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ID

38148

Beschrijving

Study ID: 109035 Clinical Study ID: 109035 Study Title: A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of GSK163090 in Subjects With Major Depressive Disorder Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00896363 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK163090 1 mg, GSK163090 Placebo, GSK163090 3 mg Trade Name: Study Indication: Depressive Disorder

Trefwoorden

  1. 22-09-19 22-09-19 -
  2. 24-10-19 24-10-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

22 september 2019

DOI

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Licentie

Creative Commons BY-NC 3.0

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    Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363

    Subject Logs

    1. StudyEvent: ODM
      1. Subject Logs
    Administrative Data
    Beschrijving

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Site
    Beschrijving

    Study Site

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2825164
    Patient
    Beschrijving

    Patient name

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1299487
    Patient No
    Beschrijving

    Patients, Identification number

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C1300638
    Date of Visit/Assessment
    Beschrijving

    Date of Visit/Assessment

    Alias
    UMLS CUI-1
    C1320303
    UMLS CUI-2
    C2985720
    Date of visit/assessment
    Beschrijving

    Date of visit; Assessment Date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C1320303
    UMLS CUI [1,2]
    C2985720
    Log Status
    Beschrijving

    Log Status

    Alias
    UMLS CUI-1
    C1708728
    UMLS CUI-2
    C0449438
    Did the subject experience a serious adverse event during the study?
    Beschrijving

    Serious Adverse Event

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    Were any concomitant medications taken by the subject prior to screening and/or during the study?
    Beschrijving

    Concomitant Agent

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    Did the subject experience any non-serious adverse events during the study?
    Beschrijving

    Non-serious Adverse Event

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1518404

    Similar models

    Subject Logs

    1. StudyEvent: ODM
      1. Subject Logs
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Study Site
    Item
    Site
    text
    C2825164 (UMLS CUI [1])
    Patient name
    Item
    Patient
    text
    C1299487 (UMLS CUI [1])
    Patients, Identification number
    Item
    Patient No
    integer
    C0030705 (UMLS CUI [1,1])
    C1300638 (UMLS CUI [1,2])
    Item Group
    Date of Visit/Assessment
    C1320303 (UMLS CUI-1)
    C2985720 (UMLS CUI-2)
    Date of visit; Assessment Date
    Item
    Date of visit/assessment
    date
    C1320303 (UMLS CUI [1,1])
    C2985720 (UMLS CUI [1,2])
    Item Group
    Log Status
    C1708728 (UMLS CUI-1)
    C0449438 (UMLS CUI-2)
    Serious Adverse Event
    Item
    Did the subject experience a serious adverse event during the study?
    boolean
    C1519255 (UMLS CUI [1])
    Concomitant Agent
    Item
    Were any concomitant medications taken by the subject prior to screening and/or during the study?
    boolean
    C2347852 (UMLS CUI [1])
    Non-serious Adverse Event
    Item
    Did the subject experience any non-serious adverse events during the study?
    boolean
    C1518404 (UMLS CUI [1])

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