ID

17464

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 4/Visit 4.

Keywords

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

September 16, 2016

DOI

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License

Creative Commons BY-NC 3.0
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NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 4

English

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 4

1 forms  
General information
Description

General information

Protocol Identifier: AVA100193
Description

Protocol Identifier

Data type

boolean

Subject Identifier
Description

Subject Identifier

Data type

integer

Visit Date
Description

Visit Date

Data type

date

Visit Description: Visit 4
Description

Visit Description

Data type

boolean

Subject Continuation (See Description)
Description

If the subject is not continuing the study, complete all assessments for this visit, and also the Early Withdrawal ADAS-cog and CIBIC+ assessments in the Assessment Scale and CIBIC+ folders. The ADAS-cog and CIBIC+ results should then be recorded on the pages at the end of this visit. Ensure that all sections of the CRF (including the Study Conclusion page) are completed appropriately. Schedule an early withdrawal follow-up visit for 14 +/- 7 days after this visit. Make a Withdrawal call to the IVRS system.

Data type

boolean

Vital signs
Description

Vital signs

Weight
Description

Weight

Data type

integer

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
Central Laboratory (Non Fasting Samples)
Description

Central Laboratory (Non Fasting Samples)

Date samples taken
Description

Date samples taken

Data type

date

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

Indication which ankle was assessed at this visit
Description

Indication which ankle was assessed at this visit

Data type

text

Monitor Data Validation Checks (See Description)
Description

Monitor Data Validation Checks (See Description)

Investigational Product (See Description)
Description

Investigational Product (See Description)

Investigational Product
Description

Investigational Product

Data type

text

Start Date
Description

Start Date

Data type

date

Stop Date
Description

Stop Date

Data type

date

IP Container No.
Description

IP Container No.

Data type

integer

Total Number of Tablets Dispensed
Description

Total Number of Tablets Dispensed

Data type

float

Total Number of Tablets Returned
Description

Total Number of Tablets Returned

Data type

float

Has the subject missed investigational product for > 7 consecutive days?
Description

Discontinuation

Data type

boolean

Alias
UMLS CUI [1]
C0457454
End of visit reminder
Description

End of visit reminder

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Similar models

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 4

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
General information
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 4
boolean
Subject Continuation
Item
Subject Continuation (See Description)
boolean
Item Group
Vital signs
Weight
Item
Weight
integer
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
Central Laboratory (Non Fasting Samples)
Date samples taken
Item
Date samples taken
date
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
Indication which ankle was assessed at this visit
text
Indication which ankle was assessed at this visit
Code List
Indication which ankle was assessed at this visit
CL Item
Right ankle (1)
CL Item
Left ankle (2)
Item Group
Monitor Data Validation Checks (See Description)
Item Group
Investigational Product (See Description)
Investigational Product
Item
Investigational Product
text
Start Date
Item
Start Date
date
Stop Date
Item
Stop Date
date
IP Container No.
Item
IP Container No.
integer
Total Number of Tablets Dispensed
Item
Total Number of Tablets Dispensed
float
Total Number of Tablets Returned
Item
Total Number of Tablets Returned
float
Discontinuation
Item
Has the subject missed investigational product for > 7 consecutive days?
boolean
C0457454 (UMLS CUI [1])
Item Group
End of visit reminder
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