ID

21952

Description

RRL100013 12 Week, Double-Blind, Placebo Controlled, Twice Daily Dosing Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Requiring Extended Treatment Coverage

Keywords

Versions (1)
  1. 5/9/17 5/9/17 -
Copyright Holder

gsk

Uploaded on

May 9, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Efficacy and Safety Ropinirole in Patients Suffering from RLS GSK Study

English

RLS DIAGNOSTIC CLINICAL INTERVIEW Case Report Form RRL100013

1 forms  
Header module
Description

Header module

Protocol Identifier
Description

Protocol Identifier

Data type

integer

Alias
UMLS CUI [1]
C2826693
Subject Identifier
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
CLINICAL INTERVIEW - WORKSHEET
Description

CLINICAL INTERVIEW - WORKSHEET

Diagnosis
Description

Diagnosis

Data type

integer

Alias
UMLS CUI [1]
C0011900
Cause of disease
Description

Cause of disease

Data type

integer

Alias
UMLS CUI [1]
C1314792
Does subject report growing pains?
Description

Growing pains

Data type

boolean

Alias
UMLS CUI [1]
C0423693
1. Have you ever had unpleasant or uncomfortable feelings in your legs that occurred mainly while you were either sitting or lying down?
Description

If no, go to #3

Data type

boolean

Alias
UMLS CUI [1,1]
C1140621
UMLS CUI [1,2]
C1527305
2. Are these feelings painful rather than just uncomfortable?
Description

Are these feelings painful rather than just uncomfortable?

Data type

boolean

Alias
UMLS CUI [1]
C0393903
2a. How would you describe these feelings or sensations?
Description

How would you describe these feelings or sensations?

Data type

text

Alias
UMLS CUI [1,1]
C0036659
UMLS CUI [1,2]
C0678257
3. Have you ever felt the need or urge to move your legs that occurred mainly while you were either sitting or lying down?
Description

If yes, go to #3a. If no, go to #4.

Data type

boolean

Alias
UMLS CUI [1,1]
C0560560
UMLS CUI [1,2]
C1140621
3a. Do these feelings in your legs ever become overwhelming to the point that you cannot resist moving your legs?
Description

Ovelwhelmed to move

Data type

boolean

Alias
UMLS CUI [1,1]
C4281815
UMLS CUI [1,2]
C0578660
3b. If you developed these feelings in your legs and you could not move your legs, or if someone were to hold your legs down, how would this effect the feelings in your legs?:
Description

(Mark One) If no to both questions #1 and #3, go to #15.

Data type

integer

Alias
UMLS CUI [1,1]
C1280500
UMLS CUI [1,2]
C1527305
UMLS CUI [1,3]
C1140621
Do you think these feelings in your legs are due to a Charlie-horse or muscle cramp? .
Description

If yes, go to #4a. If no, go to #5

Data type

boolean

Alias
UMLS CUI [1]
C0037763
UMLS CUI [2]
C0026821
4a. Are these feelings always due to a Charlie-horse or muscle cramp?
Description

If yes, go to #4a. If no, go to #5

Data type

boolean

Alias
UMLS CUI [1,1]
C0037763
UMLS CUI [1,2]
C1549493
UMLS CUI [2,1]
C0026821
UMLS CUI [2,2]
C1549493
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Similar models

RLS DIAGNOSTIC CLINICAL INTERVIEW Case Report Form RRL100013

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header module
Protocol Identifier
Item
Protocol Identifier
integer
C2826693 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
CLINICAL INTERVIEW - WORKSHEET
Item
Diagnosis
integer
C0011900 (UMLS CUI [1])
Diagnosis
Code List
Diagnosis
CL Item
Definite RLS (1)
C0035258 (UMLS CUI-1)
C0439544 (UMLS CUI-2)
CL Item
Probable RLS (2)
C0035258 (UMLS CUI-1)
C0332148 (UMLS CUI-2)
CL Item
Possible RLS (3)
C0035258 (UMLS CUI-1)
C2362652 (UMLS CUI-2)
CL Item
Not-RLS (4)
C0035258 (UMLS CUI-1)
C0497153 (UMLS CUI-2)
CL Item
Secondary Definite (5)
C0035258 (UMLS CUI-1)
C0439544 (UMLS CUI-2)
C0332138 (UMLS CUI-3)
CL Item
Secondary Possible (6)
C0035258 (UMLS CUI-1)
C2362652 (UMLS CUI-2)
C0332138 (UMLS CUI-3)
CL Item
Diagnosis Unknown (7)
C0011900 (UMLS CUI-1)
C0439673 (UMLS CUI-2)
Cause of disease
Item
Cause of disease
integer
C1314792 (UMLS CUI [1])
Growing pains
Item
Does subject report growing pains?
boolean
C0423693 (UMLS CUI [1])
unpleasant or uncomfortable feelings in your legs
Item
1. Have you ever had unpleasant or uncomfortable feelings in your legs that occurred mainly while you were either sitting or lying down?
boolean
C1140621 (UMLS CUI [1,1])
C1527305 (UMLS CUI [1,2])
Are these feelings painful rather than just uncomfortable?
Item
2. Are these feelings painful rather than just uncomfortable?
boolean
C0393903 (UMLS CUI [1])
How would you describe these feelings or sensations?
Item
2a. How would you describe these feelings or sensations?
text
C0036659 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Urge to move
Item
3. Have you ever felt the need or urge to move your legs that occurred mainly while you were either sitting or lying down?
boolean
C0560560 (UMLS CUI [1,1])
C1140621 (UMLS CUI [1,2])
Ovelwhelmed to move
Item
3a. Do these feelings in your legs ever become overwhelming to the point that you cannot resist moving your legs?
boolean
C4281815 (UMLS CUI [1,1])
C0578660 (UMLS CUI [1,2])
Item
3b. If you developed these feelings in your legs and you could not move your legs, or if someone were to hold your legs down, how would this effect the feelings in your legs?:
integer
C1280500 (UMLS CUI [1,1])
C1527305 (UMLS CUI [1,2])
C1140621 (UMLS CUI [1,3])
Effects on feeling in leg
Code List
3b. If you developed these feelings in your legs and you could not move your legs, or if someone were to hold your legs down, how would this effect the feelings in your legs?:
CL Item
a lot better (1)
C4036142 (UMLS CUI-1)
CL Item
some better (2)
C4049139 (UMLS CUI-1)
CL Item
no difference (3)
C3842396 (UMLS CUI-1)
CL Item
some worse (4)
C1279889 (UMLS CUI-1)
CL Item
a lot wore (5)
C3841448 (UMLS CUI-1)
Charlie-horse or muscle cramp
Item
Do you think these feelings in your legs are due to a Charlie-horse or muscle cramp? .
boolean
C0037763 (UMLS CUI [1])
C0026821 (UMLS CUI [2])
Charlie-horse or muscle cramp always reason
Item
4a. Are these feelings always due to a Charlie-horse or muscle cramp?
boolean
C0037763 (UMLS CUI [1,1])
C1549493 (UMLS CUI [1,2])
C0026821 (UMLS CUI [2,1])
C1549493 (UMLS CUI [2,2])
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