Information:
Fel:
ID
24137
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 Early Withdrawal
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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Early Withdrawal GSK Rosiglitazone Alzheimer's disease 100468
Early Withdrawal GSK Rosiglitazone Alzheimer's disease 100468
- StudyEvent: ODM
Similar models
Early Withdrawal GSK Rosiglitazone Alzheimer's disease 100468
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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) is indicated.
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
Make a Withdrawal call to the IVRS system.
text
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])
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])
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
Complete the Early Withdrawal ADAS-cog and CIBIC+ from the Rating Scale CRF, and record the results on the following pages.
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])
Item Group
Investigator Instructions
C1709896 (UMLS CUI-1)
C1320303 (UMLS CUI-2)
C1320303 (UMLS CUI-2)
End of Visit Reminder
Item
Investigator Instructions: Schedule the subject for an Early Withdrawal Folow-Up visit 14 days (+/- 3 days) after this visit.
text
C1709896 (UMLS CUI [1,1])
C1320303 (UMLS CUI [1,2])
C1320303 (UMLS CUI [1,2])