0 Ratings

ID

34693

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 Unscheduled ECGs should be documented in this form whenever they are performed during the study. If an ECG is deemed Abnormal, clinically significant, complete the “ECG Abnormalities” page in the CRF. 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

Keywords

  1. 1/23/19 1/23/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 23, 2019

DOI

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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

    Unscheduled 12-Lead ECG Form

    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Screening number
    Description

    Subject Screening No.

    Data type

    integer

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

    Subject Number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Unscheduled 12-Lead Electrocardiogram
    Description

    Unscheduled 12-Lead Electrocardiogram

    Alias
    UMLS CUI-1
    C0430456
    UMLS CUI-2
    C3854240
    Date
    Description

    Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
    Actual Time
    Description

    Actual Time

    Data type

    time

    Alias
    UMLS CUI [1]
    C0040223
    Reason for Unscheduled Assessment
    Description

    Reason for Unscheduled Assessment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0220825
    UMLS CUI [1,2]
    C3854240
    UMLS CUI [1,3]
    C0392360
    Comment
    Description

    Comment

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    Comment Key
    Description

    Comment Key

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C1706198
    Clinical Staff Initials
    Description

    Clinical Staff Initials

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2986440
    UMLS CUI [1,2]
    C1552089

    Similar models

    Unscheduled 12-Lead ECG Form

    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 Group
    Unscheduled 12-Lead Electrocardiogram
    C0430456 (UMLS CUI-1)
    C3854240 (UMLS CUI-2)
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Actual Time
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1])
    Reason for Unscheduled Assessment
    Item
    Reason for Unscheduled Assessment
    text
    C0220825 (UMLS CUI [1,1])
    C3854240 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Item
    Comment Key
    integer
    C0947611 (UMLS CUI [1,1])
    C1706198 (UMLS CUI [1,2])
    Code List
    Comment Key
    CL Item
    Not done due to adverse event (describe) (1)
    CL Item
    Late due to late running of previous assessment (2)
    CL Item
    Subject not in attendance (confirm time delay) (3)
    CL Item
    Late due to technical problems (confirm time delay) (4)
    CL Item
    Other (describe) (5)
    Clinical Staff Initials
    Item
    Clinical Staff Initials
    text
    C2986440 (UMLS CUI [1,1])
    C1552089 (UMLS CUI [1,2])

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