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ID

38164

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. 23/09/2019 23/09/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

23 septembre 2019

DOI

Pour une demande vous connecter.

Licence

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)

    Anglais

    Study Termination Record

    1 Formulaires  
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Patient's initials
    Description

    Patient's initials

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2986440
    Patient's trial number
    Description

    Patient's trial number

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2348585
    Centre number
    Description

    Centre number

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Date the patient took last full dose of study medication
    Description

    Date the patient took last full dose of study medication

    Type de données

    date

    Alias
    UMLS CUI [1]
    C1762893
    Date of last assessment
    Description

    Date of last assessment

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C2985720
    UMLS CUI [1,2]
    C1517741
    Study Termination
    Description

    Study Termination

    Alias
    UMLS CUI-1
    C0008972
    UMLS CUI-2
    C0013135
    Did the patient complete 16 weeks of the study?
    Description

    Did the patient complete 16 weeks of the study?

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2348577
    Did the patient discontinued prematurely?
    Description

    Did the patient discontinued prematurely?

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2718058
    If the patient completed 16 weeks did he/she continue/ start lamotrigine treatment?
    Description

    If the patient completed 16 weeks did he/she continue/ start lamotrigine treatment?

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2348577
    UMLS CUI [2,1]
    C0064636
    UMLS CUI [2,2]
    C0549178
    UMLS CUI [3,1]
    C0064636
    UMLS CUI [3,2]
    C0439659
    If the patient completed 16 weeks did he/ she taper off study medication from week 16?
    Description

    If the patient completed 16 weeks did he/ she taper off study medication from week 16?

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2348577
    UMLS CUI [2,1]
    C0441640
    UMLS CUI [2,2]
    C0304229
    If the patient discontinued prematurely, was the discontinuation due to an adverse experience regardless of association with the test agent?
    Description

    If the patient discontinued prematurely, was the discontinuation due to an adverse experience regardless of association with the test agent?

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2718058
    UMLS CUI [2]
    C0877248
    UMLS CUI [3,1]
    C0013230
    UMLS CUI [3,2]
    C0439849
    Did the patient die during the study?
    Description

    Did the patient die during the study?

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0011065
    UMLS CUI [1,2]
    C0347984
    UMLS CUI [1,3]
    C0008976
    If patient died, enter date of Death
    Description

    If patient died, enter date of Death

    Type de données

    date

    Alias
    UMLS CUI [1]
    C1148348
    Cause of Death
    Description

    Cause of Death

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0007465
    Other reasons for premature discontinuation
    Description

    Please chek on only.

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C2718058
    UMLS CUI [1,2]
    C3840932
    Investigator's Statement
    Description

    Investigator's Statement

    Alias
    UMLS CUI-1
    C0008961
    UMLS CUI-2
    C1710187
    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.

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1519316
    UMLS CUI [1,2]
    C1521895
    Prinicpal Investigator's Name
    Description

    Prinicpal Investigator's Name

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2826892
    Date of Signature
    Description

    Date of Signature

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Retour au début de la page

    Similar models

    Study Termination Record

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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])
    Centre number
    Item
    Centre number
    text
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Date the patient took last full dose of study medication
    Item
    Date the patient took last full dose of study medication
    date
    C1762893 (UMLS CUI [1])
    Date of last assessment
    Item
    Date of last assessment
    date
    C2985720 (UMLS CUI [1,1])
    C1517741 (UMLS CUI [1,2])
    Item Group
    Study Termination
    C0008972 (UMLS CUI-1)
    C0013135 (UMLS CUI-2)
    Did the patient complete 16 weeks of the study?
    Item
    Did the patient complete 16 weeks of the study?
    boolean
    C2348577 (UMLS CUI [1])
    Did the patient discontinued prematurely?
    Item
    Did the patient discontinued prematurely?
    boolean
    C2718058 (UMLS CUI [1])
    If the patient completed 16 weeks did he/she continue/ start lamotrigine treatment?
    Item
    If the patient completed 16 weeks did he/she continue/ start lamotrigine treatment?
    boolean
    C2348577 (UMLS CUI [1])
    C0064636 (UMLS CUI [2,1])
    C0549178 (UMLS CUI [2,2])
    C0064636 (UMLS CUI [3,1])
    C0439659 (UMLS CUI [3,2])
    If the patient completed 16 weeks did he/ she taper off study medication from week 16?
    Item
    If the patient completed 16 weeks did he/ she taper off study medication from week 16?
    boolean
    C2348577 (UMLS CUI [1])
    C0441640 (UMLS CUI [2,1])
    C0304229 (UMLS CUI [2,2])
    If the patient discontinued prematurely, was the discontinuation due to an adverse experience regardless of association with the test agent?
    Item
    If the patient discontinued prematurely, was the discontinuation due to an adverse experience regardless of association with the test agent?
    boolean
    C2718058 (UMLS CUI [1])
    C0877248 (UMLS CUI [2])
    C0013230 (UMLS CUI [3,1])
    C0439849 (UMLS CUI [3,2])
    Did the patient die during the study?
    Item
    Did the patient die during the study?
    boolean
    C0011065 (UMLS CUI [1,1])
    C0347984 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    If patient died, enter date of Death
    Item
    If patient died, enter date of Death
    date
    C1148348 (UMLS CUI [1])
    Cause of Death
    Item
    Cause of Death
    text
    C0007465 (UMLS CUI [1])
    Item
    Other reasons for premature discontinuation
    integer
    C2718058 (UMLS CUI [1,1])
    C3840932 (UMLS CUI [1,2])
    Other reasons for premature discontinuation
    Code List
    Other reasons for premature discontinuation
    CL Item
    Patient failed to return (1)
    CL Item
    Parent/ guardian withdrew consent (2)
    CL Item
    Protocol violation (3)
    CL Item
    General condition deteriorated (4)
    CL Item
    Clinically significant deterioration of seizure control (5)
    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])
    Prinicpal Investigator's Name
    Item
    Prinicpal Investigator's Name
    text
    C2826892 (UMLS CUI [1])
    Date of Signature
    Item
    Date of Signature
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Retour au début de la page 

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