Glossary
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Serious Adverse EventAn adverse event (AE) is called serious if it:
Other events such as those requiring emergency intervention to prevent one of the serious outcomes described above might also be reported as a serious adverse event. | |
Serious Adverse ReactionAn adverse drug reaction (ADR) is called serious if at any dose it:
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Seventh Framework Programme for Research and Technological Development (European Commission)Seventh Framework Programme for Research and Technological Development (European Commission) | |
Side EffectA side effect, or adverse reaction, is an unintended response to a medication. Side effects are generally regarded as being harmful, and may occur after a single dose or prolonged administration. They might result from the normal use of a medicine, or from the use of a medicine in a way unintended by the marketing authorisation holder (MAH) “ such as taking an overdose or from the combination of two or more medicines being taken at once. | |
SignA symptom is a manifestation of disease
apparent to the patient himself, while a sign is a manifestation of
disease that the physician perceives. The sign is objective evidence of
disease; a symptom, subjective. (source: https://jamanetwork.com/jornals/jama/article-abstract/341611) | |
SignificanceIn a clinical trial, the significance is a description of how meaningful (valid) a trial result is. When evaluating the validity of a study, one must consider both the clinical and statistical significance of the findings. A study that claims clinical relevance may lack sufficient statistical significance to make a meaningful statement. Conversely, a study that shows a statistically significant difference in two treatment options may lack clinical relevance (if, for instance, an observed effect is very small but highly consistent). | |
Significance LevelThe significance level (or О± level) is a threshold that determines whether a study result can be considered statistically significant after performing the planned statistical tests. The significance level is most often set to 5% (or 0.05), although other levels may be used depending on the study. This represents the probability of rejecting the null hypothesis when it is true. For example, a significance level of 0.05 indicates a 5% risk of concluding that a difference between the study results and the null hypothesis exists when there is no actual difference. The significance level must be stated in the trial protocol as part of the statistics section. The probability of a result being due to chance rather than due to a medicine or other intervention being studied, if the null hypothesis is true (that is, if there is really no true difference), is known as the p-value™. A result is then said to be statistically significant if it yields a p-value equal to or less than the significance level and thus will not be considered a chance occurrence. This is generally written as p ‰ 0.05. | |
SilencingSilencing refers to the ability of a cell to prevent the expression of a certain gene. Methods used to silence genes are increasingly being used in the laboratory to produce therapies against diseases, such as cancers, infectious diseases, and neurodegenerative disorders by selectively turning off specific genes in diseased tissues. | |
Single ascending dose studyA single ascending dose study (SAD study) is a type of Phase I trial. Single ascending dose studies are usually conducted in a small number of healthy volunteers (although some trials recruit patients). The aim is to find out the safe dose range, and to look for any side effects. The initial dose given will be very small and increased gradually (in a new group of volunteers) if no or only mild side effects are seen. Researchers will also take measurements to determine how the medicine is processed in the body. | |