AW: En > En (from Serbian original) - limits, norms, adverse, undesired...

[Guest guest]

Dear ,

I beg to disagree after having spent some 20 years in clinical research.

Standard terms only apply to official documents (i.e. regulatory documents)

where adverse event would be used for any events which have not yet been

evaluated by a physician and where the causal relationship with the drug has

not been ascertained, while the term adverse reaction is used AFTER a causal

relationship has been established. In many texts (particularly those for the

lay public) this distinction is not made and one generally talks about

adverse reactions /adverse effects/undesired effects. This disctinction also

exists in German at least (as for other languages I am not sure). UE

(unerwünschte Ereignisse) and UAW (unerwünschte Arneimittelwirkungen).

As for serious adverse events (SAE) these are defined as:

A " serious adverse event " is any event occurring at any dose that results in

any of the following outcomes: death, a life-threatening event, in-patient

hospitalization or prolongation of existing hospitalization, a persistent or

significant disability/incapacity, or a congenital anomaly/birth defect.

Important medical events that may not result in death, be life-threatening,

or require hospitalization also may be considered a serious adverse event

when, upon the basis of appropriate medical judgment, they may jeopardize

the human gene transfer research subject and may require medical or surgical

intervention to prevent one of the outcomes listed in this definition.

Please note that only events which meet these criteria are by definition

SERIOUS adverse events. Other " serious " events are called SEVERE adverse

events. In technical documents this distinction is essential!.

Astrid

-----Ursprüngliche Nachricht-----

Von: Lotsofwordz@...

Gesendet: September 28, 2003 3:05 AM

An: medical_translation

Betreff: Re: En > En (from Serbian original) - limits, norms, adverse,

undesired...

Hi a,

The standard term is (serious) adverse effect, sometimes written as SAE

where

relevant. It is best to use standard terms.

One makes a diagnosis, usually.

Kinory MITI