Oct 31, 2014 08:39
9 yrs ago
29 viewers *
French term
Retired as of Jan 2019!
Native in: English
Works in: German to English, French to English
gravité vs. séverité
French to English
Medical
Medical: Pharmaceuticals
clinical trial
Comes up in a clinical trial document concerning the responsibilities of certain persons in the trial.
Under the heading "Procédure" in which potential SAEs are described there are several headings, two of which are the above, in addition to "Modalités de description d’un Evénement indésirable"
Most of the wording seemds to be based on GCP, but can't seem to find the difference in English between these two notions in this specifid context.
TIA for your help.
Under the heading "Procédure" in which potential SAEs are described there are several headings, two of which are the above, in addition to "Modalités de description d’un Evénement indésirable"
Most of the wording seemds to be based on GCP, but can't seem to find the difference in English between these two notions in this specifid context.
TIA for your help.
Proposed translations
(English)
| 3 +5 | seriousness / severity |
Tony M
|
| 4 +1 | gravity vs. intensity |
liz askew
|
| 4 | severity (= gravity which is less used) |
Drmanu49
|
| 3 -1 | severity vs. virulence |
Anca Florescu-Mitchell
|
Proposed translations
+5
2 hrs
Selected
seriousness / severity
My understanding is that 'gravité' refers to the seriousness of the potential consequences — as indicated in the document Liz and John have shown us.
On the other hand, I have observed 'sévérité' used to describe how 'severe' symptoms etc. are; so you may have 'severe' symptoms of an illness which is however not inherently 'serious'; and vice-versa, you might of course have a serious condition only exhibiting mild symptoms.
Despite protestations to the contrary, n'en déplaise à l'Académie française, 'sévérité' is very often found in this meaning (anglicisim or not) — to the extent that it is even included in respectable dictionaries.
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Note added at 2 heures (2014-10-31 11:18:17 GMT)
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It is easier to see the difference if you get away from the FR noun form and use a more natural EN adjective form: 'a serious illness' / 'severe symptoms'
On the other hand, I have observed 'sévérité' used to describe how 'severe' symptoms etc. are; so you may have 'severe' symptoms of an illness which is however not inherently 'serious'; and vice-versa, you might of course have a serious condition only exhibiting mild symptoms.
Despite protestations to the contrary, n'en déplaise à l'Académie française, 'sévérité' is very often found in this meaning (anglicisim or not) — to the extent that it is even included in respectable dictionaries.
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Note added at 2 heures (2014-10-31 11:18:17 GMT)
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It is easier to see the difference if you get away from the FR noun form and use a more natural EN adjective form: 'a serious illness' / 'severe symptoms'
Peer comment(s):
| agree |
Joanne Archambault
: that's how I understand it also
58 mins
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Thanks, Joanne!
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| agree |
Gabrielle Leyden
2 hrs
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Merci, Gabrielle !
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| agree |
Bertrand Leduc
4 hrs
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Merci, Bertrand !
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| agree |
Helen Genevier
3 days 21 hrs
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Thanks, Helen!
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| agree |
B D Finch
: Well explained, though "gravity" can also be used to translate "gravité".
4 days
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Thanks, B! Yes, I agree that 'gravity' is also possible, but i'd say arguably less common, and perhaps with a slightly more formal ring to it?
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4 KudoZ points awarded for this answer.
Comment: "Thanks for confirming my notion, and to all who contributed."
-1
1 hr
Anca Florescu-Mitchell
France
France
Native in French
&
English
France
Fast and accurate technical translations
Native in: French 
, English
Works in: French to English, English to French
Related KudoZ points
:
8
severity vs. virulence
Although I agree with Drmanu49, if you need to use both, here is a suggestion.
Peer comment(s):
| disagree |
Tony M
: 'virulence' has a quite different meaning and would not fit in this specific context. / One wouldn't say "How severe are the symptoms?" "Oh, they're virulent." — it's just not idiomatic.
1 hr
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I disagree.// Severity translates "gravité". Virulence is the equivalent of "sévérité" which does not mean anything in French (cf. Drmanu39). But the Asker needed two terms.
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5 mins
severity (= gravity which is less used)
but sévérité is a nonsense in French and should NEVER be used. It means strict and not severe.
Anglicisme stupide pour gravité en français et bien trop utilisé de manière complètement abusive
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Note added at 1 heure (2014-10-31 10:10:24 GMT)
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so severity vs. gravity = intensity in English
Anglicisme stupide pour gravité en français et bien trop utilisé de manière complètement abusive
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Note added at 1 heure (2014-10-31 10:10:24 GMT)
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so severity vs. gravity = intensity in English
Note from asker:
| Thanks Manu, but I need to distinguise between the two. |
+1
14 mins
gravity vs. intensity
Explanation:
Gestion des EIG - ANRS
www.anrs.fr/content/download/2316/.../PV6s1v1.pdf
Translate this page
Gestion des Évènements Indésirables Graves ..... La sévérité d'un événement indésirable n'est pas synonyme de gravité: la sévérité se rapporte à l'intensité d' ..
