ID

36011

Description

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 The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Alcohol Consumption and Smoking History form. It has to be filled in for screening.

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

April 9, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

English

Alcohol Consumption, Smoking History

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject No.
Description

Subject No.

Data type

text

Alias
UMLS CUI [1]
C2348585
Panel ID
Description

Panel ID

Data type

text

Alias
UMLS CUI [1]
C3846158
Visit Date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
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

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]
C0560579
Smoking History
Description

Smoking History

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

if Yes, please complete the itemgroup "smoking history details"

Data type

text

Alias
UMLS CUI [1]
C0543414
Smoking history details
Description

Smoking history details

Alias
UMLS CUI-1
C0543414
UMLS CUI-2
C1522508
Number of years the subject has been a smoker?
Description

Smoking years

Data type

integer

Measurement units
  • years
Alias
UMLS CUI [1,1]
C0037369
UMLS CUI [1,2]
C0439234
UMLS CUI [1,3]
C0449788
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
Description

(eg. pipe, chigar, chewing tobacco or cigarette)

Data type

text

Alias
UMLS CUI [1]
C3166496
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Similar models

Alcohol Consumption, Smoking History

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject No.
Item
Subject No.
text
C2348585 (UMLS CUI [1])
Panel ID
Item
Panel ID
text
C3846158 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (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)
Item
Is the subject a smoker?
text
C0543414 (UMLS CUI [1])
Smoker
Code List
Is the subject a smoker?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Smoking history details
C0543414 (UMLS CUI-1)
C1522508 (UMLS CUI-2)
Smoking years
Item
Number of years the subject has been a smoker?
integer
C0037369 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
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
text
C3166496 (UMLS CUI [1])
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