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

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

    No comments

    In order to download data models you must be logged in. Please log in or register for free.

    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
    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
    UMLS CUI [1,2]
    C0518766
    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
    UMLS CUI [1,2]
    C0518766
    Systolic Blood Pressure
    Description

    Systolic Blood Pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Diastolic Blood Pressure
    Description

    Diastolic Blood Pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart rate
    Description

    Heart rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    Weight
    Description

    Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Pregnancy Test
    Description

    Pregnancy Test

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

    Pregnancy test applicable

    Data type

    boolean

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

    Pregnancy test performed

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C0884358
    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
    UMLS CUI [1,2]
    C1274040
    Psychiatric Evaluation
    Description

    Psychiatric Evaluation

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

    Positive and Negative Syndrome Scale (PANSS)

    Data type

    integer

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

    Clinicians Global Impressions - Severity (CGI-S)

    Data type

    integer

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

    Clinicians Global Impressions - Improvement (CGI-I)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3639888
    Back to the top of the page

    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 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial