ID

26065

Description

Exclusion Criteria second visit Ropinirole Case Report Form Concomitant Medication Ropinirole Case Report Form GSK Study ID: 100013 Clinical Study ID: RRL100013 A 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

  1. 10/5/17 10/5/17 -
Copyright Holder

gsk

Uploaded on

October 5, 2017

DOI

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License

Creative Commons BY-NC 3.0

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Exclusion Criteria second visit Ropinirole Case Report Form GSK RRL100013

Exclusion Criteria second visit Ropinirole Case Report Form GSK RRL100013

Administrative documentation
Description

Administrative documentation

Alias
UMLS CUI-1
C1320722
Study No
Description

Study No

Data type

integer

Alias
UMLS CUI [1]
C2826693
Subject No.:
Description

Subject No.

Data type

integer

Alias
UMLS CUI [1]
C2348585
Panel ID:
Description

Group identity

Data type

integer

Alias
UMLS CUI [1]
C3826248
Visit:
Description

Visit

Data type

integer

Alias
UMLS CUI [1]
C1549755
Date
Description

DD/MON/YY

Data type

date

Alias
UMLS CUI [1]
C0011008
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
7. Does the subject have an abuse of alcohol, defined as an average weekly intake of greater than 21 units or an average daily intake greater than 3 units for men; greater than 14 units per week or greater than 2 units per day for women?
Description

One unit is equivalent to half a pint of beer, one measure of spirits or one glass of wine.

Data type

boolean

Alias
UMLS CUI [1]
C0038586
8. Has the subject participated in another clinical trial, blood donation or has the subject lost blood less than 90 days before the present study?
Description

Other clinical trial, blood donation or blood loss

Data type

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C1516648
UMLS CUI [2]
C0005794
UMLS CUI [3]
C3163616
9. Does the subject have a positive pre-study screening result for hepatitis B surface antigen, hepatitis C antibody or HIV-1/2 antibodies?
Description

Hepatitis B, C or HIV antibodies

Data type

boolean

Alias
UMLS CUI [1]
C2711110
UMLS CUI [2]
C0019683
10. Is the subject pregnant and/or breast-feeding?
Description

Pregnant or breast-feeding

Data type

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C0006147
11. Is the subject a female of child-bearing potential who is not practising a clinically accepted method of contraception such as surgical sterilisation, 1.U.D., diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant)?
Description

No contraception

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0445107
UMLS CUI [1,3]
C0700589
12. Is the subject a female with positive urine/serum pregnancy test result at screening?
Description

Positive pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0240802

Similar models

Exclusion Criteria second visit Ropinirole Case Report Form GSK RRL100013

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative documentation
C1320722 (UMLS CUI-1)
Study No
Item
Study No
integer
C2826693 (UMLS CUI [1])
Subject No.
Item
Subject No.:
integer
C2348585 (UMLS CUI [1])
Group identity
Item
Panel ID:
integer
C3826248 (UMLS CUI [1])
Visit
Item
Visit:
integer
C1549755 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Alcohol abuse
Item
7. Does the subject have an abuse of alcohol, defined as an average weekly intake of greater than 21 units or an average daily intake greater than 3 units for men; greater than 14 units per week or greater than 2 units per day for women?
boolean
C0038586 (UMLS CUI [1])
Other clinical trial, blood donation or blood loss
Item
8. Has the subject participated in another clinical trial, blood donation or has the subject lost blood less than 90 days before the present study?
boolean
C0679823 (UMLS CUI [1,1])
C1516648 (UMLS CUI [1,2])
C0005794 (UMLS CUI [2])
C3163616 (UMLS CUI [3])
Hepatitis B, C or HIV antibodies
Item
9. Does the subject have a positive pre-study screening result for hepatitis B surface antigen, hepatitis C antibody or HIV-1/2 antibodies?
boolean
C2711110 (UMLS CUI [1])
C0019683 (UMLS CUI [2])
Pregnant or breast-feeding
Item
10. Is the subject pregnant and/or breast-feeding?
boolean
C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
No contraception
Item
11. Is the subject a female of child-bearing potential who is not practising a clinically accepted method of contraception such as surgical sterilisation, 1.U.D., diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant)?
boolean
C3831118 (UMLS CUI [1,1])
C0445107 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Positive pregnancy test
Item
12. Is the subject a female with positive urine/serum pregnancy test result at screening?
boolean
C0240802 (UMLS CUI [1])

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