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24989
Beschreibung
Study ID: 101468/166 Clinical Study ID: SKF-101468/166 Study Title: A Phase II, randomised, double-blind, active-controlled, dose-escalation study to determine the maximum well-tolerated starting dose of a new formulation of ropinirole in Parkinson's Disease patients not receiving other dopaminergic therapies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Parkinson Disease
Stichworte
Versionen (2)
- 23.08.17 23.08.17 -
- 04.09.17 04.09.17 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
23. August 2017
DOI
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Creative Commons BY-NC 3.0
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study drug compliance determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166
study drug compliance determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166
Ähnliche Modelle
study drug compliance determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
patient's initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
patient number
Item
Patient No.
integer
C1830427 (UMLS CUI [1])
CL Item
Study Period Visit 3 (Day 4) (1)
CL Item
Study Period VIsit 4 (Day 8) (2)
Item
Has the patient returned the bottles and any unused study drug?
integer
C2699071 (UMLS CUI [1])
CL Item
Yes (1)
CL Item
No (2)
Item Group
Regimen: prescribed number of tablets per day
C3166216 (UMLS CUI-1)
C0039225 (UMLS CUI-2)
C0237753 (UMLS CUI-3)
C0039225 (UMLS CUI-2)
C0237753 (UMLS CUI-3)
number of tablets
Item
Tablets Bottle 1
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
number of tablets
Item
Tablets Bottle 2
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
number of tablets
Item
Tablets Bottle 3
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
number of tablets
Item
Tablets Bottle 4
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Item Group
Total number of tablets dispensed at last visit
C0805077 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C0304229 (UMLS CUI-2)
number of tablets
Item
Tablets Bottle 1
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
number of tablets
Item
Tablets Bottle 2
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
number of tablets
Item
Tablets Bottle 3
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
number of tablets
Item
Tablets Bottle 4
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Item Group
Total number of tablets returned at this visit
C0993159 (UMLS CUI-1)
C2699071 (UMLS CUI-2)
C2699071 (UMLS CUI-2)
number of tablets
Item
Tablets Bottle 1
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
number of tablets
Item
Tablets Bottle 2
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
number of tablets
Item
Tablets Bottle 3
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
number of tablets
Item
Tablets Bottle 4
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Item Group
Number of tablets taken by the patient (according to the diary card)
C1290952 (UMLS CUI-1)
number of tablets
Item
Tablets Bottle 1
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
number of tablets
Item
Tablets Bottle 2
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
number of tablets
Item
Tablets Bottle 3
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
number of tablets
Item
Tablets Bottle 4
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Item Group
TOTAL Number of tablets taken - all bottles
C0039225 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
C1883727 (UMLS CUI-3)
C0237753 (UMLS CUI-2)
C1883727 (UMLS CUI-3)
number of tablets
Item
Tablets
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Item Group
TOTAL Number of tablets patient should have taken ( assuming 100% compliance)
C0039225 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
C1883727 (UMLS CUI-3)
C0237753 (UMLS CUI-2)
C1883727 (UMLS CUI-3)
number of tablets
Item
Tablets
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
compliance
Item
Percent compliance (Total# of tablets taken/ Total# of tablets should have taken)
integer
C1321605 (UMLS CUI [1])
Item
Is tablet count internally consistent (i.e., # dispensed = # taken +#returned)?
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Code List
Is tablet count internally consistent (i.e., # dispensed = # taken +#returned)?
CL Item
Yes (1)
CL Item
No (2)
Item
Is tablet count internally consistent (i.e., # dispensed = # taken +#returned)?
text
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Code List
Is tablet count internally consistent (i.e., # dispensed = # taken +#returned)?