Informationen:
Fehler:
ID
19258
Beschreibung
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.
Stichworte
Versionen (4)
- 08.09.16 08.09.16 -
- 02.10.16 02.10.16 -
- 09.12.16 09.12.16 -
- 15.12.16 15.12.16 -
Hochgeladen am
15. Dezember 2016
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY-NC 3.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
M.Alzheimer GSK Eligibility Criteria NCT00334568/ GSK-AVA100193
M.Alzheimer GSK Eligibility Criteria NCT00334568/ GSK-AVA100193
- StudyEvent: ODM
Ähnliche Modelle
M.Alzheimer GSK Eligibility Criteria NCT00334568/ GSK-AVA100193
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (1)
CL Item
Female (2)
CL Item
Arabic/North Africa (1)
CL Item
Black (2)
CL Item
East & South East Asian (3)
CL Item
Japanese (4)
CL Item
South Asian (5)
CL Item
White/Caucasian (6)
CL Item
Other (7)
Item Group
Alzheimer´s Disease Diagnosis and Course
C0002395 (UMLS CUI-1)
C0011900 (UMLS CUI-2)
C0002395 (UMLS CUI-4)
C0750729 (UMLS CUI-5)
C0011900 (UMLS CUI-2)
C0002395 (UMLS CUI-4)
C0750729 (UMLS CUI-5)
Date of first symptoms
Item
Date of first symptoms
date
C2316983 (UMLS CUI [1,1])
C0449990 (UMLS CUI [1,2])
C0449990 (UMLS CUI [1,2])
Date of diagnosis of probable AD
Item
Date of diagnosis of probable AD
date
C2316983 (UMLS CUI [1,1])
C0002395 (UMLS CUI [1,2])
C0002395 (UMLS CUI [1,2])
Has there been a significant worsening in the past 6 month?
Item
Has there been a significant worsening in the past 6 month?
boolean
C0002395 (UMLS CUI [1,1])
C1272688 (UMLS CUI [1,2])
C1272688 (UMLS CUI [1,2])
Item
Is there any family history of AD? Parents/sibling/child?
text
C0002395 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])
C1266851 (UMLS CUI [1,3])
C0241889 (UMLS CUI [1,2])
C1266851 (UMLS CUI [1,3])
Code List
Is there any family history of AD? Parents/sibling/child?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item
Is there any family history of AD? Other relative
text
C0002395 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Systolic Blood Pressure
Item
Blood pressure: Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Blood pressure: Diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
How many full years of education did the subject complete? (include primary to post-university education)
Item
How many full years of education did the subject complete? (include primary to post-university education)
integer
C0013622 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
Neurological Examination
Item
Results from Neurological Examination
text
C0027853 (UMLS CUI [1])
Item
What is the subject´s history of tobacco use (include all tobacco products)?
text
C0841002 (UMLS CUI [1])
Code List
What is the subject´s history of tobacco use (include all tobacco products)?
CL Item
Never smoked (1)
CL Item
Current smoker (2)
CL Item
Former smoker (3)
Date last smoked cigarette
Item
If former smoker: When did the subject last smoke?
date
C3172718 (UMLS CUI [1])
Number of cigarettes smoked per day
Item
If current or former smoker: number of cigarettes smoked per day
integer
C3694146 (UMLS CUI [1])
If current or former smoker: Number of years during which the subject has smoked?
Item
If current or former smoker: Number of years during which the subject has smoked?
