ID

24328

Description

Part 1 of Module 12: Wk 52, Follow-Up & Study Conc 101468/243 Study ID: 101468/243 Clinical Study ID: 101468/243 Study Title: A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Keywords

Versions (1)
  1. 7/30/17 7/30/17 -
Copyright Holder

glaxoSmithKline

Uploaded on

July 30, 2017

DOI

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License

Creative Commons BY-NC 3.0
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GSK study: Ropinirole in RLS patients 101468/243 - Week 52

English

GSK study: Ropinirole in RLS patients 101468/243 - Week 52

1 forms  
Study medication record since last visit
Description

Study medication record since last visit

Alias
UMLS CUI-1
C2734539
UMLS CUI-2
C0008972
Study medication record since last visit
Description

Please complete the study medication record in the Study Medication and Compliance Section at the back of this module.

Data type

text

Alias
UMLS CUI [1,1]
C2734539
UMLS CUI [1,2]
C0008972
RLS Rating scale
Description

RLS Rating scale

Alias
UMLS CUI-1
C0681889
UMLS CUI-2
C0035258
RLS Rating scale
Description

Please complete the appropriate RLS Rating Scale from the RLS Rating Scale Book

Data type

text

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0035258
Vital signs
Description

Vital signs

Alias
UMLS CUI-1
C0518766
Weight in kg
Description

Weight in kg

Data type

integer

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C0439209
Weight in lbs
Description

Weight in lbs

Data type

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C0439219
Weight (without shoes)
Description

Weight

Data type

float

Alias
UMLS CUI [1]
C0005910
Pulse
Description

after 5min sitting

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Sitting systolic blood pressure
Description

after 5 minutes sitting

Data type

integer

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

after 5 minutes sitting

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mmHg
Laboratory evaluation
Description

Laboratory evaluation

Alias
UMLS CUI-1
C0022885
Date of blood sample
Description

Please take a blood sample for routine analysis.

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Please affix the Quest Diagnostics Laboratory label here.
Description

Laboratory label

Data type

text

Alias
UMLS CUI [1]
C4273937
Were any clinically significant abnormalities detected?
Description

If ’Yes’, please record details in the Adverse Experiences and/or SAE section and repeat at Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1704258
Urine dipstick
Description

Urine dipstick

Alias
UMLS CUI-1
C0430370
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 and repeat at Follow-up. Please send a sample to Quest Diagnostics for further evaluation.

Data type

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0456984
Pregnancy dipstick
Description

Pregnancy dipstick

Alias
UMLS CUI-1
C0430056
Is the patient a female of child-bearing potential?
Description

If ’Yes’, please perform a pregnancy dipstick test and record result below.

Data type

boolean

Alias
UMLS CUI [1]
C1960468
Record the result of the pregnancy dipstick, if the patient is a female of child-bearing potential
Description

If ’Positive’, please record details on the Pregnancy Notification Form.

Data type

integer

Alias
UMLS CUI [1,1]
C0430056
UMLS CUI [1,2]
C0456984
Medical procedures
Description

Medical procedures

Alias
UMLS CUI-1
C0199171
Medical Procedures
Description

Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this module

Data type

text

Alias
UMLS CUI [1]
C0199171
Concomitant Medication
Description

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Concomitant Medication
Description

Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this module

Data type

text

Alias
UMLS CUI [1]
C2347852
Adverse reaction
Description

Adverse reaction

Alias
UMLS CUI-1
C0559546
Adverse reaction
Description

Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the last visit?" in the Adverse Experience section at the back of this module

Data type

text

Alias
UMLS CUI [1]
C0559546
Clinical global impression
Description

Clinical global impression

Alias
UMLS CUI-1
C3639708
Clinical global impression
Description

This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.

Data type

text

Alias
UMLS CUI [1]
C3639708
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Similar models

GSK study: Ropinirole in RLS patients 101468/243 - Week 52

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Study medication record since last visit
C2734539 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Study medication record since last visit
Item
Study medication record since last visit
text
C2734539 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
Item Group
RLS Rating scale
C0681889 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
RLS Rating scale
Item
RLS Rating scale
text
C0681889 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Weight in kg
Item
Weight in kg
integer
C0005910 (UMLS CUI [1,1])
C0439209 (UMLS CUI [1,2])
Weight in lbs
Item
Weight in lbs
boolean
C0005910 (UMLS CUI [1,1])
C0439219 (UMLS CUI [1,2])
Weight
Item
Weight (without shoes)
float
C0005910 (UMLS CUI [1])
Pulse rate
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Sitting systolic blood pressure
Item
Sitting systolic blood pressure
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Sitting diastolic blood pressure
Item
Sitting diastolic blood pressure
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Item Group
Laboratory evaluation
C0022885 (UMLS CUI-1)
Date of blood sample
Item
Date of blood sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Laboratory label
Item
Please affix the Quest Diagnostics Laboratory label here.
text
C4273937 (UMLS CUI [1])
laboratory results abnormalities
Item
Were any clinically significant abnormalities detected?
boolean
C0005834 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item Group
Urine dipstick
C0430370 (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)
Item Group
Pregnancy dipstick
C0430056 (UMLS CUI-1)
female child-bearing potential
Item
Is the patient a female of child-bearing potential?
boolean
C1960468 (UMLS CUI [1])
Item
Record the result of the pregnancy dipstick, if the patient is a female of child-bearing potential
integer
C0430056 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Pregnancy dipstick result
Code List
Record the result of the pregnancy dipstick, if the patient is a female of child-bearing potential
CL Item
negative (1)
CL Item
positive (2)
Item Group
Medical procedures
C0199171 (UMLS CUI-1)
Medical Procedures
Item
Medical Procedures
text
C0199171 (UMLS CUI [1])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Concomitant Medication
Item
Concomitant Medication
text
C2347852 (UMLS CUI [1])
Item Group
Adverse reaction
C0559546 (UMLS CUI-1)
Adverse reaction
Item
Adverse reaction
text
C0559546 (UMLS CUI [1])
Item Group
Clinical global impression
C3639708 (UMLS CUI-1)
Clinical global impression
Item
Clinical global impression
text
C3639708 (UMLS CUI [1])
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