0 Bedömningar
ID

29039

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2018-02-21 2018-02-21 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

21 februari 2018

DOI

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Licens

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

    Engelsk

    End of Study Record

    1 Formulär  
    1. StudyEvent: ODM
      1. End of Study Record
    Study Conclusion
    Beskrivning

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008976
    Did the subject discontinue the study prematurely?
    Beskrivning

    NOTE : The subject is considered to have discontinued if they did not complete the 8 weeks of treatment, the Taper Visit (if necessary), the Mandatory Safety Follow-Up Visit, the Additional Safety Follow-Up Visit (if required) and the home pregnancy test (if required). If 'Yes' please mark the primary reason for discontinuation.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0457454
    UMLS CUI [1,3]
    C4018905
    Reason
    Beskrivning

    reason for premature discontinuation

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0457454
    UMLS CUI [1,3]
    C0008976
    Date of subject completion or discontinuation from the study
    Beskrivning

    date of study completion or discontinuation

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C2348577
    UMLS CUI [1,2]
    C0011008
    Status of Treatment Blind
    Beskrivning

    Status of Treatment Blind

    Alias
    UMLS CUI-1
    C0749659
    UMLS CUI-2
    C2347038
    Was the treatment blind for this subject broken during the study?
    Beskrivning

    If 'Yes' please complete the following.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3897431
    Date
    Beskrivning

    date of broken treatment blind

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0011008
    Reason
    Beskrivning

    (Medical emergency requiring identity of investigational product for further treatment)

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0392360
    Investigational Product Discontinuation
    Beskrivning

    Investigational Product Discontinuation

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C0457454
    Was the investigational product stopped permanently before the end of the scheduled treatment period?
    Beskrivning

    If Yes, select the primary reason the investigational product was stopped.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0457454
    Select the primary reason the investigational product was stopped.
    Beskrivning

    reason for investigational product discontinuation

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [1,3]
    C0457454
    Comments
    Beskrivning

    Comments

    Alias
    UMLS CUI-1
    C0947611
    Comments
    Beskrivning

    Research Comments

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0947611
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    Similar models

    End of Study Record

    1 Formulär
    1. StudyEvent: ODM
      1. End of Study Record
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Study Conclusion
    C1707478 (UMLS CUI-1)
    C0008976 (UMLS CUI-2)
    premature discontination
    Item
    Did the subject discontinue the study prematurely?
    boolean
    C2348568 (UMLS CUI [1,1])
    C0457454 (UMLS CUI [1,2])
    C4018905 (UMLS CUI [1,3])
    reason for premature discontinuation
    Item
    Reason
    text
    C0392360 (UMLS CUI [1,1])
    C0457454 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    date of study completion or discontinuation
    Item
    Date of subject completion or discontinuation from the study
    date
    C2348577 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Status of Treatment Blind
    C0749659 (UMLS CUI-1)
    C2347038 (UMLS CUI-2)
    treatment blind broken
    Item
    Was the treatment blind for this subject broken during the study?
    boolean
    C3897431 (UMLS CUI [1])
    date of broken treatment blind
    Item
    Date
    boolean
    C3897431 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    reason of broken treatment blind
    Item
    Reason
    text
    C3897431 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Item Group
    Investigational Product Discontinuation
    C0304229 (UMLS CUI-1)
    C0457454 (UMLS CUI-2)
    Investigational Product Discontinuation
    Item
    Was the investigational product stopped permanently before the end of the scheduled treatment period?
    boolean
    C0304229 (UMLS CUI [1,1])
    C0457454 (UMLS CUI [1,2])
    reason for investigational product discontinuation
    Item
    Select the primary reason the investigational product was stopped.
    text
    C0392360 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C0457454 (UMLS CUI [1,3])
    Item Group
    Comments
    C0947611 (UMLS CUI-1)
    Research Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Tillbaka till toppen 

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