ID

29038

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

German English

Early Withdrawal

1 forms  
  1. StudyEvent: ODM
    1. Early Withdrawal
Patient related scales
Description

Patient related scales

Alias
UMLS CUI-1
C0030705
UMLS CUI-2
C0450973
Montgomery-Asberg Depression Rating Scale Questionnaire
Description

Montgomery-Asberg Depression Rating Scale Questionnaire

Data type

integer

Alias
UMLS CUI [1]
C4054475
Hamilton Anxiety Rating Scale Questionnaire
Description

Hamilton Anxiety Rating Scale Questionnaire

Data type

integer

Alias
UMLS CUI [1]
C3541258
Clinical Global Impression
Description

Clinical Global Impression

Data type

boolean

Alias
UMLS CUI [1]
C3639708
Der Fragebogen Sheehan-Disability-Scale wurde bearbeitet.
Description

Sheehan Disability Scale Questionnaire

Data type

integer

Alias
UMLS CUI [1]
C3813719
Quality of life enjoyment and satisfaction questionaire - short form Q-LES-Q-SF
Description

Quality of life enjoyment and satisfaction questionaire - short form Q-LES-Q-SF

Data type

boolean

Alias
UMLS CUI [1]
C130318
Motivation and energy inventory - MEI
Description

Motivation and energy inventory - MEI

Data type

integer

Alias
UMLS CUI [1]
C3846158
UMLS CUI [2,1]
C0449820
UMLS CUI [2,2]
C0026605
Changes in sexual functioning questionaire
Description

Changes in sexual functioning questionaire

Data type

text

Alias
UMLS CUI [1]
C3846158
UMLS CUI [2,1]
C0278092
UMLS CUI [2,2]
C0205307
UMLS CUI [2,3]
C1705241
Subject satisfaction with study medication
Description

Subject satisfaction with study medication

Alias
UMLS CUI-1
C0242428
UMLS CUI-2
C0013216
Date of assessment
Description

Date of assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Satisfaction with study medication
Description

Satisfaction with study medication

Data type

float

Alias
UMLS CUI [1,1]
C0242428
UMLS CUI [1,2]
C0013216
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Blood Pressure Systolic
Description

Blood Pressure Systolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Description

Diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Adverse Events
Description

Adverse Events

Alias
UMLS CUI-1
C0877248
adverse events
Description

adverse events

Data type

boolean

Alias
UMLS CUI [1]
C0877248
Concomitant Medication Prompt
Description

Concomitant Medication Prompt

Alias
UMLS CUI-1
C2347852
concomitant medication changes
Description

concomitant medication changes

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2169461
12-lead Electrocardiogram
Description

12-lead Electrocardiogram

Alias
UMLS CUI-1
C0430456
ECG completed
Description

ECG completed

Data type

boolean

Alias
UMLS CUI [1]
C1623258
Date of ECG
Description

Date of ECG

Data type

date

Alias
UMLS CUI [1]
C2826640
ECG Finding
Description

ECG Finding

Data type

boolean

Alias
UMLS CUI [1]
C0438154
Laboratory tests
Description

Laboratory tests

Alias
UMLS CUI-1
C0022885
Date of blood sample
Description

Date of blood sample

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Date of urine samples
Description

Date of urine samples

Data type

date

Alias
UMLS CUI [1,1]
C2371162
UMLS CUI [1,2]
C0011008
laboratory abnormalities
Description

laboratory abnormalities

Data type

boolean

Alias
UMLS CUI [1]
C1853129
Serum hCG
Description

Serum hCG

Alias
UMLS CUI-1
C2348195
Serum hCG
Description

Serum hCG

Data type

boolean

Alias
UMLS CUI [1]
C2348195
Sample Date hCG
Description

Sample Date hCG

Data type

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C2348195
Serum hCG Result
Description

Serum hCG Result

Data type

boolean

Alias
UMLS CUI [1]
C2348195
Investigational Product
Description

Investigational Product

Alias
UMLS CUI-1
C0304229
Investigational Product
Description

Investigational Product

Data type

boolean

Alias
UMLS CUI [1]
C0304229
Comments
Description

Comments

Research Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0022885
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Similar models

Early Withdrawal

1 forms
  1. StudyEvent: ODM
    1. Early Withdrawal
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C0030705 (UMLS CUI-1)
C0450973 (UMLS CUI-2)
Montgomery-Asberg Depression Rating Scale Questionnaire
Item
integer
C4054475 (UMLS CUI [1])
Hamilton Anxiety Rating Scale Questionnaire
Item
integer
C3541258 (UMLS CUI [1])
Clinical Global Impression
Item
boolean
C3639708 (UMLS CUI [1])
Sheehan Disability Scale Questionnaire
Item
Der Fragebogen Sheehan-Disability-Scale wurde bearbeitet.
integer
C3813719 (UMLS CUI [1])
Quality of life enjoyment and satisfaction questionaire - short form Q-LES-Q-SF
Item
boolean
C130318 (UMLS CUI [1])
Motivation and energy inventory - MEI
Item
integer
C3846158 (UMLS CUI [1])
C0449820 (UMLS CUI [2,1])
C0026605 (UMLS CUI [2,2])
Changes in sexual functioning questionaire
Item
text
C3846158 (UMLS CUI [1])
C0278092 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C1705241 (UMLS CUI [2,3])
Item Group
C0242428 (UMLS CUI-1)
C0013216 (UMLS CUI-2)
Date of assessment
Item
date
C2985720 (UMLS CUI [1])
Satisfaction with study medication
Item
float
C0242428 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
Item Group
C0518766 (UMLS CUI-1)
Weight
Item
float
C0005910 (UMLS CUI [1])
Heart rate
Item
integer
C0018810 (UMLS CUI [1])
Blood Pressure Systolic
Item
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
integer
C0428883 (UMLS CUI [1])
Item Group
C0877248 (UMLS CUI-1)
adverse events
Item
boolean
C0877248 (UMLS CUI [1])
Item Group
C2347852 (UMLS CUI-1)
concomitant medication changes
Item
boolean
C2347852 (UMLS CUI [1,1])
C2169461 (UMLS CUI [1,2])
Item Group
C0430456 (UMLS CUI-1)
ECG completed
Item
boolean
C1623258 (UMLS CUI [1])
Date of ECG
Item
date
C2826640 (UMLS CUI [1])
ECG Finding
Item
boolean
C0438154 (UMLS CUI [1])
Item Group
C0022885 (UMLS CUI-1)
Date of blood sample
Item
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Date of urine samples
Item
date
C2371162 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
laboratory abnormalities
Item
boolean
C1853129 (UMLS CUI [1])
Item Group
C2348195 (UMLS CUI-1)
Serum hCG
Item
boolean
C2348195 (UMLS CUI [1])
Sample Date hCG
Item
date
C1302413 (UMLS CUI [1,1])
C2348195 (UMLS CUI [1,2])
Serum hCG Result
Item
boolean
C2348195 (UMLS CUI [1])
Item Group
C0304229 (UMLS CUI-1)
Investigational Product
Item
boolean
C0304229 (UMLS CUI [1])
Item Group
Research Comments
Item
text
C25704 (NCI Thesaurus ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0947611 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
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