0 Ratings
ID

36004

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 Demographic Details and demography for females form. It has to be filled in for screening.

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Versions (1)
  1. 4/9/19 4/9/19 -
Copyright Holder

GlaxoSmithKline

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April 9, 2019

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

    English

    Demographic Details, demography for females

    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
    Demographic Details
    Description

    Demographic Details

    Alias
    UMLS CUI-1
    C0011298
    Date of birth
    Description

    Date of birth

    Data type

    date

    Alias
    UMLS CUI [1]
    C0421451
    Sex
    Description

    Sex

    Data type

    text

    Alias
    UMLS CUI [1]
    C0079399
    Height
    Description

    Body Height

    Data type

    integer

    Measurement units
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Weight
    Description

    Body Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Body mass index
    Description

    Body mass index

    Data type

    float

    Measurement units
    • kg/m^2
    Alias
    UMLS CUI [1]
    C1305855
    kg/m^2
    Clinical Staff Signature
    Description

    Clinical Staff Signature

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0025106
    UMLS CUI [1,2]
    C1519316
    Date of signature
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Racial group
    Description

    Racial group

    Alias
    UMLS CUI-1
    C0034510
    American Hispanic
    Description

    American Hispanic race

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019576
    Arabic/North African
    Description

    Arabic/North African race

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0238604
    Black race
    Description

    Black race

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0005680
    East and South East Asia
    Description

    East and South East Asian race

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0003983
    Japanese
    Description

    Japanese race

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1556094
    South Asia
    Description

    South Asian race

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1519427
    White/Caucasian
    Description

    White/Caucasian race

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0043157
    Other
    Description

    Other race

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0034510
    If other race, please specify
    Description

    Other race, specification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0034510
    UMLS CUI [1,3]
    C2348235
    Childbearing potential
    Description

    Childbearing potential

    Alias
    UMLS CUI-1
    C3831118
    Childbearing potential
    Description

    Tick one. If you tick Potentially able to conceive children: is she practising a clinically accepted method of contraception such as surgical sterilisation, LU .D., diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3831118
    Pregnancy Test
    Description

    Pregnancy Test

    Alias
    UMLS CUI-1
    C0032976
    Was a pregnancy test carried out?
    Description

    Pregnancy test

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C1272682
    If no pregnancy test, please specify reason
    Description

    No pregnancy test, reason

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0566251
    UMLS CUI [1,2]
    C3841220
    UMLS CUI [1,3]
    C0032976
    If pregnancy test was performed, please note date of test
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C0011008
    If pregnancy test was performed, please note time of test
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C0040223
    Pregnancy Test result
    Description

    If 'Positive', DO NOT include the subject in the study.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0427777
    Pregnancy test type
    Description

    Please tick box for test type

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C0332307
    If other pregnancy test type, please specify
    Description

    Other pregnancy test type

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0032976
    UMLS CUI [1,3]
    C0332307
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    Similar models

    Demographic Details, demography for females

    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
    Demographic Details
    C0011298 (UMLS CUI-1)
    Date of birth
    Item
    Date of birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Sex
    text
    C0079399 (UMLS CUI [1])
    Sex
    Code List
    Sex
    CL Item
    Male (M)
    CL Item
    Female (F)
    Body Height
    Item
    Height
    integer
    C0005890 (UMLS CUI [1])
    Body Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Body mass index
    Item
    Body mass index
    float
    C1305855 (UMLS CUI [1])
    Clinical Staff Signature
    Item
    Clinical Staff Signature
    text
    C0025106 (UMLS CUI [1,1])
    C1519316 (UMLS CUI [1,2])
    Date of signature
    Item
    Date of signature
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Racial group
    C0034510 (UMLS CUI-1)
    American Hispanic race
    Item
    American Hispanic
    boolean
    C0019576 (UMLS CUI [1])
    Arabic/North African race
    Item
    Arabic/North African
    boolean
    C0238604 (UMLS CUI [1])
    Black race
    Item
    Black race
    boolean
    C0005680 (UMLS CUI [1])
    East and South East Asian race
    Item
    East and South East Asia
    boolean
    C0003983 (UMLS CUI [1])
    Japanese race
    Item
    Japanese
    boolean
    C1556094 (UMLS CUI [1])
    South Asian race
    Item
    South Asia
    boolean
    C1519427 (UMLS CUI [1])
    White/Caucasian race
    Item
    White/Caucasian
    boolean
    C0043157 (UMLS CUI [1])
    Other race
    Item
    Other
    text
    C0205394 (UMLS CUI [1,1])
    C0034510 (UMLS CUI [1,2])
    Other race, specification
    Item
    If other race, please specify
    text
    C0205394 (UMLS CUI [1,1])
    C0034510 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item Group
    Childbearing potential
    C3831118 (UMLS CUI-1)
    Item
    Childbearing potential
    integer
    C3831118 (UMLS CUI [1])
    Childbearing potential
    Code List
    Childbearing potential
    CL Item
    Premenarcheal (1)
    CL Item
    Sterile ( of childbearing age) (2)
    CL Item
    Postmenopausal (3)
    CL Item
    Potentially able to conceive children (4)
    CL Item
    contraception (i.e., Norplant) (5)
    Item Group
    Pregnancy Test
    C0032976 (UMLS CUI-1)
    Item
    Was a pregnancy test carried out?
    text
    C0032976 (UMLS CUI [1,1])
    C1272682 (UMLS CUI [1,2])
    Pregnancy test
    Code List
    Was a pregnancy test carried out?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    No pregnancy test, reason
    Item
    If no pregnancy test, please specify reason
    text
    C0566251 (UMLS CUI [1,1])
    C3841220 (UMLS CUI [1,2])
    C0032976 (UMLS CUI [1,3])
    Date of pregnancy test
    Item
    If pregnancy test was performed, please note date of test
    date
    C0032976 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time of pregnancy test
    Item
    If pregnancy test was performed, please note time of test
    time
    C0032976 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item
    Pregnancy Test result
    text
    C0427777 (UMLS CUI [1])
    Pregnancy Test result
    Code List
    Pregnancy Test result
    CL Item
    Positive (P)
    CL Item
    Negative (N)
    Item
    Pregnancy test type
    integer
    C0032976 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Pregnancy test, test type
    Code List
    Pregnancy test type
    CL Item
    Dipstick urine HCG (1)
    CL Item
    SerurnHCG (2)
    CL Item
    Other (3)
    Other pregnancy test type
    Item
    If other pregnancy test type, please specify
    text
    C0205394 (UMLS CUI [1,1])
    C0032976 (UMLS CUI [1,2])
    C0332307 (UMLS CUI [1,3])
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