ID
29023
Descripción
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
Palabras clave
Versiones (1)
- 21/2/18 21/2/18 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
21 de febrero de 2018
DOI
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Licencia
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
Descripción
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Descripción
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.
Tipo de datos
float
Unidades de medida
- cm
Alias
- UMLS CUI [1]
- C0005890
Descripción
Weight is recorded in kg - see conversion table for lbs to kg. Weight is recorded to the nearest 1/10 kg.
Tipo de datos
float
Unidades de medida
- kg
Alias
- UMLS CUI [1]
- C0005910
Descripción
Heart rate
Tipo de datos
integer
Unidades de medida
- bpm
Alias
- UMLS CUI [1]
- C0018810
Descripción
Blood Pressure Systolic
Tipo de datos
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Descripción
Diastolic blood pressure
Tipo de datos
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Descripción
Baseline Adverse Events
Alias
- UMLS CUI-1
- C0877248
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0877248
Descripción
Concomitant Medication Prompt
Alias
- UMLS CUI-1
- C2347852
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2169461
Descripción
Urine dipstick pregnancy test
Alias
- UMLS CUI-1
- C0430056
Descripción
Repeat 12-lead electrocardiogram prompt
Alias
- UMLS CUI-1
- C0013798
- UMLS CUI-2
- C0205341
Descripción
Repeat Laboratory tests
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0205341
Descripción
Baseline Inclusion Criteria
Descripción
If 'No', check all all boxes corresponding to violations of any of the Baseline Visit inclusion criteria.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1512693
Descripción
HAM-D score
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0451203
Descripción
CGI Severity of Illness score
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C3639887
Descripción
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Descripción
If 'Yes', check all boxes corresponding to the Baseline Visit exclusion criteria that disqualified the subject from entry
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0680251
Descripción
HAM-D total delta
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0451203
- UMLS CUI [1,2]
- C0439097
Descripción
Note: Subjects should not be withdrawn from their current treatment regimen for the primary purpose of enrolling into this study
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0033978
Descripción
systolic blood pressure | diastolic blood pressure
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0871470
- UMLS CUI [2]
- C0428883
Descripción
Subject continuation prompt
Alias
- UMLS CUI-1
- C0805733
Descripción
----> 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.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0805733
Descripción
randomisation number
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Descripción
Comments
Tipo de datos
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])