ID
19258
Description
NCT00334568/ GSK-AVA100193: M.Alzheimer GSK A 24 week double-blind, randomized, placebo-controlled, parallel-group dose-raging study to investigate the effects of rosiglitazone (extended release tablets) on cognition in subjects with mild to moderate Alzheimer´s disease. Medicine: rosiglitazone, Condition: Alzheimer´s Disease, Phase: 2, Clinical Study ID: AVA 100193, Sponsor: GSK This ODM contains Book 1/Visit 1.
Keywords
Versions (4)
- 9/8/16 9/8/16 -
- 10/2/16 10/2/16 -
- 12/9/16 12/9/16 -
- 12/15/16 12/15/16 -
Uploaded on
December 15, 2016
DOI
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License
Creative Commons BY-NC 3.0
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M.Alzheimer GSK Eligibility Criteria NCT00334568/ GSK-AVA100193
M.Alzheimer GSK Eligibility Criteria NCT00334568/ GSK-AVA100193
- StudyEvent: ODM
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
Date of Birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Sex
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Race
Data type
text
Alias
- UMLS CUI [1]
- C0034510
Description
Alzheimer´s Disease Diagnosis and Course
Alias
- UMLS CUI-1
- C0002395
- UMLS CUI-2
- C0011900
- UMLS CUI-4
- C0002395
- UMLS CUI-5
- C0750729
Description
Date of first symptoms
Data type
date
Alias
- UMLS CUI [1,1]
- C2316983
- UMLS CUI [1,2]
- C0449990
Description
Date of diagnosis of probable AD
Data type
date
Alias
- UMLS CUI [1,1]
- C2316983
- UMLS CUI [1,2]
- C0002395
Description
Has there been a significant worsening in the past 6 month?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0002395
- UMLS CUI [1,2]
- C1272688
Description
Is there any family history of AD?
Data type
text
Alias
- UMLS CUI [1,1]
- C0002395
- UMLS CUI [1,2]
- C0241889
- UMLS CUI [1,3]
- C1266851
Description
Is there any family history of AD?
Data type
text
Alias
- UMLS CUI [1,1]
- C0002395
- UMLS CUI [1,2]
- C0241889
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Height
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Data type
integer
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic Blood Pressure
Data type
integer
Measurement units
- mmHg Sitting
Alias
- UMLS CUI [1]
- C0428883
Description
Heart rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
Education History
Alias
- UMLS CUI-1
- C0013622
Description
How many full years of education did the subject complete? (include primary to post-university education)
Data type
integer
Measurement units
- years
Alias
- UMLS CUI [1,1]
- C0013622
- UMLS CUI [1,2]
- C0449238
Description
Neurological Examination
Alias
- UMLS CUI-1
- C0027853
Description
History of Tobacco Use
Alias
- UMLS CUI-1
- C0841002
Description
What is the subject´s history of tobacco use (include all tobacco products)?
Data type
text
Alias
- UMLS CUI [1]
- C0841002
Description
Date last smoked cigarette
Data type
date
Alias
- UMLS CUI [1]
- C3172718
Description
Number of cigarettes smoked per day
Data type
integer
Measurement units
- per day
Alias
- UMLS CUI [1]
- C3694146
Description
If current or former smoker: Number of years during which the subject has smoked?
Data type
integer
Alias
- UMLS CUI [1]
- C1277691
Description
Medical Conditions
Alias
- UMLS CUI-1
- C0012634
Description
Row number
Data type
integer
Alias
- UMLS CUI [1]
- C0237753
Description
Record only one condition per item.
