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Serious adverse event
A serious adverse event (SAE) in human drug trials are defined as any untoward medical occurrence that at any dose results in
Additional recommended knowledge
Investigators in human clinical trials are obligated to report these events in clinical study reports  . Research suggests that these events are often inadequately reported in publicly available reports. Because of the lack of these data and uncertainty about methods for synthesising them, individuals conducting systematic reviews and meta-analysis of therapeutic interventions often unknowingly overemphasise health benefit. In order to balance the overemphasis on benefit, scholars have called for more complete reporting of harm from clinical trials.
Serious adverse effects , serious adverse reactions, or suspected unexpected serious adverse reactions (SUSAR) are serious adverse events judged to be related to therapy. A SUSAR is to be reported to the regulatory authority by using the CIOMS form:
|This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "Serious_adverse_event". A list of authors is available in Wikipedia.|