ID

29045

Description

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

Mots-clés

Versions (1)
  1. 22.02.18 22.02.18 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

22. Februar 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

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

Anglais

Additional Forms

1 Formulaires  
  1. StudyEvent: ODM
    1. Additional Forms
Home Pregnancy Test Result
Description

Home Pregnancy Test Result

Alias
UMLS CUI-1
C0032976
Sample date
Description

sample date pregnancy test

Type de données

date

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

result pregnancy test

Type de données

boolean

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

Prior and Concomitant Medications

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

drug name

Type de données

text

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

indication for concomitant medication

Type de données

text

Alias
UMLS CUI [1]
C2826696
Date started
Description

concomitant medication start date

Type de données

date

Alias
UMLS CUI [1]
C2826734
Continuing?
Description

concomitant medication continuation status

Type de données

boolean

Alias
UMLS CUI [1]
C2826666
Date Stopped
Description

concomitant medication end date

Type de données

date

Alias
UMLS CUI [1]
C2826744
Adverse Events
Description

Adverse Events

Alias
UMLS CUI-1
C0877248
Adverse Event
Description

adverse event

Type de données

text

Alias
UMLS CUI [1]
C0877248
Date of Onset
Description

date of onset

Type de données

date

Alias
UMLS CUI [1]
C2985916
Frequency
Description

frequency of adverse event

Type de données

date

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

maximum intensity of adverse event

Type de données

text

Alias
UMLS CUI [1]
C1710066
Outcome
Description

outcome of adverse event

Type de données

text

Alias
UMLS CUI [1]
C1705586
Date Of Resolution
Description

date of adverse event resolution

Type de données

date

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

action taken with investigational product

Type de données

text

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

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

Type de données

boolean

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

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

Type de données

text

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

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

Type de données

boolean

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

Repeat 12-lead electrocardiogram

Alias
UMLS CUI-1
C0430456
Date of ECG
Description

date of ecg

Type de données

date

Alias
UMLS CUI [1]
C2826640
Result of ECG
Description

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

Type de données

text

Alias
UMLS CUI [1]
C0438154
Repeat Laboratory Tests
Description

Repeat Laboratory Tests

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

blood sample | urine sample

Type de données

text

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

date of sample

Type de données

date

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

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

Type de données

boolean

Alias
UMLS CUI [1]
C1853129
Investigational Product
Description

Investigational Product

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

return of investigational product

Type de données

date

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

Investigational Product

Type de données

text

Alias
UMLS CUI [1]
C0304229
Dose level
Description

Dose level

Type de données

text

Alias
UMLS CUI [1]
C0178602
Start Date
Description

investigational product start date

Type de données

date

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

investigational product end date

Type de données

date

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

investigational product number dispensed

Type de données

integer

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

investigational product number returned

Type de données

integer

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

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

Type de données

boolean

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

Comments

Comments
Description

Research Comments

Type de données

text

Alias
UMLS CUI [1]
C0947611
Retour au début de la page

Similar models

Additional Forms

1 Formulaires
  1. StudyEvent: ODM
    1. Additional Forms
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial