0 Evaluaciones
ID

29785

Descripción

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

Palabras clave

Versiones (1)
  1. 2018-04-19 2018-04-19 - Sarah Riepenhausen
Titular de derechos de autor

GlaxoSmithKline

Subido en

19 april 2018

DOI

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Licencia

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

    Inglés

    Week 6 - Visit 8

    1 formularios  
    1. StudyEvent: ODM
      1. Week 6 - Visit 8
    Vital Signs
    Descripción

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Date
    Descripción

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

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0518766
    Subject Position
    Descripción

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

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1262869
    UMLS CUI [1,2]
    C0518766
    Systolic Blood Pressure
    Descripción

    Systolic Blood Pressure

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Diastolic Blood Pressure
    Descripción

    Diastolic Blood Pressure

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart rate
    Descripción

    Heart rate

    Tipo de datos

    integer

    Unidades de medida
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    Weight
    Descripción

    Weight

    Tipo de datos

    float

    Unidades de medida
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Pregnancy Test
    Descripción

    Pregnancy Test

    Alias
    UMLS CUI-1
    C0430056
    Is a pregnancy test applicable?
    Descripción

    Pregnancy test applicable

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C1706839
    If a pregnancy test is applicable, was it performed?
    Descripción

    Pregnancy test performed

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C0884358
    If a pregnancy test was performed, what was the result?
    Descripción

    If positive, complete PREGNANCY NOTIFICATION FORM.

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C1274040
    Psychiatric Evaluation
    Descripción

    Psychiatric Evaluation

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

    Positive and Negative Syndrome Scale (PANSS)

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0451383
    Score of Clinicians Global Impressions, Part Severity (CGI-S)
    Descripción

    Clinicians Global Impressions - Severity (CGI-S)

    Tipo de datos

    integer

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

    Clinicians Global Impressions - Improvement (CGI-I)

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C3639888
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    Similar models

    Week 6 - Visit 8

    1 formularios
    1. StudyEvent: ODM
      1. Week 6 - Visit 8
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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])
    Volver a la parte superior de la página 

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