ID
29023
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)
- 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
Visit 2 (Baseline)
- StudyEvent: ODM
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Height is recorded in cm. The following conversion factor must be used : inches x 2.54 = height in cm. Height is recorded to the nearest 1/2 cm.
Data type
float
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
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
Description
Heart rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
Blood Pressure Systolic
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic blood pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Baseline Adverse Events
Alias
- UMLS CUI-1
- C0877248
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
Description
Concomitant Medication Prompt
Alias
- UMLS CUI-1
- C2347852
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
Description
Urine dipstick pregnancy test
Alias
- UMLS CUI-1
- C0430056
Description
Repeat 12-lead electrocardiogram prompt
Alias
- UMLS CUI-1
- C0013798
- UMLS CUI-2
- C0205341
Description
Repeat Laboratory tests
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0205341
Description
Baseline Inclusion Criteria
Description
If 'No', check all all boxes corresponding to violations of any of the Baseline Visit inclusion criteria.
Data type
boolean
Alias
- UMLS CUI [1]
- C1512693
Description
HAM-D score
Data type
boolean
Alias
- UMLS CUI [1]
- C0451203
Description
CGI Severity of Illness score
Data type
boolean
Alias
- UMLS CUI [1]
- C3639887
Description
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Description
If 'Yes', check all boxes corresponding to the Baseline Visit exclusion criteria that disqualified the subject from entry
Data type
boolean
Alias
- UMLS CUI [1]
- C0680251
Description
HAM-D total delta
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0451203
- UMLS CUI [1,2]
- C0439097
Description
Note: Subjects should not be withdrawn from their current treatment regimen for the primary purpose of enrolling into this study
Data type
boolean
Alias
- UMLS CUI [1]
- C0033978
Description
systolic blood pressure | diastolic blood pressure
Data type
boolean
Alias
- UMLS CUI [1]
- C0871470
- UMLS CUI [2]
- C0428883
Description
Subject continuation prompt
Alias
- UMLS CUI-1
- C0805733
Description
----> If 'No', please complete the Study Conclusion panel and any outstanding data. ----> If 'Yes', please: - Randomise the subject into the study via the IVR system. - Dispense allocated study medication packs to the subject. - Complete the Randomisation Number panel. - Schedule Visit 3 for 7 days (+/- 3 days) time.
Data type
boolean
Alias
- UMLS CUI [1]
- C0805733
Description
randomisation number
Data type
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Description
Comments
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Similar models
Visit 2 (Baseline)
- StudyEvent: ODM
C0449820 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,2])
C1705241 (UMLS CUI [1,3])
C2169461 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
C0439097 (UMLS CUI [1,2])
C0428883 (UMLS CUI [2])
C0237753 (UMLS CUI [1,2])