ID

39163

Beschrijving

Study ID: 111569 Clinical Study ID: 111569 Study Title: A fixed dose, dose-response study for ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01494532 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Ropinirole, placebo Study Indication: Parkinson's Disease

Trefwoorden

Versies (2)
  1. 06-12-19 06-12-19 -
  2. 09-01-20 09-01-20 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

6 december 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

  • Nieuwste
  • Oudste
  • Populair
  • Nieuwste
    • Nieuwste
    • Oudste
    • Populair

Geen commentaren

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease

Engels

Baseline - IP Compliance; Pharmacogenetic (PGx) Research

1 Formulieren  
Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Study Name
Beschrijving

Study Name

Datatype

text

Alias
UMLS CUI [1]
C2348560
Subject ID
Beschrijving

Subject ID

Datatype

text

Alias
UMLS CUI [1]
C2348585
Study Site
Beschrijving

Study Site

Datatype

text

Alias
UMLS CUI [1]
C2825164
Investigational Product - Study drug dispensed
Beschrijving

Investigational Product - Study drug dispensed

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0947323
Was study drug dispensed?
Beschrijving

Was study drug dispensed?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0947323
Investigational Product #
Beschrijving

Investigational Product #

Datatype

text

Alias
UMLS CUI [1]
C0304229
Date investigational product dispensed
Beschrijving

Date investigational product dispensed

Datatype

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0947323
UMLS CUI [1,3]
C0011008
Investigational Product - Total # tablets dispensed
Beschrijving

Investigational Product - Total # tablets dispensed

Datatype

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0805077
Investigational Product - Additional bottle(s) disepensed?
Beschrijving

Investigational Product - Additional bottle(s) disepensed?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0947323
UMLS CUI [1,3]
C0179376
UMLS CUI [1,4]
C1524062
Additional bottle(s) dispensed
Beschrijving

Additional bottle(s) dispensed

Alias
UMLS CUI-1
C0947323
UMLS CUI-2
C0179376
UMLS CUI-3
C1524062
Additional bottle(s) dispensed - Sequence Number
Beschrijving

Additional bottle(s) dispensed - Sequence Number

Datatype

integer

Alias
UMLS CUI [1,1]
C0947323
UMLS CUI [1,2]
C0179376
UMLS CUI [1,3]
C1524062
UMLS CUI [2]
C2348184
Additional bottle(s) dispensed - Investigational Product #
Beschrijving

Additional bottle(s) dispensed - Investigational Product #

Datatype

integer

Alias
UMLS CUI [1,1]
C0947323
UMLS CUI [1,2]
C0179376
UMLS CUI [1,3]
C1524062
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0237753
Additional bottle(s) dispensed - Date disepensed
Beschrijving

Additional bottle(s) dispensed - Date disepensed

Datatype

date

Alias
UMLS CUI [1,1]
C0947323
UMLS CUI [1,2]
C0179376
UMLS CUI [1,3]
C1524062
UMLS CUI [2,1]
C0947323
UMLS CUI [2,2]
C0011008
Additional bottle(s) dispensed - Total # tablets dispensed
Beschrijving

Additional bottle(s) dispensed - Total # tablets dispensed

Datatype

integer

Alias
UMLS CUI [1,1]
C0947323
UMLS CUI [1,2]
C0179376
UMLS CUI [1,3]
C1524062
UMLS CUI [2]
C0805077
Current investigational product level
Beschrijving

Current investigational product level

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0441889
UMLS CUI-3
C0521116
Current investigational product level
Beschrijving

Current investigational product level

Datatype

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0441889
UMLS CUI [1,3]
C0521116
L-Dopa medication
Beschrijving

L-Dopa medication

Alias
UMLS CUI-1
C0023570
L-dopa dose
Beschrijving

L-dopa dose

Datatype

float

Maateenheden
  • mg
Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0178602
mg
L-dopa release
Beschrijving

L-dopa release

Datatype

integer

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0391871
Controlled release amt
Beschrijving

Controlled release amt

Datatype

float

Maateenheden
  • mg
Alias
UMLS CUI [1,1]
C1707506
UMLS CUI [1,2]
C1561574
mg
Immediate release amt
Beschrijving

Immediate release amt

Datatype

float

Maateenheden
  • mg
Alias
UMLS CUI [1,1]
C1708470
UMLS CUI [1,2]
C1561574
mg
Was L-dopa dose reduced?
Beschrijving

Was L-dopa dose reduced?

Datatype

integer

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C1707814
Date L-dopa dose reduced
Beschrijving

Date L-dopa dose reduced

Datatype

date

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C1707814
UMLS CUI [1,3]
C0011008
Pharmacogenetic Research
Beschrijving

Pharmacogenetic Research

Alias
UMLS CUI-1
C0031325
Has informed consent been obtained for PGx research?
Beschrijving

Has informed consent been obtained for PGx research?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
Date of PGx consent
Beschrijving

Date of PGx consent

Datatype

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0011008
Has sample been collected for PGx research?
Beschrijving

Has sample been collected for PGx research?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C2347500
Date sample taken
Beschrijving

Date sample taken

Datatype

date

Alias
UMLS CUI [1]
C1302413
Select reason
Beschrijving

Select reason

Datatype

integer

Alias
UMLS CUI [1]
C0566251
Specify other reason
Beschrijving

Specify other reason

Datatype

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Has subject withdrawn consent for PGx research?
Beschrijving

Has subject withdrawn consent for PGx research?

