ID
29247
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 (3)
- 1/31/18 1/31/18 -
- 2/22/18 2/22/18 -
- 3/11/18 3/11/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
March 11, 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
Visit 1 (Screening)
- StudyEvent: ODM
Description
Contraceptive Methods
Alias
- UMLS CUI-1
- C0700589
Description
Psychiatric History
Alias
- UMLS CUI-1
- C0748059
Description
Psychiatric Condition
Data type
text
Alias
- UMLS CUI [1]
- C0004936
Description
Start Date
Data type
date
Alias
- UMLS CUI [1]
- C0808070
Description
Continuing psychiatric condition
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0439598
- UMLS CUI [1,2]
- C0004936
Description
Stop Date
Data type
date
Alias
- UMLS CUI [1]
- C0806020
Description
Psychiatric History (cont.)
Alias
- UMLS CUI-1
- C0748061
- UMLS CUI-2
- C0205394
Description
Psychiatric History_Other_List
Alias
- UMLS CUI-1
- C0748061
- UMLS CUI-2
- C0205394
Description
Psychiatric Condition
Data type
text
Alias
- UMLS CUI [1]
- C0004936
Description
DSM-IV code
Data type
text
Alias
- UMLS CUI [1]
- C0220952
Description
Start Date
Data type
date
Alias
- UMLS CUI [1]
- C0808070
Description
Continuing psychiatric condition
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0439598
- UMLS CUI [1,2]
- C0004936
Description
Stop Date
Data type
date
Alias
- UMLS CUI [1]
- C0806020
Description
History of Major Depression
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C1269683
Description
If yes, continue with questions 2-4.
Data type
boolean
Alias
- UMLS CUI [1]
- C1269683
Description
Date of first previous episode of Major Depression
Data type
partialDate
Alias
- UMLS CUI [1,1]
- C0024517
- UMLS CUI [1,2]
- C0205435
Description
Number of previous episodes of depressive illness
Data type
integer
Alias
- UMLS CUI [1,1]
- C0349217
- UMLS CUI [1,2]
- C4086638
Description
If 'Yes' please record details in the Depression Medication History panel.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1269683
Description
Depresison medication history
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0013227
- UMLS CUI-3
- C1269683
Description
Record the details of any medication that the subject has received for past episodes of Major Depression. Only record medication that was stopped more than one month prior to the screening visit. Note: Medication received for Major Depression within one month prior to the screening visit should be recorded on the Prior and Concomitant Medications panel.
Data type
text
Alias
- UMLS CUI [1]
- C0013227
Description
HAM-D 17 IVRS prompt
Alias
- UMLS CUI-1
- C3639712
Description
----> If 'Yes', continue below ----> If 'No', the subject is not eligible to continue in this study.
Data type
boolean
Alias
- UMLS CUI [1]
- C3639712
Description
If 'No', the subject is not eligible to continue in this study
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3639712
- UMLS CUI [1,2]
- C0449820
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Vital signs should be measured after the subject has been seated for at least 5 minutes. Heart Rate will be measured for 30 seconds.
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Description
Vital signs should be measured after the subject has been seated for at least 5 minutes. Average Blood Pressure from 2 readings is recorded.
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Vital signs should be measured after the subject has been seated for at least 5 minutes. Average Blood Pressure from 2 readings is recorded.
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Physical Examination Prompt
Alias
- UMLS CUI-1
- C0031809
Description
Physical Examination
Data type
boolean
Alias
- UMLS CUI [1]
- C0031809
Description
If 'Yes', please record the appropriate details in the Current Medical Conditions panel which is the next panel.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C1704258
Description
Current Medical Conditions
Alias
- UMLS CUI-1
- C3899485
Description
Record any current medical condition. Enter a separate record for each condition, selecting the appropriate body system. Psychiatric history should NOT be recorded here, but in the Psychiatric History panel. Allergic conditions should be recorded on the Allergic History panel.
Data type
text
Alias
- UMLS CUI [1]
- C0460002
Description
Record any current medical condition. Enter a separate record for each condition, selecting the appropriate body system. Psychiatric history should NOT be recorded here, but in the Psychiatric History panel. Allergic conditions should be recorded on the Allergic History panel.
