ID

17742

Descripción

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.

Palabras clave

Versiones (3)
  1. 16/9/16 16/9/16 -
  2. 2/10/16 2/10/16 -
  3. 14/12/16 14/12/16 -
Subido en

2 de octubre de 2016

DOI

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Licencia

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

Inglés

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

1 formularios  
General information
Descripción

General information

Protocol Identifier: AVA100193
Descripción

Protocol Identifier

Tipo de datos

boolean

Subject Identifier
Descripción

Subject Identifier

Tipo de datos

integer

Visit Date
Descripción

Visit Date

Tipo de datos

date

Visit Description: Visit 4
Descripción

Visit Description

Tipo de datos

boolean

Subject Continuation (See Description)
Descripción

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.

Tipo de datos

boolean

Vital signs
Descripción

Vital signs

Weight
Descripción

Weight

Tipo de datos

integer

Unidades de medida
  • kg
kg
Blood pressure: Systolic
Descripción

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

Tipo de datos

integer

Blood pressure: Diastolic
Descripción

Blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
mmHg
Heart rate
Descripción

Heart rate

Tipo de datos

integer

Unidades de medida
  • bpm
bpm
Central Laboratory (Non Fasting Samples)
Descripción

Central Laboratory (Non Fasting Samples)

Date samples taken
Descripción

Date samples taken

Tipo de datos

date

Concomitant Medications
Descripción

Concomitant Medications

Concomitant Medications
Descripción

Concomitant Medications

Tipo de datos

text

Adverse Events
Descripción

Adverse Events

Adverse Events
Descripción

Adverse Events

Tipo de datos

text

Physical Examination
Descripción

Physical Examination

Results from Physical Examination
Descripción

Results from Physical Examination

Tipo de datos

text

Pedal Oedema
Descripción

Pedal Oedema

Depth of Indentation
Descripción

Depth of Indentation

Tipo de datos

text

Indication which ankle was assessed at this visit
Descripción

Indication which ankle was assessed at this visit

Tipo de datos

text

Monitor Data Validation Checks
Descripción

Monitor Data Validation Checks

Results from Monitor Data Validation Checks
Descripción

Results from Monitor Data Validation Checks

Tipo de datos

text

Investigational Product
Descripción

Investigational Product

Investigational Product
Descripción

Investigational Product

Tipo de datos

text

Start Date
Descripción

Start Date

Tipo de datos

date

Stop Date
Descripción

Stop Date

Tipo de datos

date

IP Container No.
Descripción

IP Container No.

Tipo de datos

integer

Total Number of Tablets Dispensed
Descripción

Total Number of Tablets Dispensed

Tipo de datos

float

Total Number of Tablets Returned
Descripción

Total Number of Tablets Returned

Tipo de datos

float

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

Discontinuation

Tipo de datos

boolean

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

End of visit reminder

Next Visit Scheduled
Descripción

Next Visit Scheduled

Tipo de datos

boolean

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Similar models

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

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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