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ID

33645

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 the result of the physical examination. It should be filled out at screening visit and updated throughout the study if necessary. 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 (3)
  1. 12/1/18 12/1/18 -
  2. 12/9/18 12/9/18 -
  3. 12/18/18 12/18/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

December 18, 2018

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

    English

    Physical Examination

    1 forms  
    1. StudyEvent: ODM
      1. Physical Examination
    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
    Date Information Collected
    Description

    Date Information Collected

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C3244127
    UMLS CUI [1,2]
    C0011008
    Physical Examination
    Description

    Physical Examination

    Alias
    UMLS CUI-1
    C0031809
    Examination
    Description

    Examination

    Data type

    text

    Alias
    UMLS CUI [1]
    C0031809
    Examination Result
    Description

    Examination Result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C1274040
    If abnormal please describe
    Description

    Examination Result Abnormal

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C1274040
    UMLS CUI [1,3]
    C0205161
    Examination Result Clinically Significant
    Description

    Examination Result Clinically Significant

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0459424
    UMLS CUI [1,2]
    C2826634
    Conclusion
    Description

    Conclusion

    Alias
    UMLS CUI-1
    C1707478
    Is the subject healthy as determined by the clinical examination?
    Description

    Subject Healthy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3898900
    Physician's Initials
    Description

    Physician's Initials

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2986440
    UMLS CUI [1,2]
    C0031831
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    Similar models

    Physical Examination

    1 forms
    1. StudyEvent: ODM
      1. Physical Examination
    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])
    Date Information Collected
    Item
    Date Information Collected
    date
    C3244127 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Physical Examination
    C0031809 (UMLS CUI-1)
    Item
    Examination
    text
    C0031809 (UMLS CUI [1])
    Examination Area
    Code List
    Examination
    CL Item
    General appearance (General appearance)
    CL Item
    HEENT (HEENT)
    CL Item
    Neck and Thyroid (Neck and Thyroid)
    CL Item
    Skin (incl. hair, nails) (Skin (incl. hair, nails))
    CL Item
    Cardiovascular (Cardiovascular)
    CL Item
    Chest/Lungs (Chest/Lungs)
    CL Item
    Abdomen (Abdomen)
    CL Item
    Neurological (Neurological)
    CL Item
    Musculoskeletal (Musculoskeletal)
    CL Item
    Fundoscopy (Fundoscopy)
    CL Item
    Lymph (Lymph)
    CL Item
    Nodes (Nodes)
    CL Item
    Other (Other)
    Item
    Examination Result
    text
    C0031809 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Examination Result
    Code List
    Examination Result
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)
    CL Item
    Not done (Not done)
    Examination Result Abnormal
    Item
    If abnormal please describe
    text
    C0031809 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    C0205161 (UMLS CUI [1,3])
    Examination Result Clinically Significant
    Item
    Examination Result Clinically Significant
    boolean
    C0459424 (UMLS CUI [1,1])
    C2826634 (UMLS CUI [1,2])
    Item Group
    Conclusion
    C1707478 (UMLS CUI-1)
    Subject Healthy
    Item
    Is the subject healthy as determined by the clinical examination?
    boolean
    C3898900 (UMLS CUI [1])
    Physician's Initials
    Item
    Physician's Initials
    text
    C2986440 (UMLS CUI [1,1])
    C0031831 (UMLS CUI [1,2])
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