Information:
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ID
17574
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)
- 9/11/16 9/11/16 -
- 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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REFELCT-1 Visit 6 NCT00428090
REFLECT-1 Visit 6 NCT00428090
- StudyEvent: ODM
Similar models
REFLECT-1 Visit 6 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
C1880016 (UMLS CUI-1)
C1442085 (UMLS CUI-2)
C1442085 (UMLS CUI-2)
Central Laboratory Instructions
Item
Laboratory samples are to be collected when the subject is the fasting state (No food or dring (except water) for at least 8 hours prior to sampling). If the subject is not in the fasted state, do not take samples. Schedule the subject to attend the clinical in the fasted state within the next 5 days for collection for laboratory samples.
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. (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])
Subject Continuation
Item
If the subject is not continuing in the study, complete all assessments for this visit, ans also the Early Withdrawal ADAS-cog and CIBIC+ assessments in the Assessment Scale and CIBIC+ folders. The ADAS-cog and CIBIC+ results should then be recorded on the pages at the end of this visit. Esnure that all sections of the CRF (including the Study Conclusion page) are completed appropriately. Schedule an early withdrawal follow-up visit for 14 +/- 7 days after this visit. Make a Withdrawal call to the IVRS system.
text
C0805733 (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])
Neurologic Examination
Item
Perform a Neurologic examination on hte subject, including assessment of gait balance, coordination, cranial nerves and mtor and sensory systems. Note: If any abnormalities are found as a result of the physical examination, these must be recorded on the No-Serious Adverse Events page.
text
C0027853 (UMLS CUI [1])
Dates sample taken
Item
Dates sample taken
date
C0460065 (UMLS CUI [1])
Pregnancy Test
Item
If Subject is female and of childbearing potential a serum pregnancy test must be performed.
text
C0032976 (UMLS CUI [1])
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
CL Item
Normal (Normal)
CL Item
Abnormal - not clinically significant (Abnormal - not clinically significant)
CL Item
Abnormal - clinically significant (--> Complete an Adverse Event (AE) or Serious Adverse Event (SAE) page8s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. (Abnormal - clinically significant (--> Complete an Adverse Event (AE) or Serious Adverse Event (SAE) page8s) if clinically significant abnormalities meet the protocol definition for an AE or SAE.)
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
Rating Scale Instrucitions - The following scales should be completed at this visit: ADAS-cog, CIBIC+, NPI, DAD
C0681889 (UMLS CUI-1)
ADAS-cog Summary
Item
ADAS-cog Summary
text
C3539026 (UMLS CUI [1])
CIBIC-Plus Summary
Item
CIBIC-Plus Summary
text
Neuropsychiatric Inventory (NPI)
Item
Neuropsychiatric Inventory (NPI)
text
C3539727 (UMLS CUI [1])
Item Group
Investigational Product - Dispense Weeks 25 - 32 study medication as specified by the IVRS system. Record start date, container number and number of tablets dispensed below (stop date and tablets returned will be completed when the bottle is returned).
C0304229 (UMLS CUI-1)
Investigational Product
Item
Investigational Product (e.g Bottle 1)
text
C0304229 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Dose
Item
Dose
float
C3174092 (UMLS CUI [1])
IP Container No.
Item
IP Container No.
float
C0180098 (UMLS CUI [1])
Discontinuation
Item
Has the subject missed investigational product for > 7 consecutive days?
boolean
C0457454 (UMLS CUI [1])
Item Group
Compliance - Dispense Weeks 25 - 32 study medication as specified by the IVRS system. Record start date, container number and number of tablets dispensed below (stop date and tablets returned will be completed when the bottle is returned).
C1321605 (UMLS CUI-1)
Total number of Tablets Dispensed
Item
Total number of Tablets Dispensed
float
C0805077 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,2])
Total number of Tablets Returned
Item
Total number of Tablets Returned
float
C2699071 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,2])
End of Visit Reminder
Item
Schedule Visit 7 for 8 weeeks (+- 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])
C1320303 (UMLS CUI [1,2])