Canada Vigilance adverse reaction online database: How to use the dashboard
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About the dashboard
The new interface (visualization) for the Canada Vigilance Adverse Reaction Online Database is called the Canada Vigilance Dashboard. It's an interactive, web-based tool that will make it easier to search the data and view the information and results.
If you wish to provide comments or if you encounter problems with the dashboard, you may email us at CVInterfaceFeedback.CommentairesInterfaceCV@hc-sc.gc.ca.
There are 2 displays of the dashboard offering slightly different features: the consumer view and the advanced view. The consumer display provides straightforward search options and several basic summaries of the data. The advanced display provides a few additional data visualizations as well as access to report line listings and data download.
In both dashboard displays, the default view provides a summary of all adverse reaction reports received through the Canada Vigilance Program since January 1, 2010, to the latest date that data are available. This is 90 days before the date of access for most reports and 7 days before for reports involving treatments and vaccinations for COVID-19. For details, refer to the "What is the database" section of the "Overview" page.
It's best to view the dashboard from a large screen.
The search methods described as follows apply to both the consumer and advanced views of the dashboard.
Use the search bar at the top of the dashboard to do a general search of the database. It will give you reports where the search terms appear anywhere in a given report. For example, if an active ingredient or brand name is entered, reports with that active ingredient or brand name listed as a suspect product or as a concomitant medication will be included in the search results.
Pay particular attention to search terms that could refer to both patient characteristics and reaction terms. For example, searching "pregnant" or "pregnancy" will return reports that include "pregnant" or "pregnancy" in the adverse reaction term (like pregnancy on contraceptive, bleeding during pregnancy and maternal exposure during pregnancy), and not necessarily all reports where the patient was pregnant.
A search for a particular active ingredient or brand name as a suspect product using this search bar will result in a synonym search. That is, the search will retrieve adverse reaction reports whose suspect product includes the active ingredient or brand name as well as other active ingredients or brand names that are the same but have a different name (that is, synonyms of the active ingredient or brand name).
For exact searching, please follow the instructions for Suspected Health Product Search Criteria.
You can do multiple searches at the same time by including "and" between search terms. The search results will include all reports that mention all of the search terms. If you use "or" between search terms, you will get reports where at least 1 search term is mentioned. If the desired search term contains multiple words, enclose search term in quotation marks.
By clicking on the empty search bar, a drop-down list of items will appear, which will allow you to search a particular data field. Autocomplete will assist with term selection. You must use a colon to separate the field and search term. For example, if you want to search for adverse reactions related to a drug called DRUGNAME, type "report_drugname_suspect : DRUGNAME" into the search bar.
This method of searching can be useful for performing wildcard searches. One example of a wildcard search is to include an asterisk (*) at the end of your search term. For instance, if we use our same DRUGNAME example, you could type in "report_drugname_suspect : DRUGNAM*" in the search bar and press enter. This allows you to search for variable endings of the search term "DRUGNAM". The search syntax is defined at the right of the search bar (the options are Kibana Query Language (KQL) or Lucerne).
For more information on complex syntaxes, please consult the complete reference.
Suspected health product search criteria
You can search by brand name or active ingredient using the search panels on the upper left-hand side of the dashboard. For active ingredient searches, use the Search by Suspect Ingredient panel. For brand name searches, use the Search by Suspect Brand Name panel.
For either search, begin by entering at least 1 letter of the active ingredient or brand name you would like to retrieve. Once you have started typing, a list of active ingredients or brand names will appear. The list will include single and multi-ingredient products. You may select the product of interest by clicking on it.
To search for multiple active ingredients or multiple brand names, type a second set of at least 1 letter and select the active ingredient or brand name from the list that appears. You may repeat this process as many times as necessary to obtain the complete list of active ingredients or brand names you would like to retrieve.
The selected active ingredients or brand names will appear in white boxes in the search panel. The dashboard graphics will automatically update to reflect the search results.
To remove an active ingredient or brand name from your search, simply click on the "x" on the right-hand side of the white box.
When searching by brand name or by active ingredient in this database, use the English version of a brand name or active ingredient. The accented character will be replaced by the non-accented equivalent during the search. While every effort has been made to make coded data available in both official languages, searching on non-coded attributes may not reliably retrieve reports submitted in the other official language. This is because the reports submitted to the Canada Vigilance Program are often not bilingual.
