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not-suspected events

Russian translation: НЯ, не являющиеся подозреваемыми

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00:17 Mar 21, 2017
English to Russian translations [PRO]
Medical - Medical: Pharmaceuticals
English term or phrase: not-suspected events
The Summary Tabulation includes both suspected (ADRs) и not-suspected events (AEs). The tabulation is organised by MedDRA SOC, in the internationally agreed order, by the Sandoz investigational drug, as well as for the comparator arm(s) (active comparators, placebo) used in the clinical development program. The tabulations include blinded and unblinded clinical data.
Liudmila Grande
United States
Local time: 17:47
Russian translation:НЯ, не являющиеся подозреваемыми
Explanation:
The Summary Tabulation includes both suspected (ADRs) и not-suspected events (AEs) = В табличном перечне указаны как подозреваемые НЛР, так и НЯ, не являющиеся подозреваемыми.

НЯ, не являющиеся подозреваемыми - это НЯ, в отношении которых не имеется подозрений о причинно-следственной связи с принимаемым лекарственным препаратом.


Ссылок на сайты фармаконадзора очень много, так что я даже не стану приводить их здесь.
Selected response from:

Natalie
Poland
Local time: 22:47
Grading comment
4 KudoZ points were awarded for this answer

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Summary of answers provided
5 +1НЯ, не являющиеся подозреваемыми
Natalie
4 +1см.
Margarita Vidkovskaia
3неблагоприятное событие
Sofia Gutkin


  

Answers


1 hr   confidence: Answerer confidence 3/5Answerer confidence 3/5
неблагоприятное событие


Explanation:
The sentence is trying to differentiate between adverse drug reactions (ADRs) and adverse events (AEs). Adverse events are medical symptoms or events that might not have a link to the study drug, but occur during the clinical study.

This site explains the difference: http://www.innovativescience.net/blog/bid/103583/How-to-Dist...

It also quotes a textbook to say: "The principal difference between an adverse event and an adverse drug reaction is that a causal relationship is suspected for the latter, but is not required for the former. In this framework, adverse drug reactions are a subset of adverse event reports."

Sofia Gutkin
Australia
Local time: 08:47
Specializes in field
Native speaker of: Native in EnglishEnglish, Native in RussianRussian
PRO pts in category: 20

Peer comments on this answer (and responses from the answerer)
neutral  Margarita Vidkovskaia: Adverse Events - это все AEs, включая non-suspected AEs, suspected ADRs и ADRs
6 hrs
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7 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
см.


Explanation:
В сводную таблицу были включены нежелательные лекарственные реакции (ADRs) и нежелательные явления, не обусловленные действием лекарственного препарата (non-suspected AEs)


AEs = non-suspected AEs + SARs (SADRs) + ARs (ADRs)



AE (Adverse Event) = Any untoward medical occurrence associated with the use of a drug, whether or not considered drug related
Non-suspected AE = Adverse Event not considered drug related
Suspected AR/ADR (Suspected Adverse Reaction/Adverse Drug Reaction) = Any Adverse Event suspected drug related
AR/ADR = Any Adverse Event considered drug related, caused by a drug

https://www.fda.gov/downloads/drugs/scienceresearch/research...

Margarita Vidkovskaia
Russian Federation
Local time: 00:47
Specializes in field
Native speaker of: Native in RussianRussian
PRO pts in category: 350

Peer comments on this answer (and responses from the answerer)
agree  Oleg Lozinskiy
3 hrs
  -> Спасибо!

neutral  Natalie: У вас вообще потерялось suspected/unsuspected (чего делать нельзя), к тому же unsuspected совершенно не означает "не обусловленные" (просто подозрений таких нет)
4 hrs
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11 hrs   confidence: Answerer confidence 5/5 peer agreement (net): +1
НЯ, не являющиеся подозреваемыми


Explanation:
The Summary Tabulation includes both suspected (ADRs) и not-suspected events (AEs) = В табличном перечне указаны как подозреваемые НЛР, так и НЯ, не являющиеся подозреваемыми.

НЯ, не являющиеся подозреваемыми - это НЯ, в отношении которых не имеется подозрений о причинно-следственной связи с принимаемым лекарственным препаратом.


Ссылок на сайты фармаконадзора очень много, так что я даже не стану приводить их здесь.

Natalie
Poland
Local time: 22:47
Specializes in field
Native speaker of: Native in RussianRussian
PRO pts in category: 7366

Peer comments on this answer (and responses from the answerer)
agree  Nina Nikitina
32 mins
  -> Спасибо!
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