ID

17576

Beskrivning

NCT00428090 / GSK-AVA105640 A 24-week, double-blind, double-dummy, randomized, parallel-group study to investigate the effects of rosiglitazone (extended release tablets), donepezil, and placebo as monotherapy on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer’s disease. (REFLECT-1)

Nyckelord

  1. 2016-09-11 2016-09-11 -
  2. 2016-09-25 2016-09-25 -
Uppladdad den

25 september 2016

DOI

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Licens

Creative Commons BY-NC-ND 3.0

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REFLECT-1 Visit 2 NCT00428090

REFLECT-1 Visit 2 NCT00428090

Patient Information
Beskrivning

Patient Information

Alias
UMLS CUI-1
C1955348
Subject Identifier
Beskrivning

Patient Study ID

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beskrivning

Visit Date

Datatyp

date

Måttenheter
  • dd/MMM/yy
Alias
UMLS CUI [1]
C1320303
dd/MMM/yy
Investigator Instructions
Beskrivning

Investigator Instructions

Alias
UMLS CUI-1
C1442085
Telephone the IVRS system to register the visit. (Note that if the subject is not continuiing in the study, you should make a Withdrawal call rather than a Visit Registration call). Review study medication compliance.
Beskrivning

Investigator Instructions

Datatyp

text

Alias
UMLS CUI [1]
C1442085
Subject Continuation
Beskrivning

Subject Continuation

Alias
UMLS CUI-1
C0805733
If the subject is not continuing in the study, complete all assessments and ensure that all sections of the CRF (including the Study Conclusion section) are completed appropriately. Schedule an early withdrawal follow-up visit for 14 +/- 7 days after thsi visit.
Beskrivning

Subject Continuation

Datatyp

text

Alias
UMLS CUI [1]
C0805733
Vital signs
Beskrivning

Vital signs

Alias
UMLS CUI-1
C0518766
Weight
Beskrivning

Weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Systolic Blood Pressure. Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
Beskrivning

Systolic Blood Pressure

Datatyp

float

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure. Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
Beskrivning

Diastolic Blood Pressure

Datatyp

float

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Patient Position: Sitting. Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
Beskrivning

Patient Position

Datatyp

boolean

Alias
UMLS CUI [1]
C0449850
Heart rate. Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
Beskrivning

Heart Rate

Datatyp

float

Måttenheter
  • Beats/Min
Alias
UMLS CUI [1]
C0018810
Beats/Min
Central Laboratory (Non Fasting Samples)
Beskrivning

Central Laboratory (Non Fasting Samples)

Alias
UMLS CUI-1
C1880016
Dates sample taken
Beskrivning

Dates sample taken

Datatyp

date

Måttenheter
  • dd/MMM/yy
Alias
UMLS CUI [1]
C0460065
dd/MMM/yy
Concomitant medication
Beskrivning

Concomitant medication

Alias
UMLS CUI-1
C2347852
Record any changes to the subject's concomitant medications or any new medications taken since the last visit in the apporpriate Concomitant Medications sections.
Beskrivning

Concomitant medication

Datatyp

text

Alias
UMLS CUI [1]
C2347852
Adverse Event
Beskrivning

Adverse Event

Alias
UMLS CUI-1
C0877248
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.
Beskrivning

Adverse Event

Datatyp

text

Alias
UMLS CUI [1]
C0877248
Physical Examination
Beskrivning

Physical Examination

Alias
UMLS CUI-1
C0031809
Perform a physical examination on the subject, including auscultation of heart and lungs. Note: If any abnormalities are found as a result of the physical examination, these must be recorded on the Non-Serious Adverse Events page.
Beskrivning

Physical Examination

Datatyp

text

Alias
UMLS CUI [1]
C0031809
Pedal Oedema
Beskrivning

Pedal Oedema

Alias
UMLS CUI-1
C0574002
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 thoughout the study. Tick one:
Beskrivning

Pedal Oedema: depth

Datatyp

text

Alias
UMLS CUI [1,1]
C0574002
UMLS CUI [1,2]
C0205125
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 thoughout the study. Tick the appropriate box below to indicate which ankle was assessed at this visit:
Beskrivning

Pedal Oedema: Site

Datatyp

text

Alias
UMLS CUI [1,1]
C0574002
UMLS CUI [1,2]
C1515974
End of Visit Reminder
Beskrivning

End of Visit Reminder

Alias
UMLS CUI-1
C1709896
UMLS CUI-2
C1320303
Schedule Visit 3 for 14 days (+- 3 days) after this visit. It is not necessary for the subject to be fasted.
Beskrivning

End of Visit Reminder

Datatyp

text

Alias
UMLS CUI [1,1]
C1709896
UMLS CUI [1,2]
C1320303

Similar models

REFLECT-1 Visit 2 NCT00428090

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Patient Information
C1955348 (UMLS CUI-1)
Patient Study ID
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Investigator Instructions
C1442085 (UMLS CUI-1)
Investigator Instructions
Item
Telephone the IVRS system to register the visit. (Note that if the subject is not continuiing in the study, you should make a Withdrawal call rather than a Visit Registration call). Review study medication compliance.
text
C1442085 (UMLS CUI [1])
Item Group
Subject Continuation
C0805733 (UMLS CUI-1)
Subject Continuation
Item
If the subject is not continuing in the study, complete all assessments and ensure that all sections of the CRF (including the Study Conclusion section) are completed appropriately. Schedule an early withdrawal follow-up visit for 14 +/- 7 days after thsi visit.
text
C0805733 (UMLS CUI [1])
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure. Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
float
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure. Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
float
C0428883 (UMLS CUI [1])
Patient Position
Item
Patient Position: Sitting. Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
boolean
C0449850 (UMLS CUI [1])
Heart Rate
Item
Heart rate. Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
float
C0018810 (UMLS CUI [1])
Item Group
Central Laboratory (Non Fasting Samples)
C1880016 (UMLS CUI-1)
Dates sample taken
Item
Dates sample taken
date
C0460065 (UMLS CUI [1])
Item Group
Concomitant medication
C2347852 (UMLS CUI-1)
Concomitant medication
Item
Record any changes to the subject's concomitant medications or any new medications taken since the last visit in the apporpriate Concomitant Medications sections.
text
C2347852 (UMLS CUI [1])
Item Group
Adverse Event
C0877248 (UMLS CUI-1)
Adverse Event
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])
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Physical Examination
Item
Perform a physical examination on the subject, including auscultation of heart and lungs. Note: If any abnormalities are found as a result of the physical examination, these must be recorded on the Non-Serious Adverse Events page.
text
C0031809 (UMLS CUI [1])
Item Group
Pedal Oedema
C0574002 (UMLS CUI-1)
Pedal Oedema: depth
Item
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 thoughout the study. Tick one:
text
C0574002 (UMLS CUI [1,1])
C0205125 (UMLS CUI [1,2])
Item
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 thoughout the study. Tick the appropriate box below to indicate which ankle was assessed at this visit:
text
C0574002 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Code List
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 thoughout the study. Tick the appropriate box below to indicate which ankle was assessed at this visit:
CL Item
Right Ankle (Right Ankle)
CL Item
Left Ankle (Left Ankle)
Item Group
End of Visit Reminder
C1709896 (UMLS CUI-1)
C1320303 (UMLS CUI-2)
End of Visit Reminder
Item
Schedule Visit 3 for 14 days (+- 3 days) after this visit. It is not necessary for the subject to be fasted.
text
C1709896 (UMLS CUI [1,1])
C1320303 (UMLS CUI [1,2])

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