Glossary

Subpopulations are groups within a population. The population might be defined by, for example, the presence of a certain disease of interest to researchers. A subpopulation within that will have additional traits, such as disease severity, or failure of previous treatments, or specific genetic traits, or belonging to a certain age group that are also of interest. Subpopulations are identified in this way to allow statistical analysis with respect to the additional traits of interest.

A vaccine derived from physical separation of the antigen from the pathogen.

The Summary of Product Characteristics (SmPC) is a document approved as part of the marketing authorisation of each medicine. It is aimed at healthcare professionals and includes information such as:

• How to use the medicine
  
• What the medicine should be used to treat (therapeutic indications)

Danish Health Authority. https://sundhedsstyrelsen.dk"

The endpoint in a clinical trial is an event such as the occurrence of a disease, or symptom, or a particular laboratory result. Once someone reaches the endpoint, they are generally excluded from further research in the trial.

A surrogate endpoint (or marker) is a measure which in itself is not the outcome that the study treatment aims to elicit. For example, blood pressure is used as a surrogate endpoint in trials because it is a risk factor for heart attacks and strokes “ even though in itself blood pressure might not be important for patients.

Surrogate endpoints are useful if it would take a very long time for clinical endpoints to appear. Surrogate endpoints must be proven to be valid markers of clinical endpoints when they are used in clinical trials.

A Suspected Unexpected Serious Adverse Reaction (SUSAR), is a serious adverse reaction (SAR) for which a reasonable causal relationship with the medicine use is suspected but not confirmed. Unexpected in this context means not consistent with the applicable product information (e.g. investigator's brochure for an unapproved investigational product or summary of product characteristics (SmPC) for an authorised product).

Swiss National Competent Authority. https://www.swissmedic.ch"

This refers to toxic effects caused as a result of absorption and distribution of a substance that affects the whole body rather than a specific (local) area, i.e. to an area distant from its entry point. Most chemicals that produce systemic toxicity do not cause a similar degree of toxicity in all organs, but usually cause major toxicity to one or two organs. These are referred to as the target organs of toxicity for that chemical.