safety run-in data

Hungarian translation: biztonságossági bevezetö szakasz adatai

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:safety run-in data
Hungarian translation:biztonságossági bevezetö szakasz adatai
Entered by: Zsuzsanna Dr Sassiné Riffer

07:59 Apr 24, 2020
English to Hungarian translations [PRO]
Medical - Medical: Pharmaceuticals
English term or phrase: safety run-in data
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(approximately 12 patients per arm) have been enrolled and have completed at least two cycles of study treatment or withdrawn treatment."
Zsuzsanna Dr Sassiné Riffer
Hungary
Local time: 13:54
biztonságossági bevezetö szakasz adatai
Explanation:

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...

Selected response from:

Kata Paulin
Hungary
Local time: 13:54
Grading comment
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +1biztonságossági bevezetö szakasz adatai
Kata Paulin
5gyógyszerbiztonsági szoktatási idő alatt kigyűjtött adatok
JANOS SAMU


  

Answers


1 hr   confidence: Answerer confidence 5/5
gyógyszerbiztonsági szoktatási idő alatt kigyűjtött adatok


Explanation:
Itt kifejezetten a készítmény biztonságos alkalmazásáról van szó.

JANOS SAMU
United States
Local time: 02:54
Works in field
PRO pts in category: 92
Login to enter a peer comment (or grade)

24 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
biztonságossági bevezetö szakasz adatai


Explanation:

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".

--------------------------------------------------
Note added at 1 hr (2020-04-24 09:36:51 GMT)
--------------------------------------------------

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...



Kata Paulin
Hungary
Local time: 13:54
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 44

Peer comments on this answer (and responses from the answerer)
agree  Katalin Szilárd: Igen, vagy lead-in: bevezető szakasz.
5 hrs
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