0 Bewertungen
ID

29045

Beschreibung

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

Stichworte

Versionen (1)
  1. 22.02.18 22.02.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

22. Februar 2018

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

  • Neueste
  • Älteste
  • Beliebt
  • Neueste
    • Neueste
    • Älteste
    • Beliebt

    Keine Kommentare

    Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

    Study Evaluating Extended-Release Bupropion Hydrochloride and Extended-Release Venlafaxine Hydrochloride in Subjects with Major Depressive Disorder - 101497

    Englisch

    Additional Forms

    1 Formulare  
    1. StudyEvent: ODM
      1. Additional Forms
    Home Pregnancy Test Result
    Beschreibung

    Home Pregnancy Test Result

    Alias
    UMLS CUI-1
    C0032976
    Sample date
    Beschreibung

    sample date pregnancy test

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C0011008
    Result
    Beschreibung

    result pregnancy test

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C1274040
    Prior and Concomitant Medications
    Beschreibung

    Prior and Concomitant Medications

    Alias
    UMLS CUI-1
    C2826257
    UMLS CUI-2
    C2347852
    Drug Name (trade name preferred)
    Beschreibung

    drug name

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0013227
    Indication (or symptoms in the absence of diagnosis)
    Beschreibung

    indication for concomitant medication

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2826696
    Date started
    Beschreibung

    concomitant medication start date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C2826734
    Continuing?
    Beschreibung

    concomitant medication continuation status

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826666
    Date Stopped
    Beschreibung

    concomitant medication end date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C2826744
    Adverse Events
    Beschreibung

    Adverse Events

    Alias
    UMLS CUI-1
    C0877248
    Adverse Event
    Beschreibung

    adverse event

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0877248
    Date of Onset
    Beschreibung

    date of onset

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C2985916
    Frequency
    Beschreibung

    frequency of adverse event

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0439603
    Maximum Intensity
    Beschreibung

    maximum intensity of adverse event

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1710066
    Outcome
    Beschreibung

    outcome of adverse event

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1705586
    Date Of Resolution
    Beschreibung

    date of adverse event resolution

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C2985918
    Action Taken With IP
    Beschreibung

    action taken with investigational product

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1704758
    UMLS CUI [1,2]
    C0877248
    Withdrawn Due to AE?
    Beschreibung

    If subject is withdrawn due to Adverse Event, complete the Early Withdrawal visit.

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0877248
    Relationship to Investigational Drug
    Beschreibung

    Is there a reasonable possibility that the Adverse Event may have been caused by the investigational product?

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [1,3]
    C0439849
    Serious Adverse Event?
    Beschreibung

    If this is a Serious Adverse Event, complete the Serious Adverse Event paper form and follow instructions.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    Repeat 12-lead electrocardiogram
    Beschreibung

    Repeat 12-lead electrocardiogram

    Alias
    UMLS CUI-1
    C0430456
    Date of ECG
    Beschreibung

    date of ecg

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C2826640
    Result of ECG
    Beschreibung

    If 'Abnormal - clinically significant' please record on the Current Medical Conditions or the Adverse Events panel as appropriate.

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0438154
    Repeat Laboratory Tests
    Beschreibung

    Repeat Laboratory Tests

    Alias
    UMLS CUI-1
    C0022885
    Was this a blood or a urine sample?
    Beschreibung

    blood sample | urine sample

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1277698
    UMLS CUI [2]
    C0200354
    Date of Sample
    Beschreibung

    date of sample

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1302413
    After reviewing the laboratory results, are there any clinically significant abnormalities?
    Beschreibung

    If 'Yes', please record the findings and/or diagnosis on the Current Medical Conditions or Adverse Events panel as appropriat

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1853129
    Investigational Product
    Beschreibung

    Investigational Product

    Alias
    UMLS CUI-1
    C0304229
    Visit at Which Medication Was Returned
    Beschreibung

    return of investigational product

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0947323
    UMLS CUI [1,2]
    C0304229
    Bottle A (tablets) or Bottle B (capsules)
    Beschreibung

    Investigational Product

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0304229
    Dose level
    Beschreibung

    Dose level

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0178602
    Start Date
    Beschreibung

    investigational product start date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C0304229
    End Date
    Beschreibung

    investigational product end date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C0304229
    Number dispensed
    Beschreibung

    investigational product number dispensed

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0805077
    Number Returned
    Beschreibung

    investigational product number returned

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C2699071
    Interruption >=4 consecutive days
    Beschreibung

    The subject should be withdrawn from the study if there is an interruption of >=4 consecutive days or if compliance is <75% or >125%

