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ID

38162

Description

Study ID: 105-123 Clinical Study ID: 105-123 Study Title: Lamotrigine as add-on therapy in patients with clinical diagnosis of a Lennox-Gastaut syndrome (severe generalised epilepsy of childhood onset.) A multicentre, double-blind, placebo controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Lamotrigine Study Indication: Seizures

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Versions (1)
  1. 9/23/19 9/23/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 23, 2019

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License

Creative Commons BY-NC 3.0
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    Lamotrigine as add-on therapy in patients with a clinical diagnosis of a Lennox-Gastaut syndrome (105-123)

    English

    Comment Log; Investigator's Statement

    1 forms  
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Patient's initials
    Description

    Patient's initials

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986440 (Person Initials)
    Patient's trial number
    Description

    Patient's trial number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Center number
    Description

    Center number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1301943 (Institution name)
    SNOMED
    398321007
    UMLS CUI [1,2]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Comment Log
    Description

    Comment Log

    Alias
    UMLS CUI-1
    C0947611 (Comment)
    LOINC
    LP72293-1
    Date
    Description

    Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Comments
    Description

    Comments

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Investigator's Statement
    Description

    Investigator's Statement

    Alias
    UMLS CUI-1
    C0008961 (Clinical Investigators)
    UMLS CUI-2
    C1710187 (Statement)
    Principal Investigator's signature
    Description

    I confirm that I have carefully examined all entries on the Case Report Forms for this patient. All Information entered by myself or my colleagues is, to the best of my knowledge, correct as of the date below.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519316 (Signature)
    LOINC
    LP248948-4
    UMLS CUI [1,2]
    C1521895 (Principal Investigator)
    SNOMED
    768818001
    Principal Investigator's Name
    Description

    Principal Investigator's Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892 (Investigator Name)
    Signature Date
    Description

    Signature Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2346576 (Investigator Signature)
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
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    Similar models

    Comment Log; Investigator's Statement

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Patient's initials
    Item
    Patient's initials
    text
    C2986440 (UMLS CUI [1])
    Patient's trial number
    Item
    Patient's trial number
    text
    C2348585 (UMLS CUI [1])
    Center number
    Item
    Center number
    text
    C1301943 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Item Group
    Comment Log
    C0947611 (UMLS CUI-1)
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Investigator's Statement
    C0008961 (UMLS CUI-1)
    C1710187 (UMLS CUI-2)
    Principal Investigator's signature
    Item
    Principal Investigator's signature
    text
    C1519316 (UMLS CUI [1,1])
    C1521895 (UMLS CUI [1,2])
    Principal Investigator's Name
    Item
    Principal Investigator's Name
    text
    C2826892 (UMLS CUI [1])
    Signature Date
    Item
    Signature Date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
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