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33764

Beschreibung

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains information about any recorded rash during the study. It should be filled out everytime a rash occurs during study. A blood sample for PK analysis is to be obtained. Enter details on the “Protocol Deviation Log”

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Versionen (2)
  1. 05.12.18 05.12.18 -
  2. 25.12.18 25.12.18 -
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GlaxoSmithKline

Hochgeladen am

25. Dezember 2018

DOI

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Creative Commons BY-NC 3.0
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    Effect of Lamictal on Resting Motor Threshold Study-ID 107434

    Englisch

    Record of Rash

    1 Formulare  
    1. StudyEvent: ODM
      1. Record of Rash
    Administrative Data
    Beschreibung

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Screening number
    Beschreibung

    Subject Screening No.

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0220908
    UMLS CUI [1,2]
    C0600091
    Subject no.
    Beschreibung

    Subject Number

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Record of Rash
    Beschreibung

    Record of Rash

    Alias
    UMLS CUI-1
    C0015230
    Has a photograph been taken of the affected area?
    Beschreibung

    If yes, comment and complete below.

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1879646
    UMLS CUI [1,2]
    C0031749
    UMLS CUI [1,3]
    C0920316
    Comment
    Beschreibung

    Comment

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1879646
    UMLS CUI [1,2]
    C0031749
    UMLS CUI [1,3]
    C0920316
    UMLS CUI [1,4]
    C0947611
    Date of Photograph
    Beschreibung

    Date of Photograph

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C1879646
    UMLS CUI [1,2]
    C0031749
    UMLS CUI [1,3]
    C0920316
    UMLS CUI [1,4]
    C0011008
    Actual Time
    Beschreibung

    Actual Time

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C1879646
    UMLS CUI [1,2]
    C0031749
    UMLS CUI [1,3]
    C0920316
    UMLS CUI [1,4]
    C0040223
    Has a punch biopsy sample been collected?
    Beschreibung

    If yes, comment (include site and number taken).

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0191321
    Comment
    Beschreibung

    Comment

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0947611
    Conclusion
    Beschreibung

    Conclusion

    Alias
    UMLS CUI-1
    C1707478
    Clinical Staff initials
    Beschreibung

    Clinical Staff initials

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2986440
    UMLS CUI [1,2]
    C0871685
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Record of Rash

    1 Formulare
    1. StudyEvent: ODM
      1. Record of Rash
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Screening No.
    Item
    Subject Screening number
    integer
    C0220908 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Subject Number
    Item
    Subject no.
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Record of Rash
    C0015230 (UMLS CUI-1)
    Affected Area Photographed
    Item
    Has a photograph been taken of the affected area?
    boolean
    C1879646 (UMLS CUI [1,1])
    C0031749 (UMLS CUI [1,2])
    C0920316 (UMLS CUI [1,3])
    Comment
    Item
    Comment
    text
    C1879646 (UMLS CUI [1,1])
    C0031749 (UMLS CUI [1,2])
    C0920316 (UMLS CUI [1,3])
    C0947611 (UMLS CUI [1,4])
    Date of Photograph
    Item
    Date of Photograph
    date
    C1879646 (UMLS CUI [1,1])
    C0031749 (UMLS CUI [1,2])
    C0920316 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Actual Time
    Item
    Actual Time
    time
    C1879646 (UMLS CUI [1,1])
    C0031749 (UMLS CUI [1,2])
    C0920316 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Punch Biopsy Sample
    Item
    Has a punch biopsy sample been collected?
    boolean
    C0191321 (UMLS CUI [1])
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Conclusion
    C1707478 (UMLS CUI-1)
    Clinical Staff initials
    Item
    Clinical Staff initials
    text
    C2986440 (UMLS CUI [1,1])
    C0871685 (UMLS CUI [1,2])
    Zum Seitenanfang zurückkehren 

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