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ID

33764

Description

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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Versions (2)
  1. 05/12/2018 05/12/2018 -
  2. 25/12/2018 25/12/2018 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

25 décembre 2018

DOI

Pour une demande vous connecter.

Licence

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

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    Record of Rash

    1 Formulaires  
    1. StudyEvent: ODM
      1. Record of Rash
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Screening number
    Description

    Subject Screening No.

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0220908 (Screening procedure)
    SNOMED
    20135006
    LOINC
    LP34059-3
    UMLS CUI [1,2]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Subject no.
    Description

    Subject Number

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Record of Rash
    Description

    Record of Rash

    Alias
    UMLS CUI-1
    C0015230 (Exanthema)
    SNOMED
    271807003
    LOINC
    LP30547-1
    Has a photograph been taken of the affected area?
    Description

    If yes, comment and complete below.

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1879646 (Affected Area)
    UMLS CUI [1,2]
    C0031749 (Photography)
    UMLS CUI [1,3]
    C0920316 (Documentation)
    LOINC
    LA17600-0
    Comment
    Description

    Comment

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1879646 (Affected Area)
    UMLS CUI [1,2]
    C0031749 (Photography)
    UMLS CUI [1,3]
    C0920316 (Documentation)
    LOINC
    LA17600-0
    UMLS CUI [1,4]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Date of Photograph
    Description

    Date of Photograph

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C1879646 (Affected Area)
    UMLS CUI [1,2]
    C0031749 (Photography)
    UMLS CUI [1,3]
    C0920316 (Documentation)
    LOINC
    LA17600-0
    UMLS CUI [1,4]
    C0011008 (Date in time)
    SNOMED
    410671006
    Actual Time
    Description

    Actual Time

    Type de données

    time

    Alias
    UMLS CUI [1,1]
    C1879646 (Affected Area)
    UMLS CUI [1,2]
    C0031749 (Photography)
    UMLS CUI [1,3]
    C0920316 (Documentation)
    LOINC
    LA17600-0
    UMLS CUI [1,4]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Has a punch biopsy sample been collected?
    Description

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

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0191321 (Punch biopsy of skin (procedure))
    SNOMED
    87697008
    Comment
    Description

    Comment

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Conclusion
    Description

    Conclusion

    Alias
    UMLS CUI-1
    C1707478 (Conclusion)
    Clinical Staff initials
    Description

    Clinical Staff initials

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C2986440 (Person Initials)
    UMLS CUI [1,2]
    C0871685 (Clinician)
    Retour au début de la page

    Similar models

    Record of Rash

    1 Formulaires
    1. StudyEvent: ODM
      1. Record of Rash
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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])
    Retour au début de la page 

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