ID
29023
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)
- 21.02.18 21.02.18 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
21. Februar 2018
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY-NC 3.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
Study Evaluating Extended-Release Bupropion Hydrochloride and Extended-Release Venlafaxine Hydrochloride in Subjects with Major Depressive Disorder 101497
Visit 2 (Baseline)
- StudyEvent: ODM
Beschreibung
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschreibung
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.
Datentyp
float
Maßeinheiten
- cm
Alias
- UMLS CUI [1]
- C0005890
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
Beschreibung
Heart rate
Datentyp
integer
Maßeinheiten
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
Blood Pressure Systolic
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
Diastolic blood pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
Baseline Adverse Events
Alias
- UMLS CUI-1
- C0877248
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
Beschreibung
Concomitant Medication Prompt
Alias
- UMLS CUI-1
- C2347852
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
Beschreibung
Urine dipstick pregnancy test
Alias
- UMLS CUI-1
- C0430056
Beschreibung
Repeat 12-lead electrocardiogram prompt
Alias
- UMLS CUI-1
- C0013798
- UMLS CUI-2
- C0205341
Beschreibung
Repeat Laboratory tests
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0205341
Beschreibung
Baseline Inclusion Criteria
Beschreibung
If 'No', check all all boxes corresponding to violations of any of the Baseline Visit inclusion criteria.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1512693
Beschreibung
HAM-D score
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0451203
Beschreibung
CGI Severity of Illness score
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3639887
Beschreibung
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beschreibung
If 'Yes', check all boxes corresponding to the Baseline Visit exclusion criteria that disqualified the subject from entry
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0680251
Beschreibung
HAM-D total delta
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0451203
- UMLS CUI [1,2]
- C0439097
Beschreibung
Note: Subjects should not be withdrawn from their current treatment regimen for the primary purpose of enrolling into this study
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0033978
Beschreibung
systolic blood pressure | diastolic blood pressure
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0871470
- UMLS CUI [2]
- C0428883
Beschreibung
Subject continuation prompt
Alias
- UMLS CUI-1
- C0805733
Beschreibung
----> 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.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0805733
Beschreibung
randomisation number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Beschreibung
Comments
Datentyp
text
Alias
- UMLS CUI [1]
- C0947611
Ähnliche Modelle
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])