ID

17464

Beschreibung

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.

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Versionen (3)
  1. 16.09.16 16.09.16 -
  2. 02.10.16 02.10.16 -
  3. 14.12.16 14.12.16 -
Hochgeladen am

16. September 2016

DOI

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

Englisch

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

1 Formulare  
General information
Beschreibung

General information

Protocol Identifier: AVA100193
Beschreibung

Protocol Identifier

Datentyp

boolean

Subject Identifier
Beschreibung

Subject Identifier

Datentyp

integer

Visit Date
Beschreibung

Visit Date

Datentyp

date

Visit Description: Visit 4
Beschreibung

Visit Description

Datentyp

boolean

Subject Continuation (See Description)
Beschreibung

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.

Datentyp

boolean

Vital signs
Beschreibung

Vital signs

Weight
Beschreibung

Weight

Datentyp

integer

Maßeinheiten
  • kg
kg
Blood pressure (See Description): Systolic
Beschreibung

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

Datentyp

integer

Blood pressure: Diastolic
Beschreibung

Blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
mmHg
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • bpm
bpm
Central Laboratory (Non Fasting Samples)
Beschreibung

Central Laboratory (Non Fasting Samples)

Date samples taken
Beschreibung

Date samples taken

Datentyp

date

Concomitant Medications (See Description)
Beschreibung

Concomitant Medications (See Description)

Adverse Events (See Description)
Beschreibung

Adverse Events (See Description)

Physical Examination (See Description)
Beschreibung

Physical Examination (See Description)

Pedal Oedema (See Description)
Beschreibung

Pedal Oedema (See Description)

Depth of Indentation
Beschreibung

Depth of Indentation

Datentyp

text

Indication which ankle was assessed at this visit
Beschreibung

Indication which ankle was assessed at this visit

Datentyp

text

Monitor Data Validation Checks (See Description)
Beschreibung

Monitor Data Validation Checks (See Description)

Investigational Product (See Description)
Beschreibung

Investigational Product (See Description)

Investigational Product
Beschreibung

Investigational Product

Datentyp

text

Start Date
Beschreibung

Start Date

Datentyp

date

Stop Date
Beschreibung

Stop Date

Datentyp

date

IP Container No.
Beschreibung

IP Container No.

Datentyp

integer

Total Number of Tablets Dispensed
Beschreibung

Total Number of Tablets Dispensed

Datentyp

float

Total Number of Tablets Returned
Beschreibung

Total Number of Tablets Returned

Datentyp

float

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

Discontinuation

Datentyp

boolean

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

End of visit reminder

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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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