0 Ratings
ID

29036

Description

A Multi-Centre, Randomised, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Flexible Dose Study Evaluating the Efficacy, Safety and Tolerability of Extended-Release Bupropion Hydrochloride (150mg - 300mg once daily), Extended-Release Venlafaxine Hydrochloride (75mg - 150mg once daily) and Placebo in Subjects with Major Depressive Disorder

Keywords

Versions (1)
  1. 2/21/18 2/21/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 21, 2018

DOI

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License

Creative Commons BY-NC 3.0
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    Study Evaluating Extended-Release Bupropion Hydrochloride and Extended-Release Venlafaxine Hydrochloride in Subjects with Major Depressive Disorder 101497

    English

    Visit 9 (Mandatory Safety Follow-Up)

    1 forms  
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Heart rate
    Description

    Heart rate

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    Blood Pressure Systolic
    Description

    Blood Pressure Systolic

    Data type

    integer

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

    Diastolic blood pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Baseline Adverse Events
    Description

    Baseline Adverse Events

    Alias
    UMLS CUI-1
    C0877248
    Were there any adverse events observed or elicited by the following direct questions to the subject: "How are you feeling?" "Have you had any other medical problems since your last visit/assessment?"
    Description

    If 'Yes', please record on the Current Medical Conditions or Adverse Events panel as appropriate. NOTE: At the Baseline Visit, only serious adverse events related to study procedures must be recorded on the Adverse Events panel. All other adverse events at the Baseline visit should be recorded on the Current Medical Conditions panel.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0877248
    Concomitant Medication Prompt
    Description

    Concomitant Medication Prompt

    Alias
    UMLS CUI-1
    C2347852
    Were there any changes in concomitant medication since the last visit?
    Description

    If 'Yes', please record on the Prior and Concomitant Medications panel. Saving this panel after selecting 'Yes' will take you to the Prior and Concomitant Medications panel located in the Additional Forms section of the eCRF.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C2169461
    Repeat 12-lead electrocardiogram prompt
    Description

    Repeat 12-lead electrocardiogram prompt

    Alias
    UMLS CUI-1
    C0013798
    UMLS CUI-2
    C0205341
    Was a repeat 12-Lead Electrocardiogram performed at this visit ?
    Description

    If 'Yes', please record on the Repeat 12-Lead Electrocardiogram panel.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013798
    UMLS CUI [1,2]
    C0205341
    Repeat Laboratory tests
    Description

    Repeat Laboratory tests

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0205341
    Were repeat laboratory tests performed at this visit ?
    Description

    If 'Yes', please record on the Repeat Laboratory Tests panel.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0205341
    Investigational Product Prompt
    Description

    Investigational Product Prompt

    Alias
    UMLS CUI-1
    C0304229
    Details of the Investigational Product dispensed at the previous visit need to be entered into the eCRF at this visit. Do you have the details available to enter the data?
    Description

    If 'Yes', please record on the Investigational Product panel.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0304229
    Urine dipstick pregnancy test
    Description

    Urine dipstick pregnancy test

    Alias
    UMLS CUI-1
    C0430056
    Was a urine dipstick performed?
    Description

    If "Yes", please record result below.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0430056
    Sample Date
    Description

    Urine dipstick pregnancy sample date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0430056
    UMLS CUI [1,2]
    C1302413
    Result
    Description

    If "Positive", withdraw the subject and complete the paper Pregnancy Notification form. Also complete the Early Withdrawal Visit and the End of Study Record panels.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0430056
    UMLS CUI [1,2]
    C0456984
    Comments
    Description

    Comments

    Alias
    UMLS CUI-1
    C0947611
    UMLS CUI-2
    C0022885
    Comments
    Description

    Research Comments

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
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    Similar models

    Visit 9 (Mandatory Safety Follow-Up)

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C0518766 (UMLS CUI-1)
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Blood Pressure Systolic
    Item
    Blood Pressure Systolic
    integer
    C0871470 (UMLS CUI [1])
    Diastolic blood pressure
    Item
    Diastolic
    integer
    C0428883 (UMLS CUI [1])
    Item Group
    Baseline Adverse Events
    C0877248 (UMLS CUI-1)
    adverse events
    Item
    Were there any adverse events observed or elicited by the following direct questions to the subject: "How are you feeling?" "Have you had any other medical problems since your last visit/assessment?"
    boolean
    C0877248 (UMLS CUI [1])
    Item Group
    Concomitant Medication Prompt
    C2347852 (UMLS CUI-1)
    concomitant medication changes
    Item
    Were there any changes in concomitant medication since the last visit?
    boolean
    C2347852 (UMLS CUI [1,1])
    C2169461 (UMLS CUI [1,2])
    Item Group
    C0013798 (UMLS CUI-1)
    C0205341 (UMLS CUI-2)
    Repeated 12-lead EKG
    Item
    Was a repeat 12-Lead Electrocardiogram performed at this visit ?
    boolean
    C0013798 (UMLS CUI [1,1])
    C0205341 (UMLS CUI [1,2])
    Item Group
    C0022885 (UMLS CUI-1)
    C0205341 (UMLS CUI-2)
    Repeat Laboratory tests
    Item
    Were repeat laboratory tests performed at this visit ?
    boolean
    C0022885 (UMLS CUI [1,1])
    C0205341 (UMLS CUI [1,2])
    Item Group
    Investigational Product Prompt
    C0304229 (UMLS CUI-1)
    Investigational Product
    Item
    Details of the Investigational Product dispensed at the previous visit need to be entered into the eCRF at this visit. Do you have the details available to enter the data?
    boolean
    C0304229 (UMLS CUI [1])
    Item Group
    Urine dipstick pregnancy test
    C0430056 (UMLS CUI-1)
    Urine dipstick pregnancy test
    Item
    Was a urine dipstick performed?
    boolean
    C0430056 (UMLS CUI [1])
    Urine dipstick pregnancy sample date
    Item
    Sample Date
    date
    C0430056 (UMLS CUI [1,1])
    C1302413 (UMLS CUI [1,2])
    Urine dipstick pregnancy result
    Item
    Result
    boolean
    C0430056 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    Item Group
    Comments
    C0947611 (UMLS CUI-1)
    C0022885 (UMLS CUI-2)
    Research Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Back to the top of the page 

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