Information:
Fel:
ID
24134
Beskrivning
Study ID: 100468 Clinical Study ID: AVA100468 Study Title: An open-label extension to study AVA100193, to assess the long-term safety and efficacy of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Avandia XR,Rosiglitazone XR,Avandia Study Indication: Alzheimer's Disease Visit 9
Nyckelord
Versioner (1)
- 2017-07-25 2017-07-25 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
25 juli 2017
DOI
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Licens
Creative Commons BY-NC-ND 3.0
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Visit 9 GSK Rosiglitazone Alzheimer's disease 100468
Visit 9 GSK Rosiglitazone Alzheimer's disease 100468
- StudyEvent: ODM
Similar models
Visit 9 GSK Rosiglitazone Alzheimer's disease 100468
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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 in the fasting state (No food or dirng [except water] for at least 8 hours prior to sampling). If the subject isnot in the fasted state, do not take samples. Schedule the subject to attend the clinic in the fasted state within the next 5 days for collection of laboratory samples.
text
C1880016 (UMLS CUI [1,1])
C1442085 (UMLS CUI [1,2])
C1442085 (UMLS CUI [1,2])
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
Investigator Instructions
Item
Please make a Completion call to the IVRS system.
text
Subject Continuation
Item
If the subject is not continuing in the stduy, complete all assessments for this visit, and 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. Ensure 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
Blood Pressure: Systolic
float
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Blood Pressure: Diastolic
float
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
float
C0018810 (UMLS CUI [1])
Neurological Examination
Item
Perform a Neurological examination on the subject, including assessment of gait, balance, coordination, cranial nerves and motor and sensory systems. Note: If any abnormalities are found as a result of the physial examination, these must be recorded on the Non-Serious Adverse Events page.
text
C0027853 (UMLS CUI [1])
Collection Date
Item
Date samples taken
text
C1317250 (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 (1)
CL Item
Abnormal, not clinically significant (2)
CL Item
Abnormal, clinically significant (3)
Concomitant Medication
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 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])
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:
integer
C0574002 (UMLS CUI [1,1])
C0205125 (UMLS CUI [1,2])
C0205125 (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 one:
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
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:
integer
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
Left Ankle (1)
CL Item
Right Ankle (2)
Item Group
The following scales should be completed at this visit: ADAS-cog, CIBIC+, NPI, DAD
C0681889 (UMLS CUI-1)
ADAS-COG
Item
ADAS-COG Summary
text
C3539026 (UMLS CUI [1])
CIBIC-Plus Summary
Item
CIBIC-Plus Summary
text
C0443172 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,2])
Neuropsychiatric Inventory (NPI)
Item
Neuropsychiatric Inventory (NPI) Definitions for frequency, severity and distress
text
C3539727 (UMLS CUI [1])
Item Group
Investigational Product/ Compliance
C0304229 (UMLS CUI-1)
C1321605 (UMLS CUI-2)
C1321605 (UMLS CUI-2)
Investigational Product Compliance
Item
Turn to the Investigational Product/ Compliance section for the previous visit to record the stop dates and number of tablets returned and to answer the question 'Has the subject missed taking investigational prodruct for > 7 consecutive days?'
text
C0304229 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,2])
End of Visit Reminder
Item
Ensure the following sections are fully completed at this time: - Concomitant Medication - Non-serious Adverse Events - Pharmacogenetic and Pharmacogenomic Research - Study Conclusion Schedule a study end safety follow-up for 14 +/- 7 days after this visit.
text
C1709896 (UMLS CUI [1,1])
C1320303 (UMLS CUI [1,2])
C1320303 (UMLS CUI [1,2])