ID

36908

Description

Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole 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 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the smoking history form. It has to be filled in at screening.

Keywords

Versions (2)
  1. 8/31/17 8/31/17 -
  2. 6/21/19 6/21/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 21, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201

English

Smoking History

1 forms  
  1. StudyEvent: ODM
    1. Smoking History
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Volunteer panel number
Description

Identification number

Data type

integer

Alias
UMLS CUI [1]
C1300638
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Smoking History
Description

Smoking History

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

If you tick yes, please complete the smoking history in the following items

Data type

text

Alias
UMLS CUI [1]
C1519386
Number of years subject has been smoking?
Description

Number of years smoking

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

Number of cigarettes smoked per day

Data type

integer

Alias
UMLS CUI [1]
C3694146
Please state type of tobacco product
Description

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

Data type

text

Alias
UMLS CUI [1]
C3166496
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Similar models

Smoking History

1 forms
  1. StudyEvent: ODM
    1. Smoking History
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Identification number
Item
Volunteer panel number
integer
C1300638 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Smoking History
C1519384 (UMLS CUI-1)
Item
Is the subject a smoker?
text
C1519386 (UMLS CUI [1])
Smoking status
Code List
Is the subject a smoker?
CL Item
Yes (Y)
CL Item
No (N)
Number of years smoking
Item
Number of years subject has been smoking?
integer
C0037369 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Number of cigarettes smoked per day
Item
Average number of cigarettes smoked per day?
integer
C3694146 (UMLS CUI [1])
Tobacco product
Item
Please state type of tobacco product
text
C3166496 (UMLS CUI [1])
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