ID

27261

Beschrijving

Study ID: 101468/188 Clinical Study ID: SKF-101468/188 Study Title:A Study of the Maintained Efficacy and Safety of Ropinirole Versus Placebo in the Long Term Treatment of Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication: Parkinson Disease Module: Mandatory 7 Day Follow Up Assessment

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  1. 06-11-17 06-11-17 -
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GlaxoSmithKline

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6 november 2017

DOI

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Creative Commons BY-NC 3.0
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GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/188

Engels

Mandatory 7 Day Follow Up Assessment

1 Formulieren  
Vital signs
Beschrijving

Vital signs

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0031809
UMLS CUI-4
C1522577
Sitting blood pressure systolic
Beschrijving

Sitting blood pressure systolic

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
mmHg
Sitting blood pressure diastolic
Beschrijving

Sitting blood pressure diastolic

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mmHg
Sitting heart rate
Beschrijving

Sitting heart rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0277814
beats/min
Laboratory Evaluation
Beschrijving

Laboratory Evaluation

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0430370
Date of blood sample
Beschrijving

Date of blood sample

Datatype

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Were any clinically significant abnormalities detected?
Beschrijving

If ’Yes’, please record details in the Adverse Experiences and/or SAE Section at the back of this book and repeat at Follow-up.

Datatype

boolean

Alias
UMLS CUI [1]
C1853129
What was the result of the urine dipstick performed at this visit?
Beschrijving

Please perform a urine dipstick test for presence of blood or protein. If ’Positive’, please record details in the Adverse Experiences and/or SAE Section at the back of this book, send a sample to Quest Diagnostics for further evaluation and repeat at Follow-up.

Datatype

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0456984
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Similar models

Mandatory 7 Day Follow Up Assessment

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Vital signs
C0518766 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
C1522577 (UMLS CUI-4)
Sitting blood pressure systolic
Item
Sitting blood pressure systolic
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Sitting blood pressure diastolic
Item
Sitting blood pressure diastolic
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Sitting heart rate
Item
Sitting heart rate
integer
C0018810 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Item Group
Laboratory Evaluation
C0022885 (UMLS CUI-1)
C0430370 (UMLS CUI-2)
Date of blood sample
Item
Date of blood sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
abnormalities laboratory
Item
Were any clinically significant abnormalities detected?
boolean
C1853129 (UMLS CUI [1])
Item
What was the result of the urine dipstick performed at this visit?
integer
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
urine dipstick result
Code List
What was the result of the urine dipstick performed at this visit?
CL Item
Negative (1)
CL Item
Positive (2)
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