ID

25662

Beschrijving

Study ID: 101468/228 Clinical Study ID: 101468/228 Study Title:A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363727 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Dyskinesias; Parkinson Disease; Parkinson's Disease Study part: Dyskinesias.

Trefwoorden

Versies (2)
  1. 12-08-17 12-08-17 -
  2. 08-09-17 08-09-17 -
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8 september 2017

DOI

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Creative Commons BY-NC 3.0
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Dyskinesias GSK study Dyskinesia in Parkinson's disease NCT00363727

Engels

Dyskinesias GSK study Dyskinesia in Parkinson's disease NCT00363727

1 Formulieren  
General information
Beschrijving

General information

Protocol Identifier
Beschrijving

Protocol Identifier

Datatype

integer

Alias
UMLS CUI [1]
C2826693
Subject Identifier
Beschrijving

Subject Identifier

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschrijving

Visit Date

Datatype

date

Alias
UMLS CUI [1]
C1320303
Visit Description
Beschrijving

Visit Description

Datatype

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0678257
Dyskinesia
Beschrijving

Dyskinesia

Is dyskinesia present?
Beschrijving

Complete the Dyskinesia panel at each visit. Determine, using your own clinical judgement whether the subject has dyskinesia. Do not confuse morning dystonia for dyskinesia. If dyskinesia is Yes, make sure all information is transferred to the Early Withdrawal Visit and that the Study Conclusion page is completed correctly.

Datatype

boolean

Alias
UMLS CUI [1]
C0013384
Dyskinesia history: If yes, check only one box below and complete Study Conclusion page.
Beschrijving

If you have determined that the subject has dyskinesia, Check Yes for dyskinesia and complete the bottom part of the dyskinesia panel to explain how you reach your conclusion. That is, (1) you observed the subject in clinic with dyskinesia, or (2) the verbal history that the subject related to you at this visit clearly and unequivocally provided an account of dyskinesia even though it was not present during the visit. Where there is doubt as to whether the verbal description provided by the subject was not clear enough to be considered dyskinesia. then make a note to this effect in your source documents and check No on the dyskinesia panel. If at the next consecutive visit the subject provides you with a similar account, you may then note this subject as dyskinetic and check the third check box, History suspicious and noted at 2 consecutive visits.

Datatype

integer

Alias
UMLS CUI [1,1]
C0013384
UMLS CUI [1,2]
C0262926
Date of Onset dyskinesia
Beschrijving

Make sure the date of onset of dyskinesia is between the last visit date and this visit date.

Datatype

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C0013384
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Similar models

Dyskinesias GSK study Dyskinesia in Parkinson's disease NCT00363727

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
General information
Protocol Identifier
Item
Protocol Identifier
integer
C2826693 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Visit Description
Item
Visit Description
text
C0545082 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item Group
Dyskinesia
Presence of dyskinesia
Item
Is dyskinesia present?
boolean
C0013384 (UMLS CUI [1])
Item
Dyskinesia history: If yes, check only one box below and complete Study Conclusion page.
integer
C0013384 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Dyskinesia history
Code List
Dyskinesia history: If yes, check only one box below and complete Study Conclusion page.
CL Item
Dyskinesia present at clinic visit and observed by Pl (1)
C0013384 (UMLS CUI-1)
C0262512 (UMLS CUI-2)
(Comment:en)
CL Item
Dyskinesia history is unequivocal (2)
C0013384 (UMLS CUI-1)
(Comment:en)
CL Item
History suspicious and reported at 2 consecutive visits (3)
C0013384 (UMLS CUI-1)
(Comment:en)
Onset of dyskinesia
Item
Date of Onset dyskinesia
date
C0574845 (UMLS CUI [1,1])
C0013384 (UMLS CUI [1,2])
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