--------------------------------------------------
Note added at 11 mins (2014-10-31 08:51:09 GMT)
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see 6.1.1
and 6.1.2
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Note added at 12 mins (2014-10-31 08:51:54 GMT)
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Definitions and Standards for Expedited Reporting - Food ...
www.fda.gov/downloads/Drugs/Guidances/ucm073087.pdf
by E Reporting - 1995
1 Mar 1995 - Serious Adverse Event or Adverse Drug Reaction . . . . . . . . . . . . . . . . 4. C. .... The term "severe" is often used to describe the intensity (severity).
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Note added at 13 mins (2014-10-31 08:52:45 GMT)
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study protocol sm ws 02_Redacted.pdf - FDA Home Page
www.accessdata.fda.gov/.../study protocol sm ws 02_Red...
17 Sep 2002 - |7.2 Adverse Event Reporting Period . ... |7.3 Seriousness (Gravity) . ..... If a SERIOUS adverse event occurs, the Investigator is responsible for ... Note the distinction between the gravity and the intensity of an adverse event.
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Note added at 15 mins (2014-10-31 08:54:49 GMT)
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OR
seriousness vs. intensity
--------------------------------------------------
Note added at 20 mins (2014-10-31 09:00:17 GMT)
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p.s.
I have also found evidence for "seriousness vs. severity"
ADVERSE EVENTS Throughout the course of the ... - DHMH
dhmh.maryland.gov/optometry/Documents/adversereportform.pdf
Throughout the course of the study, all adverse events will be monitored and ... an adverse event case report form, including seriousness, severity, action taken ...
so I don't know which is the most used/bona fide term
but "severity" doesn't cover both:)
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Note added at 2 hrs (2014-10-31 11:21:04 GMT)
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Further information:
HTTP://ONBIOSTATISTICS.BLOGSPOT.CO.UK/2011/12/SERIOUS-ADVERSE-EVENTS-SAE-VS-SEVERE.HTML
FRIDAY, DECEMBER 02, 2011
Serious Adverse Events (SAE) vs Severe Adverse Events
Professionals who are new to the clinical trial field are often confused with the concept of 'SeriousAdverse Events (SAEs)' and 'Severe Adverse Events". Severity is not synonymous with seriousness. SAE is based on patient/event outcome or action criteria usually associated with events that pose a threat to a patient's life or functioning. Seriousness (not severity) serves as a guide for defining regulatory reporting obligations. In other words, the SAEs need to be filfill additional reporting process (reported to corporate global drug safety group or pharmacovigilence group, regulatory authorities, EC/IRBs). Severe AE is one class of AEs with severity (old term intensity) classified as 'severe'. Severe AE is one of the AE classifications – AE severity (other classifications are relationships/causality).
The FDA defines a serious adverse event (SAE) as one when the patient outcome is one of the following:
• Death
• Life-threatening
• Hospitalization (initial or prolonged)
• Disability - significant, persistent, or permanent change, impairment, damage or disruption in the patient's body function/structure, physical activities or quality of life.
• Congenital anomaly
• Requires intervention to prevent permanent impairment or damage
On the other hand, Severity of an AE is a point on an arbitrary scale of intensity of the adverse event in question. The terms "severe" and "serious" when applied to adverse events are technically very different. They are easily confused but can not be used interchangeably, require care in usage.
Gestion des EIG - ANRS
www.anrs.fr/content/download/2316/.../PV6s1v1.pdf
Translate this page
Gestion des Évènements Indésirables Graves ..... La sévérité d'un événement indésirable n'est pas synonyme de gravité: la sévérité se rapporte à l'intensité d' ..
--------------------------------------------------
Note added at 11 mins (2014-10-31 08:51:09 GMT)
--------------------------------------------------
see 6.1.1
and 6.1.2
--------------------------------------------------
Note added at 12 mins (2014-10-31 08:51:54 GMT)
--------------------------------------------------
Definitions and Standards for Expedited Reporting - Food ...
www.fda.gov/downloads/Drugs/Guidances/ucm073087.pdf
by E Reporting - 1995
1 Mar 1995 - Serious Adverse Event or Adverse Drug Reaction . . . . . . . . . . . . . . . . 4. C. .... The term "severe" is often used to describe the intensity (severity).
