Canada Vigilance adverse reaction online database: Interpreting the dashboard output

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Dashboard output

Consumer view

The following data summaries are available in the consumer view of the dashboard:

Advanced view

The advanced view of the dashboard includes the following additional data summaries:

Report listings output

A table of individual adverse reaction reports is available from the advanced view of the dashboard in the "Adverse Drug Reaction Drilldown" link in the "Navigation" panel. The following table provides the field names in the database. Definitions for each of the terms below is provided in the glossary.

Heading Field name
Active ingredient: concomitant product report_ingredient_concomitant
Active ingredient: suspect product report_ingredient_suspect
Adverse event report number report_no
Adverse event report version number version_no
Adverse reaction term reaction_pt_en
Age patient_age
Age group patient_age_group_en
Brand name: concomitant product report_drugname_concomitant
Brand name: suspect product report_drugname_suspect
COVID product covid_product
Date received: initial datintreceived
Date received: latest datreceived
Sex patient_gender_en
Height patient_height
Height: units patient_height_unit_en
Indication report_indication_en
Market authorization holder AER number mah_no
MedDRA system organ class reaction_soc_en
Reason for seriousness: congenital anomaly congenital_anomaly
Reason for seriousness: death death
Reason for seriousness: disability disability
Reason for seriousness: hospitalization hosp_required
Reason for seriousness: life threatening life_threatening
Reason for seriousness: other medically important condition other_medically_imp_cond
Report outcome outcome_en
Reporter type reporter_type_en
Serious report seriousness
Source of report source_en
Type of report report_type_en
Weight patient_weight
Weight: units patient_weight_unit_en

JSON data structure

The detailed adverse reaction report information is available in a table or JSON format. The following technical information is provided for users who are familiar with working with JSON objects.

The main JSON object consists of a series of values, some of which are nested arrays and nested objects. Details can be found in the following tables. Field names that begin with underscores refer to system fields. Note that there can be missing information for any of the values listed.

fields Nested object: This object provides information about the report and patient
Value logical name Value physical name Data type
Reason for seriousness: death death Logical (true/false)
Adverse event reaction number plus version number aer_id Number
Market authorization holder adverse event report number mah_no String
Detailed reaction information reactions Nested array
Adverse event report number (6 digits) report_id Number
Adverse event report number (9 digits) report_no String
Report source: English source_en String
Report source: French source_fr String
Disability disability Logical (true/false)
Report outcome: English outcome_en String
Report outcome: French outcome_fr String
Adverse event report version number version_no Number
Latest received date datreceived Date
Age patient_age Number
Serious adverse reaction seriousness Logical (true/false)
Date of last refresh last_refresh Date
COVID-19-related product covid_product Logical (true/false)
Hospitalization required hosp_required Logical (true/false)
Age in years patient_age_y Number
Initial received date datintreceived Date
Adverse reaction preferred terms: English reaction_pt_en Array
Adverse reaction preferred terms: French reaction_pt_fr Array
Type of report: English report_type_en String
Type of report: French report_type_fr String
Adverse reaction system organ class: English reaction_soc_en Array
Adverse reaction system organ class: French reaction_soc_fr Array
Life-threatening life_threatening Logical (true/false)
Reporter type: English reporter_type_en String
Reporter type: French reporter_type_fr String
Sex: English patient_gender_en String
Sex: French patient_gender_fr String
Congenital anomaly congenital_anomaly Logical (true/false)
Number of drugs included in the report n_drugs_per_report Number
Detailed drug information report_drug_detail Nested array
Age unit: English patient_age_unit_en String
Age unit: French patient_age_unit_fr String
Indications for all drugs included in the report: English report_indication_en Array
Indications for all drugs included in the report: French report_indication_fr Array
Brand name of suspect product(s) report_drugname_suspect String
Other medically important condition other_medically_imp_cond Logical (true/false)
Active ingredient of suspect product(s) report_ingredient_suspect Array
Brand name of concomitant product(s) report_drugname_concomitant Array
Active ingredient of concomitant product(s) report_ingredient_concomitant Array
Linked report details report_links Nested array
 
reactions Nested array: Objects in this array provide details on the reaction(s) listed in the report
Value logical name Value physical name Data type
Adverse reaction term: English pt_name_en String
Adverse reaction term: French pt_name_fr String
Reaction identifier reaction_id Number
System organ class: English soc_name_en String
System organ class: French soc_name_fr String
MedDRA version meddra_version String
 
report_drug_detail Nested array: Objects in this array provide details about the drug(s) listed in the report
Value logical name Value physical Name Data type
Adverse event reaction number plus version number aer_id Number
Brand name drugname String
Adverse reaction report number (6 digits) report_id Number
Suspect product identifier product_id Number
Active ingredient name ingredients String
Product record identifier seq_product Number
Therapy record identifier seq_therapy Number
Dose unit: French dose_unit_fr String
Dosage form: French dosageform_fr String
Dose unit: English dose_unit_eng String
Dosage form: English dosageform_eng String
Health product role: French druginvolv_fr String (concomitant/drug used to treat adverse effect/suspect)
Route of administration: French routeadmin_fr String
Dose unit_dose_qty Number
Health product role: English druginvolv_eng String (concomitant/drug used to treat adverse effect/suspect)
Route of administration: English routeadmin_eng String
Dosage form code dosageform_code String
Drug product identifier drug_product_id String
Health product role code druginvolv_code String
Route of administration code routeadmin_code String
Therapy duration therapy_duration Number
Frequency unit: French freq_time_unit_fr String
Frequency time: French frequency_time_fr String
Frequency unit: English freq_time_unit_eng String
Frequency time: English frequency_time_eng String
Indication: French indication_name_fr String
Frequency unit code freq_time_unit_code String
Indication: English indication_name_eng String
Therapy duration: French therapy_duration_fr String
Therapy duration: English therapy_duration_eng String
Therapy duration code therapy_duration_code String
 
report_links Nested array: Objects in this array provide details about the linked/duplicate report(s)
Value logical name Value physical name Data type
Record type: English record_type_en String (duplicate/linked)
Record type: French record_type_fr String (duplicate/linked)
Report link identifier report_link_id Number
Duplicate or linked adverse reaction report number report_link String
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