Informações:
Falhas:
ID
19117
Descrição
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 8/Visit 8.
Palavras-chave
Versões (2)
- 28/09/2016 28/09/2016 -
- 05/12/2016 05/12/2016 -
Transferido a
5 de dezembro de 2016
DOI
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Licença
Creative Commons BY-NC 3.0
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M.Alzheimer GSK - Book 8 NCT00334568/ GSK-AVA100193
NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 8
- StudyEvent: ODM
Similar models
NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 8
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Protocol Identifier
Item
Protocol Identifier: AVA100193
boolean
C2826693 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Visit Description
Item
Visit Description: Visit 8
boolean
C0545082 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
Instructions completed
Item
Instructions completed
boolean
C1442085 (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])
Neurological Examination
Item
Results of Neurological Exam
text
C0027853 (UMLS CUI [1])
Item Group
Central Laboratory (Fasting samples)
C1880016 (UMLS CUI-1)
Date samples taken
Item
Date samples taken
date
C1302413 (UMLS CUI [1])
CL Item
Pregnant (1)
CL Item
Not pregnant (2)
Item Group
Pharmacogenetic (PGx) and Pharmacogenomic (PGm) Research
C0031325 (UMLS CUI-1)
Pharmacogenetic (PGx) and Pharmacogenomic (PGm) Research completed
Item
Pharmacogenetic (PGx) and Pharmacogenomic (PGm) Research completed
boolean
C0031325 (UMLS CUI [1])
Blood sample collection
Item
Has a blood sample been collected for PGm-Transcriptomic research?
boolean
C0005834 (UMLS CUI [1])
Date sample taken
Item
If yes, record date and time sample taken
datetime
C1302413 (UMLS CUI [1])
Blood sample collection
Item
Has a blood sample been collected for PGm-Proteomic research?
boolean
C0005834 (UMLS CUI [1])
Date and time
Item
If yes, record date and time sample taken
datetime
C1302413 (UMLS CUI [1])
C0040223 (UMLS CUI [2])
C0040223 (UMLS CUI [2])
Volume
Item
Volume of one aliquot
float
C2700258 (UMLS CUI [1])
Centrifuge time
Item
Length of time the centrifuge ran
integer
C0179834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Item
Temperature of the centrifuge
text
C0039476 (UMLS CUI [1,1])
C0179834 (UMLS CUI [1,2])
C0179834 (UMLS CUI [1,2])
CL Item
Room temperature (1)
CL Item
Refrigerated centrifuge (2)
Centrifugation speed
Item
Centrifugation speed
integer
C0678536 (UMLS CUI [1,1])
C0179834 (UMLS CUI [1,2])
C0179834 (UMLS CUI [1,2])
Centrifugation rotor radius
Item
Centrifugation rotor radius
integer
C0179834 (UMLS CUI [1,1])
C1279083 (UMLS CUI [1,2])
C1279083 (UMLS CUI [1,2])
Time in freezer
Item
Time aliquotted samples were placed in the freezer
time
C0175738 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Temperature of freezer
Item
Temperature of freezer
integer
C2957069 (UMLS CUI [1])
Date of ECG
Item
Date of the ECG
date
C2826640 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (-> complete an Adverse Event or Serious Adverse Event page) (3)
Concomitant Medications
Item
Concomitant Medications recorded -if applicable-
boolean
C2347852 (UMLS CUI [1])
Adverse Events
Item
Adverse Events
text
C0877248 (UMLS CUI [1])
Physical examination
Item
Results of physical examination
text
C0031809 (UMLS CUI [1])
CL Item
< 1 mm (1)
CL Item
1-2 mm (2)
CL Item
3-5 mm (3)
CL Item
6-10 mm (4)
CL Item
> 10 mm (5)
CL Item
Right Ankle (1)
CL Item
Left Ankle (2)
Rating Scale Instructions
Item
Rating Scale Instructions completed
boolean
C0681889 (UMLS CUI [1])
Item Group
Investigational Product Compliance
C0304229 (UMLS CUI-1)
C1321605 (UMLS CUI-2)
C1321605 (UMLS CUI-2)
Discontinuation
Item
Has the subject missed taking investigational product for > 7 consecutive days?
boolean
C0457454 (UMLS CUI [1])
Completion
Item
All required sections completed?
boolean
C0805732 (UMLS CUI [1])