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ID
17697
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 8/Visit 8.
Stichworte
Versionen (2)
- 28.09.16 28.09.16 -
- 05.12.16 05.12.16 -
Hochgeladen am
28. September 2016
DOI
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Lizenz
Creative Commons BY-NC 3.0
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NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 8
NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 8
- StudyEvent: ODM
Ähnliche Modelle
NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 8
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Protocol Identifier
Item
Protocol Identifier: AVA100193
boolean
Subject Identifier
Item
Subject Identifier
integer
Visit Date
Item
Visit Date
date
Visit Description
Item
Visit Description: Visit 8
boolean
Instructions completed
Item
Instructions completed
boolean
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Blood pressure
Item
Blood pressure: systolic
integer
Blood pressure
Item
Blood pressure: diastolic
integer
Heart rate
Item
Heart rate
integer
Results of Neurological Exam
Item
Results of Neurological Exam
text
Date samples taken
Item
Date samples taken
date
CL Item
Pregnant (1)
CL Item
Not pregnant (2)
Item Group
Pharmacogenetic (PGx) and Pharmacogenomic (PGm) Research
Pharmacogenetic (PGx) and Pharmacogenomic (PGm) Research completed
Item
Pharmacogenetic (PGx) and Pharmacogenomic (PGm) Research completed
boolean
Blood sample collection
Item
Has a blood sample been collected for PGm-Transcriptomic research?
boolean
Date
Item
If yes, record date and time sample taken
datetime
Blood sample collection
Item
Has a blood sample been collected for PGm-Proteomic research?
boolean
Date and time
Item
If yes, record date and time sample taken
datetime
Volume
Item
Volume of one aliquot
float
Length of time the centrifuge ran
Item
Length of time the centrifuge ran
integer
CL Item
Room temperature (1)
CL Item
Refrigerated centrifuge (2)
Centrifugation speed
Item
Centrifugation speed
integer
Centrifugation rotor radius
Item
Centrifugation rotor radius
integer
Time aliquotted samples were placed in the freezer
Item
Time aliquotted samples were placed in the freezer
time
Temperature of freezer
Item
Temperature of freezer
integer
Date
Item
Date of the ECG
date
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
Adverse Events
Item
Adverse Events
text
Results of physical examination
Item
Results of physical examination
text
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
Has the subject missed taking investigational product for > 7 consecutive days
Item
Has the subject missed taking investigational product for > 7 consecutive days?
boolean
All required sections completed?
Item
All required sections completed?
boolean