ID

17742

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 -
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2 oktober 2016

DOI

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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: 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
Beskrivning

Concomitant Medications

Concomitant Medications
Beskrivning

Concomitant Medications

Datatyp

text

Adverse Events
Beskrivning

Adverse Events

Adverse Events
Beskrivning

Adverse Events

Datatyp

text

Physical Examination
Beskrivning

Physical Examination

Results from Physical Examination
Beskrivning

Results from Physical Examination

Datatyp

text

Pedal Oedema
Beskrivning

Pedal Oedema

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
Beskrivning

Monitor Data Validation Checks

Results from Monitor Data Validation Checks
Beskrivning

Results from Monitor Data Validation Checks

Datatyp

text

Investigational Product
Beskrivning

Investigational Product

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

Next Visit Scheduled
Beskrivning

Next Visit Scheduled

Datatyp

boolean

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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
Item
Blood pressure: 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
Concomitant Medications
Item
Concomitant Medications
text
Item Group
Adverse Events
Adverse Events
Item
Adverse Events
text
Item Group
Physical Examination
Results from Physical Examination
Item
Results from Physical Examination
text
Item Group
Pedal Oedema
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
Results from Monitor Data Validation Checks
Item
Results from Monitor Data Validation Checks
text
Item Group
Investigational Product
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
Next Visit Scheduled
Item
Next Visit Scheduled
boolean
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