0 Ratings
ID

29797

Description

Study ID: 101464 Clinical Study ID: SCA101464 Study Title: A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive Therapy to an Atypical Antipsychotic Agent(s) in Subjects with Schizophrenia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00086593 https://clinicaltrials.gov/ct2/show/NCT00086593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Study Indication: Lamictal XR,Lamictal,LAMICTIN This ODM form contains End of Study Record / Hospitalization and Status of Treatment Blind.

Link

https://clinicaltrials.gov/ct2/show/NCT00086593

Keywords

Versions (1)
  1. 4/19/18 4/19/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

April 19, 2018

DOI

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License

Creative Commons BY-NC 3.0
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    Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593

    English

    End of Study Record / Hospitalization and Status of Treatment Blind

    1 forms  
    End of Study Record
    Description

    End of Study Record

    Alias
    UMLS CUI-1
    C0008972
    UMLS CUI-2
    C0444930
    Date of subject completion or discontinuation from the study
    Description

    Record the date of the last follow-up visit or contact. Completion of the study is defined as a subject who completes the Week 12 End of Study Visit.

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2348577
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [2,1]
    C0457454
    UMLS CUI [2,2]
    C0011008
    Did the subject become pregnant during the study?
    Description

    This question must be answered for all subjects. For females not of childbearing potential or males, mark NOT APPLICABLE. If no pregnancy was known before a subject was lost to follow-up, mark NO. If the subject became pregnant before either premature discontinuation from the study or completion of the study, mark YES and record details on PREGNANCY NOTIFICATION FORM.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0008976
    Did the subject discontinue the study prematurely?
    Description

    Premature Study Discontinuation

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0457454
    UMLS CUI [1,2]
    C2348568
    If yes, mark the primary reason for discontinuation
    Description

    If A: Record details on NON-SERIOUS ADVERSE EVENTS or SERIOUS ADVERSE EVENT page as appropriate.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0457454
    UMLS CUI [1,3]
    C0008976
    If other reason for discontinuation, specify:
    Description

    Reason for discontinuation

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0457454
    UMLS CUI [1,3]
    C0008976
    Hospitalization Status
    Description

    Hospitalization Status

    Alias
    UMLS CUI-1
    C0019993
    UMLS CUI-2
    C0449438
    Did the subject admit or discharge from the hospital?
    Description

    Hospitalization

    Data type

    text

    Alias
    UMLS CUI [1]
    C0019993
    Date of Admittance 1
    Description

    Date of Admittance

    Data type

    date

    Alias
    UMLS CUI [1]
    C0806429
    Date of discharge 1
    Description

    Date of discharge

    Data type

    date

    Alias
    UMLS CUI [1]
    C2361123
    Date of Admittance 2
    Description

    Date of Admittance

    Data type

    date

    Alias
    UMLS CUI [1]
    C0806429
    Date of discharge 2
    Description

    Date of discharge

    Data type

    date

    Alias
    UMLS CUI [1]
    C2361123
    Status of Treatment Blind
    Description

    Status of Treatment Blind

    Alias
    UMLS CUI-1
    C2347038
    UMLS CUI-2
    C0449438
    Was the treatment blind for this subject broken during the study?
    Description

    If YES, check that a date and reason are present and that the appropriate NON-SERIOUS ADVERSE EVENT, SERIOUS ADVERSE EVENT, END OF STUDY RECORD, and /or INVESTIGATIONAL PRODUCT pages are completed.

