ID

25845

Beschreibung

A 24 week double-blind, randomised, placebo-controlled, parallel-group dose-ranging study to investigate the effects of rosiglitazone (extended release tablets) on cognition in subjects with mild to moderate Alzheimer's disease.

Stichworte

Versionen (1)
  1. 21.09.17 21.09.17 -
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Glaxo Smith Kline

Hochgeladen am

21. September 2017

DOI

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Creative Commons BY-NC 3.0
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GSK AVA100193 Rosiglitazone in Alzheimer´s Disease -Early withdrawal

Englisch

Early Withdrawal and Early Withdrawal Follow-up

1 Formulare  
Early withdrawal
Beschreibung

Early withdrawal

Alias
UMLS CUI-1
C2349954
UMLS CUI-2
C0011008
UMLS CUI-3
C1710477
Centre or investigator number
Beschreibung

Centre or investigator number

Datentyp

integer

Alias
UMLS CUI [1]
C2826689
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Make a Withdrawal call to the IVRS system.
Beschreibung

Investigator Instructions

Datentyp

text

Alias
UMLS CUI [1]
C1442085
Patient weight
Beschreibung

Weight

Datentyp

float

Alias
UMLS CUI [1]
C0005910
Systolic Blood Pressure
Beschreibung

Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.

Datentyp

integer

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

Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beschreibung

Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Central Laboratory (Non fasting samples)
Beschreibung

Central Laboratory (Non fasting samples)

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C2585491
Date samples taken
Beschreibung

Collection Date

Datentyp

date

Alias
UMLS CUI [1]
C1317250
Pregnancy test
Beschreibung

If subject is female and of childbearing potential a serum pregnancy test must be performed.

Datentyp

text

Alias
UMLS CUI [1]
C0032976
Record any changes to the subject's concomitant medications or any new medications taken since the last visit in the appropriate Concomitant Medications section.
Beschreibung

Concomitant Medications

Datentyp

text

Alias
UMLS CUI [1]
C2347852
Record details of any new non-serious adverse events/serious adverse events observed or reported by the subject or any changes to ongoing non-serious adverse events in the appropriate Non-Serious Adverse Events/ Serious Adverse Events section.
Beschreibung

Adverse Events

Datentyp

text

Alias
UMLS CUI [1]
C0877248
Perform a physical examination on the subject, including auscultation of heart and lungs.
Beschreibung

Note: If any abnormalities are found as a result of the physical examination, these must be recorded on the NonSerious Adverse Events page.

Datentyp

text

Alias
UMLS CUI [1]
C0031809
Estimated Depth of Indentation
Beschreibung

Press firmly with thumb anterior to the worst affected ankle until further pressure produces no greater indentation. Visually estimate depth of pit and record the Estimated Depth of Indentation below. Note: Use the same ankle throughout the study

Datentyp

integer

Alias
UMLS CUI [1,1]
C0574002
UMLS CUI [1,2]
C0205125
Which ankle was assessed at this visit
Beschreibung

Pedal edema

Datentyp

integer

Alias
UMLS CUI [1]
C0574002
Schedule the subject for an Early Withdrawal Follow-Up visit 14 days(± 3 days) after this visit.
Beschreibung

Investigator instructions

Datentyp

text

Alias
UMLS CUI [1]
C1442085
Complete the Early Withdrawal ADAS-cog and CIBIC+ from the Rating Scale CRF and record the results on the following pages.
Beschreibung

Rating scale Instructions

Datentyp

boolean

Alias
UMLS CUI [1]
C0681889
Alzheimer Disease Assessment Scale
Beschreibung

Alzheimer Disease Assessment Scale

Datentyp

text

Alias
UMLS CUI [1]
C0450989
CIBIC+
Beschreibung

Clinician Interview-Based Impression of Change

Datentyp

boolean

Alias
UMLS CUI [1]
C3641327
Early Withdrawal Follow-up
Beschreibung

Early Withdrawal Follow-up

Alias
UMLS CUI-1
C2349954
UMLS CUI-2
C0011008
UMLS CUI-3
C1710477
UMLS CUI-4
C3274571
Telephone the IVRS system to register the visit.
Beschreibung

Investigator Instructions

Datentyp

text

Alias
UMLS CUI [1]
C1442085
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Patient weight
Beschreibung

Weight

Datentyp

float

Alias
UMLS CUI [1]
C0005910
Systolic Blood Pressure
Beschreibung

Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.

Datentyp

integer

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

Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beschreibung

Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Central Laboratory (Non fasting samples)
Beschreibung

Central Laboratory (Non fasting samples)

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C2585491
Date samples taken
Beschreibung

Collection Date

Datentyp

date

Alias
UMLS CUI [1]
C1317250
Record any changes to the subject's concomitant medications or any new medications taken since the last visit in the appropriate Concomitant Medications section.
Beschreibung

Concomitant Medications

Datentyp

text

Alias
UMLS CUI [1]
C2347852
Record details of any new non-serious adverse events/serious adverse events observed or reported by the subject or any changes to ongoing non-serious adverse events in the appropriate Non-Serious Adverse Events/ Serious Adverse Events section.
Beschreibung

Adverse Events

Datentyp

text

Alias
UMLS CUI [1]
C0877248
Perform a physical examination on the subject, including auscultation of heart and lungs.
Beschreibung

Note: If any abnormalities are found as a result of the physical examination, these must be recorded on the NonSerious Adverse Events page.

