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ID

29038

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

    Tysk Engelsk

    Early Withdrawal

    1 Formulär  
    1. StudyEvent: ODM
      1. Early Withdrawal
    Patient related scales
    Beskrivning

    Patient related scales

    Alias
    UMLS CUI-1
    C0030705
    UMLS CUI-2
    C0450973
    Montgomery-Asberg Depression Rating Scale Questionnaire
    Beskrivning

    Montgomery-Asberg Depression Rating Scale Questionnaire

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C4054475
    Hamilton Anxiety Rating Scale Questionnaire
    Beskrivning

    Hamilton Anxiety Rating Scale Questionnaire

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C3541258
    Clinical Global Impression
    Beskrivning

    Clinical Global Impression

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3639708
    Der Fragebogen Sheehan-Disability-Scale wurde bearbeitet.
    Beskrivning

    Sheehan Disability Scale Questionnaire

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C3813719
    Quality of life enjoyment and satisfaction questionaire - short form Q-LES-Q-SF
    Beskrivning

    Quality of life enjoyment and satisfaction questionaire - short form Q-LES-Q-SF

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C130318
    Motivation and energy inventory - MEI
    Beskrivning

    Motivation and energy inventory - MEI

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C3846158
    UMLS CUI [2,1]
    C0449820
    UMLS CUI [2,2]
    C0026605
    Changes in sexual functioning questionaire
    Beskrivning

    Changes in sexual functioning questionaire

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C3846158
    UMLS CUI [2,1]
    C0278092
    UMLS CUI [2,2]
    C0205307
    UMLS CUI [2,3]
    C1705241
    Subject satisfaction with study medication
    Beskrivning

    Subject satisfaction with study medication

    Alias
    UMLS CUI-1
    C0242428
    UMLS CUI-2
    C0013216
    Date of assessment
    Beskrivning

    Date of assessment

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C2985720
    Satisfaction with study medication
    Beskrivning

    Satisfaction with study medication

    Datatyp

    float

    Alias
    UMLS CUI [1,1]
    C0242428
    UMLS CUI [1,2]
    C0013216
    Vital Signs
    Beskrivning

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Weight
    Beskrivning

    Weight

    Datatyp

    float

    Måttenheter
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Heart rate
    Beskrivning

    Heart rate

    Datatyp

    integer

    Måttenheter
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    Blood Pressure Systolic
    Beskrivning

    Blood Pressure Systolic

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Diastolic blood pressure
    Beskrivning

    Diastolic blood pressure

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Adverse Events
    Beskrivning

    Adverse Events

    Alias
    UMLS CUI-1
    C0877248
    adverse events
    Beskrivning

    adverse events

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0877248
    Concomitant Medication Prompt
    Beskrivning

    Concomitant Medication Prompt

    Alias
    UMLS CUI-1
    C2347852
    concomitant medication changes
    Beskrivning

    concomitant medication changes

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C2169461
    12-lead Electrocardiogram
    Beskrivning

    12-lead Electrocardiogram

    Alias
    UMLS CUI-1
    C0430456
    ECG completed
    Beskrivning

    ECG completed

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1623258
    Date of ECG
    Beskrivning

    Date of ECG

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C2826640
    ECG Finding
    Beskrivning

    ECG Finding

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0438154
    Laboratory tests
    Beskrivning

    Laboratory tests

    Alias
    UMLS CUI-1
    C0022885
    Date of blood sample
    Beskrivning

    Date of blood sample

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    Date of urine samples
    Beskrivning

    Date of urine samples

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C2371162
    UMLS CUI [1,2]
    C0011008
    laboratory abnormalities
    Beskrivning

    laboratory abnormalities

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1853129
    Serum hCG
    Beskrivning

    Serum hCG

    Alias
    UMLS CUI-1
    C2348195
    Serum hCG
    Beskrivning

    Serum hCG

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2348195
    Sample Date hCG
    Beskrivning

    Sample Date hCG

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C1302413
    UMLS CUI [1,2]
    C2348195
    Serum hCG Result
    Beskrivning

    Serum hCG Result

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2348195
    Investigational Product
    Beskrivning

