ID

29035

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2018-02-21 2018-02-21 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

21 februari 2018

DOI

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Licens

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 [ID 101497]

Engelsk

Visit 8 (End of Taper Phase Visit)

1 Formulär  
Vital Signs
Beskrivning

Vital Signs

Alias
UMLS CUI-1
C0518766
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Blood Pressure Systolic
Beskrivning

Blood Pressure Systolic

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic
Beskrivning

Diastolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Baseline Adverse Events
Beskrivning

Baseline 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?"
Beskrivning

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.

Datatyp

boolean

Alias
UMLS CUI [1]
C0877248
Concomitant Medication Prompt
Beskrivning

Concomitant Medication Prompt

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

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.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2169461
Repeat 12-lead electrocardiogram prompt
Beskrivning

Repeat 12-lead electrocardiogram prompt

Alias
UMLS CUI-1
C0013798
UMLS CUI-2
C0205341
Was a repeat 12-Lead Electrocardiogram performed at this visit ?
Beskrivning

If 'Yes', please record on the Repeat 12-Lead Electrocardiogram panel.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0205341
Repeat Laboratory tests
Beskrivning

Repeat Laboratory tests

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0205341
Were repeat laboratory tests performed at this visit ?
Beskrivning

If 'Yes', please record on the Repeat Laboratory Tests panel.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0205341
Investigational Product Prompt
Beskrivning

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?
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0304229
Comments
Beskrivning

Comments

Alias
UMLS CUI-1
C0947611
UMLS CUI-2
C0022885
Comments
Beskrivning

Research Comments

Datatyp

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Visit 8 (End of Taper Phase Visit)

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C0518766 (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
Baseline 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
C0013798 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
Repeated 12-lead EKG
Item
Was a repeat 12-Lead Electrocardiogram performed at this visit ?
boolean
C0013798 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Item Group
C0022885 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
Repeat Laboratory tests
Item
Were repeat laboratory tests performed at this visit ?
boolean
C0022885 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
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
C0947611 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Research Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
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