ID

25280

Description

Alcohol Consumption/Smoking History form Study ID: 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

Keywords

Versions (5)
  1. 8/29/17 8/29/17 -
  2. 9/5/17 9/5/17 -
  3. 9/6/17 9/6/17 -
  4. 10/5/17 10/5/17 -
  5. 4/9/19 4/9/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 29, 2017

DOI

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License

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

English

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

1 forms  
Header
Description

Header

Alias
UMLS CUI-1
C1320722
Study No.:
Description

Study No.:

Data type

text

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

Subject No.:

Data type

integer

Alias
UMLS CUI [1]
C2348585
Panel ID:
Description

Panel ID

Data type

text

Alias
UMLS CUI [1,1]
C0441833
UMLS CUI [1,2]
C0600091
Visit:
Description

Visit

Data type

text

Alias
UMLS CUI [1]
C0545082
Date
Description

DD/MON/YY

Data type

date

Alias
UMLS CUI [1]
C0011008
Alcohol Consumption
Description

Alcohol Consumption

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

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

Data type

integer

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

Units per week

Data type

integer

Alias
UMLS CUI [1]
C0560579
Smoking History
Description

Smoking History

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

if Yes, please complete smoking history details

Data type

boolean

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

Smoking years

Data type

integer

Measurement units
  • years
Alias
UMLS CUI [1]
C3694955
years
Average number of cigarettes smoked per day?
Description

Cigarettes per day

Data type

integer

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

Type of tobacco product

Data type

text

Alias
UMLS CUI [1]
C3166496
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Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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.:
integer
C2348585 (UMLS CUI [1])
Panel ID
Item
Panel ID:
text
C0441833 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
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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