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May 29, 2015 11:23
8 yrs ago
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Spanish term

EASRI

Spanish to English Medical Medical (general)
From clinical trial documentation.

What I am unsure of whether there is an equivalent English abbreviation for the whole of this one.

The Spanish stands for Eventos Adversos Serios Relacionados e Inesperados.

I know of the English abbreviation SEAs (serious adverse events), but is there a more complete one to include "unexpected associated serious adverse events" that is in common use?

Thanks in advance for any thoughts.

Discussion

philgoddard, I think you're probably the closest, though the serious wouldn't normally go at the front. Your attempt should be rearrange to 'Unexpected Related Serious Adverse Events', or, as I have seen it in many official documents "Unexpected Drug-Related Serious Adverse Events'. I wouldn't abbreviate it though, as it is not a commonly abbreviated term.
philgoddard, I think you're probably the closest, though the serious wouldn't normally go at the front. Your attempt should be rearrange to 'Unexpected Related Serious Adverse Events', or, as I have seen it in many official documents "Unexpected Drug-Related Serious Adverse Events'. I wouldn't abbreviate it though, as it is not a commonly abbreviated term.
lugoben May 29, 2015:
Dr. Jane I found these definitions for event/reaction that may help you decide. SUSAR didn't convince as there is an extra "Suspected" which was not in your ST. But if it appears in your document and is related directly to it, that could be your solution.

Adverse Event -Any untoward medical occurrence associated with
the use of a drug, whether or not considered drug related

• Adverse Reaction – Any Adverse Event caused by a drug
http://www.fda.gov/downloads/Drugs/ScienceResearch/ResearchA...

I hope you are getting closer!
Dr Jane Marshall (asker) May 29, 2015:
Thanks Lugoben. Yes, I agree, I am trying to find an established/already in use abbreviation.
In fact, I have since found the SUSAR abbreviation in other documentation from the same job. My understanding was that "adverse events" were slightly different to "adverse reactions" in that the reactions are directly caused by the drug, but the events may not be (eg developing a cancer.)
lugoben May 29, 2015:
Asker What it is meant is that these terms usually end up being abbreviated. This abbreviation might have already been used, so the search would be to find it. It also highlights that the way to conform such an abbreviation one has to analyze those that are already mentioned in the WEB. It cannot be decided out of the blue.
The English version is not accurate enough and needs refinement. The proposed by philgodard needs also be analyzed. The major hurdle is finding where to place "related" or if it should be left out. When one considers events of these nature they are probably not connected (related) but they may have a similar end(death, physical damage, etc).
Dr Jane Marshall (asker) May 29, 2015:
Lugoben, that link is helpful, thank you, but I don´t fully follow your comment - do you think the English version is inaccurate, or do you mean that it should be abbreviated?
lugoben May 29, 2015:
Asker In the medical field there are many repeated instances that are present requiring abbreviations. This situation needs to be looked carefully and cannot be dismissed summarily as one thinks it fit. As an example, I include the following article:
Code of Federal Regulations
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrs...
philgoddard May 29, 2015:
I think you're getting too fixated on abbreviations. You've understood the Spanish correctly, though I think it would be better expressed as "serious, related and unexpected adverse events". There is no need to abbreviate this unless it comes up several times in the document, but if you do, and you accept my suggested translation, it would be SRUAEs.

Proposed translations

-1
1 hr

Suspected Unexpected Serious Adverse Reactions (SUSAR)

Suspected Unexpected Serious Adverse Reactions (SUSAR)
An adverse reaction that is both unexpected (not consistent with the applicable product information) and also meets the definition of a Serious Adverse Event/Reaction.

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Note added at 6 hrs (2015-05-29 17:48:05 GMT)
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http://www.ct-toolkit.ac.uk/__data/assets/pdf_file/0011/3502...

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Note added at 6 hrs (2015-05-29 17:51:03 GMT)
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Please click on the flow chart and it will become very clear. SUSAR applies to events both related and unrelated to the IMP.
Peer comment(s):

disagree Bozena Elizabeth Jablonski : the source says 'related', not 'suspected'. Although it's not much different, the correct translation for this is Unexpected Drug-Related Serious Adverse Events (even though it's frustrating that there isn't an official abbreviation.
562 days
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