0 Ratings
ID

38277

Description

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

Keywords

Versions (2)
  1. 10/6/19 10/6/19 -
  2. 10/24/19 10/24/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 6, 2019

DOI

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License

Creative Commons BY-NC 3.0
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    Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363

    English

    Common CRF: Concomitant Medications

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Site
    Description

    Study Site

    Data type

    text

    Alias
    UMLS CUI [1]
    C2825164
    Patient
    Description

    Patient name

    Data type

    text

    Alias
    UMLS CUI [1]
    C1299487
    Patient No
    Description

    Patients, Identification number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C1300638
    Concomitant Medications
    Description

    Concomitant Medications

    Alias
    UMLS CUI-1
    C2347852
    Were any medications recorded on the In-Clinic Medications Taken Diary?
    Description

    Concomitant Agent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    Sequence Number
    Description

    Concomitant Agent, Sequence Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C2348184
    Drug Name (Trade Name preferred)
    Description

    Concomitant Agent, Medication name

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C2360065
    Modified reported term
    Description

    Concomitant Agent, Medication name, Reported Term

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C2360065
    UMLS CUI [1,3]
    C2826302
    GSK Drug synonym
    Description

    Concomitant Agent, Pharmaceutical Preparations, Synonym

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0013227
    UMLS CUI [1,3]
    C0871468
    GSK Drug Collection code
    Description

    Concomitant Agent, Code

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0805701
    Failed coding
    Description

    Concomitant Agent, Code, Failed

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0805701
    UMLS CUI [1,3]
    C0231175
    Reason for Medication
    Description

    Concomitant Agent, Indication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C3146298
    Start Date
    Description

    Concomitant Medication Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826734
    Taken Prior to Study?
    Description

    Concomitant Medication Previous Occurrence

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826667
    Ongoing?
    Description

    Concomitant Medication Ongoing

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826666
    No, specify End Date
    Description

    Concomitant Medication End Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826744
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    Similar models

    Common CRF: Concomitant Medications

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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
    Concomitant Medications
    C2347852 (UMLS CUI-1)
    Concomitant Agent
    Item
    Were any medications recorded on the In-Clinic Medications Taken Diary?
    boolean
    C2347852 (UMLS CUI [1])
    Concomitant Agent, Sequence Number
    Item
    Sequence Number
    integer
    C2347852 (UMLS CUI [1,1])
    C2348184 (UMLS CUI [1,2])
    Concomitant Agent, Medication name
    Item
    Drug Name (Trade Name preferred)
    text
    C2347852 (UMLS CUI [1,1])
    C2360065 (UMLS CUI [1,2])
    Concomitant Agent, Medication name, Reported Term
    Item
    Modified reported term
    text
    C2347852 (UMLS CUI [1,1])
    C2360065 (UMLS CUI [1,2])
    C2826302 (UMLS CUI [1,3])
    Concomitant Agent, Pharmaceutical Preparations, Synonym
    Item
    GSK Drug synonym
    text
    C2347852 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C0871468 (UMLS CUI [1,3])
    Concomitant Agent, Code
    Item
    GSK Drug Collection code
    text
    C2347852 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    Concomitant Agent, Code, Failed
    Item
    Failed coding
    text
    C2347852 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    C0231175 (UMLS CUI [1,3])
    Concomitant Agent, Indication
    Item
    Reason for Medication
    text
    C2347852 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    Concomitant Medication Start Date
    Item
    Start Date
    date
    C2826734 (UMLS CUI [1])
    Concomitant Medication Previous Occurrence
    Item
    Taken Prior to Study?
    boolean
    C2826667 (UMLS CUI [1])
    Concomitant Medication Ongoing
    Item
    Ongoing?
    boolean
    C2826666 (UMLS CUI [1])
    Concomitant Medication End Date
    Item
    No, specify End Date
    date
    C2826744 (UMLS CUI [1])
    Back to the top of the page 

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