Information:
Error:
ID
17587
Description
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)
Keywords
Versions (2)
- 9/18/16 9/18/16 -
- 9/25/16 9/25/16 -
Uploaded on
September 25, 2016
DOI
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License
Creative Commons BY-NC-ND 3.0
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REFLECT-1 Early Withdrawal Follow Up NCT00428090
REFLECT-1 Early Withdrawal Follow Up NCT00428090
- StudyEvent: ODM
Similar models
REFLECT-1 Early Withdrawal Follow Up NCT00428090
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Patient Study ID
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Central Laboratory Instructions (Non fasting samples)
C1880016 (UMLS CUI-1)
C1442085 (UMLS CUI-2)
C1442085 (UMLS CUI-2)
Central Laboratory Instructions
Item
Blood samples to be taken for laboratory assessment only where follow-up of abnormal value(s) indicated.
text
C1880016 (UMLS CUI [1,1])
C1442085 (UMLS CUI [1,2])
C1442085 (UMLS CUI [1,2])
Investigator Instructions
Item
Telephone the IVRS system to register the visit.
text
C1442085 (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])
Dates sample taken
Item
Dates sample taken
date
C0460065 (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])
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])
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])
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])
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])
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 Study Assessments
C0444496 (UMLS CUI-1)
C1516048 (UMLS CUI-3)
C1516048 (UMLS CUI-3)
End of Study Assessments
Item
Ensure the follwing sections are fully completed at this time: - Concomitant Medication - Non-serious Adverse Events - Study Conclusion
text
C0444496 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,2])