The glossary contains a list of the fields and terminology used in the Canada Vigilance Adverse Reaction Online Database along with their definition.
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. The name and strength of each active ingredient contained in a health product is indicated on its packaging or label. Health products can contain multiple active ingredients. The same active ingredient(s) may be marketed under different brand names.
When conducting a keyword search by active ingredient in this database, the English version of an active ingredient should be used. International characters, such as accents and symbols, are not recognized in the database and should be avoided as part of keywords. The sources for active ingredient are the Drug Product Database (DPD) and Licensed Natural Health Products Database (LNHPD). Product information found within the DPD and LNHPD databases originates from organizations that are not subject to the Official Languages Act.
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 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 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
When a regulator is the initial sender this number should populated with their unique identifier. This number should remain unchanged for any transmissions subsequent to the original transmission. Re-transmitters should not change this number. No case should ever have an authority number and company number.
The brand name is the name assigned by the manufacturer under which the product is sold or advertised. A health product's brand name is indicated on its packaging or label. Multiple brand names may exist for products containing the same active ingredient. The same active ingredient(s) may be marketed under different brand names.
When conducting a keyword search by brand name in this database, the English version of a brand name should be used. International characters, such as accents and symbols, are not recognized in the database and should be avoided as part of keywords. The sources for brand name are the Drug Product Database (DPD) and Licensed Natural Health Products Database (LNHPD). Product information found within the DPD and LNHPD databases originates from organizations that are not subject to the Official Languages Act.
Also see Active Ingredient and Suspected Health Product.
Possible reasons why the duplicate adverse reaction report number indicated in the
Duplicate or Linked Adverse Report Report (AER) Number field did not appear in the list of retrieved reports:
- Time period searched does not cover the Initial Received Date for the duplicate reports. For example, a search was performed for the period January 1, 2008 to December 31, 2008. A duplicate report for report X (report Y) was received in February 2009. The report X will indicate the duplicate report Y in the Duplicate or Linked AER Number field but report Y will not appear in the list of retrieved reports.
- Report X has been determined to be a duplicate of report Y due to the patient identifiers, suspect product, dose, therapy dates and date of onset, however, the description of the AR within report X is not identical to the adverse reaction described in its duplicate report Y. Adverse reaction term selection is based on the reporter's description of the adverse reaction; therefore the same adverse reaction described differently by 2 individual reporters would result in different adverse reaction terms selected. The duplicate might not appear in the list of retrieved reports depending of the adverse reaction term searched. For example, report X reports Anaphylactic shock as the adverse reaction and report Y reports only the symptoms and no diagnosis (i.e. Hypotension, Hyperventilation, Dyspnea, Bronchospasm, etc.) therefore, if a search is performed with the adverse reaction term Anaphylactic shock only, it will not retrieve the report Y.
- When adverse reaction reports for a single patient are based on literature articles reported by market authorization holder, as per their regulatory reporting requirements, the suspect product may be dependent on the particular market authorization holder that is reporting it. This means that a product that is suspect in one report may been a concomitant in the duplicate report.
When a company is the initial sender this number should populated with their unique identifier. This number should remain unchanged for any transmissions subsequent to the original transmission. Re-transmitters should not change this number. No case should ever have an authority number and company number.
- 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.
- 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).
E2B Safety Report Number
This unique identifier is the complete safety report identification number assigned to the case by the sender. This identifier remains constant in subsequent transmissions of the case by the same sender. Re-transmitters should replace this value with their own unique identifier.
- How often the drug was being taken or administered at the time the reaction occurred.
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 of the patient when the adverse effect occurred in centimetres or inches.
Indication refers to the particular condition for which a health product was taken.
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 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".
The reference to the literature article where the case(s) originated from.
- 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
- The adverse reaction data contained within this online database is coded using MedDRA terminology. MedDRA is composed of standardized terms for symptoms, signs, diseases, syndromes and diagnoses. The terminology is organized into five distinct levels of hierarchy ranging from System Organ Class (SOC), High Level Group Term (HLGT), High Level Term (HLT), Preferred Term (PT), to Low Level Term (LLT). These groupings aid in the retrieval, evaluation, and presentation of adverse reaction data coded with MedDRA.
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 adverse reaction 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 adverse reaction reports previously contained in this online database.
- 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 15.0 of MedDRA, there are over 18,000 unique preferred terms. Therefore, when searching adverse reaction data, it may be difficult to retrieve all the cases associated with one broad medical concept without using a System Organ Class (SOC) or by performing multiple searches using a variety of similar adverse reaction terms.
- MedDRA System Organ Class ( SOC)
- A System Organ Class is the highest level of the hierarchy that provides the broadest concept for data retrieval. An SOC contains several similar adverse reaction terms that relate to one specific organ system of the body (i.e. Cardiac Disorders). SOCs are useful when searching for a set of similar adverse reaction terms (i.e. Cardiac arrest and Heart attack).
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
- 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
A product monograph is a factual, scientific document on the drug product that, devoid of promotional material, describes the properties, claims, indications, and conditions of use for the drug, and that contains any other information that may be required for optimal, safe, and effective use of the drug.
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
- Life Threatening
- Other Medically Important Condition
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.
- Recovering/resolving - The patient is continuing to recover.
- Unknown - The reporter of report did not know the outcome at the time the report was submitted.
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)
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).
- Hospital - Report received directly from a hospital.
- MAH (Market Authorization Holder) - Report received from a MAH.
- Other - Reports received from other source.
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
Indicates the health product that was suspected to have caused the reported reaction. For the purpose of the database health products include prescription and non-prescription medications; natural health products; biologics (includes biotechnology products, vaccines, fractionated blood products, human blood and blood components, as well as human cells, tissues and organs); radiopharmaceuticals; and disinfectants and sanitizers with disinfectant claims. Information concerning vaccines used for immunization have only been included in the database since January 1, 2011. Information concerning human blood and blood components has only been included in the database since September 1, 2015.
Health products possess both a brand name, the name under which the product is marketed, as well as one or more active ingredients, the names of the components that have medicinal properties.
Also see Brand Name and Active Ingredient.
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:
- Other - The report originates from another program or source.
- Published - The report originates from an article published in health professional literature.
- Safety Update Report - The report originates from a safety update report.
- 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 of the patient when the adverse effect occurred in kilograms or pounds.