Datentyp

text

Alias
UMLS CUI [1]
C0031809
Estimated Depth of Indentation
Beschreibung

Press firmly with thumb anterior to the worst affected ankle until further pressure produces no greater indentation. Visually estimate depth of pit and record the Estimated Depth of Indentation below. Note: Use the same ankle throughout the study

Datentyp

integer

Alias
UMLS CUI [1,1]
C0574002
UMLS CUI [1,2]
C0205125
Which ankle was assessed at this visit
Beschreibung

Pedal edema

Datentyp

integer

Alias
UMLS CUI [1]
C0574002
Ensure the follwing sections are fully completed at this time: - Concomitant Medication - Non-serious Adverse Events - Pharmacogenetic and Pharmacogenomic Research - Study Conclusion
Beschreibung

End of Study Assessments

Datentyp

text

Alias
UMLS CUI [1,1]
C0444496
UMLS CUI [1,2]
C1516048
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Early Withdrawal and Early Withdrawal Follow-up

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Early withdrawal
C2349954 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
C1710477 (UMLS CUI-3)
Centre or investigator number
Item
Centre or investigator number
integer
C2826689 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Investigator Instructions
Item
Make a Withdrawal call to the IVRS system.
text
C1442085 (UMLS CUI [1])
Weight
Item
Patient weight
float
C0005910 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Central Laboratory (Non fasting samples)
Item
Central Laboratory (Non fasting samples)
text
C0022885 (UMLS CUI [1,1])
C2585491 (UMLS CUI [1,2])
Collection Date
Item
Date samples taken
date
C1317250 (UMLS CUI [1])
Pregnancy test
Item
Pregnancy test
text
C0032976 (UMLS CUI [1])
Concomitant Medications
Item
Record any changes to the subject's concomitant medications or any new medications taken since the last visit in the appropriate Concomitant Medications section.
text
C2347852 (UMLS CUI [1])
Adverse Events
Item
Record details of any new non-serious adverse events/serious adverse events observed or reported by the subject or any changes to ongoing non-serious adverse events in the appropriate Non-Serious Adverse Events/ Serious Adverse Events section.
text
C0877248 (UMLS CUI [1])
Physical Examination
Item
Perform a physical examination on the subject, including auscultation of heart and lungs.
text
C0031809 (UMLS CUI [1])
Item
Estimated Depth of Indentation
integer
C0574002 (UMLS CUI [1,1])
C0205125 (UMLS CUI [1,2])
Pedal edema
Code List
Estimated Depth of Indentation
CL Item
<1 mm  (0)
CL Item
1 - 2 mm  (1)
CL Item
3- 5 mm  (2)
CL Item
6 - 10 mm  (3)
CL Item
> 10 mm (4)
Item
Which ankle was assessed at this visit
integer
C0574002 (UMLS CUI [1])
Pedal edema
Code List
Which ankle was assessed at this visit
CL Item
Right Ankle (1)
CL Item
Left Ankle (2)
Investigator instructions
Item
Schedule the subject for an Early Withdrawal Follow-Up visit 14 days(± 3 days) after this visit.
text
C1442085 (UMLS CUI [1])
Rating scale Instructions
Item
Complete the Early Withdrawal ADAS-cog and CIBIC+ from the Rating Scale CRF and record the results on the following pages.
boolean
C0681889 (UMLS CUI [1])
Alzheimer Disease Assessment Scale
Item
Alzheimer Disease Assessment Scale
text
C0450989 (UMLS CUI [1])
Clinician Interview-Based Impression of Change
Item
CIBIC+
boolean
C3641327 (UMLS CUI [1])
Item Group
Early Withdrawal Follow-up
C2349954 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
C1710477 (UMLS CUI-3)
C3274571 (UMLS CUI-4)
Investigator Instructions
Item
Telephone the IVRS system to register the visit.
text
C1442085 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Weight
Item
Patient weight
float
C0005910 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Central Laboratory (Non fasting samples)
Item
Central Laboratory (Non fasting samples)
text
C0022885 (UMLS CUI [1,1])
C2585491 (UMLS CUI [1,2])
Collection Date
Item
Date samples taken
date
C1317250 (UMLS CUI [1])
Concomitant Medications
Item
Record any changes to the subject's concomitant medications or any new medications taken since the last visit in the appropriate Concomitant Medications section.
text
C2347852 (UMLS CUI [1])
Adverse Events
Item
Record details of any new non-serious adverse events/serious adverse events observed or reported by the subject or any changes to ongoing non-serious adverse events in the appropriate Non-Serious Adverse Events/ Serious Adverse Events section.
text
C0877248 (UMLS CUI [1])
Physical Examination
Item
Perform a physical examination on the subject, including auscultation of heart and lungs.
text
C0031809 (UMLS CUI [1])
Item
Estimated Depth of Indentation
integer
C0574002 (UMLS CUI [1,1])
C0205125 (UMLS CUI [1,2])
Pedal edema
Code List
Estimated Depth of Indentation
CL Item
<1 mm  (0)
CL Item
1 - 2 mm  (1)
CL Item
3- 5 mm  (2)
CL Item
6 - 10 mm  (3)
CL Item
> 10 mm (4)
Item
Which ankle was assessed at this visit
integer
C0574002 (UMLS CUI [1])
Pedal edema
Code List
Which ankle was assessed at this visit
CL Item
Right Ankle (1)
CL Item
Left Ankle (2)
End of Study Assessments
Item
Ensure the follwing sections are fully completed at this time: - Concomitant Medication - Non-serious Adverse Events - Pharmacogenetic and Pharmacogenomic Research - Study Conclusion
text
C0444496 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
Zum Seitenanfang zurückkehren 

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