Data type
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Description
Current
Data type
boolean
Alias
- UMLS CUI [1]
- C0521116
Description
Past
Data type
boolean
Alias
- UMLS CUI [1]
- C0455458
Description
Prior and Concomitant Medications
Description
Drug Name
Data type
text
Alias
- UMLS CUI [1]
- C0013227
Description
Total Daily Dose
Data type
integer
Alias
- UMLS CUI [1]
- C2348070
Description
Units
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
Route
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
Reason for Medication
Data type
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Description
Start Date
Data type
date
Alias
- UMLS CUI [1]
- C0808070
Description
Stop Date
Data type
date
Alias
- UMLS CUI [1]
- C0806020
Description
Ongoing Medication
Data type
boolean
Description
Central Laboratory (Fasting Samples)
Alias
- UMLS CUI-1
- C1880016
Description
Pregnancy test
Alias
- UMLS CUI-1
- C0032976
Description
12-Lead-ECG
Alias
- UMLS CUI-1
- C0430456
Description
HADS summary
Alias
- UMLS CUI-1
- C3539657
Description
MMSE summary
Alias
- UMLS CUI-1
- C0451306
Description
Echocardiogram
Alias
- UMLS CUI-1
- C2243117
Description
Eligibility Question
Alias
- UMLS CUI-1
- C1516637
Description
Inclusion criteria
Alias
- UMLS CUI-1
- C1512693
Description
NINCDS-ADRDA criteria
Data type
boolean
Alias
- UMLS CUI [1]
- C2828081
Description
MMSE score
Data type
boolean
Alias
- UMLS CUI [1]
- C2225229
Description
Age
Data type
boolean
Alias
- UMLS CUI [1]
- C0001779
Description
Current medication
Data type
boolean
Alias
- UMLS CUI [1]
- C1553892
Description
Gynaecological status
Data type
boolean
Alias
- UMLS CUI [1]
- C0232970
- UMLS CUI [2]
- C0015787
- UMLS CUI [3]
- C0700589
Description
CT or MRI scan
Data type
boolean
Alias
- UMLS CUI [1]
- C0040405
- UMLS CUI [2]
- C0917711
Description
Neurological examination
Data type
boolean
Alias
- UMLS CUI [1]
- C0027853
Description
Compliance behaviour
Data type
boolean
Alias
- UMLS CUI [1]
- C1321605
Description
Permanent caregiver
Data type
boolean
Alias
- UMLS CUI [1]
- C0085537
Description
Informed consent
Data type
boolean
Alias
- UMLS CUI [1]
- C0021430
Description
Caregiver: Informed consent
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0085537
- UMLS CUI [1,2]
- C0021430
Description
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Description
Diabetes mellitus
Data type
boolean
Alias
- UMLS CUI [1]
- C0011849
Description
Fasting plasma glucose level
Data type
boolean
Alias
- UMLS CUI [1]
- C0583513
Description
New York Heart Association Classification
Data type
boolean
Alias
- UMLS CUI [1]
- C1275491
Description
Ejection fraction
Data type
boolean
Alias
- UMLS CUI [1]
- C0232174
- UMLS CUI [2]
- C0476369
- UMLS CUI [3]
- C0438154
Description
cardiovascular event or major intervention
Data type
boolean
Alias
- UMLS CUI [1]
- C1320716
- UMLS CUI [2]
- C0184661
Description
Cerebrovascular disease
Data type
boolean
Alias
- UMLS CUI [1]
- C0007820
Description
CNS disorder
Data type
boolean
Alias
- UMLS CUI [1]
- C0007682
Description
Significant psychiatric illness
Data type
boolean
Alias
- UMLS CUI [1]
- C0004936
Description
Peripheral oedema
Data type
boolean
Alias
- UMLS CUI [1]
- C0085649
Description
Systolic and Diastolic Blood Pressure
Data type
boolean
Alias
- UMLS CUI [1]
- C0871470
- UMLS CUI [2]
- C0428883
Description
Anaemia
Data type
boolean
Alias
- UMLS CUI [1]
- C0002871
Description
Creatinine clearance
Data type
boolean
Alias
- UMLS CUI [1]
- C0373595
Description
Liver enzymes
Data type
boolean
Alias
- UMLS CUI [1]
- C1287351
Description
Fasting triglycerides
Data type
boolean
Alias
- UMLS CUI [1]
- C0202236
Description
Vitamin B12, syphilis serology, thyroid stimulating hormone
Data type
boolean
Alias
- UMLS CUI [1]
- C0202252
- UMLS CUI [2]
- C0919842
- UMLS CUI [3]
- C0202230
Description
Comorbidity
Data type
boolean
Alias
- UMLS CUI [1]
- C0009488
Description
Blood donation
Data type
boolean
Alias
- UMLS CUI [1]
- C0005794
Description
Substance use disorder
Data type
boolean
Alias
- UMLS CUI [1]
- C0038586
Description
Non-compliance
Data type
boolean
Alias
- UMLS CUI [1]
- C0457432
Description
Relationship
Data type
boolean
Alias
- UMLS CUI [1]
- C0015608
Description
Investigator´s Signature
Alias
- UMLS CUI-1
- C2346576
Description
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the data below.
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Date of report
Data type
date
Alias
- UMLS CUI [1]
- C1302584
Description
Investigator´s name
Data type
text
Alias
- UMLS CUI [1]
- C2361125
Similar models
M.Alzheimer GSK Eligibility Criteria NCT00334568/ GSK-AVA100193
- StudyEvent: ODM
C0011900 (UMLS CUI-2)
C0002395 (UMLS CUI-4)
C0750729 (UMLS CUI-5)
C0449990 (UMLS CUI [1,2])
C0002395 (UMLS CUI [1,2])
C1272688 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,2])
C1266851 (UMLS CUI [1,3])
C0241889 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0015787 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C0917711 (UMLS CUI [2])
C0021430 (UMLS CUI [1,2])
C0476369 (UMLS CUI [2])
C0438154 (UMLS CUI [3])
C0184661 (UMLS CUI [2])
C0428883 (UMLS CUI [2])
C0919842 (UMLS CUI [2])
C0202230 (UMLS CUI [3])