Datatype

boolean

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C0031325
Date PGx consent withdrawn
Beschrijving

Date PGx consent withdrawn

Datatype

date

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0011008
Has request been made for PGx sample destruction?
Beschrijving

Has request been made for PGx sample destruction?

Datatype

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C1948029
UMLS CUI [1,3]
C0178913
UMLS CUI [1,4]
C1272683
Enter the reason for request for sample destruction
Beschrijving

Enter the reason for request for sample destruction

Datatype

integer

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
UMLS CUI [1,4]
C0392360
Specify other reason for request for sample destruction
Beschrijving

Specify other reason for request for sample destruction

Datatype

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
UMLS CUI [1,4]
C0392360
UMLS CUI [1,5]
C0205394
UMLS CUI [1,6]
C2348235
Terug naar het begin van de pagina

Similar models

Baseline - IP Compliance; Pharmacogenetic (PGx) Research

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Study Name
Item
Study Name
text
C2348560 (UMLS CUI [1])
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Study Site
Item
Study Site
text
C2825164 (UMLS CUI [1])
Item Group
Investigational Product - Study drug dispensed
C0304229 (UMLS CUI-1)
C0947323 (UMLS CUI-2)
Was study drug dispensed?
Item
Was study drug dispensed?
boolean
C0304229 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
Investigational Product #
Item
Investigational Product #
text
C0304229 (UMLS CUI [1])
Date investigational product dispensed
Item
Date investigational product dispensed
date
C0304229 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Investigational Product - Total # tablets dispensed
Item
Investigational Product - Total # tablets dispensed
integer
C0304229 (UMLS CUI [1,1])
C0805077 (UMLS CUI [1,2])
Investigational Product - Additional bottle(s) disepensed?
Item
Investigational Product - Additional bottle(s) disepensed?
boolean
C0304229 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
C0179376 (UMLS CUI [1,3])
C1524062 (UMLS CUI [1,4])
Item Group
Additional bottle(s) dispensed
C0947323 (UMLS CUI-1)
C0179376 (UMLS CUI-2)
C1524062 (UMLS CUI-3)
Additional bottle(s) dispensed - Sequence Number
Item
Additional bottle(s) dispensed - Sequence Number
integer
C0947323 (UMLS CUI [1,1])
C0179376 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
C2348184 (UMLS CUI [2])
Additional bottle(s) dispensed - Investigational Product #
Item
Additional bottle(s) dispensed - Investigational Product #
integer
C0947323 (UMLS CUI [1,1])
C0179376 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
Additional bottle(s) dispensed - Date disepensed
Item
Additional bottle(s) dispensed - Date disepensed
date
C0947323 (UMLS CUI [1,1])
C0179376 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
C0947323 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Additional bottle(s) dispensed - Total # tablets dispensed
Item
Additional bottle(s) dispensed - Total # tablets dispensed
integer
C0947323 (UMLS CUI [1,1])
C0179376 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
C0805077 (UMLS CUI [2])
Item Group
Current investigational product level
C0304229 (UMLS CUI-1)
C0441889 (UMLS CUI-2)
C0521116 (UMLS CUI-3)
Item
Current investigational product level
integer
C0304229 (UMLS CUI [1,1])
C0441889 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
Current investigational product level
Code List
Current investigational product level
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
Item Group
L-Dopa medication
C0023570 (UMLS CUI-1)
L-dopa dose
Item
L-dopa dose
float
C0023570 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Item
L-dopa release
integer
C0023570 (UMLS CUI [1,1])
C0391871 (UMLS CUI [1,2])
L-dopa release
Code List
L-dopa release
CL Item
Controlled-release (prolonged release) (1)
CL Item
Immediate-release (conventional release) (2)
CL Item
Both (3)
Controlled release amt
Item
Controlled release amt
float
C1707506 (UMLS CUI [1,1])
C1561574 (UMLS CUI [1,2])
Immediate release amt
Item
Immediate release amt
float
C1708470 (UMLS CUI [1,1])
C1561574 (UMLS CUI [1,2])
Item
Was L-dopa dose reduced?
integer
C0023570 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
Was L-dopa dose reduced?
Code List
Was L-dopa dose reduced?
CL Item
Yes (1)
CL Item
No (2)
CL Item
half tablet (3)
CL Item
whole tablet (4)
Date L-dopa dose reduced
Item
Date L-dopa dose reduced
date
C0023570 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Pharmacogenetic Research
C0031325 (UMLS CUI-1)
Has informed consent been obtained for PGx research?
Item
Has informed consent been obtained for PGx research?
boolean
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Date of PGx consent
Item
Date of PGx consent
date
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Has sample been collected for PGx research?
Item
Has sample been collected for PGx research?
boolean
C0005834 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item
Select reason
integer
C0566251 (UMLS CUI [1])
Select reason
Code List
Select reason
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigato (2)
CL Item
Other (3)
Specify other reason
Item
Specify other reason
text
C0566251 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Has subject withdrawn consent for PGx research?
Item
Has subject withdrawn consent for PGx research?
boolean
C1707492 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
Date PGx consent withdrawn
Item
Date PGx consent withdrawn
date
C1707492 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Has request been made for PGx sample destruction?
Item
Has request been made for PGx sample destruction?
boolean
C2347500 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
Item
Enter the reason for request for sample destruction
integer
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
Enter the reason for request for sample destruction
Code List
Enter the reason for request for sample destruction
CL Item
Subject withdrew consent for PG (1)
CL Item
Other (2)
Specify other reason for request for sample destruction
Item
Specify other reason for request for sample destruction
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,5])
C2348235 (UMLS CUI [1,6])
Terug naar het begin van de pagina 

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial