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36093

Beschreibung

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 pregnancy test form. It has to be filled in for all sessions each for day 1 and for follow-up.

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  1. 15.04.19 15.04.19 -
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GlaxoSmithKline

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15. April 2019

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    Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

    Englisch

    Pregnancy Test

    1 Formulare  
    1. StudyEvent: ODM
      1. Pregnancy Test
    Administrative data
    Beschreibung

    Administrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject No.
    Beschreibung

    Subject No.

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Panel ID
    Beschreibung

    Panel ID

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C3846158 (Other Coding)
    LOINC
    LA4728-7
    Visit type
    Beschreibung

    Visit type

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0545082 (Visit)
    UMLS CUI [1,2]
    C0332307 (Type - attribute)
    SNOMED
    261664005
    Visit Date
    Beschreibung

    day month year

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Pregnancy Test
    Beschreibung

    Pregnancy Test

    Alias
    UMLS CUI-1
    C0032976 (Pregnancy Tests)
    SNOMED
    74036000
    Was a pregnancy test carried out?
    Beschreibung

    Pregnancy test

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0032976 (Pregnancy Tests)
    SNOMED
    74036000
    UMLS CUI [1,2]
    C1272682 (To be done)
    SNOMED
    385643006
    If no pregnancy test, please specify reason
    Beschreibung

    No pregnancy test, reason

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0566251 (Reason and justification)
    SNOMED
    288830005
    UMLS CUI [1,2]
    C3841220 (Test not performed)
    LOINC
    LA13546-9
    UMLS CUI [1,3]
    C0032976 (Pregnancy Tests)
    SNOMED
    74036000
    If pregnancy test, please note Date of test
    Beschreibung

    day month year

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0032976 (Pregnancy Tests)
    SNOMED
    74036000
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    If pregnancy test, please note Time of test
    Beschreibung

    00:00-23:59

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0032976 (Pregnancy Tests)
    SNOMED
    74036000
    UMLS CUI [1,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Pregnancy test Result
    Beschreibung

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

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0427777 (Pregnancy test finding)
    SNOMED
    250421003
    Test type
    Beschreibung

    Please mark box for test type

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0032976 (Pregnancy Tests)
    SNOMED
    74036000
    UMLS CUI [1,2]
    C0332307 (Type - attribute)
    SNOMED
    261664005
    If Other test type, please specify
    Beschreibung

    Other pregnancy test

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    UMLS CUI [1,2]
    C0032976 (Pregnancy Tests)
    SNOMED
    74036000
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Pregnancy Test

    1 Formulare
    1. StudyEvent: ODM
      1. Pregnancy Test
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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])
    Item
    Visit type
    integer
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Visit type
    Code List
    Visit type
    CL Item
    Session 1 day 1 (1)
    CL Item
    Session 2 day 1  (2)
    CL Item
    Session 3 day 1 (3)
    CL Item
    Session 4 day 1 (4)
    CL Item
    Session 5 day 1 (5)
    CL Item
    Follow-up (6)
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    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, please note Date of test
    date
    C0032976 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time of pregnancy test
    Item
    If pregnancy test, 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
    Test type
    integer
    C0032976 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Test type
    Code List
    Test type
    CL Item
    Dipstick urine HCG (1)
    CL Item
    Serum HCG (2)
    CL Item
    Other (3)
    Other pregnancy test
    Item
    If Other test type, please specify
    text
    C0205394 (UMLS CUI [1,1])
    C0032976 (UMLS CUI [1,2])
    Zum Seitenanfang zurückkehren 

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