    Investigational Product

    Alias
    UMLS CUI-1
    C0304229
    Investigational Product
    Beskrivning

    Investigational Product

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0304229
    Comments
    Beskrivning

    Comments

    Research Comments
    Beskrivning

    Research Comments

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C0022885
    Tillbaka till toppen

    Similar models

    Early Withdrawal

    1 Formulär
    1. StudyEvent: ODM
      1. Early Withdrawal
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C0030705 (UMLS CUI-1)
    C0450973 (UMLS CUI-2)
    Montgomery-Asberg Depression Rating Scale Questionnaire
    Item
    integer
    C4054475 (UMLS CUI [1])
    Hamilton Anxiety Rating Scale Questionnaire
    Item
    integer
    C3541258 (UMLS CUI [1])
    Clinical Global Impression
    Item
    boolean
    C3639708 (UMLS CUI [1])
    Sheehan Disability Scale Questionnaire
    Item
    Der Fragebogen Sheehan-Disability-Scale wurde bearbeitet.
    integer
    C3813719 (UMLS CUI [1])
    Quality of life enjoyment and satisfaction questionaire - short form Q-LES-Q-SF
    Item
    boolean
    C130318 (UMLS CUI [1])
    Motivation and energy inventory - MEI
    Item
    integer
    C3846158 (UMLS CUI [1])
    C0449820 (UMLS CUI [2,1])
    C0026605 (UMLS CUI [2,2])
    Changes in sexual functioning questionaire
    Item
    text
    C3846158 (UMLS CUI [1])
    C0278092 (UMLS CUI [2,1])
    C0205307 (UMLS CUI [2,2])
    C1705241 (UMLS CUI [2,3])
    Item Group
    C0242428 (UMLS CUI-1)
    C0013216 (UMLS CUI-2)
    Date of assessment
    Item
    date
    C2985720 (UMLS CUI [1])
    Satisfaction with study medication
    Item
    float
    C0242428 (UMLS CUI [1,1])
    C0013216 (UMLS CUI [1,2])
    Item Group
    C0518766 (UMLS CUI-1)
    Weight
    Item
    float
    C0005910 (UMLS CUI [1])
    Heart rate
    Item
    integer
    C0018810 (UMLS CUI [1])
    Blood Pressure Systolic
    Item
    integer
    C0871470 (UMLS CUI [1])
    Diastolic blood pressure
    Item
    integer
    C0428883 (UMLS CUI [1])
    Item Group
    C0877248 (UMLS CUI-1)
    adverse events
    Item
    boolean
    C0877248 (UMLS CUI [1])
    Item Group
    C2347852 (UMLS CUI-1)
    concomitant medication changes
    Item
    boolean
    C2347852 (UMLS CUI [1,1])
    C2169461 (UMLS CUI [1,2])
    Item Group
    C0430456 (UMLS CUI-1)
    ECG completed
    Item
    boolean
    C1623258 (UMLS CUI [1])
    Date of ECG
    Item
    date
    C2826640 (UMLS CUI [1])
    ECG Finding
    Item
    boolean
    C0438154 (UMLS CUI [1])
    Item Group
    C0022885 (UMLS CUI-1)
    Date of blood sample
    Item
    date
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Date of urine samples
    Item
    date
    C2371162 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    laboratory abnormalities
    Item
    boolean
    C1853129 (UMLS CUI [1])
    Item Group
    C2348195 (UMLS CUI-1)
    Serum hCG
    Item
    boolean
    C2348195 (UMLS CUI [1])
    Sample Date hCG
    Item
    date
    C1302413 (UMLS CUI [1,1])
    C2348195 (UMLS CUI [1,2])
    Serum hCG Result
    Item
    boolean
    C2348195 (UMLS CUI [1])
    Item Group
    C0304229 (UMLS CUI-1)
    Investigational Product
    Item
    boolean
    C0304229 (UMLS CUI [1])
    Item Group
    Research Comments
    Item
    text
    C25704 (NCI Thesaurus ValueDomain)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)
    C0947611 (UMLS CUI [1,1])
    C0022885 (UMLS CUI [1,2])
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