ID

25668

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: PGx-Pharamacogenetic research.

Trefwoorden

Versies (2)
  1. 25-08-17 25-08-17 -
  2. 08-09-17 08-09-17 -
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8 september 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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PGx-Pharamacogenetic research GSK study Dyskinesia in Parkinson's disease NCT00363727

Engels

PGx-Pharamacogenetic research 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
Consent for PGx-Pharamacogenetic research
Beschrijving

Consent for PGx-Pharamacogenetic research

Has informed consent been obtained for PGx-Pharmacogenetic research?
Beschrijving

The question "Has informed consent been obtained for PGx-Pharmacogenetic research?" should be completed at either Visit 6, Early Withdrawal, or Follow-Up Visit. If the question is answered No, check one box for reason and do not complete the remainder of the page.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
If Yes, record the date informed consent obtained for PGx-Pharmacogenetic research
Beschrijving

date consent PGx-Pharmacogenetic research

Datatype

date

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C2985782
If No, check one reason:
Beschrijving

reason consent unavailable

Datatype

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0392360
If other reason, specify
Beschrijving

reason consent unavailable specification

Datatype

text

Alias
UMLS CUI [1,1]
C1511481
UMLS CUI [1,2]
C0686905
Blood sample collection (DNA)
Beschrijving

Blood sample collection (DNA)

Has a blood sample been collected for PGx-pharmacogenetic research?
Beschrijving

Blood sample collection

Datatype

boolean

Alias
UMLS CUI [1]
C0005834
If Yes, record the date sample taken
Beschrijving

Blood sample collection date

Datatype

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Withdrawal of consent
Beschrijving

Withdrawal of consent

Has subject withdrawn consent for PGx-Pharmacogenetic research?
Beschrijving

The question "Has the subject withdrawn consent for PGx-Pharmacogenetic research?" must be completed immediately if the subject withdraws consent. Otherwise, it must be completed when the subject leaves the study. It must be completed for all subjects for whom informed consent was obtained for PGx-Pharmacogenetic research. If consent is withdrawn, a request for destruction must be made and Blood Sample Destruction section below completed.

Datatype

boolean

Alias
UMLS CUI [1]
C1707492
Blood sample destruction
Beschrijving

Blood sample destruction

Has a request been made for sample destruction?
Beschrijving

Do not complete this section if a blood sample was not collected. The question "Has a request been made for sample destruction?" must be completed immediately if there is a request for sample destruction. Otherwise, it must be completed when the subject leaves the study. It must be completed for all subjects for whom a blood sample was obtained for PGx-Pharmacogenetic research.

Datatype

boolean

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
If Yes, check one reason:
Beschrijving

Blood sample destruction reason

Datatype

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C0392360
If other reason, specify
Beschrijving

Blood sample destruction reason specification

Datatype

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C0392360
UMLS CUI [1,4]
C3840932
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Similar models

PGx-Pharamacogenetic research 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])
Item Group
Consent for PGx-Pharamacogenetic research
Consent for PGx-pharmagogenetic research
Item
Has informed consent been obtained for PGx-Pharmacogenetic research?
boolean
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
date consent PGx-Pharmacogenetic research
Item
If Yes, record the date informed consent obtained for PGx-Pharmacogenetic research
date
C2347500 (UMLS CUI [1,1])
C2985782 (UMLS CUI [1,2])
Item
If No, check one reason:
text
C0021430 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
reason consent unavailable
Code List
If No, check one reason:
CL Item
Subject declined (1)
C1136454 (UMLS CUI-1)
(Comment:en)
CL Item
Subject not asked by Investigator (2)
(Comment:en)
CL Item
Other (Z)
C0205394 (UMLS CUI-1)
(Comment:en)
reason consent unavailable specification
Item
If other reason, specify
text
C1511481 (UMLS CUI [1,1])
C0686905 (UMLS CUI [1,2])
Item Group
Blood sample collection (DNA)
Blood sample collection
Item
Has a blood sample been collected for PGx-pharmacogenetic research?
boolean
C0005834 (UMLS CUI [1])
Blood sample collection date
Item
If Yes, record the date sample taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Withdrawal of consent
Withdrawal of consent
Item
Has subject withdrawn consent for PGx-Pharmacogenetic research?
boolean
C1707492 (UMLS CUI [1])
Item Group
Blood sample destruction
Blood sample destruction
Item
Has a request been made for sample destruction?
boolean
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
Item
If Yes, check one reason:
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Blood sample destruction reason
Code List
If Yes, check one reason:
CL Item
Subject requested (1)
C1272683 (UMLS CUI-1)
(Comment:en)
CL Item
Screen failure (2)
C1710476 (UMLS CUI-1)
(Comment:en)
CL Item
Other (Z)
C0205394 (UMLS CUI-1)
(Comment:en)
Blood sample destruction reason specification
Item
If other reason, specify
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C3840932 (UMLS CUI [1,4])
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