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ID
21943
Description
This is an open-label extension to study 49653/461, to assess the long-term safety of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's Disease. GSK Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT00381238?term=NCT00381238&rank=1
Link
https://clinicaltrials.gov/ct2/show/NCT00381238?term=NCT00381238&rank=1
Keywords
Versions (2)
- 5/9/17 5/9/17 -
- 5/22/17 5/22/17 -
Uploaded on
May 9, 2017
DOI
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License
Creative Commons BY-NC 3.0
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Serious Adverse Event (SAE) Open-Label Extension Assessing Long-Term Safety Of Rosiglitazone In Subjects With Mild To Moderate Alzheimer's Disease NCT00381238
Serious Adverse Event (SAE) Open-Label Extension Assessing Long-Term Safety Of Rosiglitazone In Subjects With Mild To Moderate Alzheimer's Disease NCT00381238
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Serious Adverse Event (SAE) Open-Label Extension Assessing Long-Term Safety Of Rosiglitazone In Subjects With Mild To Moderate Alzheimer's Disease NCT00381238
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Serious Adverse Event (SAE)
Item
Did the subject experience a serious adverse events during the study? If YES, record details below.
boolean
C1519255 (UMLS CUI [1])
Serious Adverse Event
Item
Event Diagnosis Only (if known) Otherwise Sign/Symptoms e.g. Headache
text
C151925 (UMLS CUI [1])
Start Date
Item
Start Date (Day Month Year) (e.g. 25 JAN 03)
date
C0808070 (UMLS CUI [1])
CL Item
Single episode (1)
CL Item
Intermittent (2)
End Date
Item
End Date e.g. 27 Jan 03
date
C0806020 (UMLS CUI [1])
CL Item
Single episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity
integer
C0518690 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
CL Item
Single episode (1)
CL Item
Intermittent (2)
Item
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
integer
C1704758 (UMLS CUI [1])
CL Item
Single episode (1)
CL Item
Intermittent (2)
Withdrawal
Item
Withdrawal
boolean
C2349954 (UMLS CUI [1])
Relationship to Investigational Product
Item
Relationship to Investigational Product(s) Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0085978 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
Fatal
Item
If fatal, was a post-mortem/autopsy performed? If yes, summaries findings in Section 11 Narrative Remarks of this SAE form.
boolean
C1705586 (UMLS CUI [1])
Item
Specify reson(s) for considering this a SAE, check all that apply:
integer
C1519255 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
CL Item
Results in death (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalisation or prolongation of existing hospitalization (3)
CL Item
Results in disability/incapicity (4)
CL Item
Congenital abnormality/birth defect (5)
CL Item
Other (6)
Specification other
Item
Specify other:
text
C2348235 (UMLS CUI [1])