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3843191
    UMLS CUI [1,2]
    C1512900
    Comments
    Beschreibung

    Comments

    Comments
    Beschreibung

    Research Comments

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0947611
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Additional Forms

    1 Formulare
    1. StudyEvent: ODM
      1. Additional Forms
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Home Pregnancy Test Result
    C0032976 (UMLS CUI-1)
    sample date pregnancy test
    Item
    Sample date
    date
    C0032976 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    result pregnancy test
    Item
    Result
    boolean
    C0032976 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Item Group
    Prior and Concomitant Medications
    C2826257 (UMLS CUI-1)
    C2347852 (UMLS CUI-2)
    drug name
    Item
    Drug Name (trade name preferred)
    text
    C0013227 (UMLS CUI [1])
    indication for concomitant medication
    Item
    Indication (or symptoms in the absence of diagnosis)
    text
    C2826696 (UMLS CUI [1])
    concomitant medication start date
    Item
    Date started
    date
    C2826734 (UMLS CUI [1])
    concomitant medication continuation status
    Item
    Continuing?
    boolean
    C2826666 (UMLS CUI [1])
    concomitant medication end date
    Item
    Date Stopped
    date
    C2826744 (UMLS CUI [1])
    Item Group
    Adverse Events
    C0877248 (UMLS CUI-1)
    adverse event
    Item
    Adverse Event
    text
    C0877248 (UMLS CUI [1])
    date of onset
    Item
    Date of Onset
    date
    C2985916 (UMLS CUI [1])
    frequency of adverse event
    Item
    Frequency
    date
    C0877248 (UMLS CUI [1,1])
    C0439603 (UMLS CUI [1,2])
    maximum intensity of adverse event
    Item
    Maximum Intensity
    text
    C1710066 (UMLS CUI [1])
    outcome of adverse event
    Item
    Outcome
    text
    C1705586 (UMLS CUI [1])
    date of adverse event resolution
    Item
    Date Of Resolution
    date
    C2985918 (UMLS CUI [1])
    action taken with investigational product
    Item
    Action Taken With IP
    text
    C1704758 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    withdrawn due to adverse event
    Item
    Withdrawn Due to AE?
    boolean
    C0422727 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    relation of investigational drug to adverse event
    Item
    Relationship to Investigational Drug
    text
    C0877248 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C0439849 (UMLS CUI [1,3])
    serious adverse event
    Item
    Serious Adverse Event?
    boolean
    C1519255 (UMLS CUI [1])
    Item Group
    Repeat 12-lead electrocardiogram
    C0430456 (UMLS CUI-1)
    date of ecg
    Item
    Date of ECG
    date
    C2826640 (UMLS CUI [1])
    result of ecg
    Item
    Result of ECG
    text
    C0438154 (UMLS CUI [1])
    Item Group
    Repeat Laboratory Tests
    C0022885 (UMLS CUI-1)
    blood sample | urine sample
    Item
    Was this a blood or a urine sample?
    text
    C1277698 (UMLS CUI [1])
    C0200354 (UMLS CUI [2])
    date of sample
    Item
    Date of Sample
    date
    C1302413 (UMLS CUI [1])
    laboratory abnormalities
    Item
    After reviewing the laboratory results, are there any clinically significant abnormalities?
    boolean
    C1853129 (UMLS CUI [1])
    Item Group
    Investigational Product
    C0304229 (UMLS CUI-1)
    return of investigational product
    Item
    Visit at Which Medication Was Returned
    date
    C0947323 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    Item
    Bottle A (tablets) or Bottle B (capsules)
    text
    C0304229 (UMLS CUI [1])
    Investigational Product
    Code List
    Bottle A (tablets) or Bottle B (capsules)
    CL Item
    tablets (A)
    CL Item
    capsules (B)
    Dose level
    Item
    Dose level
    text
    C0178602 (UMLS CUI [1])
    investigational product start date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    investigational product end date
    Item
    End Date
    date
    C0806020 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    investigational product number dispensed
    Item
    Number dispensed
    integer
    C0304229 (UMLS CUI [1,1])
    C0805077 (UMLS CUI [1,2])
    investigational product number returned
    Item
    Number Returned
    integer
    C0304229 (UMLS CUI [1,1])
    C2699071 (UMLS CUI [1,2])
    investigational product intake interrupted
    Item
    Interruption >=4 consecutive days
    boolean
    C3843191 (UMLS CUI [1,1])
    C1512900 (UMLS CUI [1,2])
    Item Group
    Comments
    Research Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Zum Seitenanfang zurückkehren 

    Hilfe

    Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

    Zum Video