ID

17447

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 september 2016

DOI

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Licentie

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

Engels

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

1 Formulieren  
General information
Beschrijving

General information

Subject Identifier
Beschrijving

Subject Identifier

Datatype

integer

Visit Date
Beschrijving

Visit Date

Datatype

date

Visit Description: Visit 3
Beschrijving

Visit Description

Datatype

boolean

Investigator Instructions (See Description)
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

Subject Continuation (See Description)
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

Vital Signs
Beschrijving

Vital Signs

Weight
Beschrijving

Weight

Datatype

float

Maateenheden
  • kg
kg
Blood pressure (See Description): Systolic
Beschrijving

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

Datatype

integer

Blood pressure: Diastolic
Beschrijving

Blood pressure

Datatype

integer

Maateenheden
  • mmHg
mmHg
Heart Rate
Beschrijving

Heart Rate

Datatype

integer

Maateenheden
  • bpm
bpm
Concomitant Medications (See Description)
Beschrijving

Concomitant Medications (See Description)

Adverse Events (See Description)
Beschrijving

Adverse Events (See Description)

Physical Examination (See Description)
Beschrijving

Physical Examination (See Description)

Pedal Oedema (See Description)
Beschrijving

Pedal Oedema (See Description)

Depth of Indentation
Beschrijving

Depth of Indentation

Datatype

text

Indicate which ankle was assessed at this visit
Beschrijving

Ankle

Datatype

text

End of visit reminder (See Description)
Beschrijving

End of visit reminder (See Description)

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Similar models

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

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
General information
Subject Identifier
Item
Subject Identifier
integer
Visit Date
Item
Visit Date
date
Visit Description
Item
Visit Description: Visit 3
boolean
Investigator Instructions (See Description)
Item
Investigator Instructions (See Description)
boolean
Subject Continuation (See Description)
Item
Subject Continuation (See Description)
boolean
Item Group
Vital Signs
Weight
Item
Weight
float
Blood pressure (See Description)
Item
Blood pressure (See Description): Systolic
integer
Blood pressure
Item
Blood pressure: Diastolic
integer
Heart Rate
Item
Heart Rate
integer
Item Group
Concomitant Medications (See Description)
Item Group
Adverse Events (See Description)
Item Group
Physical Examination (See Description)
Item Group
Pedal Oedema (See Description)
Item
Depth of Indentation
text
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
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 (See Description)
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