Data type
text
Alias
- UMLS CUI [1]
- C0012634
Description
Allergic History
Alias
- UMLS CUI-1
- C0020517
Description
Medical History
Data type
text
Alias
- UMLS CUI [1]
- C0262926
Description
Asthma
Data type
boolean
Alias
- UMLS CUI [1]
- C0004096
Description
ie.hayfever, seasonal rhinitis
Data type
boolean
Alias
- UMLS CUI [1]
- C0282504
Description
Food Allergy
Data type
boolean
Alias
- UMLS CUI [1]
- C0016470
Description
Food Allergy - Specify Food
Data type
text
Alias
- UMLS CUI [1]
- C0016452
Description
Drug Hypersensitivity / Allergy
Data type
boolean
Alias
- UMLS CUI [1]
- C0013182
- UMLS CUI [2,1]
- C0020517
- UMLS CUI [2,2]
- C0015237
Description
Drug Hypersensitivity / Allergy - Specify Drug
Data type
text
Alias
- UMLS CUI [1]
- C0013227
Description
Bronchospasm
Data type
boolean
Alias
- UMLS CUI [1]
- C0006266
Description
Rash
Data type
boolean
Alias
- UMLS CUI [1]
- C0015230
Description
Urticaria
Data type
boolean
Alias
- UMLS CUI [1]
- C0042109
Description
Pruritis
Data type
boolean
Alias
- UMLS CUI [1]
- C0033774
Description
Angioedema
Data type
text
Alias
- UMLS CUI [1]
- C0002994
Description
ie. myalgia, fatigue
Data type
boolean
Alias
- UMLS CUI [1]
- C0036830
Description
(severe rash with fever, fatigue, lymphedema)
Data type
boolean
Alias
- UMLS CUI [1]
- C0038325
Description
Anaphylaxis
Data type
boolean
Alias
- UMLS CUI [1]
- C0002792
Description
OTHER allergy
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0205394
Description
OTHER allergy - specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0205394
Description
Prior and Concomitant Medication Prompt
Alias
- UMLS CUI-1
- C2826257
- UMLS CUI-3
- C2347852
Description
If 'Yes', please record on the Prior and Concomitant Medications panel.
Data type
boolean
Alias
- UMLS CUI [1]
- C2826257
- UMLS CUI [2]
- C2347852
Description
12-lead Electrocardiogram
Alias
- UMLS CUI-1
- C0430456
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
Description
Date of ECG
Data type
date
Alias
- UMLS CUI [1]
- C2826640
Description
If 'Abnormal - clinically significant', please record on the Current Medical Conditions panel.
Data type
integer
Alias
- UMLS CUI [1]
- C0438154
Description
Laboratory tests
Alias
- UMLS CUI-1
- C0022885
Description
Date of blood sample
Data type
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Description
Date of urine samples
Data type
date
Alias
- UMLS CUI [1,1]
- C2371162
- UMLS CUI [1,2]
- C0011008
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
Description
Please answer the question AFTER the laboratory results are back. If "Yes", the subject is not eligible for the study. A positive blood alcohol level test may not be repeated
Data type
boolean
Alias
- UMLS CUI [1]
- C0202304
Description
Please answer the question AFTER the laboratory results are back. If "Positive", the subject is not eligible for the study. A positive urine drug screen test may not be repeated.
Data type
boolean
Alias
- UMLS CUI [1]
- C0202274
Description
Serum hCG
Alias
- UMLS CUI-1
- C2348195
Description
If "Yes", please record result below.
Data type
boolean
Alias
- UMLS CUI [1]
- C2348195
Description
Sample Date hCG
Data type
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C2348195
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
Description
Eligibility Criteria and Comments
Alias
- UMLS CUI-1
- C1516637
- UMLS CUI-3
- C0947611
Description
see seperate form If 'No', check all boxes corresponding to violations of any of the Screening Visit inclusion criteria. Note that the numbering of the criteria is as in the protocol but those criteria that can only be assessed at the Screening Visit are listed. If the subject passed all of the Screening Visit inclusion and exclusion criteria, schedule the Baseline Visit for when the laboratory and ECG results are due back but no more than 14 days time.
Data type
boolean
Alias
- UMLS CUI [1]
- C1512693
Description
If 'Yes', check all boxes corresponding to the Screening Visit exclusion criteria that disqualified the subject from entry. Note that the numbering of the criteria is as in the protocol but those criteria that can only be assessed at the Screening Visit are listed. If the subject passed all of the Screening Visit inclusion and exclusion criteria, schedule the Baseline Visit for when the laboratory and ECG results are due back but no more than 14 days time.
Data type
boolean
Alias
- UMLS CUI [1]
- C0680251
Description
Comments
Data type
text
Alias
- UMLS CUI [1]
- C0947611
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Visit 1 (Screening)
- StudyEvent: ODM
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C0004936 (UMLS CUI [1,2])
C0205394 (UMLS CUI-2)
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI-2)
C0004936 (UMLS CUI [1,2])
C1269683 (UMLS CUI-2)
C0205435 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,2])
C1269683 (UMLS CUI [1,2])
C0013227 (UMLS CUI-2)
C1269683 (UMLS CUI-3)
C0449820 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0015237 (UMLS CUI [2,2])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2347852 (UMLS CUI-3)
C2347852 (UMLS CUI [2])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C2348195 (UMLS CUI [1,2])
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