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ID
25845
Beschrijving
A 24 week double-blind, randomised, placebo-controlled, parallel-group dose-ranging study to investigate the effects of rosiglitazone (extended release tablets) on cognition in subjects with mild to moderate Alzheimer's disease.
Trefwoorden
Versies (1)
- 21-09-17 21-09-17 -
Houder van rechten
Glaxo Smith Kline
Geüploaded op
21 september 2017
DOI
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Licentie
Creative Commons BY-NC 3.0
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GSK AVA100193 Rosiglitazone in Alzheimer´s Disease -Early withdrawal
Early Withdrawal and Early Withdrawal Follow-up
- StudyEvent: ODM
Similar models
Early Withdrawal and Early Withdrawal Follow-up
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Early withdrawal
C2349954 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
C1710477 (UMLS CUI-3)
C0011008 (UMLS CUI-2)
C1710477 (UMLS CUI-3)
Centre or investigator number
Item
Centre or investigator number
integer
C2826689 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Investigator Instructions
Item
Make a Withdrawal call to the IVRS system.
text
C1442085 (UMLS CUI [1])
Weight
Item
Patient weight
float
C0005910 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Central Laboratory (Non fasting samples)
Item
Central Laboratory (Non fasting samples)
text
C0022885 (UMLS CUI [1,1])
C2585491 (UMLS CUI [1,2])
C2585491 (UMLS CUI [1,2])
Collection Date
Item
Date samples taken
date
C1317250 (UMLS CUI [1])
Pregnancy test
Item
Pregnancy test
text
C0032976 (UMLS CUI [1])
Concomitant Medications
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 Events
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.
text
C0031809 (UMLS CUI [1])
Item
Estimated Depth of Indentation
integer
C0574002 (UMLS CUI [1,1])
C0205125 (UMLS CUI [1,2])
C0205125 (UMLS CUI [1,2])
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)
CL Item
Right Ankle (1)
CL Item
Left Ankle (2)
Investigator instructions
Item
Schedule the subject for an Early Withdrawal Follow-Up visit 14 days(± 3 days) after this visit.
text
C1442085 (UMLS CUI [1])
Rating scale Instructions
Item
Complete the Early Withdrawal ADAS-cog and CIBIC+ from the Rating Scale CRF and record the results on the following pages.
boolean
C0681889 (UMLS CUI [1])
Alzheimer Disease Assessment Scale
Item
Alzheimer Disease Assessment Scale
text
C0450989 (UMLS CUI [1])
Clinician Interview-Based Impression of Change
Item
CIBIC+
boolean
C3641327 (UMLS CUI [1])
Item Group
Early Withdrawal Follow-up
C2349954 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
C1710477 (UMLS CUI-3)
C3274571 (UMLS CUI-4)
C0011008 (UMLS CUI-2)
C1710477 (UMLS CUI-3)
C3274571 (UMLS CUI-4)
Investigator Instructions
Item
Telephone the IVRS system to register the visit.
text
C1442085 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Weight
Item
Patient weight
float
C0005910 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Central Laboratory (Non fasting samples)
Item
Central Laboratory (Non fasting samples)
text
C0022885 (UMLS CUI [1,1])
C2585491 (UMLS CUI [1,2])
C2585491 (UMLS CUI [1,2])
Collection Date
Item
Date samples taken
date
C1317250 (UMLS CUI [1])
Concomitant Medications
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 Events
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.
text
C0031809 (UMLS CUI [1])
Item
Estimated Depth of Indentation
integer
C0574002 (UMLS CUI [1,1])
C0205125 (UMLS CUI [1,2])
C0205125 (UMLS CUI [1,2])
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)
CL Item
Right Ankle (1)
CL Item
Left Ankle (2)
End of Study Assessments
Item
Ensure the follwing sections are fully completed at this time: - Concomitant Medication - Non-serious Adverse Events - Pharmacogenetic and Pharmacogenomic Research - Study Conclusion
text
C0444496 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,2])