Searching by brand name retrieves adverse reactions specific to the product's brand name selected. However, there may be multiple brand names for the same active ingredient. To expand the scope of a search, consider searching by active ingredient.
Adverse reaction term search criteria
Adverse reaction information is coded in the database using terminology from the Medical Dictionary of Regulatory Activities (MedDRA). This dictionary includes standardized terms for symptoms, signs, diseases, syndromes and diagnoses.
To specify adverse reaction term criteria when searching the database, search by the adverse reaction preferred term or system organ class. All adverse reactions will be included in the search if an adverse reaction term is not specified.
To search for an adverse reaction preferred term or MedDRA SOC, simply type the term of interest in the main search bar. You may also use the "+ Add filter" button on the top left of the dashboard and enter "reaction_pt_en" or "reaction_soc_en" in the "Field" box, respectively. Under "Operator", select "is" from the drop-down menu. Under "Value", enter the adverse reaction preferred term of interest. Finally, click save to perform the search. The dashboard will update automatically. You can repeat either process to include other adverse reactions or system organ classes of interest.
Searching by system organ class can be useful when searching for reports grouped by such things as:
- aetiology (for example, infections and infestations)
- manifestation site (for example, gastrointestinal disorders) or
- purpose (for example, surgical and medical procedures)
Note that MedDRA contains over 18,000 unique adverse reaction terms. Thus, it may be difficult to retrieve all the cases associated with 1 broad medical concept without using a system organ class or by performing multiple searches using a similar adverse reaction terms.
Once you have searched for an active ingredient, brand name and/or adverse reaction, you can use filters to narrow the search results. The methods for filtering your results apply to both the consumer and advanced views of the dashboard. You have several options for filtering:
- date range
- patient characteristics
- source of report
- report outcome
Filters can also be applied using the main search bar by typing in the desired field name followed by a colon followed by the term. For example, if you wanted to look at only reports coming from hospitals, you would type "source_en : hospitals". Multiple filters can be applied at the same time using an "and" between terms.
To customize the date range of your search, click on the date in the upper right-hand corner next to the "Refresh" button. This will open a calendar where you can specify your start date. Or, type in your start date underneath the calendar using the MMM D, YYYY format, where MMM is the first 3 letters of the month of interest, D is the day and YYYY is the 4-digit year of interest.
You can specify the end date in the same way by selecting "now" on the right-hand side of the arrow, if you want your end date to be before the current date. You can also customize the date range by highlighting the period of interest in the histogram found in the "Report Timeline" panel. It's more difficult to be precise in your date range using this approach. To undo your selection or to reset the date range using either method when viewing the advanced dashboard, click "Reset Time Filter" in the "Navigation" panel.
You can specify criteria related to the patient(s) who experienced the adverse reaction(s) described in each report, including sex and age, using the "+ Add filter" button located at the top of the dashboard. You can specify patient age (in years) by selecting "patient_age_y" from the "Field" drop-down menu and "is between" from the "Operator" drop-down menu. You can then specify the desired age range. Clicking "Save" will apply this age range to your search results.
If the person who reported the adverse reaction (the 'reporter') provided an age such as 5½ years old in the report, we have rounded the age up to the closest year. Note that the upper limit of the age range is not included in the search. For example, if you wish to search for patients up to and including age 30 years, you would select the age range 0 to 31 years. Similarly, if you wish to search for patients less than 1 year of age, select the age range 0 to 1 year.
You may also select a particular age group by selecting "patient_age_group_en" from the "Field" drop-down menu and "is" from the "Operator" drop-down menu. You may then select the age group of interest from the "Value" drop-down menu. Possible age groups include the following:
- neonate (from birth up to 25 days old)
- infant (from 25 days to 1 year old)
- child (1 year old up to 13 years old)
- adolescent (13 years old up to 18 years old)
- adult (18 years old up to 65 years old) and
- elderly (65 years old or older)
Click "Save" to apply the filter to the dashboard.
You can specify patient sex by using the "+ Add filter" button located at the top of the dashboard. Select "patient_gender_en" from the "Field" drop-down menu and "is" from the "Operator" drop-down menu. Then select "female" or "male" from the "Value" drop-down menu. Click "Save" to apply the filter to the dashboard.
