ID

29034

Beschreibung

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

Stichworte

Versionen (1)
  1. 21.02.18 21.02.18 -
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GlaxoSmithKline

Hochgeladen am

21. Februar 2018

DOI

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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

Deutsch Englisch

Visit 7 (End of Week 8)

1 Formulare  
Patient related scales
Beschreibung

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.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Subject satisfaction with study medication

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

Date of assessment

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Since beginning this study, how satisfied are you with the study medication you are taking for your depression ?
Beschreibung

Satisfaction with study medication

Datentyp

float

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

Vital Signs

Alias
UMLS CUI-1
C0518766
Weight
Beschreibung

Weight is recorded in kg - see conversion table for lbs to kg. Weight is recorded to the nearest 1/10 kg

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Blood Pressure Systolic
Beschreibung

Blood Pressure Systolic

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic
Beschreibung

Diastolic blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Adverse Events
Beschreibung

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?"
Beschreibung

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.

Datentyp

boolean

Alias
UMLS CUI [1]
C0877248
Concomitant Medication Prompt
Beschreibung

Concomitant Medication Prompt

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

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.

Datentyp

boolean

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

12-lead Electrocardiogram

Alias
UMLS CUI-1
C0430456
Was the ECG trace completed at this visit?
Beschreibung

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.

Datentyp

boolean

Alias
UMLS CUI [1]
C1623258
Date of ECG
Beschreibung

Date of ECG

Datentyp

date

Alias
UMLS CUI [1]
C2826640
Result of ECG
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0438154
Laboratory tests
Beschreibung

Laboratory tests

Alias
UMLS CUI-1
C0022885
Date of blood sample
Beschreibung

Date of blood sample

Datentyp

date

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

Date of urine samples

Datentyp

date

Alias
UMLS CUI [1,1]
C2371162
UMLS CUI [1,2]
C0011008
After reviewing the laboratory results, are there any clinically significant abnormalities?
Beschreibung

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.

Datentyp

boolean

Alias
UMLS CUI [1]
C1853129
Serum hCG
Beschreibung

Serum hCG

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

If "Yes", please record result below.

Datentyp

boolean

Alias
UMLS CUI [1]
C2348195
Sample Date
Beschreibung

Sample Date hCG

Datentyp

date

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

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

Datentyp

boolean

Alias
UMLS CUI [1]
C2348195
Investigational Product Prompt
Beschreibung

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?
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0304229
Comments
Beschreibung

Comments

Comments
Beschreibung

Research Comments

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS CUI [1]
C0947611
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Ähnliche Modelle

Visit 7 (End of Week 8)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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