Temporal relationship is considered positive if the event occurred during the use of the drug and/or within a plausible range based on the half-life of

A (augmented): common dose-related reaction, related to a pharmacological action of the drug, predictable and with low mortality. B (bizarre): uncommon non-dose-related reaction, not related

A de facto industry standard that provides standardized taxonomy and metadata and outlines a reference definition of TMF content using standard nomenclature.

The words, names, slogans, pictures or symbols that are used to identify a company. In common usage, trade name is often used inappropriately for brand

A grouping of similar diseases or conditions under a generalised heading, eg diabetes, oncology, cardiovascular.