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ID

33645

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 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

Stichworte

Versionen (3)
  1. 01.12.18 01.12.18 -
  2. 09.12.18 09.12.18 -
  3. 18.12.18 18.12.18 - Sarah Riepenhausen
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GlaxoSmithKline

Hochgeladen am

18. 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

    Physical Examination

    1 Formulare  
    1. StudyEvent: ODM
      1. Physical Examination
    Administrative Data
    Beschreibung

    Administrative Data

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

    Subject Screening No.

    Datentyp

    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.
    Beschreibung

    Subject Number

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Date Information Collected
    Beschreibung

    Date Information Collected

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C3244127 (information collection)
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Physical Examination
    Beschreibung

    Physical Examination

    Alias
    UMLS CUI-1
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    Examination
    Beschreibung

    Examination

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    Examination Result
    Beschreibung

    Examination Result

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C1274040 (Result)
    SNOMED
    394617004
    If abnormal please describe
    Beschreibung

    Examination Result Abnormal

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C1274040 (Result)
    SNOMED
    394617004
    UMLS CUI [1,3]
    C0205161 (Abnormal)
    SNOMED
    263654008
    LOINC
    LP28764-6
    Examination Result Clinically Significant
    Beschreibung

    Examination Result Clinically Significant

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0459424 (Abnormal result)
    SNOMED
    280415008
    UMLS CUI [1,2]
    C2826634 (Physical Examination Clinically Significant)
    Conclusion
    Beschreibung

    Conclusion

    Alias
    UMLS CUI-1
    C1707478 (Conclusion)
    Is the subject healthy as determined by the clinical examination?
    Beschreibung

    Subject Healthy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C3898900 (Healthy)
    LOINC
    LA28121-4
    Physician's Initials
    Beschreibung

    Physician's Initials

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2986440 (Person Initials)
    UMLS CUI [1,2]
    C0031831 (Physicians)
    SNOMED
    158965000
    LOINC
    LA18968-0
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Physical Examination

    1 Formulare
    1. StudyEvent: ODM
      1. Physical Examination
    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])
    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])
    Zum Seitenanfang zurückkehren 

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