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Adverse events categorized as "serious" (results in death, illness requiring hospitalization, events deemed life-threatening, results in persistent or significant incapacity, a congenital anomaly or medically important condition) must be reported to the regulatory authorities immediately, whereas non-serious adverse events are merely documented ...
In statistics, an effect size is a value measuring the strength of the relationship between two variables in a population, or a sample-based estimate of that quantity. It can refer to the value of a statistic calculated from a sample of data, the value of one parameter for a hypothetical population, or to the equation that operationalizes how statistics or parameters lead to the effect size ...
The Vaccine Adverse Event Reporting System (VAERS) is a passive surveillance program administered jointly by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). [38] VAERS is intended to track adverse events associated with vaccines.
A type of effect size, the NNT was described in 1988 by McMaster University's Laupacis, Sackett and Roberts. [3] While theoretically, the ideal NNT is 1, where everyone improves with treatment and no one improves with control, in practice, NNT is always rounded up to the nearest round number [4] and so even a NNT of 1.1 becomes a NNT of 2 [5 ...
The Vaccine Adverse Event Reporting System (VAERS) is a United States program for vaccine safety, co-managed by the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). [1]
The United States Environmental Protection Agency defines NOAEL as 'an exposure level at which there are no statistically or biologically significant increases in the frequency or severity of adverse effects between the exposed population and its appropriate control; some effects may be produced at this level, but they are not considered as adverse, or as precursors to adverse effects. [5]
The group exposed to treatment (left) has the risk of an adverse outcome (black) reduced by 50% (RRR = 0.5) compared to the unexposed group (right). In epidemiology , the relative risk reduction (RRR) or efficacy is the relative decrease in the risk of an adverse event in the exposed group compared to an unexposed group.
Adverse event (AE) is a side effect occurring with a drug. By definition, the causal relationship between the AE and the drug is unknown. An investigator must establish causality and severity and then report it, especially during clinical trials (not necessarily after marketing is approved).