0 Ratings
ID

29785

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 Week 6 - Visit 8.

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

    Week 6 - Visit 8

    1 forms  
    1. StudyEvent: ODM
      1. Week 6 - Visit 8
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    Date
    Description

    If assessments are taken on 2 separate dates for this visit, the Visit Date is the first date the subject is seen.

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    Subject Position
    Description

    Record both; record sitting heart rate and blood pressure prior to recording standing heart rate and blood pressure.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1262869 (Body position)
    SNOMED
    397155001
    LOINC
    LP120681-4
    UMLS CUI [1,2]
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    Systolic Blood Pressure
    Description

    Systolic Blood Pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    mmHg
    Diastolic Blood Pressure
    Description

    Diastolic Blood Pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    mmHg
    Heart rate
    Description

    Heart rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    beats/min
    Weight
    Description

    Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910 (Body Weight)
    SNOMED
    27113001
    kg
    Pregnancy Test
    Description

    Pregnancy Test

    Alias
    UMLS CUI-1
    C0430056 (Urine pregnancy test)
    SNOMED
    167252002
    Is a pregnancy test applicable?
    Description

    Pregnancy test applicable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0032976 (Pregnancy Tests)
    SNOMED
    74036000
    UMLS CUI [1,2]
    C1706839 (Applicable)
    If a pregnancy test is applicable, was it performed?
    Description

    Pregnancy test performed

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0032976 (Pregnancy Tests)
    SNOMED
    74036000
    UMLS CUI [1,2]
    C0884358 (Performed)
    SNOMED
    398166005
    LOINC
    LA19974-7
    If a pregnancy test was performed, what was the result?
    Description

    If positive, complete PREGNANCY NOTIFICATION FORM.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0032976 (Pregnancy Tests)
    SNOMED
    74036000
    UMLS CUI [1,2]
    C1274040 (Result)
    SNOMED
    394617004
    Psychiatric Evaluation
    Description

    Psychiatric Evaluation

    Alias
    UMLS CUI-1
    C0846574 (Psychiatric evaluation)
    Total Score in Positive and Negative Syndrome Scale (PANSS)
    Description

    Positive and Negative Syndrome Scale (PANSS)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0451383 (Positive and negative syndrome scale)
    SNOMED
    273703003
    Score of Clinicians Global Impressions, Part Severity (CGI-S)
    Description

    Clinicians Global Impressions - Severity (CGI-S)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3639887 (CGI - Severity of Illness)
    Score of Clinicians Global Impressions, Part Improvement (CGI-I)
    Description

    Clinicians Global Impressions - Improvement (CGI-I)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3639888 (CGI - Global Improvement)
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    Similar models

    Week 6 - Visit 8

    1 forms
    1. StudyEvent: ODM
      1. Week 6 - Visit 8
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1,1])
    C0518766 (UMLS CUI [1,2])
    Item
    Subject Position
    integer
    C1262869 (UMLS CUI [1,1])
    C0518766 (UMLS CUI [1,2])
    Subject Position
    Code List
    Subject Position
    CL Item
    Sitting (1)
    CL Item
    Standing (2)
    Systolic Blood Pressure
    Item
    Systolic Blood Pressure
    integer
    C0871470 (UMLS CUI [1])
    Diastolic Blood Pressure
    Item
    Diastolic Blood Pressure
    integer
    C0428883 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Item Group
    Pregnancy Test
    C0430056 (UMLS CUI-1)
    Pregnancy test applicable
    Item
    Is a pregnancy test applicable?
    boolean
    C0032976 (UMLS CUI [1,1])
    C1706839 (UMLS CUI [1,2])
    Pregnancy test performed
    Item
    If a pregnancy test is applicable, was it performed?
    boolean
    C0032976 (UMLS CUI [1,1])
    C0884358 (UMLS CUI [1,2])
    Item
    If a pregnancy test was performed, what was the result?
    text
    C0032976 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Pregnancy Test Result
    Code List
    If a pregnancy test was performed, what was the result?
    CL Item
    positive (positive)
    CL Item
    negative (negative)
    Item Group
    Psychiatric Evaluation
    C0846574 (UMLS CUI-1)
    Positive and Negative Syndrome Scale (PANSS)
    Item
    Total Score in Positive and Negative Syndrome Scale (PANSS)
    integer
    C0451383 (UMLS CUI [1])
    Clinicians Global Impressions - Severity (CGI-S)
    Item
    Score of Clinicians Global Impressions, Part Severity (CGI-S)
    integer
    C3639887 (UMLS CUI [1])
    Clinicians Global Impressions - Improvement (CGI-I)
    Item
    Score of Clinicians Global Impressions, Part Improvement (CGI-I)
    integer
    C3639888 (UMLS CUI [1])
    Back to the top of the page 

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