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 :

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 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

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