Glossary of Fields in the Canada Vigilance Adverse Reaction Online Database

The glossary contains a list of the fields and terminology used in the Canada Vigilance Adverse Reaction Online Database along with their definition.

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Active Ingredient
An active ingredient is any component that has medicinal properties, and supplies pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body of man or other animals.

Adverse Reaction Report (AER) Number
The adverse reaction report number is the identification number of the report assigned by Health Canada.

Adverse Reaction Report (AER) Version Number
The adverse reaction report version number of the report assigned by Health Canada. Version 0 is considered the initial version of the report. Subsequent version numbers refer to follow-up reports.

Age
Age of the patient when the adverse effect occurred. Age specific searches may be completed by specifying an age or a range of ages from the pick list. Ages have been rounded up to the closest year for searching, but are displayed in the results as received. Where the age is unknown, the reporter has not specified the patient's age in the report, or the reporter is unaware of the age. To retrieve cases where the age of the patient is "Unknown", the "age to" criteria must be set to "ALL".

Age Group
Age group of the patient when the adverse effect occurred. The age group values are as follows:

• Adolescent: greater or equal to 13 and less than 18 years
• Adult: greater or equal to 18 and up to 65 years, inclusively
• Child: greater or equal to 1 and less than 13 years
• Elderly: greater than 65
• Infant: greater than 25 days and less than 1 year
• Neonate: greater than zero and up to 25 days, inclusively

Brand Name
This is the brand name or trade name under which the health product is marketed.

Dosage Form
The dosage form is the form of presentation in which the product is supplied. It is the combination of the form in which a pharmaceutical product is presented by the manufacturer (form of presentation) e.g., tablet, capsule, powder, etc., and the form in which it is administered including the physical form (form of administration) e.g. powder for solution. A product can have more than one dosage form when it is a kit (e.g., tablet, capsule).

Dose
Amount or dose of the drug administered at the time the reaction occurred.

Duplicate Report
Duplicate reports are reports related to the same patient and event received from more than one source (e.g., pharmacist and consumer). Each duplicate report received will appear separately on the summary and will be identified as duplicate in the Link/Duplicate Report Information field. Please note that there may be additional reports that have not yet been identified as duplicates.

Duplicate or Linked Adverse Reaction Report (AER) Number
The identification number(s) of the related report(s).

Feature of Report
The feature of report represents the scope of the report. It is represented as one of the following:

• Accidental exposure - A noxious or unintended response to a drug occurring in a person who was not using the medication for treatment but was exposed to the medication by other than oral means.
• Accidental ingestion - A noxious or unintended response to a drug by a person who accidentally ingested (took orally) a drug product.
• Adverse reaction - A noxious or unintended response to a drug occurring at doses normally used or tested for the diagnosis, treatment or prevention of a disease or modification of an organic function.
• Drug abuse - A health product use disorder characterized by the intentional use of a mood or behaviour-altering substance for a reason other than that for which it was intended, or in a manner or in quantities other than directed.
• Drug dependency - Compulsive use of a health product despite significant problems resulting from such use. It may include taking the product longer or in larger amounts than planned, repeatedly expressing a desire or attempting unsuccessfully to cut down or regulate use, or continuing use in the face of acknowledged product-induced physical or mental problems.
• Drug misuse - Intentional or unintentional use of a health product for a reason other than that for which it was intended, or in a manner or in quantities other than as directed.
• Drug withdrawal - A noxious or unintended response to a drug occurring after and related to the discontinuation of a medication.
• Mother/child report - Report in which administration of medicines to a mother or father results in a "suspected" reaction in child/fetus.
• Manufacturing change/problem - Report that describes a manufacturing change or problem (e.g., a change in dosage form or formulation).
• Medication error - A medication error is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labelling, packaging, and nomenclature; compounding; dispensing; distribution administration; education; monitoring; and use. (National Coordinating Council for Medication Error Reporting and Prevention - NCC MERP).
• Overdose - A noxious or unintended response to a drug occurring at doses in excess of those used or tested for the diagnosis, treatment or prevention of disease or modification of an organic function. Overdose does not apply if physician has intentionally prescribed a dose in excess of the labelled dose recommendations.

Frequency
How often the drug was being taken or administered at the time the reaction occurred.

