ID

39163

Beschreibung

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

Stichworte

Versionen (2)
  1. 06.12.19 06.12.19 -
  2. 09.01.20 09.01.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

6. Dezember 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease

Englisch

Baseline - IP Compliance; Pharmacogenetic (PGx) Research

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Study Name
Beschreibung

Study Name

Datentyp

text

Alias
UMLS CUI [1]
C2348560
Subject ID
Beschreibung

Subject ID

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Study Site
Beschreibung

Study Site

Datentyp

text

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

Investigational Product - Study drug dispensed

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

Was study drug dispensed?

Datentyp

boolean

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

Investigational Product #

Datentyp

text

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

Date investigational product dispensed

Datentyp

date

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

Investigational Product - Total # tablets dispensed

Datentyp

integer

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

Investigational Product - Additional bottle(s) disepensed?

Datentyp

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
Beschreibung

Additional bottle(s) dispensed

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

Additional bottle(s) dispensed - Sequence Number

Datentyp

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 #
Beschreibung

Additional bottle(s) dispensed - Investigational Product #

Datentyp

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
Beschreibung

Additional bottle(s) dispensed - Date disepensed

Datentyp

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
Beschreibung

Additional bottle(s) dispensed - Total # tablets dispensed

Datentyp

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
Beschreibung

Current investigational product level

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

Current investigational product level

Datentyp

integer

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

L-Dopa medication

Alias
UMLS CUI-1
C0023570
L-dopa dose
Beschreibung

L-dopa dose

Datentyp

float

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

L-dopa release

Datentyp

integer

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

Controlled release amt

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C1707506
UMLS CUI [1,2]
C1561574
mg
Immediate release amt
Beschreibung

Immediate release amt

Datentyp

float

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

Was L-dopa dose reduced?

Datentyp

integer

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

Date L-dopa dose reduced

Datentyp

date

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

Pharmacogenetic Research

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

Has informed consent been obtained for PGx research?

Datentyp

boolean

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

Date of PGx consent

Datentyp

date

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

Has sample been collected for PGx research?

Datentyp

boolean

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

Date sample taken

Datentyp

date

Alias
UMLS CUI [1]
C1302413
Select reason
Beschreibung

Select reason

Datentyp

integer

Alias
UMLS CUI [1]
C0566251
Specify other reason
Beschreibung

Specify other reason

Datentyp

text

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

Has subject withdrawn consent for PGx research?

Datentyp

boolean

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

Date PGx consent withdrawn

Datentyp

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?
Beschreibung

Has request been made for PGx sample destruction?

Datentyp

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
Beschreibung

Enter the reason for request for sample destruction

Datentyp

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
Beschreibung

Specify other reason for request for sample destruction

Datentyp

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
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Ähnliche Modelle

Baseline - IP Compliance; Pharmacogenetic (PGx) Research

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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