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ID
26065
Beschrijving
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
Trefwoorden
Versies (1)
- 05-10-17 05-10-17 -
Houder van rechten
gsk
Geüploaded op
5 oktober 2017
DOI
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Licentie
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
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Exclusion Criteria second visit Ropinirole Case Report Form GSK RRL100013
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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])
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])
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])
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])
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])
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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