Gender
Gender of the patient as it was provided by the reporter. Gender specific searches may be completed by choosing the required gender(s) from the list of options. Where the gender is unknown, the reporter is unaware of the gender. Those reports with unknown gender will only be included in searches where the gender criteria is set to "ALL" or "Unknown". Where the gender is not specified, the reporter did not specify the gender of the patient. Those reports with not specified gender will only be included in searches where the gender criteria are set to "ALL" or "Not specified".

Health Product Role
The characterization of the role of the product as provided by the original reporter. The health product role represents the suspicion, opinion or observation of the individual reporter. Cause and effect relationships have not been established.

Health product role is represented by one of the following:

• Concomitant - The health product is not suspected, but the patient was taking it at the time of the adverse reaction.
• Drug Used to Treat Adverse Effect (AE) - The health product was administered to treat the adverse reaction.
• Suspect - The reporter suspects that the health product caused the adverse reaction.

Height
Height of the patient when the adverse effect occurred in centimetres or inches.

Initial Received Date
The date the first version (version 0) of the adverse reaction report was received by Health Canada's Marketed Health Products Directorate.

Latest Received Date
The date that the last follow-up report was received by Health Canada's Marketed Health Products Directorate. Latest received date is the same date as initial received date if no follow-up reports have been received.

Linked Report
Linked reports are reports where the product suspected of causing the adverse reaction was utilized by one patient and a second patient who received the product via an alternate route of administration experienced an adverse reaction e.g. transplacental, semen. This would include reports concerning a parent/child where the parent utilized the product and the child/foetus experienced the adverse reaction. For reports received prior to January 1, 2008, information for parent-foetus/child cases may be found in two linked reports: one for the foetus/child and one for the parent patient. The reaction terms for a linked parent-foetus/child cases will only be found on the report for the foetus/child and the report for the parent will have "no adverse reaction" coded unless the parent experienced an adverse reaction.

See also "Note: Possible reasons why the duplicate adverse reaction report number indicated in the Duplicate or Linked Adverse Reaction Report (AER) Number field did not appear in the list of retrieved reports".

Market Authorization Holder Adverse Reaction Report (AER) Number
The version identification number assigned by the market authorization holder (MAH) for reports originating from a MAH.

Medical Dictionary for Regulatory Activities (MedDRA) Terminology and Updates
MedDRA is an internationally recognized set of terms used to facilitate the regulation of medical products. This standardized dictionary of medical terminology is used throughout the regulatory process to enter, retrieve, analyse and present data both before and after a product has been authorized for sale.

Updates to MedDRA
The adverse reaction (AR) data contained within this online database is coded using MedDRA terminology. This terminology is updated on a biannual, scheduled basis (and reflected in the database in May and November). Following each new version release of MedDRA, the AR data is reviewed and updated in order to reflect any changes that may have occurred to the terminology. Therefore, some MedDRA terms have changed in some AR reports previously contained in this online database.

More information concerning the MedDRA Terminology

MedDRA includes terminology for symptoms, signs, diseases and diagnoses. In addition, it contains standardized terms for:

• Device malfunction
• Medication errors
• Medical, social and family history information
• Sites (e.g., application, implant and injection site reactions)
• Surgical and medical procedures
• Therapeutic indications
• Types of investigations (e.g., liver function analyses, metabolism tests)

Adverse Reaction Term (MedDRA preferred Term)
Adverse Reaction Term is a distinct descriptor (single medical concept) for a symptom, sign, disease, diagnosis, therapeutic indication, investigation, surgical, or medical procedure, and medical, social, or family history characteristic. The list of adverse reaction terms in MedDRA is very extensive. For example, in version 12.0 of MedDRA, there are over 18,000 unique preferred terms.

MedDRA System Organ Class (SOC)
A System Organ Classes is the highest level of the hierarchy that provides the broadest concept for data retrieval. Each adverse reaction term is assigned one primary SOC.

There are 26 System Organ Classes in MedDRA, they include:

• Blood and lymphatic system disorders
• Cardiac disorders
• Congenital, familial and genetic disorders
• Ear and labyrinth disorders
• Endocrine disorders
• Eye disorders
• Gastrointestinal disorders
• General disorders and administration site conditions
• Hepatobiliary disorders
• Immune system disorders
• Infections and infestations
• Injury, poisoning and procedural complications
• Investigations
• Metabolism and nutrition disorders
• Musculoskeletal and connective tissue disorders
• Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Nervous system disorders
• Pregnancy, puerperium and perinatal conditions
• Psychiatric disorders
• Renal and urinary disorders
• Reproductive system and breast disorders
• Respiratory, thoracic and mediastinal disorders
• Skin and subcutaneous tissue disorders
• Social circumstances
• Surgical and medical procedures
• Vascular disorders

Reaction Duration
The time from start of the reaction to the end of reaction.

