Information:
Fel:
ID
23044
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 5
Nyckelord
Versioner (1)
- 2017-06-20 2017-06-20 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
20 juni 2017
DOI
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Licens
Creative Commons BY-NC-ND 3.0
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Visit 5 GSK Rosiglitazone Alzheimer's disease 100468
Visit 5 GSK Rosiglitazone Alzheimer's disease 100468
- StudyEvent: ODM
Similar models
Visit 5 GSK Rosiglitazone Alzheimer's disease 100468
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
Investigator Instructions
Item
Telephone the IVRS system to register the visit. (Note that if the subject is not continuing in the study, you should make a Withdrawal call rather than a Visit Registration call). Review study medication compliance.
text
Subject Continuation
Item
If the subject is not continuing in the stduy, 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 14 +/- 7 days after this visit.
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])
Collection Date
Item
Date samples taken
text
C1317250 (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
Investigational Product/ Compliance - Dispense Weeks 5 - 8 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)
C1321605 (UMLS CUI-3)
C1321605 (UMLS CUI-3)
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
integer
IP Container Number
Item
IP Container No.
text
C0180098 (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])
Discontinuation
Item
Has the subject missed investigational product for > 7 consecutive days?
boolean
C0457454 (UMLS CUI [1])
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