual Reaction and corresponding shown by Reaction Groups cases shown by
cases Reaction Group(s) Reported Suspected
(Tab 4 and Tab 5)
Adverse Reaction
(Tab 1)
(Tab 6)
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1 individual Reaction A -> Reaction Group X 1 case for Reaction A
1 case for Reaction Group X
case Reaction B -> Reaction Group X 1 case for Reaction B
1 individual Reaction A -> Reaction Group X 1 case for Reaction Group X 1 case for Reaction A
case Reaction C -> Reaction Group Y 1 case for Reaction Group Y 1 case for Reaction C
In this example, the web report shows two individual cases for the medicine or active substance selected
in Tab 1; using the classification of the MedDRA dictionary, the suspected adverse reactions are
associated to the corresponding Reaction Groups.
In Tabs 3 and 4, the number of individual cases shown depends on the number of Reaction Groups in
each individual case; the same individual case appears as many times as there are distinct Reaction
Groups.
In Tab 6, the number of individual cases shown depends on the number of suspected adverse reactions
in each individual case; the same case appears as many times as there are distinct suspected adverse
reactions.
7. Web report functionalities
7.1. General Navigation
Users of the adrreports.eu portal can access details of the ICSRs submitted to EudraVigilance by name
of the medicine (for centrally authorised products), or by name of the active substance of a medicine for
non-centrally authorised products). Users can access reports via the Search page of the adrreports.eu
portal by selecting a product or active substance from the alphabetical overview menu.
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Once a product / active substance is selected, a corresponding web report is launched in the browser. To
navigate between tabs, click on the tab of interest at the top of the window.
7.1.1. Graph/Grid view
The web report allows to quickly change from a Graph view to a Grid view (and back) by clicking on
the icon.
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7.1.2. Legend
The Graph view allows visualising relevant information by hovering the mouse over the graph.
7.2. Navigation in Tab 2 – Number of individual cases received over time
Individual data points on the trend line available in Tab 2 can be viewed by hovering the mouse over
the trend line at a position corresponding to the desired month.
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7.3. Navigation in Tab 4 – Number of individual cases by reaction groups
This allows to select the variable for the reaction group data by using the relevant tab.
7.4. Navigation in Tab 5 – Number of individual cases for a selected
reaction group
This allows choosing and clicking on a Reaction Group to view the corresponding information.
7.5. Navigation in Tab 6 – Number of individual cases for a selected
adverse reaction
An interactive selector allows choosing a reaction group and a reported suspected adverse reaction. The
reaction group and the reported suspected adverse reaction can be selected from the MedDRA dictionary
and are part of the same classification:
1. This allows choosing and clicking on a Reaction Group:
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2. The list of reported suspected adverse reactions belonging to that group is updated
accordingly;
3. This allows choosing and clicking on a Reported Suspected Reaction to see the corresponding
information:
If a reaction group or a reported suspected reaction cannot be found, this means that no spontaneous
reports with the undesirable effect (adverse reaction) for this medicine or active substance have been
submitted so far to EudraVigilance, i.e. there are no individual cases available.
7.6. Navigation in Tab 7 – Line Listing
7.6.1. Filtering the Line Listing
A list of nine filtering conditions is available to create a customised line listing of individual cases relating
to the selected medicinal product or active substance. If more than one filtering condition is selected,
the logical condition will be an ‘AND’ condition. Clicking on a filtering condition will open a list of all
possible filtering options, which can be selected via the appropriate tick-box.
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Multiple filtering conditions can be specified using this view or alternatively through the advanced value
selection menu. This can be accessed by clicking the “Search…” field at the bottom of any filtering option
list (see the section in the red box in the figure above). If the option ‘Match Case’ is selected, the search
will be performed for the specific text string in the ‘Search’ box.
This view provides enhanced filtering criteria search functionality, including the ability to search for values
starting with, ending with, or containing stated characters, and the ability to select / deselect multiple
options. Users can also manually enter a filtering condition using this view by clicking on the pencil icon
(see the section in the green box in the figure below) and by typing the condition into the text box.
For numerical filtering conditions such as the EudraVigilance Gateway Date, the advanced value selection
menu enables users to search for all possible values within the stated parameters (see figure below).
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Once all desired filters are selected, users can access the line listing of all pertinent cases by clicking
“Run Line Listing Report”.
7.6.2. Line Listing and ICSR Form functionality
Once a user has submitted their filtering criteria, a corresponding line listing of cases submitted to
EudraVigilance will be returned. Details of the data provided in this line listing are explored in section
5.7. The returned line listing displays up to 25 reports matching the filtering criteria stipulated by the
user. If there are more than 25 cases, users can navigate through the dataset using the buttons at the
bottom of each page:
Users can also select other functions using the buttons situated at the bottom left of each page:
Return navigates the user back to the line listing filtering menu detailed in section 7.6.1.
Refresh prompts the system to re-apply the previously defined filtering conditions to the live
EudraVigilance data set.
Print presents the line listing in a printable format as either a PDF or html page, based on the user’s
preference.
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Export enables users to download the line listing data into one of file formats listed in the table below:
Export category Export option File type
PDF Adobe Portable Document Format .pdf
Excel 2003 compatible workbook .xls
Excel
Excel 2007+ compatible workbook .xlsx
PowerPoint 2003 compatible
.ppt
presentation
Powerpoint
PowerPoint 2007+ compatible
.pptx
presentation
Web Archive MIME HTML web archive file .mht
Comma-separated value file .csv
Tab delimited comma-separated value
Data .csv
file
XML Format .xml
Downloads are limited to 13,000 rows for Excel 2003/2007 and PDF/PowerPoint; and 100,000 rows for
CSV, Tab delimited and XML. An ICSR form is also available for each report included within the queried
line listing, when clicking ICSR form in the last column of the line listing.
These can be downloaded as a .pdf file and contain data elements from the ICSR according to the
EudraVigilance Access Policy (public access). For further information regarding the data elements
included in the ICSR form, refer to section 5.7.
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8. List of acronyms used in the document
Acronym Meaning
CSV Comma-separated value file
EEA European Economic Area
EMA European Medicines Agency
EU European Union
EV EudraVigilance
ICSR Individual case Safety Report
NCA National Competent Authority of an EEA Member State
PT Preferred Term
SOC System Organ Class
ICH International Council for Harmonisation of Technical Requirements for Pharmaceuticals
for Human Use
PDF Portable Document Format
XML Extensible Markup Language
MedDRA Medical Dictionary for Regulatory Activities
MIME Multipurpose Internet Mail Extensions
HTML HyperText Markup Language
9. Supporting documents
Guidance on the interpretation of spontaneous case reports of suspected adverse reactions
to medicines
https://www.ema.europa.eu/en/documents/report/guide-interpretation-spontaneous-case-reports-
suspected-adverse-reactions-medicines_en.pdf
EudraVigilance Access Policy -
https://www.ema.europa.eu/en/human-regulatory-overview/research-
development/pharmacovigilance-research-development/eudravigilance/access-eudravigilance-data
EU ICSR Implementation Guide -
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2014
/04/WC500165979.pdf
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来源：EMA Regulatory and Procedural Guidelines · ema.europa.eu