Reason for Seriousness
The reason for seriousness is represented by one of the following:

• Congenital Anomaly
• Death
• Disability
• Hospitalization
• Life Threatening
• Other Medically Important Condition

Report Outcome
The report outcome represents the outcome of the reported case as described by the reporter at the time of reporting and does not infer a causal relationship. The report outcome is not based on a scientific evaluation by Health Canada.

The report outcome can represent one of the following:

• Death - The drug may have contributed to the death.
• Not recovered/not resolved - The patient has not yet recovered.
• Recovered/resolved with sequelae - The patient recovered, but with an after effect possibly due to disease, injury, treatment, or procedure.
• Recovered/resolved - The patient fully recovered.
• Unknown - The reporter of report did not know the outcome at the time the report was submitted.

Reporter Type
Indicates who reported the adverse reaction and their relationship to the patient.

Route of Administration
Indicates the part of the body on which, through which or into which the product is to be introduced. (e.g., oral, topical, intramuscular, rectal, etc.)

Serious Report
Defined as yes or no. A serious report contains a serious adverse reaction, determined by the reporter of the report at the time of reporting.

Health Canada defines a serious adverse reaction as:

"A noxious and unintended response to a drug, which occurs at any dose and requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death. Important medical events that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the patient or may require intervention to prevent one of the outcomes listed above, may also be considered serious."

Source of Report
Indicates the location through which the reporter sent the report.

• Community - Report received from the community (e.g., pharmacy).
• Federal Government - Report received from the Federal Government.
• Hospital - Report received directly from a hospital.
• Hospital/Regional Centre - Report received from a hospital/Regional Adverse Reaction Reporting Centre.
• HPFB Regional Office (Health Product and Food Branch Regional Office) - Report received from the regional office of HPFB, Health Canada.
• Literature - Report received via a published article in health professional literature.
• MAH (Market Authorization Holder) - Report received from a MAH.
• Other - Reports received from other source.
• Poison Control Centre - Report received from a poison control centre.
• Professional Association - Report received from a professional association.
• Provincial Government - Report received from the Provincial Government.
• Regional AR Office (Regional Adverse Reaction Office) - Report received from a Canada Vigilance Regional Office.
• University - Report received from a university.

Strength
This refers to the strength of the active (medicinal) ingredient. If the strength is reported per dosage unit (e.g., 5 mL or 15 mL), this information will immediately follow the strength (e.g., 10 mg/5 mL).

Suspected Health Product

For the purpose of the database set it includes pharmaceutical drugs (which includes prescription and non-prescription pharmaceutical drugs); biologics as set out in Schedule D to the Food and Drugs Act (which include biotechnology products, therapeutic and diagnostic vaccines and fractionated blood products), but excluding blood and blood components and preventative immunization vaccines; radiopharmaceutical drugs set out in Schedule C to the Food and Drugs Act; and natural health products as defined in Section 1 of the Natural Health Products Regulations.

Also see Brand Name and Active Ingredient.

Therapy Duration
The amount of time the health product has been taken by the patient.

Type of Report
The type of report is represented by one of the following:

• Clinical Trial - Adverse reaction occurred during a post-market clinical trial.
• HIV Surveillance Report - Report generated through the HIV Surveillance Pilot Project.
• Other - The report originates from another program or source.
• PMS-Special Monitoring (Post-market Surveillance Special Monitoring) - Report concerning a marketed Canadian health product where all patients receiving the product are monitored for benefits and risks.
• Published - The report originates from an article published in health professional literature.
• Registry - The report originates from a registry or list of all patients who received the drug in Canada.
• Safety Update Report - The report originates from a safety update report.
• Solicited Report - The report was obtained through manufacturer sponsored patient support and disease management programs, surveys of healthcare providers or information gathering of efficacy or patient compliance.
• Special Access Program - The report concerns a product that is not marketed in Canada, but is available through the Special Access Program.
• Spontaneous - An unsolicited communication by healthcare professional or consumer to Health Canada that describes one or more adverse drug reactions in a patient who was given one or more medicinal products and that does not derive from a study or any organized data collection scheme.
• Study - The report was received as part of a post-marketing study.
• Unknown - The report originates from an unknown program or source.

Weight
Weight of the patient when the adverse effect occurred in kilograms or pounds.