ID

17447

Description

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.

Keywords

Versions (3)
  1. 9/14/16 9/14/16 -
  2. 10/2/16 10/2/16 -
  3. 12/14/16 12/14/16 -
Uploaded on

September 14, 2016

DOI

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License

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

English

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

1 forms  
General information
Description

General information

Subject Identifier
Description

Subject Identifier

Data type

integer

Visit Date
Description

Visit Date

Data type

date

Visit Description: Visit 3
Description

Visit Description

Data type

boolean

Investigator Instructions (See Description)
Description

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).

Data type

boolean

Subject Continuation (See Description)
Description

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.

Data type

boolean

Vital Signs
Description

Vital Signs

Weight
Description

Weight

Data type

float

Measurement units
  • kg
kg
Blood pressure (See Description): Systolic
Description

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

Data type

integer

Blood pressure: Diastolic
Description

Blood pressure

Data type

integer

Measurement units
  • mmHg
mmHg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
bpm
Concomitant Medications (See Description)
Description

Concomitant Medications (See Description)

Adverse Events (See Description)
Description

Adverse Events (See Description)

Physical Examination (See Description)
Description

Physical Examination (See Description)

Pedal Oedema (See Description)
Description

Pedal Oedema (See Description)

Depth of Indentation
Description

Depth of Indentation

Data type

text

Indicate which ankle was assessed at this visit
Description

Ankle

Data type

text

End of visit reminder (See Description)
Description

End of visit reminder (See Description)

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Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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