ID

29045

Beschrijving

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

Trefwoorden

Versies (1)
  1. 22-02-18 22-02-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

22 februari 2018

DOI

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Licentie

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

Engels

Additional Forms

1 Formulieren  
  1. StudyEvent: ODM
    1. Additional Forms
Home Pregnancy Test Result
Beschrijving

Home Pregnancy Test Result

Alias
UMLS CUI-1
C0032976
Sample date
Beschrijving

sample date pregnancy test

Datatype

date

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

result pregnancy test

Datatype

boolean

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

Prior and Concomitant Medications

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

drug name

Datatype

text

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

indication for concomitant medication

Datatype

text

Alias
UMLS CUI [1]
C2826696
Date started
Beschrijving

concomitant medication start date

Datatype

date

Alias
UMLS CUI [1]
C2826734
Continuing?
Beschrijving

concomitant medication continuation status

Datatype

boolean

Alias
UMLS CUI [1]
C2826666
Date Stopped
Beschrijving

concomitant medication end date

Datatype

date

Alias
UMLS CUI [1]
C2826744
Adverse Events
Beschrijving

Adverse Events

Alias
UMLS CUI-1
C0877248
Adverse Event
Beschrijving

adverse event

Datatype

text

Alias
UMLS CUI [1]
C0877248
Date of Onset
Beschrijving

date of onset

Datatype

date

Alias
UMLS CUI [1]
C2985916
Frequency
Beschrijving

frequency of adverse event

Datatype

date

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

maximum intensity of adverse event

Datatype

text

Alias
UMLS CUI [1]
C1710066
Outcome
Beschrijving

outcome of adverse event

Datatype

text

Alias
UMLS CUI [1]
C1705586
Date Of Resolution
Beschrijving

date of adverse event resolution

Datatype

date

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

action taken with investigational product

Datatype

text

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Withdrawn Due to AE?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

If subject is withdrawn due to Adverse Event, complete the Early Withdrawal visit.

Datatype

boolean

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

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

Datatype

text

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

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

Datatype

boolean

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

Repeat 12-lead electrocardiogram

Alias
UMLS CUI-1
C0430456
Date of ECG
Beschrijving

date of ecg

Datatype

date

Alias
UMLS CUI [1]
C2826640
Result of ECG
Beschrijving

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

Datatype

text

Alias
UMLS CUI [1]
C0438154
Repeat Laboratory Tests
Beschrijving

Repeat Laboratory Tests

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

blood sample | urine sample

Datatype

text

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

date of sample

Datatype

date

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

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

Datatype

boolean

Alias
UMLS CUI [1]
C1853129
Investigational Product
Beschrijving

Investigational Product

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

return of investigational product

Datatype

date

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

Investigational Product

Datatype

text

Alias
UMLS CUI [1]
C0304229
Dose level
Beschrijving

Dose level

Datatype

text

Alias
UMLS CUI [1]
C0178602
Start Date
Beschrijving

investigational product start date

Datatype

date

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

investigational product end date

Datatype

date

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

investigational product number dispensed

Datatype

integer

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

investigational product number returned

Datatype

integer

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

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

Datatype

boolean

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

Comments

Comments
Beschrijving

Research Comments

Datatype

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Additional Forms

1 Formulieren
  1. StudyEvent: ODM
    1. Additional Forms
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
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