ID

29039

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

Keywords

Versions (1)
  1. 2/21/18 2/21/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 21, 2018

DOI

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License

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

English

End of Study Record

1 forms  
  1. StudyEvent: ODM
    1. End of Study Record
Study Conclusion
Description

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
Did the subject discontinue the study prematurely?
Description

NOTE : The subject is considered to have discontinued if they did not complete the 8 weeks of treatment, the Taper Visit (if necessary), the Mandatory Safety Follow-Up Visit, the Additional Safety Follow-Up Visit (if required) and the home pregnancy test (if required). If 'Yes' please mark the primary reason for discontinuation.

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C4018905
Reason
Description

reason for premature discontinuation

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Date of subject completion or discontinuation from the study
Description

date of study completion or discontinuation

Data type

date

Alias
UMLS CUI [1,1]
C2348577
UMLS CUI [1,2]
C0011008
Status of Treatment Blind
Description

Status of Treatment Blind

Alias
UMLS CUI-1
C0749659
UMLS CUI-2
C2347038
Was the treatment blind for this subject broken during the study?
Description

If 'Yes' please complete the following.

Data type

boolean

Alias
UMLS CUI [1]
C3897431
Date
Description

date of broken treatment blind

Data type

boolean

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
Reason
Description

(Medical emergency requiring identity of investigational product for further treatment)

Data type

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
Investigational Product Discontinuation
Description

Investigational Product Discontinuation

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0457454
Was the investigational product stopped permanently before the end of the scheduled treatment period?
Description

If Yes, select the primary reason the investigational product was stopped.

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0457454
Select the primary reason the investigational product was stopped.
Description

reason for investigational product discontinuation

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0457454
Comments
Description

Comments

Alias
UMLS CUI-1
C0947611
Comments
Description

Research Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
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Similar models

End of Study Record

1 forms
  1. StudyEvent: ODM
    1. End of Study Record
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
premature discontination
Item
Did the subject discontinue the study prematurely?
boolean
C2348568 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C4018905 (UMLS CUI [1,3])
reason for premature discontinuation
Item
Reason
text
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
date of study completion or discontinuation
Item
Date of subject completion or discontinuation from the study
date
C2348577 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Status of Treatment Blind
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
treatment blind broken
Item
Was the treatment blind for this subject broken during the study?
boolean
C3897431 (UMLS CUI [1])
date of broken treatment blind
Item
Date
boolean
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
reason of broken treatment blind
Item
Reason
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Item Group
Investigational Product Discontinuation
C0304229 (UMLS CUI-1)
C0457454 (UMLS CUI-2)
Investigational Product Discontinuation
Item
Was the investigational product stopped permanently before the end of the scheduled treatment period?
boolean
C0304229 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
reason for investigational product discontinuation
Item
Select the primary reason the investigational product was stopped.
text
C0392360 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,3])
Item Group
Comments
C0947611 (UMLS CUI-1)
Research Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
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