0 Ratings
ID

33653

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 is for documentation of the dermatological examination. It should be filled out at each treatment period and follow-up visit. Note: In the event of a subject experiencing a suspected drug induced rash, the subject should be withdrawn from the study immediately. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

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Versions (2)
  1. 12/3/18 12/3/18 -
  2. 12/18/18 12/18/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 18, 2018

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License

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

    English

    Dermatological Examination Form

    1 forms  
    Administrative Data
    Description

    Administrative Data

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

    Subject Screening No.

    Data type

    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

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Study Visit
    Description

    Study Visit

    Data type

    text

    Alias
    UMLS CUI [1]
    C0545082 (Visit)
    Dermatological Examination
    Description

    Dermatological Examination

    Alias
    UMLS CUI-1
    C0560169 (dermatological finding)
    Protocol Time
    Description

    Protocol Time

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C2348563 (Study Protocol)
    Study Day
    Description

    Study Day

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826182 (Study Day)
    Date of Assessment
    Description

    Date of Assessment

    Data type

    date

    Alias
    UMLS CUI [1]
    C2985720 (Assessment Date)
    Actual Time
    Description

    Actual Time

    Data type

    time

    Alias
    UMLS CUI [1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Has a Dermatological examination been performed?
    Description

    If no, please comment If yes, The following need to be completed: - Add a comment on the “Additional Information” page of the CRF - Complete the Adverse Event source document. - Complete the Dermatological / Hypersensitivity Adverse Event page

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0560169 (dermatological finding)
    Comment
    Description

    Comment

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Has the subject experienced any type of rash?
    Description

    If yes, complete the subject’s Adverse Event source document book.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0015230 (Exanthema)
    SNOMED
    271807003
    LOINC
    LP30547-1
    How long after administration of the drug did the rash occur?
    Description

    Time After Administration Exanthema Occurred

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0015230 (Exanthema)
    SNOMED
    271807003
    LOINC
    LP30547-1
    UMLS CUI [1,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,3]
    C0439568 (Post-dose)
    SNOMED
    255566006
    In the opinion of the physician, is the subject experiencing a suspected drug induced rash?
    Description

    If yes, complete the “Record of Rash” page at the back of the CRF.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0015230 (Exanthema)
    SNOMED
    271807003
    LOINC
    LP30547-1
    UMLS CUI [1,2]
    C0458082 (Drug-induced)
    SNOMED
    278993004
    Was a dermatologist consulted?
    Description

    Dermatologist Consulted

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0259831 (Dermatologist)
    SNOMED
    18803008
    UMLS CUI [1,2]
    C0009818 (Consultation)
    SNOMED
    11429006
    LOINC
    LA7553-6
    Physician's Signature
    Description

    Physician's Signature

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519316 (Signature)
    LOINC
    LP248948-4
    UMLS CUI [1,2]
    C0031831 (Physicians)
    SNOMED
    158965000
    LOINC
    LA18968-0
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    Similar models

    Dermatological Examination Form

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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
    Study Visit
    text
    C0545082 (UMLS CUI [1])
    Study Visit
    Code List
    Study Visit
    CL Item
    Treatment Period 1 (Treatment Period 1)
    CL Item
    Treatment Period 2 (Treatment Period 2)
    CL Item
    Treatment Period 3 (Treatment Period 3)
    CL Item
    Follow-Up Visit (Follow-Up Visit)
    Item Group
    Dermatological Examination
    C0560169 (UMLS CUI-1)
    Item
    Protocol Time
    text
    C0040223 (UMLS CUI [1,1])
    C2348563 (UMLS CUI [1,2])
    Protocol Time
    Code List
    Protocol Time
    CL Item
    Pre Dose (Pre Dose)
    CL Item
    48h00 post dose (48h00 post dose)
    CL Item
    24h00 post dose (24h00 post dose)
    CL Item
    216h00 post dose (216h00 post dose)
    Item
    Study Day
    text
    C2826182 (UMLS CUI [1])
    Study Day
    Code List
    Study Day
    CL Item
    Day 1 (Day 1)
    CL Item
    Day 3 (Day 3)
    CL Item
    Day 2 (Day 2)
    CL Item
    Day 10 (Day 10)
    Date of Assessment
    Item
    Date of Assessment
    date
    C2985720 (UMLS CUI [1])
    Actual Time
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1])
    Dermatological Examination Performed
    Item
    Has a Dermatological examination been performed?
    boolean
    C0560169 (UMLS CUI [1])
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Rashes
    Item
    Has the subject experienced any type of rash?
    boolean
    C0015230 (UMLS CUI [1])
    Time After Administration Exanthema Occurred
    Item
    How long after administration of the drug did the rash occur?
    text
    C0015230 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C0439568 (UMLS CUI [1,3])
    Sespected Drug induced Rash
    Item
    In the opinion of the physician, is the subject experiencing a suspected drug induced rash?
    boolean
    C0015230 (UMLS CUI [1,1])
    C0458082 (UMLS CUI [1,2])
    Dermatologist Consulted
    Item
    Was a dermatologist consulted?
    boolean
    C0259831 (UMLS CUI [1,1])
    C0009818 (UMLS CUI [1,2])
    Physician's Signature
    Item
    Physician's Signature
    text
    C1519316 (UMLS CUI [1,1])
    C0031831 (UMLS CUI [1,2])
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