    Data type

    text

    Alias
    UMLS CUI [1]
    C3897431
    If treatment blind was broken, give the date:
    Description

    Date of Treatment Blind breaking

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0011008
    If treatment blind was broken, give a reason:
    Description

    Reason for Treatment Blind breaking

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0392360
    If there was another reason for treatment blind breaking, specify:
    Description

    Other Reason

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3840932
    UMLS CUI [1,2]
    C3897431
    Investigator's Statement
    Description

    Investigator's Statement

    Alias
    UMLS CUI-1
    C0008961
    UMLS CUI-2
    C1710187
    I confirm that I have carefully examined all entries on the Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, correct as of the date below.
    Description

    Investigator's signature

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date of signature
    Description

    Date of signature

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Investigator's Name (Print)
    Description

    Investigator's Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892
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    Similar models

    End of Study Record / Hospitalization and Status of Treatment Blind

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    End of Study Record
    C0008972 (UMLS CUI-1)
    C0444930 (UMLS CUI-2)
    Date of subject completion or discontinuation from the study
    Item
    Date of subject completion or discontinuation from the study
    date
    C2348577 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0457454 (UMLS CUI [2,1])
    C0011008 (UMLS CUI [2,2])
    Item
    Did the subject become pregnant during the study?
    text
    C0032961 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    Pregnancy during study
    Code List
    Did the subject become pregnant during the study?
    CL Item
    Not applicable (X)
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item
    Did the subject discontinue the study prematurely?
    text
    C0457454 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    Premature Study Discontinuation
    Code List
    Did the subject discontinue the study prematurely?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    If yes, mark the primary reason for discontinuation
    text
    C0392360 (UMLS CUI [1,1])
    C0457454 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    Reason for discontinuation
    Code List
    If yes, mark the primary reason for discontinuation
    CL Item
    Adverse Event (A)
    CL Item
    Consent withdrawn (C)
    CL Item
    Lost to Follow up (L)
    CL Item
    Protocol violation (P)
    CL Item
    Lack of Efficacy (E)
    CL Item
    Other (X)
    Reason for discontinuation
    Item
    If other reason for discontinuation, specify:
    text
    C0392360 (UMLS CUI [1,1])
    C0457454 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    Item Group
    Hospitalization Status
    C0019993 (UMLS CUI-1)
    C0449438 (UMLS CUI-2)
    Item
    Did the subject admit or discharge from the hospital?
    text
    C0019993 (UMLS CUI [1])
    Hospitalization
    Code List
    Did the subject admit or discharge from the hospital?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Date of Admittance
    Item
    Date of Admittance 1
    date
    C0806429 (UMLS CUI [1])
    Date of discharge
    Item
    Date of discharge 1
    date
    C2361123 (UMLS CUI [1])
    Date of Admittance
    Item
    Date of Admittance 2
    date
    C0806429 (UMLS CUI [1])
    Date of discharge
    Item
    Date of discharge 2
    date
    C2361123 (UMLS CUI [1])
    Item Group
    Status of Treatment Blind
    C2347038 (UMLS CUI-1)
    C0449438 (UMLS CUI-2)
    Item
    Was the treatment blind for this subject broken during the study?
    text
    C3897431 (UMLS CUI [1])
    Treatment Blind broken
    Code List
    Was the treatment blind for this subject broken during the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Date of Treatment Blind breaking
    Item
    If treatment blind was broken, give the date:
    date
    C3897431 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    If treatment blind was broken, give a reason:
    text
    C3897431 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Reason for Treatment Blind breaking
    Code List
    If treatment blind was broken, give a reason:
    CL Item
    Medical emergency requiring identity of investigational product for further treatment (E)
    CL Item
    Other (X)
    Other Reason
    Item
    If there was another reason for treatment blind breaking, specify:
    text
    C3840932 (UMLS CUI [1,1])
    C3897431 (UMLS CUI [1,2])
    Item Group
    Investigator's Statement
    C0008961 (UMLS CUI-1)
    C1710187 (UMLS CUI-2)
    Investigator's signature
    Item
    I confirm that I have carefully examined all entries on the Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, correct as of the date below.
    text
    C2346576 (UMLS CUI [1])
    Date of signature
    Item
    Date of signature
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Investigator's Name
    Item
    Investigator's Name (Print)
    text
    C2826892 (UMLS CUI [1])
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