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  3. Medical: Pharmaceuticals

more than a 5 minutes higher endpoint value

18:19 Jun 23, 2019
This question was closed without grading. Reason: Other

English to Spanish translations [PRO]
Medical - Medical: Pharmaceuticals / Clinical Study protocol
English term or phrase: more than a 5 minutes higher endpoint value
Hola a todos:
Esta es la sinopsis de un estudio clínico y tengo dudas con la frase " more than a 5 minutes higher":

Proportion of Subjects Whose subjective Sleep Onset Latency (sSOL) or subjective Wake After Sleep Onset (sWASO) Was Higher at Specific Time Points of the Follow-Up Period Than at Screening by at Least 5 Minutes:
Rebound insomnia was also defined as more than a 5 minutes higher endpoint value at the specified time point than Screening (last 7 nights prior to Run-In Period).

Acá un poco más de contexto:
Run-In Period: The Run-in Period (Visit 2b) began when eligible subjects were dispensed Placebo tablets and continued until the Baseline Period on Day 1. During the Run-in Period, subjects took Placebo each night immediately (ie, within 5 minutes) before bedtime (defined as the time the subject intended to try to fall asleep).
Screening Period:
The Screening Period began no more than 35 days before the subject was randomized, and consisted of 2 visits. At the first screening visit (Visit 1), informed consent was obtained after the study had been fully explained to each subject and before the conduct of any screening procedures or assessments. A medical, psychiatric, and sleep history interview was conducted, and included confirmation that the subject met diagnostic criteria for insomnia disorder, and further that the subject complained of difficulties with sleep onset or sleep maintenance, or both.

Rebound insomnia endpoints as assessed from the Sleep Diary during the Follow-Up Period - Change from Screening of subjective sleep onset latency (sSOL) on each of the first 3 nights, mean sSOL of the first 7 nights, and mean sSOL of the second 7 nights of the Follow-Up Period - Change from Screening of subjective Wake After Sleep Onset (sWASO) on each of the first 3 nights, mean sWASO of the first 7 nights and mean sWASO of the second 7 nights of the Follow-Up Period - Proportion of subjects whose sSOL was longer than at Screening for each of the first 3 nights, or whose mean sSOL is longer than at Screening for the first 7 nights or the second 7 nights of the Follow-Up Period - Proportion of subjects whose sWASO is higher than at Screening for each of the first 3 nights, or whose mean sWASO is higher than at Study Baseline for the first 7 nights or the second 7 nights of the Follow-Up Period

Study Endpoints

For Sleep Diary endpoints at Month 6 and earlier time point, those time points were defined as the mean of the final 7 nights before the visit, unless otherwise stated. Data from Period 1 (Drug and Drug compared to Placebo) are presented and discussed in the Core Clinical Study Report (CSR); therefore these endpoints and analyses are not described in this synoptic report.
Primary Endpoint: The primary endpoint was the mean change from Study Baseline in subjective sleep onset latency (sSOL) at Month 6.


Desde ya muchas gracias!
Belén Nieto
Local time: 03:00


Summary of answers provided
3superior a 5 minutos del valor mas alto del criterio principal de valoración
José Patrício


  

Answers


36 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5
superior a 5 minutos del valor mas alto del criterio principal de valoración


Explanation:
endpoint - Criterio de valoración - https://forum.wordreference.com/threads/endpoint.27707/
Primary endpoint
criterio principal de valoración - https://esl.proz.com/personal-glossaries/64163-medicina?lang...

José Patrício
Portugal
Local time: 07:00
Native speaker of: Native in PortuguesePortuguese
PRO pts in category: 24
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