ID

19242

Beschrijving

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 3/Visit 3.

Trefwoorden

Versies (3)
  1. 14-09-16 14-09-16 -
  2. 02-10-16 02-10-16 -
  3. 14-12-16 14-12-16 -
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14 december 2016

DOI

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Licentie

Creative Commons BY-NC 3.0
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M.Alzheimer GSK - Book 3 NCT00334568/ GSK-AVA100193

Engels

M.Alzheimer GSK - Book 3 NCT00334568/ GSK-AVA100193

1 Formulieren  
General information
Beschrijving

General information

Alias
UMLS CUI-1
C1508263
Subject Identifier
Beschrijving

Subject Identifier

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschrijving

Visit Date

Datatype

date

Alias
UMLS CUI [1]
C1320303
Visit Description: Visit 3
Beschrijving

Visit Description

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0678257
Investigator Instructions
Beschrijving

Telephone the IVRS system to register the visit. (Note that if the subject is not continuing in the study, you should make a withdrawal call rather that a Visit Registration call).

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C1442085
Subject Continuation
Beschrijving

If the subject is not continuing in the study, complete all assessments and ensure that all sections of the CRF (including the Study Conclusion section) are completely appropriately. Schedule an early withdrawal follow-up visit for 14 +/- 7 days after this visit.

Datatype

boolean

Alias
UMLS CUI [1]
C0805733
Vital Signs
Beschrijving

Vital Signs

Alias
UMLS CUI-1
C0518766
Weight
Beschrijving

Weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Blood pressure: Systolic
Beschrijving

Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.

Datatype

integer

Alias
UMLS CUI [1]
C0871470
Blood pressure: Diastolic
Beschrijving

Diastolic Blood Pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart Rate
Beschrijving

Heart Rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Concomitant Medications
Beschrijving

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Concomitant Medications
Beschrijving

Concomitant Medications

Datatype

text

Alias
UMLS CUI [1]
C2347852
Adverse Events
Beschrijving

Adverse Events

Alias
UMLS CUI-1
C0877248
Adverse Events
Beschrijving

Adverse Events

Datatype

text

Alias
UMLS CUI [1]
C0877248
Physical Examination
Beschrijving

Physical Examination

Alias
UMLS CUI-1
C0031809
Results from Physical Examination
Beschrijving

Physical Examination

Datatype

text

Alias
UMLS CUI [1]
C0031809
Pedal Oedema
Beschrijving

Pedal Oedema

Alias
UMLS CUI-1
C0574002
Depth of Indentation
Beschrijving

Depth of Indentation

Datatype

text

Alias
UMLS CUI [1]
C2081478
Indicate which ankle was assessed at this visit
Beschrijving

Ankle

Datatype

text

Alias
UMLS CUI [1]
C0003086
End of visit reminder
Beschrijving

End of visit reminder

Alias
UMLS CUI-1
C1709896
UMLS CUI-2
C1320303
Next Visit Scheduled
Beschrijving

Next Visit Scheduled

Datatype

boolean

Alias
UMLS CUI [1]
C0515681
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Similar models

M.Alzheimer GSK - Book 3 NCT00334568/ GSK-AVA100193

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
General information
C1508263 (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 3
boolean
C0545082 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Investigator Instructions
Item
Investigator Instructions
boolean
C0008961 (UMLS CUI [1,1])
C1442085 (UMLS CUI [1,2])
Subject Continuation
Item
Subject Continuation
boolean
C0805733 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (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])
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
Concomitant Medications
Item
Concomitant Medications
text
C2347852 (UMLS CUI [1])
Item Group
Adverse Events
C0877248 (UMLS CUI-1)
Adverse Events
Item
Adverse Events
text
C0877248 (UMLS CUI [1])
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Physical Examination
Item
Results from Physical Examination
text
C0031809 (UMLS CUI [1])
Item Group
Pedal Oedema
C0574002 (UMLS CUI-1)
Item
Depth of Indentation
text
C2081478 (UMLS CUI [1])
Depth of Indentation
Code List
Depth of Indentation
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)
Item
Indicate which ankle was assessed at this visit
text
C0003086 (UMLS CUI [1])
Ankle
Code List
Indicate which ankle was assessed at this visit
CL Item
Right Ankle (1)
CL Item
Left Ankle (2)
Item Group
End of visit reminder
C1709896 (UMLS CUI-1)
C1320303 (UMLS CUI-2)
Next Visit Scheduled
Item
Next Visit Scheduled
boolean
C0515681 (UMLS CUI [1])
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