ID

29037

Beschrijving

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

Trefwoorden

Versies (1)
  1. 21-02-18 21-02-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

21 februari 2018

DOI

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Licentie

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

Engels

Visit 10 (Additional Safety Follow-Up)

1 Formulieren  
Vital Signs
Beschrijving

Vital Signs

Alias
UMLS CUI-1
C0518766
Heart rate
Beschrijving

Heart rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Blood Pressure Systolic
Beschrijving

Blood Pressure Systolic

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic
Beschrijving

Diastolic blood pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Baseline Adverse Events
Beschrijving

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?"
Beschrijving

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.

Datatype

boolean

Alias
UMLS CUI [1]
C0877248
Concomitant Medication Prompt
Beschrijving

Concomitant Medication Prompt

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

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.

Datatype

boolean

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

Repeat 12-lead electrocardiogram prompt

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

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

Datatype

boolean

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

Repeat Laboratory tests

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

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

Datatype

boolean

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

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?
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C0304229
Urine dipstick pregnancy test
Beschrijving

Urine dipstick pregnancy test

Alias
UMLS CUI-1
C0430056
Was a urine dipstick performed?
Beschrijving

If "Yes", please record result below.

Datatype

boolean

Alias
UMLS CUI [1]
C0430056
Sample Date
Beschrijving

Urine dipstick pregnancy sample date

Datatype

date

Alias
UMLS CUI [1,1]
C0430056
UMLS CUI [1,2]
C1302413
Result
Beschrijving

If "Positive", withdraw the subject and complete the paper Pregnancy Notification form. Also complete the Early Withdrawal Visit and the End of Study Record panels.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0430056
UMLS CUI [1,2]
C0456984
Comments
Beschrijving

Comments

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

Research Comments

Datatype

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Visit 10 (Additional Safety Follow-Up)

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
Urine dipstick pregnancy test
C0430056 (UMLS CUI-1)
Urine dipstick pregnancy test
Item
Was a urine dipstick performed?
boolean
C0430056 (UMLS CUI [1])
Urine dipstick pregnancy sample date
Item
Sample Date
date
C0430056 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Urine dipstick pregnancy result
Item
Result
boolean
C0430056 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Item Group
Comments
C0947611 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Research Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
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