ID

17743

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 3/Visit 3.

Palabras clave

Versiones (3)
  1. 14/9/16 14/9/16 -
  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 3

Inglés

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 3

1 formularios  
General information
Descripción

General information

Subject Identifier
Descripción

Subject Identifier

Tipo de datos

integer

Visit Date
Descripción

Visit Date

Tipo de datos

date

Visit Description: Visit 3
Descripción

Visit Description

Tipo de datos

boolean

Investigator Instructions
Descripción

Telephone the IVRS system to register the visit. (Note that if the subject is not continuing in the study, you should make a withdrawal call rather that a Visit Registration call).

Tipo de datos

boolean

Subject Continuation
Descripción

If the subject is not continuing in the study, complete all assessments and ensure that all sections of the CRF (including the Study Conclusion section) are completely appropriately. Schedule an early withdrawal follow-up visit for 14 +/- 7 days after this visit.

Tipo de datos

boolean

Vital Signs
Descripción

Vital Signs

Weight
Descripción

Weight

Tipo de datos

float

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
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

Indicate which ankle was assessed at this visit
Descripción

Ankle

Tipo de datos

text

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 3

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
General information
Subject Identifier
Item
Subject Identifier
integer
Visit Date
Item
Visit Date
date
Visit Description
Item
Visit Description: Visit 3
boolean
Investigator Instructions
Item
Investigator Instructions
boolean
Subject Continuation
Item
Subject Continuation
boolean
Item Group
Vital Signs
Weight
Item
Weight
float
Blood pressure
Item
Blood pressure: Systolic
integer
Blood pressure
Item
Blood pressure: Diastolic
integer
Heart Rate
Item
Heart Rate
integer
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
Indicate which ankle was assessed at this visit
text
Ankle
Code List
Indicate which ankle was assessed at this visit
CL Item
Right Ankle (1)
CL Item
Left Ankle (2)
Item Group
End of visit reminder
Next Visit Scheduled
Item
Next Visit Scheduled
boolean
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