integer
C1277691 (UMLS CUI [1])
Row number
Item
Row number
integer
C0237753 (UMLS CUI [1])
Specific Condition
Item
Specific Condition
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Current
Item
Current
boolean
C0521116 (UMLS CUI [1])
Past
Item
Past
boolean
C0455458 (UMLS CUI [1])
Drug Name
Item
Drug Name (Trade Name preferred)
text
C0013227 (UMLS CUI [1])
Total Daily Dose
Item
Totally Daily Dose
integer
C2348070 (UMLS CUI [1])
Units
Item
Units (e.g mg)
text
C1519795 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Ongoing Medication
Item
Ongoing Medication
boolean
Item Group
Central Laboratory (Fasting Samples)
C1880016 (UMLS CUI-1)
Date samples taken
Item
Date samples taken
date
C1302413 (UMLS CUI [1])
Results from Pregnancy Test
Item
Pregnant
boolean
C0427777 (UMLS CUI [1])
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (Assess eligibility and record abnormalities within the medical conditions item) (3)
Depression score
Item
Depression score
integer
C3539657 (UMLS CUI [1])
MMSE score
Item
MMSE score
integer
C0451306 (UMLS CUI [1])
Ejection fraction
Item
Ejection fraction
integer
C0232174 (UMLS CUI [1])
Entry criteria
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
NINCDS-ADRDA criteria
Item
Male or female subject with a clinical diagnosis of probable (!) Alzheimer´s disease in accordance with NINCDS-ADRDA criteria. (Subject with a clinical diagnosis of possible Alzheimer´s disease are not eligible.)
boolean
C2828081 (UMLS CUI [1])
MMSE score
Item
Subject has mild to moderate Alzheimer´s disease with MMSE score 16-26 inclusive at screening.
boolean
C2225229 (UMLS CUI [1])
Age
Item
Age 50 - 85 years.
boolean
C0001779 (UMLS CUI [1])
Current medication
Item
Prior and current medication is in accordance with the criteria on facing page.
boolean
C1553892 (UMLS CUI [1])
Gynaecological status
Item
Female subjects must be post-menopausal (i.e > 6 month without menstrual period), surgically sterile, or if of child-bearing potential, using effective contraceptives measures (oral contraceptives, Norplant, Depo-Provera, an intra-uterine device (IUD), a diaphragm with spermicide or a condom with spermicide). Woman of childbearing potential must use effective contraceptive measures for at least one month prior to screening, and should continue to use the same contraceptive method during the study and for 30 days after discontinuing study medication.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C0015787 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
CT or MRI scan
Item
CT or MRI scan performed within the past 12 month or at screening, showing no evidence of tumor, other structural abnormality, or degenerative disease other than Alzheimer´s disease.
boolean
C0040405 (UMLS CUI [1])
C0917711 (UMLS CUI [2])
C0917711 (UMLS CUI [2])
Neurological examination
Item
Neurological exam without focal changes (excluding changes attributable to peripheral trauma).
boolean
C0027853 (UMLS CUI [1])
Compliance behaviour
Item
Subject has the ability to comply with procedures for cognitive and other testing.
boolean
C1321605 (UMLS CUI [1])
Permanent caregiver
Item
Subject lives with permanent caregiver who is willing wo attend all visits, oversees the subject´s compliance with protocol-specified procedures and study medication, and report on subject´s status. (Subjects living alone or in a nursing home are not eligible).
boolean
C0085537 (UMLS CUI [1])
Informed consent
Item
Subject has provided full written informed consent prior to the performance of any protocol-specified procedure; or if unable to provide informed consent due to cognitive status, full written informed consent on behalf of the subject has been provided by a legally acceptable representative.
boolean
C0021430 (UMLS CUI [1])
Caregiver: Informed consent
Item
Caregiver has provided full written informed consent on their own behalf prior to the performance of any protocol-specified procedure.
boolean
C0085537 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,2])
Diabetes mellitus
Item
History of Type I or Type II diabetes mellitus.
boolean
C0011849 (UMLS CUI [1])
Fasting plasma glucose level
Item
Fasting plasma glucose level > 126 mg/dL (>7.0 mmol/L) or HbA 1c >6.2%
boolean
C0583513 (UMLS CUI [1])
New York Heart Association Classification
Item
History or clinical/laboratory evidence of moderate to severe congestive heart failure defined by the New York Heart Association criteria (class II-IV)
boolean
C1275491 (UMLS CUI [1])
Ejection fraction
Item
Ejection fraction ≤ 40% determined by echocardiogram, or any other abnormality on echocardiography which in the view of the investigator required further investigation or intervention, or significant abnormalities on screening ECG (in accordance with definitions on facing page).
