ID

26064

Description

Exclusion Criteria 1 Ropinirole Case Report 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

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Versions (1)
  1. 05/10/2017 05/10/2017 -
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gsk

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5 octobre 2017

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Creative Commons BY-NC 3.0
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Exclusion Criteria 1 Ropinirole Case Report Form GSK RRL100013

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Exclusion Criteria 1 Ropinirole Case Report Form GSK RRL100013

1 Formulaires  
Administrative documentation
Description

Administrative documentation

Study number
Description

Study number

Type de données

integer

Alias
UMLS CUI [1]
C2826693
Subject Nr.:
Description

Clinical Trial Subject Unique Identifier

Type de données

text

Alias
UMLS CUI [1]
C2348585
Panel ID:
Description

Panel ID

Type de données

integer

Alias
UMLS CUI [1]
C3826248
Visit
Description

Visit

Type de données

integer

Alias
UMLS CUI [1]
C0545082
Date
Description

DD/MON/YY

Type de données

date

Alias
UMLS CUI [1]
C0011008
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
1. Does the subject have a definite or suspected personal history or family history of adverse reactions or hypersensitivity to the study drug or to drugs with a similar chemical structure?
Description

Adverse reaction to study drug

Type de données

boolean

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C0013175
2. Does the subject have a history or presence of clinically significant cardiovascular, neurological, psychiatric, haemotological or renal abnormalities?
Description

Abnormality of organs or blood

Type de données

boolean

Alias
UMLS CUI [1]
C0243050
UMLS CUI [2]
C0027765
UMLS CUI [3]
C0004936
UMLS CUI [4]
C0475182
UMLS CUI [5]
C0151746
3. Does the subject have a history of postural hypotension or faints?
Description

Postural hypotension or faints

Type de données

boolean

Alias
UMLS CUI [1]
C0020651
UMLS CUI [2]
C0039070
4. Does the subject have a history or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs?
Description

Gastrointestinal, hepatic or renal disease

Type de données

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0022658
UMLS CUI [4]
C1512073
5. Has the subject received prescribed medication (including the oral contraceptive pill and hormone replacement therapy) within 14 days or over-the-counter (OTC) medicine within 7 days before the first dosing day, which in the opinion of the Principal Investigator may interfere with the study procedures or compromise a subject's safety?
Description

Subjects who have taken OTC medication (apart from CYP1A2 medications, see below) may still be entered into the study, if, in the opinion of the Principal/Co-investigator in agreement with the Sponsor, the medication received will not interfere with the study procedures or compromise subject1s safety.

Type de données

boolean

Alias
UMLS CUI [1]
C3166216
UMLS CUI [2]
C0013231
UMLS CUI [3,1]
C4054723
UMLS CUI [3,2]
C0008972
6. Has the subject withdrawn, introduced, or changed the dose of any drug known to substantially inhibit CYP 1A2 (e.g., ciprofloxacin, fluvoxarnine, cimetidine, ethinyloestradiol) or induce CYP1A2 (e.g., tobacco, omeprazole) within 7 days prior to first day of dosing?
Description

Drugs with effect on CYP1A2

Type de données

boolean

Alias
UMLS CUI [1]
C1827490
UMLS CUI [2,1]
C0919438
UMLS CUI [2,2]
C0207509
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Similar models

Exclusion Criteria 1 Ropinirole Case Report Form GSK RRL100013

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative documentation
Study number
Item
Study number
integer
C2826693 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Subject Nr.:
text
C2348585 (UMLS CUI [1])
Panel ID
Item
Panel ID:
integer
C3826248 (UMLS CUI [1])
Visit
Item
Visit
integer
C0545082 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Adverse reaction to study drug
Item
1. Does the subject have a definite or suspected personal history or family history of adverse reactions or hypersensitivity to the study drug or to drugs with a similar chemical structure?
boolean
C0559546 (UMLS CUI [1,1])
C0013175 (UMLS CUI [1,2])
Abnormality of organs or blood
Item
2. Does the subject have a history or presence of clinically significant cardiovascular, neurological, psychiatric, haemotological or renal abnormalities?
boolean
C0243050 (UMLS CUI [1])
C0027765 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
C0475182 (UMLS CUI [4])
C0151746 (UMLS CUI [5])
Postural hypotension or faints
Item
3. Does the subject have a history of postural hypotension or faints?
boolean
C0020651 (UMLS CUI [1])
C0039070 (UMLS CUI [2])
Gastrointestinal, hepatic or renal disease
Item
4. Does the subject have a history or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs?
boolean
C0017178 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C1512073 (UMLS CUI [4])
Subject's medication
Item
5. Has the subject received prescribed medication (including the oral contraceptive pill and hormone replacement therapy) within 14 days or over-the-counter (OTC) medicine within 7 days before the first dosing day, which in the opinion of the Principal Investigator may interfere with the study procedures or compromise a subject's safety?
boolean
C3166216 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C4054723 (UMLS CUI [3,1])
C0008972 (UMLS CUI [3,2])
Drugs with effect on CYP1A2
Item
6. Has the subject withdrawn, introduced, or changed the dose of any drug known to substantially inhibit CYP 1A2 (e.g., ciprofloxacin, fluvoxarnine, cimetidine, ethinyloestradiol) or induce CYP1A2 (e.g., tobacco, omeprazole) within 7 days prior to first day of dosing?
boolean
C1827490 (UMLS CUI [1])
C0919438 (UMLS CUI [2,1])
C0207509 (UMLS CUI [2,2])
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