ID

27261

Description

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

Keywords

Versions (1)
  1. 11/6/17 11/6/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 6, 2017

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License

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

English

Mandatory 7 Day Follow Up Assessment

1 forms  
Vital signs
Description

Vital signs

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

Sitting blood pressure systolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
mmHg
Sitting blood pressure diastolic
Description

Sitting blood pressure diastolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mmHg
Sitting heart rate
Description

Sitting heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0277814
beats/min
Laboratory Evaluation
Description

Laboratory Evaluation

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

Date of blood sample

Data type

date

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

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

Data type

boolean

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

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.

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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