This question was closed without grading. Reason: No acceptable answer
May 29, 2015 11:23
8 yrs ago
18 viewers *
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.
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.
Proposed translations
(English)
5 -1 | Suspected Unexpected Serious Adverse Reactions (SUSAR) | Michelle Kusuda |
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.
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.
--------------------------------------------------
Note added at 6 hrs (2015-05-29 17:48:05 GMT)
--------------------------------------------------
http://www.ct-toolkit.ac.uk/__data/assets/pdf_file/0011/3502...
--------------------------------------------------
Note added at 6 hrs (2015-05-29 17:51:03 GMT)
--------------------------------------------------
Please click on the flow chart and it will become very clear. SUSAR applies to events both related and unrelated to the IMP.
Reference:
http://www.ct-toolkit.ac.uk/glossary/suspected-unexpected-serious-adverse-reactions-susar
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
|
Discussion
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!
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.)
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).
Code of Federal Regulations
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrs...