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Clinic Visits per Time and Events Table

Glossary entry

English term or phrase:

adjudicated CV death

Spanish translation:

evento(s) adjudicado(s) por muerte CV

    The asker opted for community grading. The question was closed on 2015-12-28 10:54:08 based on peer agreement (or, if there were too few peer comments, asker preference.)
Dec 24, 2015 17:05
9 yrs ago
30 viewers *
English term

adjudicated CV death

English to Spanish Medical Medical: Pharmaceuticals Transthyretin amyloidosis
Context:

This is an event driven study with a planned maximum treatment duration of 24 months, in which the Sponsor projects that 240 adjudicated primary endpoint events are expected to be accrued.

Thanks
Proposed translations (Spanish)
1 evento(s) adjudicado(s) por muerte CV
References
CV endpoint adjudication procedure / event adjudication of CV outcomes
Change log

Dec 24, 2015 17:05: changed "Kudoz queue" from "In queue" to "Public"

Discussion

Andres Larsen Dec 25, 2015:
muerte CV (adjudicada / evento adjudicado) El criterio de valoración primario del tiempo hasta la progresión clínica se define por el tiempo hasta la primera ocurrencia de:
Muerte CV (adjudicada / evento adjudicado)

fuente:

Endpoint: el rompecabezas de la traducción farmacéutica ...
www.argos-tsp.com/.../endpoint-el-rompecabezas-de-l...
The primary efficacy variable will be the time to first event from the composite endpoint of cardiovascular death, ... Literalmente, endpoint significa “punto final”.
Maria Iglesia Ramos (asker) Dec 25, 2015:
@all Sorry, in my haste I didn't pick up the appropriate context.

Here it is:

The primary endpoint of time to clinical progression is defined by the time to first occurrence of:
CV death (adjudicated)

Thanks
Taña Dalglish Dec 24, 2015:
TranslatorENFR Nowhere in the both pieces of context provided is there mention of the phrase "adjudicated CV death". Is that the phrase you need? Or it is something else, in which case the heading is incorrect. You will not get proper help if you have posted incorrectly. Regards.
Maria Iglesia Ramos (asker) Dec 24, 2015:
@Taña More context:

A total of 240 adjudicated primary progression events, will provide at least 85% power with a 2‑sided alpha=0.05 to achieve statistical significance based on a 34% reduction in the true hazard of progression in the GSK2998728 group compared with the placebo group.

Thanks
liz askew Dec 24, 2015:
=
Supplement 2. Definitions and Adjudication Methods of ...
annals.org/data/Journals/AIM/24774/157-4-263_Supplement2.pdf
Adjudication. Cardiovascular death. Major cardiovascular event. Myocardial infarction. Elevated creatine kinase. Lam et al(30). 1995 ... ... ... Significant elevation.
Taña Dalglish Dec 24, 2015:
@TranslatorENFR Where is "adjudicated CV death" in your context?

Proposed translations

4 hrs
Selected

evento(s) adjudicado(s) por muerte CV

evento(s) adjudicado(s) por muerte CV

fuentes:

EU Clinical Trials Register
https://www.clinicaltrialsregister.eu/ctr-search/.../ES
y 25 mg administrados por vía oral una vez al día) comparado con el .... eventos adjudicados: • La combinación de todos los eventos adjudicados: muerte CV ...

EFIENT, prasugrel - Europa
www.ema.europa.eu/.../es.../WC500021971.pdf
a Eventos centralmente adjudicados definidos por los criterios del Grupo de Estudio de ..... incidencia más baja de muerte CV, IM no-mortal o ictus no-mortal, ...

CELEBRA MAX 200/400 Cápsulas - Farmacias Ahumada
www.farmaciasahumada.cl/fasaonline/.../P4695.HTM
Por lo tanto, a dosis terapéuticas, celecoxib no tiene un efecto en los .... la tasa de eventos adjudicados para el punto final compuesto de muerte CV, infarto del ...

AVANDARYL 4 mg/1 mg Comprimidos Recubiertos
saludquillota.cl/vademecum/PRODUCTO/P7995.HTM
La expresión del transportador de glucosa regulado por insulina GLUT-4 estuvo .... La adjudicación posterior al estudio de eventos de IM y muerte CV fue ...

Celebra 400/200 FEM cápsulas
www.ispch.cl/sites/default/files/celebra_400_200.pdf
seguida a las 12 horas por una dosis adicional de una cápsula de 200 mg, si se ..... la tasa de eventos adjudicados para el punto final compuesto de muerte CV,.

AVANDIA 8 mg Comprimidos Recubiertos - Salcobrand
www.salcobrand.cl/cl/mft_2011/MFT/.../P7806.HTM
Además, se observó que la CL/F de rosiglitazona es mediada tanto por el peso ..... La adjudicación posterior al estudio de eventos de IM y muerte CV fue ...

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Note added at 1 day25 mins (2015-12-25 17:30:26 GMT)
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El criterio de valoración primario del tiempo hasta la progresión clínica se define por el tiempo hasta la primera ocurrencia de:
Muerte CV (adjudicada / evento adjudicado)

fuente:

Endpoint: el rompecabezas de la traducción farmacéutica ...
www.argos-tsp.com/.../endpoint-el-rompecabezas-de-l...
The primary efficacy variable will be the time to first event from the composite endpoint of cardiovascular death, ... Literalmente, endpoint significa “punto final”.
Something went wrong...
4 KudoZ points awarded for this answer. Comment: "perfect"

Reference comments

4 hrs
Reference:

CV endpoint adjudication procedure / event adjudication of CV outcomes

Centralised Endpoint Adjudication in Cardiovascular ...
www.quintiles.com/.../centralised-endpoint-adjudication-car...
centralised adjudication of these clinical endpoints to control ... Composite Endpoints in Cardiovascular Outcomes Studies ... and cardiovascular death. This is ...

Standardized Definitions for Cardiovascular and ... - CDISC
www.cdisc.org/.../Draft Definitions for CDISC August%2...
KA Hicks - ‎
Aug 20, 2014 - Cardiovascular death includes death resulting from an acute myocardial .... such as the endpoint adjudication procedures and/or the statistical ...

III. HOPE Event Adjudication Definitions
www.fda.gov/ohrms/dockets/ac/00/backgrd/3612b1f.pdf
Event Adjudication Definitions. -. Primary Outcomes. 1 .O Cardiovascular. Death. 1 .I 1 Unexpected Death: Unexpected death presumed to be due to ischemic ...

Adjudicated CV Death by Investigator-reported ...
www.fda.gov/.../CardiovascularandRenalDrugsAdvisoryCommitte...
Adjudicated CV Death by Investigator-reported. Cardiovascular AE. * 2 LI = Sepsis (endocarditis). 0. 1. 0. Unknown. 0. 2. 0. No CV AE reported by investigator*.

Do we need to adjudicate major clinical events?
ctj.sagepub.com/content/5/1/56.abstract
CB Granger - ‎2008 - ‎
A study of the use of mortality review versus death certificates in four ... Evaluating the benefit of event adjudication of cardiovascular outcomes in large simple ...
Something went wrong...
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