ID

25904

Descripción

Study ID: 101468/204 Clinical Study ID: 101468/204 Study Title:A 12-Week, Randomized, Double-Blind, Parallel Group, Multicentre Study to Assess the Tolerability and Clinical Benefits of Ropinirole Extended Release (XR) Tablets Compared with Ropinirole Immediate Release (IR) Tablets in Subjects with Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00314860 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome; Restless Legs Syndrome (RLS)

Palabras clave

Versiones (1)
  1. 26/9/17 26/9/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

26 de septiembre de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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GSK LKA204 Ropinirole in Subjects with Restless Legs Syndrome INFORM SCREENING (SCREEN)

Inglés

GSK LKA204 Ropinirole in Subjects with Restless Legs Syndrome INFORM SCREENING (SCREEN)

1 formularios  
Inform Screening
Descripción

Inform Screening

Subject initials
Descripción

initials

Tipo de datos

text

Alias
UMLS CUI [1]
C2986440
Date of birth
Descripción

Date of birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Was this subject a screen failure?
Descripción

screening failure

Tipo de datos

integer

Alias
UMLS CUI [1]
C1512714
If other, please specify
Descripción

screening failure other reason

Tipo de datos

text

Alias
UMLS CUI [1]
C1512714
Volver a la parte superior de la página

Similar models

GSK LKA204 Ropinirole in Subjects with Restless Legs Syndrome INFORM SCREENING (SCREEN)

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Inform Screening
initials
Item
Subject initials
text
C2986440 (UMLS CUI [1])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Was this subject a screen failure?
integer
C1512714 (UMLS CUI [1])
screening failure
Code List
Was this subject a screen failure?
CL Item
No (1)
CL Item
Yes, Adverse Event (Record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate.) (2)
CL Item
Yes, Lost to follow-up (4)
CL Item
Yes, Protocol violation (5)
CL Item
Yes, Subject decided to withdraw from the study (6)
CL Item
Yes, Prohibited medication use (7)
CL Item
Yes, Did not fulfill eligibility criteria (8)
CL Item
Yes, Exacerbation of medical condition under investigation. (9)
CL Item
Yes, Non-compliance (10)
CL Item
Yes, Genotype quota filled (11)
CL Item
Yes, Did not fulfill continuation criteria (12)
CL Item
Other, specify (13)
screening failure other reason
Item
If other, please specify
text
C1512714 (UMLS CUI [1])
Volver a la parte superior de la página 

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