ID

25568

Beskrivning

Alcohol Consumption/Smoking History form Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title: An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP, Zygara; Zygara, ZIPEREVE, ZEPREVE, Requip Depot, REQUIP, REPREVE, Modutab, ADARTREL Study Indication: Restless Legs Syndrome

Nyckelord

Versioner (5)
  1. 2017-08-29 2017-08-29 -
  2. 2017-09-05 2017-09-05 -
  3. 2017-09-06 2017-09-06 -
  4. 2017-10-05 2017-10-05 -
  5. 2019-04-09 2019-04-09 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

6 september 2017

DOI

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Licens

Creative Commons BY-NC 3.0
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Alcohol Consumption/Smoking History Ropinirole Restless Legs Syndrome 101468/198

Engelsk

Alcohol Consumption/Smoking History Ropinirole Restless Legs Syndrome 101468/198

1 Formulär  
Header
Beskrivning

Header

Alias
UMLS CUI-1
C1320722
Study No.:
Beskrivning

Study No.:

Datatyp

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0600091
Subject No.:
Beskrivning

Subject No.:

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Panel ID:
Beskrivning

Panel ID

Datatyp

text

Alias
UMLS CUI [1]
C3826248
Visit:
Beskrivning

Visit

Datatyp

text

Alias
UMLS CUI [1]
C0545082
Date
Beskrivning

DD/MON/YY

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Alcohol Consumption
Beskrivning

Alcohol Consumption

Alias
UMLS CUI-1
C0001948
Average number of units per day
Beskrivning

1 unit is equivalent to half a pint of beer (ca. 0,57 l), one measure of spirits or one glass of wine.

Datatyp

integer

Alias
UMLS CUI [1]
C0560578
Average number of units per week
Beskrivning

1 unit is equivalent to half a pint of beer (ca. 0,57 l), one measure of spirits or one glass of wine.

Datatyp

integer

Alias
UMLS CUI [1]
C0560579
Smoking History
Beskrivning

Smoking History

Alias
UMLS CUI-1
C1519384
Is the subject a smoker?
Beskrivning

if Yes, please complete smoking history details

Datatyp

boolean

Alias
UMLS CUI [1]
C0543414
Number of years the subject has been a smoker?
Beskrivning

Smoking years

Datatyp

integer

Måttenheter
  • years
Alias
UMLS CUI [1]
C3694955
years
Average number of cigarettes smoked per day?
Beskrivning

Cigarettes per day

Datatyp

integer

Alias
UMLS CUI [1]
C3694146
Please state what type of tobacco product (eg. pipe, chigar, chewing tobacco or cigarette)
Beskrivning

Type of tobacco product

Datatyp

text

Alias
UMLS CUI [1]
C3166496
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Similar models

Alcohol Consumption/Smoking History Ropinirole Restless Legs Syndrome 101468/198

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
Study No.:
Item
Study No.:
text
C0008976 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject No.:
Item
Subject No.:
text
C2348585 (UMLS CUI [1])
Panel ID
Item
Panel ID:
text
C3826248 (UMLS CUI [1])
Visit
Item
Visit:
text
C0545082 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item Group
Alcohol Consumption
C0001948 (UMLS CUI-1)
Units per day
Item
Average number of units per day
integer
C0560578 (UMLS CUI [1])
Units per week
Item
Average number of units per week
integer
C0560579 (UMLS CUI [1])
Item Group
Smoking History
C1519384 (UMLS CUI-1)
Smoker
Item
Is the subject a smoker?
boolean
C0543414 (UMLS CUI [1])
Smoking years
Item
Number of years the subject has been a smoker?
integer
C3694955 (UMLS CUI [1])
Cigarettes per day
Item
Average number of cigarettes smoked per day?
integer
C3694146 (UMLS CUI [1])
Type of tobacco product
Item
Please state what type of tobacco product (eg. pipe, chigar, chewing tobacco or cigarette)
text
C3166496 (UMLS CUI [1])
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