Glossary entry (derived from question below)
English term or phrase:
safety run-in data
Hungarian translation:
biztonságossági bevezetö szakasz adatai
Added to glossary by
Zsuzsanna Dr Sassiné Riffer
Apr 24, 2020 07:59
4 yrs ago
19 viewers *
English term
Hungary
Translation: profession and passion
Native in: Hungarian 
Works in: English to Hungarian, Hungarian to English, French to Hungarian
safety run-in data
English to Hungarian
Medical
Medical: Pharmaceuticals
Kontextus: protokoll szinopszis
"The first safety review of unblinded data by the iDMC will occur at approximately 6 months from the time of randomization of the first patient or when the safety run-in data are ready to be reviewed, whichever occurs first. For the safety run-in, unblinded safety data will be reviewed by the iDMC after the first 24 patients (approximately 12 patients per arm) have been enrolled and have completed at least two cycles of study treatment or withdrawn treatment."
"The first safety review of unblinded data by the iDMC will occur at approximately 6 months from the time of randomization of the first patient or when the safety run-in data are ready to be reviewed, whichever occurs first. For the safety run-in, unblinded safety data will be reviewed by the iDMC after the first 24 patients (approximately 12 patients per arm) have been enrolled and have completed at least two cycles of study treatment or withdrawn treatment."
Proposed translations
(Hungarian)
| 4 +1 | biztonságossági bevezetö szakasz adatai |
Kata Paulin
|
| 5 | gyógyszerbiztonsági szoktatási idő alatt kigyűjtött adatok |
JANOS SAMU
|
Proposed translations
+1
24 mins
Kata Paulin
Hungary
Hungary
Native in English
Specializes in field
Hungary
Life Sciences & Clinical Trials expert
Native in: English 
Works in: Hungarian to English, French to English, English to Hungarian
Related KudoZ points
:
44
Selected
biztonságossági bevezetö szakasz adatai
Run-in period is a period before a clinical trial is commenced, it can be passive "when a placebo or no treatment is given" or active "when treatment is used".
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Note added at 1 hr (2020-04-24 09:36:51 GMT)
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Konkrét példák:
"Betegek, akik nem reagáltak a placebóra a bevezető (run-in) szakasz alatt"
(Ref: https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-...
Klinikai Vizsgálatok kézikönyve
"A bevezető placeboperiódus (placebo run-in)"
(Ref: http://members.iif.hu/lakner/download/cikkek/kvk/KVK_LaknerG...
4 KudoZ points awarded for this answer.
1 hr
JANOS SAMU
United States
United States
Works in field
United States
We know the language and the system too.
Works in: English to zzz Other zzz, English to Lao, English to Lithuanian, and 91 more.
Related KudoZ points
:
100
gyógyszerbiztonsági szoktatási idő alatt kigyűjtött adatok
Itt kifejezetten a készítmény biztonságos alkalmazásáról van szó.
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