ID

26064

Beschreibung

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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Versionen (1)
  1. 05.10.17 05.10.17 -
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gsk

Hochgeladen am

5. Oktober 2017

DOI

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Exclusion Criteria 1 Ropinirole Case Report Form GSK RRL100013

Englisch

Exclusion Criteria 1 Ropinirole Case Report Form GSK RRL100013

1 Formulare  
Administrative documentation
Beschreibung

Administrative documentation

Study number
Beschreibung

Study number

Datentyp

integer

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

Clinical Trial Subject Unique Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Panel ID:
Beschreibung

Panel ID

Datentyp

integer

Alias
UMLS CUI [1]
C3826248
Visit
Beschreibung

Visit

Datentyp

integer

Alias
UMLS CUI [1]
C0545082
Date
Beschreibung

DD/MON/YY

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Exclusion Criteria
Beschreibung

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?
Beschreibung

Adverse reaction to study drug

Datentyp

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?
Beschreibung

Abnormality of organs or blood

Datentyp

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?
Beschreibung

Postural hypotension or faints

Datentyp

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?
Beschreibung

Gastrointestinal, hepatic or renal disease

Datentyp

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?
Beschreibung

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.

Datentyp

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?
Beschreibung

Drugs with effect on CYP1A2

Datentyp

boolean

Alias
UMLS CUI [1]
C1827490
UMLS CUI [2,1]
C0919438
UMLS CUI [2,2]
C0207509
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Ähnliche Modelle

Exclusion Criteria 1 Ropinirole Case Report Form GSK RRL100013

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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