boolean
C0232174 (UMLS CUI [1])
C0476369 (UMLS CUI [2])
C0438154 (UMLS CUI [3])
C0476369 (UMLS CUI [2])
C0438154 (UMLS CUI [3])
cardiovascular event or major intervention
Item
History of new cardiovascular event within the last 6 month (i.e intervention, percutaneous coronary intervention, vascular surgery, acute coronary syndrome (non Q-wave myocardial infarction, Q-wave myocardial infarction, unstable angina) or significant arrhythmia; or major intervention (e.g cardiac surgery or angiography plus stenting) scheduled).
boolean
C1320716 (UMLS CUI [1])
C0184661 (UMLS CUI [2])
C0184661 (UMLS CUI [2])
Cerebrovascular disease
Item
History or clinical laboratory evidence of cerebrovascular disease (stroke, transient ischaemic attack, haemorrhage), or diagnosis of possible, probable or definite vascular dementia in accordance with NINDS-AIREN criteria.
boolean
C0007820 (UMLS CUI [1])
CNS disorder
Item
History or evidence of any other CNS disorder that could be interpreted as a cause of dementia: e.g structural abnormality, epilepsy, infectious or inflammatory/demyelinating CNS conditions, Parkinson´s disease.
boolean
C0007682 (UMLS CUI [1])
Significant psychiatric illness
Item
History of significant psychiatric illness such as schizophrenia or bipolar affective disorder, that in the opinion of the investigator would interfere with participation in the study, or current depression (score on Hospital Anxiety and Depression Scale (HADS) depression questions >7)
boolean
C0004936 (UMLS CUI [1])
Peripheral oedema
Item
Significant peripheral oedema at the time of screening.
boolean
C0085649 (UMLS CUI [1])
Systolic and Diastolic Blood Pressure
Item
Systolic blood pressure > 165 mmHg or diastolic blood pressure > 95 mmHg whilst receiving optimal antihypertensive therapy according to local practice.
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C0428883 (UMLS CUI [2])
Anaemia
Item
Clinically significant anaemia (i.e. hemoglobin <11 g/dL for males or < 10 g/dL for females) or presence of haemoglobinopathies which would prevent accurate assessment of HbA 1c.
boolean
C0002871 (UMLS CUI [1])
Creatinine clearance
Item
Renal dysfunction, defined as creatinine clearance <30 ml/min (calculated from serum creatinine using the Cockcroft-Gault formula).
boolean
C0373595 (UMLS CUI [1])
Liver enzymes
Item
ALT, AST, total bilirubin or alkaline phosphatase values > 2.5 times the upper limit of normal, or history of severe hepatobiliary disease (e.g hepatitis B or C, or cirrhosis).
boolean
C1287351 (UMLS CUI [1])
Fasting triglycerides
Item
Fasting triglycerides > 12 mmol/L.
boolean
C0202236 (UMLS CUI [1])
Vitamin B12, syphilis serology, thyroid stimulating hormone
Item
Abnormal/positive result within the past 12 months or at screening for any of the following tests: vitamin B12, syphilis serology, thyroid stimulating hormone (TSH).
boolean
C0202252 (UMLS CUI [1])
C0919842 (UMLS CUI [2])
C0202230 (UMLS CUI [3])
C0919842 (UMLS CUI [2])
C0202230 (UMLS CUI [3])
Comorbidity
Item
History or presence of gastro-intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs, or any other clinically relevant abnormality, medical or psychiatric condition, which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study.
boolean
C0009488 (UMLS CUI [1])
Blood donation
Item
Subject has given a blood donation of ≥ 450ml within the past 2 months.
boolean
C0005794 (UMLS CUI [1])
Substance use disorder
Item
History of drug or alcohol abuse.
boolean
C0038586 (UMLS CUI [1])
Non-compliance
Item
Subject is unable (with assistance, if appropriate) to take study medication as prescribed throughout the study, has a history of non-compliance with prescribed medication, or is at risk of non-compliance with study medication or procedures.
boolean
C0457432 (UMLS CUI [1])
Relationship
Item
Subject is an immediate family member or employee of the participating investigator or of any of the participating site staff.
boolean
C0015608 (UMLS CUI [1])
Investigator´s Signature
Item
Investigator´s Signature
text
C2346576 (UMLS CUI [1])
Date of report
Item
Date
date
C1302584 (UMLS CUI [1])
Investigator´s name
Item
Investigator´s name (print)
text
C2361125 (UMLS CUI [1])