--------------------------------------------------
Note added at 13 mins (2014-10-31 08:52:45 GMT)
--------------------------------------------------
study protocol sm ws 02_Redacted.pdf - FDA Home Page
www.accessdata.fda.gov/.../study protocol sm ws 02_Red...
17 Sep 2002 - |7.2 Adverse Event Reporting Period . ... |7.3 Seriousness (Gravity) . ..... If a SERIOUS adverse event occurs, the Investigator is responsible for ... Note the distinction between the gravity and the intensity of an adverse event.
--------------------------------------------------
Note added at 15 mins (2014-10-31 08:54:49 GMT)
--------------------------------------------------
OR
seriousness vs. intensity
--------------------------------------------------
Note added at 20 mins (2014-10-31 09:00:17 GMT)
--------------------------------------------------
p.s.
I have also found evidence for "seriousness vs. severity"
ADVERSE EVENTS Throughout the course of the ... - DHMH
dhmh.maryland.gov/optometry/Documents/adversereportform.pdf
Throughout the course of the study, all adverse events will be monitored and ... an adverse event case report form, including seriousness, severity, action taken ...
so I don't know which is the most used/bona fide term
but "severity" doesn't cover both:)
--------------------------------------------------
Note added at 2 hrs (2014-10-31 11:21:04 GMT)
--------------------------------------------------
Further information:
HTTP://ONBIOSTATISTICS.BLOGSPOT.CO.UK/2011/12/SERIOUS-ADVERSE-EVENTS-SAE-VS-SEVERE.HTML
FRIDAY, DECEMBER 02, 2011
Serious Adverse Events (SAE) vs Severe Adverse Events
Professionals who are new to the clinical trial field are often confused with the concept of 'SeriousAdverse Events (SAEs)' and 'Severe Adverse Events". Severity is not synonymous with seriousness. SAE is based on patient/event outcome or action criteria usually associated with events that pose a threat to a patient's life or functioning. Seriousness (not severity) serves as a guide for defining regulatory reporting obligations. In other words, the SAEs need to be filfill additional reporting process (reported to corporate global drug safety group or pharmacovigilence group, regulatory authorities, EC/IRBs). Severe AE is one class of AEs with severity (old term intensity) classified as 'severe'. Severe AE is one of the AE classifications – AE severity (other classifications are relationships/causality).
The FDA defines a serious adverse event (SAE) as one when the patient outcome is one of the following:
• Death
• Life-threatening
• Hospitalization (initial or prolonged)
• Disability - significant, persistent, or permanent change, impairment, damage or disruption in the patient's body function/structure, physical activities or quality of life.
• Congenital anomaly
• Requires intervention to prevent permanent impairment or damage
On the other hand, Severity of an AE is a point on an arbitrary scale of intensity of the adverse event in question. The terms "severe" and "serious" when applied to adverse events are technically very different. They are easily confused but can not be used interchangeably, require care in usage.
Note from asker:
| Thanks for all the helpful research. |
Peer comment(s):
| agree |
Tony M
: I agree with your later added comments (only just seen!), which are in line with my own experience, as explained in my own suggestion. / Yes, that helps a lot, and illustrates exactly the point I've been trying to make to certain colleagues.
2 hrs
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Thank you! The last reference is clearer
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Discussion
ou alors je commence à me mélanger les pédales...
vous devriez arriver sur le PDF en question
http://en.wikipedia.org/wiki/Pharmacovigilance
http://www.ema.europa.eu/docs/en_GB/document_library/Scienti...
6.1.1 Gravité
La condition de déclaration immédiate est leur gravité :
- entraine la mort
- met en danger la vie de la personne qui se prête à la recherche
- nécessite une hospitalisation ou une prolongation de l’hospitalisation
- provoque une incapacité ou un handicap important ou durable
- se traduit par une anomalie ou une malformation congénitale
- nécessite une intervention médicale destinée à empêcher la survenue des états précités
- est jugé par l’investigateur comme potentiellement grave
et ce quelque soit la dose utilisée
6.1.2 Sévérité
La sévérité d’un évènement sera établie selon les tables de graduation de l’ANRS
(www.anrs.fr; rubrique « outils pour la recherche/pays en développement » ; Echelle de Cotation de la Gravité des Evenements Indésirables chez l’adulte ; version N°6 du 9 Septembre 2003 en français).
Gestion des EIG - ANRS
www.anrs.fr/content/download/2316/.../PV6s1v1.pdf
Translate this page
Gestion des Évènements Indésirables Graves ..... La sévérité d'un événement indésirable n'est pas synonyme de gravité: la sévérité se rapporte à l'intensité d' ..