ID

29036

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)
  1. 21/02/2018 21/02/2018 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

21 février 2018

DOI

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Lizenz

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

Englisch

Visit 9 (Mandatory Safety Follow-Up)

1 Formulare  
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Blood Pressure Systolic
Beschreibung

Blood Pressure Systolic

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic
Beschreibung

Diastolic blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Baseline Adverse Events
Beschreibung

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?"
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
Concomitant Medication Prompt
Beschreibung

Concomitant Medication Prompt

Alias
UMLS CUI-1
C2347852
Were there any changes in concomitant medication since the last visit?
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
Repeat 12-lead electrocardiogram prompt
Beschreibung

Repeat 12-lead electrocardiogram prompt

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

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

Datentyp

boolean

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

Repeat Laboratory tests

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

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

Datentyp

boolean

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

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?
Beschreibung

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

Datentyp

boolean

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

Urine dipstick pregnancy test

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

If "Yes", please record result below.

Datentyp

boolean

Alias
UMLS CUI [1]
C0430056
Sample Date
Beschreibung

Urine dipstick pregnancy sample date

Datentyp

date

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

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.

Datentyp

boolean

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

Comments

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

Research Comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611
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Ähnliche Modelle

Visit 9 (Mandatory Safety Follow-Up)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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