ID

17464

Beskrivning

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.

Nyckelord

Versioner (3)
  1. 2016-09-16 2016-09-16 -
  2. 2016-10-02 2016-10-02 -
  3. 2016-12-14 2016-12-14 -
Uppladdad den

16 september 2016

DOI

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Licens

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

Engelsk

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

1 Formulär  
General information
Beskrivning

General information

Protocol Identifier: AVA100193
Beskrivning

Protocol Identifier

Datatyp

boolean

Subject Identifier
Beskrivning

Subject Identifier

Datatyp

integer

Visit Date
Beskrivning

Visit Date

Datatyp

date

Visit Description: Visit 4
Beskrivning

Visit Description

Datatyp

boolean

Subject Continuation (See Description)
Beskrivning

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.

Datatyp

boolean

Vital signs
Beskrivning

Vital signs

Weight
Beskrivning

Weight

Datatyp

integer

Måttenheter
  • kg
kg
Blood pressure (See Description): Systolic
Beskrivning

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

Datatyp

integer

Blood pressure: Diastolic
Beskrivning

Blood pressure

Datatyp

integer

Måttenheter
  • mmHg
mmHg
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • bpm
bpm
Central Laboratory (Non Fasting Samples)
Beskrivning

Central Laboratory (Non Fasting Samples)

Date samples taken
Beskrivning

Date samples taken

Datatyp

date

Concomitant Medications (See Description)
Beskrivning

Concomitant Medications (See Description)

Adverse Events (See Description)
Beskrivning

Adverse Events (See Description)

Physical Examination (See Description)
Beskrivning

Physical Examination (See Description)

Pedal Oedema (See Description)
Beskrivning

Pedal Oedema (See Description)

Depth of Indentation
Beskrivning

Depth of Indentation

Datatyp

text

Indication which ankle was assessed at this visit
Beskrivning

Indication which ankle was assessed at this visit

Datatyp

text

Monitor Data Validation Checks (See Description)
Beskrivning

Monitor Data Validation Checks (See Description)

Investigational Product (See Description)
Beskrivning

Investigational Product (See Description)

Investigational Product
Beskrivning

Investigational Product

Datatyp

text

Start Date
Beskrivning

Start Date

Datatyp

date

Stop Date
Beskrivning

Stop Date

Datatyp

date

IP Container No.
Beskrivning

IP Container No.

Datatyp

integer

Total Number of Tablets Dispensed
Beskrivning

Total Number of Tablets Dispensed

Datatyp

float

Total Number of Tablets Returned
Beskrivning

Total Number of Tablets Returned

Datatyp

float

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

Discontinuation

Datatyp

boolean

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

End of visit reminder

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Similar models

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

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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