You can narrow your search results by seriousness of the adverse reaction report in 2 ways. If you want to get adverse reaction reports that contain only serious or non-serious adverse reactions, select "seriousness" from the "Field" drop-down menu of the "+ Add filter" button and select "is" from the "Operator" drop-down menu. Then select "true" or "false" from the "Value" drop-down menu. Click "Save" to apply the filter to the dashboard.
If you're interested in a particular seriousness category, you will need to type in the category field name from the "Field" drop-down menu of the "+ Add filter" button and select the desired reason. Select "is" from the "Operator" drop-down menu and then select "true" from the "Value" drop-down menu. The field names for the seriousness categories are:
- death: death
- life-threatening: life_threatening
- hospitalization required: hosp_required
- congenital malformation: congenital_anomaly
- disability: disability
- other medically important condition: other_medically_imp_cond
Conversely, if there is a reason for seriousness that you would like to exclude, follow the same procedure and select "false" from the "Value" drop-down menu. Click "Save" to apply the filter to the dashboard.
Note that not all reports marked as serious have a reason for seriousness included in the report.
Source of report
The source of report indicates the location through which the reporter sent the report. You may narrow your search results by selecting "source_en" from the "Field" drop-down menu of the "+ Add filter" button and then "is" from the "Operator" drop-down menu. Select the source of interest from the "Value" drop-down menu. Click "Save" to apply the filter to the dashboard.
You may also narrow your search results on the report outcome. From the "Field" drop-down menu of the "+ Add filter" button, select "outcome_en" and "is" from the "Operator" drop-down menu. Then select an outcome of interest from the "Value" drop-down menu. Possible selections are as follows:
- not recovered/not resolved
- recovered/resolved with sequelae
Click "Save" to apply the filter to the dashboard.
The dashboard updates automatically every time that filters are applied to the search. For interpretations for each panel of the dashboard, see the "Interpreting the dashboard output" page.
From the advanced view of the dashboard, you can view a table of individual adverse reaction reports. To do so, click on the "Adverse Drug Reaction Drilldown" link in the box located in the "Navigation" panel. One hundred matching records are displayed on each page of the table, unless otherwise specified. You can modify the number of records displayed on each page of the table by clicking on the "Rows per page" in the bottom left of the table. You may view 25, 50, 100 or 250 records at a time.
Click on the greater than (>) symbol in the bottom right-hand corner of the table to view the next set of results. For definitions for each of the columns, see the "Interpreting the dashboard output" page. Blank fields mean that the reporter did not provide information for these fields. Highlighted entries in the table indicate matched search terms.
You can adjust the column widths of the table by hovering your mouse between the column headers until you see a white, double-sided arrow. Click and drag your mouse to the left or to the right to make the column narrower or wider.
To adjust the order of the columns, click on "Columns" in the upper left-hand corner of the table, where the column headers are listed. Simply drag the column headers up and down the list to change the order.
You can sort each column in the table by clicking on the down arrowhead (v) on the right of each column header. Depending on the nature of the column contents, the column can be sorted alphabetically or by age.
To access complete information for a specific report, click on the "expand" icon on the left of the corresponding row. A new inset will appear on the right of your screen, which will display the detailed information of the report. You can view this information in a table or JSON format. To view the contents of subsequent reports in the table in the same window, click on the greater than (>) symbol in the upper right-hand corner of the inset. Click on the "x" in the uppermost right-hand corner to exit from the inset window.
You can add other fields to the table by clicking on the "toggle column in table" icon found in the 4 hidden icons to the left of the field name. To access the hidden icons, hover your mouse over the white space to the left of the field name and select the third icon from the left. The new fields will be automatically added to the table as they are selected. As more fields are added, the table will become too wide for the screen and a scroll bar will appear at the bottom of the table, which will allow you to view all columns in the table.
To save your search results as a comma-separated values (CSV) file, click on the 3 dots in the upper right-hand corner of the table, select "More" and select "Download CSV". A CSV file is a delimited text file that uses commas to separate values. This type of file can be viewed using Microsoft Excel. The column headers of the CSV file will be the corresponding variable names found in the database. The table displaying the database names and aliases is provided in the "Interpreting the dashboard output" page. The custom download will only include the fields and rows appearing in the main table. Be sure to add all fields of interest to the table before downloading your data.
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