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
This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.
Description

This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.

Data type

integer

Alias
UMLS CUI [1]
C4054475
This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.
Description

This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.

Data type

integer

Alias
UMLS CUI [1]
C3541258
This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded
Description

This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded

Data type

boolean

Alias
UMLS CUI [1]
C3639708
This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.
Description

This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.

Data type

integer

Alias
UMLS CUI [1]
C3813719
This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.
Description

This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.

Data type

boolean

Alias
UMLS CUI [1]
C130318
This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.
Description

This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.

Data type

integer

Alias
UMLS CUI [1]
C3846158
UMLS CUI [2,1]
C0449820
UMLS CUI [2,2]
C0026605
This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.
Description

This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.

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
Since beginning this study, how satisfied are you with the study medication you are taking for your depression ?
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 is recorded in kg - see conversion table for lbs to kg. Weight is recorded to the nearest 1/10 kg

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
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
Were there any adverse events observed or elicited by the following direct questions to the subject: "How are you feeling?" "Have you had any other medical problems since your last visit/assessment?"
Description

If 'Yes', please record on the Current Medical Conditions or Adverse Events panel as appropriate. NOTE: At the Baseline Visit, only serious adverse events related to study procedures must be recorded on the Adverse Events panel. All other adverse events at the Baseline visit should be recorded on the Current Medical Conditions panel.

Data type

boolean

Alias
UMLS CUI [1]
C0877248
Concomitant Medication Prompt
Description

Concomitant Medication Prompt

Alias
UMLS CUI-1
C2347852
Were there any changes in concomitant medication since the last visit?
Description

If 'Yes', please record on the Prior and Concomitant Medications panel. Saving this panel after selecting 'Yes' will take you to the Prior and Concomitant Medications panel located in the Additional Forms section of the eCRF.

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
Was the ECG trace completed at this visit?
Description

If 'Yes': Ensure the trace is sent to the Central ECG Reader. Refer to the Investigator Guidelines. Please enter the ECG result below AFTER the Central ECG Reader provides the result.

Data type

boolean

Alias
UMLS CUI [1]
C1623258
Date of ECG
Description

Date of ECG

Data type

date

Alias
UMLS CUI [1]
C2826640
Result of ECG
Description

If 'Abnormal - clinically significant', please record on the Current Medical Conditions panel.

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
After reviewing the laboratory results, are there any clinically significant abnormalities?
Description

Please answer the questions AFTER the laboratory results are back. If 'Yes' please record the appropriate details in the Current Medical Conditions panel. Saving this panel after selecting 'Yes' will take you to the Current Medical Conditions panel.

Data type

boolean

Alias
UMLS CUI [1]
C1853129
Serum hCG
Description

Serum hCG

Alias
UMLS CUI-1
C2348195
Was a serum HCG performed?
Description

If "Yes", please record result below.

Data type

boolean

Alias
UMLS CUI [1]
C2348195
Sample Date
Description

Sample Date hCG

Data type

date

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

If "Positive", withdraw the subject and complete the paper Pregnancy Notification form. Also complete the End of Study Record panels

Data type

boolean

Alias
UMLS CUI [1]
C2348195
Investigational Product Prompt
Description

Investigational Product Prompt

Alias
UMLS CUI-1
C0304229
Details of the Investigational Product dispensed at the previous visit need to be entered into the eCRF at this visit. Do you have the details available to enter the data?
Description

If 'Yes', please record on the Investigational Product panel.

Data type

boolean

Alias
UMLS CUI [1]
C0304229
Comments
Description

Comments

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
Patient related scales
C0030705 (UMLS CUI-1)
C0450973 (UMLS CUI-2)
Montgomery-Asberg Depression Rating Scale Questionnaire
Item
This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.
integer
C4054475 (UMLS CUI [1])
Hamilton Anxiety Rating Scale Questionnaire
Item
This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.
integer
C3541258 (UMLS CUI [1])
Clinical Global Impression
Item
This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded
boolean
C3639708 (UMLS CUI [1])
Sheehan Disability Scale Questionnaire
Item
This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.
integer
C3813719 (UMLS CUI [1])
Quality of life enjoyment and satisfaction questionaire - short form Q-LES-Q-SF
Item
This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.
boolean
C130318 (UMLS CUI [1])
Motivation and energy inventory - MEI
Item
This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.
integer
C3846158 (UMLS CUI [1])
C0449820 (UMLS CUI [2,1])
C0026605 (UMLS CUI [2,2])
Changes in sexual functioning questionaire
Item
This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.
text
C3846158 (UMLS CUI [1])
C0278092 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C1705241 (UMLS CUI [2,3])
Item Group
Subject satisfaction with study medication
C0242428 (UMLS CUI-1)
C0013216 (UMLS CUI-2)
Date of assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Satisfaction with study medication
Item
Since beginning this study, how satisfied are you with the study medication you are taking for your depression ?
float
C0242428 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
Item Group
C0518766 (UMLS CUI-1)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic
integer
C0428883 (UMLS CUI [1])
Item Group
Adverse Events
C0877248 (UMLS CUI-1)
adverse events
Item
Were there any adverse events observed or elicited by the following direct questions to the subject: "How are you feeling?" "Have you had any other medical problems since your last visit/assessment?"
boolean
C0877248 (UMLS CUI [1])
Item Group
Concomitant Medication Prompt
C2347852 (UMLS CUI-1)
concomitant medication changes
Item
Were there any changes in concomitant medication since the last visit?
boolean
C2347852 (UMLS CUI [1,1])
C2169461 (UMLS CUI [1,2])
Item Group
12-lead Electrocardiogram
C0430456 (UMLS CUI-1)
ECG completed
Item
Was the ECG trace completed at this visit?
boolean
C1623258 (UMLS CUI [1])
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
ECG Finding
Item
Result of ECG
boolean
C0438154 (UMLS CUI [1])
Item Group
Laboratory tests
C0022885 (UMLS CUI-1)
Date of blood sample
Item
Date of blood sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Date of urine samples
Item
Date of urine samples
date
C2371162 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
laboratory abnormalities
Item
After reviewing the laboratory results, are there any clinically significant abnormalities?
boolean
C1853129 (UMLS CUI [1])
Item Group
C2348195 (UMLS CUI-1)
Serum hCG
Item
Was a serum HCG performed?
boolean
C2348195 (UMLS CUI [1])
Sample Date hCG
Item
Sample Date
date
C1302413 (UMLS CUI [1,1])
C2348195 (UMLS CUI [1,2])
Serum hCG Result
Item
Result
boolean
C2348195 (UMLS CUI [1])
Item Group
Investigational Product Prompt
C0304229 (UMLS CUI-1)
Investigational Product
Item
Details of the Investigational Product dispensed at the previous visit need to be entered into the eCRF at this visit. Do you have the details available to enter the data?
boolean
C0304229 (UMLS CUI [1])
Item Group
Comments
Research Comments
Item
Comments
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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